79C3C34C52B45572883A05D425EB0F82

Conflict of Interest in Biomedical Research (2014)

http://www.bioethics.gr/images/pdf/EKDOSEIS/OPINIONS_AND_REPORTS_2008-2013_EN.pdf

http://leaux.net/URLS/ConvertAPI Text Files/B172FEFBE93EBF9258864003A84264A0.en.txt

Examining the file media/Synopses/B172FEFBE93EBF9258864003A84264A0.html:

This file was generated: 2020-12-01 05:53:39

Indicators in focus are typically shown highlighted in yellow;

Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink;

"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green;

Trigger Words/Phrases are shown highlighted in gray.

Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	Criminal Convictions	felon	1
Political	Criminal Convictions	prisoners	1
Political	Illegal Activity	crime	1
Political	Illegal Activity	illegal	5
Political	Indigenous	native	1
Political	criminal	criminal	7
Political	immigrants	immigrants	5
Political	political affiliation	party	11
Political	political affiliation	political	10
Political	stateless persons	nation	2
Political	vulnerable	vulnerable	12
Political	vulnerable	vulnerability	1
Health	Cognitive Impairment	cognitive	71
Health	Cognitive Impairment	impairment	1
Health	Drug Dependence	dependence	1
Health	Drug Usage	drug	49
Health	Drug Usage	influence	8
Health	Drug Usage	substance	10
Health	Drug Usage	usage	1
Health	HIV/AIDS	HIV	11
Health	HIV/AIDS	hiv/aids	0
Health	Healthy People	healthy volunteers	1
Health	Healthy People	volunteers	9
Health	Mentally Disabled	mentally	1
Health	Mentally Disabled	disability	2
Health	Mentally Incapacitated	incapable	5
Health	Motherhood/Family	family	31
Health	Physically Disabled	illness	4
Health	Physically Disabled	physically	3
Health	Physically Ill	sick	4
Health	Unconscious People	unconscious	1
Health	hospitalized patients	hospitalized	4
Health	hospitalized patients	hospitalizedXpatients	1
Health	ill	ill	2
Health	patients in emergency situations	emergencies	3
Health	stem cells	stem cells	3
Health	substance use	substance use	2
Health	visual impairment	blind	4
Social	Access to Social Goods	necessities	1
Social	Access to Social Goods	social welfare	1
Social	Access to Social Goods	access	37
Social	Access to information	access to information	2
Social	Age	age	28
Social	Child	child	10
Social	Child	children	23
Social	Elderly	elderly	2
Social	Ethnicity	ethnic	3
Social	Ethnicity	ethnicity	2
Social	Fetus/Neonate	fetus	1
Social	Fetus/Neonate	foetus	1
Social	Incarcerated	restricted	8
Social	LGBTQ+ Status	gender identity	2
Social	Linguistic Proficiency	language	1
Social	Marital Status	single	18
Social	Occupation	occupation	4
Social	Police Officer	police	3
Social	Presence of Coercion	coerced	1
Social	Property Ownership	home	1
Social	Property Ownership	property	1
Social	Racial Minority	minority	1
Social	Racial Minority	race	2
Social	Racial Minority	racial	5
Social	Religion	belief	2
Social	Religion	religion	3
Social	Religion	religious	1
Social	Soldier	armedXforces	1
Social	Soldier	military	12
Social	Soldier	soldier	1
Social	Student	student	3
Social	Threat of Stigma	stigma	10
Social	Threat of Stigma	threat	6
Social	Threat of Stigma	stigmatization	8
Social	Threat of Stigma	stigmatized	1
Social	Trade Union Membership	union	11
Social	Victim of Abuse	trauma	1
Social	Victim of Abuse	victim	1
Social	Victim of Abuse	abuse	2
Social	Women	women	11
Social	Youth/Minors	minor	5
Social	Youth/Minors	youth	3
Social	education	education	42
Social	education	educational	6
Social	embryo	embryo	3
Social	employees	employees	2
Social	gender	gender	27
Social	genetic heritage	genetic heritage	1
Social	orphan	orphan	1
Social	parents	parent	1
Social	parents	parents	12
Social	philosophical differences/differences of opinion	opinion	102
Social	philosophical differences/differences of opinion	philosophy	24
Economic	Economic/Poverty	poor	5
General/Other	Dependent	dependent	1
General/Other	Developing Country	third world	2
General/Other	Impaired Autonomy	autonomy	119
General/Other	Incapacitated	incapacitated	1
General/Other	Incapacitated	incapacity	5
General/Other	Manipulable	manipulate	1
General/Other	Manipulable	manipulated	2
General/Other	Public Emergency	emergency	16
General/Other	Relationship to Authority	authority	10
General/Other	cioms guidelines	cioms	6
General/Other	cultural difference	cultural difference	1
General/Other	declaration of helsinki	helsinki	1
General/Other	oviedo	oviedo	20
General/Other	participants in a control group	placebo	4

Political / Criminal Convictions

Searching for indicator felon:

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p.000223: fundamental right to person- ality development encompasses, undoubtedly, a person’s control over his/her
p.000223: external appearance. However, that does not mean that plastic sur- gery escapes from the principles and rules of law
p.000223: and medical ethics.
p.000223:
p.000223:
p.000223:
p.000223:
p.000223:
p.000224: 224
p.000224:
p.000224: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000224: OPINION
p.000224:
p.000224: 2. Altering facial features and identity confusion
p.000224:
p.000224: A person’s desire to change his/her facial features in order to cause identity confusion is a borderline
p.000224: case of self-determination, which may af- fect the public interest (e.g. in order to avoid legal prosecution). In this
p.000224: case, the Commission believes that certain restrictions on a person’s autonomy are justifiable.
p.000224: Consequently, the Commission considers that there is an issue regarding the physician’s rights and obligations. In this
p.000224: case, the physician has a duty to review the relative desire of the person interested. Under particular con- ditions,
p.000224: this review justifies that the physician may refuse to carry out a pro- cedure, however, without setting general and
p.000224: abstract rules. Ιn this case, it is required to assess each case separately. However, it is not the physician’s duty to
p.000224: report the incident to the law enforcement authorities, apart from exceptional cases in which, as the law provides, the
p.000224: offense of harboring a felon or crime concealment is constituted.
p.000224:
p.000224: 3. Plastic surgery and gender specific features
p.000224:
p.000224: In cases of altering gender specific features or even gender reassign- ment, plastic surgery is part of the
p.000224: therapy used. Hermaphroditism and gen- der identity disorder fall within these cases.
p.000224: Regardless of the aetiology of a person’s mental and physical condition, which may be due to neurodevelopmental or
p.000224: genetic causes, the Commis- sion considers that such kind of procedures are essentially reconstructive and
p.000224: therapeutic, since they aim to match the psychosomatic disposition of a person with gender specific features.
p.000224: In this case, the ethical principles and rules of law, as outlined in a previ- ous Opinion of the Commission ("Consent
p.000224: in the patient-physician relation- ship," 2010) are entirely valid. The authentic will of the person him/herself is the
p.000224: determining factor here, in view of the right of personality. However, since there is a particularly
p.000224: sensitive issue of autonomy, it is right to allow for a period of time between the initial decision and the plastic
p.000224: surgery pro- cedure, during which the person concerned receives psychological and med- ical counseling.
p.000224:
p.000224:
p.000224:
p.000225: 225
p.000225:
...

Searching for indicator prisoners:

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p.000104: repeated meetings. The issue arises in regard to all medical acts either preventive or therapeutic. Fur-
p.000104: thermore, it lies at the heart of a contemporary reflection in bioethics as the model of the so-called “paternalistic”
p.000104: medicine tends to be replaced world- wide by the model of “informed consent”.
p.000104: Having considered the modified approach to the relationship patient- physician brought about by this change and
p.000104: conscious of the wide scope of autonomy, the Commission thought it appropriate to highlight a number of typical
p.000104: problems and suggest solutions to address them.
p.000104:
p.000104: I. In general
p.000104:
p.000104: A. Paternalism and autonomy in medicine
p.000104:
p.000104: The ethics governing the relationship patient-physician has been going through a change of model since the
p.000104: second half of the XX Century. Histori- cally, this relationship was defined by the dominant position of the physician
p.000104: as the only one responsible to appraise the situation and to decide on the course of treatment. Patients were merely
p.000104: able to select the treating physi- cian; as for the rest, they had to rely on the latter’s knowledge and
p.000104: skills without any say in therapy. This absolute dominion of physicians did not imply any form of
p.000104: arbitrariness on their part since they pledged themselves through the Hippocratic Oath to act in the best interests of
p.000104: patients.
p.000104: Following the end of World War II -and spurred by the dismal experience of the experiments performed on the prisoners
p.000104: of the Nazi regime among others- this model of medical “self-commitment” was seriously questioned. It was realized
p.000104: that self-commitment on the part of physicians does not en- sure the protection of patients. It became obvious that the
p.000104: participation of patients themselves in the course of treatment as active agents at all stages is the best safeguard
p.000104: for their well-being.
p.000104:
p.000104:
p.000105: 105
p.000105:
p.000105: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000105: OPINION
p.000105:
p.000105: But first and foremost, the development of medicine itself has made the active involvement of patients a practical
p.000105: necessity in view of the fragmen- tation in the provision of health services brought about by increasing medi- cal
p.000105: specialization and the broad introduction of new technologies that mul- tiply possible alternative treatments.
p.000105: It is almost certain that no treatment is free of adverse effects. There- fore, the classical principle of “doing
p.000105: good or not doing harm” is no longer sufficient to determine treatment. Patients need to be involved to
p.000105: deter- mine the treatment whose likely adverse effects are more acceptable to them. Especially in our
p.000105: country, the need for this involvement becomes all the more urgent due to the absence, until now, of a single
p.000105: registration sys- tem to record the complete history of patients which deprives physicians from unmediated
p.000105: access to consistent and reliable data.
...

Political / Illegal Activity

Searching for indicator crime:

Searching for indicator illegal:

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p.000141: Limits to the general autonomy of patients -especially the freedom of movement and establishment- are
p.000141: justified only if they are absolutely in- dispensable to protect public health pursuant to the Constitution
p.000141: (arts. 5 [4], 25 [1]). The principle of proportionality as discussed above applies in all circumstances. For
p.000141: example, hospitalized patients should be restricted in specially contained facilities.
p.000141:
p.000141: b) The risk of social stigma
p.000141: The Commission stresses the risk of social stigma that may arise from the isolation (“ghetto-ing”) of specific
p.000141: sub-populations with distinctive cultural characteristics or ways of living when an infectious disease erupts
p.000141: within such groups.
p.000141:
p.000141:
p.000141:
p.000141:
p.000142: 142
p.000142:
p.000142: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000142: OPINION
p.000142:
p.000142: Such cases must be dealt with by personalized medical care and social welfare measures especially as
p.000142: regards the improvement of hygiene in their living conditions.
p.000142:
p.000142: c) Illegal immigrants
p.000142: In case of manifestation of infectious disease or in cases when preven- tive measures (e.g. vaccination) need to
p.000142: be applied on illegal immigrants, the government must ensure that immigrants would be addressed to the
p.000142: health services. The access of immigrants to health services should be un- hindered and independent on their
p.000142: immigration status; otherwise the risks for public health in general will be multiplied.
p.000142:
p.000142: d) HIV/AIDS
p.000142: This particular disease presents a set of peculiar problems. Even though the spread of the virus is in general
p.000142: relatively difficult, the disease is very severe despite progress in treatment in the recent years. Moreover, social
p.000142: perceptions -especially regarding high risk vulnerable groups- remain ex- tremely negative in our country. The
p.000142: following call for attention:
p.000142: The autonomy of HIV seropositives or HIV patients can be restricted in view of public health protection only if the
p.000142: particular setting of social con- tact is prone to the transmission of the disease. Thus, although mandatory testing
p.000142: for seropositivity is not justified in the absence of qualifying circum- stances, it can be legitimate for certain
p.000142: occupations like physicians or nurs- es or for participation in certain social activities such as sports. In
...

p.000148: ly, the stigma against population groups on public health grounds has been a recurring phenomenon, from the
p.000148: persecutions and massacres of Jews dur- ing the times of “Black Death” in the Dark Ages (the plague pandemic), to the
p.000148: persecution of beggars on the same grounds in the XIX century or of prostitutes for spreading syphilis in
p.000148: World War I, to contemporary practices of discrimination against AIDS patients. In our country, stigmatization phe-
p.000148: nomena occurred in the past in the cases of leprosy and tuberculosis.
p.000148: These facts demonstrate that public health is not to be considered only as a medical problem, but involves a serious
p.000148: social and political dimension. The latter must be taken into account when adopting restrictions to general autonomy.
p.000148: Such restrictions are not justified unless accompanied by social measures aimed at minimizing the likelihood of
p.000148: transmission (e.g. housing, food, etc. for the poor or disadvantaged groups of the population) and by steps ensuring
p.000148: fair treatment (not distinguishing, for example, between prostitutes and their clients regarding the risk
p.000148: of transmission of venereal diseases).
p.000148: The current wave of immigration carries great potential of stigma on public health grounds. The fact
p.000148: that the country of origin -particularly of illegal immigrants- is often afflicted by a high prevalence
p.000148: of infectious dis- eases (especially sub-Saharan Africa and southern Asia), while local health services
p.000148: remain rudimentary, represents a real cause of concern for the spreading of these diseases in the
p.000148: hosting countries. However, stigmatiza- tion practices -unfair treatment, “ghettos” etc.- stem rather from the idea
p.000148: of “miasma” due to lack of information or misinformation about the medical- biological particulars of disease,
p.000148: especially infectivity. Hansen’s disease (lep- rosy) and, more recently, HIV/AIDS confirm this observation
p.000148: since these
p.000148:
p.000148:
p.000149: 149
p.000149:
p.000149: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000149: REPORT
p.000149:
p.000149: population groups are stigmatized, although the disease is relatively difficult to contract.
p.000149: In case of Hansen’s disease, the exact path of transmission is still un- known, but it is accepted
p.000149: that although it can be contracted through pro- longed social contact, approximately 95% of the population are
p.000149: immune to it, though the mechanisms of immunity have not been identified. Perhaps it was this last parameter in
p.000149: combination with the deformity caused by the disease that has led to social stigma against these patients in the
p.000149: past.
p.000149: In case of HIV/AIDS, the path of transmission is known and involves ex- posure to body fluids through sexual
...

p.000199: as Huntington’s disease. Even in the case where an expert decides that such a test is necessary for the parent(s),
p.000199: the same genetic test must be delayed for the child until he/she is able to participate in the decision
p.000199: making process, since there is no direct value to his/her health. On the contrary, DTC genetic testing is
p.000199: ac- ceptable in cases of children with first or second degree relatives with a monogenic disorder,
p.000199: showing a clear mode of inheritance e.g. familial hy- percholesterolemia. Nonetheless, such genetic tests must
p.000199: be allowed only in the case that the results will be used for early treatment and/or prevention of the complications
p.000199: caused by the disease.
p.000199:
p.000199:
p.000199:
p.000199:
p.000200: 200
p.000200:
p.000200: DIRECT-TO-CONSUMER GENETIC TESTING
p.000200: OPINION
p.000200:
p.000200: C. The promotion campaigns of DTC genetic testing must be governed by the same rules as in the case of health services,
p.000200: i.e. to be based on precise information and the true prognostic or diagnostic value of the test.
p.000200: Misleading advertising of the alleged “prediction” of serious diseases or other phenotypes, overlook the role of other
p.000200: genetic factors which are not determined yet or the critical role of environmental factors, and lead to ge- netic
p.000200: determinism.
p.000200: D. DTC genetic tests that determine a person’s identity without his/her consent is in principle illegal, since they
p.000200: directly offend the right to privacy.
p.000200: E. In any case, providers of DTC genetic services (especially via the inter- net) need to ensure high protection of
p.000200: the personal data that they collect and process. The Data Protection Authority must control the way that such data are
p.000200: managed by the genetic service providers.
p.000200: F. Finally, the development of this commercial activity imposes yet more the need to adopt a specific legislation for
p.000200: the management of genetic in- formation and its potential use for research purposes, a need that is repeat- edly noted
p.000200: by the Commission in previous Opinions. This specific legislation must particularly include:
p.000200: a) Recognition of the specialty or specialization of “Medical Genetics” in Greece (according to the 2/204
p.000200: 21.9.2006 decision of the Central Council of Health.
p.000200: b) Establishment of a previous state license for the operation of genetic centers, where the genetic tests are
p.000200: performed according to valid cri- teria for quality certification.
p.000200: c) Requirement of a regulation governing the above mentioned centers, which will include specific warranties to
p.000200: correctly inform the con- sumers, especially concerning advertising of genetic services, accord- ing to the
p.000200: paragraph C.
p.000200: d) The potential use of the biologic materials or genetic information for research purposes, on the condition
p.000200: that they are anonymized or that the subject has given consent.
p.000200:
p.000200:
p.000200: Athens, 30 March 2012
p.000200:
p.000200:
p.000200:
p.000201: 201
p.000201:
...

p.000283: Directive 90/385, incorporated by JMD DY8d/GP. Oik.130644/2.10.2009) and the Regulation 726/2004, regarding
p.000283: the centralized authorization procedure of substances at the EU level (STOA, 136) also apply here.
p.000283: In a more specific level, the use of the above mentioned substances or implants is subjected to the provisions of Law
p.000283: 3418/2005 (Code of Medical Ethics), regarding the responsibility of the physician who gives the
p.000283: prescription. There is no doubt that the physician performs a medical act, which is covered by the
p.000283: provisions of CME (equivalent to aesthetic surgery), although enhancement is not explicitly mentioned in
p.000283: the legislative definition of “medical act”.
p.000283: In addition, the legislation on the liability of physicians, pharmacists and
p.000283:
p.000283:
p.000284: 284
p.000284:
p.000284: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000284: REPORT
p.000284:
p.000284: traders, which is controlled by the National Organization for Medicines (Directive 2001/1983, as
p.000284: incorporated by DYG 3a/83657/24.1.2006, Law 1316/83, as in force, Decree 96/1973, as in force) also apply here,
p.000284: according to what is already mentioned in the Report on “Human enhancement - Physical Characteristics”.
p.000284: In particular, the case of Ritalin falls under the drug law (Law 1729/1987, as in force), and therefore, it is only
p.000284: allowed to prescribe it for therapeutic purposes, which means that its use for enhancement purposes is illegal in
p.000284: our country, as in other countries (e.g. USA).
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
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p.000284:
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p.000284:
p.000284:
p.000285: 285
p.000285:
p.000285: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000285: REPORT
p.000285:
p.000285: SUGGESTED LITERATURE
p.000285:
p.000285: Ahmadian P, Cagnoni S, Ascari L (2013). How capable is non-invasive EEG data of predicting the next
p.000285: movement? A mini review. Front Hum Neurosci 8, 124.
p.000285: Andersen R (2012). Why cognitive enhancement is in your future (and your past). The Atlantic.
p.000285: Bostrom N, Sandberg A (2009). Cognitive enhancement: Methods, ethics, regulatory challenges. Sci Eng Ethics 15,
p.000285: 311-41.
p.000285: Cakic V (2009). Smart drugs for cognitive enhancement: Ethical and pragmatic considerations in the
p.000285: era of cosmetic neurology. J Med Ethics 35, 611-615.
p.000285: de Jongh R, Bolt I, Schermer M, Olivier B (2008). Botox for the brain: En- hancement of cognition, mood
p.000285: and pro-social behavior and blunting of un- wanted memories. Neurosci Biobehav Rev, 32, 760-76.
...

Political / Indigenous

Searching for indicator native:

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p.000080: Infrastructure for Biodiversity Data and Observato- ries”.
p.000080:
p.000080: SECOND CHAPTER
p.000080:
p.000080: THE ETHICAL-SOCIAL DIMENSION
p.000080:
p.000080: In our culture, the management of biological wealth is mainly associated with three factors that set the ethical-social
p.000080: context for the relevant discus- sion: sustainable development, the value of biodiversity and the “rights of future
p.000080: generations”. These considerations can be interconnected in many ways as will be shown below.
p.000080:
p.000080: Sustainable development
p.000080:
p.000080: The term was coined in the ’80s and denotes the use of natural re- sources in a way that the satisfaction
p.000080: of human needs in the future remains constantly possible. Put in different words, sustainable development meets our
p.000080: present needs without compromising the needs of future generations3.
p.000080:
p.000080:
p.000080: 1 A table of the NATURA habitats is available at the website of the network of re- searchers of
p.000080: environmental management: http://natura.minenv.gr/natura/server/user/biotopoi_list.asp?Ing=GR.
p.000080: 2 OJ 1289B.
p.000080: 3 The term was established by the report of the World Committee for the Environ- ment and Development
p.000080: (Brundtland Report, 1987).
p.000080:
p.000081: 81
p.000081:
p.000081: MANAGEMENT OF BIOLOGICAL WEALTH
p.000081: REPORT
p.000081:
p.000081: Environmental sustainability is considered as part of sustainable devel- opment. The economic, socio-political
p.000081: and cultural sustainability (especially in regard to the preservation of native populations) are also crucial aspects
p.000081: to be taken into consideration in an arduous task of balancing conflicting demands and interests.
p.000081: Environmental sustainability, in particular, is often associated with the term “green development” which
p.000081: assigns priority to the protection of the natural environment. This can potentially come in conflict with
p.000081: the other aspects of sustainability, especially the economic one, for instance, when there is a demand to
p.000081: preserve certain natural species at all costs in countries without sufficient financial resources. Seen in a different
p.000081: light, though, the demand to combine different aspects of biodiversity creates new needs and, with that, new
p.000081: opportunities for unprecedented economic “post-industrial” initiatives with the use of information technologies4.
p.000081: Nowadays, the ubiquitous use of the term “sustainable development” and its association by the UN with a
p.000081: plethora of sectors and initiatives ex- plains the criticism that, in actual fact, the term is of little explanatory
p.000081: value, despite efforts to create systems of quantitative measurement of “sustaina- bility” with various indicators.
p.000081: This problem aside, sustainable development as an ethical-social de- mand raises questions on many levels.
p.000081: The first general question is whether it corresponds to some overarching value that would justify such a vast
p.000081: reorientation of socioeconomic activi- ties. The prevailing answer seems to be that such a value may consist in en-
p.000081: suring the survival of the human species in the future, hence some degree of responsibility to future generations.
...

Political / criminal

Searching for indicator criminal:

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p.000117: should be taken into account, and how. It is worth noting that both the CME (art. 2[2]) and the Oviedo
p.000117: Convention (art.
p.000117: 9) stipulate so though failing to specify the ensuing legal effects (see below). Finally, there is a wider issue with
p.000117: the consent of minors. The law totally precludes it (art. 12 [2] [b] CME) even when minors are obviously
p.000117: able to exercise control over their health given that other provisions recognize their capacity to enter into
p.000117: legal relationships (e.g. to marry). At issue here is whether the scope of this provision should be
p.000117: interpreted stricto sensu to apply only when the intellectual immaturity of the minor obviously justifies that the
p.000117: consent be given by his/her parents or custodian in order to har- monize this rule with the constitutional protection
p.000117: of personality (Constitu-
p.000117: tion, art. 5 [1]).
p.000117:
p.000117:
p.000118: 118
p.000118:
p.000118: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000118: REPORT
p.000118:
p.000118: c) Medical liability and other legal consequences
p.000118:
p.000118: In legal terms, the answers to all the above questions have an impact, first and foremost, on the extent of
p.000118: medical liability (criminal, civil and pro- fessional). Liability, in this case, is not connected with fault in the
p.000118: execution of a medical act (which is judged according to lege artis execution) but with fault at the stage preceding
p.000118: the act, i.e. during the legal procedure of deci- sion-making7.
p.000118: Thus the implementation of the Oviedo Convention and the CME provi- sions on “informed consent” (and of the provisions
p.000118: of special legislation on transplants, assisted reproduction, etc.) complement the general legislation on medical
p.000118: liability (e.g. arts. 57, 914 CC, art. 8 Law 2251/1994) and may provide grounds for particular claims in
p.000118: action8.
p.000118: Secondly, the answers may have an impact on the legal situation of third parties (hospitals, relatives) insofar as
p.000118: compliance with the principle of con- sent is associated with individual rights and obligations pertaining to them.
p.000118:
p.000118: C. SPECIAL PROBLEMS IN THE IMPLEMENTATION OF AUTONOMY WITH EMPHASIS ON THE GREEK SITUATION
p.000118:
p.000118: The model of patient consent is based on the assumption of appropriate education on personal autonomy, on the one hand,
p.000118: and on the allocation of relatively adequate time for a sober evaluation of information, on the other. These
p.000118: assumptions rarely permit the application of the model in its pure form. As a matter of fact, special
p.000118: circumstances call for adjustments. There- fore, certain areas of medical practice must be considered separately.
p.000118:
p.000118:
p.000118:
p.000118:
...

p.000152: issued by WHO. These guidelines are not legally binding, of course, but non-compliance can lead to other types of
p.000152: sanctions (e.g. WHO travel alerts). Considering that international move- ments, immigration flows and trade
p.000152: have become easier with globalization and with the recent experiences of wide-spreading transmissible diseases in mind,
p.000152: proposals are under discussion with a view to developing internation- al instruments in this field.
p.000152:
p.000152: 2. Greek law
p.000152:
p.000152: The protection of the population from the transmission of contagious diseases is governed by arts. 21
p.000152: (3) and 5 (4) of the Constitution and art. 5(1)(e) of the European Convention of Human Rights (ECHR)1.
p.000152: Under art. 21 (3), the Constitution recognizes health as a social right in addition to its recognition as an individual
p.000152: right2. Thus, a distinction is drawn between the right of the individual citizen to take care of matters pertaining to
p.000152: personal health and public health care for all. In this sense, the social en- titlement to health can be taken as
p.000152: a basis for adopting health protection measures (organizing vaccination programmes, blood donations, etc.).
p.000152:
p.000152: 1Article 5 (4) of the Constitution: “Individual administrative measures restricting the free movement or residency in
p.000152: the national territory or the free entry into or exit from it to any Greek citizen shall be prohibited. Such
p.000152: restrictive measures may be imposed only as ancillary sanctions by criminal court ruling in exceptional emergency
p.000152: circum- stances exclusively for the prevention of indictable offences as specified by Law”.
p.000152: Interpretation clause:
p.000152: Paragraph 4 does not preclude the prohibition to leave the country by order of public prosecutor due to criminal
p.000152: proceedings or measures imposed on grounds of public health protection or the protection of patients as
p.000152: specified by Law”.
p.000152: Article 21 (3) of the Constitution: “The State shall care for the health of citizens and shall adopt specific measures
p.000152: to protect youth, old age, disability and health care for indigents”.
p.000152: 2 Article 5 (5) of the Constitution: “Everyone is entitled to the protection of their health and genetic
p.000152: identity…”.
p.000152:
p.000153: 153
p.000153:
p.000153: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000153: REPORT
p.000153:
p.000153: However, both the Constitution and the ECHR acknowledge the need of re- strictive measures to protect public health.
p.000153: Thus, the art. 5(4) of the Constitution (interpretation statement) excep- tionally accepts individual administrative
p.000153: measures “on grounds of public health protection or the protection of patients as specified by Law”. It is im-
p.000153: portant to stress that such measures amount to extensive inroads into indi- vidual freedom -prohibiting “the free
p.000153: movement and residency in the na- tional territory or the entry into and exit from it”- and can be decided by any
...

p.000184: public funding for bi- omedical research- to satisfy similar needs, with fair criteria.
p.000184:
p.000184: 9. The law
p.000184:
p.000184: Accordingly to the above data, it is important at this point to examine the involvement of law in the
p.000184: argumentation concerning conflict of interest. The law is particularly concerned, primarily, with the issue of
p.000184: responsibil-
p.000184: ity of the physician/researcher on one hand and the financier on the other hand. Preliminarily, however, we must define
p.000184: the constitutional context, in which the matter of liability lies, especially in the field of medical research.
p.000184:
p.000184: a. The Constitutional context
p.000184: There are mainly three provisions of interest in the Constitution: art. 16 par.1 which regulates freedom of
p.000184: research (and equates with the unob- structed pursuit of truth by any scientist), art. 5 par. 1 which
p.000184: regulates fi- nancial freedom under the reservation that the “Constitution”, “the rights of others” and “public
p.000184: morals” are respected (and equates with the pursuit of financial profit by the sponsor of a trial) and moreover, art.
p.000184: 21 par. 3 which regulates health as a social right under the state’s care.
p.000184: This last provision is crucial in resolving a conflict between the previous two, a conflict of interest in clinical
p.000184: research.
p.000184:
p.000184:
p.000184:
p.000184:
p.000184:
p.000185: 185
p.000185:
p.000185: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000185: REPORT
p.000185:
p.000185: b. The physician’s/researcher’s liability
p.000185: From a legal point of view, the liability of the physician as a researcher is defined both by the general provisions
p.000185: of criminal and civil law (especially those concerning contract and torts) and by the special provisions concern- ing
p.000185: “scientific research” in the 7th (Z΄) chapter (art. 24-27) of the Medical Code of Ethics (Law 3418/2005).
p.000185: In these special provisions, apart from obli- gations concerning the planning of a clinical trial (also found in texts
p.000185: such as the Oviedo Convention or the 2001/20/EU Directive, as in force in our coun- try), other special obligations of
p.000185: the physicians/researchers are regulated:
p.000185: - Publishing the results of a trial to the medical community by priority, so that they can be subjected to scientific
p.000185: critique and,
p.000185: - revealing the sponsor of the trial.
p.000185: Law 3418/2005 completes the above with the general provision of art. 6 par. 4, which forbids the physician “to serve,
p.000185: depend on or be a part of busi- nesses which manufacture or merchandise drugs”.
p.000185: In the context of the EU Directive 2001/20, the National Committee of Ethics for Clinical Trials -among
p.000185: others- takes the researcher’s “adequacy” into account (art. 6 par. 3e Medical Directorate 3/89292/2003), along
p.000185: with the “guidelines for good medical practice”, as must be followed in that spe- cific facility and by those
p.000185: specific researchers (art. 6 par. 4 Medical Direc- torate 3a/79602/2007)40.
p.000185: These provisions result in a commitment of the physician/researcher to the medical society. This commitment, however,
p.000185: is not connected to medi- cal liability towards the patient taking part in a clinical research, i.e. it can- not be
p.000185: converted to criminal or civil liability of the physician during the rele- vant medical actions41.
p.000185: However, liability towards the patient can arise from other provisions that concern planning of a clinical
p.000185: study, in our case, provided that they are ignored e.g. for reasons of “accelerating” the process, in order to come up
p.000185: directly with commercially exploitable results. Thus, if there is pressure to
p.000185:
p.000185:
p.000185: 40 It is worth mentioning that explicit reference in the issue of conflict of interests is made by our legislation
p.000185: concerning the inspectors of clinical studies (art. 21 par. 7 Medical Directorate 3a/79602/2007), as well as
p.000185: the members of the National Ethics Committee (art. 3 Medical Directorate 3a69150/2004).
p.000185: 41 It is, on the other hand, connected to the physician’s disciplinary liability.
p.000185:
p.000186: 186
p.000186:
p.000186: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000186: REPORT
p.000186:
p.000186: deviate from the terms of a patient’s valid consent, the doctor’s relevant liability arises (criminal
p.000186: -depending on the case-, civil and disciplinary).
p.000186: In conclusion, the current legislation “shields” the physician’s
p.000186: /researcher’s scientific independence with liability provisions, in the sense that they can be raised
p.000186: against possible pressure from the sponsor’s part. Vice versa, the law does not justify a physician’s own
p.000186: spontaneous disregard of the rules of science and ethics in favor of financial purposes, when the later
p.000186: can result in harming the patient’s interests. In this case, there is medi- cal error, an intentional one, either due
p.000186: to a poor choice or practice of the medical action in question (according to rules of science) or due to a defi- ance
p.000186: of some rule of ethics (e.g. providing information to the patient).
p.000186:
p.000186: c. The sponsor’s liability
p.000186: Another interesting side for legislation is the liability of the sponsor, as a commercial enterprise. The general
p.000186: context is defined by the legislation concerning the liability of providers of goods and services and the consum-
p.000186: ers’ protection42.
p.000186: Based on the relevant regulations, a business trading new products in the market -as for example a
p.000186: pharmaceutical industry launching a new pharmaceutical product- is responsible for the product’s quality (i.e.
p.000186: wheth- er it responds to the need it is meant to satisfy), as well as for informing the consumer (in this case, the
p.000186: patients) adequately about the efficacy (in this case, the therapeutic factors) and the safety (in this case, the
...

p.000246: or even irreversible. Although they are not considered as illegitimate (as in the case of advertising
p.000246: therapeutic agents to the general public), these advertisements must be under tighter ethical review
p.000246: regarding the accuracy of the messages and the methods of conveyance.
p.000246:
p.000246:
p.000246:
p.000246:
p.000247: 247
p.000247:
p.000247: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000247: REPORT
p.000247:
p.000247: 4. The law
p.000247:
p.000247: According to the definition described in Law 3418/2005 (CME) art. 1, only plastic surgeries that complete
p.000247: a treatment (and therefore do not constitute “enhancement”) fall within the relevant regulations.
p.000247: On the other hand, art. 11 par. 3 CME (on the obligation to inform the patient), explicitly includes “aesthetic or
p.000247: cosmetic surgeries” in the “special surgeries”, for which intensification of attention is required during the
p.000247: process of informing the patient. From this formulation, the legislator seems to imply that these interventions
p.000247: are included in the term of medical act, even if they do not satisfy the definition of art. 1.
p.000247: The conclusion is that the latter, at least, are the only authentic enhancement interventions,
p.000247: for which the analytical CME regulations are applied, particularly regarding the rights and obligations of
p.000247: patients and physicians (art. 2-15). For all the other interventions that were mentioned above, the serious
p.000247: issue of medical liability is not covered by a specific legislation, but by the general legislation, basically
p.000247: the Criminal and the Civil Code or the Law 2251/1994 (on the liability of service providers). Essentially, the
p.000247: analogous application of the CME during the analysis of this general law, is imposed in an interpretative way,
p.000247: especially when taking into account that, in some enhancement methods, the health of the person concerned
p.000247: may be in danger.
p.000247: Plastic surgeries that change the gender and aim to restore a normal social life for the person
p.000247: involved, have been legally associated with the issue of modifying public documents and,
p.000247: particularly, registry office records. This amendment was accepted by the ECHR (decision Goodwin v. United
p.000247: Kingdom, 2002), even if the rule of keeping unchanged such registry documents (which serves the security of law) is
p.000247: bended, precisely because the right to freely develop a personality is a priority.
p.000247: Finally, the law for tissue transplantation (Law 3984/2011) is applicable for plastic surgery procedures, as
p.000247: long as it is not an autologous transplantation (the donor is a third party, living or not). This law
p.000247: provides special conditions aiming to protect the donor and the recipient of the transplant, with informed
p.000247: consent as the central concept here.
p.000247:
p.000247:
p.000247:
p.000247:
p.000248: 248
p.000248:
p.000248: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000248: REPORT
p.000248:
p.000248: II. Enhancing performance
p.000248:
p.000248: 1. The facts
p.000248:
p.000248: a) Overview
p.000248:
...

Political / immigrants

Searching for indicator immigrants:

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p.000141: justified only if they are absolutely in- dispensable to protect public health pursuant to the Constitution
p.000141: (arts. 5 [4], 25 [1]). The principle of proportionality as discussed above applies in all circumstances. For
p.000141: example, hospitalized patients should be restricted in specially contained facilities.
p.000141:
p.000141: b) The risk of social stigma
p.000141: The Commission stresses the risk of social stigma that may arise from the isolation (“ghetto-ing”) of specific
p.000141: sub-populations with distinctive cultural characteristics or ways of living when an infectious disease erupts
p.000141: within such groups.
p.000141:
p.000141:
p.000141:
p.000141:
p.000142: 142
p.000142:
p.000142: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000142: OPINION
p.000142:
p.000142: Such cases must be dealt with by personalized medical care and social welfare measures especially as
p.000142: regards the improvement of hygiene in their living conditions.
p.000142:
p.000142: c) Illegal immigrants
p.000142: In case of manifestation of infectious disease or in cases when preven- tive measures (e.g. vaccination) need to
p.000142: be applied on illegal immigrants, the government must ensure that immigrants would be addressed to the
p.000142: health services. The access of immigrants to health services should be un- hindered and independent on their
p.000142: immigration status; otherwise the risks for public health in general will be multiplied.
p.000142:
p.000142: d) HIV/AIDS
p.000142: This particular disease presents a set of peculiar problems. Even though the spread of the virus is in general
p.000142: relatively difficult, the disease is very severe despite progress in treatment in the recent years. Moreover, social
p.000142: perceptions -especially regarding high risk vulnerable groups- remain ex- tremely negative in our country. The
p.000142: following call for attention:
p.000142: The autonomy of HIV seropositives or HIV patients can be restricted in view of public health protection only if the
p.000142: particular setting of social con- tact is prone to the transmission of the disease. Thus, although mandatory testing
p.000142: for seropositivity is not justified in the absence of qualifying circum- stances, it can be legitimate for certain
p.000142: occupations like physicians or nurs- es or for participation in certain social activities such as sports. In
p.000142: these cases, a positive test result justifies the removal of the seropositive, but just from this
p.000142: particular social context. By contrast, social environments, which are not prone to the transmission of the
...

p.000148: persecutions and massacres of Jews dur- ing the times of “Black Death” in the Dark Ages (the plague pandemic), to the
p.000148: persecution of beggars on the same grounds in the XIX century or of prostitutes for spreading syphilis in
p.000148: World War I, to contemporary practices of discrimination against AIDS patients. In our country, stigmatization phe-
p.000148: nomena occurred in the past in the cases of leprosy and tuberculosis.
p.000148: These facts demonstrate that public health is not to be considered only as a medical problem, but involves a serious
p.000148: social and political dimension. The latter must be taken into account when adopting restrictions to general autonomy.
p.000148: Such restrictions are not justified unless accompanied by social measures aimed at minimizing the likelihood of
p.000148: transmission (e.g. housing, food, etc. for the poor or disadvantaged groups of the population) and by steps ensuring
p.000148: fair treatment (not distinguishing, for example, between prostitutes and their clients regarding the risk
p.000148: of transmission of venereal diseases).
p.000148: The current wave of immigration carries great potential of stigma on public health grounds. The fact
p.000148: that the country of origin -particularly of illegal immigrants- is often afflicted by a high prevalence
p.000148: of infectious dis- eases (especially sub-Saharan Africa and southern Asia), while local health services
p.000148: remain rudimentary, represents a real cause of concern for the spreading of these diseases in the
p.000148: hosting countries. However, stigmatiza- tion practices -unfair treatment, “ghettos” etc.- stem rather from the idea
p.000148: of “miasma” due to lack of information or misinformation about the medical- biological particulars of disease,
p.000148: especially infectivity. Hansen’s disease (lep- rosy) and, more recently, HIV/AIDS confirm this observation
p.000148: since these
p.000148:
p.000148:
p.000149: 149
p.000149:
p.000149: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000149: REPORT
p.000149:
p.000149: population groups are stigmatized, although the disease is relatively difficult to contract.
p.000149: In case of Hansen’s disease, the exact path of transmission is still un- known, but it is accepted
p.000149: that although it can be contracted through pro- longed social contact, approximately 95% of the population are
p.000149: immune to it, though the mechanisms of immunity have not been identified. Perhaps it was this last parameter in
p.000149: combination with the deformity caused by the disease that has led to social stigma against these patients in the
p.000149: past.
p.000149: In case of HIV/AIDS, the path of transmission is known and involves ex- posure to body fluids through sexual
...

Political / political affiliation

Searching for indicator party:

Searching for indicator political:

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p.000056: national policies for research and technology worldwide (European Commission, 2007a). It has promoted pro- gress in
p.000056: science and technology and has often made up for the inability of the state to provide adequate funds to all scientific
p.000056: fields. The decoding of
p.000056:
p.000056:
p.000057: 57
p.000057:
p.000057: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000057: REPORT
p.000057:
p.000057: the human genome, for instance, was made possible by a partnership of private and public bodies.
p.000057: The source of financing, however, can affect the validity of research find- ings especially if the sponsor has a
p.000057: vested interest in the outcome of the research. One example is clinical trials financed by pharmaceutical compa-
p.000057: nies. It has been reported that trials of new drugs used in oncology and fi- nanced by the pharmaceutical company which
p.000057: is going to produce the drugs are eight times more likely not to reach negative results compared to inde- pendently
p.000057: funded trials (Friedberg et al., 1999). Similar cases of manipulated research have been reported in other clinical and
p.000057: epidemiological trials in- cluding the notorious example of research manipulated by the tobacco in- dustry (Tong and
p.000057: Olsen, 2005; Lesser et al., 2007). Public sources of financ- ing can also be interventionist. The “Union of
p.000057: Concerned Scientists” has a list of cases of government intervention to conceal or manipulate research findings for
p.000057: political reasons.
p.000057: To give the problem its real dimensions, according to US data on re- search conducted by publicly
p.000057: funded agencies, in the last 200 years there have been 200 cases of confirmed misconduct (Resnik, 2007).
p.000057: This figure which represents approximately 0.01% of the entire research community for this period probably
p.000057: underestimates reality but implies that such phenome- na and specific cases of deliberate fraud are relatively limited.
p.000057: This, howev- er, does not mean that the problem does not require serious consideration. As the above examples
p.000057: demonstrate, the validity of biological research has a direct impact on society and often affects public health
p.000057: directly. The exist- ence of and compliance with recognized code of ethics is important not only in order to defend the
p.000057: safety and the rights of volunteers or lab animals. It is also required to ensure the quality of the results, to
p.000057: maintain public support for research, to achieve accountability to society -the source of funds- and for the
p.000057: harmonious and effective co-operation between researchers (Resnik, 2007).
p.000057: To deal with serious issues of research ethics like those mentioned above and in recognition of the
p.000057: significance of educating researchers in eth- ical topics, international scientific societies, universities and
p.000057: research cen- tres have issued codes of ethics or ethical guidelines and specialized correct research practices for
...

p.000062: Law 3536/21.3.2008: Statutory Framework for research and technology and other stipulations. Official Journal of the
p.000062: Greek Government.
p.000062: Lesser LI, Ebbeling CB, Goozner M, Wypij D, Ludwig DS (2007). Relationship between funding source and conclusion
p.000062: among nutrition-related scientific articles. PLoS Med 4, e5.
p.000062: Parascandola M (2005). Science, industry, and tobacco harm reduction: A case study of tobacco industry
p.000062: scientists' involvement in the national cancer institute's smoking and health program, 1964-1980. Public Health
p.000062: Reports 120, 338-349.
p.000062: Resnik DB (2007). What is ethics in research and why is it important? Na- tional Institute of
p.000062: Environmental Health Sciences.
p.000062: Resnik DB, Shamoo AE, Krimsky S (2006). Fraudulent human embryonic stem cell research in South Korea: Lessons learned.
p.000062: Account Res 13, 101-109.
p.000062:
p.000063: 63
p.000063:
p.000063: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000063: REPORT
p.000063:
p.000063: Rosenstock L and Lee LJ (2002). Attacks on science: The risks to evidence- based policy. American Journal
p.000063: of Public Health 92, 14-18.
p.000063: Shamoo AE and Resnik DB (2002). Responsible conduct of research. Oxford University Press.
p.000063: Tong S and Olsen J (2005). The threat to scientific integrity in environmental and occupational medicine.
p.000063: Occupational and Environmental Medicine 62, 843-846.
p.000063: Union of Concerned Scientists. Scientific integrity, Political interference.
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000064: 64
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000003: 3
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: MANAGEMENT OF BIOLOGICAL WEALTH
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000065: 65
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000066: 66
p.000066:
p.000066: MANAGEMENT OF BIOLOGICAL WEALTH
p.000066: OPINION
p.000066:
p.000066: O P I N I O N MANAGEMENT OF BIOLOGICAL WEALTH
p.000066: The National Bioethics Commission discussed at several meetings the
p.000066: ethical aspects of biological wealth management issues that need to be con- sidered as priorities by any modern
p.000066: society. Here, the term “biological wealth” includes the diversity of life forms that exist at a specific place and
p.000066: time.
...

p.000073: Pavlos Sourlas, Professor of Philosophy of Law, University of Athens.
p.000073: Constantinos Tsoukalas, Emeritus Professor of Sociology, University of Ath- ens.
p.000073: Ioannis Vlahoyiannis, Professor of Medicine and Nephrology, University of Patras.
p.000073:
p.000073:
p.000073:
p.000073: PERSONNEL
p.000073:
p.000073: Scientific Officers:
p.000073: Takis Vidalis, Lawyer, PhD in Law.
p.000073: Ariadne L. Hager-Theodoridou, Agronomist, PhD in Genetics.
p.000073:
p.000073: Secretariat:
p.000073: Marianna Drakopoulou, Lawyer, Head of Secretariat.
p.000073:
p.000073:
p.000073:
p.000074: 74
p.000074:
p.000074: MANAGEMENT OF BIOLOGICAL WEALTH
p.000074: REPORT
p.000074:
p.000074: R E P O R T MANAGEMENT OF BIOLOGICAL WEALTH
p.000074: Rapporteurs: T. Vidalis, A. Hager-Theodoridou
p.000074: In collaboration with: D. Roupakias
p.000074:
p.000074: The management of biological wealth is among the most critical issues of our times. Extensive and increasingly
p.000074: intensive human intervention in the natural environment to satisfy ever expanding needs, reveal that: a)
p.000074: the future of life in any particular place or country as well as on the planet as a whole is crucially affected by
p.000074: human activity, and, b) there are limits to the tolerance of the natural environment beyond which restoration is very
p.000074: diffi- cult, if not impossible, with all which that implies for our life, and for the survival and that
p.000074: of all living organisms.
p.000074: The above observations call for an, as far as possible, rational approach to the utilisation of biological
p.000074: resources by any organized society. Every country needs to reflect on the issue and elaborate specific
p.000074: political deci- sions accordingly: decisions on the exploitation of natural resources (soil, water) and land
p.000074: use, the management of agricultural and live stock produc- tion, the conservation of ecosystems, the protection
p.000074: of specific biological species and of biodiversity at large, biotechnological research and the appli- cation of its
p.000074: findings.
p.000074: In the present report, we aim to present the basic parameters of this reflection focusing on the
p.000074: management of biological wealth and trying to identify special priority areas for our country. Naturally, this is
p.000074: meant only as a starting point that needs to be further developed in scope and in depth in future considerations.
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000074:
p.000075: 75
p.000075:
p.000075: MANAGEMENT OF BIOLOGICAL WEALTH
p.000075: REPORT
p.000075:
p.000075: FIRST CHAPTER
p.000075:
p.000075: BIOLOGICAL WEALTH IN OUR COUNTRY AND HUMAN ACTIVITY HAZARDS
p.000075:
p.000075: Biodiversity and benefits for humanity
p.000075:
p.000075: A country’s biological wealth is synonymous to the biodiversity it com- prises as a whole. Although the term
p.000075: biodiversity is widely used and consid- ered as having a commonly accepted content, there are different definitions as
p.000075: to its biological content. The most comprehensive definition is “the varie- ty of life at all levels of biological
p.000075: organization” (Gaston and Spicer, 2004). In particular, biodiversity occurs: (i) at the level of genes
p.000075: (genetic diversity which refers to the totality of the genetic characteristics of each species), (ii) at the level
...

p.000080: inactivity. Recently, the General Secretariat for Research and Technology (GSRT) launched a call for tender to award
p.000080: the coordination of research in national biodiversity in the framework of EU action “LIFEWATCH: Science and Technology
p.000080: Infrastructure for Biodiversity Data and Observato- ries”.
p.000080:
p.000080: SECOND CHAPTER
p.000080:
p.000080: THE ETHICAL-SOCIAL DIMENSION
p.000080:
p.000080: In our culture, the management of biological wealth is mainly associated with three factors that set the ethical-social
p.000080: context for the relevant discus- sion: sustainable development, the value of biodiversity and the “rights of future
p.000080: generations”. These considerations can be interconnected in many ways as will be shown below.
p.000080:
p.000080: Sustainable development
p.000080:
p.000080: The term was coined in the ’80s and denotes the use of natural re- sources in a way that the satisfaction
p.000080: of human needs in the future remains constantly possible. Put in different words, sustainable development meets our
p.000080: present needs without compromising the needs of future generations3.
p.000080:
p.000080:
p.000080: 1 A table of the NATURA habitats is available at the website of the network of re- searchers of
p.000080: environmental management: http://natura.minenv.gr/natura/server/user/biotopoi_list.asp?Ing=GR.
p.000080: 2 OJ 1289B.
p.000080: 3 The term was established by the report of the World Committee for the Environ- ment and Development
p.000080: (Brundtland Report, 1987).
p.000080:
p.000081: 81
p.000081:
p.000081: MANAGEMENT OF BIOLOGICAL WEALTH
p.000081: REPORT
p.000081:
p.000081: Environmental sustainability is considered as part of sustainable devel- opment. The economic, socio-political
p.000081: and cultural sustainability (especially in regard to the preservation of native populations) are also crucial aspects
p.000081: to be taken into consideration in an arduous task of balancing conflicting demands and interests.
p.000081: Environmental sustainability, in particular, is often associated with the term “green development” which
p.000081: assigns priority to the protection of the natural environment. This can potentially come in conflict with
p.000081: the other aspects of sustainability, especially the economic one, for instance, when there is a demand to
p.000081: preserve certain natural species at all costs in countries without sufficient financial resources. Seen in a different
p.000081: light, though, the demand to combine different aspects of biodiversity creates new needs and, with that, new
p.000081: opportunities for unprecedented economic “post-industrial” initiatives with the use of information technologies4.
p.000081: Nowadays, the ubiquitous use of the term “sustainable development” and its association by the UN with a
p.000081: plethora of sectors and initiatives ex- plains the criticism that, in actual fact, the term is of little explanatory
p.000081: value, despite efforts to create systems of quantitative measurement of “sustaina- bility” with various indicators.
p.000081: This problem aside, sustainable development as an ethical-social de- mand raises questions on many levels.
p.000081: The first general question is whether it corresponds to some overarching value that would justify such a vast
p.000081: reorientation of socioeconomic activi- ties. The prevailing answer seems to be that such a value may consist in en-
...

p.000081: Michigan).
p.000081:
p.000082: 82
p.000082:
p.000082: MANAGEMENT OF BIOLOGICAL WEALTH
p.000082: REPORT
p.000082:
p.000082: water) which are goods of supranational or universal values? Or, is the sur- vival of local populations to be granted
p.000082: absolute priority that would justify the unrestrained consumption of natural resources as was the case in
p.000082: the western developed countries in previous centuries?
p.000082: And by extension, can we think of some measure of justice in the alloca- tion of duties emanating from sustainable
p.000082: development, even at the level of local, or indeed individual activities? Is thus justifiable that industries
p.000082: may “purchase” pollution (“the polluter pays” principle) or that the intensive exploitation of natural
p.000082: resources by traditional agriculture may go on as it has in the past, and what are the limits in view of the
p.000082: preservation of sus- tainability?
p.000082: The third question concerns some form of regulation of the needs of contemporary societies at a global,
p.000082: national or local level. If the current conditions of globalized economy command a more or less free determina-
p.000082: tion of needs, a broad regulation -which might even lead to pre-industrial concepts of life according to
p.000082: some- appears contrary to a fundamental con- dition of collective and individual freedom. This question can become
p.000082: quite practical: even if sustainable development were to be considered as ethical- ly justifiable, is such a wide
p.000082: project for the economy and for society feasible, and who can ensure its implementation?
p.000082: Be that as it may, it appears that a system of regulation of needs is no longer only a political demand. The fact
p.000082: that, ultimately, human activity leads to an ever growing demand for energy at the end of which lies global warming
p.000082: -with the well-known result of the “greenhouse effect”- implies that such regulation is directly imposed as a
p.000082: mere but indispensable condi- tion for the survival of our species outside and beyond all political expedien- cies.
p.000082: According to the voice of some sceptic scientists, on the other hand, the term sustainable development is
p.000082: contradictory, as any further development, even at a slower pace compared with the current one, fatally leads to the
p.000082: destruction of the planet due to the inevitable thermal pollution (Kalopissis, 2001). This position, though
p.000082: rejecting any call for development, does not deny the need of regulation for the protection of the environment.
p.000082:
p.000082:
p.000082:
p.000082:
p.000082:
p.000083: 83
p.000083:
p.000083: MANAGEMENT OF BIOLOGICAL WEALTH
p.000083: REPORT
p.000083:
p.000083: The value of biodiversity
p.000083:
p.000083: The perception of biodiversity as a value is the second issue to be con- sidered.
p.000083: Biodiversity represents a “wealth” of biological resources that we exploit to meet our various needs (food,
p.000083: health, clothing, housing, etc.). It is cur- rently considered as threatened because of environmental pollution,
p.000083: urban expansion, the destruction of the habitats of certain species, and the intro- duction of alien plant or
p.000083: animal species in particular areas leading to the gradual extinction of local species5.
p.000083: It is precisely as a “wealth” of biological resources that biodiversity is seen as worthy of protection
p.000083: other than a mere fact of nature. Our culture values the conservation of current species although we know that
p.000083: in the history of our planet the content of biodiversity has been constantly chang- ing, namely that millions of
p.000083: species have disappeared or appeared -and con- tinue to disappear or appear. This is natural -an inherent
p.000083: characteristic of life and the result of changing environmental conditions- but we are aware that the action of one
p.000083: species in particular -the human species- can become critical (Markl: 38, 40). In this sense, the state of biodiversity
p.000083: inevitably de- pends on our own decisions and activities, economic, political, social, etc., and so the discussion
p.000083: about its value becomes meaningful.
p.000083: Care to maintain the wealth of biological resources is also part of sus- tainable development. Certain
p.000083: questions arise in this respect too.
p.000083: Given the other dimensions of sustainable development that may be incompatible with the conservation of
p.000083: certain species for economic (exces- sive cost for wild animal infrastructure, etc.) or social reasons (the develop-
p.000083: ment of third world countries requiring large-scale interventions in the envi- ronment, the preservation of
p.000083: traditional professions, etc.), are there limits to the preservation of biodiversity? In the same vein, can we
p.000083: envisage some kind of hierarchy in the value of species, and with which criteria?
p.000083: Given the rapid development of biotechnology, do we have unlimited freedom in changing the content of
p.000083: biodiversity by introducing new species (even wholly “unpredictable” ones using genetic engineering methods)? Are
p.000083:
p.000083:
p.000083: 5 The free circulation of genetically modified organisms (e.g. fish) has, in some cases, had the same effect.
p.000083:
p.000084: 84
p.000084:
p.000084: MANAGEMENT OF BIOLOGICAL WEALTH
p.000084: REPORT
p.000084:
p.000084: we allowed to do so even at the risk of extinction of other, naturally occur- ring species as a result of their contact
p.000084: with the new ones?
p.000084: These questions can be answered in many ways but it is worth pointing out that the value of biodiversity is seen in
p.000084: relation to our needs. Thus, bio- diversity appears to be a rather relative and not an absolute value, as might be
...

p.000092: protection of the Mediterranean Sea from pollution. To- day 21 countries and the EU participate in the Action Plan. The
p.000092: activities of the program were extended to the integrated management of problems in coastal development zones with the
p.000092: aim to study problems and assist gov- ernments to make environmentally-friendly policies.
p.000092:
p.000092: FIFTH CHAPTER CONCLUSIONS - PROPOSALS
p.000092: General environmental policy and protection of biodiversity A Ministry for the Environment
p.000092:
p.000092: The European Union and the Greek Parliament have recognized the envi- ronment as an area of independent policy-making,
p.000092: the former by appointing a Commissioner for the Environment and the latter by setting up a Special Standing Committee
p.000092: for the Protection of the Environment. By contrast, the government has no independent Ministry for the
p.000092: environment as men- tioned earlier.
p.000092: The advantage of accommodating the current Vice-Ministry for the Envi- ronment and Land Planning in the YPEHODE is that
p.000092: it belongs to a powerful Ministry. The disadvantage is that the sector of public works has always pre- vailed in
p.000092: practice and continue to override the priorities of the Ministry.
p.000092: According to one argument, a separate Ministry for the Environment may rank low in government priorities and
p.000092: thus undermine the efficacy of initia- tives. This is not a convincing argument for it fails to consider that, already
p.000092: on the symbolic political level, environmental protection now strongly af- fects the political behaviour
p.000092: of both citizens and politicians themselves.
p.000092:
p.000092:
p.000093: 93
p.000093:
p.000093: MANAGEMENT OF BIOLOGICAL WEALTH
p.000093: REPORT
p.000093:
p.000093: With this in mind, the possibility to take initiatives that will no longer con- flict with other interests in the same
p.000093: Ministry, and a clearly defined respon- sibility for the Minister inside the cabinet must be evaluated. Taking all that
p.000093: into account, the creation of an independent Ministry for the Environment calls for immediate consideration.
p.000093:
p.000093: The environment and the financial crisis
p.000093:
p.000093: Globally, there is already an attempt to use the current conditions of global recession as a pretext in
p.000093: order to downgrade the questions of envi- ronmental protection. Thus, a number of economists and politicians argue
p.000093: that these are really “luxury issues” that should be left aside until recovery.
p.000093: At the other side of this line of reasoning, the recession can be seen as an opportunity to redefine the notion of
p.000093: “development”. That is, to recog- nize the quality of the environment and, by extension, environmental pro- tection as
p.000093: a non-negotiable value, an indispensable aspect of development.
p.000093: To achieve this, it will be necessary to turn the spotlights more on ques- tions of environmental policy and
p.000093: related actions in order to upgrade the priority of environmental protection issues at large, and of
p.000093: biodiversity in particular. Critical here is the encouragement by government of business initiatives to take
p.000093: targeted actions to protect the environment.
p.000093:
...

p.000148: REPORT
p.000148:
p.000148: easily and less easily transmitted diseases as well as between mild and seri- ous diseases (influenza versus HIV, for
p.000148: example).
p.000148: Mild diseases, even when easily transmitted, do not justify such re- strictions to general autonomy; the same
p.000148: is true of serious diseases that are hard to contract. Of course, there are many variations of these
p.000148: combina- tions, which prevent the formulation of more specific rules of universal ef- fect.
p.000148: Restrictions to general autonomy can lead to unfair discrimination aris- ing from a kind of “stigmatization” which
p.000148: isolates patients -even if temporar- ily- from social life. Above all, this raises a wider ethical problem. Historical-
p.000148: ly, the stigma against population groups on public health grounds has been a recurring phenomenon, from the
p.000148: persecutions and massacres of Jews dur- ing the times of “Black Death” in the Dark Ages (the plague pandemic), to the
p.000148: persecution of beggars on the same grounds in the XIX century or of prostitutes for spreading syphilis in
p.000148: World War I, to contemporary practices of discrimination against AIDS patients. In our country, stigmatization phe-
p.000148: nomena occurred in the past in the cases of leprosy and tuberculosis.
p.000148: These facts demonstrate that public health is not to be considered only as a medical problem, but involves a serious
p.000148: social and political dimension. The latter must be taken into account when adopting restrictions to general autonomy.
p.000148: Such restrictions are not justified unless accompanied by social measures aimed at minimizing the likelihood of
p.000148: transmission (e.g. housing, food, etc. for the poor or disadvantaged groups of the population) and by steps ensuring
p.000148: fair treatment (not distinguishing, for example, between prostitutes and their clients regarding the risk
p.000148: of transmission of venereal diseases).
p.000148: The current wave of immigration carries great potential of stigma on public health grounds. The fact
p.000148: that the country of origin -particularly of illegal immigrants- is often afflicted by a high prevalence
p.000148: of infectious dis- eases (especially sub-Saharan Africa and southern Asia), while local health services
p.000148: remain rudimentary, represents a real cause of concern for the spreading of these diseases in the
p.000148: hosting countries. However, stigmatiza- tion practices -unfair treatment, “ghettos” etc.- stem rather from the idea
p.000148: of “miasma” due to lack of information or misinformation about the medical- biological particulars of disease,
p.000148: especially infectivity. Hansen’s disease (lep- rosy) and, more recently, HIV/AIDS confirm this observation
p.000148: since these
p.000148:
p.000148:
p.000149: 149
p.000149:
...

Political / stateless persons

Searching for indicator nation:

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p.000021:
p.000021: The funds allocated to research in human genetics reflect the magnitude of expected benefits for public health. It is
p.000021: thus crucial that everybody should be able to enjoy the benefits of scientific progress and people should not be
p.000021: discouraged on non-medical grounds such as fear of exclusion from insur- ance.
p.000021: To give an example of the speedy pace of developments, the cost and time required to decode the human
p.000021: genome dropped dramatically in the last 15 years from 4 billion to 2 million dollars. An important international
p.000021: effort is underway to further curtail the cost to less than 1,000 dollars12 to make decoding practically feasible for
p.000021: patients and healthy-individuals. This could lead to important discoveries from the comparative analysis of
p.000021: ge- nomes13.
p.000021: Genetic information may revolutionize medical practice and it is im- portant for the public not to be put off
p.000021: from preventive genetic tests that can prove crucial for personal health. Many believe that the eventual use of
p.000021: genetic data in insurance (and at the workplace too) discourages many citi- zens not only from undergoing testing
p.000021: but also from participating in re- search, a view shared by the editors of the highly respected scientific review
p.000021: Nature Genetics (editorial, 39:2, Feb 2007) which prompted them to support the GINA Bill, which bars the use of genetic
p.000021: data in insurance. Therefore, it is necessary to keep the public informed about the latest developments in
p.000021: genetics to avoid unfounded fears and also for an informed demand for a fair regulation of the protection of
p.000021: personal genetic data, to avoid discrimi- nation in life and health insurance as well as in other sectors -which fall
p.000021: out- side the scope of the present report- like employment.
p.000021:
p.000021:
p.000021: 12 George Church’s team in Harvard University endeavours to decode the genome of 100,000 people in one year at a cost
p.000021: below 1,000 dollars per person. This effort takes place in the context of the Personal Genome Pr
p.000021: (http://arep.med.harvard.edu/PGP/). Besides, the X Price Foundation launched the Archon Genomics Competition that will
p.000021: award 10 million dollars to the first team that will decode the complete genome of 100 people in 10 days at less than
p.000021: 1,000 dollars per genome.
p.000021: 13 We have seen tokens of the potential of this methodology from projects like the so- called “Iceland experiment”
p.000021: where genetic and other medical data of a big chunk of the population is filed into a database managed
p.000021: by the decode company (http://www.decode.com/) following the adoption of special legislation. This data
p.000021: has already led to significant scientific discoveries.
p.000021:
p.000022: 22
p.000022:
p.000022: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000022: REPORT
p.000022:
p.000022: D. High risk groups for genetic disorders
p.000022:
p.000022: The development of genetics and of genetic testing for specific diseases has confirmed empirical knowledge about
p.000022: the higher incidence of certain genetic disorders in particular geographic or racial groups. Examples include
p.000022: β-thalassaemia that has a higher incidence in people originating from the Eastern Mediterranean, Africa and
p.000022: Asia14 and various disorders with a high incidence in descendants of Ashkenazi Jews like the BRCA1/2 breast/ovarian
...

p.000226:
p.000226: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000226: OPINION
p.000226:
p.000226: b) As part of this responsibility, the physician must particularly consider the possibility of an underlying
p.000226: psychological or psychiatric disorder in the person concerned, and refer him/her for a psychological or
p.000226: psychiatric as- sessment. The physician should not comply with the wishes of the interest- ed person in an
p.000226: uncritical manner, since there may be defects in the per- son’s will that affect the validity of
p.000226: his/her consent. Individuals with Body Dysmorphic Disorders (BDDs or dysmorphobia) fall into this category,
p.000226: and indeed, plastic surgery offers no actual prospect of improving their condi- tion.
p.000226:
p.000226: 6. Production of a code of conduct
p.000226:
p.000226: The Commission indicates the lack of a specific Code of Conduct for plas- tic surgery and recommends that the
p.000226: relevant scientific societies should produce such a code, with the assistance of the Ministry of Health.
p.000226: The relevant code must refer to the general obligations of physicians towards the persons interested
p.000226: -especially the increased responsibility to fully inform the person concerned- and may include specific
p.000226: chapters on different types of procedures, so that the above mentioned obligations are adjusted accordingly.
p.000226:
p.000226: ΙΙ. Enhancing physical abilities
p.000226:
p.000226: 1. Overview
p.000226:
p.000226: The enhancement of physical abilities usually includes characteristics such as physical strength, speed,
p.000226: agility, endurance, accuracy, motor coordi- nation and dexterity. The artificial enhancement is achieved mainly by
p.000226: the use of pharmaceutical substances combined with physical exercise.
p.000226: The Commission considers that, in the frame of the general right to per- sonality development, improving physical
p.000226: abilities is, in principle, a legiti- mate choice. However, the Commission notes that this choice is subject to
p.000226: restrictions, which are related both to the person him/herself and third par- ties.
p.000226:
p.000226:
p.000226:
p.000226:
p.000227: 227
p.000227:
p.000227: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000227: OPINION
p.000227:
p.000227: 2. Safe use of substances for a person’s health
p.000227:
p.000227: It is imperative to protect a person’s health from potentially harmful enhancing substances, given that
p.000227: many of them are freely available in the market, with no prescription required.
p.000227: Regardless of the autonomy of the person in various health issues, the Commission emphasizes the importance of the
p.000227: strict control over these sub- stances by the competent authorities, and particularly the importance of
p.000227: providing complete and accurate information to consumers regarding any possible side effects.
p.000227: For substances administered after prompt (either by sports medicine physicians, or gymnasts, trainers etc.),
p.000227: the relevant responsibility -moral, but also legal- belongs primarily to those who recommend the substance
p.000227: use. Regarding the apportionment of responsibility, it should not be overlooked that the interested persons that use
...

Political / vulnerable

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p.000088: “preserving the ecological balance of natural ecosystems and ensuring their regenerative capacity”.
p.000088: This includes measures for the protection of domestic flora and fauna and the manage- ment of natural resources.
p.000088: Law 743/1977 on the marine environment and law 998/1979 on the pro- tection of forests also cover issues of management
p.000088: of biological resources. The major part of relevant Greek legislation, however, transposes interna- tional or
p.000088: community law.
p.000088: Numerous problems arise in the practical implementation of this legisla- tion as demonstrated formally in the
p.000088: case-law of the Environmental Panel
p.000088: (V) of the Judicial Review Court6 and in related reports of the Ombudsman’s Environmental Department. The Proposals of
p.000088: the present report make spe- cific reference to these problems.
p.000088:
p.000088: FOURTH CHAPTER
p.000088:
p.000088: ENVIRONMENT, SOCIETY, GOVERNMENT
p.000088:
p.000088: The social parameter
p.000088:
p.000088: The relationship between human beings and nature directly affects the planning, social acceptance and efficacy of any
p.000088: policy on the protection of biodiversity and the environment. The place occupied by the environment in the personal
p.000088: scale of values and the minds of individuals determines their attitude in respect to proposed policies. This
p.000088: relationship is not one and the same for everyone but common characteristics can be traced in particular
p.000088:
p.000088: 6 Strictly by way of indication, see JRC 2304/95 (national parks), 4950-4953/95 (wild flora/fauna), 1184/96
p.000088: (vulnerable ecosystems), 1821/95, 3067/01, 3135/02, 2601- 2603/05 (protection of the caretta-caretta turtle) etc.
p.000088:
p.000089: 89
p.000089:
p.000089: MANAGEMENT OF BIOLOGICAL WEALTH
p.000089: REPORT
p.000089:
p.000089: groups which are determined by residence, occupation, environment- related choices in everyday life and
p.000089: the reasons leading to such choices. The place of the environment and biodiversity in the individual’s scale of values
p.000089: and the individual’s relationship with nature in general is reflected both in professional choices and in everyday life
p.000089: (choice of intensive, integrated or biological agriculture) as well as in the different motives leading to
p.000089: such choices (e.g. the use of more efficient irrigation systems in agriculture may be due to a conscious effort to
p.000089: protect water resources or to apply for sub- sidies).
p.000089: According to the Eurobarometer, Greeks are highly concerned with the environment. However, there is great
p.000089: difference between word and prac- tice. The causes that relegate the environment to a lesser position in
p.000089: the minds of citizens in practice have to be investigated and analysed.
p.000089: However this may be, at the level of civil society, the activity of Non- Governmental Organizations of
p.000089: environmental denomination in Greece is particularly important for raising awareness among citizens and
p.000089: bringing pressure to bear on governments.
p.000089: After the devastating fires of 2007 and their tragic toll there is a sharp increase in the number of volunteers
...

p.000124: only for physicians but for society as a whole.
p.000124:
p.000124: 4. Epidemiology: Vaccination
p.000124:
p.000124: In the prevention of infectious diseases, especially in the example of vac- cination, free will of the individual must
p.000124: be weighed against the interest of society as a whole. Should the Commission decide to consider the question of patient
p.000124: consent to vaccination the following observations may be of use.
p.000124: The success of mass vaccination is based on the greatest possible partic- ipation; in democratic societies,
p.000124: however, people may not be coerced to participate (Asveld, 2008). Here, the State, on the one hand, and the
p.000124: scien- tific community, on the other, while obliged to respect individual autonomy, are called upon to ensure the
p.000124: greatest possible participation, provided the benefits of vaccination and the safety of the vaccine have been
p.000124: foreseen and documented as far as possible. But individual citizens also bear a re- sponsibility to
p.000124: society, and their decision to participate or not in a vaccina- tion program cannot be based solely on the argument of
p.000124: autonomy. Individ- ual people themselves will probably not benefit directly from participating in a vaccination
p.000124: program, but they contribute to the protection of society and of vulnerable groups in particular.
p.000124: The importance of confidence in the safety of vaccines and the major role of the State and of the scientific
p.000124: community were recently illustrated in
p.000124:
p.000124:
p.000125: 125
p.000125:
p.000125: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000125: REPORT
p.000125:
p.000125: Great Britain in the MMR vaccine against measles, mumps and rubella. Be- fore the beginning of mass vaccination,
p.000125: measles cost Britain an average of 100 casualties annually. In 1988 the rate of participation in mass vaccination was
p.000125: 76%. The launching of the triple vaccine that year in replacement of the three separate ones increased the rate of
p.000125: participation to 91% until 1998. At that moment, however, fears began to spread about side-effects; autism in
p.000125: particular. Although the vaccine had been tested for many years and there was no data commonly accepted by the
p.000125: scientific community suggesting any side effects, certain studies published by a medical researcher undermined the
p.000125: confidence of parents and participation in the vaccination program dwindled significantly after 1998. The study
p.000125: which supported the allegations of some parents about side effects proved fallacious; in fact, it contained
p.000125: fabricated data. The slump in participation rates, however, led to the loss of the so-called indirect or herd
p.000125: immunity causing an important increase in measles cases before confidence in the vaccine was restored and broad
p.000125: par- ticipation resumed (Jansen et al., 2003).
p.000125: Whereas in case of tested vaccines, the decision to abstain is not ethical- ly neutral, the example of new and
p.000125: insufficiently tested vaccines is different. The experience of mass vaccination against swine influenza in the
p.000125: US in 1976 illustrates the risks inherent in a reckless decision for extended vac- cination based on
p.000125: unfounded, as it proved, fears of a pandemics, and with inadequately tested vaccines at that. While the influenza
p.000125: claimed only one victim, the side effects from the vaccine caused 25 casualties and may have led to permanent damage
p.000125: (it was associated with the auto-immune syn- drome of Guillain-Barré). Such examples justify the reluctance to
p.000125: participate and the ethical duty to society as a whole cannot remain as strong if weighed against an
p.000125: increased likelihood of unknown side-effects from the vaccine.
p.000125:
p.000125: 5. Patients in hospitals - The case of ICUs
p.000125:
p.000125: Implementing the model of consent in hospitals is met with certain limits to patient autonomy.
p.000125: First of all, the hospitalized patient is situated in a public environment which does not allow full freedom
p.000125: of movement, expression and communi- cation while drastically restricting privacy and family life. In these
p.000125: circum-
p.000125:
p.000125:
p.000126: 126
p.000126:
p.000126: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000126: REPORT
p.000126:
p.000126: stances, patients are particularly vulnerable. Especially in the ICU, these re- strictions are much more
p.000126: encroaching; moreover, patients are under psy- chological stress due to their critical condition. Taking into
p.000126: account that the potential for a sober appraisal of the situation by the patient -and in exten- sion, for a rational
p.000126: decision on the course of treatment- is significantly cur- tailed by the hospital environment, the role of the medical
p.000126: and nursing staff becomes even more decisive.
p.000126: Hospitalized patients, however, even patients in the ICU, are usually ca- pable to give an informed consent. This means
p.000126: that physicians remain fully liable for allowing patients to participate in the course of the particular
p.000126: treatment and may not legitimately act alone. In conditions of “internment”
p.000126: -especially in ICUs- the risks of manipulation of the patient’s will by the phy- sician are increased. Patients can be
p.000126: easily forced into accepting things for they are understandably eager to have their health restored as soon as pos-
p.000126: sible in order to return to the freedom of everyday life and recover the full exercise of their autonomy.
p.000126: At this point we must underline that physicians have a heightened ethi- cal duty to provide complete information.
p.000126: The more comprehensive the information, the greater the likelihood for an independent appraisal of the situation
p.000126: -and decision-making- by a de facto vulnerable will. By contrast, limited information can more easily lead to
p.000126: manipulation of the patient by the physician since the patient is called upon to evaluate and decide in an unfamiliar
p.000126: environment of internment, more prone to “blind obedience” rather than genuine exercise of autonomy.
p.000126:
p.000126: 6. Incapacity to consent
p.000126:
p.000126: The legal capacity to consent must be distinguished from the corre- sponding physical capacity. Patients
p.000126: with full legal competence to consent may suffer a temporary disorder of their mental functions which
p.000126: prevents the forming and expression of free will (e.g. under the influence of alcohol or narcotics or in state of
p.000126: shock because of an accident or the announce- ment of a serious disease, etc.)10.
p.000126:
p.000126:
p.000126: 10 This is a case for the application of art. 131 CC which stipulates the nullity of ex- pression of will in such
p.000126: circumstances. See generally on the problem of “irrational”
p.000126:
p.000127: 127
p.000127:
p.000127: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000127: REPORT
p.000127:
...

p.000140: OPINION
p.000140:
p.000140: 1. Restrictions to autonomy relating to personal health
p.000140:
p.000140: a) Basic principles
p.000140: Preventive measures adopted by public authorities to address threats against the health of others may include
p.000140: restrictions on personal autonomy in matters of health but only in exceptional circumstances. “Exceptional” are the
p.000140: circumstances of spreading epidemics or pandemics, according to the internationally accepted definitions of
p.000140: these terms. National authorities may not arbitrarily dilate these definitions.
p.000140: In such circumstances, medics and designated health authorities do not have the obligation to ask for patient
p.000140: consent and they could act on their own initiative (self-action). The legal basis for such restrictions
p.000140: consists mainly in art. 8 of the Convention on Human Rights and Biomedicine (Ovie- do Convention), which justifies
p.000140: medical self-action in “emergency situa- tions”.
p.000140: In this context, restrictions must comply with the principle of propor- tionality, i.e. they must be
p.000140: appropriate and necessary in order to protect public health without exceeding the purpose for which they are
p.000140: adopted.
p.000140:
p.000140: b) Vaccination
p.000140: In principle, the vaccination of the population as a measure of preven- tion, particularly the vaccination of
p.000140: vulnerable groups, requires informed consent. In this context, relevant information may be also provided to the
p.000140: general public through the media. The duty of public authorities is to ensure the validity of this information by
p.000140: allocating the task exclusively to a respon- sible entity and by taking steps to avoid inaccuracies which may inspire
p.000140: dis- trust or fear. It is worth noting that 99% of children in the US are vaccinated with a minimum rate of
p.000140: complications, which proves that benefits far ex- ceed any drawbacks; therefore, it is not justified to
p.000140: spread doubts. In “emergency situations” in the above sense, the Commission feels that even mandatory vaccination is
p.000140: not to be excluded, especially for those who are highly probable to become carriers and transmit the
p.000140: infection due to the nature of their occupation. They should be offered, however, the option of changing duties. The
p.000140: established scientific requirements for clinical trials of new treatments (vaccines or medicines) may not be
p.000140: bypassed in order to
p.000140:
p.000140:
p.000140:
p.000141: 141
p.000141:
p.000141: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000141: OPINION
p.000141:
p.000141: accelerate the availability of such treatments to the public. Otherwise their efficacy will remain uncertain and
p.000141: citizens will be misinformed as a result.
p.000141: In addition, the Commission thinks that in the exceptional circumstances of epidemics or pandemics, limits to
p.000141: patents on new treatments could be justified to the extent possible. Such limits could be argued as a legal/policy
p.000141: choice in competent international and supra-national fora.
p.000141:
p.000141: c) Treatment
p.000141: The treatment of those infected should also be based on informed con- sent. Forced treatment is not justified in
p.000141: principle, except in “emergency situations”.
p.000141: When the number of medical and nursing staff or the available treat- ments do not suffice to ensure care to
p.000141: all those infected (especially in case an infection spreads rapidly) the Commission stresses that the government must
p.000141: establish in advance general priority rules for access to treatment. The basic priority criteria should preferably be
p.000141: prescribed by law. By way of indi- cation, such priority criteria may include the severity of symptoms, the age of the
p.000141: patient and the definition of relevant vulnerable groups.
p.000141:
p.000141: 2. Limits to autonomy on public health grounds
p.000141:
p.000141: a) General rule
p.000141: Limits to the general autonomy of patients -especially the freedom of movement and establishment- are
p.000141: justified only if they are absolutely in- dispensable to protect public health pursuant to the Constitution
p.000141: (arts. 5 [4], 25 [1]). The principle of proportionality as discussed above applies in all circumstances. For
p.000141: example, hospitalized patients should be restricted in specially contained facilities.
p.000141:
p.000141: b) The risk of social stigma
p.000141: The Commission stresses the risk of social stigma that may arise from the isolation (“ghetto-ing”) of specific
p.000141: sub-populations with distinctive cultural characteristics or ways of living when an infectious disease erupts
p.000141: within such groups.
p.000141:
p.000141:
p.000141:
p.000141:
p.000142: 142
p.000142:
p.000142: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000142: OPINION
p.000142:
p.000142: Such cases must be dealt with by personalized medical care and social welfare measures especially as
p.000142: regards the improvement of hygiene in their living conditions.
p.000142:
p.000142: c) Illegal immigrants
p.000142: In case of manifestation of infectious disease or in cases when preven- tive measures (e.g. vaccination) need to
p.000142: be applied on illegal immigrants, the government must ensure that immigrants would be addressed to the
p.000142: health services. The access of immigrants to health services should be un- hindered and independent on their
p.000142: immigration status; otherwise the risks for public health in general will be multiplied.
p.000142:
p.000142: d) HIV/AIDS
p.000142: This particular disease presents a set of peculiar problems. Even though the spread of the virus is in general
p.000142: relatively difficult, the disease is very severe despite progress in treatment in the recent years. Moreover, social
p.000142: perceptions -especially regarding high risk vulnerable groups- remain ex- tremely negative in our country. The
p.000142: following call for attention:
p.000142: The autonomy of HIV seropositives or HIV patients can be restricted in view of public health protection only if the
p.000142: particular setting of social con- tact is prone to the transmission of the disease. Thus, although mandatory testing
p.000142: for seropositivity is not justified in the absence of qualifying circum- stances, it can be legitimate for certain
p.000142: occupations like physicians or nurs- es or for participation in certain social activities such as sports. In
p.000142: these cases, a positive test result justifies the removal of the seropositive, but just from this
p.000142: particular social context. By contrast, social environments, which are not prone to the transmission of the
p.000142: virus, do not justify devia- tions from the respect of autonomy which is generally applicable.
p.000142: Finally, special attention is required when the virus occurs in enclosed areas of mandatory containment, like
p.000142: schools, hospitals, military barracks or prisons. Any limits to autonomy which are considered indispensable
p.000142: must be combined with additional measures of supervision in order not to betray the purpose of the presence of the HIV
...

p.000168: unequal doses violates the scientific principle of “clinical equipoise”, repre- senting that a subject may be enrolled
p.000168: in a clinical study only if there is true uncertainty about which of the study arms is most likely to benefit the pa-
p.000168: tient11. For instance, in 13 studies comparing the antifungals fluconazole and
p.000168:
p.000168: 7 Jorgensen AW, Maric KL, Tendal B, Faurschou A, Gotzsche PC (2008). Industry- supported meta-analyses
p.000168: compared with meta-analyses with non-profit or no sup- port: Differences in methodological quality and
p.000168: conclusions. BMC Med Res Methodol 8, 60.
p.000168: 8 Hampson LA, Joffe S, Fowler R, Verter J, Emanuel EJ (2007). Frequency, type, and monetary value of financial
p.000168: conflicts of interest in cancer clinical research. J Clin On- col 25, 3609-3614.
p.000168: 9 Heres S, Davis J, Maino K, Jetzinger E, Kissling W, Leucht S (2006). Why olanzapine beats risperidone, risperidone
p.000168: beats quetiapine, and quetiapine beats olanzapine: An exploratory analysis of head-to-head comparison studies of
p.000168: second-generation anti- psychotics. Am J Psychiatry 163, 185-194.
p.000168: 10 Perlis RH, Perlis CS, Wu Y, Hwang C, Joseph M, Nierenberg AA (2005). Industry sponsorship and
p.000168: financial conflict of interest in the reporting of clinical trials in psy- chiatry. Am J Psychiatry 162, 1957-1960.
p.000168: 11 Djulbegovic B, Cantor A, Clarke M (2003). The importance of preservation of the ethical principle of equipoise
p.000168: in the design of clinical trials: Relative impact of the
p.000168:
p.000169: 169
p.000169:
p.000169: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000169: REPORT
p.000169:
p.000169: amphotericin B in cancer patients who are vulnerable to fungal infections due to low white blood cell counts,
p.000169: 80% of the patients had the drug admin- istered orally in suspension, which shows poor absorption, not as an injec-
p.000169: tion. Conducting such clinical studies not only leads to misinformation but is also unethical, since the lack of
p.000169: therapeutic utility, endangers the patients and prolongs their pain.
p.000169:
p.000169: c. Selective publication
p.000169: Occasionally, industries intervene and prevent publication of negative results about their product which is
p.000169: under trial. Such interference is report- ed by almost 20% of researchers12. On the contrary, industries ensure that
p.000169: clinical studies with positive results are mentioned in more than one refer- ence in the literature. An illustrative
p.000169: example is a study revealing that the results from 6 different clinical studies testing duloxetine were used in more
p.000169: than 20 publications13.
p.000169:
p.000169: d. Different interpretation of results
p.000169: It is observed that industries interpret and present the results of a clini- cal study in different ways depending on
p.000169: whether they aim to publish them or submit them to the competent authorities. According to the existing lit- erature,
p.000169: 94% of the clinical studies showed positive results, whereas accord- ing to the US Food and Drug Administration (FDA)
p.000169: only 51% of the clinical studies had positive results14.
p.000169:
p.000169:
p.000169:
p.000169:
p.000169:
p.000169: methodological quality domains on the treatment effect in randomized controlled trials. Account Res 10,
p.000169: 301-315.
...

p.000175: There are three main aims of “Declaration” and “Notification” 30:
p.000175: 1. The comprehensive knowledge of possible relationships allows the participating patients or healthy
p.000175: volunteers to exercise informed choice on the right to autonomy. A condition to exercise this right, is that the
p.000175: “Notification” includes all the details of the “reconcilia- tion”. The clarity and timeliness of the
p.000175: notification are prerequi- sites.
p.000175: 2. To protect the researcher from potential legal entanglements. Alt- hough currently there is no legal obligation
p.000175: to reveal the sponsors, nevertheless, the researchers may be involved in legal matters31. Existence of a declaration
p.000175: facilitates transparency.
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175: 29 USA General Accounting Office, Biomedical Research, GAO-02-89, (2001).
p.000175: 30 Weinfurt KP, Dinan MA, Allsbrook JS et al. (2006). Policies of academic medical centers for disclosing
p.000175: financial conflicts of interest to potential research participants. Acad Med 81, 113-118.
p.000175: 31 Resnik DB (2004). Disclosing conflicts of interest to research subjects: An ethical and legal analysis.
p.000175: Account Res 11, 141-159.
p.000175:
p.000176: 176
p.000176:
p.000176: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000176: REPORT
p.000176:
p.000176: 3. A third aim, is the moral prevention of researchers and Institutions providing health services to receive
p.000176: sponsorships, especially high subsidies32.
p.000176: The fact that a researcher submitting the Declaration/Notification feels that he/she is vulnerable to criticism over
p.000176: the “transaction”, acts as a deter- rent. Approximately half of the Academic Centers state that granting the
p.000176: declaration has become mandatory in research. This declaration may be independent or may be included in the
p.000176: informed consent form.
p.000176: The declaration must include the following details:
p.000176: i. First name and surname of the researcher.
p.000176: ii. Name of the Institute.
p.000176: iii. Type of sponsorship.
p.000176: iv. Amount of sponsorship33.
p.000176: v. Sponsoring company/industry.
p.000176: vi. Approval of the CRC.
p.000176: A relevant study revealed that approximately 50% of Institutions accept the establishment of a declaration32. However,
p.000176: half of them wish to include it in the informed consent form, whereas the remaining prefer to inform the participating
p.000176: patients orally. In addition, unanimity does don exist on the extend of details to be disclosed, and many
p.000176: support that the sponsor’s name is adequate. Others claim that the disclosure must be complete and include, not only
p.000176: the sponsor’s name and type of sponsorship, but also the amount, and the participant must be informed of any possible
p.000176: effects of the sponsor- ship on the research outcome, suggesting an honest discussion between the researcher and the
p.000176: patient.
p.000176: A declaration must also be submitted for a 1st stage research, where there are no human participants, but is
p.000176: intended to move to the 2nd clinical stage within the next 12 months. In that case, it is within the authority of
...

p.000198: OPINION
p.000198:
p.000198: tect the consumer (Law 2251/1994) are applied in all types of genetic test- ing.
p.000198: However, one must not overlook that the above mentioned provisions are broad, and there is no special
p.000198: legislation governing this specific activity, both in Greece and most European countries. Absence of a
p.000198: relative law means that anyone can offer DTC genetic services in an unrestricted and uncontainable manner,
p.000198: without being subjected to any kind of preventive quality control. The legislation stated above,
p.000198: partially covers the need of such a control and is unable to monitor the dynamics of a developing new market.
p.000198:
p.000198: III. Recommendations
p.000198:
p.000198: 1. General principles
p.000198:
p.000198: The Commission believes that an important aspect of autonomy in health matters is the unrestricted access
p.000198: to health information, including genetic information. Especially, however, regarding genetic tests which pre- dict
p.000198: the risk to develop a disease, the Commission considers that it is equally important to provide genetic information
p.000198: after the appropriate instructions, preferably, by an expert-physician, clinical geneticist or biologist-geneticist.
p.000198: The Commission notes that it is important to maintain the balance be- tween free access to health information and
p.000198: protection of vulnerable people who are subjected to inappropriate or unnecessary genetic testing. This per- spective
p.000198: is supported by the particular nature of genetic information and by the misleading impression about “genetic
p.000198: determinism”, which tends to dominate the public consciousness. Specifically, genetic data provide an
p.000198: element of predisposition to common complex diseases (cancer, cardiovas- cular disease, diabetes etc.) classifying
p.000198: (or not) an individual in a high risk group, without a definite result that he/she will develop the
p.000198: disease. The Commission believes that it is critical to emphasize that genetic data must not be overvalued, as
p.000198: erroneously and commonly presented.
p.000198: In regard to prenatal genetic tests, the Commission reiterates its position that they must not be performed for eugenic
p.000198: purposes. It notes the danger especially in the case of DTC genetic tests, where genetic counseling is ab- sent.
p.000198:
p.000198:
p.000199: 199
p.000199:
p.000199: DIRECT-TO-CONSUMER GENETIC TESTING
p.000199: OPINION
p.000199:
p.000199: Finally, the Commission considers that genetic tests revealing a person’s identity definitely presuppose consent from
p.000199: all the involved parties. Other- wise such genetic tests require a relevant judicial licensing.
p.000199:
p.000199: 2. Special issues
p.000199:
p.000199: In the context of the above mentioned general principles, the Commis- sion notes:
p.000199: A. It is recommended that DTC genetic tests for health reasons or prena- tal diagnosis must be performed following a
p.000199: suitable prescription by a liable expert physician, clinical geneticist or biologist-geneticist. The expert
...

p.000224: In this case, the ethical principles and rules of law, as outlined in a previ- ous Opinion of the Commission ("Consent
p.000224: in the patient-physician relation- ship," 2010) are entirely valid. The authentic will of the person him/herself is the
p.000224: determining factor here, in view of the right of personality. However, since there is a particularly
p.000224: sensitive issue of autonomy, it is right to allow for a period of time between the initial decision and the plastic
p.000224: surgery pro- cedure, during which the person concerned receives psychological and med- ical counseling.
p.000224:
p.000224:
p.000224:
p.000225: 225
p.000225:
p.000225: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000225: OPINION
p.000225:
p.000225: According to the Commission, if prenatal testing results in ambiguous results about the gender identity of a
p.000225: foetus, an artificial termination of the pregnancy is not justified, especially since there are the
p.000225: aforementioned reconstructive options after birth. However, given that persons in this cate- gory (seeking plastic
p.000225: surgery to alter gender specific features or gender re- assignment) belong to vulnerable social groups that
p.000225: generally suffer from social discrimination, access to relevant treatment must be ensured. For example,
p.000225: based on the principle of equality and the social right to health, the State may possibly develop counseling
p.000225: programs, but also provide ther- apy possibilities within the National Health System.
p.000225:
p.000225: 4. Face transplants
p.000225:
p.000225: Reconstructive face transplantation (e.g. in case of severe deformities caused by an accident) is, in
p.000225: principle, an acceptable alteration of the recipi- ent’s characteristics. However, it must be carried out in such a
p.000225: manner that it does not affect respect for the body of the (dead) donor. The relevant principle that rules
p.000225: transplants from a deceased donor is absolutely valid in this case too.
p.000225:
p.000225: 5. The physician’s role
p.000225:
p.000225: According to the Commission, the physician who carries out cosmetic plastic surgery has a particular
p.000225: responsibility, since he/she does not act in order to prevent a threat to a patient’s health (or life).
p.000225: Unquestionably, the consent of the person interested is a prerequisite for any relevant medical intervention. However,
p.000225: it should be noted that in the case of cosmetic plas- tic surgery, the following particularities must be taken into
p.000225: account:
p.000225: a) The physician has an increased responsibility to fully inform the person concerned as to the expected outcome
p.000225: and particularly the possible side effects on his/her health. This increased responsibility is explained
...

p.000226: the use of pharmaceutical substances combined with physical exercise.
p.000226: The Commission considers that, in the frame of the general right to per- sonality development, improving physical
p.000226: abilities is, in principle, a legiti- mate choice. However, the Commission notes that this choice is subject to
p.000226: restrictions, which are related both to the person him/herself and third par- ties.
p.000226:
p.000226:
p.000226:
p.000226:
p.000227: 227
p.000227:
p.000227: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000227: OPINION
p.000227:
p.000227: 2. Safe use of substances for a person’s health
p.000227:
p.000227: It is imperative to protect a person’s health from potentially harmful enhancing substances, given that
p.000227: many of them are freely available in the market, with no prescription required.
p.000227: Regardless of the autonomy of the person in various health issues, the Commission emphasizes the importance of the
p.000227: strict control over these sub- stances by the competent authorities, and particularly the importance of
p.000227: providing complete and accurate information to consumers regarding any possible side effects.
p.000227: For substances administered after prompt (either by sports medicine physicians, or gymnasts, trainers etc.),
p.000227: the relevant responsibility -moral, but also legal- belongs primarily to those who recommend the substance
p.000227: use. Regarding the apportionment of responsibility, it should not be overlooked that the interested persons that use
p.000227: them are more vulnerable to inaccurate or misleading information, as they often choose to enhance their
p.000227: physical abilities and performance and consider that such enhancement is, by de- fault, desired and
p.000227: "innocent", with no special consideration of the potential health effects.
p.000227:
p.000227: 3. The interest of third parties, particularly in sport
p.000227:
p.000227: The Commission also dealt with the case of enhancing abilities through doping, in order to participate in athletic
p.000227: contests. The Commission pointed out that the use of relevant substances must be controlled, not only in order to
p.000227: preserve equality in competition, but also to protect the athletes’ health.
p.000227: In particular, the following points are exceptionally significant:
p.000227: i) Prohibition of the use of certain substances in sport is not only related to the impressive results concerning
p.000227: the primacy of the athlete that uses them, but also to the serious risks to his/her health. This means that, even
p.000227: if one assumes that all sport participants can have equal access to such sub- stances, the use of the latter
p.000227: would still be unfair, not for reasons of fair- ness, but because the endangerment of health is incompatible
p.000227: with the very notion of rivalry.
p.000227: ii) Enhancing physical abilities by other means (e.g. strenuous exercise in particular environmental conditions) could
p.000227: also be equated with substance
p.000227:
p.000227:
p.000228: 228
p.000228:
p.000228: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000228: OPINION
p.000228:
...

Searching for indicator vulnerability:

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p.000235:
p.000235:
p.000235: Platelet rich plasma
p.000235: Scar repair after accidents or burns Enhancing appearance
p.000235: Restoration of anterior cruciate
p.000235:
p.000235: (gel)
p.000235: Restoration of joints with
p.000235: osteoarthritis
p.000235: Enhancing athletic performance
p.000235:
p.000235:
p.000235:
p.000235:
p.000235:
p.000236: 236
p.000236:
p.000236: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT REPORT
p.000236:
p.000236: Table I (continued). Interventions applied to both treatment and human enhancement.
p.000236:
p.000236: Treatment Human enhancement Technological interventions
p.000236:
p.000236:
p.000236:
p.000236: Artificial implants
p.000236: Early and accurate diagnosis Effective and targeted drug therapy Restoration of joints, organs
p.000236:
p.000236: Enhancing athletic performance Increasing life expectancy
p.000236:
p.000236:
p.000236:
p.000236: Implants - sensors
p.000236:
p.000236:
p.000236:
p.000236: Brain implants
p.000236: Diagnosis and treatment of diseases
p.000236: e.g. sensor of sugar levels and use of insulin
p.000236:
p.000236: Increasing memory in patients with neurodegenerative diseases Restoration of mobility in paralyzed patients
p.000236:
p.000236: Enhancing athletic performance
p.000236:
p.000236: Enhancing senses, memory, intelligence
p.000236: Free access and opportunity to intervene in the physical world by thought
p.000236: Increasing life expectancy
p.000236:
p.000236: Nanotechnology Targeted therapy e.g. targeting cancer cells
p.000236:
p.000236: Aesthetic (surgical) interventions
p.000236: Reducing the vulnerability of soldiers by controlling their metabolism
p.000236: Skin graft Patients with severe burns Enhancing appearance and signs of
p.000236: aging
p.000236:
p.000236: Reconstructive surgery
p.000236: Scar repair after accidents or burns Restoration of anterior cruciate
p.000236: Enhancing appearance and signs of aging
p.000236: Liposuction Reducing the risk of obesity Enhancing appearance
p.000236:
p.000236: Gender change Agreement of physical and sexual
p.000236: identity
p.000236: Breast implants Breast reconstruction after total mastectomy
p.000236: Enhancing gender characteristics
p.000236:
p.000236: Enhancing appearance
p.000236:
p.000236: Breast size reduction
p.000236: Treatment of dermatitis Decrease neck pain
p.000236: Enhancing appearance Enhancing athletic performance
p.000236:
p.000236:
p.000236:
p.000236:
p.000236:
p.000236:
p.000236:
p.000236:
p.000237: 237
p.000237:
p.000237: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000237: REPORT
p.000237:
p.000237: c) The “business” of enhancement
p.000237:
p.000237: Human enhancement technologies are an opportunity for businesses to invest in, and may soon become a
p.000237: lucrative industry. Pharmaceutical companies, research institutes, universities and even governments spent
p.000237: and continue to spend huge amounts on drug research and human enhancement technologies. Similarly
p.000237: to the development of pharmaceutical drugs, for which companies invest in research with the ultimate aim to
...

Health / Cognitive Impairment

Searching for indicator cognitive:

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p.000004: Opinion
p.000009: 9
p.000009: Report
p.000015: 15
p.000015: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES 39
p.000015: Opinion
p.000041: 41
p.000041: Report
p.000047: 47
p.000047: MANAGEMENT OF BIOLOGICAL WEALTH 65
p.000047: Opinion
p.000067: 67
p.000067: Report
p.000075: 75
p.000075: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN 103
p.000075: Opinion
p.000105: 105
p.000105: Report
p.000113: 113
p.000113: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND
p.000113: AUTONOMY
p.000137: 137
p.000137: Opinion
p.000139: 139
p.000139: Report
p.000145: 145
p.000145: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH 157
p.000145: Opinion
p.000159: 159
p.000159: Report
p.000165: 165
p.000165: DIRECT-TO-CONSUMER GENETIC TESTING 193
p.000165: Opinion
p.000195: 195
p.000195: Report
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p.000203: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT 221
p.000203: Opinion
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p.000223: Report
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p.000233: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE AND MENTAL STATE 267
p.000233: Opinion
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p.000269: Report
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p.000001: USE OF GENETIC DATA IN PRIVATE INSURANCE
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p.000222: O P I N I O N
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p.000222: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000222:
p.000222:
p.000222: Introduction
p.000222:
p.000222: The Hellenic National Bioethics Commission met repeatedly upon invita- tion by the President in order to consider the
p.000222: ethical issues within its juris- diction regarding “Human Enhancement”. This term includes medical inter- ventions on
p.000222: the healthy body, aimed at shaping desirable characteristics, basically for psychological and social
p.000222: reasons (aesthetic preferences, in- creased physical or cognitive performance, etc.).
p.000222: In view of the purpose of such interventions, which is not to treat health damages, specific issues arise
p.000222: concerning the extend of autonomy of the person interested and the appropriate approach of physicians. However,
p.000222: it is worth noting that, based on the broad definition of health provided by the World Health Organization,
p.000222: according to which “Health is a state of com- plete physical, mental and social well-being and not merely the
p.000222: absence of disease or infirmity”, such interventions are, undoubtedly, included in the practice of medicine,
p.000222: and therefore ruled by the general medical ethics.
p.000222: One can distinguish various categories of enhancing interventions, de- pending on the purpose they serve.
p.000222: Thus, there are interventions that en- hance:
p.000222: a) Physical characteristics and abilities,
p.000222: b) mental characteristics and personality, and
p.000222: c) cognitive abilities.
p.000222: The Commission considers that it is useful to issue an Opinion on the first category, which will precede
p.000222: the other two, so as to better highlight the relevant issues.
p.000222:
p.000222: Improvement of physical characteristics and abilities
p.000222:
p.000222: The category of improving physical characteristics and abilities includes, in particular, the cases of:
p.000222: Ι) Plastic surgery (surgical or non-surgical),
p.000222:
p.000223: 223
p.000223:
p.000223: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000223: OPINION
p.000223:
p.000223: II) enhancing physical abilities,
p.000223: III) using mechanical means of enhancement.
p.000223: To examine the issue of physical enhancement, the Commission held hearings on Dr. G. Christodoulou, Emeritus
p.000223: Professor of Psychiatry, Medical School, University of Athens and Honorary President of the Greek Psychiat- ric
p.000223: Association, Dr. A. Mandrekas, President of the Greek Association of Plas- tic, Reconstructive and Aesthetic Surgery,
p.000223: Dr. G. Creatsas, Professor of Gy- necology and Director of the 2nd Obstetrics and Gynecology Clinic, “Are-
p.000223: taieion” Hospital, Medical School, University of Athens, Dr. G. Vassilopoulos, Associate Professor of Pathology -
p.000223: Hematology, Medical School, University of Thessaly and Associate Researcher, Department of Genetics and
p.000223: Gene Therapy, Biomedical Research Foundation of the Academy of Athens, and Dr. C. Spiliopoulou,
p.000223: Associate Professor of Forensic Medicine, Medical School, University of Athens and President of the
p.000223: Hellenic National Anti- doping Council.
p.000223:
p.000223: Ι. Plastic Surgery
p.000223:
p.000223: 1. Overview
p.000223:
...

p.000233: difficult to define “healthy” since the World Health Organization (WHO) describes in its constitution that "health is a
p.000233: state of complete physical, mental and social well-being and not merely the absence of disease or infirmity". This
p.000233: definition expands the boundaries of health, including non-medical problems such as those resulting from spe- cific
p.000233: social characteristics. The definition of normal is even more difficult if one considers that there are “natural”
p.000233: differences, not only between indi- viduals but also within the same individual at different developmental stag-
p.000233: es.
p.000233: On the other hand, the modern medical practice already applies practis- es that aim not only at the correction of
p.000233: pathological conditions and diseas- es:
p.000233: First and foremost, preventive medicine, which aims to prevent and ultimately avoid disease. Preventive medicine
p.000233: includes preventive vaccination.
p.000233: Palliative care, which is offered in order to relieve from pain and prevent the suffering of patients.
p.000233: Infertility treatments, aiming, ultimately, to reproduction.
p.000233:
p.000233:
p.000234: 234
p.000234:
p.000234: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000234: REPORT
p.000234:
p.000234: Plastic surgery, which is offered to healthy people who want to enhance or change their physical
p.000234: characteristics.
p.000234:
p.000234: b) Techniques of human enhancement
p.000234:
p.000234: Human enhancement can be achieved by various methods and techniques, including:
p.000234: Pharmaceutical substances causing for example exaltation and happiness that enhance memory, physical
p.000234: strength and stamina and cognitive abilities.
p.000234: Techniques of genetic intervention that facilitate for example the selection and creation of healthy or smarter
p.000234: children and increase life expectancy.
p.000234: Regenerative medicine, which aim to regenerate tissues and organs.
p.000234: Technological interventions that improve human capabilities. Cosmetic interventions (surgical or non-surgical) that aim
p.000234: to improve the external appearance and physical characteristics.
p.000234: Table I presents indicative examples of the above mentioned techniques, which can be applied to both treatment and
p.000234: human enhancement.
p.000234:
p.000234:
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p.000235: 235
p.000235:
p.000235: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT REPORT
p.000235:
p.000235: Table I. Interventions applied to both treatment and human enhancement.
p.000235:
p.000235: Treatment Human enhancement Pharmaceutical substances
p.000235:
p.000235: Growth hormone Developmental problems in
p.000235: children
p.000235: Enhancing appearance Enhancing athletic performance
p.000235: Insulin growth factor Muscular dystrophy Increasing muscle mass Enhancing athletic
p.000235: performance
p.000235:
p.000235: Rimonabant and sibutramine
p.000235: Obesity Enhancing appearance Increase strength in patients
p.000235:
p.000235: Erythropoietin
p.000235: undergoing chemotherapy and present with anemia
p.000235: Enhancing athletic performance
...

p.000238: over-extending the area of “unhealthy” (if not the area of “patient”). Therefore, it seems that the first position
p.000238: ignores that the “full development” of an organism’s abilities is strongly subjective. The subjective assessment of
p.000238: our abilities is amplified by the fact that, nowadays, technology provides great opportunities for
p.000238: interventions and therefore for satisfaction of our real or non-real needs. The gradual
p.000238: “medicalization” of life may be a side effect of this problem.
p.000238: On the other hand, the “moderate” definition of health, marginally, remains unclear. That is because, if
p.000238: the development of a disease or an illness after an accident can be, in general, easily identifiable with
p.000238: objective methods, this is not the case with preventive medicine, that aims at reducing risks:
p.000238: frequently, “risk” is being confused with “health damage”
p.000238:
p.000238:
p.000238: 1 In a similar direction the so-called transhumanists do not consider that distinguish- ing between therapy and human
p.000238: enhancement is important. They comprise a move- ment which claims that humans must lead their own evolution
p.000238: beyond the limits imposed by biology. Tanshumanists believe that enhancement must be addressed as treatment, i.e. to
p.000238: use freely all the possibilities provided by science and technology for enhancement purposes. Like transhumanists,
p.000238: proponents of human enhancement in general, consider that any delays in the use of technologies, such as genetic
p.000238: interven- tions to improve cognitive abilities, have harmful effects on our health, quality and life expectancy. In
p.000238: contrast, opponents of human enhancement argue that the new technologies will not solve the problems of inequality and
p.000238: social justice.
p.000238:
p.000239: 239
p.000239:
p.000239: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000239: REPORT
p.000239:
p.000239: and is amenable to medical care in order to reduce it (e.g. taking drugs to reduce glucose or cholesterol
p.000239: levels). But beyond that, the physical deterioration of the organism with the occurrence of aging is
p.000239: undoubtedly “damage” and is regularly treated with advanced medical care (in many levels), however, it leads
p.000239: to a fatal “medicalization” of the life of the elderly. But if we accept this natural decay as inevitable, we
p.000239: should define more precisely the limits of medical intervention, finding eventually a “gray zone” to the moderate
p.000239: definition of health.
p.000239: The so-called “enhancement” raises this general issue on the very own concept of health, and consequently, the nature
p.000239: of the medical profession, which are complemented by two additional ethical issues that must be addressed
p.000239: specifically.
p.000239: Firstly, there is the question of our own self-determination in health issues. In other words, is
p.000239: “enhancement” a right of the person who wishes it? Namely, does enhancement fall within the realm of biological
p.000239: autonomy, and indeed, is it an aspect of the fundamental right to health? Regardless of the legal dimension of such
...

p.000243: otherwise dysmorphophophia (Crerand et al., 2006). BDD is a common psychiatric disorder that affects 1-2%
p.000243: of the general population and occurs with equal frequency in men and women. It is characterized by an excessive
p.000243: preoccupation of the person with imaginary or minor physical defects in various body parts. The
p.000243: condition is often associated with frequent hospitalization (48%) and high rates of depression and
p.000243: obsessive-compulsive disorders leading to suicidal tendencies and attempts (Phillips et al., 2006).
p.000243: Individuals suffering from BDD often resort to plastic surgeries in order to enhance their appearance. According
p.000243: to studies, 50%-76% of these patients seek plastic surgery, while 58%-66% of them eventually undergo
p.000243: plastic surgery and 26% of them undergo more than one plastic surgery (Crerand et al., 2006).
p.000243: Nevertheless, studies show that only a small percentage of these patients -just about 2%- are eventually
p.000243: satisfied by their body image after plastic surgery, while most of them continue to have symptoms of BDD.
p.000243: In most cases, these patients showed no improvement on their symptoms, while they often threaten or even
p.000243: sue the plastic surgeon who carried out the surgery (Crerand et al., 2010).
p.000243: Unlike plastic surgery, the therapy which is indicated for individuals who suffer from BDD is the use of certain
p.000243: drugs, mainly selective serotonin re- uptake inhibitors, and psychotherapeutic methods, and in
p.000243: particular, cognitive psychotherapy (Crerand et al., 2010).
p.000243: For the aforementioned reasons, it is essential that the plastic surgeon who suspects that a person seeking
p.000243: plastic surgery may present with BDD symptoms, refers the patient to a psychiatrist for proper mental
p.000243: help. However up to now, data coming from the USA show that plastic surgeons are aware of the BDD and often
p.000243: refuse to offer plastic surgeries in these patients at a percentage ranging from 21 to 84%, depending on the
p.000243: survey
p.000243:
p.000243:
p.000244: 244
p.000244:
p.000244: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000244: REPORT
p.000244:
p.000244: (Phillips et al., 2001; Crerand et al., 2005; Sarwer 2002). Nevertheless, there are no similar studies in European
p.000244: countries.
p.000244:
p.000244: d) Gender characteristics and plastic surgery
p.000244:
p.000244: Plastic surgery is applied as a treatment to change gender characteristics in specific cases, which include:
p.000244: Gender identity disorder (or gender dysphoria). This is a neuro- developmental disorder, in which individuals
p.000244: with the phenotype of one gender have the psychism of the opposite gender (GIRES 2008). These individuals do not
p.000244: present with hermaphro-ditism. The recommended treatment in such cases is hormonal treatment or plastic
p.000244: surgery or psychotherapy, or a combination of the above. The World Professional Association for Transgender Health
...

p.000261: 240, 333-41.
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p.000261: health of transsexual, transgender, and gender- nonconforming people, Version 7. International Journal of
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p.000261: Comité Consultatif National d` Éthique (CCNE) (1998). Rapport sur le vieillissement, Opinion No 59.
p.000261: Comité Consultatif National d` Éthique (CCNE) (2004). L’ allotransplantation de tissu composite (ATC) au niveau de la
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p.000261: 167e-80e.
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p.000261: persons with body dysmorphic disorder. Ann Plast Surg 65, 11-6.
p.000261:
p.000261:
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p.000262:
p.000262: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000262: REPORT
p.000262:
p.000262: Crerand CE, Phillips KA, Menard W, Fay C (2005). Nonpsychiatric medical treatment of body dysmorphic
p.000262: disorder. Psychosomatics 46, 549-55.
p.000262: European Group on Ethics (EGE) (1999). Ethical aspects arising from doping in sport, Opinion No 14, 1.6, 2.10.
p.000262: Farah MJ (2005). Neuroethics: The practical and the philosophical trends in cognitive sciences, p. 34.
p.000262: Fukuyama F (2002). Our posthuman future: Consequences of the biotechnology revolution, Farrar,
p.000262: Strauss and Giroux, N. York.
p.000262: Garcia-Verdugo M (2005). Medio fondo y fondo. La preparacion del corridor de resistencia. Atletismo 4. Madrid. RFEA.
p.000262: GIRES (Gender Identity Research and Education Society) (2008). Gender var- iance (dysphoria) (www.gires.org.uk).
p.000262: Hayflick L (2003). Living forever and dying in the attempt. Exp Gerontol 38, 1231-1241.
p.000262: Hildt E (2005). Living longer: Ethical aspects of age-retardation, Paper presented at the 19th European
p.000262: Conference on Philosophy of Medicine and Health Care and 22nd EACME Conference “Ethics and Philosophy of Emerging
p.000262: Medical Technologies”, Barcelona.
p.000262: House of Commons, Select Committee on Culture, Media and Sport (2004). Seventh Report of Session 2003-2004, UK
p.000262: Parliament, HC 499-I.
p.000262: Huxtable R, Woodley J (2005). Gaining face or losing face? Framing the debate on face transplants.
p.000262: Bioethics, p. 505.
p.000262: Ingram DK, Anson RM, De Cabo R, Mamczarz J, Zhu M, Mattison JA, Lane MA, Roth GS (2004). Development of
p.000262: calorie restriction mimetics as a pro- longevity strategy. Ann NY Acad Sci 1019, 412-423.
p.000262: Kriari-Katrani I (2001). The constitutional protection of genetic identity. A first approach. DtA 2001, p.347.
...

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p.000262:
p.000262:
p.000262:
p.000263: 263
p.000263:
p.000263: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000263: REPORT
p.000263:
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p.000263: Mayer-Rokitansky-Küster-Hauser (MRKH) syn- drome. Orphanet J Rare Dis 14, 2:13.
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p.000263: Parasidis E (2012). Human enhancement and experimental research in the military. Connecticut Law Review 44, 1117.
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p.000263: with body dysmorphic disorder. Psycho- somatics 42(6):504-10.
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p.000263: Report from a joint workshop hosted by the Academy of Medical Sciences, the British Academy, the Royal Academy of
p.000263: Engineering and the Royal Socie- ty (2012). Human enhancement and the future of work.
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p.000263: survey of American Society for Aes- thetic Plastic Surgery Members. Aesthet Surg J 22, 531-5.
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p.000264: 264
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p.000264: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000264: REPORT
p.000264:
p.000264: Smith SL (2008). Mustard Gas and American Race-Based Human Experimen- tation in World War II. Journal of Law, Medicine
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p.000264: Takata H, Suzuki M, Ishii T, Sekiguchi S, Iri H (1987). Influence of major histo- compatibility complex region on
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p.000264: Vidalis TK (2007). Biolaw. 1st volume. The Person. Eds. Sakkoulas 2007, p. 239.
p.000264: Wolpe PR (2002). Treatment, enhancement, and the ethics of neurotherapeutics, brain and
p.000264: cognition, p. 387.
p.000264: World Anti-Doping Agency (2001). Health, Medical and Research Committee Meeting. Minutes. Lausanne.
p.000264: World Anti-Doping Agency (2002). WADA conference sheds light on the po- tential of gene doping. Press release, World
p.000264: Anti-Doping Agency, New York.
p.000264: World Anti-Doping Agency (2003). International standard for the prohibited list 2004.
p.000264: World Anti-Doping Agency (2005). The Stockholm Declaration. Montreal: World Anti-Doping Agency.
p.000264:
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p.000268: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000268: OPINION
p.000268:
p.000268: O P I N I O N
p.000268:
p.000268: HUMAN ENHANCEMENT -
p.000268: EFFECT ON COGNITIVE AND MENTAL STATE
p.000268:
p.000268: The Hellenic National Bioethics Commission, as previously announced, continued to examine the issue of “human
p.000268: enhancement”, focusing on the effects of enhancement methods on the cognitive and mental state of the human organism.
p.000268: To study the issue, the Commission held relevant hearings of Dr. G. Christodoulou, Emeritus Professor of
p.000268: Psychiatry, Medical School, Athens University and Honorary President of the Greek Psychiatric Association and Dr. G.
p.000268: Kolaitis, Associate Professor of Child Psychiatry, Medical School, Ath- ens University.
p.000268:
p.000268: I. The data
p.000268:
p.000268: Modern science enabled the development of specific interventions for the “cognitive" functions of the human
p.000268: body, with a main purpose to treat mental illnesses and disorders. However, the possibilities offered by modern science
p.000268: highlight the problem of whether it is legitimate to use such meth- ods in healthy organisms, aiming to enhance the
p.000268: mental or emotional condi- tion.
p.000268: Such methods are particularly: a) selective stimulation of brain regions, with electrical or magnetic signals, and b)
p.000268: drug use. In the future, it is likely that these methods are enriched by targeted genetic modification of genes
p.000268: associated with cognitive functions, as well as by brain/computer interfaces, which is expected to allow access
p.000268: to electronic information -and generally use of computer programs- by just activating certain cognitive functions.
p.000268: The Commission notices that there is internationally, a widespread use of substances by healthy individuals
p.000268: (nicotine, caffeine) or even prescription drugs, with the aim to further enhance their cognitive functions.
p.000268: Users mainly pursue memory and attention enhancement, but also to treat nor- mal hyperactivity, which occurs
p.000268: particularly in children. In addition, the ap- pearance of anxiety or phobias, typical elements of everyday life in a
p.000268: mod-
p.000268:
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p.000269: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000269: OPINION
p.000269:
p.000269: ern social context, puts pressure on healthy individuals to use sedatives, antianxiety and antidepressant
p.000269: drugs.
p.000269: The Commission considers that, as in the case of enhancing physical characteristics, the autonomy of a
p.000269: healthy person includes options for en- hancing the cognitive or mental state of the human body. This enhancement
p.000269: is part of the right to develop freely a personality.
p.000269:
p.000269: II. Suggestions
p.000269:
p.000269: However, the aforementioned principle must be supplemented with necessary remarks.
p.000269: 1. The use of drugs to enhance memory or attention may adversely af- fect other cognitive functions. Due to this
p.000269: eventuality, the person concerned must be fully informed, in order to have the opportunity of an independent choice.
p.000269: 2. The issue of influencing the personality is particularly emphasized in the case of antidepressants use. The above
p.000269: mentioned influence is in princi- ple legitimate, as a fundamental right of the person, but it encloses the risk of
p.000269: uncontrolled effects on the nervous system and the general physical and mental condition of the person. The Commission
p.000269: notes the risk when chil- dren use such drugs since such a use may lead to the substitution of all the efforts made to
p.000269: integrate the person into society. A personality is developed by the gradual and smooth integration of the
p.000269: person into the social envi- ronment, owing to the family, friends or educational mechanisms that have the
p.000269: advantage of being subjected to constant scrutiny and revision, and are reversible if necessary, depending on the
p.000269: person’s maturity. For the Com- mission, this advantage is necessary to be ensured, especially in the case of
p.000269: children. For this reason, the use of substances for non-therapeutic purpos- es is not legitimate in children.
p.000269: 3. The use of enhancement methods to improve cognitive and mental functions always requires that the
p.000269: person concerned is fully informed and updated, in terms of the expected results and possible side
p.000269: effects. The Commission considers that the risk of misinformation, especially for drugs which are not
p.000269: prescribed, is serious. The promotion of these drugs to the public and the information leaflets about their
p.000269: use should be subjected to special inspection by the authorities (National Organization for Medicines,
p.000269:
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p.000270: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000270: OPINION
p.000270:
p.000270: General Secretariat for Commerce, etc.). It is apparent that for prescription drugs, the physician and the pharmacist
p.000270: have an increased responsibility to properly inform the person concerned, especially since it remains doubtful whether
p.000270: the prescription for enhancement purposes falls within the medical responsibilities, such as those described in the
p.000270: Code of Medical Ethics (Law 3418/2005).
p.000270: 4. Noting the complete lack of evidence in our country, regarding the extent of use of human
p.000270: enhancement methods to improve cognitive and mental characteristics, the Commission considers that it is
p.000270: essential for re- search institutions to develop initiative to monitor the phenomenon sys- tematically, with
p.000270: the support of the Ministry of Health.
p.000270: The increasing number or reasons causing mental disorders in the popu- lation (especially among young people), most of
p.000270: which cannot be defined as “pathological”, due to prolonged economic crisis (excessive growth of un-
p.000270: employment, underemployment, strong economic downturn, uncertainty about the future, etc.), absolutely requires a
p.000270: well-organized initiative from the State.
p.000270:
p.000270:
p.000270: Athens, 5 November 2013
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p.000271: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000271: OPINION
p.000271:
p.000271: COMPOSITION AND PERSONELL
p.000271: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000271: Chairman: John Papadimitriou, Emeritus Professor of Surgery, Medical School, University of Athens.
p.000271:
p.000271: Members:
p.000271: Julia Iliopoulou-Stranga, Professor of Constitutional Law, Law School, Uni- versity of Athens.
p.000271: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000271: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000271: Athens.
p.000271: Evangelos Moutsopoulos, Member of the Academy of Athens, Emeritus Professor of Philosophy, University of
p.000271: Athens.
p.000271: Theocharis Patargias, Emeritus Professor of Genetics, University of Athens
p.000271: Constantinos Tsoukalas, Emeritus Professor of Sociology, University of Ath- ens.
p.000271: Christos Voulgaris, Emeritus Professor of Theology, University of Athens.
p.000271:
p.000271: PERSONELL
p.000271:
p.000271: Scientific Officers:
p.000271: Takis Vidalis, Lawyer, PhD in Law.
p.000271: Vasiliki Mollaki, Geneticist, PhD in Genetics.
p.000271:
p.000271: Secretariat:
p.000271: Marianna Drakopoulou, Lawyer, Head of Secretariat.
p.000271:
p.000271:
p.000271:
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p.000272:
p.000272: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000272: REPORT
p.000272:
p.000272: R E P O R T
p.000272:
p.000272: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE AND MENTAL STATE
p.000272:
p.000272: Rapporteurs: Takis Vidalis, Vasiliki Mollaki
p.000272: Introduction
p.000272:
p.000272: Many psychiatric, neurodegenerative and neurodevelopmental disorders coexist with abnormalities in “normal”
p.000272: cognitive and mental functions. Autism, intellectual disability, attention deficit disorder,
p.000272: schizophrenia, depression but also neurodegenerative diseases, such as Alzheimer's, Parkinson's and
p.000272: Huntington's chorea, are associated with impairment of cognitive functions. Aging of the brain also leads
p.000272: to similar effects. The continuous and rapid scientific developments make it possible, to some extent, to
p.000272: intervene in the development of these diseases and delay their symptoms, mainly through pharmaceutical
p.000272: substances that aim to enhance cognitive functions. Therefore, the moral issue raised here, is whether these
p.000272: pharmaceutical substances could be used in healthy people in order to enhance their cognitive and mental
p.000272: characteristics.
p.000272: The term “cognitive” functions refers to the procedures and processes of an organism that organize information.
p.000272: This includes the acquisition, selection, clarification and recollection of information, which correspond to
p.000272: the perception, attention, understanding and memory of the organism, as well as the way these processes
p.000272: determine behavior.
p.000272:
p.000272: I. The data
p.000272:
p.000272: Unquestionably, education, consumption of certain nutrients and the use of information processing devices,
p.000272: such as calculators and computers, constitute tools to improve cognitive activity and performance. However,
p.000272: these are considered as “conventional” and are commonly accepted. New technologies such as brain stimulation,
p.000272: and new uses of older technologies such as psychotropic drugs, are the subject of discussion and reflection
p.000272: in bioethics, in the context of human enhancement.
p.000272:
p.000272:
p.000273: 273
p.000273:
p.000273: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000273: REPORT
p.000273:
p.000273: 1. Brain stimulation
p.000273:
p.000273: a. “Deep brain stimulation”
p.000273:
p.000273: The so-called “deep brain stimulation” is an invasive, research method in which electrodes are implanted in the
p.000273: brain sending electrical stimulatory signals in selected regions of the brain. This method, among others,
p.000273: has been used experimentally to treat depression, epilepsy and Parkinson's disease with relatively good
p.000273: results. Indeed, deep brain stimulation has been approved by the U.S. Food and Drug Administration (FDA) for the
p.000273: treatment of essential tremor, dystonia and Parkinson's disease. Even though this technology could be used to
p.000273: enhance human cognitive and mental abilities, nevertheless there are no reports on the use of these
p.000273: experimental technologies in healthy subjects.
p.000273:
p.000273: b. Magnetic brain stimulation
p.000273:
p.000273: Magnetic stimulation of the cerebral cortex is a similar, but non-invasive method, which is approved by the FDA
p.000273: for the treatment of depression, while it is also tested experimentally in stroke patients. Yet, several studies
p.000273: have been conducted in order to investigate the effect of magnetic brain stimulation in healthy subjects,
p.000273: showing positive results for enhancement of cognitive and mental functions. For example, magnetic stimulation
p.000273: of the brain changes brain plasticity (neural plasticity), namely, the ability of the nervous system to
p.000273: adapt to changing conditions, enhances performance and changes the person’s behavior1, learning ability2, memory3, and
p.000273: even hand- writing or spelling ability4. Nevertheless, it must be noted that the above mentioned studies
p.000273: were performed in a relatively small number of healthy
p.000273:
p.000273: 1Hummel FC, Cohen LG (2005). Drivers of brain plasticity. Curr Opin Neurol 18, 667- 74.
p.000273: 2Pascual-Leone A, Tarazona F, Keenan J, et al. (1999).Transcranial magnetic stimula- tion and neuroplasticity.
p.000273: Neuropsychologia 37, 207-17.
p.000273: 3Fregni F, Boggio PS, Nitsche M, et al. (2005). Anodal transcranial direct current stim- ulation of prefrontal cortex
p.000273: enhances working memory. Exp Brain Res 166, 23-30.
p.000273: 4Snyder AW, Mulcahy E, Taylor JL, et al. (2003). Savant-like skills exposed in normal people by suppressing the
p.000273: leftfronto-temporal lobe. J Integr Neurosci 2, 149-58.
p.000273:
p.000274: 274
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p.000274: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000274: REPORT
p.000274:
p.000274: volunteers whereas individual differences in the brain of healthy subjects should be taken into account when
p.000274: interpreting the results. As a final point, the possible side effects that may result from magnetic
p.000274: stimulation of the brain, such as seizures, is an important reason for such technologies not be used for human
p.000274: enhancement.
p.000274:
p.000274: 2. Use of pharmaceutical agents
p.000274:
p.000274: a. Enhancement of mental/cognitive characteristics
p.000274:
p.000274: In general, nutrients or chemicals which enhance cognitive functions are often referred to as “nootropics”, a term
p.000274: which was first used in 1972 by the Romanian psychologist and chemist Cornelius Giurgea5. Nootropic drugs, or else
p.000274: “smart drugs” function in the human body based on two processes:
p.000274: 1. By either affecting glucose metabolism and blood flow in the brain or,
p.000274: 2. by increasing the levels of neurotransmitters or neuromodulators which play a role in memory or attention.
p.000274: Early studies of strokes showed that strokes could be due to narrowing of blood vessels that supply the brain with
p.000274: blood, and hence, with oxygen and glucose. Consequently, it was considered that nootropics, which
p.000274: increase blood flow in the brain, such as propranolol (beta-adrenergic blocker), phenytoin (for epilepsy)
p.000274: and dihydroergotoxin (cerebrovascular vasodilator), could enhance neuron performance (Rose et al., 2005).
p.000274: Later studies in people suffering from Alzheimer's disease showed that their neurons are destroyed, especially
p.000274: neurons secreting acetylcholine. This led to the hypothesis that an increase of acetylcholine in the brain
p.000274: may result in better memory and the consequent use of drugs such as piracetam, which is a psychostimulant, as well
p.000274: as substances that interact with other neurotransmitters, such as serotonin and dopamine (Rose et al., 2005).
p.000274: Such studies in patients (with strokes or Alzheimer's disease) contributed to the development of smart drugs for
p.000274: healthy people. In contrast to technologies of brain stimulation by electrical or magnetic signals, the use of
p.000274: substances by non-patients to enhance cognitive functions is more frequent.
p.000274:
p.000274: 5 Giurgea CE, Greindl MG, Preat S (1983). Nootropic drugs and aging. Acta Psychiatr Belg 83, 349-58.
p.000274:
p.000275: 275
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p.000275: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000275: REPORT
p.000275:
p.000275: Stimulants such as nicotine and caffeine have a proven effect on the increase of attention and memory 6,7
p.000275: and are widely used on a daily basis. However, nowadays, the use of prescription stimulants is also common.
p.000275: Methylphenidate (known under the commercial names Ritalin, Concerta, Metadate, Methylin) and amphetamine
p.000275: (commercial name Adderall) are used to treat attention deficit hyperactivity disorder (ADHD) in children.
p.000275: Nevertheless, these stimulant substances are commonly used by young people to enhance their attention and
p.000275: academic performance.
p.000275: A study in 4,580 American college students showed that 8.3% of students reported illicit use of
p.000275: prescription stimulants at least once in their lifetime, while 5.9% of them used it during the previous year.
p.000275: Of these, 75.8% used amphetamine while 24.5% used methylphenidate, with a higher rate of use among Caucasians. The
p.000275: study indicates that the most frequent incentives for stimulant use is to increase concentration, receive help during
p.000275: studying and increase attention8. These results were confirmed by similar studies9 indicating the problem
p.000275: of frequent use, especially amphetamine use, in college students.
p.000275: Modafinil is also a stimulating substance indicated for the treatment of excessive sleepiness in patients with
p.000275: narcolepsy. However, studies in healthy subjects showed that Modafinil improves memory10, as well as the levels
p.000275: of wakefulness and alertness in physicians11 and pilots12, making
p.000275:
p.000275: 6Warburton DM (1992). Nicotine as a cognitive enhancer. Progress in Neuro- Psychopharmacology and
p.000275: Biological Psychiatry, 16, 181-191.
p.000275: 7Newhouse PA, Potter A & Singh A (2004). Effects of nicotinic stimulation on cognitive performance. Current Opinion in
p.000275: Pharmacology, 4, 36-46.
p.000275: 8Teter CJ, McCabe SE, Boyd CJ, Guthrie SK (2003). Illicit methylphenidate use in an undergraduate student
p.000275: sample: Prevalence and risk factors. Pharmacotherapy 23, 609-17.
p.000275: 9McCabe SE, Teter CJ, Boyd CJ (2006). Medical use, illicit use and diversion of pre- scription stimulant
p.000275: medication. J Psychoactive Drugs 38, 43-56.
p.000275: 10Müller U, Steffenhagen N, Regenthal R, Bublak P (2004). Effects of modafinil on working memory processes
p.000275: in humans. Psychopharmacology (Berl) 177, 161-9.
p.000275: 11Gill M, Haerich P, Westcott K, et al., (2006). Cognitive performance following modafinil versus placebo
p.000275: in sleep-deprived emergency physicians: A double-blind randomized crossover study. Acad Emerg Med 13, 158-65.
p.000275: 12Caldwell JA Jr, Caldwell JL, Smythe NK 3rd, Hall KK (2000). A double-blind, placebo- controlled investigation of the
p.000275: efficacy of modafinil for sustaining the alertness and
p.000275:
p.000276: 276
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p.000276: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000276: REPORT
p.000276:
p.000276: modafinil a substance capable of enhancing cognitive functions in humans.
p.000276:
p.000276: b. Enhancement of mental characteristics and mood
p.000276:
p.000276: At this point, it would be impossible not to mention other pharmaceutical substances,
p.000276: the use of which aims to relieve from phobias and addictions, and could well be used to improve mental
p.000276: characteristics. Illustrative examples are propranolol, which seems to have a preventive effect on
p.000276: post-traumatic stress13 and D-cycloserine, which reduces fear in individuals with phobias14and social anxiety
p.000276: disorder15.
p.000276: Finally, mood enhancers used to enhance a person’s mood, are an issue of concern. Selective Serotonin Reuptake
p.000276: Inhibitors (SSRIs), such as Prozac, Zoloft and other antidepressants are administered in mood and anxiety
p.000276: disorders. In his book “Listening to Prozac” the psychiatrist Peter Kramer reports discussions that he
p.000276: had with patients but also with people not suffering from depression, who all used Prozac to enhance their
p.000276: confidence and self-esteem and felt “better” and “socially more attractive”16. Nevertheless,
p.000276: consequent reviews of the book focused mainly on the subjectivity of diagnosing the symptoms and the
p.000276: severity of depression, as well as to the questions: “How can one distinct an existential crisis from a clinical
p.000276: depression?” and “how can we know if a depressed state is normal, abnormal, healthy or unhealthy?”17.
p.000276: Subsequent studies in healthy volunteers showed that antidepressants do not constitute “happiness pills”, as
p.000276: many people call them. The admini-
p.000276:
p.000276: performance of aviators: A helicopter simulator study. Psychopharmacology (Berl) 150, 272-82.
p.000276: 13Pitman RK, Sanders KM, Zusman RM, et al. (2002).Pilot study of secondary preven- tion of posttraumatic stress
p.000276: disorder with propranolol. Biol Psychiatry 51, 189-92.
p.000276: 14Ressler KJ, Rothbaum BO, Tannenbaum L, et al. (2004). Cognitive enhancers as ad- juncts to psychotherapy: Use of
p.000276: D-cycloserine in phobic individuals to facilitate extinc- tion of fear. Arch Gen Psychiatry 61, 1136-44.
p.000276: 15Hofmann SG, Meuret AE, Smits JA, et al. (2006). Augmentation of exposure therapy with D-cycloserine for social
p.000276: anxiety disorder. Arch Gen Psychiatry 63, 298-304.
p.000276: 16Kramer PD. Listening to Prozac. Penguin Books 1993.
p.000276: 17Bjorklund P (2005). Can there be a “cosmetic” psychopharmacology? Prozac un- plugged: The search for an
p.000276: ontologically distinct cosmetic psychopharmacology. Nurs Philos 6, 131-43.
p.000276:
p.000277: 277
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p.000277: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000277: REPORT
p.000277:
p.000277: stration of paroxetine, a SSRI, was shown to reduce markers of hostility through a more general reduction of
p.000277: negative effects, but did not alter the positive effect18. Additionally, the social behavior of healthy volunteers was
p.000277: changed during an exercise that required cooperation19. Nevertheless, the use of SSRIs was accompanied by side
p.000277: effects, mainly changes in memory20 and alertness21.
p.000277:
p.000277: 3. Use of genetic technologies
p.000277:
p.000277: Genetic studies in humans showed that there are genetic polymorphisms (normal variants) in genes such as WWC122,23, and
p.000277: APOE24, that explain, at least to some extent, differences in memory between individuals. Similar studies
p.000277: showed that human intelligence is determined, to a lesser extent, by genetic polymorphisms in various genes25. These
p.000277: genes are potential targets for genetic intervention to enhance human memory and intelligence.
p.000277:
p.000277:
p.000277:
p.000277: 18Knutson B, Wolkowitz OM, Cole SW, et al. (1998). Selective alteration of personality and social behavior by
p.000277: serotonergic intervention. Am J Psychiatry 155, 373-9.
p.000277: 19Tse WS and Bond AJ, (2002). Serotonergic intervention affects both social domi- nance and affiliative
p.000277: behavior. Psychopharmacology (Berl) 161, 324-30.
p.000277: 20Schmitt JA, Kruizinga MJ, Riedel WJ (2001). Non-serotonergic pharmacological pro- files and associated cognitive
p.000277: effects of serotonin reuptake inhibitors. J Psychophar- macol 15, 173-9.
p.000277: 21Riedel WJ, Eikmans K, Heldens A, Schmitt JA (2005). Specific serotonergic reuptake inhibition impairs vigilance
p.000277: performance acutely and after subchronic treatment. J Psychopharmacol 19, 12-20.
p.000277: 22Papassotiropoulos A, Stephan DA, Huentelman MJ, et al. (2006). Common Kibra alleles are associated with
p.000277: human memory performance. Science20; 314, 475-8.
p.000277: 23Milnik A, Heck A, Vogler C, et al., (2012). Association of KIBRA with episodic and working memory: A
p.000277: meta-analysis. Am J Med Genet B Neuropsychiatr Genet 159B, 958-69.
p.000277: 24Mondadori CR, de Quervain DJ, Buchmann A, et al. (2007). Better memory and neu- ral efficiency in young
p.000277: apolipoprotein E epsilon4 carriers. Cereb Cortex 17, 1934-47. 25Craig I, Plomin R (2006). Quantitative trait loci for
p.000277: IQ and other complex traits: Sin- gle-nucleotide polymorphism genotyping using pooled DNA and microarrays. Genes Brain
p.000277: Behav 5 Suppl 1, 32-7.
p.000277:
p.000278: 278
p.000278:
p.000278: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000278: REPORT
p.000278:
p.000278: However there are studies in animal models, particularly mice, sugge- sting new gene targets for enhancing
p.000278: intellectual and mental characteristics, with a possible extension of the use in humans. A typical example
p.000278: is the receptor subunit NR2B of the NMDA receptor, which leads to an increased learning and memory ability of mice
p.000278: when it is overexpressed after genetic modification26.
p.000278:
p.000278: 4. Human brain-computer interfaces
p.000278:
p.000278: Brain-computer interfaces refer to a number of technologies having as an ultimate aim to achieve
p.000278: interaction and communication between the human nervous system and a computer or an external device27.
p.000278: Brain- computer interfaces use the brain’s electrical activity as a command to a machine, e.g. a computer
p.000278: or a prosthetic arm, causing operation of the system directly through thoughts. Brain electrical signals are
p.000278: recorded with an electroencephalogram, either with electrodes attached to the scalp (non- invasive method) or
p.000278: with electrodes implanted in the brain (invasive method). While the non-invasive method is less
p.000278: accurate in recording signals, the invasive method poses risks since electrodes are implanted in the brain
p.000278: cortex with possibilities of infection and brain damage.
p.000278: The main objective of brain-computer interfaces is to replace or restore function in patients suffering from
p.000278: neuromuscular diseases, by controlling the movement of prosthetic limbs or a wheelchair. However, such te-
p.000278: chnologies may also be applied to control robots, military vehicles and airplanes, games and virtual
p.000278: environments. According to brain-computer interface experiments, paralyzed patients can control a computer
p.000278: cursor using electrodes28,29,30, allowing the use of brain-computer interfaces for
p.000278:
p.000278: 26Tang YP, Shimizu E, Dube GR, et al. (1999). Genetic enhancement of learning and memory in mice. Nature 401, 63-9.
p.000278: 27Nicolas-Alonso LF, Gomez-Gil J (2012). Brain computer interfaces, a review. Sensors (Basel) 12, 1211-79.
p.000278: 28Hochberg LR, Bacher D, Jarosiewicz B, et al. (2012). Reach and grasp by people with tetraplegia using a neurally
p.000278: controlled robotic arm. Nature 485, 372-5.
p.000278: 29Pereira CA, Bolliger Neto R, et al. (2009). Development and evaluation of a head- controlled human-computer
p.000278: interface with mouse-like functions for physically disa- bled users. Clinics (Sao Paulo) 64, 975-81.
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p.000279: 279
p.000279:
p.000279: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000279: REPORT
p.000279:
p.000279: continuous access to the internet, databases and information processing systems, which can enhance the
p.000279: abilities of human mind. Although these technologies are notable, however they must progress in order to
p.000279: achieve precision in manipulating external devices after stimulation of specific brain cells31.
p.000279:
p.000279: ΙΙ. The dimension of ethics
p.000279:
p.000279: 1. Overview
p.000279:
p.000279: Setting aside the general bioethics concern about human enhancement, for enhancement of cognitive and mental
p.000279: characteristics, in particular, it is worth insisting on three issues: a) the safety of interventions on
p.000279: memory functions, b) the safety in a wider range of cognitive and mental functions, and, c) the prospect of equal
p.000279: access to means of enhancement.
p.000279: These specific issues presuppose the general premise that enhancement is a legitimate pursuit for the development of a
p.000279: personality, in the context of self-determination, as long as goods of other people are not put at risk.
p.000279:
p.000279: 2. Memory enhancement
p.000279:
p.000279: Drug use aiming at enhancing specific memory functions, may be challenged as unsafe, when there may
p.000279: be uncertain consequences for other memory functions. There are data showing that, for evolutionary reasons,
p.000279: the various memory functions are not independent, but instead, they are closely linked. Thus, for
p.000279: example, the progressive memory loss of remote events appears to be associated with the speed to recall most
p.000279: recent events, in order to facilitate decision making. In addition, it seems that the ability of symbolic memory, may
p.000279: affect the ability of imaging memory or event memory (Glannon, 76-77).
p.000279: This means that the artificial increase of memory contents is likely to
p.000279:
p.000279: 30Kim SP, Simeral JD, Hochberg LR, et al. (2008). Neural control of computer cursor velocity by decoding motor
p.000279: cortical spiking activity in humans with tetraplegia. J Neu- ral Eng 5, 455-76.
p.000279: 31Robinson JT, Jorgolli M, Park H (2013). Nanowire electrodes for high-density stimu- lation and measurement of neural
p.000279: circuits. Front Neural Circuits 7, 38.
p.000279:
p.000280: 280
p.000280:
p.000280: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000280: REPORT
p.000280:
p.000280: cause difficulties in recalling specific events or images etc., unexpectedly changing the balance of
p.000280: memory functions. It is a situation where enhancement means can cause uncertain consequences, which may
p.000280: lead to the production of multiple problems to the user. Given the relative ignorance of many brain
p.000280: functions, there is a safety issue here. Even if we get certainty about the side effects of such drugs for other areas
p.000280: of memory, an issue will be raised about whether it is legitimate for a person to encounter the dilemma
p.000280: of enhancing certain functions at the expense of others.
p.000280:
p.000280: 3. Balancing cognitive and psychological functions - Personality change
p.000280:
p.000280: In the case of mental characteristics, in a broader context, we encounter the same problem regarding the balance
p.000280: of increased cognitive abilities (memory, ability to concentrate, etc.). It seems that here, there is some kind of
p.000280: connection, e.g. with the emotional life of the person. Thus, enhan- cement of cognitive abilities
p.000280: that allows an employee to perform exceptionally, has been reported to negatively affect his/her
p.000280: emotional world (events of apathy, indifference, etc.), with unknown consequences for the personality (Glannon, 77-78).
p.000280: Generally, the question of changing a personality by drug use (particularly antidepressants) is a
p.000280: central concern, as does the question of whether this increases or limits autonomy (STOA, 135). There is
p.000280: no doubt that personality changes, anyway, with the assistance of external actors - particularly by
p.000280: the socialization mechanisms during childhood and adolescence- the effects of which often are not
p.000280: controlled by the person itself. Thus, a child’s personality is constantly changing under the influence of family,
p.000280: school, friends, television, internet etc. However, there are also changes during adulthood, even if
p.000280: certain characteristics are gradually stabilized, comprising foundations for the “development” of
p.000280: personality. The very term “development”, suggests “change” anyway.
p.000280: Therefore, the critical point to our subject is not whether, in general, personality development is
p.000280: legitimate, but rather whether such a change can be so radical that can lead to psychological
p.000280: pathologies, i.e. to cause damage to a person’s mental health. Besides extreme exceptions,
p.000280: mechanisms of socialization do not cause so deep “sections” in a person’s
p.000280:
p.000280:
p.000281: 281
p.000281:
p.000281: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000281: REPORT
p.000281:
p.000281: personality. On the contrary, socialization mechanisms “build” on the grounds formed in infancy,
p.000281: which are associated with inherent cognitive abilities (including perception of space, time, etc.),
p.000281: learning the mother tongue, but also the evolution of the unconscious processes (especially the libido). In
p.000281: contrast, the use of pharmaceuticals -similarly to the use of substances such as alcohol or drugs- can
p.000281: cause such sections, which may lead to serious mental illness. The main reason is that these substances have a
p.000281: strong invasive impact on the function of the nervous system, with largely unpredictable effects on the mechanisms of
p.000281: cognition.
p.000281: This point is important in order to distinguish schematically between “safe” and “unsafe” personality change,
p.000281: but it is not enough to answer the question of whether the second one is legitimate or not. Similarly to alcohol or
p.000281: drug use, a person intentionally uses pharmaceutical agents, and this is done in the context of self-determination,
p.000281: even if the person is aware of the potential serious harm to his/her health. It is generally accepted that self-
p.000281: determination does not exclude choices of an even great risk or choices of “self-destruction”, since otherwise we
p.000281: must adopt paternalistic lifestyles, something that would be fundamentally in contrast to our freedom.
p.000281: Consequently, the possibility of drug use for enhancement purposes that could lead to a radical personality change (or
p.000281: to milder effects on memory capacity, emotional life, etc.), cannot be considered as an illegitimate
p.000281: choice, given the primacy of personal autonomy (Racine & Forlini, 3).
p.000281: However, two reservations remain:
p.000281: - The consequences of drug use do not cause damage to goods of a third party (e.g. in the context of
p.000281: family life or working environment of the user). Thus, for example, drug use that leads to indifference or threat for
p.000281: the user’s children or creates tension with colleagues etc., is illegitimate).
p.000281: - The user has actually made the decision freely, i.e. after providing the appropriate information to him/her, with
p.000281: all the potential risks being identified (Cakic, 613-614, Racine & Forlini, 3, Farah et al., 423). This is not certain,
p.000281: especially when the drugs are administered without a prescription or, at least, without consulting a physician.
p.000281: The re- sponsibility of the latter, here, is certainly increased, as it is about enhancing cognitive or
p.000281: mental characteristics and not about restoring relevant health damage.
p.000281:
p.000281:
p.000282: 282
p.000282:
p.000282: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000282: REPORT
p.000282:
p.000282: 4. Equal access
p.000282:
p.000282: The issue of equal access to means of cognitive or mental enhancement is mainly associated with the
p.000282: opportunities offered in competitive environments (Farah et al., 423) and, secondly, with improvement
p.000282: of our lifestyle. This is an issue of concern which is similar to that of enhancing physical abilities
p.000282: (e.g. doping in sports).
p.000282: Here, enhancement is usually associated with memory or concentration, especially during challenges in education or
p.000282: work. The general principle that wants to prevent distortion of rivalry is valid here, but it constitutes a
p.000282: “defensive” attitude. Equal access means, mainly, that anyone who desires it is able to use substances, under the two
p.000282: reservations mentioned above.
p.000282: An objection here would be that equal access does not exist anyway, regarding the conventional ways to
p.000282: enhance cognitive performance, namely through education or training. Pupils, students or employees have strongly
p.000282: differentiated possibilities of access to adequate education, mainly because of the economic inequality, which
p.000282: significantly affects their opportunities. Generally, equal opportunities presuppose equality to
p.000282: material means, which is practically impossible.
p.000282: On the other hand, one could argue that substance use may be an option to restore the general inequality of access to
p.000282: conventional means. Thus, for example, a student with artificially enhanced memory capacity and
p.000282: concentration could cover gaps with his/her own effort, gaps that his/her socially and economically
p.000282: “'privileged'” classmates cover with expensive teaching methods. The same applies to an employee who is a candidate
p.000282: for a better position, and objectively cannot devote the same time to study compared to a well-trained
p.000282: new candidate for the same position. Nevertheless, this argument would not be convincing. For the reason
p.000282: that, on the one hand, one cannot prevent the use of substances by “privileged” people and therefore restoring
p.000282: inequality, and on the other hand, one would encourage the easy, but temporary, way of going
p.000282: through meritocratic procedures instead of constantly trying to cultivate cognitive abilities (Farah et al.,
p.000282: 424). In fact, the concern of doping in sports applies here as well.
p.000282: In general, one must not overlook that -at least with the current data- the use of enhancement substances
p.000282: has temporary effects and does not
p.000282:
p.000282:
p.000283: 283
p.000283:
p.000283: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000283: REPORT
p.000283:
p.000283: replace the solid acquisition of knowledge through education. But overall, the use of such substances
p.000283: that aim to obtain cognitive balance or psychological well-being appears at present as an
p.000283: easy substitute for education. In a sense, one could consider that the emergence of this alternative
p.000283: choice is a failure of the educational and cultural mission of the State, and a substitute for fundamental
p.000283: deficiencies. Therefore, the issue constitutes a motivation for reflection on the wider environment that forms a
p.000283: personality. Persistence on the actions that change this environment - particularly in the areas of
p.000283: education (including continuous effort for real equality in opportunities) and culture- seems to acquire a
p.000283: timely, moral significance so that enhancement substances will stop being an option.
p.000283:
p.000283: ΙΙΙ. The law
p.000283:
p.000283: In terms of law, the general framework for dealing with enhancement of cognitive and mental characteristics does not
p.000283: differ from that of enhancing physical characteristics. On one hand, the constitutional provisions for the
p.000283: development of a personality (Art. 5 § 1) and the right to health (Art. 5 § 5) (in view of which, substance use for
p.000283: enhancement purposes is, in principle, permissible) and on the other hand, the protection of health (Art. 21
p.000283: § 3) (which highlights the responsibility of the state in controlling the use of substances or implants
p.000283: that are not intended for therapeutic purposes) are essential here.
p.000283: The EU legislation on the use of implants (Directive 93/42, incorporated with JMD DY8d/GP. Oik.130648/2.10.2009,
p.000283: Directive 90/385, incorporated by JMD DY8d/GP. Oik.130644/2.10.2009) and the Regulation 726/2004, regarding
p.000283: the centralized authorization procedure of substances at the EU level (STOA, 136) also apply here.
p.000283: In a more specific level, the use of the above mentioned substances or implants is subjected to the provisions of Law
p.000283: 3418/2005 (Code of Medical Ethics), regarding the responsibility of the physician who gives the
p.000283: prescription. There is no doubt that the physician performs a medical act, which is covered by the
p.000283: provisions of CME (equivalent to aesthetic surgery), although enhancement is not explicitly mentioned in
p.000283: the legislative definition of “medical act”.
p.000283: In addition, the legislation on the liability of physicians, pharmacists and
p.000283:
p.000283:
p.000284: 284
p.000284:
p.000284: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000284: REPORT
p.000284:
p.000284: traders, which is controlled by the National Organization for Medicines (Directive 2001/1983, as
p.000284: incorporated by DYG 3a/83657/24.1.2006, Law 1316/83, as in force, Decree 96/1973, as in force) also apply here,
p.000284: according to what is already mentioned in the Report on “Human enhancement - Physical Characteristics”.
p.000284: In particular, the case of Ritalin falls under the drug law (Law 1729/1987, as in force), and therefore, it is only
p.000284: allowed to prescribe it for therapeutic purposes, which means that its use for enhancement purposes is illegal in
p.000284: our country, as in other countries (e.g. USA).
p.000284:
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p.000285: 285
p.000285:
p.000285: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000285: REPORT
p.000285:
p.000285: SUGGESTED LITERATURE
p.000285:
p.000285: Ahmadian P, Cagnoni S, Ascari L (2013). How capable is non-invasive EEG data of predicting the next
p.000285: movement? A mini review. Front Hum Neurosci 8, 124.
p.000285: Andersen R (2012). Why cognitive enhancement is in your future (and your past). The Atlantic.
p.000285: Bostrom N, Sandberg A (2009). Cognitive enhancement: Methods, ethics, regulatory challenges. Sci Eng Ethics 15,
p.000285: 311-41.
p.000285: Cakic V (2009). Smart drugs for cognitive enhancement: Ethical and pragmatic considerations in the
p.000285: era of cosmetic neurology. J Med Ethics 35, 611-615.
p.000285: de Jongh R, Bolt I, Schermer M, Olivier B (2008). Botox for the brain: En- hancement of cognition, mood
p.000285: and pro-social behavior and blunting of un- wanted memories. Neurosci Biobehav Rev, 32, 760-76.
p.000285: European Parliament, Science and Technology Options Assessment (STOA) (2009). Human Enhancement Study, Brussels.
p.000285: Farah MJ, Illes J, Cook-Deegan R, Gardner H, Kandel E, King P, Parens E, Sa- hakian B, Root Wolpe P (2004).
p.000285: Neurocognitive enhancement: What can we do and what should we do? Nature 5, 421-425.
p.000285: Glannon W (2006). Psychopharmacology and memory. J Med Ethics 32, 74- 78.
p.000285: Racine E & Forlini C (2010). Cognitive enhancement, lifestyle choice or misuse of prescription drugs?
p.000285: Ethics blind spots in current debates. Neuroethics, 3, 1-4.
p.000285: Rose, S (2005). “No Way To Treat The Mind” (www.nootropics.com).
p.000285:
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...

Searching for indicator impairment:

(return to top)
p.000271: Athens.
p.000271: Theocharis Patargias, Emeritus Professor of Genetics, University of Athens
p.000271: Constantinos Tsoukalas, Emeritus Professor of Sociology, University of Ath- ens.
p.000271: Christos Voulgaris, Emeritus Professor of Theology, University of Athens.
p.000271:
p.000271: PERSONELL
p.000271:
p.000271: Scientific Officers:
p.000271: Takis Vidalis, Lawyer, PhD in Law.
p.000271: Vasiliki Mollaki, Geneticist, PhD in Genetics.
p.000271:
p.000271: Secretariat:
p.000271: Marianna Drakopoulou, Lawyer, Head of Secretariat.
p.000271:
p.000271:
p.000271:
p.000271:
p.000271:
p.000272: 272
p.000272:
p.000272: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000272: REPORT
p.000272:
p.000272: R E P O R T
p.000272:
p.000272: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE AND MENTAL STATE
p.000272:
p.000272: Rapporteurs: Takis Vidalis, Vasiliki Mollaki
p.000272: Introduction
p.000272:
p.000272: Many psychiatric, neurodegenerative and neurodevelopmental disorders coexist with abnormalities in “normal”
p.000272: cognitive and mental functions. Autism, intellectual disability, attention deficit disorder,
p.000272: schizophrenia, depression but also neurodegenerative diseases, such as Alzheimer's, Parkinson's and
p.000272: Huntington's chorea, are associated with impairment of cognitive functions. Aging of the brain also leads
p.000272: to similar effects. The continuous and rapid scientific developments make it possible, to some extent, to
p.000272: intervene in the development of these diseases and delay their symptoms, mainly through pharmaceutical
p.000272: substances that aim to enhance cognitive functions. Therefore, the moral issue raised here, is whether these
p.000272: pharmaceutical substances could be used in healthy people in order to enhance their cognitive and mental
p.000272: characteristics.
p.000272: The term “cognitive” functions refers to the procedures and processes of an organism that organize information.
p.000272: This includes the acquisition, selection, clarification and recollection of information, which correspond to
p.000272: the perception, attention, understanding and memory of the organism, as well as the way these processes
p.000272: determine behavior.
p.000272:
p.000272: I. The data
p.000272:
p.000272: Unquestionably, education, consumption of certain nutrients and the use of information processing devices,
p.000272: such as calculators and computers, constitute tools to improve cognitive activity and performance. However,
...

Health / Drug Dependence

Searching for indicator dependence:

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p.000048: The newly-legislated EOET which was created by the new “Statutory Framework for research and technology” has
p.000048: two sectors, one for basic and one for applied research, and its main mission is the “implementation and
p.000048:
p.000048: 1 a) Internal Affairs, b) Economy and Finance, c) External Affairs, d) National Defense,
p.000048: e) Development, f) Environment, Planning and Public Works, g) National Education and Religion, h) Employment
p.000048: and Social Protection, i) Health and Social Solidarity, j) Rural Development and Foodstuffs, k) Justice, l) Culture and
p.000048: m) Transport and Com- munication.
p.000048:
p.000049: 49
p.000049:
p.000049: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000049: REPORT
p.000049:
p.000049: management of actions in basic research, applied-technological research and innovation”2. In practical
p.000049: terms, EOET’s task is to support research through the management of public funds mainly in order to finance
p.000049: research projects to be carried out in national research institutions following call opening and evaluation
p.000049: of submitted proposals. The proposals will be peer reviewed by Greek or foreign scientists of international acclaim.
p.000049: EOET was established by Law 3653/21.3.2008 and was still inoperative at the time the present report was drawn up.
p.000049: Again, the law does not provide for a separate council dedicated to biological research.
p.000049: Despite their dependence on public funds, Universities and Research Centres can determine the orientation of
p.000049: their research activity by appoint- ing staff with desirable research interests and by raising non-public funds for
p.000049: research. According to data from the GSRT, the major source of non- government funding for Greek research
p.000049: centres comes from abroad, mainly the European Union.
p.000049:
p.000049: b. Financing
p.000049: The biggest provider of funds for public research in Greece is the state. In 2005, 47% of the expenditure was met with
p.000049: public funds, 31% of funds for research originated from the industry and 19% from abroad (Table 2). Re- search in
p.000049: Public Research Centres and Higher Education Institutions is fi- nanced mainly with public funds or funds
p.000049: from abroad while the domestic private sector contributes very little (Table 2).
p.000049: The largest part of foreign funding is absorbed by public research centres and universities. Research in the
p.000049: private sector absorbs one third of the overall funds most of which is self-financing. Public research
p.000049: absorbs ap- proximately 67% of the overall funds allocated for research (Table 3).
p.000049: Compared to the respective European Union average Greece spends a smaller share of its Gross Domestic
p.000049: Product (GDP) for research (0.7% as against 1.9%) whereas the contribution of the industry is even smaller (30%
p.000049: compared to 55%). The goal for 2010 is to increase the share of GDP for re- search and the contribution of the private
p.000049: sector (Table 4).
p.000049:
p.000049:
p.000049:
...

Health / Drug Usage

Searching for indicator drug:

(return to top)
p.000020: application of genetics in medi- cine create an urgent need to ensure the quality of services offered by ge- netic
p.000020: laboratories. The operation of certified genetic laboratories is gov- erned by international certification
p.000020: rules. Among the requirements for quali- ty control according to relevant ISO regulations are the validity of method,
p.000020: the evaluation of the results by trained professionals and safeguard clauses for the protection of patient rights. With
p.000020: regards to the latter, in particular, the rules for certification require a referral by the treating physician and the
p.000020: consent of the person taking the test following comprehensive information by qualified scientists on the
p.000020: consequences of the test for those involved and their families. The anonymity of samples and the duty of
p.000020: confidentiality of the staff are also ensured. Without certification or some other kind of regulation of
p.000020: lab operation, the validity and protection of the results cannot be guaranteed.
p.000020:
p.000020: C. The value of genetic information for individual health and scientific pro- gress and the potential of genetic
p.000020: testing
p.000020:
p.000020: With the development of genetics, especially of pharmacogenomics and personalized genetics, genetic information becomes
p.000020: increasingly important. Personalized genetics and pharmacogenomics help to predict individual sen- sitivity to
p.000020: environmental factors, individual response or lack of response to a specific treatment or medicine, etc.
p.000020: Pharmacogenomics exploits the association between the potency of a particular drug and genetic markers to
p.000020: develop genetic tests for more effec- tive diagnosis and treatment (Goldmann, 2005). For instance, genetic infor-
p.000020: mation can be used to define the appropriate treatment for various cancer types. It is worth noting here that the case
p.000020: of pharmacogenetics is an exam- ple where the use of genetic testing is beneficial to both the insured and
p.000020: insurance companies since the appropriate genetic information helps to save time and resources by applying
p.000020: tailor-made treatments based on the outcome of genetic testing. In this case, avoiding a test for fear of refusal
p.000020: of insurance can be detrimental to both the insured and the insurer.
p.000020: At the moment many genetic applications may look like something of the distant future for everyday medicine
p.000020: but progress is expected to be fast.
p.000020:
p.000020:
p.000021: 21
p.000021:
p.000021: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000021: REPORT
p.000021:
p.000021: The funds allocated to research in human genetics reflect the magnitude of expected benefits for public health. It is
p.000021: thus crucial that everybody should be able to enjoy the benefits of scientific progress and people should not be
p.000021: discouraged on non-medical grounds such as fear of exclusion from insur- ance.
p.000021: To give an example of the speedy pace of developments, the cost and time required to decode the human
p.000021: genome dropped dramatically in the last 15 years from 4 billion to 2 million dollars. An important international
p.000021: effort is underway to further curtail the cost to less than 1,000 dollars12 to make decoding practically feasible for
p.000021: patients and healthy-individuals. This could lead to important discoveries from the comparative analysis of
p.000021: ge- nomes13.
...

p.000151: At all events, health care priorities must be set by public authorities in advance on the basis of fixed rules in
p.000151: order to prevent physicians from hav- ing to make so many ethically questionable judgments.
p.000151:
p.000151: 4. Special issues: Clinical trials, patents
p.000151:
p.000151: The urgent need for prevention and treatment in times of epidemics painfully illustrates the question of
p.000151: the adverse effects of trials of new treatments (medicines, vaccines) to contain the risk.
p.000151: Given that clinical trials are now subjected to a specific control proce- dure, ensuring the safety of
p.000151: volunteering participants and of the end- product before it becomes available to the public, at issue is
p.000151: whether this procedure should be relativized in case of an urgent need to supply new cures. Since the
p.000151: pursuit of absolute safety, even in normal circumstances, obviously undermines the effort to find new cures (as
p.000151: being too time- and resource-consuming) the debate on the “maximization of risk” is not with- out cause. The criteria
p.000151: of socially acceptable risks from a new medicine or vaccine are ultimately a matter for bioethics, and must
p.000151: be considered as such.
p.000151: Similar arguments can be made on the scope of patents -and, with that, on the scope of trade prerogative- on new
p.000151: treatments in case of emergency. Here too, limiting the duration of privilege of the patent holder for the sake of
p.000151: providing easier (and cheaper) access to a highly needed drug or vaccine is a matter for bioethics.
p.000151:
p.000151: III. The legal dimension
p.000151:
p.000151: 1. International law
p.000151:
p.000151: Public health is considered as a remit of national sovereignty. As a result, there are no international policies
p.000151: underpinned by international rules for the moment on the protection from epidemics except from trade in food-
p.000151:
p.000151:
p.000152: 152
p.000152:
p.000152: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000152: REPORT
p.000152:
p.000152: stuffs and animal feed. To this, we must add the reluctance of developed countries to effectively combat
p.000152: serious transmissible diseases, which are endemic in developing countries (e.g. malaria, tuberculosis, HIV).
p.000152: Nevertheless, provisions on international protection from epidemics exist in the form of guidelines (IHRS)
p.000152: issued by WHO. These guidelines are not legally binding, of course, but non-compliance can lead to other types of
p.000152: sanctions (e.g. WHO travel alerts). Considering that international move- ments, immigration flows and trade
p.000152: have become easier with globalization and with the recent experiences of wide-spreading transmissible diseases in mind,
p.000152: proposals are under discussion with a view to developing internation- al instruments in this field.
p.000152:
p.000152: 2. Greek law
p.000152:
...

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p.000157:
p.000158: 158
p.000158:
p.000158: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000158: OPINION
p.000158:
p.000158: O P I N I O N
p.000158:
p.000158: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000158:
p.000158: The Hellenic National Bioethics Commission met repeatedly upon invita- tion by the President in order to consider the
p.000158: ethical and social issues within its jurisdiction with regard to conflict of interest in clinical research,
p.000158: espe- cially in clinical trials of pharmaceutical agents. Dealing with this issue is a continuance of the already
p.000158: issued expert opinions on clinical trials on human subjects (2004), the establishment of ethics committees that
p.000158: review bio- medical research (2005) and research ethics in the biological sciences (2008). The timeliness
p.000158: of the matter is due to the usual criticism on the ac- countability of clinical trials of pharmaceutical agents
p.000158: or biomedical tech- nology appliances that are funded by the pharmaceutical industry. The ac- countability of
p.000158: clinical studies is crucial for public health, as it remains the single guarantee for drug efficiency and
p.000158: non-hazardous research products directed to the public.
p.000158:
p.000158: 1. General principle
p.000158: The Commission believes that the collaboration between the private sector and hospitals or research
p.000158: institutes is desirable because it ensures innovation, but under the strict condition that the ethical
p.000158: integrity of re- search is protected.
p.000158: In this context, “conflict of interest” may emerge between pursuing the truth, which is the aim of scientific research,
p.000158: and the financial profit antici- pated by the research sponsors.
p.000158:
p.000158: a) The relationship between researcher/sponsor: The duty to reveal the truth
p.000158: In clinical studies, the person that primarily encounters conflict of inter- est is the researcher who realizes
p.000158: that the research results may not be of financial benefit to the sponsor, and faces the dilemma of
p.000158: revealing the truth or defending the financial interest.
p.000158: The Commission believes that the researcher has always the moral duty to search for and reveal the truth, even
p.000158: when this is unfavorable to the sponsor. Serving health via the accuracy of the results of clinical studies is
p.000158:
p.000159: 159
p.000159:
p.000159: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000159: OPINION
p.000159:
p.000159: absolutely preceding, even in the case that this is discouraging for funding research in the future. The Commission
p.000159: feels that the risk of such discour- agement should be undertaken by the scientific community, due to the sig-
p.000159: nificance of protecting public health.
p.000159:
p.000159: b) Revealing the truth and the right to information
...

p.000163: Members:
p.000163: Julia Iliopoulou-Stranga, Professor of Constitutional Law, Law School, Uni- versity of Athens.
p.000163: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000163: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000163: Athens.
p.000163: Evangelos Moutsopoulos, Member of the Academy of Athens, Emeritus Professor of Philosophy, University of
p.000163: Athens.
p.000163: Athanasios Papachristou, Professor of Civil Law, Law School, University of Athens.
p.000163: Theocharis Patargias, Emeritus Professor of Genetics, University of Athens Constantinos Tsoukalas, Emeritus Professor
p.000163: of Sociology, University of Ath- ens.
p.000163: Christos Voulgaris, Emeritus Professor of Theology, University of Athens.
p.000163:
p.000163:
p.000163: PERSONNEL
p.000163:
p.000163: Scientific Officers:
p.000163: Takis Vidalis, Lawyer, PhD in Law.
p.000163: Stefania Lymperi, Biologist, PhD in Cell Biology.
p.000163:
p.000163: Secretariat:
p.000163: Marianna Drakopoulou, Lawyer, Head of Secretariat.
p.000163:
p.000164: 164
p.000164:
p.000164: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000164: REPORT
p.000164:
p.000164: R E P O R T
p.000164:
p.000164: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000164:
p.000164: Rapporteurs: S. Lymperi, T. Vidalis In collaboration with: J. Papadimitriou
p.000164:
p.000164: 1. Introduction
p.000164:
p.000164: In a former Opinion the Hellenic National Bioethics Commission dealt with the ethics of drug clinical
p.000164: studies and other therapeutic procedures. Particular issues concerning the lack of credibility for several studies,
p.000164: due to the financial interests of the sponsor, were already identified in that docu- ment.
p.000164: With the present report, it is attempted to probe deep into the issue of conflict of interest, since it is a
p.000164: serious matter commonly encountered by the physician/researcher. In addition, the credibility of clinical studies
p.000164: is now at the forefront of public interest, not only due to the high cost of medical products, but also because the
p.000164: demand of rapid and effective new treat- ments is imminent (a recent example is the H1N1 influenza virus).
p.000164: Progress in biomedical technology changes medicine with an extremely high pace. In the past, biomedical research was
p.000164: mainly conducted in Univer- sities and large hospitals, as opposed to the present situation, where phar- maceutical
p.000164: companies and the pharmaceutical industry have taken the reins. Large companies eagerly convert scientific
p.000164: results into “pharmaceuti- cal products” or into biomedical materials, aiming at financial profits of course.
p.000164: Relationships between physicians and pharmaceutical industries generate -rightly or wrongly- suspicions both
p.000164: to the society and the State. The publicity -often unfounded- which is given in such a relationship has a serious
p.000164: effect on the accountability of health workers, especially when legal entanglements arise.
p.000164: Sponsoring medical research is initially desirable. There is no doubt that many of the new discoveries, both in
p.000164: the field of pharmacology and bio- technology, are a result of the combination of knowledge -generated in Uni-
...

p.000165: 2. Is it possible for the average physician and citizen to show absolute confidence in the scientific “findings” of
p.000165: a research study?
p.000165: 3. Is there a possibility that the general financial deterioration of aca- demic institutions or public
p.000165: hospitals, causing incapability to sup- port independently research programs, would lead to a lack in the complete
p.000165: control of results?
p.000165: 4. Does the search for accuracy in research results discourage spon- sors from funding, due to high cost
p.000165: (e.g. because of possible repli- cation of an experiment producing negative results)?
p.000165:
p.000165: 2. Financial data
p.000165:
p.000165: During the past years, the industry has increased respectfully the funds on clinical research. Data from the USA show
p.000165: that in the 1980s, 68% of funds for Phase II and III clinical studies derived from the government and only
p.000165: 32% from the pharmaceutical companies, whereas in 2000 the relevant per- centages were reversed, i.e. 38% of
p.000165: funds was from governmental grants and 62% from pharmaceutical companies. Similarly, in the United Kingdom, 70% of
p.000165: the research outlay stems from pharmaceutical industries and only 30% from other sources.
p.000165: It is estimated that the cost of drugs is increasing in a two-digit percent- age rate, and is already up to $162.4
p.000165: billion in the USA2. The pharmaceutical
p.000165:
p.000165: 1 Bodenheimer T (2000). Uneasy alliance-clinical investigators and the pharmaceuti- cal industry. N Engl J Med 342,
p.000165: 1539-1544.
p.000165: 2 Blumenthal D (2004). Doctors and drug companies. N Engl J Med, 351, 1885-1890.
p.000165:
p.000166: 166
p.000166:
p.000166: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000166: REPORT
p.000166:
p.000166: industries spend 35% of their income for “sale and advertising” expenses. An illustrative, extensive
p.000166: research in the USA in 2010 reported that out of 2,938 participating physicians (primary care physicians, specialized
p.000166: cardiolo- gists, anesthetists, general surgeons and psychiatrists), 83.6% declared they had some kind of
p.000166: relationship with pharmaceutical and medical-device companies, in the form of financial aid, travel expenses, meals
p.000166: and profes- sional services3. The estimated amount spent by the pharmaceutical indus- tries on “sale and advertising”
p.000166: outlay is $8,000-15,000 per physician1.
p.000166: Another study in the USA in 2004, revealed that 44 pharmaceutical com- panies spent $2.47 billion on sponsorships. The
p.000166: average production cost for a new drug is between $300-600 million. Out of the total $6 billion spent on “research”,
p.000166: $3.3 billion are actually into spent on research itself.
p.000166: The pharmaceutical companies have additional reasons to urgently seek approval of a product. It has been estimated
p.000166: that due to “industrial espio- nage”, “competitive” industries are very eager to secure the first approval of the
p.000166: product, whatever the consequences. Each day delaying the product approval costs on average $1.3 billion to the
p.000166: industry2.
p.000166: This results in rapid drug approval, without the appropriate evaluation of long-term results (on safety and efficacy),
p.000166: with whatever that implies. A re- cent example is the withdrawal of Avastatin, a drug that had been “prema- turely and
p.000166: unnecessarily” approved by the Food and Drug Association (FDA) for use by patients in an advanced stage of breast
p.000166: cancer, a drug approval that proved to be rather hasty, as showed by four subsequent clinical stud- ies examining its
p.000166: safety and efficiency. All four studies proved that this drug not only didn’t offer any advantage to women with breast
p.000166: cancer, but also, in many cases, caused adverse side effects putting the patients’ life in dan- ger.
p.000166: Suspicions are generated by the fact that when a study is funded by a non-profit Institution, the negative
p.000166: results rise up to 38%, whereas when the study is supported by private grants the figure comes up to 5%.
p.000166: Some claim that the reason why industry-sponsored research shows more positive results, derives from the
p.000166: fact that financial resources are available to conduct studies with a large number of participating
p.000166: patients
p.000166:
p.000166: 3 Campbell EG, Rao SR, DesRoches CM et al. (2010). Physician professionalism and changes in
p.000166: physician-industry relationships from 2004 to 2009. Arch Intern Med 170, 1820-1826.
p.000166:
p.000167: 167
p.000167:
p.000167: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000167: REPORT
p.000167:
p.000167: (large sample size), leading to a high possibility of finding statistically signifi- cant differences. Another
p.000167: reason is the use of preliminary data-results, al- lowing for better planning of a clinical study and increasing
p.000167: the possibility of positive results4.
p.000167: The first argument refers to the question whether a statistically signifi- cant difference is of clinical value as
p.000167: well. Regarding the second argument, we should consider that most of the preliminary data derive from laboratory animal
p.000167: studies and often cannot be directly applied to humans.
p.000167: In addition, it is surprising that different clinical studies come up with contradictory results, depending
p.000167: on the funding company. During an evalua- tion of previous clinical studies on second generation drugs used
p.000167: to treat mental diseases, such as schizophrenia, Heres and his colleagues examined 9 different clinical studies
p.000167: testing the efficacy of the two following substanc- es: olanzapine and risperidone5. They discovered that 5 of the
p.000167: above men- tioned studies were sponsored by the company producing olanzapine -and their results were in favor of this
p.000167: substance- while 3 out of 4 studies spon- sored by the producer company of risperidone, were also in favor
p.000167: of this particular drug. Similarly, several studies conducting direct comparison of statins, were more likely
p.000167: to be in favor of a drug, which was produced by the sponsor company, against other drugs6.
p.000167:
p.000167: 3. Research misconduct
p.000167:
p.000167: The term research misconduct refers to:
p.000167: a) Data fabrication, i.e. creating non-existent or fictitious results during the recording or publication process.
p.000167: b) Data falsification, i.e., modification or concealment of critical results.
p.000167:
p.000167:
p.000167: 4 Fries JF, Krishnan E (2004). Equipoise, design bias, and randomized controlled trials: The elusive ethics of new drug
p.000167: development. Arthritis Res Ther 6, R250-R255.
p.000167: 5 Heres S, Davis J, Maino K, Jetzinger E, Kissling W, Leucht S (2006). Why olanzapine beats risperidone, risperidone
p.000167: beats quetiapine, and quetiapine beats olanzapine: An exploratory analysis of head-to-head comparison studies of
p.000167: second-generation anti- psychotics. Am J Psychiatry 163, 185-194.
p.000167: 6 Bero LA, Rennie D (1996). Influences on the quality of published drug studies. Int J Technol Assess Health Care 12,
p.000167: 209-237.
p.000167:
p.000168: 168
p.000168:
p.000168: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000168: REPORT
p.000168:
p.000168: c) Plagiarism, i.e. repetition of referencing results, opinions, ideas or re- search methods, without the
p.000168: appropriate reference to the person who used them or reported them originally.
p.000168:
p.000168: Specifically, it is worth noting:
p.000168:
p.000168: a. Quality of methodology
p.000168: Although some people believe that clinical studies sponsored by the pharmaceutical industry are associated
p.000168: with poor methodological quality7, most of the authors stress that research protocols sponsored by the private
p.000168: sector are no less methodological8 and in fact, show better quality of meth- odology9,10.
p.000168:
p.000168: b. Inappropriate selection of dose and administration route
p.000168: It is observed that in clinical studies where two drugs are directly com- pared, the sponsor’s drug is administered
p.000168: in high doses to show better ef- fectiveness or in low doses to show fewer side effects. Administration of
p.000168: unequal doses violates the scientific principle of “clinical equipoise”, repre- senting that a subject may be enrolled
p.000168: in a clinical study only if there is true uncertainty about which of the study arms is most likely to benefit the pa-
p.000168: tient11. For instance, in 13 studies comparing the antifungals fluconazole and
p.000168:
p.000168: 7 Jorgensen AW, Maric KL, Tendal B, Faurschou A, Gotzsche PC (2008). Industry- supported meta-analyses
p.000168: compared with meta-analyses with non-profit or no sup- port: Differences in methodological quality and
p.000168: conclusions. BMC Med Res Methodol 8, 60.
p.000168: 8 Hampson LA, Joffe S, Fowler R, Verter J, Emanuel EJ (2007). Frequency, type, and monetary value of financial
p.000168: conflicts of interest in cancer clinical research. J Clin On- col 25, 3609-3614.
p.000168: 9 Heres S, Davis J, Maino K, Jetzinger E, Kissling W, Leucht S (2006). Why olanzapine beats risperidone, risperidone
p.000168: beats quetiapine, and quetiapine beats olanzapine: An exploratory analysis of head-to-head comparison studies of
p.000168: second-generation anti- psychotics. Am J Psychiatry 163, 185-194.
p.000168: 10 Perlis RH, Perlis CS, Wu Y, Hwang C, Joseph M, Nierenberg AA (2005). Industry sponsorship and
p.000168: financial conflict of interest in the reporting of clinical trials in psy- chiatry. Am J Psychiatry 162, 1957-1960.
p.000168: 11 Djulbegovic B, Cantor A, Clarke M (2003). The importance of preservation of the ethical principle of equipoise
p.000168: in the design of clinical trials: Relative impact of the
p.000168:
p.000169: 169
p.000169:
p.000169: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000169: REPORT
p.000169:
p.000169: amphotericin B in cancer patients who are vulnerable to fungal infections due to low white blood cell counts,
p.000169: 80% of the patients had the drug admin- istered orally in suspension, which shows poor absorption, not as an injec-
p.000169: tion. Conducting such clinical studies not only leads to misinformation but is also unethical, since the lack of
p.000169: therapeutic utility, endangers the patients and prolongs their pain.
p.000169:
p.000169: c. Selective publication
p.000169: Occasionally, industries intervene and prevent publication of negative results about their product which is
p.000169: under trial. Such interference is report- ed by almost 20% of researchers12. On the contrary, industries ensure that
p.000169: clinical studies with positive results are mentioned in more than one refer- ence in the literature. An illustrative
p.000169: example is a study revealing that the results from 6 different clinical studies testing duloxetine were used in more
p.000169: than 20 publications13.
p.000169:
p.000169: d. Different interpretation of results
p.000169: It is observed that industries interpret and present the results of a clini- cal study in different ways depending on
p.000169: whether they aim to publish them or submit them to the competent authorities. According to the existing lit- erature,
p.000169: 94% of the clinical studies showed positive results, whereas accord- ing to the US Food and Drug Administration (FDA)
p.000169: only 51% of the clinical studies had positive results14.
p.000169:
p.000169:
p.000169:
p.000169:
p.000169:
p.000169: methodological quality domains on the treatment effect in randomized controlled trials. Account Res 10,
p.000169: 301-315.
p.000169: 12 12 von Elm E, Rollin A, Blumle A, Huwiler K, Witschi M, Egger M (2008). Publication and non-publication of clinical
p.000169: trials: Longitudinal study of applications submitted to a research ethics committee. Swiss Med Wkly 138, 197-203.
p.000169: 13 Spielmans GI, Biehn TL, Sawrey DL (2010). A case study of salami slicing: Pooled analyses of duloxetine
p.000169: for depression. Psychother Psychosom 79, 97-106.
p.000169: 14 Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R (2008). Selective pub- lication of antidepressant trials
p.000169: and its influence on apparent efficacy. N Engl J Med 358, 252-260.
p.000169:
p.000170: 170
p.000170:
p.000170: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000170: REPORT
p.000170:
p.000170: e. Discrepancy between results and conclusions
p.000170: Although the results reported in some studies are accurate, it is common that authors misrepresent their meaning and
p.000170: draw more favorable conclu- sions compared to what the results can really support. For instance, 19 out of 22
p.000170: clinical studies of non-steroidal, anti-inflammatory drugs (NSAIDS) concluded that the drug manufactured by the
p.000170: sponsor was less toxic com- pared to others, but in fact such a conclusion could only be drawn by the results of 12
p.000170: clinical studies15.
p.000170:
p.000170: f. “Authors on demand”
p.000170: “Authors on demand” are exclusively employed to interpret the results of a clinical study and write up
p.000170: manuscripts that are in favor of the drug manufactured by the sponsor. The company, i.e. the drug
p.000170: manufacturer, hires a prestigious academic or physician to sign the manuscript as an au- thor. When the
p.000170: manuscript reaches the publication stage, there is no refer- ence to the original role of the “author on demand”. There
p.000170: are multiple ref- erences in the literature about “authors on demand”, some of which are analyzed in the
p.000170: paper by Dunbar and Tallman16.
p.000170: “Authors on demand” are not only used in order to ensure that positive results of clinical studies are reported, but
p.000170: also to create doubts about stud- ies that showed negative results. A good example of such a case is the clini- cal
p.000170: study “Heart and Estrogen/progestin Replacement Study, (HERS)”. The study concluded that administration of
p.000170: hormones to women with coronary heart disease offered no advantage to secondary prevention17. Publication of the study
p.000170: was followed by “manuscripts on demand” which questioned
p.000170:
p.000170:
p.000170:
p.000170:
p.000170: 15 Rochon PA, Gurwitz JH, Simms RW et al., (2004). A study of manufacturer- supported trials of
p.000170: non-steroidal anti-inflammatory drugs in the treatment of arthri- tis. Arch Intern Med 154, 157-163.
p.000170: 16 Dunbar CE, Tallman MS (2009). “Ghostbusting” at blood. Blood 113, 502-503.
p.000170: 17 Hulley S, Grady D, Bush T et al., (1998). Randomized trial of estrogen plus progestin for secondary prevention of
p.000170: coronary heart disease in postmenopausal women. Heart and Estrogen/progestin Replacement Study (HERS) Research Group.
p.000170: JAMA 280, 605- 613.
p.000170:
p.000171: 171
p.000171:
p.000171: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH REPORT
p.000171:
p.000171: the results of the study, supporting that hormone therapy had a protective effect18.
p.000171:
p.000171: g. “Seeding studies”
p.000171: Finally, conducting clinical studies after a drug is approved may be an- other way of misleading the public.
p.000171: In many cases, clinical studies conducted after the drug release solely intend to establish the drug on the market -to
p.000171: be more frequently prescribed by physicians and become better known amongst patients- and not to answer a
p.000171: scientific question.
p.000171:
p.000171: 4. Types of sponsorship
p.000171: Sponsorships of clinical research can be classified into five categories (Table 1).
p.000171:
p.000171: Table 1. Categories of sponsorship.
p.000171: 1st Free pharmaceutical products
p.000171: 2nd Gifts, meals, tickets to cultural events 3rd Travel (tickets, accommodation etc.) 4th Conference
p.000171: registrations etc.
p.000171: 5th Counseling services, lecture fees
p.000171:
p.000171: Figures from 2004 and 2005 show that ¾ of researchers having a finan- cial relationship with the pharmaceutical
p.000171: industry, received sponsorships within the established limits19, i.e. below $10,000 annually. A relationship
p.000171: with a commercial company operating in healthcare is reported by 5.9%- 6.2% of researchers. In addition, when
p.000171: the results were presented in prestig- ious fora, the researchers received more frequent and higher sponsorship.
p.000171:
p.000171:
p.000171: 18 Fugh-Berman AJ (2010). The haunting of medical journals: How ghostwriting sold "HRT". PLoS Med 7, e1000335.
p.000171: 19 McCrary SV, Anderson CB, Jakovljevic J et al. (2000). A national survey of policies on disclosure of conflicts of
p.000171: interest in biomedical research. N Engl J Med 343, 1621- 1626.
p.000171:
p.000172: 172
p.000172:
p.000172: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000172: REPORT
p.000172:
p.000172: The largest proportion of the above mentioned researchers originated from the USA (9.2%) compared to researchers from
p.000172: other countries (4.2%).
p.000172:
p.000172: 5. Conflict of interest
p.000172:
...

p.000172: conditions for conflict of interest20.
p.000172: The pharmaceutical industries have any reason to seek participation of major centers in research, because:
p.000172: a) Industries lack the necessary infrastructure and experience for such studies.
p.000172: b) Institutions ensure patient/volunteer participation.
p.000172: c) Institutions have the necessary status that will contribute to confi- dence in the pharmaceutical
p.000172: product.
p.000172:
p.000172:
p.000172: 20 Henry D, Doran E, Kerridge I, Hill S, McNeill PM, Day R (2005). Ties that bind: Mul- tiple relationships between
p.000172: clinical researchers and the pharmaceutical industry. Arch Intern Med 165, 2493-2496.
p.000172:
p.000173: 173
p.000173:
p.000173: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000173: REPORT
p.000173:
p.000173: According to some experts, the relation between academic Institutions and the pharmaceutical industries creates
p.000173: problems which become increas- ingly complex, not only to researchers but also to academic Institutions, due to the
p.000173: suspicion surrounding their moral integrity and the transparency of research21.
p.000173: “Cooperation”, may be in the form of: direct research funding from the industry, provision of technical knowledge from
p.000173: the Institution to the indus- try, academic “coverage” of the industry, student scholarships and product recognition by
p.000173: the Institutions. In 1994, the industries offered $1.5 million funding to USA Universities, for use in 6,000 research
p.000173: projects22.
p.000173: Publication of favorable research results to a high impact scientific jour- nal is a positive step towards the
p.000173: establishment of a drug or any other healthcare product. Subsequently, some companies seek “improvement” of their
p.000173: results, as indicated by the fact that 59% of pharmaceutical industries sponsored scientists who work for scientific
p.000173: societies and issue guidelines on how not to affect research results23.
p.000173: The private sector comprises the final stage in the availability of a drug. There is an increasing number of private
p.000173: healthcare physicians participating in clinical studies, either as “researchers” in non-profit centers or as patient
p.000173: providers. In the USA, the number of the above mentioned physicians is increasing24. Medical advisors
p.000173: visit more often private-sector physicians. It
p.000173:
p.000173:
p.000173:
p.000173:
p.000173: 21 Association of American Medical Colleges (2002). Task Force on Financial Conflicts of Interest in Clinical Research,
p.000173: Protecting subjects, preserving trust, promoting pro- gress. II. Principles and recommendations for oversight of
p.000173: an institution's financial interest in human subjects research. Washing-ton, D.C.
p.000173: 22 Hampson LA, Joffe S, Fowler R, Verter J, Emanuel EJ (2007). Frequency, type, and monetary value of financial
p.000173: conflicts of interest in cancer clinical research. J Clin On- col 25, 3609-3614.
p.000173: 23 Rights Inventions Made by non-profit Organizations and Small business Firms. Codidied at 37 CFR, Part 401.
p.000173: 24 Fisher JA (2008). Practicing research ethics: Private-sector physicians & pharma- ceutical clinical
p.000173: trials. Soc Sci Med 66, 2495-2505.
p.000173: 24 Rights Inventions Made by non-profit Organizations and Small business Firms. Codidied at 37 CFR, Part 401.
p.000173:
p.000174: 174
p.000174:
p.000174: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000174: REPORT
p.000174:
p.000174: has been estimated that every physician has more than 16 visits per month25.
p.000174:
p.000174: 6. Measures in the USA
p.000174:
p.000174: The cooperation-partnership between academic Institutions and the private sector is, in general, promoted by
...

p.000183: have been caused by the sponsor’s pressure on the researcher. In these cases, consciously misleading the
p.000183: scientific community along with the public leads to disregard of the value of scientific truth, by prioritising the
p.000183: pursuit of an economic “efficiency” based on illicit profit.
p.000183: From the point of freedom, abandoning the goal of truth equates with a substantial elimination of the freedom of
p.000183: research, in the sense that the researcher does not act unobstructed but is subjected to external pressure in
p.000183: order to present prefabricated results. Moreover, when it comes to finan- cial freedom, one must consider an important
p.000183: issue. Indeed, the pursuit of profit by means of deceit ignores the basic social aspect of this freedom, i.e. that its
p.000183: moral status derives from the fact that, after all, it actually aims at satisfying the necessaries of life. In this
p.000183: context, the pursuit of profit is not a morally accepted exercise of financial freedom, even if it benefits the spon-
p.000183: sor of a clinical trial, since it does not relate to the satisfaction of neces- saries. The interest of
p.000183: this argumentation purely concentrates on the ethical aspect of the issue and does not relate to probable financial or
p.000183: other type of damages (e.g. legal penalties) that a business might suffer after exposing the deceit for purposes of
p.000183: profit.
p.000183: Beyond the above mentioned, however, an actual balancing between the interest of truth and the business
p.000183: interests is theoretically necessary only when during a clinical trial the researchers discover findings
p.000183: that are not crucial for the efficiency and safety of the drug tested. In this case, the business’ interest for
p.000183: concluding the trial and publishing the results prevails, even if the above findings are not included in the results.
p.000183: As a conclusion, the goal of serving health imposes, as a rule, that the researcher’s pursuit of the true
p.000183: results does not retreat before the sponsor’s business interest. In other words, the sponsor is morally obliged to
p.000183: under- take the risk that a clinical trial might lead to results that are not satisfacto-
p.000183:
p.000183:
p.000184: 184
p.000184:
p.000184: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000184: REPORT
p.000184:
p.000184: ry, with the respective cost, precisely because the specific need to serve health weighs more.
p.000184: These observations do not relate with the choice of a trial’s objective,
p.000184: i.e. whether it is ethically justifiable to prefer conducting trials for certain diseases instead of others.
p.000184: The matter is definitely critical, especially when it concerns substantial disregard of rare diseases (“orphan” drugs),
p.000184: as well as high competition in the production of drugs for specific diseases, that often leads to scientifically
p.000184: unreliable clinical trial results. However, financial free- dom does not allow a moral control on the private sector
p.000184: (pharmaceutical industry), which would result in enforcing research in certain areas of clinical trials, ignoring the
p.000184: element of business profit (and business risk respective- ly). It is basically the responsibility of the state -or the
p.000184: public funding for bi- omedical research- to satisfy similar needs, with fair criteria.
p.000184:
p.000184: 9. The law
...

p.000186: In conclusion, the current legislation “shields” the physician’s
p.000186: /researcher’s scientific independence with liability provisions, in the sense that they can be raised
p.000186: against possible pressure from the sponsor’s part. Vice versa, the law does not justify a physician’s own
p.000186: spontaneous disregard of the rules of science and ethics in favor of financial purposes, when the later
p.000186: can result in harming the patient’s interests. In this case, there is medi- cal error, an intentional one, either due
p.000186: to a poor choice or practice of the medical action in question (according to rules of science) or due to a defi- ance
p.000186: of some rule of ethics (e.g. providing information to the patient).
p.000186:
p.000186: c. The sponsor’s liability
p.000186: Another interesting side for legislation is the liability of the sponsor, as a commercial enterprise. The general
p.000186: context is defined by the legislation concerning the liability of providers of goods and services and the consum-
p.000186: ers’ protection42.
p.000186: Based on the relevant regulations, a business trading new products in the market -as for example a
p.000186: pharmaceutical industry launching a new pharmaceutical product- is responsible for the product’s quality (i.e.
p.000186: wheth- er it responds to the need it is meant to satisfy), as well as for informing the consumer (in this case, the
p.000186: patients) adequately about the efficacy (in this case, the therapeutic factors) and the safety (in this case, the
p.000186: possible side effects of a drug). In case a business launches defective products -e.g. drugs based on misleading
p.000186: results of clinical studies or new drugs with significant differences than the established ones, also based on
p.000186: unreliable clinical trials, it can be compelled to compensate, apart from possible administrative pen- alties (fines,
p.000186: license removal).
p.000186: Therefore, from this point of view, the law opts in favor of searching for scientifically valid results in clinical
p.000186: research, independently from purely financial purposes. Indeed, it is interesting that the above mentioned legisla-
p.000186: tion concerns providers of all kinds of products and services towards the public, as consumers in general.
p.000186: There is no special relevant legislation for products and services concerning health or consumers respectively
p.000186: (i.e.
p.000186:
p.000186:
p.000186: 42 See especially art. 7 of Law 2251/1994.
p.000186:
p.000187: 187
p.000187:
p.000187: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000187: REPORT
p.000187:
p.000187: mostly patients). Even so, however, the businesses’ liability is specified. De lege ferenda it could be argued
p.000187: that, in view of the Constitution’s art. 21 par. 3, it is necessary to adopt a special -stricter- legislation
p.000187: about the com- mercial liability of businesses in the field of healthcare products in order to operate -amongst others-
p.000187: as a dissuasive factor in cases of conflict of inter- est in clinical research.
p.000187:
p.000187: 10. Conclusion - Control mechanisms in our country
p.000187:
p.000187: The possibility of conflict of interest in clinical research has already been regulated by the relevant
p.000187: legislation. The Ministerial Decision of 2003, by which the 2001/20 Commission Directive about clinical studies
...

p.000187: for rules of good manufacturing of medicinal products).
p.000187:
p.000188: 188
p.000188:
p.000188: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000188: REPORT
p.000188:
p.000188: “source”. This Institution -in which the Hellenic National Bioethics Commis- sion has been repeatedly referred to -is
p.000188: still inactive even though it has been regulated by our legislation (Law 2071/1992).
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000189: 189
p.000189:
p.000189: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000189: REPORT
p.000189:
p.000189: SUGGESTED LITERATURE
p.000189:
p.000189: AAV Advisory Committee on financial conflicts of interest in human subjects research, AAMC, AAV (2008). Protecting
p.000189: patients, preserving integrity, ad- vancing health report of the AAMC.
p.000189: Association American Universities (2001). Task force on research accounta- bility report and recommendation. USA.
p.000189: Association of American Medical Colleges (2001). Protecting subjects, pre- serving trust, promoting progress.
p.000189: USA.
p.000189: Association of American Medical Colleges (2002). Task force on financial conflicts of interest in clinical
p.000189: research, protecting subjects, preserving trust, promoting progress. II. Principles and recommendations for oversight
p.000189: of an institution's financial interest in human subjects research. Washington, D.C.
p.000189: Bero LA, Rennie D (1996). Influences on the quality of published drug stud- ies. Int J Technol Assess Health Care 12,
p.000189: 209-237.
p.000189: Blumenthal D (2003). Academic-industrial relationships in the life sciences. N Engl J Med 349, 2452-2459.
p.000189: Blumenthal D (2004). Doctors and drug companies. N Engl J Med 351, 1885- 1890.
p.000189: Bodenheimer T (2000). Uneasy alliance-clinical investigators and the phar- maceutical industry. N Engl J Med
p.000189: 342, 1539-1544.
p.000189: Campbell EG, Rao SR, DesRoches CM et al., (2010). Physician professional- ism and changes in physician-industry
p.000189: relationships from 2004 to 2009. Arch Intern Med 170, 1820-1826.
p.000189: Campbell EG, Weissman JS, Vogeli C et al., (2006). Financial relationships be- tween institutional review board members
p.000189: and industry. N Engl J Med 355, 2321-2329.
p.000189: Djulbegovic B, Cantor A, Clarke M (2003). The importance of preservation of the ethical principle of equipoise in the
p.000189: design of clinical trials: relative im- pact of the methodological quality domains on the treatment effect in ran-
p.000189: domized controlled trials. Account Res 10, 301-315.
p.000189:
p.000189:
p.000190: 190
p.000190:
p.000190: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000190: REPORT
p.000190:
p.000190: Dunbar CE, Tallman MS (2009). “Ghostbusting” at blood. Blood 113, 502- 503.
p.000190: Echt DS, Liebson PR, Mitchell LB et al., (1991). Mortality and morbidity in patients receiving encainide,
p.000190: flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med 324, 781-788.
p.000190: Fisher JA (2008). Practicing research ethics: Private-sector physicians & pharmaceutical clinical trials. Soc
p.000190: Sci Med 66, 2495-2505.
p.000190: Fries JF, Krishnan E (2004). Equipoise, design bias, and randomized con- trolled trials: the elusive ethics
p.000190: of new drug development. Arthritis Res Ther 6, R250-R255.
p.000190: Fugh-Berman AJ (2010). The haunting of medical journals: How ghostwriting sold "HRT". PLoS Med 7, e1000335.
p.000190: Hampson LA, Joffe S, Fowler R, Verter J, Emanuel EJ (2007). Frequency, type, and monetary value of financial
p.000190: conflicts of interest in cancer clinical re- search. J Clin Oncol 25, 3609-3614.
p.000190: Henry D, Doran E, Kerridge I, Hill S, McNeill PM, Day R (2005). Ties that bind: multiple relationships between clinical
p.000190: researchers and the pharmaceutical industry. Arch Intern Med 165, 2493-2496.
p.000190: Heres S, Davis J, Maino K, Jetzinger E, Kissling W, Leucht S (2006). Why olanzapine beats risperidone,
p.000190: risperidone beats quetiapine, and quetiapine beats olanzapine: An exploratory analysis of head-to-head comparison stud-
p.000190: ies of second-generation antipsychotics. Am J Psychiatry 163, 185-194.
p.000190: Hulley S, Grady D, Bush T et al., (1998). Randomized trial of estrogen plus progestin for secondary prevention of
p.000190: coronary heart disease in postmeno- pausal women. Heart and Estrogen/progestin Replacement Study (HERS) Re- search
p.000190: Group. JAMA 280, 605-613.
p.000190: Jorgensen AW, Maric KL, Tendal B, Faurschou A, Gotzsche PC (2008). Indus- try-supported meta-analyses compared with
p.000190: meta-analyses with non-profit or no support: Differences in methodological quality and conclusions. BMC Med Res
p.000190: Methodol 8, 60.
p.000190:
p.000190:
p.000190:
p.000191: 191
p.000191:
p.000191: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000191: REPORT
p.000191:
p.000191: McCrary SV, Anderson CB, Jakovljevic J et al., (2000). A national survey of policies on disclosure of
p.000191: conflicts of interest in biomedical research. N Engl J Med 343, 1621-1626.
...

p.000207: and benefits, but involves risks as well (Recommendations of the SACGT on Genetic Testing, 2000). The benefits
p.000207: and risks always exist in relation to the nature and the severity of the dis- ease.
p.000207: Genetic tests for health reasons have some diagnostic limits:
p.000207:
p.000207:
p.000208: 208
p.000208:
p.000208: DIRECT-TO-CONSUMER GENETIC TESTING
p.000208: REPORT
p.000208:
p.000208: 1. A test may not detect a singe mutation (a gene can bear several mutations in different parts). E.g. there are over
p.000208: 1,300 mutations in the gene causing familial hypercholesterolaemia, which are dis- tributed throughout the gene and
p.000208: show different frequencies be- tween populations. Moreover, a negative test that does not de- tect a
p.000208: mutation cannot completely exclude the disease. This oc- curs either because many tests screen only for the most
p.000208: common mutations or because the method used has certain restrictions.
p.000208: 2. Multifactorial diseases are complex and result from both genetic and environmental factors. Even if two
p.000208: individuals bear the same mutation, disease onset, severity and progress may differ due to interaction with other
p.000208: genes or different environmental factors, to which each individual is exposed. Thus, genetic tests cannot
p.000208: determine with certainty whether a person will develop the dis- ease, but only estimate the possibility to develop
p.000208: it.
p.000208: 3. Often, data produced by genetic tests are not directly related to the treatment of the disease or on certain
p.000208: occasions, there are no available treatments. Pharmacogenetic tests are an exception, since they provide
p.000208: information about drug response and side ef- fects based on a person’s genetic composition.
p.000208: The benefits of genetic testing are mainly related to the health and psy- chology of the individual or his/her family:
p.000208: 1. In case of a family history which is confirmed by genetic testing, the individual has a chance of
p.000208: responsible guidance by the geneticist, aiming at prevention. E.g. if a person has a family history of
p.000208: colon cancer, genetic tests detecting a mutation or predisposition will put an end to his worries and may
p.000208: become the start for regular tests which may detect precancerous polyps and even prevent death by this cause.
p.000208: Respectively, other members of the family who share the same genetic profile may also benefit.
p.000208: 2. In case of a negative result, the individual is relieved and freed from possible regular tests that can
p.000208: be painful and/or costly.
p.000208: 3. When it comes to pharmacogenetic testing, one can ensure a personalized, more effective treatment,
p.000208: with reduced side effects. E.g. people who suffer from Alzheimer’s disease and bear a single copy of a
p.000208: gene have no advantage with a certain
p.000208:
p.000208:
p.000209: 209
p.000209:
p.000209: DIRECT-TO-CONSUMER GENETIC TESTING
p.000209: REPORT
p.000209:
p.000209: treatment, while people with two copies of the gene demonstrate a slow progress of the disease under the same
p.000209: treatment.
...

p.000232: advances enable interventions in basic, “normal” human capabilities, a fact that raises serious social and
p.000232: ethical issues. Some forms of enhancement already have practical applications, whereas other forms
p.000232: belong to the realm of science fiction.
p.000232: The term refers to the improvement or enhancement of human performance, appearance, behavior or
p.000232: emotions, through the use of medical technology (including genetics and biotechnology).
p.000232: Biomedical applications are used in order to develop capabilities beyond of what is considered as normal
p.000232: or healthy. Perhaps instead of “enhancement”, “expansion” is a different term that can be used, and does
p.000232: not necessarily imply that such interventions are beneficial to the person.
p.000232:
p.000232: 2. The facts
p.000232:
p.000232: a) Distinctions
p.000232:
p.000232: Certain distinctions between certain concepts are important for the discussion on human enhancement.
p.000232:
p.000232: i) Internal (in the human body) and external enhancement
p.000232: Human enhancement can be achieved by means acting within the human body or by external tools acting
p.000232: on the human body. For example, the use of drugs affects normal biological functions of the human body,
p.000232: whereas an external computer could control human functions externally, after connecting with an implant.
p.000232:
p.000233: 233
p.000233:
p.000233: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000233: REPORT
p.000233:
p.000233:
p.000233: ii) Temporary and permanent enhancement
p.000233:
p.000233: Human enhancement may cause temporary changes in humans, such drug use, where the effect ceases by not
p.000233: providing these substances, or permanent changes, such as the genetic modification of gametes.
p.000233:
p.000233: iii) Treatment and human enhancement
p.000233:
p.000233: The distinction between human enhancement and treatment is also important in this discussion, although it
p.000233: is not easy. Treatment aims to correct pathological characteristics, human diseases or injuries and restores
p.000233: -to the extent possible- the normal function of the human body. In contrast, human enhancement aims to improve
p.000233: the human characteristics or capabilities beyond the normal. One might consider that therapy provides
p.000233: the means to get well, whereas human enhancement provides the means to become better.
p.000233: Of course this assumes that there is a clear definition of “normal”, “healthy” and “disease”. However, it is
p.000233: difficult to define “healthy” since the World Health Organization (WHO) describes in its constitution that "health is a
p.000233: state of complete physical, mental and social well-being and not merely the absence of disease or infirmity". This
p.000233: definition expands the boundaries of health, including non-medical problems such as those resulting from spe- cific
p.000233: social characteristics. The definition of normal is even more difficult if one considers that there are “natural”
p.000233: differences, not only between indi- viduals but also within the same individual at different developmental stag-
p.000233: es.
p.000233: On the other hand, the modern medical practice already applies practis- es that aim not only at the correction of
p.000233: pathological conditions and diseas- es:
p.000233: First and foremost, preventive medicine, which aims to prevent and ultimately avoid disease. Preventive medicine
...

p.000235:
p.000235: Genetic testing (in various genes)
p.000235:
p.000235: In somatic cells
p.000235:
p.000235:
p.000235: In gametes
p.000235: Disease diagnosis Disease prevention Effective treatment Stem cell treatment
p.000235: StemXcells to generate tissue and organs
p.000235: Correcting or avoiding abnormal genes
p.000235: Avoiding sex-linked diseases
p.000235: Increasing life expectancy Selection of “better children” Enhancing athletic performance
p.000235:
p.000235: Increasing life expectancy
p.000235:
p.000235: Enhancing non-pathological genes Enhancing skills, stamina, intelligence, memory, metabolism, etc.
p.000235: Regenerative medicine
p.000235:
p.000235:
p.000235: Tissue/organ regeneration
p.000235: Restoration of organ function Restoration of sports injuries
p.000235: Increasing life expectancy Enhancing athletic performance
p.000235:
p.000235:
p.000235: Platelet rich plasma
p.000235: Scar repair after accidents or burns Enhancing appearance
p.000235: Restoration of anterior cruciate
p.000235:
p.000235: (gel)
p.000235: Restoration of joints with
p.000235: osteoarthritis
p.000235: Enhancing athletic performance
p.000235:
p.000235:
p.000235:
p.000235:
p.000235:
p.000236: 236
p.000236:
p.000236: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT REPORT
p.000236:
p.000236: Table I (continued). Interventions applied to both treatment and human enhancement.
p.000236:
p.000236: Treatment Human enhancement Technological interventions
p.000236:
p.000236:
p.000236:
p.000236: Artificial implants
p.000236: Early and accurate diagnosis Effective and targeted drug therapy Restoration of joints, organs
p.000236:
p.000236: Enhancing athletic performance Increasing life expectancy
p.000236:
p.000236:
p.000236:
p.000236: Implants - sensors
p.000236:
p.000236:
p.000236:
p.000236: Brain implants
p.000236: Diagnosis and treatment of diseases
p.000236: e.g. sensor of sugar levels and use of insulin
p.000236:
p.000236: Increasing memory in patients with neurodegenerative diseases Restoration of mobility in paralyzed patients
p.000236:
p.000236: Enhancing athletic performance
p.000236:
p.000236: Enhancing senses, memory, intelligence
p.000236: Free access and opportunity to intervene in the physical world by thought
p.000236: Increasing life expectancy
p.000236:
p.000236: Nanotechnology Targeted therapy e.g. targeting cancer cells
p.000236:
p.000236: Aesthetic (surgical) interventions
p.000236: Reducing the vulnerability of soldiers by controlling their metabolism
p.000236: Skin graft Patients with severe burns Enhancing appearance and signs of
p.000236: aging
p.000236:
p.000236: Reconstructive surgery
p.000236: Scar repair after accidents or burns Restoration of anterior cruciate
p.000236: Enhancing appearance and signs of aging
p.000236: Liposuction Reducing the risk of obesity Enhancing appearance
p.000236:
p.000236: Gender change Agreement of physical and sexual
p.000236: identity
p.000236: Breast implants Breast reconstruction after total mastectomy
p.000236: Enhancing gender characteristics
p.000236:
p.000236: Enhancing appearance
p.000236:
p.000236: Breast size reduction
p.000236: Treatment of dermatitis Decrease neck pain
p.000236: Enhancing appearance Enhancing athletic performance
p.000236:
p.000236:
p.000236:
p.000236:
p.000236:
p.000236:
p.000236:
p.000236:
p.000237: 237
p.000237:
p.000237: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000237: REPORT
p.000237:
p.000237: c) The “business” of enhancement
p.000237:
p.000237: Human enhancement technologies are an opportunity for businesses to invest in, and may soon become a
p.000237: lucrative industry. Pharmaceutical companies, research institutes, universities and even governments spent
p.000237: and continue to spend huge amounts on drug research and human enhancement technologies. Similarly
p.000237: to the development of pharmaceutical drugs, for which companies invest in research with the ultimate aim to
p.000237: obtain approval and, consequently, to profit from drug sales, research in human enhancement comprises an
p.000237: area for business development. The growing demand for enhancing human characteristics is inseparable linked to the
p.000237: production and supply of such substances and technologies.
p.000237: Typical examples are the drugs Prozac (antidepressant) and Ritalin (prescribed in cases of
p.000237: attention deficit hyperactivity disorder), for which the demand is growing with equivalent profits for the
p.000237: companies producing them, as well as the increasing demand for plastic surgery with corre- sponding
p.000237: economic benefits for those who provide such services (AAAS, 2006). It is certain that non-invasive methods of
p.000237: human enhance-ment, such as drug use, will attract more future investments considering that people are more
p.000237: receptive to them, access is easier through the internet, and they are not regulated as stringent in all countries.
p.000237:
p.000237: 3. The dimension of ethics
p.000237:
p.000237: The possibility of changing properties of the human body by medical means, in order to seek some kind
p.000237: of “enhancement” (as the person interested understands it), poses, in principle, a general
p.000237: question: is “enhancement” a morally acceptable reason for medical interventions within the body or,
p.000237: on the contrary, does it exceed what we mean by “health care”?
p.000237: The affirmative answer to this question could be based on the above mentioned broad definition of
p.000237: health, adopted by WHO. According to this definition, any intervention aiming at the “full development” of
p.000237: human abilities is justified, even if nothing pathological is being treated, i.e. when the organism does not
p.000237: suffer from a disease or accident. In this context,
p.000237:
p.000237:
p.000237:
p.000238: 238
p.000238:
p.000238: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000238: REPORT
p.000238:
p.000238: “enhancement” is part of “health”1.
p.000238: A negative answer to the above posed question is linked to the standard aim of medicine, which is to treat the disease
p.000238: (and generally any damage of the organism). This approach accepts a more moderate definition of health, considering
p.000238: healthy anyone living in a balanced physical state, without presenting with any damages or threatened by
...

p.000005: art. 8
p.000005: p.1 ECHR), arguing that human enhancement is related to changes in the core personality.
p.000005: The Oviedo Convention and the Code of Medical Ethics (CME, Law 3418/2005) also include provisions which can
p.000005: be generally applied here.
p.000005: The regulatory scope of the Convention is the “application of Biology and Medicine” (art. 1). From this
p.000005: perspective, human enhancement falls within the Convention -as it is pursued by medical or biological
p.000005: methods- and is included in the concept of “health interventions” (which is encountered repeatedly in the
p.000005: Convention). This means that most of the Convention provisions are applied here and particularly: a) the rule of
p.000005: Informed Consent (art. 5 et seq) and the protection of privacy (art. 10).
p.000005: The CME includes regulations regarding the way medicine should be applied, in the strict sense. Indeed,
p.000005: according to art. 1 CME:
p.000005: 1. A medical act aims at prevention, diagnosis, treatment and restoration of human health, by use of
p.000005: any scientific method.
p.000005: 2. Research can also be regarded as a medical act, provided that it aims at a more accurate diagnosis, restoring
p.000005: or improving human health and the promotion of science.
p.000005:
p.000005:
p.000241: 241
p.000241:
p.000241: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000241: REPORT
p.000241:
p.000241: 3. The concept of medical act also includes drug prescriptions, the order to carry out any kind of paraclinical
p.000241: examinations, issuing medical certificates and attestations and the general counseling of the
p.000241: patient.
p.000241: This is a comprehensive definition of medical acts by the legislature, which does not include enhancement
p.000241: interventions in order to improve capabilities or aesthetics.
p.000241:
p.000241: B. ENHANCEMENT OF PHYSICAL CHARACTERISTICS AND CAPABILITIES
p.000241:
p.000241: I. Plastic (surgical) procedures
p.000241:
p.000241: 1. The data
p.000241:
p.000241: a) Reconstructive and aesthetic surgery
p.000241:
p.000241: Plastic surgery is a kind of enhancement of human characteristics, which is already applied to both men and women. The
p.000241: term plastic surgery refers to the surgical repair or correction of a feature or function of the human
p.000241: body. There are two types of plastic surgery:
p.000241: 1. Reconstructive procedures. Their purpose is to repair or enhance physiological functions and
p.000241: characteristics of the body, which are altered due to accidents, diseases or birth defects.
p.000241: The most common reconstructive procedures include reconstru- ctive plastic surgery to correct scars after
p.000241: an accident or burn, restoration of cleft lip and palate and reduction of the breast size.
p.000241: 2. Aesthetic/cosmetic procedures, which are divided into surgical and non-surgical cosmetic procedures.
p.000241: Their purpose is to reconstruct characteristics of the body in order to enhance external appearance. The
p.000241: specificity of cosmetic surgery is that the person interested is physically healthy.
...

p.000248:
p.000248:
p.000249: 249
p.000249:
p.000249: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000249: REPORT
p.000249:
p.000249: possibilities offered by biomedicine and biotechnology. For example, the
p.000249: U.S. Department of Defense and the Advanced Research Projects Agency Defense (DARPA) fund research on
p.000249: pharmaceutical agents that keep soldiers alert, reducing the need for sleep. Research is also conducted on
p.000249: nutrient preparations that fulfill the nutritional needs of soldiers for several days. DARPA’s program
p.000249: “Persistence in Combat” includes the development of a vaccine that would block pain, accelerate wound healing
p.000249: and stop bleeding soon after wounding (Parasidis, 2012).
p.000249:
p.000249: d) Enhancing athletic performance
p.000249:
p.000249: During their preparation, athletes are trained by qualified coaches, they follow a special diet that includes
p.000249: supplements and they have access to physiotherapy in order to improve their athletic performance. However,
p.000249: since professionalism came to be part of sports, the pressure for better athletic performance, imposed by
p.000249: either the athletes’ personal ambitions or by their athletic clubs including their coaches, is stronger.
p.000249: Thus, hard training, even from an early age, seems to be insufficient, and consequently, athletes turn to doping
p.000249: in order to enhance their athletic performance. “Doping” is the most common and oldest form of
p.000249: enhancing sports performance, while nowadays, it has many aspects, e.g. drug doping, gene doping, etc. “Doping” is
p.000249: defined as the use of prohibited substances or methods intended to artificially enhance the sports-racing
p.000249: skills of athletes, both during a game and during the preparation for a game.
p.000249: In 1928, the International Amateur Athletic Federation set the first official ban of substances that
p.000249: enhance athletic performance, despite the lack of relevant methods to detect the substances (House of
p.000249: Commons, Select Committee on Culture, Media and Sport, 2004). In 1967, the International Olympic
p.000249: Committee (IOC) created the Medical Commission aiming to supervise and deal with the problem of doping
p.000249: in the Olympic Games. In 2004, the World Anti-Doping Agency (WADA) undertook the role of the main anti-doping
p.000249: coordinator at an international level. Since then, the banned substances and methods are defined by the List
p.000249: of Prohibited Substances and Methods, which is reviewed annually by WADA and applies to all sports and all
p.000249: countries. According to the World Anti-Doping Code “Doping is defined as the occurrence of one or more of the
p.000249: anti-doping rule
p.000249:
p.000249:
p.000250: 250
p.000250:
p.000250: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000250: REPORT
p.000250:
p.000250: violations set forth in Articles 2.1 through 2.8 of the World Anti-Doping Code”3. In Greece, the National
p.000250: Anti-doping Council (ESKAN) is the National Anti-Doping Organization.
p.000250: According to the World Anti-Doping Code, the current criteria for includ- ing substances and methods on the prohibited
p.000250: list are:
...

p.000254: As to the second issue, our relations with third parties set limits on the enhancement of physical abilities by
p.000254: using pharmaceutical agents. Ideally, ensuring equal access to any mean that can enhance performance is a
p.000254: characteristic of justice. If this is not possible, the prohibition of specific means is, in principle,
p.000254: legitimate, in competing procedures (e.g. in education or in sports -especially championship games, where the
p.000254: interests of third parties is stronger).
p.000254: In contrast to pharmaceutical enhancement, interventions in an indi- vidual’s genome are “with no return”,
p.000254: namely they generate permanent effects on the organism. As long as there are relevant applications (as
p.000254: already discussed for championships), the concerns are stronger here, since many gene functions remain mostly
p.000254: unknown. Therefore, genetic mani- pulation imposes a greater risk on the state of the organism. Precisely due to
p.000254: this uncertainty, it is ethically questionable whether genetic manipulation methods are justifiable (“protective
p.000254: principle”) as a form of acceptable options within a person’s autonomy, because under such circumstances the
p.000254: “rational” use of freedom proves problematic. Certainly, however, the matter of providing the necessary and
p.000254: accurate information concerning the use of genetic manipulation methods is crucial.
p.000254:
p.000254: 3. The law
p.000254:
p.000254: Drug administration is subjected to the provisions of the pharmaceutical legislation (Directive 2001/1983, as
p.000254: incorporated by the Ministerial decision DYG 3a/83657/24.1.2006, Law 1316/83, as in force, Law 96/1973, as in
p.000254: force) which are particularly relevant to the responsibility of physicians, pharmacists and traders, also
p.000254: controlled by the National Organization for Medicines (NOM). In this legislation, the prohibition of
p.000254: advertising pre- scription drugs to the public and the strict terms on the physicians’ updating about these drugs, are
p.000254: of particular importance.
p.000254: Particularly for doping in sport, both the International Convention against Doping in Sport (UNESCO,
p.000254: 2005) ratified by Law 3516/2006, and the Anti-Doping Convention (Council of Europe, 1989) ratified
p.000254: by Law
p.000254:
p.000254:
p.000255: 255
p.000255:
p.000255: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000255: REPORT
p.000255:
p.000255: 2371/1996, are applied. These legislations, are “procedural” in nature and provide control, information,
p.000255: education and transnational cooperation, but without general substantive criteria for classifying substances
p.000255: as “pro- hibited”. The characterization as “prohibited” is left to the absolute discretion of
p.000255: WADA and directly adopted from the states that ratified the aforementioned legislation. It is
p.000255: interesting to note that athletes are permitted to use prohibited substances for therapeutic purposes. The
p.000255: first Convention was specialized in our country with the YA 3956/19.2.2012, specifying, in particular, the
...

p.000267:
p.000267:
p.000267:
p.000267:
p.000267:
p.000267:
p.000267:
p.000268: 268
p.000268:
p.000268: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000268: OPINION
p.000268:
p.000268: O P I N I O N
p.000268:
p.000268: HUMAN ENHANCEMENT -
p.000268: EFFECT ON COGNITIVE AND MENTAL STATE
p.000268:
p.000268: The Hellenic National Bioethics Commission, as previously announced, continued to examine the issue of “human
p.000268: enhancement”, focusing on the effects of enhancement methods on the cognitive and mental state of the human organism.
p.000268: To study the issue, the Commission held relevant hearings of Dr. G. Christodoulou, Emeritus Professor of
p.000268: Psychiatry, Medical School, Athens University and Honorary President of the Greek Psychiatric Association and Dr. G.
p.000268: Kolaitis, Associate Professor of Child Psychiatry, Medical School, Ath- ens University.
p.000268:
p.000268: I. The data
p.000268:
p.000268: Modern science enabled the development of specific interventions for the “cognitive" functions of the human
p.000268: body, with a main purpose to treat mental illnesses and disorders. However, the possibilities offered by modern science
p.000268: highlight the problem of whether it is legitimate to use such meth- ods in healthy organisms, aiming to enhance the
p.000268: mental or emotional condi- tion.
p.000268: Such methods are particularly: a) selective stimulation of brain regions, with electrical or magnetic signals, and b)
p.000268: drug use. In the future, it is likely that these methods are enriched by targeted genetic modification of genes
p.000268: associated with cognitive functions, as well as by brain/computer interfaces, which is expected to allow access
p.000268: to electronic information -and generally use of computer programs- by just activating certain cognitive functions.
p.000268: The Commission notices that there is internationally, a widespread use of substances by healthy individuals
p.000268: (nicotine, caffeine) or even prescription drugs, with the aim to further enhance their cognitive functions.
p.000268: Users mainly pursue memory and attention enhancement, but also to treat nor- mal hyperactivity, which occurs
p.000268: particularly in children. In addition, the ap- pearance of anxiety or phobias, typical elements of everyday life in a
p.000268: mod-
p.000268:
p.000268:
p.000269: 269
p.000269:
p.000269: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000269: OPINION
p.000269:
p.000269: ern social context, puts pressure on healthy individuals to use sedatives, antianxiety and antidepressant
p.000269: drugs.
p.000269: The Commission considers that, as in the case of enhancing physical characteristics, the autonomy of a
p.000269: healthy person includes options for en- hancing the cognitive or mental state of the human body. This enhancement
...

p.000272: This includes the acquisition, selection, clarification and recollection of information, which correspond to
p.000272: the perception, attention, understanding and memory of the organism, as well as the way these processes
p.000272: determine behavior.
p.000272:
p.000272: I. The data
p.000272:
p.000272: Unquestionably, education, consumption of certain nutrients and the use of information processing devices,
p.000272: such as calculators and computers, constitute tools to improve cognitive activity and performance. However,
p.000272: these are considered as “conventional” and are commonly accepted. New technologies such as brain stimulation,
p.000272: and new uses of older technologies such as psychotropic drugs, are the subject of discussion and reflection
p.000272: in bioethics, in the context of human enhancement.
p.000272:
p.000272:
p.000273: 273
p.000273:
p.000273: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000273: REPORT
p.000273:
p.000273: 1. Brain stimulation
p.000273:
p.000273: a. “Deep brain stimulation”
p.000273:
p.000273: The so-called “deep brain stimulation” is an invasive, research method in which electrodes are implanted in the
p.000273: brain sending electrical stimulatory signals in selected regions of the brain. This method, among others,
p.000273: has been used experimentally to treat depression, epilepsy and Parkinson's disease with relatively good
p.000273: results. Indeed, deep brain stimulation has been approved by the U.S. Food and Drug Administration (FDA) for the
p.000273: treatment of essential tremor, dystonia and Parkinson's disease. Even though this technology could be used to
p.000273: enhance human cognitive and mental abilities, nevertheless there are no reports on the use of these
p.000273: experimental technologies in healthy subjects.
p.000273:
p.000273: b. Magnetic brain stimulation
p.000273:
p.000273: Magnetic stimulation of the cerebral cortex is a similar, but non-invasive method, which is approved by the FDA
p.000273: for the treatment of depression, while it is also tested experimentally in stroke patients. Yet, several studies
p.000273: have been conducted in order to investigate the effect of magnetic brain stimulation in healthy subjects,
p.000273: showing positive results for enhancement of cognitive and mental functions. For example, magnetic stimulation
p.000273: of the brain changes brain plasticity (neural plasticity), namely, the ability of the nervous system to
p.000273: adapt to changing conditions, enhances performance and changes the person’s behavior1, learning ability2, memory3, and
p.000273: even hand- writing or spelling ability4. Nevertheless, it must be noted that the above mentioned studies
p.000273: were performed in a relatively small number of healthy
p.000273:
p.000273: 1Hummel FC, Cohen LG (2005). Drivers of brain plasticity. Curr Opin Neurol 18, 667- 74.
p.000273: 2Pascual-Leone A, Tarazona F, Keenan J, et al. (1999).Transcranial magnetic stimula- tion and neuroplasticity.
p.000273: Neuropsychologia 37, 207-17.
p.000273: 3Fregni F, Boggio PS, Nitsche M, et al. (2005). Anodal transcranial direct current stim- ulation of prefrontal cortex
p.000273: enhances working memory. Exp Brain Res 166, 23-30.
...

p.000278:
p.000279: 279
p.000279:
p.000279: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000279: REPORT
p.000279:
p.000279: continuous access to the internet, databases and information processing systems, which can enhance the
p.000279: abilities of human mind. Although these technologies are notable, however they must progress in order to
p.000279: achieve precision in manipulating external devices after stimulation of specific brain cells31.
p.000279:
p.000279: ΙΙ. The dimension of ethics
p.000279:
p.000279: 1. Overview
p.000279:
p.000279: Setting aside the general bioethics concern about human enhancement, for enhancement of cognitive and mental
p.000279: characteristics, in particular, it is worth insisting on three issues: a) the safety of interventions on
p.000279: memory functions, b) the safety in a wider range of cognitive and mental functions, and, c) the prospect of equal
p.000279: access to means of enhancement.
p.000279: These specific issues presuppose the general premise that enhancement is a legitimate pursuit for the development of a
p.000279: personality, in the context of self-determination, as long as goods of other people are not put at risk.
p.000279:
p.000279: 2. Memory enhancement
p.000279:
p.000279: Drug use aiming at enhancing specific memory functions, may be challenged as unsafe, when there may
p.000279: be uncertain consequences for other memory functions. There are data showing that, for evolutionary reasons,
p.000279: the various memory functions are not independent, but instead, they are closely linked. Thus, for
p.000279: example, the progressive memory loss of remote events appears to be associated with the speed to recall most
p.000279: recent events, in order to facilitate decision making. In addition, it seems that the ability of symbolic memory, may
p.000279: affect the ability of imaging memory or event memory (Glannon, 76-77).
p.000279: This means that the artificial increase of memory contents is likely to
p.000279:
p.000279: 30Kim SP, Simeral JD, Hochberg LR, et al. (2008). Neural control of computer cursor velocity by decoding motor
p.000279: cortical spiking activity in humans with tetraplegia. J Neu- ral Eng 5, 455-76.
p.000279: 31Robinson JT, Jorgolli M, Park H (2013). Nanowire electrodes for high-density stimu- lation and measurement of neural
p.000279: circuits. Front Neural Circuits 7, 38.
p.000279:
p.000280: 280
p.000280:
p.000280: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000280: REPORT
p.000280:
p.000280: cause difficulties in recalling specific events or images etc., unexpectedly changing the balance of
p.000280: memory functions. It is a situation where enhancement means can cause uncertain consequences, which may
p.000280: lead to the production of multiple problems to the user. Given the relative ignorance of many brain
p.000280: functions, there is a safety issue here. Even if we get certainty about the side effects of such drugs for other areas
p.000280: of memory, an issue will be raised about whether it is legitimate for a person to encounter the dilemma
p.000280: of enhancing certain functions at the expense of others.
p.000280:
p.000280: 3. Balancing cognitive and psychological functions - Personality change
p.000280:
p.000280: In the case of mental characteristics, in a broader context, we encounter the same problem regarding the balance
p.000280: of increased cognitive abilities (memory, ability to concentrate, etc.). It seems that here, there is some kind of
p.000280: connection, e.g. with the emotional life of the person. Thus, enhan- cement of cognitive abilities
p.000280: that allows an employee to perform exceptionally, has been reported to negatively affect his/her
p.000280: emotional world (events of apathy, indifference, etc.), with unknown consequences for the personality (Glannon, 77-78).
p.000280: Generally, the question of changing a personality by drug use (particularly antidepressants) is a
p.000280: central concern, as does the question of whether this increases or limits autonomy (STOA, 135). There is
p.000280: no doubt that personality changes, anyway, with the assistance of external actors - particularly by
p.000280: the socialization mechanisms during childhood and adolescence- the effects of which often are not
p.000280: controlled by the person itself. Thus, a child’s personality is constantly changing under the influence of family,
p.000280: school, friends, television, internet etc. However, there are also changes during adulthood, even if
p.000280: certain characteristics are gradually stabilized, comprising foundations for the “development” of
p.000280: personality. The very term “development”, suggests “change” anyway.
p.000280: Therefore, the critical point to our subject is not whether, in general, personality development is
p.000280: legitimate, but rather whether such a change can be so radical that can lead to psychological
p.000280: pathologies, i.e. to cause damage to a person’s mental health. Besides extreme exceptions,
p.000280: mechanisms of socialization do not cause so deep “sections” in a person’s
p.000280:
p.000280:
p.000281: 281
p.000281:
p.000281: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000281: REPORT
p.000281:
p.000281: personality. On the contrary, socialization mechanisms “build” on the grounds formed in infancy,
p.000281: which are associated with inherent cognitive abilities (including perception of space, time, etc.),
p.000281: learning the mother tongue, but also the evolution of the unconscious processes (especially the libido). In
p.000281: contrast, the use of pharmaceuticals -similarly to the use of substances such as alcohol or drugs- can
p.000281: cause such sections, which may lead to serious mental illness. The main reason is that these substances have a
p.000281: strong invasive impact on the function of the nervous system, with largely unpredictable effects on the mechanisms of
p.000281: cognition.
p.000281: This point is important in order to distinguish schematically between “safe” and “unsafe” personality change,
p.000281: but it is not enough to answer the question of whether the second one is legitimate or not. Similarly to alcohol or
p.000281: drug use, a person intentionally uses pharmaceutical agents, and this is done in the context of self-determination,
p.000281: even if the person is aware of the potential serious harm to his/her health. It is generally accepted that self-
p.000281: determination does not exclude choices of an even great risk or choices of “self-destruction”, since otherwise we
p.000281: must adopt paternalistic lifestyles, something that would be fundamentally in contrast to our freedom.
p.000281: Consequently, the possibility of drug use for enhancement purposes that could lead to a radical personality change (or
p.000281: to milder effects on memory capacity, emotional life, etc.), cannot be considered as an illegitimate
p.000281: choice, given the primacy of personal autonomy (Racine & Forlini, 3).
p.000281: However, two reservations remain:
p.000281: - The consequences of drug use do not cause damage to goods of a third party (e.g. in the context of
p.000281: family life or working environment of the user). Thus, for example, drug use that leads to indifference or threat for
p.000281: the user’s children or creates tension with colleagues etc., is illegitimate).
p.000281: - The user has actually made the decision freely, i.e. after providing the appropriate information to him/her, with
p.000281: all the potential risks being identified (Cakic, 613-614, Racine & Forlini, 3, Farah et al., 423). This is not certain,
p.000281: especially when the drugs are administered without a prescription or, at least, without consulting a physician.
p.000281: The re- sponsibility of the latter, here, is certainly increased, as it is about enhancing cognitive or
p.000281: mental characteristics and not about restoring relevant health damage.
p.000281:
p.000281:
p.000282: 282
p.000282:
p.000282: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000282: REPORT
p.000282:
p.000282: 4. Equal access
p.000282:
p.000282: The issue of equal access to means of cognitive or mental enhancement is mainly associated with the
p.000282: opportunities offered in competitive environments (Farah et al., 423) and, secondly, with improvement
p.000282: of our lifestyle. This is an issue of concern which is similar to that of enhancing physical abilities
p.000282: (e.g. doping in sports).
p.000282: Here, enhancement is usually associated with memory or concentration, especially during challenges in education or
...

p.000283: that are not intended for therapeutic purposes) are essential here.
p.000283: The EU legislation on the use of implants (Directive 93/42, incorporated with JMD DY8d/GP. Oik.130648/2.10.2009,
p.000283: Directive 90/385, incorporated by JMD DY8d/GP. Oik.130644/2.10.2009) and the Regulation 726/2004, regarding
p.000283: the centralized authorization procedure of substances at the EU level (STOA, 136) also apply here.
p.000283: In a more specific level, the use of the above mentioned substances or implants is subjected to the provisions of Law
p.000283: 3418/2005 (Code of Medical Ethics), regarding the responsibility of the physician who gives the
p.000283: prescription. There is no doubt that the physician performs a medical act, which is covered by the
p.000283: provisions of CME (equivalent to aesthetic surgery), although enhancement is not explicitly mentioned in
p.000283: the legislative definition of “medical act”.
p.000283: In addition, the legislation on the liability of physicians, pharmacists and
p.000283:
p.000283:
p.000284: 284
p.000284:
p.000284: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000284: REPORT
p.000284:
p.000284: traders, which is controlled by the National Organization for Medicines (Directive 2001/1983, as
p.000284: incorporated by DYG 3a/83657/24.1.2006, Law 1316/83, as in force, Decree 96/1973, as in force) also apply here,
p.000284: according to what is already mentioned in the Report on “Human enhancement - Physical Characteristics”.
p.000284: In particular, the case of Ritalin falls under the drug law (Law 1729/1987, as in force), and therefore, it is only
p.000284: allowed to prescribe it for therapeutic purposes, which means that its use for enhancement purposes is illegal in
p.000284: our country, as in other countries (e.g. USA).
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000284:
p.000285: 285
p.000285:
p.000285: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000285: REPORT
p.000285:
p.000285: SUGGESTED LITERATURE
p.000285:
p.000285: Ahmadian P, Cagnoni S, Ascari L (2013). How capable is non-invasive EEG data of predicting the next
p.000285: movement? A mini review. Front Hum Neurosci 8, 124.
p.000285: Andersen R (2012). Why cognitive enhancement is in your future (and your past). The Atlantic.
p.000285: Bostrom N, Sandberg A (2009). Cognitive enhancement: Methods, ethics, regulatory challenges. Sci Eng Ethics 15,
p.000285: 311-41.
p.000285: Cakic V (2009). Smart drugs for cognitive enhancement: Ethical and pragmatic considerations in the
p.000285: era of cosmetic neurology. J Med Ethics 35, 611-615.
...

Searching for indicator influence:

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p.000047: ELEMENTS OF ORGANISATION OF RESEARCH
p.000047:
p.000047: Research provides empirical data against which theories are tested and questions are answered. It contributes to
p.000047: fulfilling the goals of Science among which gaining new knowledge, seeking scientific truth, avoiding mis- takes
p.000047: and producing technology to facilitate everyday life.
p.000047: Biological Research, its objective being the study of life, impacts directly on essential areas of human lives such as
p.000047: health and the environment. Be- sides, due to the significant breakthroughs of recent decades and the high expectations
p.000047: for producing more innovation in the future, biological re- search has come to occupy a very prominent
p.000047: position world-wide in terms of the value attributed to it by public opinion (Eurobarometer, 2007), the
p.000047: amount of funding it absorbs and the share of economic activity it gener- ates.
p.000047:
p.000047: Biological research in Greece
p.000047:
p.000047: In Greece, biological research is mainly conducted by Higher Education Institutions, Research Centres, Hospitals
p.000047: and, to a lesser extent, by the In- dustry, e.g. pharmaceutical companies, biotechnology companies, etc. Ac-
p.000047: cording to data from the General Secretariat of Research and Technology (GSRT) on research as a whole for
p.000047: 2005, 64% of science and technology re- search staff are employed in government agencies or universities (Table 1).
p.000047:
p.000047: a. Supervision of research
p.000047: In Greece, the government influences the general orientation and scope of research through the formulation of a
p.000047: national strategic plan. The extent of influence exercised by the government on the orientation of research is based on
p.000047: the management of public funds allocated to it.
p.000047: The national strategy for research and technology is approved by the Inter-Ministerial Committee for Research
p.000047: and Technology (DEET) upon pro- posal by the National Board for Research and Technology (ESET). DEET is
p.000047:
p.000047:
p.000047:
p.000047:
p.000048: 48
p.000048:
p.000048: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES REPORT
p.000048:
p.000048: comprised of the Prime Minister and the majority of government Ministers1. The President of the ESET is invited to DEET
p.000048: meetings. The participation of virtually all Ministries in the DEET testifies to the importance of research and
p.000048: technology for all sectors of public life.
p.000048:
p.000048: Table 1. Total Research Manpower in Greece in 2005. The numbers include re- searchers, technicians and
p.000048: support staff. Source: General Secretariat of Science and Technology (GSRT).
p.000048:
p.000048: Distribution of Research Manpower per sector of employment
p.000048: Man-years (FTEE)*
p.000048: Percentile
p.000048: Industry 12,020.5
p.000048: 35.4%
p.000048: Public Research Centres 4,344.8 12.8%
p.000048: Higher Education Institutions 17,400.5 51.2%
p.000048: Non-profit Private Research Centres 192.6 0.6% Total staff
p.000048: employed in research in Greece 33,958.3 100%
...

p.000126: easily forced into accepting things for they are understandably eager to have their health restored as soon as pos-
p.000126: sible in order to return to the freedom of everyday life and recover the full exercise of their autonomy.
p.000126: At this point we must underline that physicians have a heightened ethi- cal duty to provide complete information.
p.000126: The more comprehensive the information, the greater the likelihood for an independent appraisal of the situation
p.000126: -and decision-making- by a de facto vulnerable will. By contrast, limited information can more easily lead to
p.000126: manipulation of the patient by the physician since the patient is called upon to evaluate and decide in an unfamiliar
p.000126: environment of internment, more prone to “blind obedience” rather than genuine exercise of autonomy.
p.000126:
p.000126: 6. Incapacity to consent
p.000126:
p.000126: The legal capacity to consent must be distinguished from the corre- sponding physical capacity. Patients
p.000126: with full legal competence to consent may suffer a temporary disorder of their mental functions which
p.000126: prevents the forming and expression of free will (e.g. under the influence of alcohol or narcotics or in state of
p.000126: shock because of an accident or the announce- ment of a serious disease, etc.)10.
p.000126:
p.000126:
p.000126: 10 This is a case for the application of art. 131 CC which stipulates the nullity of ex- pression of will in such
p.000126: circumstances. See generally on the problem of “irrational”
p.000126:
p.000127: 127
p.000127:
p.000127: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000127: REPORT
p.000127:
p.000127: In these circumstances acting alone is again not justified for physicians except in emergency situations. They must
p.000127: concentrate their efforts on the speedy recovery of the patient’s mental lucidity so that the patient can be informed
p.000127: in time and decide about treatment by himself/herself. Besides, it is not legitimate to substitute the patient’s
p.000127: relatives for the patient’s own will for patients may disagree with their relatives’ decision once their mental
p.000127: capacities are restored.
p.000127: Respectively, persons who are legally incompetent to consent may be physically fully capable of forming and
p.000127: expressing their will on matters con- cerning their health. We already mentioned the example of minors, espe-
p.000127: cially from the beginning of adolescence; similar, however, is the situation of persons under legal guardianship
p.000127: (even full-fledged) whereas mild mental disorders or impairments do not by definition exclude the exercise of self-
p.000127: control over one’s health.
...

p.000164: results into “pharmaceuti- cal products” or into biomedical materials, aiming at financial profits of course.
p.000164: Relationships between physicians and pharmaceutical industries generate -rightly or wrongly- suspicions both
p.000164: to the society and the State. The publicity -often unfounded- which is given in such a relationship has a serious
p.000164: effect on the accountability of health workers, especially when legal entanglements arise.
p.000164: Sponsoring medical research is initially desirable. There is no doubt that many of the new discoveries, both in
p.000164: the field of pharmacology and bio- technology, are a result of the combination of knowledge -generated in Uni-
p.000164: versities or research organizations-, and the private sector which affords the implementation of such discoveries. The
p.000164: integrity of research, meaning the
p.000164:
p.000165: 165
p.000165:
p.000165: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000165: REPORT
p.000165:
p.000165: persistence in drawing results with a valid scientific and ethical methodolo- gy, is yet a matter of great concern. To
p.000165: pose the problem schematically, it is a matter of how the researcher would be able to reconcile in practice the ideal
p.000165: of scientific truth with the commercial pursuits of the industry, which sponsors research. A number of cases are
p.000165: reported in the literature, and concern is expressed1 regarding the involvement of the industry in the po- tential
p.000165: illegitimate interaction of researchers or institutions with the “spon- sors”.
p.000165: Several particular questions, relevant to this subject, may arise:
p.000165: 1. What is the extend and the outcome of an illegitimate influence in- terfering?
p.000165: 2. Is it possible for the average physician and citizen to show absolute confidence in the scientific “findings” of
p.000165: a research study?
p.000165: 3. Is there a possibility that the general financial deterioration of aca- demic institutions or public
p.000165: hospitals, causing incapability to sup- port independently research programs, would lead to a lack in the complete
p.000165: control of results?
p.000165: 4. Does the search for accuracy in research results discourage spon- sors from funding, due to high cost
p.000165: (e.g. because of possible repli- cation of an experiment producing negative results)?
p.000165:
p.000165: 2. Financial data
p.000165:
p.000165: During the past years, the industry has increased respectfully the funds on clinical research. Data from the USA show
p.000165: that in the 1980s, 68% of funds for Phase II and III clinical studies derived from the government and only
p.000165: 32% from the pharmaceutical companies, whereas in 2000 the relevant per- centages were reversed, i.e. 38% of
p.000165: funds was from governmental grants and 62% from pharmaceutical companies. Similarly, in the United Kingdom, 70% of
p.000165: the research outlay stems from pharmaceutical industries and only 30% from other sources.
p.000165: It is estimated that the cost of drugs is increasing in a two-digit percent- age rate, and is already up to $162.4
p.000165: billion in the USA2. The pharmaceutical
p.000165:
p.000165: 1 Bodenheimer T (2000). Uneasy alliance-clinical investigators and the pharmaceuti- cal industry. N Engl J Med 342,
p.000165: 1539-1544.
p.000165: 2 Blumenthal D (2004). Doctors and drug companies. N Engl J Med, 351, 1885-1890.
p.000165:
...

p.000169: under trial. Such interference is report- ed by almost 20% of researchers12. On the contrary, industries ensure that
p.000169: clinical studies with positive results are mentioned in more than one refer- ence in the literature. An illustrative
p.000169: example is a study revealing that the results from 6 different clinical studies testing duloxetine were used in more
p.000169: than 20 publications13.
p.000169:
p.000169: d. Different interpretation of results
p.000169: It is observed that industries interpret and present the results of a clini- cal study in different ways depending on
p.000169: whether they aim to publish them or submit them to the competent authorities. According to the existing lit- erature,
p.000169: 94% of the clinical studies showed positive results, whereas accord- ing to the US Food and Drug Administration (FDA)
p.000169: only 51% of the clinical studies had positive results14.
p.000169:
p.000169:
p.000169:
p.000169:
p.000169:
p.000169: methodological quality domains on the treatment effect in randomized controlled trials. Account Res 10,
p.000169: 301-315.
p.000169: 12 12 von Elm E, Rollin A, Blumle A, Huwiler K, Witschi M, Egger M (2008). Publication and non-publication of clinical
p.000169: trials: Longitudinal study of applications submitted to a research ethics committee. Swiss Med Wkly 138, 197-203.
p.000169: 13 Spielmans GI, Biehn TL, Sawrey DL (2010). A case study of salami slicing: Pooled analyses of duloxetine
p.000169: for depression. Psychother Psychosom 79, 97-106.
p.000169: 14 Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R (2008). Selective pub- lication of antidepressant trials
p.000169: and its influence on apparent efficacy. N Engl J Med 358, 252-260.
p.000169:
p.000170: 170
p.000170:
p.000170: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000170: REPORT
p.000170:
p.000170: e. Discrepancy between results and conclusions
p.000170: Although the results reported in some studies are accurate, it is common that authors misrepresent their meaning and
p.000170: draw more favorable conclu- sions compared to what the results can really support. For instance, 19 out of 22
p.000170: clinical studies of non-steroidal, anti-inflammatory drugs (NSAIDS) concluded that the drug manufactured by the
p.000170: sponsor was less toxic com- pared to others, but in fact such a conclusion could only be drawn by the results of 12
p.000170: clinical studies15.
p.000170:
p.000170: f. “Authors on demand”
p.000170: “Authors on demand” are exclusively employed to interpret the results of a clinical study and write up
p.000170: manuscripts that are in favor of the drug manufactured by the sponsor. The company, i.e. the drug
p.000170: manufacturer, hires a prestigious academic or physician to sign the manuscript as an au- thor. When the
p.000170: manuscript reaches the publication stage, there is no refer- ence to the original role of the “author on demand”. There
p.000170: are multiple ref- erences in the literature about “authors on demand”, some of which are analyzed in the
p.000170: paper by Dunbar and Tallman16.
p.000170: “Authors on demand” are not only used in order to ensure that positive results of clinical studies are reported, but
...

p.000190: Group. JAMA 280, 605-613.
p.000190: Jorgensen AW, Maric KL, Tendal B, Faurschou A, Gotzsche PC (2008). Indus- try-supported meta-analyses compared with
p.000190: meta-analyses with non-profit or no support: Differences in methodological quality and conclusions. BMC Med Res
p.000190: Methodol 8, 60.
p.000190:
p.000190:
p.000190:
p.000191: 191
p.000191:
p.000191: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000191: REPORT
p.000191:
p.000191: McCrary SV, Anderson CB, Jakovljevic J et al., (2000). A national survey of policies on disclosure of
p.000191: conflicts of interest in biomedical research. N Engl J Med 343, 1621-1626.
p.000191: Moss AJ, Francis CW, Ryan D (2001). Collaborative clinical trials. N Engl J Med 364, 789-791.
p.000191: Perlis RH, Perlis CS, Wu Y, Hwang C, Joseph M, Nierenberg AA (2005). Indus- try sponsorship and financial conflict of
p.000191: interest in the reporting of clinical trials in psychiatry. Am J Psychiatry 162, 1957-1960.
p.000191: Resnik DB (2004). Disclosing conflicts of interest to research subjects: An ethical and legal analysis.
p.000191: Account Res 11, 141-159.
p.000191: Rights Inventions Made by non-profit Organizations and Small business Firms. Codidied at 37 CFR, Part 401.
p.000191: Rochon PA, Gurwitz JH, Simms RW et al., (2004). A study of manufacturer- supported trials of nonsteroidal
p.000191: anti-inflammatory drugs in the treatment of arthritis. Arch Intern Med 154, 157-163.
p.000191: Spielmans GI, Biehn TL, Sawrey DL (2010). A case study of salami slicing: Pooled analyses of duloxetine for
p.000191: depression. Psychother Psychosom 79, 97- 106.
p.000191: Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R (2008). Selec- tive publication of antidepressant trials and
p.000191: its influence on apparent effica- cy. N Engl J Med 358, 252-260.
p.000191: USA General Accounting Office, Biomedical Research, GAO-02-89, (2001).
p.000191: von Elm E, Rollin A, Blumle A, Huwiler K, Witschi M, Egger M (2008). Publica- tion and non-publication of clinical
p.000191: trials: Longitudinal study of applications submitted to a research ethics committee. Swiss Med Wkly 138, 197-203.
p.000191: Weinfurt KP, Dinan MA, Allsbrook JS et al., (2006). Policies of academic med- ical centers for disclosing financial
p.000191: conflicts of interest to potential research participants. Acad Med 81, 113-118.
p.000191:
p.000191:
p.000191:
p.000191:
p.000191:
p.000192: 192
p.000192:
p.000192:
p.000192:
p.000192:
p.000192:
p.000007: 7
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007: DIRECT-TO-CONSUMER GENETIC TESTING
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
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p.000007:
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p.000007:
p.000007:
p.000007:
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p.000007:
p.000193: 193
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p.000193:
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p.000193:
p.000193:
p.000193:
p.000193:
p.000194: 194
p.000194:
p.000194: DIRECT-TO-CONSUMER GENETIC TESTING
p.000194: OPINION
p.000194:
p.000194: O P I N I O N
p.000194:
...

p.000263: Engineering and the Royal Socie- ty (2012). Human enhancement and the future of work.
p.000263: Richel T (2003). Will human life expectancy quadruple in the next hundred years? Sixty gerontologists say public debate
p.000263: on life-extension is necessary. J Anti-Aging Med 6, 309-14.
p.000263: Roco MC and Bainbridge WS (2002). Foundation converging technologies for improving human performance.
p.000263: Nanotechnology, biotechnology, infor- mation technology and cognitive Science. NSF/DOC-sponsored report.
p.000263: Salvi M (2003). What is Wrong in Modifying the Human Germ Line? JIB p.34.
p.000263: Sarwer DB (2002). Awareness and identification of body dysmorphic disor- der by aesthetic surgeons: Results of a
p.000263: survey of American Society for Aes- thetic Plastic Surgery Members. Aesthet Surg J 22, 531-5.
p.000263: Schachter F, Faure-Delanef L, Guénot F, Rouger H, Froguel P, Lesueur-Ginot L, Cohen D (1994). Genetic associations with
p.000263: human longevity at the APOE and ACE loci. Nature Genet 6, 29-32.
p.000263:
p.000264: 264
p.000264:
p.000264: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000264: REPORT
p.000264:
p.000264: Smith SL (2008). Mustard Gas and American Race-Based Human Experimen- tation in World War II. Journal of Law, Medicine
p.000264: & Ethics 36, 517-521.
p.000264: Svensson EC, Black HB, Dugger DL, Tripathy SK, Goldwasser E, Hao Z, Chu L, Leiden JM (1997). Long-term erythropoietin
p.000264: expression in rodents and non- human primates following intramuscular injection of a replication-defective adenoviral
p.000264: vector. Hum Gene Ther 8, 1797-806.
p.000264: Takata H, Suzuki M, Ishii T, Sekiguchi S, Iri H (1987). Influence of major histo- compatibility complex region on
p.000264: human longevity among Okinawan Japa- nese centenarians and nonagenarians. Lancet ii, 8246.
p.000264: Vidalis TK (2007). Biolaw. 1st volume. The Person. Eds. Sakkoulas 2007, p. 239.
p.000264: Wolpe PR (2002). Treatment, enhancement, and the ethics of neurotherapeutics, brain and
p.000264: cognition, p. 387.
p.000264: World Anti-Doping Agency (2001). Health, Medical and Research Committee Meeting. Minutes. Lausanne.
p.000264: World Anti-Doping Agency (2002). WADA conference sheds light on the po- tential of gene doping. Press release, World
p.000264: Anti-Doping Agency, New York.
p.000264: World Anti-Doping Agency (2003). International standard for the prohibited list 2004.
p.000264: World Anti-Doping Agency (2005). The Stockholm Declaration. Montreal: World Anti-Doping Agency.
p.000264:
p.000264:
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p.000265: 265
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p.000266: 266
p.000266:
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p.000266:
p.000266:
p.000009: 9
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE AND MENTAL STATE
p.000009:
p.000009:
p.000009:
...

p.000268: Users mainly pursue memory and attention enhancement, but also to treat nor- mal hyperactivity, which occurs
p.000268: particularly in children. In addition, the ap- pearance of anxiety or phobias, typical elements of everyday life in a
p.000268: mod-
p.000268:
p.000268:
p.000269: 269
p.000269:
p.000269: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000269: OPINION
p.000269:
p.000269: ern social context, puts pressure on healthy individuals to use sedatives, antianxiety and antidepressant
p.000269: drugs.
p.000269: The Commission considers that, as in the case of enhancing physical characteristics, the autonomy of a
p.000269: healthy person includes options for en- hancing the cognitive or mental state of the human body. This enhancement
p.000269: is part of the right to develop freely a personality.
p.000269:
p.000269: II. Suggestions
p.000269:
p.000269: However, the aforementioned principle must be supplemented with necessary remarks.
p.000269: 1. The use of drugs to enhance memory or attention may adversely af- fect other cognitive functions. Due to this
p.000269: eventuality, the person concerned must be fully informed, in order to have the opportunity of an independent choice.
p.000269: 2. The issue of influencing the personality is particularly emphasized in the case of antidepressants use. The above
p.000269: mentioned influence is in princi- ple legitimate, as a fundamental right of the person, but it encloses the risk of
p.000269: uncontrolled effects on the nervous system and the general physical and mental condition of the person. The Commission
p.000269: notes the risk when chil- dren use such drugs since such a use may lead to the substitution of all the efforts made to
p.000269: integrate the person into society. A personality is developed by the gradual and smooth integration of the
p.000269: person into the social envi- ronment, owing to the family, friends or educational mechanisms that have the
p.000269: advantage of being subjected to constant scrutiny and revision, and are reversible if necessary, depending on the
p.000269: person’s maturity. For the Com- mission, this advantage is necessary to be ensured, especially in the case of
p.000269: children. For this reason, the use of substances for non-therapeutic purpos- es is not legitimate in children.
p.000269: 3. The use of enhancement methods to improve cognitive and mental functions always requires that the
p.000269: person concerned is fully informed and updated, in terms of the expected results and possible side
p.000269: effects. The Commission considers that the risk of misinformation, especially for drugs which are not
p.000269: prescribed, is serious. The promotion of these drugs to the public and the information leaflets about their
...

p.000280: of enhancing certain functions at the expense of others.
p.000280:
p.000280: 3. Balancing cognitive and psychological functions - Personality change
p.000280:
p.000280: In the case of mental characteristics, in a broader context, we encounter the same problem regarding the balance
p.000280: of increased cognitive abilities (memory, ability to concentrate, etc.). It seems that here, there is some kind of
p.000280: connection, e.g. with the emotional life of the person. Thus, enhan- cement of cognitive abilities
p.000280: that allows an employee to perform exceptionally, has been reported to negatively affect his/her
p.000280: emotional world (events of apathy, indifference, etc.), with unknown consequences for the personality (Glannon, 77-78).
p.000280: Generally, the question of changing a personality by drug use (particularly antidepressants) is a
p.000280: central concern, as does the question of whether this increases or limits autonomy (STOA, 135). There is
p.000280: no doubt that personality changes, anyway, with the assistance of external actors - particularly by
p.000280: the socialization mechanisms during childhood and adolescence- the effects of which often are not
p.000280: controlled by the person itself. Thus, a child’s personality is constantly changing under the influence of family,
p.000280: school, friends, television, internet etc. However, there are also changes during adulthood, even if
p.000280: certain characteristics are gradually stabilized, comprising foundations for the “development” of
p.000280: personality. The very term “development”, suggests “change” anyway.
p.000280: Therefore, the critical point to our subject is not whether, in general, personality development is
p.000280: legitimate, but rather whether such a change can be so radical that can lead to psychological
p.000280: pathologies, i.e. to cause damage to a person’s mental health. Besides extreme exceptions,
p.000280: mechanisms of socialization do not cause so deep “sections” in a person’s
p.000280:
p.000280:
p.000281: 281
p.000281:
p.000281: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000281: REPORT
p.000281:
p.000281: personality. On the contrary, socialization mechanisms “build” on the grounds formed in infancy,
p.000281: which are associated with inherent cognitive abilities (including perception of space, time, etc.),
p.000281: learning the mother tongue, but also the evolution of the unconscious processes (especially the libido). In
p.000281: contrast, the use of pharmaceuticals -similarly to the use of substances such as alcohol or drugs- can
p.000281: cause such sections, which may lead to serious mental illness. The main reason is that these substances have a
...

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p.000166: Some claim that the reason why industry-sponsored research shows more positive results, derives from the
p.000166: fact that financial resources are available to conduct studies with a large number of participating
p.000166: patients
p.000166:
p.000166: 3 Campbell EG, Rao SR, DesRoches CM et al. (2010). Physician professionalism and changes in
p.000166: physician-industry relationships from 2004 to 2009. Arch Intern Med 170, 1820-1826.
p.000166:
p.000167: 167
p.000167:
p.000167: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000167: REPORT
p.000167:
p.000167: (large sample size), leading to a high possibility of finding statistically signifi- cant differences. Another
p.000167: reason is the use of preliminary data-results, al- lowing for better planning of a clinical study and increasing
p.000167: the possibility of positive results4.
p.000167: The first argument refers to the question whether a statistically signifi- cant difference is of clinical value as
p.000167: well. Regarding the second argument, we should consider that most of the preliminary data derive from laboratory animal
p.000167: studies and often cannot be directly applied to humans.
p.000167: In addition, it is surprising that different clinical studies come up with contradictory results, depending
p.000167: on the funding company. During an evalua- tion of previous clinical studies on second generation drugs used
p.000167: to treat mental diseases, such as schizophrenia, Heres and his colleagues examined 9 different clinical studies
p.000167: testing the efficacy of the two following substanc- es: olanzapine and risperidone5. They discovered that 5 of the
p.000167: above men- tioned studies were sponsored by the company producing olanzapine -and their results were in favor of this
p.000167: substance- while 3 out of 4 studies spon- sored by the producer company of risperidone, were also in favor
p.000167: of this particular drug. Similarly, several studies conducting direct comparison of statins, were more likely
p.000167: to be in favor of a drug, which was produced by the sponsor company, against other drugs6.
p.000167:
p.000167: 3. Research misconduct
p.000167:
p.000167: The term research misconduct refers to:
p.000167: a) Data fabrication, i.e. creating non-existent or fictitious results during the recording or publication process.
p.000167: b) Data falsification, i.e., modification or concealment of critical results.
p.000167:
p.000167:
p.000167: 4 Fries JF, Krishnan E (2004). Equipoise, design bias, and randomized controlled trials: The elusive ethics of new drug
p.000167: development. Arthritis Res Ther 6, R250-R255.
p.000167: 5 Heres S, Davis J, Maino K, Jetzinger E, Kissling W, Leucht S (2006). Why olanzapine beats risperidone, risperidone
p.000167: beats quetiapine, and quetiapine beats olanzapine: An exploratory analysis of head-to-head comparison studies of
p.000167: second-generation anti- psychotics. Am J Psychiatry 163, 185-194.
p.000167: 6 Bero LA, Rennie D (1996). Influences on the quality of published drug studies. Int J Technol Assess Health Care 12,
p.000167: 209-237.
p.000167:
p.000168: 168
p.000168:
p.000168: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000168: REPORT
...

p.000226: agility, endurance, accuracy, motor coordi- nation and dexterity. The artificial enhancement is achieved mainly by
p.000226: the use of pharmaceutical substances combined with physical exercise.
p.000226: The Commission considers that, in the frame of the general right to per- sonality development, improving physical
p.000226: abilities is, in principle, a legiti- mate choice. However, the Commission notes that this choice is subject to
p.000226: restrictions, which are related both to the person him/herself and third par- ties.
p.000226:
p.000226:
p.000226:
p.000226:
p.000227: 227
p.000227:
p.000227: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000227: OPINION
p.000227:
p.000227: 2. Safe use of substances for a person’s health
p.000227:
p.000227: It is imperative to protect a person’s health from potentially harmful enhancing substances, given that
p.000227: many of them are freely available in the market, with no prescription required.
p.000227: Regardless of the autonomy of the person in various health issues, the Commission emphasizes the importance of the
p.000227: strict control over these sub- stances by the competent authorities, and particularly the importance of
p.000227: providing complete and accurate information to consumers regarding any possible side effects.
p.000227: For substances administered after prompt (either by sports medicine physicians, or gymnasts, trainers etc.),
p.000227: the relevant responsibility -moral, but also legal- belongs primarily to those who recommend the substance
p.000227: use. Regarding the apportionment of responsibility, it should not be overlooked that the interested persons that use
p.000227: them are more vulnerable to inaccurate or misleading information, as they often choose to enhance their
p.000227: physical abilities and performance and consider that such enhancement is, by de- fault, desired and
p.000227: "innocent", with no special consideration of the potential health effects.
p.000227:
p.000227: 3. The interest of third parties, particularly in sport
p.000227:
p.000227: The Commission also dealt with the case of enhancing abilities through doping, in order to participate in athletic
p.000227: contests. The Commission pointed out that the use of relevant substances must be controlled, not only in order to
p.000227: preserve equality in competition, but also to protect the athletes’ health.
p.000227: In particular, the following points are exceptionally significant:
p.000227: i) Prohibition of the use of certain substances in sport is not only related to the impressive results concerning
p.000227: the primacy of the athlete that uses them, but also to the serious risks to his/her health. This means that, even
p.000227: if one assumes that all sport participants can have equal access to such sub- stances, the use of the latter
p.000227: would still be unfair, not for reasons of fair- ness, but because the endangerment of health is incompatible
p.000227: with the very notion of rivalry.
p.000227: ii) Enhancing physical abilities by other means (e.g. strenuous exercise in particular environmental conditions) could
p.000227: also be equated with substance
p.000227:
p.000227:
p.000228: 228
p.000228:
p.000228: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000228: OPINION
p.000228:
p.000228: use, provided that the risks for one’s health were equally serious. As long as these risks are not established, the
p.000228: conditions of rivalry should not be con- sidered as adulterated for this reason alone.
p.000228: iii) New genetic technologies, such as gene therapy or gene transfer in athletes, are forms of doping, which are not
p.000228: currently detectable. In cases of gene doping, the risk to the athletes’ health is even greater, due to the nov- el and
p.000228: often experimental methods applied. However, it should be empha- sized that -according to the latest scientific data-
p.000228: such methods are at a re- search stage, even when they are used to treat patients.
p.000228: Based on the above considerations, the Commission notes the necessity of constant vigilance by the anti-doping
p.000228: authorities in our country, especially after the repeated cases during the last years.
p.000228: The Commission points out the special role of the Hellenic National Anti- Doping Council (ESKAN) for the prevention and
p.000228: fight against doping. It would be appropriate for ESKAN to acquire organizational independence (in the form of
p.000228: a legal entity or even of an independent authority), to apply its ju- risdiction at all levels of athletic
p.000228: contests (even in schools) and possibly complement its authority with the potentiality to impose all the
p.000228: relevant sanctions in cases of law violation.
...

p.000249: defined as the use of prohibited substances or methods intended to artificially enhance the sports-racing
p.000249: skills of athletes, both during a game and during the preparation for a game.
p.000249: In 1928, the International Amateur Athletic Federation set the first official ban of substances that
p.000249: enhance athletic performance, despite the lack of relevant methods to detect the substances (House of
p.000249: Commons, Select Committee on Culture, Media and Sport, 2004). In 1967, the International Olympic
p.000249: Committee (IOC) created the Medical Commission aiming to supervise and deal with the problem of doping
p.000249: in the Olympic Games. In 2004, the World Anti-Doping Agency (WADA) undertook the role of the main anti-doping
p.000249: coordinator at an international level. Since then, the banned substances and methods are defined by the List
p.000249: of Prohibited Substances and Methods, which is reviewed annually by WADA and applies to all sports and all
p.000249: countries. According to the World Anti-Doping Code “Doping is defined as the occurrence of one or more of the
p.000249: anti-doping rule
p.000249:
p.000249:
p.000250: 250
p.000250:
p.000250: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000250: REPORT
p.000250:
p.000250: violations set forth in Articles 2.1 through 2.8 of the World Anti-Doping Code”3. In Greece, the National
p.000250: Anti-doping Council (ESKAN) is the National Anti-Doping Organization.
p.000250: According to the World Anti-Doping Code, the current criteria for includ- ing substances and methods on the prohibited
p.000250: list are:
p.000250: 1. The potential of the substance or method to enhance athletic performance.
p.000250: 2. The use of the substance or method represents an actual or potential health risk to the athlete.
p.000250: 3. The use of the substance or method violates the spirit of sport.
p.000250: If two of the three criteria are met then the substance or method is classified as prohibited. None of
p.000250: the three criteria alone is considered sufficient to establish a substance or method as prohibited.
p.000250: Although doping via drugs is systematically being checked and reviewed on a regular basis by the relevant
p.000250: international and national organizations since the 1960s, other novel technologies/methods are difficult issues
p.000250: for the anti-doping authorities.
p.000250: For example, the following may constitute enhancement of the athletic performance:
p.000250:
p.000250: i) The application of genetic technologies in athletes, such as gene therapy or gene transfer
p.000250:
p.000250: Enhancement of athletic performance by using genetic technologies is a relatively recent issue needed to be
p.000250: considered by the competent anti- doping authorities, which treat genetic interventions as a form of
p.000250: doping. The modification or intervention of genetic material is a promising method of treatment which could be very
p.000250: useful for Medicine in the future. Poten- tially, however, it is possible to abuse such methods in order to
p.000250: enhance athletic performance. Normal genes or segments of genetic material could be transferred to athletes to
p.000250: enhance the function of normal cells or to overexpress specific genes.
p.000250:
p.000250:
p.000250: 3 WADA, World anti-doping Code, 2009.
p.000250: http://www.wada-ama.org/Documents/World_Anti-Doping_Program/WADP-The- Code/WADA_Anti-Doping_CODE_2009_EN.pdf.
p.000250:
p.000251: 251
p.000251:
p.000251: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000251: REPORT
p.000251:
p.000251: Genetic manipulations can be applied in two types of cells:
p.000251: Somatic cells. Altering the genetic material in somatic cells involves only the organisms where the
p.000251: changes are made -in that case the athlete-, and such modifications are not inherited in the subsequent
...

p.000274:
p.000274: 5 Giurgea CE, Greindl MG, Preat S (1983). Nootropic drugs and aging. Acta Psychiatr Belg 83, 349-58.
p.000274:
p.000275: 275
p.000275:
p.000275: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000275: REPORT
p.000275:
p.000275: Stimulants such as nicotine and caffeine have a proven effect on the increase of attention and memory 6,7
p.000275: and are widely used on a daily basis. However, nowadays, the use of prescription stimulants is also common.
p.000275: Methylphenidate (known under the commercial names Ritalin, Concerta, Metadate, Methylin) and amphetamine
p.000275: (commercial name Adderall) are used to treat attention deficit hyperactivity disorder (ADHD) in children.
p.000275: Nevertheless, these stimulant substances are commonly used by young people to enhance their attention and
p.000275: academic performance.
p.000275: A study in 4,580 American college students showed that 8.3% of students reported illicit use of
p.000275: prescription stimulants at least once in their lifetime, while 5.9% of them used it during the previous year.
p.000275: Of these, 75.8% used amphetamine while 24.5% used methylphenidate, with a higher rate of use among Caucasians. The
p.000275: study indicates that the most frequent incentives for stimulant use is to increase concentration, receive help during
p.000275: studying and increase attention8. These results were confirmed by similar studies9 indicating the problem
p.000275: of frequent use, especially amphetamine use, in college students.
p.000275: Modafinil is also a stimulating substance indicated for the treatment of excessive sleepiness in patients with
p.000275: narcolepsy. However, studies in healthy subjects showed that Modafinil improves memory10, as well as the levels
p.000275: of wakefulness and alertness in physicians11 and pilots12, making
p.000275:
p.000275: 6Warburton DM (1992). Nicotine as a cognitive enhancer. Progress in Neuro- Psychopharmacology and
p.000275: Biological Psychiatry, 16, 181-191.
p.000275: 7Newhouse PA, Potter A & Singh A (2004). Effects of nicotinic stimulation on cognitive performance. Current Opinion in
p.000275: Pharmacology, 4, 36-46.
p.000275: 8Teter CJ, McCabe SE, Boyd CJ, Guthrie SK (2003). Illicit methylphenidate use in an undergraduate student
p.000275: sample: Prevalence and risk factors. Pharmacotherapy 23, 609-17.
p.000275: 9McCabe SE, Teter CJ, Boyd CJ (2006). Medical use, illicit use and diversion of pre- scription stimulant
p.000275: medication. J Psychoactive Drugs 38, 43-56.
p.000275: 10Müller U, Steffenhagen N, Regenthal R, Bublak P (2004). Effects of modafinil on working memory processes
p.000275: in humans. Psychopharmacology (Berl) 177, 161-9.
p.000275: 11Gill M, Haerich P, Westcott K, et al., (2006). Cognitive performance following modafinil versus placebo
p.000275: in sleep-deprived emergency physicians: A double-blind randomized crossover study. Acad Emerg Med 13, 158-65.
p.000275: 12Caldwell JA Jr, Caldwell JL, Smythe NK 3rd, Hall KK (2000). A double-blind, placebo- controlled investigation of the
p.000275: efficacy of modafinil for sustaining the alertness and
p.000275:
p.000276: 276
p.000276:
p.000276: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000276: REPORT
p.000276:
p.000276: modafinil a substance capable of enhancing cognitive functions in humans.
p.000276:
p.000276: b. Enhancement of mental characteristics and mood
p.000276:
p.000276: At this point, it would be impossible not to mention other pharmaceutical substances,
p.000276: the use of which aims to relieve from phobias and addictions, and could well be used to improve mental
p.000276: characteristics. Illustrative examples are propranolol, which seems to have a preventive effect on
p.000276: post-traumatic stress13 and D-cycloserine, which reduces fear in individuals with phobias14and social anxiety
p.000276: disorder15.
p.000276: Finally, mood enhancers used to enhance a person’s mood, are an issue of concern. Selective Serotonin Reuptake
p.000276: Inhibitors (SSRIs), such as Prozac, Zoloft and other antidepressants are administered in mood and anxiety
p.000276: disorders. In his book “Listening to Prozac” the psychiatrist Peter Kramer reports discussions that he
p.000276: had with patients but also with people not suffering from depression, who all used Prozac to enhance their
p.000276: confidence and self-esteem and felt “better” and “socially more attractive”16. Nevertheless,
p.000276: consequent reviews of the book focused mainly on the subjectivity of diagnosing the symptoms and the
p.000276: severity of depression, as well as to the questions: “How can one distinct an existential crisis from a clinical
p.000276: depression?” and “how can we know if a depressed state is normal, abnormal, healthy or unhealthy?”17.
p.000276: Subsequent studies in healthy volunteers showed that antidepressants do not constitute “happiness pills”, as
p.000276: many people call them. The admini-
p.000276:
...

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p.000214: point.
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p.000214:
p.000215: 215
p.000215:
p.000215: DIRECT-TO-CONSUMER GENETIC TESTING
p.000215: REPORT
p.000215:
p.000215: - The legislation for consumer protection (Law 2251/1994, as in force), which establishes certain obligations for
p.000215: anyone providing services to the general public (mostly regarding adequate information).
p.000215: This legislation is of interest mainly when it comes to advertising the companies and the way they promote genetic
p.000215: testing in general. In this context, provisions for misleading actions (art. 9 d), misleading omissions (art. 9 e) and
p.000215: misleading commercial practices (art. 9 f) are of great importance.
p.000215: - The financial freedom (art. 5 par. 1 Constitution), in the context of which the development of
p.000215: business activities is allowed under certain conditions.
p.000215: Financial freedom needs to be combined with special provisions of the Oviedo Convention, along with legislation
p.000215: for personal data protection, so as to determine purpose legitimacy of the companies providing services and
p.000215: handle biological information. In general, however, this cannot be considered to be either a
p.000215: case of commercialization practices of the human body nor parts of it (according to art. 21 of the
p.000215: Oviedo Convention), neither some form of commercialization of personal data. Without doubt, the specific
p.000215: commercial activity involves production of sensitive data at a certain price, without usage of the biological material
p.000215: or the derived data by third parties. In this sense, this activity is regarded as an acceptable form of financial
p.000215: freedom, provided that conditions of safe handling set by law are respected.
p.000215: - The provisions of the Civil Code and the Code of Civil Procedure regarding establishment of paternity
p.000215: or its insult.
p.000215: These provisions are related to services for the revelation of people’s identity. It must be noted
p.000215: that for the typical judicial establishment of paternity or its insult through testing of genetic
p.000215: material, a specific court decision must previously be pronounced (art. 1477- CC., 615 CCP). In this sense, DTC
p.000215: genetic testing must be regulated, as there is a chance of conflict with legal interests of third parties. The
p.000215: specific court decision guarantees the protection of these interests.
p.000215:
p.000215:
p.000215:
p.000216: 216
p.000216:
p.000216: DIRECT-TO-CONSUMER GENETIC TESTING
p.000216: REPORT
p.000216:
p.000216: The importance of special international legislation
p.000216:
p.000216: For the specification of this general legislative framework, it is essential to address to certain international
p.000216: provisions of soft law, which explicitly refer to the use of human genetic material, such as the two Universal
p.000216: Decla- rations of UNESCO on the Human Genome and the Human Genetic Data, respectively. These texts are not
p.000216: legally binding, but they contribute signifi- cantly to the interpretation of general legislation, as it is
p.000216: usually the case when facing novel application in the law.
...

Health / HIV/AIDS

Searching for indicator HIV:

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p.000137: 137
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p.000138: 138
p.000138:
p.000138: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000138: OPINION
p.000138:
p.000138: O P I N I O N
p.000138:
p.000138: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000138:
p.000138: The National Bioethics Commission considered, in repeated sessions, the issue of acceptable restrictions on
p.000138: personal autonomy to protect public health in the case of transmissible infectious diseases. This debate is a major
p.000138: concern of contemporary bioethics, which influences crucial decision- making when there is an outburst of
p.000138: an epidemic or an endemic. There are frequent examples in the news, such as the avian influenza (bird flu),
p.000138: the SARS and most recently the H1N1 virus; furthermore the spread of HIV/AIDS and the recurrence of tuberculosis are
p.000138: also arising matters.
p.000138: At the core of the problem lies the fact that free decisions about person- al health may affect the health or endanger
p.000138: the lives of others in the imme- diate or wider vicinity. This perceived conflict between the principle of au- tonomy
p.000138: and public interest invites a consideration of ethically and legally acceptable choices.
p.000138: Based on the views and assumptions of its previous Opinion on the “con- sent in the relationship
p.000138: patient-physician”, the Commission felt that the question is so important as to be considered in a
p.000138: separate Opinion. The Commission issued its opinion after consulting specialized scientists, Profes- sors G.
p.000138: Saroglou, D. Trichopoulos and A. Hatzakis.
p.000138:
p.000138:
p.000138: I. General overview
p.000138:
p.000138: 1. Transmissible infectious diseases
p.000138:
p.000138: The main characteristic of transmissible infectious diseases is that the infected person is carrier for
p.000138: the transmission of the disease to others. Therefore, unlike with other diseases, decisions by patients
p.000138: have implica- tions not only for the patients themselves but also for the health of others or of the whole community
p.000138: in general.
p.000138: This already complicates the issue of patient autonomy. The risk for the health of others justifies certain limits to
p.000138: autonomy. These limits are of two
p.000138:
p.000139: 139
p.000139:
...

p.000141: sub-populations with distinctive cultural characteristics or ways of living when an infectious disease erupts
p.000141: within such groups.
p.000141:
p.000141:
p.000141:
p.000141:
p.000142: 142
p.000142:
p.000142: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000142: OPINION
p.000142:
p.000142: Such cases must be dealt with by personalized medical care and social welfare measures especially as
p.000142: regards the improvement of hygiene in their living conditions.
p.000142:
p.000142: c) Illegal immigrants
p.000142: In case of manifestation of infectious disease or in cases when preven- tive measures (e.g. vaccination) need to
p.000142: be applied on illegal immigrants, the government must ensure that immigrants would be addressed to the
p.000142: health services. The access of immigrants to health services should be un- hindered and independent on their
p.000142: immigration status; otherwise the risks for public health in general will be multiplied.
p.000142:
p.000142: d) HIV/AIDS
p.000142: This particular disease presents a set of peculiar problems. Even though the spread of the virus is in general
p.000142: relatively difficult, the disease is very severe despite progress in treatment in the recent years. Moreover, social
p.000142: perceptions -especially regarding high risk vulnerable groups- remain ex- tremely negative in our country. The
p.000142: following call for attention:
p.000142: The autonomy of HIV seropositives or HIV patients can be restricted in view of public health protection only if the
p.000142: particular setting of social con- tact is prone to the transmission of the disease. Thus, although mandatory testing
p.000142: for seropositivity is not justified in the absence of qualifying circum- stances, it can be legitimate for certain
p.000142: occupations like physicians or nurs- es or for participation in certain social activities such as sports. In
p.000142: these cases, a positive test result justifies the removal of the seropositive, but just from this
p.000142: particular social context. By contrast, social environments, which are not prone to the transmission of the
p.000142: virus, do not justify devia- tions from the respect of autonomy which is generally applicable.
p.000142: Finally, special attention is required when the virus occurs in enclosed areas of mandatory containment, like
p.000142: schools, hospitals, military barracks or prisons. Any limits to autonomy which are considered indispensable
p.000142: must be combined with additional measures of supervision in order not to betray the purpose of the presence of the HIV
p.000142: seropositive in these areas (e.g. participation in common school activities, military exercises, etc.).
p.000142:
p.000142: Athens, 18 March 2011
p.000142:
p.000143: 143
p.000143:
p.000143: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000143: OPINION
p.000143:
p.000143: COMPOSITION AND PERSONELL
p.000143: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000143: Chairman: John Papadimitriou, Emeritus Professor of Surgery, Medical School, University of Athens.
p.000143:
p.000143: Deputy Chairman: George Maniatis, Emeritus Professor of Biology, Medical School, University of Patras.
p.000143:
p.000143: Members:
p.000143: Julia Iliopoulou-Stranga, Professor of Constitutional Law, Law School, Uni- versity of Athens.
p.000143: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000143: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000143: Athens.
p.000143: Evangelos Moutsopoulos, Member of the Academy of Athens, Emeritus Professor of Philosophy, University of
p.000143: Athens.
p.000143: Athanasios Papachristou, Professor of Civil Law, Law School, University of Athens.
p.000143: Theocharis Patargias, Emeritus Professor of Genetics, University of Athens
p.000143: Constantinos Tsoukalas, Emeritus Professor of Sociology, University of Ath- ens.
p.000143: Christos Voulgaris, Emeritus Professor of Theology, University of Athens.
p.000143:
p.000143: PERSONNEL
p.000143:
p.000143: Scientific Officers:
...

p.000145: Usually, the disease can be transmitted by carriers as well as patients. The path of transmission,
p.000145: infectivity and virulence are critical factors when developing public health protection programmes or evaluating
p.000145: arguments for or against personal autonomy where an evaluation is required. By way of indication, a common cold -highly
p.000145: transmissible through droplets but caus- ing mild symptoms and posing little risk for life- is different from influenza
p.000145: - also highly infective but causing more severe symptoms as compared with common cold- or hepatitis B, which is harder
p.000145: to contract (by blood transfu- sion or exchange of bodily fluids containing blood), but has higher mortality rates or
p.000145: likelihood of permanent damage.
p.000145:
p.000145: 2. Epidemiology
p.000145:
p.000145: Infectious diseases can cause epidemics, i.e. a significant increase in the number of infected people within a given
p.000145: population in a given time period, beyond what might be normally expected, based on the epidemiological
p.000145: statistics for the particular disease (Encyclopedia of Public Health, on line).
p.000145: The geographical area, in which the rise in the number of infected peo- ple is observed, will determine whether it is a
p.000145: mere outbreak -when the rise concerns a relatively small area, e.g. a town-, an epidemic -when the rise in the number
p.000145: of infected people spreads over a wider area, e.g. a whole coun- try or district- or a pandemic -when a disease
p.000145: spreads significantly world- wide. The 1919 influenza and HIV/AIDS from the 1980s are examples of
p.000145: pandemics (Encyclopedia of Public Health, epidemics). After the manifesta- tion of an epidemic the disease may
p.000145: disappear or persist in the population in latent form causing occasional outbreaks or remain endemic with a steady
p.000145: number of patients.
p.000145: Nowadays, the term “epidemic” is not only used for contagious diseases. It can be used for other pathologies, currently
p.000145: on the rise, like cancer or car- diac disease, even for conditions that are not a proper disease, like obesity. This
p.000145: report, however, focuses only on transmissible diseases, since they give rise to the particularities of the
p.000145: implementation of personal autonomy in medical practice, when a conflict with public interest arises, i.e. the
p.000145: protec- tion of the healthy population from the transmission of pathogens from pa- tients or carriers.
p.000145:
p.000145:
p.000145:
p.000146: 146
p.000146:
p.000146: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000146: REPORT
p.000146:
p.000146: Measures of protection against infectious disease are taken by responsi- ble health authorities irrespective of
p.000146: outbreaks. Restrictions to personal autonomy can be applied even without an increased risk of epidemics.
p.000146: However, once a disease is qualified as epidemic or pandemic, emergency measures shall be taken. Accordingly,
p.000146: the legitimacy or illegitimacy of re- strictive measures will obviously be influenced by the level of
...

p.000147: populations since, in this event, the exercise of autonomy by patients is de facto affected (3).
p.000147: Finally, two related issues call for special consideration: clinical trials and respective patents for vaccines and
p.000147: medicines, for they also raise important ethical questions. On one hand, these are associated with the provision of
p.000147: accurate information to patients, and on the other hand with access of pa- tients to treatments in the context of
p.000147: exercising autonomy (4).
p.000147:
p.000147: 1. General autonomy and public health: Restrictions and the risk of stigma- tization
p.000147:
p.000147: The legitimate objective of protection of the health of others sets the grounds for imposing restrictions on
p.000147: the general autonomy of those infect- ed, especially in regard to movement and social contact.
p.000147: This calls for a number of qualifications. Indeed, not all transmissible diseases justify the same
p.000147: restrictions. Distinctions are necessary between
p.000147:
p.000147:
p.000147:
p.000148: 148
p.000148:
p.000148: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000148: REPORT
p.000148:
p.000148: easily and less easily transmitted diseases as well as between mild and seri- ous diseases (influenza versus HIV, for
p.000148: example).
p.000148: Mild diseases, even when easily transmitted, do not justify such re- strictions to general autonomy; the same
p.000148: is true of serious diseases that are hard to contract. Of course, there are many variations of these
p.000148: combina- tions, which prevent the formulation of more specific rules of universal ef- fect.
p.000148: Restrictions to general autonomy can lead to unfair discrimination aris- ing from a kind of “stigmatization” which
p.000148: isolates patients -even if temporar- ily- from social life. Above all, this raises a wider ethical problem. Historical-
p.000148: ly, the stigma against population groups on public health grounds has been a recurring phenomenon, from the
p.000148: persecutions and massacres of Jews dur- ing the times of “Black Death” in the Dark Ages (the plague pandemic), to the
p.000148: persecution of beggars on the same grounds in the XIX century or of prostitutes for spreading syphilis in
p.000148: World War I, to contemporary practices of discrimination against AIDS patients. In our country, stigmatization phe-
p.000148: nomena occurred in the past in the cases of leprosy and tuberculosis.
p.000148: These facts demonstrate that public health is not to be considered only as a medical problem, but involves a serious
p.000148: social and political dimension. The latter must be taken into account when adopting restrictions to general autonomy.
p.000148: Such restrictions are not justified unless accompanied by social measures aimed at minimizing the likelihood of
p.000148: transmission (e.g. housing, food, etc. for the poor or disadvantaged groups of the population) and by steps ensuring
p.000148: fair treatment (not distinguishing, for example, between prostitutes and their clients regarding the risk
p.000148: of transmission of venereal diseases).
p.000148: The current wave of immigration carries great potential of stigma on public health grounds. The fact
p.000148: that the country of origin -particularly of illegal immigrants- is often afflicted by a high prevalence
p.000148: of infectious dis- eases (especially sub-Saharan Africa and southern Asia), while local health services
p.000148: remain rudimentary, represents a real cause of concern for the spreading of these diseases in the
p.000148: hosting countries. However, stigmatiza- tion practices -unfair treatment, “ghettos” etc.- stem rather from the idea
p.000148: of “miasma” due to lack of information or misinformation about the medical- biological particulars of disease,
p.000148: especially infectivity. Hansen’s disease (lep- rosy) and, more recently, HIV/AIDS confirm this observation
p.000148: since these
p.000148:
p.000148:
p.000149: 149
p.000149:
p.000149: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000149: REPORT
p.000149:
p.000149: population groups are stigmatized, although the disease is relatively difficult to contract.
p.000149: In case of Hansen’s disease, the exact path of transmission is still un- known, but it is accepted
p.000149: that although it can be contracted through pro- longed social contact, approximately 95% of the population are
p.000149: immune to it, though the mechanisms of immunity have not been identified. Perhaps it was this last parameter in
p.000149: combination with the deformity caused by the disease that has led to social stigma against these patients in the
p.000149: past.
p.000149: In case of HIV/AIDS, the path of transmission is known and involves ex- posure to body fluids through sexual
p.000149: intercourse or the transfusion of con- taminated blood or use of a contaminated needle. The virus can also
p.000149: be transmitted to the fetus by the mother. Mere social contact with patients or seropositives does not constitute a
p.000149: risk of transmission. Despite this, espe- cially in the early years since the appearance of the disease, but even
p.000149: today, seropositives are treated with far greater caution, even prejudice, than is justified by medical
p.000149: fact. Apart from the severity of the disease, which meant near certainty of death in the beginning,
p.000149: whereas now there are available treatments, prejudice emanates from the fact that, initially, the disease
p.000149: had a higher incidence among male homosexuals in western coun- tries. The pre-existing stigma against homosexuals
p.000149: exacerbated the stigma against HIV/AIDS patients and carriers.
p.000149: On a practical level, the difficulty here lies in the justification of re- strictions on grounds of public
p.000149: health protection. Public authorities can be motivated by non-medical parameters (e.g. systematic deprecation or
p.000149: exclu- sion of specific groups) when considering such restrictions, in particular to the freedom of movement and
p.000149: residency. Hence, the importance of having an official entity of indisputable independence, providing accurate and un-
p.000149: derstandable medical information on the disease to the wider public, be- comes crucial.
p.000149:
p.000149: 2. Autonomy and forced treatment
p.000149:
p.000149: The second serious ethical issue arises with respect to the freedom of individuals to take care of health
p.000149: matters regarding themselves.
p.000149: Here, the principle of “informed consent” may be restricted, especially with regard to “refusal of treatment”.
p.000149: The health of others being directly at
p.000149:
p.000149:
p.000150: 150
p.000150:
p.000150: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000150: REPORT
p.000150:
p.000150: stake, the freedom to deny treatment does not enjoy the ethical justifica- tion acknowledged in different
p.000150: circumstances.
p.000150: Hence, forced treatment or prevention (e.g. mandatory vaccination) may be considered as option, especially if this is
p.000150: the only way to restore the gen- eral autonomy of the affected person (the subject of restrictions).
...

p.000151: being too time- and resource-consuming) the debate on the “maximization of risk” is not with- out cause. The criteria
p.000151: of socially acceptable risks from a new medicine or vaccine are ultimately a matter for bioethics, and must
p.000151: be considered as such.
p.000151: Similar arguments can be made on the scope of patents -and, with that, on the scope of trade prerogative- on new
p.000151: treatments in case of emergency. Here too, limiting the duration of privilege of the patent holder for the sake of
p.000151: providing easier (and cheaper) access to a highly needed drug or vaccine is a matter for bioethics.
p.000151:
p.000151: III. The legal dimension
p.000151:
p.000151: 1. International law
p.000151:
p.000151: Public health is considered as a remit of national sovereignty. As a result, there are no international policies
p.000151: underpinned by international rules for the moment on the protection from epidemics except from trade in food-
p.000151:
p.000151:
p.000152: 152
p.000152:
p.000152: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000152: REPORT
p.000152:
p.000152: stuffs and animal feed. To this, we must add the reluctance of developed countries to effectively combat
p.000152: serious transmissible diseases, which are endemic in developing countries (e.g. malaria, tuberculosis, HIV).
p.000152: Nevertheless, provisions on international protection from epidemics exist in the form of guidelines (IHRS)
p.000152: issued by WHO. These guidelines are not legally binding, of course, but non-compliance can lead to other types of
p.000152: sanctions (e.g. WHO travel alerts). Considering that international move- ments, immigration flows and trade
p.000152: have become easier with globalization and with the recent experiences of wide-spreading transmissible diseases in mind,
p.000152: proposals are under discussion with a view to developing internation- al instruments in this field.
p.000152:
p.000152: 2. Greek law
p.000152:
p.000152: The protection of the population from the transmission of contagious diseases is governed by arts. 21
p.000152: (3) and 5 (4) of the Constitution and art. 5(1)(e) of the European Convention of Human Rights (ECHR)1.
p.000152: Under art. 21 (3), the Constitution recognizes health as a social right in addition to its recognition as an individual
p.000152: right2. Thus, a distinction is drawn between the right of the individual citizen to take care of matters pertaining to
p.000152: personal health and public health care for all. In this sense, the social en- titlement to health can be taken as
p.000152: a basis for adopting health protection measures (organizing vaccination programmes, blood donations, etc.).
p.000152:
p.000152: 1Article 5 (4) of the Constitution: “Individual administrative measures restricting the free movement or residency in
p.000152: the national territory or the free entry into or exit from it to any Greek citizen shall be prohibited. Such
...

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Health / Healthy People

Searching for indicator healthy volunteers:

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p.000276: depression?” and “how can we know if a depressed state is normal, abnormal, healthy or unhealthy?”17.
p.000276: Subsequent studies in healthy volunteers showed that antidepressants do not constitute “happiness pills”, as
p.000276: many people call them. The admini-
p.000276:
p.000276: performance of aviators: A helicopter simulator study. Psychopharmacology (Berl) 150, 272-82.
p.000276: 13Pitman RK, Sanders KM, Zusman RM, et al. (2002).Pilot study of secondary preven- tion of posttraumatic stress
p.000276: disorder with propranolol. Biol Psychiatry 51, 189-92.
p.000276: 14Ressler KJ, Rothbaum BO, Tannenbaum L, et al. (2004). Cognitive enhancers as ad- juncts to psychotherapy: Use of
p.000276: D-cycloserine in phobic individuals to facilitate extinc- tion of fear. Arch Gen Psychiatry 61, 1136-44.
p.000276: 15Hofmann SG, Meuret AE, Smits JA, et al. (2006). Augmentation of exposure therapy with D-cycloserine for social
p.000276: anxiety disorder. Arch Gen Psychiatry 63, 298-304.
p.000276: 16Kramer PD. Listening to Prozac. Penguin Books 1993.
p.000276: 17Bjorklund P (2005). Can there be a “cosmetic” psychopharmacology? Prozac un- plugged: The search for an
p.000276: ontologically distinct cosmetic psychopharmacology. Nurs Philos 6, 131-43.
p.000276:
p.000277: 277
p.000277:
p.000277: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000277: REPORT
p.000277:
p.000277: stration of paroxetine, a SSRI, was shown to reduce markers of hostility through a more general reduction of
p.000277: negative effects, but did not alter the positive effect18. Additionally, the social behavior of healthy volunteers was
p.000277: changed during an exercise that required cooperation19. Nevertheless, the use of SSRIs was accompanied by side
p.000277: effects, mainly changes in memory20 and alertness21.
p.000277:
p.000277: 3. Use of genetic technologies
p.000277:
p.000277: Genetic studies in humans showed that there are genetic polymorphisms (normal variants) in genes such as WWC122,23, and
p.000277: APOE24, that explain, at least to some extent, differences in memory between individuals. Similar studies
p.000277: showed that human intelligence is determined, to a lesser extent, by genetic polymorphisms in various genes25. These
p.000277: genes are potential targets for genetic intervention to enhance human memory and intelligence.
p.000277:
p.000277:
p.000277:
p.000277: 18Knutson B, Wolkowitz OM, Cole SW, et al. (1998). Selective alteration of personality and social behavior by
p.000277: serotonergic intervention. Am J Psychiatry 155, 373-9.
p.000277: 19Tse WS and Bond AJ, (2002). Serotonergic intervention affects both social domi- nance and affiliative
p.000277: behavior. Psychopharmacology (Berl) 161, 324-30.
p.000277: 20Schmitt JA, Kruizinga MJ, Riedel WJ (2001). Non-serotonergic pharmacological pro- files and associated cognitive
p.000277: effects of serotonin reuptake inhibitors. J Psychophar- macol 15, 173-9.
p.000277: 21Riedel WJ, Eikmans K, Heldens A, Schmitt JA (2005). Specific serotonergic reuptake inhibition impairs vigilance
p.000277: performance acutely and after subchronic treatment. J Psychopharmacol 19, 12-20.
p.000277: 22Papassotiropoulos A, Stephan DA, Huentelman MJ, et al. (2006). Common Kibra alleles are associated with
p.000277: human memory performance. Science20; 314, 475-8.
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p.000030: for experts. Therefore, the concern about the management of genetic data in life and health insurance is a legitimate
p.000030: one.
p.000030:
p.000030:
p.000030:
p.000030: 23 See Law 2496/1997, arts 189-225 Code of Commerce, 400/1970 (public supervision of insurance companies), p.d.
p.000030: 252/1996 (adaptation to relevant community law).
p.000030:
p.000031: 31
p.000031:
p.000031: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000031: REPORT
p.000031:
p.000031: 2. There are racial groups with greater incidence of certain genetic dis- orders; hence there is a risk of racial
p.000031: discrimination based on genetic data.
p.000031: 3. An extensive bioethical debate has developed with regard to access of insurance companies to the genetic data of the
p.000031: insured or of insurance ap- plicants. This debate mainly revolves around two axes: a fair calculation of risk based on
p.000031: the principle of reciprocity, on the one hand, and protection of personality from discrimination and stigmatization on
p.000031: the grounds of genet- ic data, on the other hand.
p.000031: 4. Another issue to consider is the fact that the management of genetic information with regards to access by insurance
p.000031: companies directly affects public support for genetic research. This has implications for the funding of research and
p.000031: the participation of volunteers in clinical trials, both indispen- sable to achieve progress in genetics. It mainly
p.000031: leads to avoidance of testing with injurious effects on the health of insurance applicants.
p.000031: 5. Greek legislation has not adopted specialised regulation for the use of genetic data in life and health
p.000031: insurance. Likewise no regulation exists for the operation of genetic laboratories that are the source of this
p.000031: information. In view of the above we recommend the adoption of special legislation ac- cording to the model
p.000031: followed by other countries. This legislation must strike a balance between the legitimate interests of
p.000031: the insurers and the insured guided by fundamental human rights.
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000032: 32
p.000032:
p.000032: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000032: REPORT
p.000032:
p.000032: SUGGESTED LITERATURE
p.000032:
p.000032: Andrews L (1987). Medical genetics: A legal frontier. American Bar Founda- tion, Chicago.
p.000032: Ashcroft, R (2007). Should genetic information be disclosed to insurers? No. BMJ 334, 1197.
p.000032: Bird TD (1999). Early-Onset Familial Alzheimer Disease. In: Gene Reviews at GeneTests: Medical Genetics Information
p.000032: Resource.
p.000032: Burke W (2002). Genetic Testing, N Engl J Med 347, 1867-1875.
p.000032: European Commission (2005). Survey on national legislation and activities in the field of genetic testing in EU
p.000032: Member States (L. Mathiessen-Guyader ed.), Brussels.
p.000032: Geetter JS (2002). Coding for change: The power of the human genome to transform the American health insurance system.
p.000032: AJLM 28, 1-76.
...

p.000057: funded trials (Friedberg et al., 1999). Similar cases of manipulated research have been reported in other clinical and
p.000057: epidemiological trials in- cluding the notorious example of research manipulated by the tobacco in- dustry (Tong and
p.000057: Olsen, 2005; Lesser et al., 2007). Public sources of financ- ing can also be interventionist. The “Union of
p.000057: Concerned Scientists” has a list of cases of government intervention to conceal or manipulate research findings for
p.000057: political reasons.
p.000057: To give the problem its real dimensions, according to US data on re- search conducted by publicly
p.000057: funded agencies, in the last 200 years there have been 200 cases of confirmed misconduct (Resnik, 2007).
p.000057: This figure which represents approximately 0.01% of the entire research community for this period probably
p.000057: underestimates reality but implies that such phenome- na and specific cases of deliberate fraud are relatively limited.
p.000057: This, howev- er, does not mean that the problem does not require serious consideration. As the above examples
p.000057: demonstrate, the validity of biological research has a direct impact on society and often affects public health
p.000057: directly. The exist- ence of and compliance with recognized code of ethics is important not only in order to defend the
p.000057: safety and the rights of volunteers or lab animals. It is also required to ensure the quality of the results, to
p.000057: maintain public support for research, to achieve accountability to society -the source of funds- and for the
p.000057: harmonious and effective co-operation between researchers (Resnik, 2007).
p.000057: To deal with serious issues of research ethics like those mentioned above and in recognition of the
p.000057: significance of educating researchers in eth- ical topics, international scientific societies, universities and
p.000057: research cen- tres have issued codes of ethics or ethical guidelines and specialized correct research practices for
p.000057: each research field. The Council for International Or- ganizations of Medical Sciences, CIOMS) has issued
p.000057: ethical principles for
p.000057:
p.000057:
p.000058: 58
p.000058:
p.000058: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000058: REPORT
p.000058:
p.000058: biomedical research in humans4 and animals5, research in the human ge- nome6 and for epidemiological
p.000058: research7. The International Epidemiology Association recently issued principles of correct practice and conduct in
p.000058: epi- demiological research (IEA, 2007). Some of the issues dealt with in these instruments can be summarized
p.000058: as follows (Shamoo and Resnik, 2002):
p.000058: Honesty as to the method and the findings in the publication and report- ing of scientific studies.
p.000058: Objectivity in the design of trials and the analysis of results as well as in the consideration of the work of other
p.000058: scientists.
...

p.000058: Avoidance of discrimination based on gender, nationality, ethnicity or any other factor irrelevant to scientific
p.000058: competence and integrity.
p.000058: Preservation of professional competence through life-long training and education.
p.000058:
p.000058: 4 CIOMS international ethical guidelines for biomedical research involving human subjects
p.000058: (http://www.cioms.ch/frame_guidelines_nov_2002.htm).
p.000058: 5 1985 international guiding principles for biomedical research involving animals
p.000058: (http://www.cioms.ch/frame_1985_texts_of_guidelines.htm).
p.000058: 6 1990 declaration of inuyama on human genome mapping, genetic screening and gene therapy
p.000058: (http://www.cioms.ch/frame_1990_texts_of_guideline.htm).
p.000058: 7 1991 international guidelines for ethical review of epidemiological studies
p.000058: (http://www.cioms.ch/frame_1991_texts_of_guideline.htm).
p.000058:
p.000059: 59
p.000059:
p.000059: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000059: REPORT
p.000059:
p.000059: Legality, compliance with all laws and regulations governing the operation of research.
p.000059: Care for animals both in the design and the execution of research pro- jects.
p.000059: Protection of volunteers, limitation of risks and maximization of benefits for volunteers and respect of their
p.000059: personality, especially in case of vul- nerable groups.
p.000059:
p.000059: The problem of control
p.000059:
p.000059: The issue of controlling the credibility and the ethics of research often inspires fears of a possible
p.000059: “bureaucratization”, imposition of “outside” reg- ulations and interference of mechanisms irrelevant to the
p.000059: objective. Such deviations would unavoidably cause unjustified delay and, in the end, would discourage initiative even
p.000059: if designed correctly.
p.000059: This eventuality, however, does not automatically eliminate the need for control; it merely draws our attention to the
p.000059: methods to be used. It is gen- erally accepted that if control is exercised on the initiative and according to the
p.000059: procedures of the scientific community itself (self-regulation) the extent of “bureaucratization” would be
p.000059: restricted since the parties themselves have an interest in effective control.
p.000059:
p.000059: RECOMMENDATIONS
p.000059:
p.000059: The specificities of biological research call for some general guidelines: Proposal I
p.000059: The independence of research is a public good. A society that recognizes and safeguards this principle cannot accept
p.000059: the unconditional submission of researchers to purely economic parameters.
p.000059: Therefore, some space needs to be ensured -and supported financially- for the unhindered development of research
p.000059: initiatives governed by princi- ples, rules and priorities set by science itself (the respective scientific field) even
p.000059: under the afore mentioned circumstances.
p.000059:
p.000059:
p.000059:
p.000060: 60
p.000060:
...

p.000088:
p.000089: 89
p.000089:
p.000089: MANAGEMENT OF BIOLOGICAL WEALTH
p.000089: REPORT
p.000089:
p.000089: groups which are determined by residence, occupation, environment- related choices in everyday life and
p.000089: the reasons leading to such choices. The place of the environment and biodiversity in the individual’s scale of values
p.000089: and the individual’s relationship with nature in general is reflected both in professional choices and in everyday life
p.000089: (choice of intensive, integrated or biological agriculture) as well as in the different motives leading to
p.000089: such choices (e.g. the use of more efficient irrigation systems in agriculture may be due to a conscious effort to
p.000089: protect water resources or to apply for sub- sidies).
p.000089: According to the Eurobarometer, Greeks are highly concerned with the environment. However, there is great
p.000089: difference between word and prac- tice. The causes that relegate the environment to a lesser position in
p.000089: the minds of citizens in practice have to be investigated and analysed.
p.000089: However this may be, at the level of civil society, the activity of Non- Governmental Organizations of
p.000089: environmental denomination in Greece is particularly important for raising awareness among citizens and
p.000089: bringing pressure to bear on governments.
p.000089: After the devastating fires of 2007 and their tragic toll there is a sharp increase in the number of volunteers
p.000089: and the quality of volunteer activity and activism (as estimated by the WWF). A great number of NGOs are oper-
p.000089: ating in our country7 which are either wide in scope (e.g. WWF, Greenpeace, etc.) or focus on the protection of
p.000089: specific species or areas (Arctouros, Callis- to, etc.).
p.000089:
p.000089: The attitude of Government
p.000089:
p.000089: I. National policies on the protection of biodiversity
p.000089:
p.000089: In our country, environmental policy-making in general is coordinated by the Ministry for the Environment,
p.000089: Land Planning and Public Works (YPEHODE).
p.000089:
p.000089: 7 A full list of environmental NGOs is available on the website of the Ministry for the Environment. It was compiled by
p.000089: the National Centre for Social Research (EKKE) in the context of a related study that was funded by the Ministry for
p.000089: the Environment at the following address: http://www.minenv.gr/3/33/332/33201/3320113/g3320113_0.html.
p.000089:
p.000090: 90
p.000090:
p.000090: MANAGEMENT OF BIOLOGICAL WEALTH
p.000090: REPORT
p.000090:
p.000090: The coexistence of the environment and public works under the same roof is a singular case among the
p.000090: countries of the European Union. The gov- ernments of all the other member-states have independent Ministries
p.000090: for the environment sometimes including departments of rural development, fisheries or public health. This
p.000090: coexistence and the place assigned to the environment as against the other responsibilities of the
...

p.000105: deter- mine the treatment whose likely adverse effects are more acceptable to them. Especially in our
p.000105: country, the need for this involvement becomes all the more urgent due to the absence, until now, of a single
p.000105: registration sys- tem to record the complete history of patients which deprives physicians from unmediated
p.000105: access to consistent and reliable data.
p.000105: The adoption of “informed consent” presupposes that patients are in- formed by physicians and in principle,
p.000105: they consent prior to all medical acts. In this way, they can consider their condition in the context of their general
p.000105: way of living not as passive recipients but as independent agents who are involved in the whole process as much as
p.000105: possible. A good knowledge of the values and needs a patient would like the physician to take into account
p.000105: when determining treatment is an essential part of this process. It is worth noting that the requirement of
p.000105: participation is complied with even when patients express the wish to follow the suggested treatment without
p.000105: further information (right to ignorance).
p.000105:
p.000105: B. The law
p.000105:
p.000105: Initially, the new model of “informed consent” appeared in codes of eth- ics on clinical trials (Nuremberg Code,
p.000105: Helsinki Declaration) because, on this occasion, the risks for the volunteers are greater. Gradually, however,
p.000105: its effects were recognized in all areas of medical practice.
p.000105: The Oviedo Convention on Human Rights and Biomedicine is the first example of binding international law
p.000105: incorporating “informed consent” in all medical acts. In addition to the Convention, express provisions in
p.000105: Greece have been included both in the Code of Medical Ethics (CME, Law 3418/2005) and in
p.000105: special legislation (assisted reproduction, transplants, etc.).
p.000105:
p.000105:
p.000106: 106
p.000106:
p.000106: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000106: OPINION
p.000106:
p.000106: Both the Oviedo Convention and the CME provide for the event of in- competence to consent (in which
p.000106: case consent is given by relatives after prior information) whereas they hold that consent does not apply in
p.000106: emer- gency situations. However, the example of the CME stipulating that: “In the exercise of medicine, physicians act
p.000106: with total freedom within the generally accepted rules and methods of medical science… They may choose the
p.000106: method of treatment which in their view is significantly better against all others for the particular
...

p.000174: USA.
p.000174: 27 Association of American Medical Colleges (2001). Protecting Subjects, Preserving Trust, Promoting Progress.
p.000174: USA.
p.000174: 28 AAV Advisory Committee on Financial Conflicts of Interest in Human Subjects Re- search, AAMC, AAV (2008).
p.000174: Protecting Patients, Preserving Integrity, Advancing Health Report of the AAMC.
p.000174:
p.000175: 175
p.000175:
p.000175: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000175: REPORT
p.000175:
p.000175: Research, February 2008”. In 2001, the General Accounting Office (USA) addressed its concerns about the
p.000175: conflict of interest phenomena in institu- tions conducting clinical research29.
p.000175: A common component to all the above mentioned recommendations is the obligation of all individuals potentially involved
p.000175: in relevant cases during the design, conduct, assessment or announcement of research results, to disclose or
p.000175: notify of any relationship with the industry.
p.000175: A. Declaration means provision of relevant information by the “re- searcher” to the responsible internal
p.000175: authorities of the Institution, such as the “Conflict of Interest Committee” (CIC) and subsequently, notification to
p.000175: the Committee of Research Control (CRC) of the Institution.
p.000175: B. Notification (or disclosure), means notification to third parties, besides the Institution, such as the patient
p.000175: interested, the accredited responsible State authorities, the scientific societies or journals where the research
p.000175: re- sults are intended for publication.
p.000175: There are three main aims of “Declaration” and “Notification” 30:
p.000175: 1. The comprehensive knowledge of possible relationships allows the participating patients or healthy
p.000175: volunteers to exercise informed choice on the right to autonomy. A condition to exercise this right, is that the
p.000175: “Notification” includes all the details of the “reconcilia- tion”. The clarity and timeliness of the
p.000175: notification are prerequi- sites.
p.000175: 2. To protect the researcher from potential legal entanglements. Alt- hough currently there is no legal obligation
p.000175: to reveal the sponsors, nevertheless, the researchers may be involved in legal matters31. Existence of a declaration
p.000175: facilitates transparency.
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175: 29 USA General Accounting Office, Biomedical Research, GAO-02-89, (2001).
p.000175: 30 Weinfurt KP, Dinan MA, Allsbrook JS et al. (2006). Policies of academic medical centers for disclosing
p.000175: financial conflicts of interest to potential research participants. Acad Med 81, 113-118.
p.000175: 31 Resnik DB (2004). Disclosing conflicts of interest to research subjects: An ethical and legal analysis.
p.000175: Account Res 11, 141-159.
p.000175:
p.000176: 176
p.000176:
p.000176: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000176: REPORT
p.000176:
p.000176: 3. A third aim, is the moral prevention of researchers and Institutions providing health services to receive
p.000176: sponsorships, especially high subsidies32.
p.000176: The fact that a researcher submitting the Declaration/Notification feels that he/she is vulnerable to criticism over
p.000176: the “transaction”, acts as a deter- rent. Approximately half of the Academic Centers state that granting the
...

p.000273:
p.000273: Magnetic stimulation of the cerebral cortex is a similar, but non-invasive method, which is approved by the FDA
p.000273: for the treatment of depression, while it is also tested experimentally in stroke patients. Yet, several studies
p.000273: have been conducted in order to investigate the effect of magnetic brain stimulation in healthy subjects,
p.000273: showing positive results for enhancement of cognitive and mental functions. For example, magnetic stimulation
p.000273: of the brain changes brain plasticity (neural plasticity), namely, the ability of the nervous system to
p.000273: adapt to changing conditions, enhances performance and changes the person’s behavior1, learning ability2, memory3, and
p.000273: even hand- writing or spelling ability4. Nevertheless, it must be noted that the above mentioned studies
p.000273: were performed in a relatively small number of healthy
p.000273:
p.000273: 1Hummel FC, Cohen LG (2005). Drivers of brain plasticity. Curr Opin Neurol 18, 667- 74.
p.000273: 2Pascual-Leone A, Tarazona F, Keenan J, et al. (1999).Transcranial magnetic stimula- tion and neuroplasticity.
p.000273: Neuropsychologia 37, 207-17.
p.000273: 3Fregni F, Boggio PS, Nitsche M, et al. (2005). Anodal transcranial direct current stim- ulation of prefrontal cortex
p.000273: enhances working memory. Exp Brain Res 166, 23-30.
p.000273: 4Snyder AW, Mulcahy E, Taylor JL, et al. (2003). Savant-like skills exposed in normal people by suppressing the
p.000273: leftfronto-temporal lobe. J Integr Neurosci 2, 149-58.
p.000273:
p.000274: 274
p.000274:
p.000274: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000274: REPORT
p.000274:
p.000274: volunteers whereas individual differences in the brain of healthy subjects should be taken into account when
p.000274: interpreting the results. As a final point, the possible side effects that may result from magnetic
p.000274: stimulation of the brain, such as seizures, is an important reason for such technologies not be used for human
p.000274: enhancement.
p.000274:
p.000274: 2. Use of pharmaceutical agents
p.000274:
p.000274: a. Enhancement of mental/cognitive characteristics
p.000274:
p.000274: In general, nutrients or chemicals which enhance cognitive functions are often referred to as “nootropics”, a term
p.000274: which was first used in 1972 by the Romanian psychologist and chemist Cornelius Giurgea5. Nootropic drugs, or else
p.000274: “smart drugs” function in the human body based on two processes:
p.000274: 1. By either affecting glucose metabolism and blood flow in the brain or,
p.000274: 2. by increasing the levels of neurotransmitters or neuromodulators which play a role in memory or attention.
p.000274: Early studies of strokes showed that strokes could be due to narrowing of blood vessels that supply the brain with
p.000274: blood, and hence, with oxygen and glucose. Consequently, it was considered that nootropics, which
p.000274: increase blood flow in the brain, such as propranolol (beta-adrenergic blocker), phenytoin (for epilepsy)
p.000274: and dihydroergotoxin (cerebrovascular vasodilator), could enhance neuron performance (Rose et al., 2005).
p.000274: Later studies in people suffering from Alzheimer's disease showed that their neurons are destroyed, especially
p.000274: neurons secreting acetylcholine. This led to the hypothesis that an increase of acetylcholine in the brain
...

p.000276: REPORT
p.000276:
p.000276: modafinil a substance capable of enhancing cognitive functions in humans.
p.000276:
p.000276: b. Enhancement of mental characteristics and mood
p.000276:
p.000276: At this point, it would be impossible not to mention other pharmaceutical substances,
p.000276: the use of which aims to relieve from phobias and addictions, and could well be used to improve mental
p.000276: characteristics. Illustrative examples are propranolol, which seems to have a preventive effect on
p.000276: post-traumatic stress13 and D-cycloserine, which reduces fear in individuals with phobias14and social anxiety
p.000276: disorder15.
p.000276: Finally, mood enhancers used to enhance a person’s mood, are an issue of concern. Selective Serotonin Reuptake
p.000276: Inhibitors (SSRIs), such as Prozac, Zoloft and other antidepressants are administered in mood and anxiety
p.000276: disorders. In his book “Listening to Prozac” the psychiatrist Peter Kramer reports discussions that he
p.000276: had with patients but also with people not suffering from depression, who all used Prozac to enhance their
p.000276: confidence and self-esteem and felt “better” and “socially more attractive”16. Nevertheless,
p.000276: consequent reviews of the book focused mainly on the subjectivity of diagnosing the symptoms and the
p.000276: severity of depression, as well as to the questions: “How can one distinct an existential crisis from a clinical
p.000276: depression?” and “how can we know if a depressed state is normal, abnormal, healthy or unhealthy?”17.
p.000276: Subsequent studies in healthy volunteers showed that antidepressants do not constitute “happiness pills”, as
p.000276: many people call them. The admini-
p.000276:
p.000276: performance of aviators: A helicopter simulator study. Psychopharmacology (Berl) 150, 272-82.
p.000276: 13Pitman RK, Sanders KM, Zusman RM, et al. (2002).Pilot study of secondary preven- tion of posttraumatic stress
p.000276: disorder with propranolol. Biol Psychiatry 51, 189-92.
p.000276: 14Ressler KJ, Rothbaum BO, Tannenbaum L, et al. (2004). Cognitive enhancers as ad- juncts to psychotherapy: Use of
p.000276: D-cycloserine in phobic individuals to facilitate extinc- tion of fear. Arch Gen Psychiatry 61, 1136-44.
p.000276: 15Hofmann SG, Meuret AE, Smits JA, et al. (2006). Augmentation of exposure therapy with D-cycloserine for social
p.000276: anxiety disorder. Arch Gen Psychiatry 63, 298-304.
p.000276: 16Kramer PD. Listening to Prozac. Penguin Books 1993.
p.000276: 17Bjorklund P (2005). Can there be a “cosmetic” psychopharmacology? Prozac un- plugged: The search for an
p.000276: ontologically distinct cosmetic psychopharmacology. Nurs Philos 6, 131-43.
p.000276:
p.000277: 277
p.000277:
p.000277: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000277: REPORT
p.000277:
p.000277: stration of paroxetine, a SSRI, was shown to reduce markers of hostility through a more general reduction of
p.000277: negative effects, but did not alter the positive effect18. Additionally, the social behavior of healthy volunteers was
p.000277: changed during an exercise that required cooperation19. Nevertheless, the use of SSRIs was accompanied by side
p.000277: effects, mainly changes in memory20 and alertness21.
p.000277:
...

Health / Mentally Disabled

Searching for indicator mentally:

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p.000109: and Education could also be of assistance.
p.000109:
p.000109: B. Particular problems
p.000109:
p.000109: a) Power to consent and limits of autonomy
p.000109: The Commission believes that when patients who are capable to consent are committed to hospital they should appoint a
p.000109: representative in writing, if possible.
p.000109: In case of patients incapable to consent who have not appointed a rep- resentative, the Commission thinks that:
p.000109: i) The legal representatives of the patient may select one of alternative treatment methods but may not refuse all
p.000109: treatments if the treating physi- cian believes that the continuation of therapy is beneficial. Only patients
p.000109: who are capable for self-consent may refuse treatment.
p.000109: ii) In case of disagreement between the legal representatives the treat- ing physician should be able to decide taking
p.000109: into account the opinion of the hospital board of ethics which must be made mandatory in our country.
p.000109: iii) The physician must take into consideration any prior directions by the patient (id est, any wishes the patient
p.000109: expressed prior to becoming incapa- ble to consent).
p.000109: iv) The opinion of mentally mature minors on issues regarding their health must be taken into account in
p.000109: order to comply with the constitutional protection of personality.
p.000109: v) In case of refusal of parents to consent to the treatment of minors - and in case of threat against their lives or
p.000109: serious harm to their health- the physician must proceed to the indicated treatment complying with the legal procedure.
p.000109: vi) In case of patients with limited capacity to consent (minors, mental patients, persons with mental
p.000109: impairments), the attitude of the physician must consist in favoring as much as possible the expression of an
p.000109: opinion by the patients themselves according to the level of their capacity to compre- hend their situation.
p.000109: Therefore, the information to be provided to the pa- tient must be adjusted accordingly in cooperation
p.000109: with their representa- tives.
p.000109:
p.000109:
p.000110: 110
p.000110:
p.000110: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000110: OPINION
p.000110:
p.000110: vii) The Commission believes that even under the circumstances of in- tensive care units physicians must not
...

Searching for indicator disability:

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p.000152: right2. Thus, a distinction is drawn between the right of the individual citizen to take care of matters pertaining to
p.000152: personal health and public health care for all. In this sense, the social en- titlement to health can be taken as
p.000152: a basis for adopting health protection measures (organizing vaccination programmes, blood donations, etc.).
p.000152:
p.000152: 1Article 5 (4) of the Constitution: “Individual administrative measures restricting the free movement or residency in
p.000152: the national territory or the free entry into or exit from it to any Greek citizen shall be prohibited. Such
p.000152: restrictive measures may be imposed only as ancillary sanctions by criminal court ruling in exceptional emergency
p.000152: circum- stances exclusively for the prevention of indictable offences as specified by Law”.
p.000152: Interpretation clause:
p.000152: Paragraph 4 does not preclude the prohibition to leave the country by order of public prosecutor due to criminal
p.000152: proceedings or measures imposed on grounds of public health protection or the protection of patients as
p.000152: specified by Law”.
p.000152: Article 21 (3) of the Constitution: “The State shall care for the health of citizens and shall adopt specific measures
p.000152: to protect youth, old age, disability and health care for indigents”.
p.000152: 2 Article 5 (5) of the Constitution: “Everyone is entitled to the protection of their health and genetic
p.000152: identity…”.
p.000152:
p.000153: 153
p.000153:
p.000153: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000153: REPORT
p.000153:
p.000153: However, both the Constitution and the ECHR acknowledge the need of re- strictive measures to protect public health.
p.000153: Thus, the art. 5(4) of the Constitution (interpretation statement) excep- tionally accepts individual administrative
p.000153: measures “on grounds of public health protection or the protection of patients as specified by Law”. It is im-
p.000153: portant to stress that such measures amount to extensive inroads into indi- vidual freedom -prohibiting “the free
p.000153: movement and residency in the na- tional territory or the entry into and exit from it”- and can be decided by any
p.000153: public authority (health authorities, police, local government, etc.), but al- ways under specific legal
p.000153: provisions.
p.000153: Along the same lines, the ECHR (convention with overriding formal effect versus ordinary legislation) accepts the
p.000153: deprivation of individual freedom such as, among other things, “… the lawful detention of a person for the pre-
p.000153: vention of the spreading of infectious diseases, …” (art. 5[1][e]), but always “in accordance with a procedure
p.000153: prescribed by law”.
...

p.000271: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000271: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000271: Athens.
p.000271: Evangelos Moutsopoulos, Member of the Academy of Athens, Emeritus Professor of Philosophy, University of
p.000271: Athens.
p.000271: Theocharis Patargias, Emeritus Professor of Genetics, University of Athens
p.000271: Constantinos Tsoukalas, Emeritus Professor of Sociology, University of Ath- ens.
p.000271: Christos Voulgaris, Emeritus Professor of Theology, University of Athens.
p.000271:
p.000271: PERSONELL
p.000271:
p.000271: Scientific Officers:
p.000271: Takis Vidalis, Lawyer, PhD in Law.
p.000271: Vasiliki Mollaki, Geneticist, PhD in Genetics.
p.000271:
p.000271: Secretariat:
p.000271: Marianna Drakopoulou, Lawyer, Head of Secretariat.
p.000271:
p.000271:
p.000271:
p.000271:
p.000271:
p.000272: 272
p.000272:
p.000272: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000272: REPORT
p.000272:
p.000272: R E P O R T
p.000272:
p.000272: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE AND MENTAL STATE
p.000272:
p.000272: Rapporteurs: Takis Vidalis, Vasiliki Mollaki
p.000272: Introduction
p.000272:
p.000272: Many psychiatric, neurodegenerative and neurodevelopmental disorders coexist with abnormalities in “normal”
p.000272: cognitive and mental functions. Autism, intellectual disability, attention deficit disorder,
p.000272: schizophrenia, depression but also neurodegenerative diseases, such as Alzheimer's, Parkinson's and
p.000272: Huntington's chorea, are associated with impairment of cognitive functions. Aging of the brain also leads
p.000272: to similar effects. The continuous and rapid scientific developments make it possible, to some extent, to
p.000272: intervene in the development of these diseases and delay their symptoms, mainly through pharmaceutical
p.000272: substances that aim to enhance cognitive functions. Therefore, the moral issue raised here, is whether these
p.000272: pharmaceutical substances could be used in healthy people in order to enhance their cognitive and mental
p.000272: characteristics.
p.000272: The term “cognitive” functions refers to the procedures and processes of an organism that organize information.
p.000272: This includes the acquisition, selection, clarification and recollection of information, which correspond to
p.000272: the perception, attention, understanding and memory of the organism, as well as the way these processes
p.000272: determine behavior.
p.000272:
p.000272: I. The data
p.000272:
p.000272: Unquestionably, education, consumption of certain nutrients and the use of information processing devices,
p.000272: such as calculators and computers, constitute tools to improve cognitive activity and performance. However,
...

Health / Mentally Incapacitated

Searching for indicator incapable:

(return to top)
p.000108:
p.000108: d) Education and information for citizens
p.000108: The above demonstrate a need for appropriate citizen education aiming at the optimal application of the new model.
p.000108: Patients who are suitably in- formed “ahead of time” are more likely to cooperate actively, assisting phy- sicians in
p.000108: their work and enhancing the efficacy of treatment.
p.000108: Citizen education can be promoted through elementary education, in- formation campaigns by local authorities,
p.000108: local associations, regional hospi-
p.000108:
p.000108:
p.000109: 109
p.000109:
p.000109: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000109: OPINION
p.000109:
p.000109: tals and volunteer organizations. Educational programs from the media un- der the hospices of the Ministries for Health
p.000109: and Education could also be of assistance.
p.000109:
p.000109: B. Particular problems
p.000109:
p.000109: a) Power to consent and limits of autonomy
p.000109: The Commission believes that when patients who are capable to consent are committed to hospital they should appoint a
p.000109: representative in writing, if possible.
p.000109: In case of patients incapable to consent who have not appointed a rep- resentative, the Commission thinks that:
p.000109: i) The legal representatives of the patient may select one of alternative treatment methods but may not refuse all
p.000109: treatments if the treating physi- cian believes that the continuation of therapy is beneficial. Only patients
p.000109: who are capable for self-consent may refuse treatment.
p.000109: ii) In case of disagreement between the legal representatives the treat- ing physician should be able to decide taking
p.000109: into account the opinion of the hospital board of ethics which must be made mandatory in our country.
p.000109: iii) The physician must take into consideration any prior directions by the patient (id est, any wishes the patient
p.000109: expressed prior to becoming incapa- ble to consent).
p.000109: iv) The opinion of mentally mature minors on issues regarding their health must be taken into account in
p.000109: order to comply with the constitutional protection of personality.
p.000109: v) In case of refusal of parents to consent to the treatment of minors - and in case of threat against their lives or
...

p.000113: patients must be taken into considera- tion when determining treatment. There is an increasing awareness of the right
p.000113: to autonomy and of respect for dignity in medicine.
p.000113:
p.000113: B. LEGAL ISSUES
p.000113:
p.000113: In general
p.000113:
p.000113: The “Code of Medical Ethics” (CME, Law 3418/2005) has put in place a modern legal framework for the relationship
p.000113: physician-patient in Greek
p.000113:
p.000113:
p.000113:
p.000114: 114
p.000114:
p.000114: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000114: REPORT
p.000114:
p.000114: law2. The main characteristic of this law is the explicit introduction of “in- formed consent” albeit
p.000114: maintaining provisions which reflect the former “pa- ternalistic” approach.
p.000114: It must be noted that “informed consent” was already embedded in Greek law, first, through the
p.000114: ratification of the Oviedo Convention on Hu- man Rights and Biomedicine (art. 5 et seq. Law 2619/1998) and,
p.000114: second, by way of express provisions in a number of laws on various medical fields3. Naturally, the
p.000114: relevant rules of the CME are more detailed. Pursuant to the CME:
p.000114: - Informed consent is always required except in case of: a) emergen- cies, b) suicide attempts, and c) refusal to
p.000114: consent by the guardian of a person incapable to consent in a life- or health-threatening situa- tion.
p.000114: - The consent must be explicit though it may be informal.
p.000114: - In case of minors, the consent is provided by their parents or custo- dian.
p.000114: - In other cases of incapacity, the consent is given by the “next of kin” or the legal guardian.
p.000114: Consent requires that the patient (or the patient’s representative in case of incapacity) must “be informed”. This
p.000114: information:
p.000114: - Must be “complete” and “intelligible”.
p.000114: - Must reflect the truth.
p.000114: - Must cover: a) the real condition of health, b) the content of the sug- gested medical act, c) the risks and likely
p.000114: side effects, d) alternative
p.000114:
p.000114:
p.000114: 2 Despite its title (“Code of Medical Ethics”) this Law was not an instance of investing with legal authority a
p.000114: pre-existing corpus of norms accumulated by the medical pro- fession in the context of self-regulation (a stricto sensu
p.000114: code of ethics). It was genuine lawmaking by the government and went through the usual pipeline of
p.000114: law- enactment (a drafting committee was set up for that purpose; its draft text was duly tabled by the responsible
...

p.000117: consent to treatment. The Civil Code requires authorization by the Prosecutor whereas the CME does not. The question is
p.000117: whether the pro- visions of the CME provide sufficient grounds to cover the physician’s liability vis-à-vis the
p.000117: parents especially in view of the constitutional protection of parental care (Constitution, art. 21 [1]; art. 8
p.000117: [1] ECHR) whose guarantor is precisely the judiciary and not the physician -as firmly held in legal doctrine.
p.000117: Critical also is the physician’s attitude in case of disagreement between relatives which is not unlikely since
p.000117: the law does not assign any priority among relatives with regard to their power to decide. Should an
p.000117: implicit hierarchy be inferred or is it left to the physician to decide according to his/her fundamental
p.000117: duty to the patient? Could an ethics board be of assis- tance when the patient is hospitalized? Let us recall
p.000117: at this point that our national health system is not familiar with ethics boards whereas in Europe and the US they
p.000117: are well-established -and the importance of their role is not put in question- for many years.
p.000117: An even graver issue may arise when the physician is in a position to know the patient’s wishes, which
p.000117: were expressed before the patient became incapable to consent either in written or orally and the relatives
p.000117: disagree. Since the latter have by law the right to make the final decision, the ques- tion is whether these wishes
p.000117: should be taken into account, and how. It is worth noting that both the CME (art. 2[2]) and the Oviedo
p.000117: Convention (art.
p.000117: 9) stipulate so though failing to specify the ensuing legal effects (see below). Finally, there is a wider issue with
p.000117: the consent of minors. The law totally precludes it (art. 12 [2] [b] CME) even when minors are obviously
p.000117: able to exercise control over their health given that other provisions recognize their capacity to enter into
p.000117: legal relationships (e.g. to marry). At issue here is whether the scope of this provision should be
p.000117: interpreted stricto sensu to apply only when the intellectual immaturity of the minor obviously justifies that the
p.000117: consent be given by his/her parents or custodian in order to har- monize this rule with the constitutional protection
p.000117: of personality (Constitu-
p.000117: tion, art. 5 [1]).
p.000117:
p.000117:
p.000118: 118
p.000118:
p.000118: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000118: REPORT
p.000118:
p.000118: c) Medical liability and other legal consequences
p.000118:
...

p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000132: 132
p.000132:
p.000132: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000132: REPORT
p.000132:
p.000132: SUGGESTED LITERATURE
p.000132:
p.000132: Androulidaki-Demetriadi I (1993). The duty to inform the patient. A contri- bution to the assessment of civil
p.000132: medical liability. Eds. Sakkoulas, Athens- Komotini.
p.000132: Asveld L (2008). Mass-vaccination programmes and the value of respect for autonomy. Bioethics 22, 245-257.
p.000132: Blackhall LJ, Murphy ST, Frank G, Michel V, Azen S (1995). Ethnicity and atti- tudes toward patient autonomy. Jama
p.000132: Journal of the American Medical As- sociation 274, 820-825.
p.000132: Brokalaki EI, Sotiropoulos GC, Tsaras K, Brokalaki H (2005). Awareness of diagnosis, and information-seeking
p.000132: behavior of hospitalized cancer patients in Greece. Supportive Care in Cancer 13, 938-942.
p.000132: Dosios T, Markopoulos C, Vlahos I and Latsios P (1986). The views of Greek physicians on whether cancer patients should
p.000132: know of their illness. Medical Review of the Armed Forces 20, 9-315.
p.000132: Elian M and Dean G (1985). To tell or not to tell the diagnosis of multiple- sclerosis. Lancet 2, 27-28.
p.000132: Elliot C (2001). Patients doubtfully capable or incapable of consent. In Kuhse, H and Singer PA (Eds.). A
p.000132: Companion to Bioethics. Blackwell, Oxford, pp. 452.
p.000132: Erde EL, Nadal EC, Scholl TO (1988). On truth telling and the diagnosis of Alzheimers disease. Journal of
p.000132: Family Practice 26, 401-406.
p.000132: Fountedaki K (2003). Civil Medical Liability. General introduction - Issues of doctrine and legal policy -
p.000132: Fundamental concepts. Eds. Sakkoulas, Athens- Thessaloniki.
p.000132: Hartzband P and Groopman J (2009). Keeping the patient in the equation- humanism and health care reform. N Engl J Med
p.000132: 361, 554-555.
p.000132: Hebert PC, Hoffmaster B, Glass KC, Singer PA (1997). Bioethics for clinicians.
p.000132: 7. Truth telling. Canadian Medical Association Journal 156, 225-228.
p.000132:
p.000132:
p.000133: 133
p.000133:
p.000133: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000133: REPORT
p.000133:
p.000133: Higgs R (2001). Truth-Telling. In Kuhse H, Singer PA (Eds.), A Companion to Bioethics. Blackwell, Oxford, pp. 432.
p.000133: Iconomou G, Viha A, Koutras A, Vagenakis AG, Kalofonos HP (2002). Infor- mation needs and awareness of diagnosis in
p.000133: patients with cancer receiving chemotherapy: A report from Greece. Palliative Medicine 16, 315-321.
p.000133: Jansen VAA, Stollenwerk N, Jensen HJ, Ramsay ME, Edmunds WJ, Rhodes CJ (2003). Measles outbreaks in a population
p.000133: with declining vaccine uptake. Science 301, 804.
p.000133: Lavrentiadis G, Manos N, Christakis J, Semoglou C (1988). The Greek cancer- patients knowledge and attitudes toward his
p.000133: diagnosis and prognosis. Psy- chotherapy and Psychosomatics 49, 171-178.
...

p.000215: material, a specific court decision must previously be pronounced (art. 1477- CC., 615 CCP). In this sense, DTC
p.000215: genetic testing must be regulated, as there is a chance of conflict with legal interests of third parties. The
p.000215: specific court decision guarantees the protection of these interests.
p.000215:
p.000215:
p.000215:
p.000216: 216
p.000216:
p.000216: DIRECT-TO-CONSUMER GENETIC TESTING
p.000216: REPORT
p.000216:
p.000216: The importance of special international legislation
p.000216:
p.000216: For the specification of this general legislative framework, it is essential to address to certain international
p.000216: provisions of soft law, which explicitly refer to the use of human genetic material, such as the two Universal
p.000216: Decla- rations of UNESCO on the Human Genome and the Human Genetic Data, respectively. These texts are not
p.000216: legally binding, but they contribute signifi- cantly to the interpretation of general legislation, as it is
p.000216: usually the case when facing novel application in the law.
p.000216: The same applies, of course, to the new Protocol of the Oviedo Conven- tion -not yet ratified by Greece- which includes
p.000216: provisions for genetic tests for medical reasons (2008). After ratification by the Greek Parliament, this Protocol
p.000216: will be binding and will outweigh the general legislation.
p.000216: Its fundamental provisions, especially those related to DTC genetic test- ing, regardless of what it is generally
p.000216: in force (consent, protection of the incapable to consent, protection of personal data), are those demanding:
p.000216: - A high level of quality in genetic testing, according to universally accepted criteria of scientific and
p.000216: clinical accuracy (art. 5 a),
p.000216: - the appropriate experience of staff providing these services (art. 5 b),
p.000216: - regular controls of the laboratories (art. 5 c),
p.000216: - the proved clinical necessity of such a test (art. 6),
p.000216: - the essential medical counseling and examination (art. 7),
p.000216: - the adequate previous informing of the interested party (art. 8).
p.000216:
p.000216: CONCLUDING REMARKS
p.000216:
p.000216: 1. Ensuring the quality of the provided genetic tests
p.000216: The quality of genetic services primarily includes analytical and clinical accuracy of the tests, high level
p.000216: equipment of genetic centers and laborato- ries, as well as training and continuous education of their staff. Genetic
p.000216: cen- ters offering genetic testing services must have an internal system of quality control and also participate in
p.000216: external quality controls.
p.000216: The accreditation of genetic centers and tests, which could be conducted by responsible institutions (e.g. Hellenic
p.000216: Accreditation System -ESYD- which acts as the National Accreditation Body and operates within the Ministry of
p.000216: Development), safeguards the quality of genetic tests. Certified training and
p.000216:
p.000216:
p.000217: 217
p.000217:
p.000217: DIRECT-TO-CONSUMER GENETIC TESTING
p.000217: REPORT
p.000217:
...

Health / Motherhood/Family

Searching for indicator family:

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p.000008: Association of Insurance Companies and Mr. D. Kremezis, expert in insurance law and lawyer.
p.000008:
p.000008: 1. General comments
p.000008:
p.000008: The question of whether insurers may require insurance applicants to provide, in addition to conventional
p.000008: information on their medical history, the results of genetic testing has been a major issue for National Bioethics
p.000008: Committees and legislative action in many countries. The reason is that alt- hough genetic information reveals a mere
p.000008: predisposition for the manifesta- tion of certain diseases, it may lead to discrimination against insurance ap-
p.000008: plicants.
p.000008: There are currently three trends in relevant legislation. Some states have prohibited the use of genetic
p.000008: information with specific laws, others have decided to refrain from legislating while several have adopted a
p.000008: process of relevant consultation with the insurers during which the latter have pledged not to require nor make
p.000008: use of genetic data (moratorium). In Greece the issue has not yet been considered while the life and health
p.000008: insurance legisla- tion is incomplete.
p.000008:
p.000008: 2. Genetic data
p.000008:
p.000008: a. Definition
p.000008: Genetic data is data arising from genetic analysis, i.e. analysis of DNA, RNA, chromosomes, proteins or
p.000008: metabolites detecting gene mutations or
p.000008:
p.000009: 9
p.000009:
p.000009: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000009: OPINION
p.000009:
p.000009: chromosomal changes associated with diseases and conducted for medical reasons. According to one opinion, family
p.000009: history is also included in a per- son’s genetic data.
p.000009:
p.000009: b. Importance of genetic testing
p.000009: The number of diseases with a strong genetic link, for which genetic test- ing is available, for predisposition or
p.000009: diagnosis, is increasing. Of the available genetic tests, the most controversial with regards to their use in private
p.000009: in- surance are predisposition tests, i.e. tests capable for detecting disease- causing mutations in healthy
p.000009: individuals. The prognostic value of such tests varies significantly. Additionally, the processing and evaluation of
p.000009: the results of genetic testing is by no means a simple task as several factors need to be taken into account such as
p.000009: family history, medical history and lifestyle.
p.000009:
p.000009: c. Is genetic data different from medical data?
p.000009: Medical history is considered a legitimate criterion for dividing the in- sured into groups of equal
p.000009: risk and calculating the respective premium. Based on the current policy of insurance companies the insured are
p.000009: covered for diseases not manifested prior to the conclusion of the insurance contract according to their medical
p.000009: records.
p.000009: Genetic data, and more specifically the results of predisposition tests (the main focus of the present
p.000009: report), like some other types of medical da- ta, reveal a probable risk but -in most cases- not certainty of future
p.000009: sickness. The difference, at the moment, of genetic as against medical predisposition markers is that the
p.000009: association between most genetic markers and the probability of disease is not well-documented compared to
p.000009: medical mark- ers.
p.000009:
p.000009: 3. Ethical issues
p.000009:
p.000009: a. Protection of personality and economic freedom
p.000009: In view of the above, the first emerging ethical issue consists in weighing protection of personality for insurance
p.000009: applicants against freedom of busi- ness for insurers.
p.000009: Disclosure of genetic information -similarly to other health-related in- formation- as a requirement for
p.000009: contracting insurance or as a factor in the
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000010: OPINION
p.000010:
...

p.000011: of “predisposition” as a synonym for “manifestation” of a serious disease, even as a result of public misinformation,
p.000011: unless appropriately regulated, can cre-
p.000011:
p.000011: 1 According to data from the “Study on insurance contracts” that was commissioned to TNS-ICAP in 2007 by the
p.000011: Hellenic Association of Insurance Companies and was brought to the attention of the Commission by Mr. S.
p.000011: Tangopoulos.
p.000011:
p.000012: 12
p.000012:
p.000012: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000012: OPINION
p.000012:
p.000012: ate insurance market conditions unfavourable for the protection of human rights.
p.000012:
p.000012: c. The type of regulation
p.000012: The Commission is aware of the seriousness of the conflict between the rights and interests of citizens and
p.000012: insurers. It believes, however, that the protection of personality and avoidance of unfair discrimination against
p.000012: the insured outweighs the economic freedom of the insurers. And this because the implications of genetic -as any
p.000012: other biological- discrimination directly relate to human dignity and, consequentially, affect the quality
p.000012: of societal life and the principle of equal treatment in a democratic society. By contrast, the harm to the insurance
p.000012: market by the prohibition of genetic discrimina- tion in the risk calculation is not judged significant. The
p.000012: manifestation of a disease for which there is a predisposition (as estimated on the basis of ge- netic analysis or
p.000012: family history) is uncertain in most cases and it is impossible to determine the time of such manifestation. So,
p.000012: genetic data is not particu- larly important for the calculation of risk.
p.000012: Nevertheless, ways need to be identified that will safeguard the legiti- mate interests of insurers,
p.000012: especially the risk of wilful deception. For that purpose, it seems appropriate to adopt a moratorium
p.000012: with a reasonable duration. During this time, insurers must make specific commitments not to use genetic data and
p.000012: the State must pledge to enact legislation -following public dialogue. In the context of such dialogue, it is
p.000012: crucial to put in place a certification system for genetic laboratories and to recognize the specialty of geneticists
p.000012: in order to ensure the quality of genetic analysis and genetic counseling.
p.000012:
p.000012:
p.000012: Athens, 11 January 2008
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000013: OPINION
p.000013:
p.000013: COMPOSITION AND PERSONELL
p.000013: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000013: Deputy Chairman and Acting Chairman: George Maniatis, Emeritus Profes- sor of General Biology, University of Patras.
p.000013:
p.000013: Members:
p.000013: Savvas Agourides, Emeritus Professor of Theology, University of Athens.
p.000013: Myrto Dragona-Monachou, Emeritus Professor of Philosophy, University of Athens.
...

p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000015: 15
p.000015:
p.000015: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000015: REPORT
p.000015:
p.000015: 1. GENETIC TESTING AND PREDICTION OF GENETIC DISEASES
p.000015:
p.000015: A. Introduction
p.000015:
p.000015: In 1999, the Task Force for Genetic Testing came down to the following definition of genetic:
p.000015: Any “…analysis of human DNA, RNA, chromosomes, proteins, and certain metabolites in order to detect heritable
p.000015: disease-related genotypes, muta- tions, phenotypes, or karyotypes for clinical purposes” (Burke W, 2002 and Holtzman
p.000015: NA and Watson MS, 1999).
p.000015: This definition is quite broad and allows for different interpretations. With the advance of genetics, in
p.000015: particular, the limits are shifting. In the US Bill of Law GINA on genetic discrimination (Genetic
p.000015: Information Non- discrimination Act, see 3B), non-genetic tests are specified explicitly as: “an analysis of protein
p.000015: or metabolite that does not detect genotypes, mutations or chromosomal changes” or is “directly related to a
p.000015: manifested disease, disorder or pathological condition that could reasonably be detected by a health care
p.000015: professional with appropriate training and expertise in the field of medicine involved”. Based on the definition of
p.000015: genetic testing, personal genetic information is the information that is generated by genetic testing. However, here
p.000015: as well the limits are unclear as some authors, for instance the GINA Bill of Law, include in an individual’s genetic
p.000015: information data from genetic testing and the manifestation of genetic diseases in family members. Genetic testing is
p.000015: carried out for a variety of reasons such as the diagno-
p.000015: sis of an already manifested disease, prenatal control or to determine genet- ic predisposition to specific disorders.
p.000015: The first two applications are not rel- evant to this report. Here, we are interested in genetic testing that
p.000015: identifies increased risk of disease manifestation in healthy, asymptomatic individuals. Genetic tests are also
p.000015: extremely useful in pharmacogenetics and in person- alized medicine1.
p.000015: Genetic and environmental factors interact in the development of dis- ease by creating a spectrum (Figure 1),
p.000015: with the so-called genetic or heredi- tary diseases associated with exclusively genetic causes (like β-thalassaemia) at
p.000015: the one end and diseases with exclusively environmental (external) caus-
p.000015:
p.000015: 1 See par. 1(C): The value of genetic information for personal health and scientific progress and the
p.000015: potential of genetic testing.
p.000015:
p.000016: 16
p.000016:
p.000016: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000016: REPORT
p.000016:
p.000016: es (like trauma) at the other end. The causes of most human pathological conditions, however, lie
p.000016: somewhere in-between, i.e. it is a combination of genetic and environmental factors that leads to
p.000016: manifestation of disease, such as diabetes or cardiovascular diseases.
p.000016: Depending on their genetic basis, genetic diseases are divided in (i) sin- gle-gene2, (ii) polygenic3, and, (iii)
p.000016: mitochondrial4 (Human Genome Project Information5). A gene’s disease-causing mutation is either dominant or re-
...

p.000017: infor- mation on some of the most common diseases. The available genetic tests that qualify as predictive are further
p.000017: classified according to the penetrance of the disease causing mutations into pre-symptomatic and predisposition
p.000017: tests (McPherson, 2006).
p.000017: The first category comprises tests that detect mutations with complete penetrance, where the manifestation of disease
p.000017: is certain for the carriers of disease-causing mutations, e.g. the genetic test for Huntington Disease. The second
p.000017: category includes tests that detect mutations with incomplete pene- trance. The carriers of such mutations will not
p.000017: necessarily develop the dis- ease but their chances are increased compared to the general population. Tests for cancer
p.000017: belong to this category. In this case, if the result is positive, medical testing will need to be carried out more
p.000017: frequently in the future; if negative, the likelihood of disease is the same with that of the general popu- lation, but
p.000017: not zero. Below, we provide some examples of genetic tests from both categories.
p.000017:
p.000017: i. Huntington Disease
p.000017: Huntington’s disease is a neurodegenerative condition affecting 3- 7/100,000 people in western
p.000017: European populations (except among the Finns). The incidence is significantly lower in Japan, China and black
p.000017: Africans (Warby, Graham and Hayden, Table 2). The HD (IT15) gene is involved in this condition and the disease is
p.000017: inherited in an autosomal8 and dominant man- ner. The available genetic test detects the alleles of gene HD9 in the
p.000017: person undergoing the test.
p.000017: In the case of Huntington’s disease, genetic testing can answer with near certainty to whether someone, with relevant
p.000017: family history, will develop the
p.000017:
p.000017: 8 The responsible gene for the disease is situated in an autosomal, not a sexual, chromosome. Therefore,
p.000017: there is no difference in heredity between the sexes. See report on genetic data.
p.000017: 9 The test is based on DNA analysis with the PCR or the Southern hybridization meth- od and the number of repeats
p.000017: in a nucleotide triplet. The penetrance of the allele depends on the number of repeats. HD alleles are
p.000017: classified into three categories: Normal, intermediate and HD-causing.
p.000017:
p.000018: 18
p.000018:
p.000018: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000018: REPORT
p.000018:
p.000018: disease or not. The available genetic test detects the disease-causing alleles with an accuracy of 100%. However,
p.000018: it cannot predict with certainty the time of disease onset. Since there is currently no treatment for this condi-
p.000018: tion, identifying someone as a carrier has no prophylactic value.
p.000018:
p.000018: ii. Early Onset Familial Alzheimer, EOFAD
p.000018: The early onset alzheimer, like common Alzheimer, is a form of slow- progressing dementia, manifested prior
p.000018: to the age of 65 and represents less than 3% of all Alzheimer cases (Bird, 2007, Table 2). The genetic association for
p.000018: the disease seems strong since, of all the early onset alzheimer cases, 61% of patients have relevant family
p.000018: history and 13% have relatives in three generations that developed the disease. Early onset alzheimer is manifested in
p.000018: 41.2/100,000 people aged 40-59.
p.000018: The involvement of three genes has been identified, PSEN1, PSEN2, APP (Table 2). In all EOFAD cases heredity is
p.000018: autosomal and dominant. Genetic tests have been developed and are used clinically to detect disease-causing mutations
p.000018: for all three genes. The highest numbers of positive scores in EOFAD patients are achieved by tests
p.000018: detecting mutations in the PSEN1 gene. The evaluation of genetic tests for EOFAD is not as simple as
p.000018: in the test for Huntington’s disease since the available tests do not detect all the mutations and in some patients
p.000018: the test yields a negative score. Neverthe- less, penetrance of PSEN1 gene (AD3) mutations is complete whereas pene-
p.000018: trance of PSEN2 (AD4) mutations is 95%, i.e. if one of the disease-causing mutations is identified in a
p.000018: healthy subject the manifestation of the disease is almost certain.
p.000018:
p.000018: iii. BRCA1 and BRCA2 Hereditary Breast/Ovarian Cancer
p.000018: Mutations in BRCA1 and BRCA2 genes have been found to predispose for breast, ovarian, prostate and other cancers
p.000018: (Pertucelli et al., 2007, Table 2). There are genetic tests that detect mutations in these genes but the reliabil- ity
p.000018: of the test and the evaluation of the results are complex, more so than in the case of EOFAD mentioned above. Due to a
p.000018: multitude of disease-causing mutations for both genes, there is no single test capable of detecting all of them.
p.000018: For a healthy individual with a family history of this category of cancers it is important to know which mutation
p.000018: occurred in those family members that
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000019: REPORT
p.000019:
p.000019: developed cancer. Calculation of the penetrance of the mutations of genes BRCA1 and BRCA2 is not a simple task, as
p.000019: different mutations have different penetrance and the likelihood of cancer varies in different age groups. For example,
p.000019: the probability of breast cancer in BRCA1 mutations ranges from 3.2% (at the age of 30) to 85% (at the age of 70). The
p.000019: probability is similar for BRCA2 mutations.
p.000019: The likelihood of ovarian cancer is lower. The availability of several calcu- lation models for the probability of
p.000019: cancer in case disease-causing mutations are detected, which vary significantly in their predictions, is a
p.000019: sign of the complexity of the evaluation of the test results. Another important factor is that a negative score in
p.000019: the genetic test does not mean that the subject will not develop the specific cancers, only that the risk is not higher
p.000019: as compared with the general population. Finally, a positive score in a healthy subject practically means
p.000019: that the person in question must undergo more frequent examinations but it makes no difference in terms of
p.000019: treatment if cancer does occur.
p.000019: In brief, testing for BRCA1/2 gene mutations is complicated and great caution is required in the choice of
p.000019: the detection method as well as in the evaluation of the result.
p.000019: In conclusion, although most genetic tests cannot predict the manifesta- tion of a genetic disease with certainty, they
...

p.000025: REPORT
p.000025:
p.000025: A. Business risk and protection of personality
p.000025:
p.000025: 1. In general, private insurance is a business activity governed by the principle of reciprocity. The basic
p.000025: idea consists in sharing the risk by a group of individuals who are equally likely to suffer damage which would be
p.000025: unaf- fordable to the individual person: by paying premiums, a large number of insured cover the expenses
p.000025: the insurer will have to bear for the harm suf- fered by one of the insured in question (and underwritten by the
p.000025: insurer). This idea presupposes that the insurer -just as any other businessman- also assumes part of the risk arising
p.000025: from the occurrence of unpredicted events.
p.000025: With regards to life and health insurance in particular (including insur- ance for professional
p.000025: incompetence), the insurer’s risk consists in the occur- rence of damage from disease or accident to the insured. In
p.000025: these cases, the calculation of the premium by the insurer is based on statistics on the prob- ability of risk in
p.000025: population groups with common characteristics (e.g. sex, age, lifestyle). Such data include information on
p.000025: health, which the insurer requests from the insured. This information consists of the medical history (of the
p.000025: individual and/or their family) and may include new medical tests. The more accurate the information the
p.000025: more accurate the prediction. By contrast, the poorer the information, the greater the risk for the insurer. In the
p.000025: latter case, if insurance is not wholly unattractive in business terms, the insurer will try to hedge the risk by
p.000025: increasing the premium based on past data for a similar group.
p.000025: 2. But this purely economic calculation does not settle the issue, for life and health insurance cannot be
p.000025: assimilated to just any other commercial service or commodity. The nature of health information requested
p.000025: by the insurer being sensitive personal data, it goes to the core of the personality of the insured. Any illicit
p.000025: disclosure or other processing of this information may, in view of its nature, result in drastic restriction of
p.000025: individual freedoms, even in violation of human value.
p.000025: Here, we have to enter two caveats, typical of the differentiation be- tween health and other types of
p.000025: information:
p.000025: i) The “right of ignorance” pertaining to the subject of health infor- mation, i.e. a person may not
p.000025: wish to be informed of data concerning his/her health in order to go on with his/her life undisturbed
p.000025: (Nationaler Ethikrat 2007: 28-29). The disclosure of this information to the insurer as a
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000026: REPORT
p.000026:
p.000026: precondition for insurance encroaches upon this right since the applicant is then forced to choose between taking the
...

p.000036:
p.000036: Thrombosis Risk
p.000036: F5, 1q23 100% 10-15% heterozygotes
p.000036: 0.19%-0.45% per year The disease may 55
p.000036:
p.000036: Factor (Leiden V factor)
p.000036: in Greece (1/5,000 homozygotes)
p.000036: - 0.10% for non- carriers of the muta- tion
p.000036: be manifested also after 60
p.000036:
p.000036: Muscular dystro-
p.000036: DMD Xp21.2 6-85% depend- 1/5,000 births of male
p.000036: 100% in males, varies Symptoms from
p.000410: 410
p.000410:
p.000410: phies (e.g. Du- chenne, Becker)
p.000410: ing on the method
p.000410: infants
p.000410: in females (8% cardiomyopathy)
p.000410: the age of 2, immobility in adolescence. Dilative cardio- myopathy after 40 in female heterozygotes
p.000410:
p.000410: Haemochromatosis HFE, 6p21.3 60-90% 1/200-1/400 homozy-
p.000410: gotes, 11% carriers of the gene
p.000410: Depending on geno- type: from 0.5% to nearly 100%
p.000410: 40-60 (males), after menopause (females)
p.000410: 80-1,100
p.000410:
p.000410: Autosomal Domi- nant Polycystic Kidney Disease
p.000410: PKHD1, 6p21.1-p12
p.000410: 2-75% 1/20,000-2/40,000 100% From birth or childhood
p.000410: 775-
p.000410: 7,700
p.000410:
p.000410: Familial Mediterra- MEFV,
p.000410: 70-90% 1/3-1/7 carriers (they
p.000410: Unknown, probably
p.000410: 2-25 usually 290-440
p.000410:
p.000410: nean Fever
p.000410: Amyotrophic Lateral Sclerosis
p.000410: 16p13
p.000410: Many and varying
p.000410: do not manifest the disease)
p.000410: 3-20% 4-8/100,000 (90%
p.000410: without family history)
p.000410: underdiagnosed
p.000410: Unknown 40-60 400
p.000410: *From the network diagnogene (www.diagnogene.com). The cost varies depending on the number of tested mutations.
p.000410:
p.000410:
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p.000002: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
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p.000040: 40
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...

p.000125: immunity causing an important increase in measles cases before confidence in the vaccine was restored and broad
p.000125: par- ticipation resumed (Jansen et al., 2003).
p.000125: Whereas in case of tested vaccines, the decision to abstain is not ethical- ly neutral, the example of new and
p.000125: insufficiently tested vaccines is different. The experience of mass vaccination against swine influenza in the
p.000125: US in 1976 illustrates the risks inherent in a reckless decision for extended vac- cination based on
p.000125: unfounded, as it proved, fears of a pandemics, and with inadequately tested vaccines at that. While the influenza
p.000125: claimed only one victim, the side effects from the vaccine caused 25 casualties and may have led to permanent damage
p.000125: (it was associated with the auto-immune syn- drome of Guillain-Barré). Such examples justify the reluctance to
p.000125: participate and the ethical duty to society as a whole cannot remain as strong if weighed against an
p.000125: increased likelihood of unknown side-effects from the vaccine.
p.000125:
p.000125: 5. Patients in hospitals - The case of ICUs
p.000125:
p.000125: Implementing the model of consent in hospitals is met with certain limits to patient autonomy.
p.000125: First of all, the hospitalized patient is situated in a public environment which does not allow full freedom
p.000125: of movement, expression and communi- cation while drastically restricting privacy and family life. In these
p.000125: circum-
p.000125:
p.000125:
p.000126: 126
p.000126:
p.000126: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000126: REPORT
p.000126:
p.000126: stances, patients are particularly vulnerable. Especially in the ICU, these re- strictions are much more
p.000126: encroaching; moreover, patients are under psy- chological stress due to their critical condition. Taking into
p.000126: account that the potential for a sober appraisal of the situation by the patient -and in exten- sion, for a rational
p.000126: decision on the course of treatment- is significantly cur- tailed by the hospital environment, the role of the medical
p.000126: and nursing staff becomes even more decisive.
p.000126: Hospitalized patients, however, even patients in the ICU, are usually ca- pable to give an informed consent. This means
p.000126: that physicians remain fully liable for allowing patients to participate in the course of the particular
p.000126: treatment and may not legitimately act alone. In conditions of “internment”
p.000126: -especially in ICUs- the risks of manipulation of the patient’s will by the phy- sician are increased. Patients can be
p.000126: easily forced into accepting things for they are understandably eager to have their health restored as soon as pos-
p.000126: sible in order to return to the freedom of everyday life and recover the full exercise of their autonomy.
p.000126: At this point we must underline that physicians have a heightened ethi- cal duty to provide complete information.
...

p.000132:
p.000132: SUGGESTED LITERATURE
p.000132:
p.000132: Androulidaki-Demetriadi I (1993). The duty to inform the patient. A contri- bution to the assessment of civil
p.000132: medical liability. Eds. Sakkoulas, Athens- Komotini.
p.000132: Asveld L (2008). Mass-vaccination programmes and the value of respect for autonomy. Bioethics 22, 245-257.
p.000132: Blackhall LJ, Murphy ST, Frank G, Michel V, Azen S (1995). Ethnicity and atti- tudes toward patient autonomy. Jama
p.000132: Journal of the American Medical As- sociation 274, 820-825.
p.000132: Brokalaki EI, Sotiropoulos GC, Tsaras K, Brokalaki H (2005). Awareness of diagnosis, and information-seeking
p.000132: behavior of hospitalized cancer patients in Greece. Supportive Care in Cancer 13, 938-942.
p.000132: Dosios T, Markopoulos C, Vlahos I and Latsios P (1986). The views of Greek physicians on whether cancer patients should
p.000132: know of their illness. Medical Review of the Armed Forces 20, 9-315.
p.000132: Elian M and Dean G (1985). To tell or not to tell the diagnosis of multiple- sclerosis. Lancet 2, 27-28.
p.000132: Elliot C (2001). Patients doubtfully capable or incapable of consent. In Kuhse, H and Singer PA (Eds.). A
p.000132: Companion to Bioethics. Blackwell, Oxford, pp. 452.
p.000132: Erde EL, Nadal EC, Scholl TO (1988). On truth telling and the diagnosis of Alzheimers disease. Journal of
p.000132: Family Practice 26, 401-406.
p.000132: Fountedaki K (2003). Civil Medical Liability. General introduction - Issues of doctrine and legal policy -
p.000132: Fundamental concepts. Eds. Sakkoulas, Athens- Thessaloniki.
p.000132: Hartzband P and Groopman J (2009). Keeping the patient in the equation- humanism and health care reform. N Engl J Med
p.000132: 361, 554-555.
p.000132: Hebert PC, Hoffmaster B, Glass KC, Singer PA (1997). Bioethics for clinicians.
p.000132: 7. Truth telling. Canadian Medical Association Journal 156, 225-228.
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p.000133: 133
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p.000133: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000133: REPORT
p.000133:
p.000133: Higgs R (2001). Truth-Telling. In Kuhse H, Singer PA (Eds.), A Companion to Bioethics. Blackwell, Oxford, pp. 432.
p.000133: Iconomou G, Viha A, Koutras A, Vagenakis AG, Kalofonos HP (2002). Infor- mation needs and awareness of diagnosis in
p.000133: patients with cancer receiving chemotherapy: A report from Greece. Palliative Medicine 16, 315-321.
p.000133: Jansen VAA, Stollenwerk N, Jensen HJ, Ramsay ME, Edmunds WJ, Rhodes CJ (2003). Measles outbreaks in a population
p.000133: with declining vaccine uptake. Science 301, 804.
p.000133: Lavrentiadis G, Manos N, Christakis J, Semoglou C (1988). The Greek cancer- patients knowledge and attitudes toward his
p.000133: diagnosis and prognosis. Psy- chotherapy and Psychosomatics 49, 171-178.
p.000133: Manos N and Christakis J (1980). Attitudes of cancer specialists toward their patients in Greece. Int J Psychiatry Med
p.000133: 10, 305-313.
p.000133: Mystakidou K, Liossi C, Vlachos L, Papadimitriou J (1996). Disclosure of diag- nostic information to cancer patients in
p.000133: Greece. Palliat Med 10, 195-200.
p.000133: Mystakidou K, Parpa E, Tsilila E, Katsouda E, Vlahos L (2004). Cancer infor- mation disclosure in different
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p.000194: DIRECT-TO-CONSUMER GENETIC TESTING
p.000194: OPINION
p.000194:
p.000194: O P I N I O N
p.000194:
p.000194: DIRECT-TO-CONSUMER GENETIC TESTING
p.000194:
p.000194: The Hellenic National Bioethics Commission met repeatedly upon invita- tion by the President in order to consider the
p.000194: ethical issues within its juris- diction regarding Direct-to-consumer (DTC) genetic testing, available in
p.000194: pharmacies or via the internet.
p.000194: The term “DTC genetic testing” refers to any genetic test detecting DNA changes and is directly available to the public
p.000194: as a kit. It is based on the con- sumer’s own will to be examined for genetic diseases or predisposition to
p.000194: diseases -and, mainly, without prior recommendation by a doctor, medical geneticist or biologist-geneticist- or to
p.000194: genetically identify an individual. The term does not include genetic tests recommended by an expert, after exam- ining
p.000194: the clinical data and the family history of a patient, aiming to diagnose or identify the patients risk to a disease.
p.000194: “DTC genetic testing” refers to tests carried out for health reasons, pre- natal diagnosis or genetic identification of
p.000194: a person (especially the so-called “paternity tests”). A common component to all tests is that the public has direct
p.000194: access to them, without the mediation of counseling (in the first two cases) or legal authorization (judicial
p.000194: permission in the case of genetic iden- tification). Consequently, there is a rapid development of a new
p.000194: “market” for genetic services, which is already advertised to a significant extend in our country.
p.000194: The above mentioned new market is favored by the continuous progress in technology, the human genome project and the
p.000194: extensive research eluci- dating specific gene functions. At present, the technological and scientific
p.000194: progress makes methods of detecting genetic risk factors, even for serious diseases, affordable. However, specific
p.000194: sensitive ethical and social issues, associated with the way such services are provided, emerge and must
p.000194: re- ceive special attention by the involved individuals and the State.
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p.000195: DIRECT-TO-CONSUMER GENETIC TESTING
p.000195: OPINION
p.000195:
p.000195: I. The facts
p.000195:
p.000195: Genetic tests which are directly available to the public detect DNA se- quence changes. Most frequently, the
p.000195: DNA changes are associated with the etiology, diagnosis, treatment or prevention of hereditary diseases. In
p.000195: the case of monogenic disorders, a single gene is responsible for the disease and therefore DNA changes associated
p.000195: with the disease are easier to identify. However, this is not the case for complex (polygenic) diseases,
p.000195: comprising the largest proportion of the most common diseases, such as cardiovascular disease, cancer and diabetes.
p.000195: Complex diseases are caused by the combined action of many genes as well as environmental factors.
p.000195: Up to the present time, the person interested in genetic testing consult- ed an expert. Based on the clinical data and
p.000195: the family history of the patient, the expert decided whether he/she would receive a suitable biologic sample from the
p.000195: patient and request a specific genetic test for a disease. Subse- quently, specialized genetic
p.000195: laboratories, with suitable biomedical equip- ment and certified, specialized personnel, would perform genetic
p.000195: testing.
p.000195: The current genetic services are constantly modified. On the one hand, this is due to the relatively recent progress in
p.000195: molecular biology and genet- ics, and on the other hand, due to the fact that the public becomes increas- ingly
p.000195: interested in genetic testing. Important factors contributing to such changes in genetic services are:
p.000195:
p.000195: A. The detection of genetic factors associated with monogenic and com- plex diseases, as well as the human genome
p.000195: project
p.000195: Specifically, genome wide association studies lead to the assumption that DNA sequence variations among
p.000195: individuals are associated with most common diseases. These studies examine DNA sequence variations in spe- cific
p.000195: genes and ultimately aim at defining a person’s risk to develop a dis- ease. Based on such data, companies
p.000195: use specific algorithms, claiming that they are able to predict the probability that a person will develop a disease.
p.000195:
p.000195: Β. The increasing interest of the scientific community and the public in using genetic data in preventive
p.000195: medicine
p.000195: A genetic test showing that a person has a predisposition to a disease enables that person to modify
p.000195: his/her lifestyle in such a way that he/she will
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...

p.000203:
p.000203:
p.000203: THE FACTS
p.000203:
p.000203: Genetic tests
p.000203:
p.000203: Genetic tests are based on the study of genetic material in order to iden- tify changes in the DNA sequence.
p.000203: These changes are either mutations, which cause a disease, or polymorphisms that constitute normal variations among
p.000203: individuals. Polymorphisms, however, can be associated with a dis- ease, i.e. if an individual carries specific
p.000203: DNA polymorphisms, he/she may have increased risk (predisposition) to develop a disease.
p.000203: In the case of monogenic disorders (e.g. thalassaemia, cystic fibrosis, familial hypercholesterolemia),
p.000203: mutations in a single gene can cause the disease. For this reason, it is relatively easy to detect the genetic
p.000203: causes of a single-gene disease. However, this is not the case for complex (multifactori- al) diseases (e.g.
p.000203: cardiovascular disease, cancer, diabetes etc.). Complex diseases can result from mutations and/or polymorphisms in
p.000203: more than one genes and/or environmental factors (e.g. smoking, diet, obesity, exercise etc.). Therefore,
p.000203: genetic tests for complex diseases cannot give a certain answer on whether an individual will develop the
p.000203: disease, but they can only estimate the relative risk to develop the condition.
p.000203: Until recently, genetic testing for health reasons was usually conducted after mandate of an expert (clinical
p.000203: geneticist). The expert in charge as- sessed the individual’s clinical phenotype and family history, and
p.000203: recom- mended or not subsequent genetic testing. The biological material was col- lected either by a physician or
p.000203: a member of the medical personnel in the genetic centre where the tests would be performed.
p.000203:
p.000203: The new trend: Direct access to genetic testing
p.000203:
p.000203: Nowadays, the way genetic testing is provided tends to change, primarily due to the great advances in molecular
p.000203: technology and genetics. This change was mainly due to:
p.000203:
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p.000204: DIRECT-TO-CONSUMER GENETIC TESTING
p.000204: REPORT
p.000204:
p.000204: Α. The constant discovery of genes associated with, not just single-gene, but also complex diseases
p.000204: More specifically, the human genome project and genome-wide associa- tion studies produced a large amount of
p.000204: genetic data and associations of genetic polymorphisms with several diseases. In addition, DNA samples from
p.000204: many patients were also available, further facilitating the production of genetic data. Based on such type of
p.000204: studies, companies that provide ge- netic services promise to estimate an individual’s chances to develop a dis- ease.
p.000204: This means that the reasons why someone would undergo genetic testing are multiplied, so that any person
p.000204: can be informed of his/her own genetic profile and the family’s genetic profile as well.
p.000204: Β. The introduction of new tools in genome analysis, such as DNA micro- arrays, thanks to which high throughput
p.000204: analysis is possible (DNA analysis from several individuals simultaneously, in a short period of time)
p.000204: This enables companies to offer commercial methods to the public, in a relatively affordable price. The result is an
p.000204: emerging new market of private companies providing genetic testing.
p.000204: C. The physicians’ and the public’s growing interest for the importance of genetic information in preventive medicine
p.000204: This interest lies in adopting an appropriate lifestyle that will help to prevent a disease, for which
p.000204: predisposition has been defined by genetic testing. The prospect of such a “shield” against possible
p.000204: future diseases is expected to consistently attract more consumers to get tested -especially if genetic testing is
p.000204: easy and doesn’t cost much- even if the cost is not covered by public insurance.
p.000204: In this context, companies offering genetic tests directly to the public emerged. Consumers are usually drawn
p.000204: to them by personal interest and/or worry about their health, or out of curiosity. The offered tests cover a wide range
p.000204: of:
p.000204: a) Diagnostic tests confirming or not a disease (single-gene diseas- es),
p.000204: b) pre-symptomatic tests that calculate a person’s chances of devel- oping a disease (multifactorial diseases),
p.000204: c) prenatal tests that determine the embryo’s gender,
p.000204: d) pharmacogenetic tests that estimate the right dosage, effective- ness and side effects of certain drugs for an
p.000204: individual,
p.000204:
p.000204:
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p.000205: DIRECT-TO-CONSUMER GENETIC TESTING
p.000205: REPORT
p.000205:
p.000205: e) paternity tests that confirm or not paternity,
p.000205: f) kinship tests that confirm or not relationship and the degree of relationship,
p.000205: g) ancestry tests that determine the family’s origin (genealogical roots),
p.000205: h) metabolic and nutritional genomics tests that estimate predispo- sition to obesity,
p.000205: i) anti-ageing tests that study the genes affecting ageing,
p.000205: j) athletic performance tests that determine someone’s potential for athletic performance.
p.000205: Typically, the consumer receives a kit, which includes instructions to col- lect his/her own biological material
p.000205: (usually saliva or buccal mucosa swabs), and this kit is subsequently sent for analysis to the laboratory by post. The
p.000205: consumer is notified of the results by telephone, post, e-mail or a safe web- site, to which access is being
p.000205: granted. Tests requiring blood are accompa- nied by a kit to be used by a physician, who will safely collect a
p.000205: blood sample (e.g. to screen for mutations in the BRCA1 and 2 genes causing breast can- cer).
p.000205: Often, the commercial companies simply communicate the results of the genetic tests, without giving information about
p.000205: their usefulness to the inter- ested parties (genetic counseling). Other companies combine genetic results with data
p.000205: derived from a questionnaire (filled in by the consumer), providing more individualized information. Essentially, this
p.000205: is a type of genetic coun- seling, both for the recommended genetic test and the interpretation of the results. In the
p.000205: second case, counseling services are usually offered at an ex- tra charge, as a special service upon request.
p.000205: Counseling may be provided by telephone, without direct contact of the counsellor with the user of the ser- vice. In
p.000205: some cases, however, the company recommends that the results are communicated to the consumer’s physician, who will
p.000205: evaluate them.
...

p.000207: Genetic tests for health reasons have some diagnostic limits:
p.000207:
p.000207:
p.000208: 208
p.000208:
p.000208: DIRECT-TO-CONSUMER GENETIC TESTING
p.000208: REPORT
p.000208:
p.000208: 1. A test may not detect a singe mutation (a gene can bear several mutations in different parts). E.g. there are over
p.000208: 1,300 mutations in the gene causing familial hypercholesterolaemia, which are dis- tributed throughout the gene and
p.000208: show different frequencies be- tween populations. Moreover, a negative test that does not de- tect a
p.000208: mutation cannot completely exclude the disease. This oc- curs either because many tests screen only for the most
p.000208: common mutations or because the method used has certain restrictions.
p.000208: 2. Multifactorial diseases are complex and result from both genetic and environmental factors. Even if two
p.000208: individuals bear the same mutation, disease onset, severity and progress may differ due to interaction with other
p.000208: genes or different environmental factors, to which each individual is exposed. Thus, genetic tests cannot
p.000208: determine with certainty whether a person will develop the dis- ease, but only estimate the possibility to develop
p.000208: it.
p.000208: 3. Often, data produced by genetic tests are not directly related to the treatment of the disease or on certain
p.000208: occasions, there are no available treatments. Pharmacogenetic tests are an exception, since they provide
p.000208: information about drug response and side ef- fects based on a person’s genetic composition.
p.000208: The benefits of genetic testing are mainly related to the health and psy- chology of the individual or his/her family:
p.000208: 1. In case of a family history which is confirmed by genetic testing, the individual has a chance of
p.000208: responsible guidance by the geneticist, aiming at prevention. E.g. if a person has a family history of
p.000208: colon cancer, genetic tests detecting a mutation or predisposition will put an end to his worries and may
p.000208: become the start for regular tests which may detect precancerous polyps and even prevent death by this cause.
p.000208: Respectively, other members of the family who share the same genetic profile may also benefit.
p.000208: 2. In case of a negative result, the individual is relieved and freed from possible regular tests that can
p.000208: be painful and/or costly.
p.000208: 3. When it comes to pharmacogenetic testing, one can ensure a personalized, more effective treatment,
p.000208: with reduced side effects. E.g. people who suffer from Alzheimer’s disease and bear a single copy of a
p.000208: gene have no advantage with a certain
p.000208:
p.000208:
p.000209: 209
p.000209:
p.000209: DIRECT-TO-CONSUMER GENETIC TESTING
p.000209: REPORT
p.000209:
p.000209: treatment, while people with two copies of the gene demonstrate a slow progress of the disease under the same
p.000209: treatment.
p.000209: Genetic testing for health reasons involves medical, psychological or fi- nancial risks, both for the individual and
p.000209: his/her family:
p.000209: 1. Genetic tests that include sample collection of saliva, buccal mucosa swabs or blood do not involve
p.000209: physical risks for the individual. This is not however the case for prenatal genetic screening, where e.g.
p.000209: in amniocentesis the risk of miscarriage is 1 in 200-400 cases.
p.000209: 2. False positive results can cause anxiety and further unnecessary medical examinations and treatments.
p.000209: 3. False negative results cause complacency to the person or delay the diagnosis and treatment.
p.000209: 4. The results of a genetic test can affect serious decisions over a person’s life, e.g. if high risk for
p.000209: a disease is confirmed, then the person’s decision to have children may be affected. Or in the case where the genetic
p.000209: test detects a mutation that can cause breast cancer, the person might undergo a total mastectomy as an
p.000209: extreme measure of prevention.
p.000209: 5. In case of a positive result, there is always the risk of stigmatization, refusal of
p.000209: providing him/her private insurance and work.
p.000209: 6. In case of a positive result, the psychological stress imposed on the individual is severe, causing
p.000209: worries, uncertainty, confusion and, probably, despair. These consequences expand to other members of the
p.000209: family, as it is a hereditary disease.
p.000209: 7. The above (1-6) are also combined with the cost of genetic tests, which usually burdens the individual and/or
p.000209: his/her family.
p.000209:
p.000209: THE DIMENSION OF ETHICS
p.000209:
p.000209: The above mentioned highlight the main problem, which is the possibil- ity of misleading the average citizen about both
p.000209: the quality of specific ser- vices and the value of genetic tests in general.
p.000209: The Commission has repeatedly underlined the danger of overestimating the association of genetic data with a person’s
p.000209: health (Hellenic National Bio-
p.000209:
p.000209:
p.000210: 210
p.000210:
p.000210: DIRECT-TO-CONSUMER GENETIC TESTING
p.000210: REPORT
p.000210:
p.000210: ethics Commission 2006: Opinion on Human Biobanks par. 2a; Hellenic Na- tional Bioethics Commission 2008: Opinion on
p.000210: Genetic Data in Private Insur- ance par. 3b).
p.000210: It is sufficient, at this point, to note that although the genetic causes of many serious complex diseases have
p.000210: been detected, these reveal nothing more than mere “predisposition”. In order to develop a complex
p.000210: disease, relevant environmental factors must exist, otherwise genetic predisposition may remain inert. This category
p.000210: includes the vast majority of complex (mul- tifactorial) diseases, which comprise the main interest of a perfectly
p.000210: healthy individual, i.e. the consumer in this case. Monogenic diseases -that develop without the occurrence of
p.000210: environmental factors (e.g. cystic fibrosis, thalas- saemia, familial hypercholesterolemia, muscular dystrophy,
p.000210: Alzheimer’s disease, Huntington’s Chorea)- are comparatively few and, most prominent- ly, rare, in order to
p.000210: justify a commercial interest in the market of genetic testing.
...

p.000212: REPORT
p.000212:
p.000212: The physician’s position
p.000212: How can a physician react, in the context of medical ethics, when he/she is informed that the patient insists on DTC
p.000212: genetic testing that he/she does not recommend?
p.000212: According to medical ethics, a physician is not obliged to insist on caring for patients who do not cooperate or bypass
p.000212: him/her. Certainly, the physi- cian must inform the patient about the risks of misleading information or
p.000212: unnecessary tests which may affect the patient’s treatment or life (art. 9 par. 4, art. 11 CME).
p.000212:
p.000212: Handling sensitive data
p.000212: Are there any restrictions in the case where a person consents to disclose sensitive data, to a third party, about
p.000212: his/her health or lifestyle expecting to obtain information on possible consequences to him/herself or his/her fami-
p.000212: ly? Furthermore, are there any restrictions in the existing risk that the data are handled with no control and,
p.000212: eventually, used for other purposes?
p.000212: In principle, everybody has full power on his/her own personal, simple or sensitive, data. However, a person can only
p.000212: undertake the risk of unethical handling of such data only for him/herself, not for others. In the case where genetic
p.000212: information concerns - and also identifies - members of the family, they must be protected from such risks through
p.000212: appropriate procedures.
p.000212:
p.000212: Genetic tests in children
p.000212: Is it ethical to perform genetic tests in asymptomatic children, upon the parents’ request, and how does this affect
p.000212: the child’s right to ignorance?
p.000212: To protect genetic information, as well as the child’s right to ignorance, it is not justified to perform genetic tests
p.000212: in asymptomatic children for which there is no urgent medical need -particularly for late onset diseases.
p.000212: This does not mean that genetic tests for such diseases should never be performed in children. In the case where
p.000212: parents wish to have the child tested, without an immediate benefit for the child’s health (i.e. treatment or
p.000212: prevention), one must weigh the risks and the benefits, and genetic testing may be postponed until the child reaches a
p.000212: certain age and is able to con- tribute at the decision making process (British Society for Human Genetics, 2010).
p.000212:
p.000212:
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p.000213: DIRECT-TO-CONSUMER GENETIC TESTING
p.000213: REPORT
p.000213:
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p.000253:
p.000253: v) Training at high altitude and the use of artificial hypoxic environment
p.000253:
p.000253: The preparation of athletes at high altitudes, amongst others, reduces blood pressure and heart rate, and an
p.000253: increase in erythropoietin, resulting in an increased number of red blood cells and acceleration in fat metabolism
p.000253: (Garcia, Verdugo, 2005). Consequently, athletes who train in low oxygen conditions aim at a better use of the
p.000253: available oxygen and enhancement of their physical stamina during the games. According to a comment on Art.
p.000253: 4.3.2 of the World Anti-Doping Code, training in high altitudes only meets the criterion of enhancing
p.000253: athletic performance, and hence, is not consid- ered a prohibited method. However, there is no specific
p.000253: reference in the Code concerning the use of artificial hypoxic environments (e.g. hypoxia chambers) that
p.000253: simulate conditions of high altitudes.
p.000253:
p.000253: 2. The dimension of ethics
p.000253:
p.000253: The use of pharmaceutical agents to enhance physical abilities is associated with both the likelihood
p.000253: of putting the athlete’s health in danger and the corruption of justice in athletic games (doping) or tests.
p.000253: As to the first issue, a person’s autonomy in his/her health is in principle absolute. The imposition of a moral “duty”
p.000253: to take care of the good state of our health and avoid risks, for reasons related to collective interests
p.000253: (the good of our family, our productivity at work, public health or even to avoid extra burden on the public
p.000253: health insurance systems), does not seem justified. On the one hand, such an obligation would drastically restrict
p.000253: the enjoyment of many freedoms (especially in the context of professional and private life). On the other hand,
p.000253: endangerment is a structural feature of today's “risk society”, to the point that it becomes impossible
p.000253: to lead a
p.000253:
p.000253:
p.000254: 254
p.000254:
p.000254: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000254: REPORT
p.000254:
p.000254: “healthy” life. In this sense, there is no essential ethical basis in the criticism of “self-destruction”, at least as
p.000254: far as the concept of autonomy presuppo- ses the rational -and non-arbitrary- use of our freedom.
p.000254: As to the second issue, our relations with third parties set limits on the enhancement of physical abilities by
p.000254: using pharmaceutical agents. Ideally, ensuring equal access to any mean that can enhance performance is a
p.000254: characteristic of justice. If this is not possible, the prohibition of specific means is, in principle,
p.000254: legitimate, in competing procedures (e.g. in education or in sports -especially championship games, where the
p.000254: interests of third parties is stronger).
p.000254: In contrast to pharmaceutical enhancement, interventions in an indi- vidual’s genome are “with no return”,
...

p.000259: (Richel, 2003). Partici- pants in this study were among others, Michael Fossel, researcher of the effect
p.000259: of telomerase on delaying cell aging, Roy Walford who studies the effect of limited calorie consumption
p.000259: to prolong lifespan and Aubrey de Grey, a biogerontologist and a great supporter of life prolongation.
p.000259:
p.000259: 2. The dimension of ethics
p.000259:
p.000259: One cannot dispute that control of the aging mechanisms and prolongation of life are within
p.000259: the limits of a person’s autonomy. In principle, it is legitimate to pursue such a thing in the context of
p.000259: autonomy, as, indeed, it is legitimate to treat any cause that leads the body to weakness and ultimately
p.000259: to death. Therefore the relative ethical issues do not differ substantially from the issues raised by the other
p.000259: forms of physical enhancement.
p.000259: However, a crucial issue that remains is the future social consequences of a dramatic increase in life
p.000259: expectancy, as demographic data already confirm serious effects e.g. on the sustainability of
p.000259: health insurance systems, even on the adequacy of natural resources.
p.000259: Assuming that these data reflect the limited strength of modern societies, not only in a broader
p.000259: macrosocial scale but even in the scale of a
p.000259:
p.000259:
p.000260: 260
p.000260:
p.000260: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000260: REPORT
p.000260:
p.000260: family, it is possible that maintenance of a “fourth” generation of ancestors will be against human reproduction.
p.000260: Indeed, this generation will continue to burden the family budget, effectively discouraging child bearing, which will
p.000260: marginally lead to a progressive aging of societies. In this case, the effects on the viability of societies will be
p.000260: unknown.
p.000260:
p.000260: 3. The law
p.000260:
p.000260: It is difficult to detect law restrictions regarding the fundamental rights of personality development and health (5
p.000260: par. 1 and 5, Constitution) in this specific field.
p.000260: If the reservation relates elusively to the future interest of societies in age renewal, the only
p.000260: reference that could be made concerns our responsibility towards the future generations. This
p.000260: responsibility - is mainly mentioned in the non-binding environmental law (see Report in the Opinion of the NBC
p.000260: “Management of biological wealth”, 2009) - however, an ethical issue still remains: this responsibility will lead
p.000260: us to accept our biological limits (hence the finite of our lives), which could not be determined by legal rules.
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000261: 261
p.000261:
p.000261: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000261: REPORT
p.000261:
p.000261: SUGGESTED LITERATURE
p.000261:
p.000261: AAAS invitational workshop on human enhancement (2006). AAAS Human enhancement and the means of achieving it.
p.000261: Washington, DC.
p.000261: Barazzetti G, Reichlin M (2011). Life-extension: A biomedical goal? Scientific prospects, ethical concerns. Swiss Med
p.000261: Wkly 141, w13181.
...

p.000269: drugs.
p.000269: The Commission considers that, as in the case of enhancing physical characteristics, the autonomy of a
p.000269: healthy person includes options for en- hancing the cognitive or mental state of the human body. This enhancement
p.000269: is part of the right to develop freely a personality.
p.000269:
p.000269: II. Suggestions
p.000269:
p.000269: However, the aforementioned principle must be supplemented with necessary remarks.
p.000269: 1. The use of drugs to enhance memory or attention may adversely af- fect other cognitive functions. Due to this
p.000269: eventuality, the person concerned must be fully informed, in order to have the opportunity of an independent choice.
p.000269: 2. The issue of influencing the personality is particularly emphasized in the case of antidepressants use. The above
p.000269: mentioned influence is in princi- ple legitimate, as a fundamental right of the person, but it encloses the risk of
p.000269: uncontrolled effects on the nervous system and the general physical and mental condition of the person. The Commission
p.000269: notes the risk when chil- dren use such drugs since such a use may lead to the substitution of all the efforts made to
p.000269: integrate the person into society. A personality is developed by the gradual and smooth integration of the
p.000269: person into the social envi- ronment, owing to the family, friends or educational mechanisms that have the
p.000269: advantage of being subjected to constant scrutiny and revision, and are reversible if necessary, depending on the
p.000269: person’s maturity. For the Com- mission, this advantage is necessary to be ensured, especially in the case of
p.000269: children. For this reason, the use of substances for non-therapeutic purpos- es is not legitimate in children.
p.000269: 3. The use of enhancement methods to improve cognitive and mental functions always requires that the
p.000269: person concerned is fully informed and updated, in terms of the expected results and possible side
p.000269: effects. The Commission considers that the risk of misinformation, especially for drugs which are not
p.000269: prescribed, is serious. The promotion of these drugs to the public and the information leaflets about their
p.000269: use should be subjected to special inspection by the authorities (National Organization for Medicines,
p.000269:
p.000269:
p.000270: 270
p.000270:
p.000270: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000270: OPINION
p.000270:
p.000270: General Secretariat for Commerce, etc.). It is apparent that for prescription drugs, the physician and the pharmacist
p.000270: have an increased responsibility to properly inform the person concerned, especially since it remains doubtful whether
...

p.000280: of enhancing certain functions at the expense of others.
p.000280:
p.000280: 3. Balancing cognitive and psychological functions - Personality change
p.000280:
p.000280: In the case of mental characteristics, in a broader context, we encounter the same problem regarding the balance
p.000280: of increased cognitive abilities (memory, ability to concentrate, etc.). It seems that here, there is some kind of
p.000280: connection, e.g. with the emotional life of the person. Thus, enhan- cement of cognitive abilities
p.000280: that allows an employee to perform exceptionally, has been reported to negatively affect his/her
p.000280: emotional world (events of apathy, indifference, etc.), with unknown consequences for the personality (Glannon, 77-78).
p.000280: Generally, the question of changing a personality by drug use (particularly antidepressants) is a
p.000280: central concern, as does the question of whether this increases or limits autonomy (STOA, 135). There is
p.000280: no doubt that personality changes, anyway, with the assistance of external actors - particularly by
p.000280: the socialization mechanisms during childhood and adolescence- the effects of which often are not
p.000280: controlled by the person itself. Thus, a child’s personality is constantly changing under the influence of family,
p.000280: school, friends, television, internet etc. However, there are also changes during adulthood, even if
p.000280: certain characteristics are gradually stabilized, comprising foundations for the “development” of
p.000280: personality. The very term “development”, suggests “change” anyway.
p.000280: Therefore, the critical point to our subject is not whether, in general, personality development is
p.000280: legitimate, but rather whether such a change can be so radical that can lead to psychological
p.000280: pathologies, i.e. to cause damage to a person’s mental health. Besides extreme exceptions,
p.000280: mechanisms of socialization do not cause so deep “sections” in a person’s
p.000280:
p.000280:
p.000281: 281
p.000281:
p.000281: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000281: REPORT
p.000281:
p.000281: personality. On the contrary, socialization mechanisms “build” on the grounds formed in infancy,
p.000281: which are associated with inherent cognitive abilities (including perception of space, time, etc.),
p.000281: learning the mother tongue, but also the evolution of the unconscious processes (especially the libido). In
p.000281: contrast, the use of pharmaceuticals -similarly to the use of substances such as alcohol or drugs- can
p.000281: cause such sections, which may lead to serious mental illness. The main reason is that these substances have a
p.000281: strong invasive impact on the function of the nervous system, with largely unpredictable effects on the mechanisms of
p.000281: cognition.
p.000281: This point is important in order to distinguish schematically between “safe” and “unsafe” personality change,
p.000281: but it is not enough to answer the question of whether the second one is legitimate or not. Similarly to alcohol or
p.000281: drug use, a person intentionally uses pharmaceutical agents, and this is done in the context of self-determination,
p.000281: even if the person is aware of the potential serious harm to his/her health. It is generally accepted that self-
p.000281: determination does not exclude choices of an even great risk or choices of “self-destruction”, since otherwise we
p.000281: must adopt paternalistic lifestyles, something that would be fundamentally in contrast to our freedom.
p.000281: Consequently, the possibility of drug use for enhancement purposes that could lead to a radical personality change (or
p.000281: to milder effects on memory capacity, emotional life, etc.), cannot be considered as an illegitimate
p.000281: choice, given the primacy of personal autonomy (Racine & Forlini, 3).
p.000281: However, two reservations remain:
p.000281: - The consequences of drug use do not cause damage to goods of a third party (e.g. in the context of
p.000281: family life or working environment of the user). Thus, for example, drug use that leads to indifference or threat for
p.000281: the user’s children or creates tension with colleagues etc., is illegitimate).
p.000281: - The user has actually made the decision freely, i.e. after providing the appropriate information to him/her, with
p.000281: all the potential risks being identified (Cakic, 613-614, Racine & Forlini, 3, Farah et al., 423). This is not certain,
p.000281: especially when the drugs are administered without a prescription or, at least, without consulting a physician.
p.000281: The re- sponsibility of the latter, here, is certainly increased, as it is about enhancing cognitive or
p.000281: mental characteristics and not about restoring relevant health damage.
p.000281:
p.000281:
p.000282: 282
p.000282:
p.000282: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000282: REPORT
p.000282:
p.000282: 4. Equal access
p.000282:
p.000282: The issue of equal access to means of cognitive or mental enhancement is mainly associated with the
p.000282: opportunities offered in competitive environments (Farah et al., 423) and, secondly, with improvement
p.000282: of our lifestyle. This is an issue of concern which is similar to that of enhancing physical abilities
p.000282: (e.g. doping in sports).
...

Health / Physically Disabled

Searching for indicator illness:

(return to top)
p.000131: practical solutions to implement respect for patient autonomy in practice not only as a value in itself but also as a
p.000131: safety valve for the efficiency of health services.
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000132: 132
p.000132:
p.000132: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000132: REPORT
p.000132:
p.000132: SUGGESTED LITERATURE
p.000132:
p.000132: Androulidaki-Demetriadi I (1993). The duty to inform the patient. A contri- bution to the assessment of civil
p.000132: medical liability. Eds. Sakkoulas, Athens- Komotini.
p.000132: Asveld L (2008). Mass-vaccination programmes and the value of respect for autonomy. Bioethics 22, 245-257.
p.000132: Blackhall LJ, Murphy ST, Frank G, Michel V, Azen S (1995). Ethnicity and atti- tudes toward patient autonomy. Jama
p.000132: Journal of the American Medical As- sociation 274, 820-825.
p.000132: Brokalaki EI, Sotiropoulos GC, Tsaras K, Brokalaki H (2005). Awareness of diagnosis, and information-seeking
p.000132: behavior of hospitalized cancer patients in Greece. Supportive Care in Cancer 13, 938-942.
p.000132: Dosios T, Markopoulos C, Vlahos I and Latsios P (1986). The views of Greek physicians on whether cancer patients should
p.000132: know of their illness. Medical Review of the Armed Forces 20, 9-315.
p.000132: Elian M and Dean G (1985). To tell or not to tell the diagnosis of multiple- sclerosis. Lancet 2, 27-28.
p.000132: Elliot C (2001). Patients doubtfully capable or incapable of consent. In Kuhse, H and Singer PA (Eds.). A
p.000132: Companion to Bioethics. Blackwell, Oxford, pp. 452.
p.000132: Erde EL, Nadal EC, Scholl TO (1988). On truth telling and the diagnosis of Alzheimers disease. Journal of
p.000132: Family Practice 26, 401-406.
p.000132: Fountedaki K (2003). Civil Medical Liability. General introduction - Issues of doctrine and legal policy -
p.000132: Fundamental concepts. Eds. Sakkoulas, Athens- Thessaloniki.
p.000132: Hartzband P and Groopman J (2009). Keeping the patient in the equation- humanism and health care reform. N Engl J Med
p.000132: 361, 554-555.
p.000132: Hebert PC, Hoffmaster B, Glass KC, Singer PA (1997). Bioethics for clinicians.
p.000132: 7. Truth telling. Canadian Medical Association Journal 156, 225-228.
p.000132:
p.000132:
p.000133: 133
p.000133:
p.000133: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000133: REPORT
p.000133:
p.000133: Higgs R (2001). Truth-Telling. In Kuhse H, Singer PA (Eds.), A Companion to Bioethics. Blackwell, Oxford, pp. 432.
p.000133: Iconomou G, Viha A, Koutras A, Vagenakis AG, Kalofonos HP (2002). Infor- mation needs and awareness of diagnosis in
p.000133: patients with cancer receiving chemotherapy: A report from Greece. Palliative Medicine 16, 315-321.
p.000133: Jansen VAA, Stollenwerk N, Jensen HJ, Ramsay ME, Edmunds WJ, Rhodes CJ (2003). Measles outbreaks in a population
...

p.000238: A negative answer to the above posed question is linked to the standard aim of medicine, which is to treat the disease
p.000238: (and generally any damage of the organism). This approach accepts a more moderate definition of health, considering
p.000238: healthy anyone living in a balanced physical state, without presenting with any damages or threatened by
p.000238: -unforeseen or not- damages of the organism. In this context, health is not connected with the
p.000238: development of physical abilities -let alone with any desired change in external features- but simply
p.000238: comprises a state of equilibrium.
p.000238: Both of these positions can be reconciled with the Hippocratic principle of “to do good or to do no harm”, which
p.000238: encapsulates the moral duty of the physician during medical practice. However, the two above mentioned
p.000238: positions are problematic as well.
p.000238: The first position limits in a completely ideal situation, the ascertainment that an organism is “healthy”,
p.000238: over-extending the area of “unhealthy” (if not the area of “patient”). Therefore, it seems that the first position
p.000238: ignores that the “full development” of an organism’s abilities is strongly subjective. The subjective assessment of
p.000238: our abilities is amplified by the fact that, nowadays, technology provides great opportunities for
p.000238: interventions and therefore for satisfaction of our real or non-real needs. The gradual
p.000238: “medicalization” of life may be a side effect of this problem.
p.000238: On the other hand, the “moderate” definition of health, marginally, remains unclear. That is because, if
p.000238: the development of a disease or an illness after an accident can be, in general, easily identifiable with
p.000238: objective methods, this is not the case with preventive medicine, that aims at reducing risks:
p.000238: frequently, “risk” is being confused with “health damage”
p.000238:
p.000238:
p.000238: 1 In a similar direction the so-called transhumanists do not consider that distinguish- ing between therapy and human
p.000238: enhancement is important. They comprise a move- ment which claims that humans must lead their own evolution
p.000238: beyond the limits imposed by biology. Tanshumanists believe that enhancement must be addressed as treatment, i.e. to
p.000238: use freely all the possibilities provided by science and technology for enhancement purposes. Like transhumanists,
p.000238: proponents of human enhancement in general, consider that any delays in the use of technologies, such as genetic
p.000238: interven- tions to improve cognitive abilities, have harmful effects on our health, quality and life expectancy. In
p.000238: contrast, opponents of human enhancement argue that the new technologies will not solve the problems of inequality and
p.000238: social justice.
p.000238:
p.000239: 239
p.000239:
p.000239: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000239: REPORT
p.000239:
p.000239: and is amenable to medical care in order to reduce it (e.g. taking drugs to reduce glucose or cholesterol
p.000239: levels). But beyond that, the physical deterioration of the organism with the occurrence of aging is
p.000239: undoubtedly “damage” and is regularly treated with advanced medical care (in many levels), however, it leads
...

p.000247: provides special conditions aiming to protect the donor and the recipient of the transplant, with informed
p.000247: consent as the central concept here.
p.000247:
p.000247:
p.000247:
p.000247:
p.000248: 248
p.000248:
p.000248: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000248: REPORT
p.000248:
p.000248: II. Enhancing performance
p.000248:
p.000248: 1. The facts
p.000248:
p.000248: a) Overview
p.000248:
p.000248: The concept of enhancing performance includes skills, such as the physical strength, speed,
p.000248: agility, stamina, accuracy and movement co- ordination as well as dexterity. In this case,
p.000248: enhancement is mainly accomplished by the use of pharmaceutical agents, whereas in the future, one cannot
p.000248: preclude that performance enhancement will be achieved by the use of genetic technologies.
p.000248:
p.000248: b) Enhancing performance at work
p.000248:
p.000248: The wish to strengthen performance in the working environment may have significant effects on work, which
p.000248: require careful consideration by the policymakers, employers and employees themselves. Enhancement techno- logies could
p.000248: change the way people work, making it possible to work under difficult conditions (e.g. extreme climate conditions, low
p.000248: light conditions and low oxygen concentration), to increase strength and reduce physical fatigue even during
p.000248: prolonged labor or to reduce recovery and return earlier to work after illness (Academy of Medical
p.000248: Sciences, British Academy, Royal Academy of Engineering and Royal Society joint Workshop Report, 2012).
p.000248:
p.000248: c) Enhancing military performance
p.000248:
p.000248: The history of conducting experiments in order to enhance the performance of soldiers started
p.000248: almost a century ago. After the use of yperite (also known as mustard gas) during the First World War, there
p.000248: were reports of yperite trials on soldiers in the USA that examined resistance to yperite depending on race. It was
p.000248: just five decades later, in 1991, that the USA government admitted these experiments (Smith, 2008). Reports of
p.000248: experiments with nuclear energy and psychotropic drugs then followed (Parasidis, 2012).
p.000248: However, enhancement of military performance has evolved due to the
p.000248:
p.000248:
p.000249: 249
p.000249:
p.000249: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000249: REPORT
p.000249:
p.000249: possibilities offered by biomedicine and biotechnology. For example, the
p.000249: U.S. Department of Defense and the Advanced Research Projects Agency Defense (DARPA) fund research on
p.000249: pharmaceutical agents that keep soldiers alert, reducing the need for sleep. Research is also conducted on
p.000249: nutrient preparations that fulfill the nutritional needs of soldiers for several days. DARPA’s program
p.000249: “Persistence in Combat” includes the development of a vaccine that would block pain, accelerate wound healing
p.000249: and stop bleeding soon after wounding (Parasidis, 2012).
p.000249:
p.000249: d) Enhancing athletic performance
p.000249:
...

p.000280: school, friends, television, internet etc. However, there are also changes during adulthood, even if
p.000280: certain characteristics are gradually stabilized, comprising foundations for the “development” of
p.000280: personality. The very term “development”, suggests “change” anyway.
p.000280: Therefore, the critical point to our subject is not whether, in general, personality development is
p.000280: legitimate, but rather whether such a change can be so radical that can lead to psychological
p.000280: pathologies, i.e. to cause damage to a person’s mental health. Besides extreme exceptions,
p.000280: mechanisms of socialization do not cause so deep “sections” in a person’s
p.000280:
p.000280:
p.000281: 281
p.000281:
p.000281: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000281: REPORT
p.000281:
p.000281: personality. On the contrary, socialization mechanisms “build” on the grounds formed in infancy,
p.000281: which are associated with inherent cognitive abilities (including perception of space, time, etc.),
p.000281: learning the mother tongue, but also the evolution of the unconscious processes (especially the libido). In
p.000281: contrast, the use of pharmaceuticals -similarly to the use of substances such as alcohol or drugs- can
p.000281: cause such sections, which may lead to serious mental illness. The main reason is that these substances have a
p.000281: strong invasive impact on the function of the nervous system, with largely unpredictable effects on the mechanisms of
p.000281: cognition.
p.000281: This point is important in order to distinguish schematically between “safe” and “unsafe” personality change,
p.000281: but it is not enough to answer the question of whether the second one is legitimate or not. Similarly to alcohol or
p.000281: drug use, a person intentionally uses pharmaceutical agents, and this is done in the context of self-determination,
p.000281: even if the person is aware of the potential serious harm to his/her health. It is generally accepted that self-
p.000281: determination does not exclude choices of an even great risk or choices of “self-destruction”, since otherwise we
p.000281: must adopt paternalistic lifestyles, something that would be fundamentally in contrast to our freedom.
p.000281: Consequently, the possibility of drug use for enhancement purposes that could lead to a radical personality change (or
p.000281: to milder effects on memory capacity, emotional life, etc.), cannot be considered as an illegitimate
p.000281: choice, given the primacy of personal autonomy (Racine & Forlini, 3).
p.000281: However, two reservations remain:
...

Searching for indicator physically:

(return to top)
p.000126: with full legal competence to consent may suffer a temporary disorder of their mental functions which
p.000126: prevents the forming and expression of free will (e.g. under the influence of alcohol or narcotics or in state of
p.000126: shock because of an accident or the announce- ment of a serious disease, etc.)10.
p.000126:
p.000126:
p.000126: 10 This is a case for the application of art. 131 CC which stipulates the nullity of ex- pression of will in such
p.000126: circumstances. See generally on the problem of “irrational”
p.000126:
p.000127: 127
p.000127:
p.000127: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000127: REPORT
p.000127:
p.000127: In these circumstances acting alone is again not justified for physicians except in emergency situations. They must
p.000127: concentrate their efforts on the speedy recovery of the patient’s mental lucidity so that the patient can be informed
p.000127: in time and decide about treatment by himself/herself. Besides, it is not legitimate to substitute the patient’s
p.000127: relatives for the patient’s own will for patients may disagree with their relatives’ decision once their mental
p.000127: capacities are restored.
p.000127: Respectively, persons who are legally incompetent to consent may be physically fully capable of forming and
p.000127: expressing their will on matters con- cerning their health. We already mentioned the example of minors, espe-
p.000127: cially from the beginning of adolescence; similar, however, is the situation of persons under legal guardianship
p.000127: (even full-fledged) whereas mild mental disorders or impairments do not by definition exclude the exercise of self-
p.000127: control over one’s health.
p.000127: In the case of minors, it would be more appropriate to recognize their capacity for self-consent after a certain
p.000127: age (thus precluding consent by the minor’s legal representatives) for there is an objective presumption of suffi-
p.000127: cient maturity in contemporary societal life that can hardly be put in ques- tion (e.g. from the age 15 years).
p.000127: Meanwhile the assent of minors must be given considerable weight in relevant decisions, especially if coinciding with
p.000127: the physician’s advice, even when the parents disagree.
p.000127: For adults, it is difficult to assume a similar objective presumption. Therefore, the view of the concerned
p.000127: person must be given particular atten- tion (as must the appropriateness of prior information) and evaluated on a
p.000127: case-by-case basis although the power of legal representatives to decide cannot be questioned.
p.000127: The problem of advance directives is a much harder nut to crack. The event of becoming incompetent to
...

p.000241: examinations, issuing medical certificates and attestations and the general counseling of the
p.000241: patient.
p.000241: This is a comprehensive definition of medical acts by the legislature, which does not include enhancement
p.000241: interventions in order to improve capabilities or aesthetics.
p.000241:
p.000241: B. ENHANCEMENT OF PHYSICAL CHARACTERISTICS AND CAPABILITIES
p.000241:
p.000241: I. Plastic (surgical) procedures
p.000241:
p.000241: 1. The data
p.000241:
p.000241: a) Reconstructive and aesthetic surgery
p.000241:
p.000241: Plastic surgery is a kind of enhancement of human characteristics, which is already applied to both men and women. The
p.000241: term plastic surgery refers to the surgical repair or correction of a feature or function of the human
p.000241: body. There are two types of plastic surgery:
p.000241: 1. Reconstructive procedures. Their purpose is to repair or enhance physiological functions and
p.000241: characteristics of the body, which are altered due to accidents, diseases or birth defects.
p.000241: The most common reconstructive procedures include reconstru- ctive plastic surgery to correct scars after
p.000241: an accident or burn, restoration of cleft lip and palate and reduction of the breast size.
p.000241: 2. Aesthetic/cosmetic procedures, which are divided into surgical and non-surgical cosmetic procedures.
p.000241: Their purpose is to reconstruct characteristics of the body in order to enhance external appearance. The
p.000241: specificity of cosmetic surgery is that the person interested is physically healthy.
p.000241: The most common types of aesthetic plastic surgery is botox/ wrinkle implants, face lift to reshape
p.000241: the forehead/eyebrows, blepharoplasty, breast augmentation, tummy tuck, rhinoplasty, oto- plasty and liposuction.
p.000241: It should be taken account that in some cases, the line between reco-
p.000241:
p.000241:
p.000242: 242
p.000242:
p.000242: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000242: REPORT
p.000242:
p.000242: nstructive and cosmetic surgery is unclear. Both reconstructive and aesthetic surgeries are, basically,
p.000242: permanent, since it is not easy to reverse the changes without a second surgery (with the exception of
p.000242: botox). Therefore, the enhancement of physical characteristics in this case, is not temporary.
p.000242:
p.000242: b) Motivations and psychological profile of the persons interested
p.000242:
p.000242: The reasons that may lead a person to seek plastic surgery vary, depending on the psychological
p.000242: profile as well as the type of surgery.
p.000242: It is important to stress that reconstructive interventions are offered to persons who were patients, and aim to
p.000242: improve their physical characteristics that were altered because of a medical/pathological condition or
p.000242: an accident. The decision to undergo plastic surgery is mainly driven by the need to restore the initial
p.000242: or normal state.
p.000242: In contrast, cosmetic procedures are offered to healthy individuals, who do not present with pathological findings or
p.000242: abnormal functions. Certainly, in this case one cannot overlook the impact of enhancing physical
p.000242: characteristics on the mental health of these individuals. There are many people who believe that
...

p.000278: or a prosthetic arm, causing operation of the system directly through thoughts. Brain electrical signals are
p.000278: recorded with an electroencephalogram, either with electrodes attached to the scalp (non- invasive method) or
p.000278: with electrodes implanted in the brain (invasive method). While the non-invasive method is less
p.000278: accurate in recording signals, the invasive method poses risks since electrodes are implanted in the brain
p.000278: cortex with possibilities of infection and brain damage.
p.000278: The main objective of brain-computer interfaces is to replace or restore function in patients suffering from
p.000278: neuromuscular diseases, by controlling the movement of prosthetic limbs or a wheelchair. However, such te-
p.000278: chnologies may also be applied to control robots, military vehicles and airplanes, games and virtual
p.000278: environments. According to brain-computer interface experiments, paralyzed patients can control a computer
p.000278: cursor using electrodes28,29,30, allowing the use of brain-computer interfaces for
p.000278:
p.000278: 26Tang YP, Shimizu E, Dube GR, et al. (1999). Genetic enhancement of learning and memory in mice. Nature 401, 63-9.
p.000278: 27Nicolas-Alonso LF, Gomez-Gil J (2012). Brain computer interfaces, a review. Sensors (Basel) 12, 1211-79.
p.000278: 28Hochberg LR, Bacher D, Jarosiewicz B, et al. (2012). Reach and grasp by people with tetraplegia using a neurally
p.000278: controlled robotic arm. Nature 485, 372-5.
p.000278: 29Pereira CA, Bolliger Neto R, et al. (2009). Development and evaluation of a head- controlled human-computer
p.000278: interface with mouse-like functions for physically disa- bled users. Clinics (Sao Paulo) 64, 975-81.
p.000278:
p.000279: 279
p.000279:
p.000279: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000279: REPORT
p.000279:
p.000279: continuous access to the internet, databases and information processing systems, which can enhance the
p.000279: abilities of human mind. Although these technologies are notable, however they must progress in order to
p.000279: achieve precision in manipulating external devices after stimulation of specific brain cells31.
p.000279:
p.000279: ΙΙ. The dimension of ethics
p.000279:
p.000279: 1. Overview
p.000279:
p.000279: Setting aside the general bioethics concern about human enhancement, for enhancement of cognitive and mental
p.000279: characteristics, in particular, it is worth insisting on three issues: a) the safety of interventions on
p.000279: memory functions, b) the safety in a wider range of cognitive and mental functions, and, c) the prospect of equal
p.000279: access to means of enhancement.
p.000279: These specific issues presuppose the general premise that enhancement is a legitimate pursuit for the development of a
p.000279: personality, in the context of self-determination, as long as goods of other people are not put at risk.
p.000279:
p.000279: 2. Memory enhancement
p.000279:
...

Health / Physically Ill

Searching for indicator sick:

(return to top)
p.000010: participation in such research is not discouraged for fear of use of genetic data or of the findings of research to
p.000010: the detriment of participants.
p.000010: Despite the significance of genetic data for both personal and public health, its prognostic value should
p.000010: not be overrated in order to avoid the impression that genetic tests are decisive for the individual. The use
p.000010: of ge- netic data in insurance would reinforce the misleading notion of “genetic determinism”, i.e. the
p.000010: belief that an individual’s genetic make-up absolutely determines their future health or other personal
p.000010: characteristics. Therefore, it is important to safeguard genetic data so that not only genetic testing and
p.000010: participation in research, which could yield many benefits to the individual and to society as a whole, are not
p.000010: discouraged but also to avoid an errone-
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000011: OPINION
p.000011:
p.000011: ous use of these data disproportionate to their true value for disease pro- gnosis.
p.000011:
p.000011: 4. General directions
p.000011:
p.000011: a. The principle
p.000011: In view of the above analysis, the Commission believes that any settle- ment of the issue should give serious
p.000011: consideration to the following:
p.000011: i) Personal insurance is a value of public interest and not a common commodity.
p.000011: ii) Genetic data yields a statistical probability of becoming sick and not a definite prediction; therefore, it should
p.000011: not be overestimated.
p.000011: iii) Research of the human genome is primarily beneficial for human health, a fundamental societal right
p.000011: and should therefore not be dis- couraged.
p.000011:
p.000011: b. A need for regulation
p.000011: Starting from this position, the Commission believes that some form of regulation of the use of genetic data in
p.000011: insurance is needed in our country. It points out the following:
p.000011: i) The fact that Greece has an organized system of social security (where discrimination between the insured is
p.000011: inadmissible) does not diminish the relevance of the issue. For, considering the well-known weaknesses of the
p.000011: social security system, the market of private life and health insurance is steadily expanding and is
p.000011: currently relevant to an important part of the population (11 and 16% respectively in big conurbations1). The
p.000011: same is true in other countries with well-developed social security systems that have already been studying
p.000011: the question systematically (UK, Germany).
p.000011: ii) The widespread notion of “genetic determinism” -a result of unwar- ranted overstatements in recent years
p.000011: based on the achievements of genet- ics- can easily lead to practices of unfair discrimination. The confusion
p.000011: of “predisposition” as a synonym for “manifestation” of a serious disease, even as a result of public misinformation,
p.000011: unless appropriately regulated, can cre-
p.000011:
p.000011: 1 According to data from the “Study on insurance contracts” that was commissioned to TNS-ICAP in 2007 by the
p.000011: Hellenic Association of Insurance Companies and was brought to the attention of the Commission by Mr. S.
p.000011: Tangopoulos.
p.000011:
p.000012: 12
...

p.000021: by the decode company (http://www.decode.com/) following the adoption of special legislation. This data
p.000021: has already led to significant scientific discoveries.
p.000021:
p.000022: 22
p.000022:
p.000022: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000022: REPORT
p.000022:
p.000022: D. High risk groups for genetic disorders
p.000022:
p.000022: The development of genetics and of genetic testing for specific diseases has confirmed empirical knowledge about
p.000022: the higher incidence of certain genetic disorders in particular geographic or racial groups. Examples include
p.000022: β-thalassaemia that has a higher incidence in people originating from the Eastern Mediterranean, Africa and
p.000022: Asia14 and various disorders with a high incidence in descendants of Ashkenazi Jews like the BRCA1/2 breast/ovarian
p.000022: cancer. In fact, there is a genetic test for a whole range of genetic disorders occurring more frequently in Ashkenazi
p.000022: Jews15.
p.000022: The development of genetic tests can contribute to early and accurate diagnosis of genetic conditions
p.000022: thus improving the prospects of manage- ment or treatment. Notwithstanding the medical benefits, however, there is
p.000022: an increasing risk of discrimination against these racial groups. Examples of such discrimination appeared in the US,
p.000022: for instance, in the ’70s when Afri- can-Americans, who were carriers of sickle cell anaemia, i.e. who were het-
p.000022: erozygotes and not actually sick, were either deprived of health insurance or charged with higher premiums
p.000022: (Rothenberg and Terry, 2002; Andrews, 1987). Today testing is optional and this case of “genetic” discrimination
p.000022: and stigmatization is used as an example to learn from in the findings of the American GINA Bill of Law.
p.000022: In the future, if no regulation is adopted, there is a risk that individuals belonging to high incidence groups
p.000022: for one or more genetic disorders will be required to undergo genetic testing prior to insur- ance.
p.000022:
p.000022: E. Genetic discrimination in insurance
p.000022:
p.000022: There is no clear-cut definition for the term “genetic discrimination” (Geetter, 2002). In insurance
p.000022: “genetic discrimination” means any form of differential treatment of insurance applicants or insured based on
p.000022: their ge- netic make-up. Practically, discrimination in insurance manifests either with refusal of insurance or with
p.000022: the application of increased premiums. Another form of discrimination is refusal to pay compensation (Pfeffer et al.,
p.000022: 2003).
p.000022:
p.000022:
p.000022: 14 Regions where malaria used to be endemic.
p.000022: 15 http://www.diagnogene.com/temp.php?page=laboratory<est=jew.
p.000022:
p.000023: 23
p.000023:
p.000023: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000023: REPORT
p.000023:
p.000023: In private health insurance, particularly in individual plans (as opposed to group health plans that are governed
p.000023: by different rules), discrimination based on personal medical history or, generally, on the level of risk that the
...

p.000112:
p.000112:
p.000112: Rapporteurs: T. Vidalis, A. Hager-Theodoridou In collaboration with: G. Maniatis, A. Papachristou
p.000112:
p.000112:
p.000112: A. INTRODUCTION: NEW DEVELOPMENTS IN MEDICAL PRACTICE
p.000112:
p.000112: Until recently the physician-patient relationship was governed by a “pa- ternalistic” model developed as a product
p.000112: of Hippocrates’ ethics subse- quently interpreted or modified by a succession of physicians-philosophers like
p.000112: Galen, in combination with the prevailing social conditions. According to this model, the physician decides on all
p.000112: matters pertaining to the patient’s treatment while the latter has little or no say in it at all1. The contemporary
p.000112: conditions of medical practice exhibit new qualities suggesting a need for a new model, different from the one which
p.000112: prevailed over the world until the ’50s and the ’60s.
p.000112: Unlike the paternalistic model, the new one, which appears to find favor particularly with Anglo-Saxon and north
p.000112: European countries, emphasizes patient’s autonomy. In the context of this model, the relationship physician- patient
p.000112: is one of cooperation with either party having more or less equal say on the making of decisions. The new
p.000112: characteristics of medical practice and
p.000112:
p.000112:
p.000112: 1Although the so-called “paternalistic” model of the relationship patient-physician is attributed to Hippocrates or to
p.000112: his followers, in the extant Hippocratic texts the au- thor considers as a virtue of the physician that “he makes sure
p.000112: to foresee and foretell to the sick their present condition, what preceded it and what will happen in the fu- ture”.
p.000112: He considers also that “any irrational thing that happens needs to be dis- cussed” (Rigatos, 1997) while he
p.000112: argues that when the physician analyses the present condition of the patient and what he foretells for the future in
p.000112: the presence of the patient the latter will find it easier to believe that the physician is well acquainted
p.000112: with the situation and will have more confidence in him (Hippocrates, Prognostics, introduction to the
p.000112: text).
p.000112:
p.000113: 113
p.000113:
p.000113: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000113: REPORT
p.000113:
p.000113: the conditions in which it operates which affect the relationship physician- patient can be summarized as follows:
p.000113: 1. Medicine is divided into several specialties and one physician alone is no longer able to treat all the health
p.000113: problems of an individual.
p.000113: 2. The physicians of different specialties as involved to consult in the course of his/her life will
p.000113: not necessarily work together; therefore, the patient is the only one with a complete picture of his/her medical
p.000113: history. It should be noted also that in Greece, records of medical his- tory are not kept for each patient.
p.000113: 3. Medicine has progressed in such a way that there is no single indicat- ed treatment for each particular condition.
p.000113: 4. The level of education in our country has been improved in recent decades. As a result, most patients
p.000113: are able to understand the medi- cal facts of their condition and are seeking more detailed infor- mation.
...

p.000144: other people, their personal autonomy as the only factor in making such decisions is put in question. The
p.000144: present report discusses the limits of per- sonal autonomy when a conflict with public interest arises, particularly
p.000144: with the protection of public health.
p.000144: Such conflict of interests becomes an issue mainly with regard to infec- tious (transmissible) diseases, which can
p.000144: spread from one person to anoth- er. Decisions on the prevention and treatment of such diseases put at stake the health
p.000144: and lives of not only the patients themselves but also of healthy individuals in their immediate or wider vicinity.
p.000144: Thus, if a person affected by a contagious disease or belonging to a high risk group decide against a diag- nostic
p.000144: test or treatment, they automatically become a certain or likely “source” of transmission of the disease.
p.000144:
p.000144: 1. Infectious diseases
p.000144:
p.000144: Infectious or transmissible diseases are caused by pathogen agents in- vading the organism (viruses,
p.000144: bacteria, fungi, parasites -monocellular or multicellular- or infectious proteins [e.g. prions in case of
p.000144: spongiform en- cephalitis]). Pathogens are transmitted in specific ways e.g. by saliva drop- lets (path of
p.000144: transmission), take hold and proliferate more or less successful- ly in young subjects (infectivity), provoking
p.000144: symptoms of varying severity or no symptoms at all (virulence), in which case they remain latent and the
p.000144: host becomes a carrier, but not actually sick.
p.000144:
p.000145: 145
p.000145:
p.000145: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000145: REPORT
p.000145:
p.000145: Usually, the disease can be transmitted by carriers as well as patients. The path of transmission,
p.000145: infectivity and virulence are critical factors when developing public health protection programmes or evaluating
p.000145: arguments for or against personal autonomy where an evaluation is required. By way of indication, a common cold -highly
p.000145: transmissible through droplets but caus- ing mild symptoms and posing little risk for life- is different from influenza
p.000145: - also highly infective but causing more severe symptoms as compared with common cold- or hepatitis B, which is harder
p.000145: to contract (by blood transfu- sion or exchange of bodily fluids containing blood), but has higher mortality rates or
p.000145: likelihood of permanent damage.
p.000145:
p.000145: 2. Epidemiology
p.000145:
p.000145: Infectious diseases can cause epidemics, i.e. a significant increase in the number of infected people within a given
p.000145: population in a given time period, beyond what might be normally expected, based on the epidemiological
p.000145: statistics for the particular disease (Encyclopedia of Public Health, on line).
p.000145: The geographical area, in which the rise in the number of infected peo- ple is observed, will determine whether it is a
p.000145: mere outbreak -when the rise concerns a relatively small area, e.g. a town-, an epidemic -when the rise in the number
...

Health / Unconscious People

Searching for indicator unconscious:

(return to top)
p.000280: the socialization mechanisms during childhood and adolescence- the effects of which often are not
p.000280: controlled by the person itself. Thus, a child’s personality is constantly changing under the influence of family,
p.000280: school, friends, television, internet etc. However, there are also changes during adulthood, even if
p.000280: certain characteristics are gradually stabilized, comprising foundations for the “development” of
p.000280: personality. The very term “development”, suggests “change” anyway.
p.000280: Therefore, the critical point to our subject is not whether, in general, personality development is
p.000280: legitimate, but rather whether such a change can be so radical that can lead to psychological
p.000280: pathologies, i.e. to cause damage to a person’s mental health. Besides extreme exceptions,
p.000280: mechanisms of socialization do not cause so deep “sections” in a person’s
p.000280:
p.000280:
p.000281: 281
p.000281:
p.000281: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000281: REPORT
p.000281:
p.000281: personality. On the contrary, socialization mechanisms “build” on the grounds formed in infancy,
p.000281: which are associated with inherent cognitive abilities (including perception of space, time, etc.),
p.000281: learning the mother tongue, but also the evolution of the unconscious processes (especially the libido). In
p.000281: contrast, the use of pharmaceuticals -similarly to the use of substances such as alcohol or drugs- can
p.000281: cause such sections, which may lead to serious mental illness. The main reason is that these substances have a
p.000281: strong invasive impact on the function of the nervous system, with largely unpredictable effects on the mechanisms of
p.000281: cognition.
p.000281: This point is important in order to distinguish schematically between “safe” and “unsafe” personality change,
p.000281: but it is not enough to answer the question of whether the second one is legitimate or not. Similarly to alcohol or
p.000281: drug use, a person intentionally uses pharmaceutical agents, and this is done in the context of self-determination,
p.000281: even if the person is aware of the potential serious harm to his/her health. It is generally accepted that self-
p.000281: determination does not exclude choices of an even great risk or choices of “self-destruction”, since otherwise we
p.000281: must adopt paternalistic lifestyles, something that would be fundamentally in contrast to our freedom.
p.000281: Consequently, the possibility of drug use for enhancement purposes that could lead to a radical personality change (or
p.000281: to milder effects on memory capacity, emotional life, etc.), cannot be considered as an illegitimate
...

Health / hospitalized patients

Searching for indicator hospitalized:

(return to top)
p.000117: REPORT
p.000117:
p.000117: be “obligated” to allow treatment for this would defeat the basic tenet of their freedom to consent on behalf of the
p.000117: patient.
p.000117: Continuing on the question of derogations, it is worth noting the differ- ent approach of the CME as compared with art.
p.000117: 1534 of the Civil Code (CC) which allows the physician to act alone in case the parents of a minor refuse to give their
p.000117: consent to treatment. The Civil Code requires authorization by the Prosecutor whereas the CME does not. The question is
p.000117: whether the pro- visions of the CME provide sufficient grounds to cover the physician’s liability vis-à-vis the
p.000117: parents especially in view of the constitutional protection of parental care (Constitution, art. 21 [1]; art. 8
p.000117: [1] ECHR) whose guarantor is precisely the judiciary and not the physician -as firmly held in legal doctrine.
p.000117: Critical also is the physician’s attitude in case of disagreement between relatives which is not unlikely since
p.000117: the law does not assign any priority among relatives with regard to their power to decide. Should an
p.000117: implicit hierarchy be inferred or is it left to the physician to decide according to his/her fundamental
p.000117: duty to the patient? Could an ethics board be of assis- tance when the patient is hospitalized? Let us recall
p.000117: at this point that our national health system is not familiar with ethics boards whereas in Europe and the US they
p.000117: are well-established -and the importance of their role is not put in question- for many years.
p.000117: An even graver issue may arise when the physician is in a position to know the patient’s wishes, which
p.000117: were expressed before the patient became incapable to consent either in written or orally and the relatives
p.000117: disagree. Since the latter have by law the right to make the final decision, the ques- tion is whether these wishes
p.000117: should be taken into account, and how. It is worth noting that both the CME (art. 2[2]) and the Oviedo
p.000117: Convention (art.
p.000117: 9) stipulate so though failing to specify the ensuing legal effects (see below). Finally, there is a wider issue with
p.000117: the consent of minors. The law totally precludes it (art. 12 [2] [b] CME) even when minors are obviously
p.000117: able to exercise control over their health given that other provisions recognize their capacity to enter into
p.000117: legal relationships (e.g. to marry). At issue here is whether the scope of this provision should be
p.000117: interpreted stricto sensu to apply only when the intellectual immaturity of the minor obviously justifies that the
...

p.000125: which supported the allegations of some parents about side effects proved fallacious; in fact, it contained
p.000125: fabricated data. The slump in participation rates, however, led to the loss of the so-called indirect or herd
p.000125: immunity causing an important increase in measles cases before confidence in the vaccine was restored and broad
p.000125: par- ticipation resumed (Jansen et al., 2003).
p.000125: Whereas in case of tested vaccines, the decision to abstain is not ethical- ly neutral, the example of new and
p.000125: insufficiently tested vaccines is different. The experience of mass vaccination against swine influenza in the
p.000125: US in 1976 illustrates the risks inherent in a reckless decision for extended vac- cination based on
p.000125: unfounded, as it proved, fears of a pandemics, and with inadequately tested vaccines at that. While the influenza
p.000125: claimed only one victim, the side effects from the vaccine caused 25 casualties and may have led to permanent damage
p.000125: (it was associated with the auto-immune syn- drome of Guillain-Barré). Such examples justify the reluctance to
p.000125: participate and the ethical duty to society as a whole cannot remain as strong if weighed against an
p.000125: increased likelihood of unknown side-effects from the vaccine.
p.000125:
p.000125: 5. Patients in hospitals - The case of ICUs
p.000125:
p.000125: Implementing the model of consent in hospitals is met with certain limits to patient autonomy.
p.000125: First of all, the hospitalized patient is situated in a public environment which does not allow full freedom
p.000125: of movement, expression and communi- cation while drastically restricting privacy and family life. In these
p.000125: circum-
p.000125:
p.000125:
p.000126: 126
p.000126:
p.000126: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000126: REPORT
p.000126:
p.000126: stances, patients are particularly vulnerable. Especially in the ICU, these re- strictions are much more
p.000126: encroaching; moreover, patients are under psy- chological stress due to their critical condition. Taking into
p.000126: account that the potential for a sober appraisal of the situation by the patient -and in exten- sion, for a rational
p.000126: decision on the course of treatment- is significantly cur- tailed by the hospital environment, the role of the medical
p.000126: and nursing staff becomes even more decisive.
p.000126: Hospitalized patients, however, even patients in the ICU, are usually ca- pable to give an informed consent. This means
p.000126: that physicians remain fully liable for allowing patients to participate in the course of the particular
p.000126: treatment and may not legitimately act alone. In conditions of “internment”
p.000126: -especially in ICUs- the risks of manipulation of the patient’s will by the phy- sician are increased. Patients can be
p.000126: easily forced into accepting things for they are understandably eager to have their health restored as soon as pos-
...

p.000131: opinion between physicians and pa- tients were identified and discussed in the previous chapters. Primary
p.000131: among them are the lack of appropriate training for physicians and the lack of time. It is important to look for
p.000131: practical solutions to implement respect for patient autonomy in practice not only as a value in itself but also as a
p.000131: safety valve for the efficiency of health services.
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000132: 132
p.000132:
p.000132: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000132: REPORT
p.000132:
p.000132: SUGGESTED LITERATURE
p.000132:
p.000132: Androulidaki-Demetriadi I (1993). The duty to inform the patient. A contri- bution to the assessment of civil
p.000132: medical liability. Eds. Sakkoulas, Athens- Komotini.
p.000132: Asveld L (2008). Mass-vaccination programmes and the value of respect for autonomy. Bioethics 22, 245-257.
p.000132: Blackhall LJ, Murphy ST, Frank G, Michel V, Azen S (1995). Ethnicity and atti- tudes toward patient autonomy. Jama
p.000132: Journal of the American Medical As- sociation 274, 820-825.
p.000132: Brokalaki EI, Sotiropoulos GC, Tsaras K, Brokalaki H (2005). Awareness of diagnosis, and information-seeking
p.000132: behavior of hospitalized cancer patients in Greece. Supportive Care in Cancer 13, 938-942.
p.000132: Dosios T, Markopoulos C, Vlahos I and Latsios P (1986). The views of Greek physicians on whether cancer patients should
p.000132: know of their illness. Medical Review of the Armed Forces 20, 9-315.
p.000132: Elian M and Dean G (1985). To tell or not to tell the diagnosis of multiple- sclerosis. Lancet 2, 27-28.
p.000132: Elliot C (2001). Patients doubtfully capable or incapable of consent. In Kuhse, H and Singer PA (Eds.). A
p.000132: Companion to Bioethics. Blackwell, Oxford, pp. 452.
p.000132: Erde EL, Nadal EC, Scholl TO (1988). On truth telling and the diagnosis of Alzheimers disease. Journal of
p.000132: Family Practice 26, 401-406.
p.000132: Fountedaki K (2003). Civil Medical Liability. General introduction - Issues of doctrine and legal policy -
p.000132: Fundamental concepts. Eds. Sakkoulas, Athens- Thessaloniki.
p.000132: Hartzband P and Groopman J (2009). Keeping the patient in the equation- humanism and health care reform. N Engl J Med
p.000132: 361, 554-555.
p.000132: Hebert PC, Hoffmaster B, Glass KC, Singer PA (1997). Bioethics for clinicians.
p.000132: 7. Truth telling. Canadian Medical Association Journal 156, 225-228.
p.000132:
p.000132:
p.000133: 133
p.000133:
p.000133: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000133: REPORT
p.000133:
p.000133: Higgs R (2001). Truth-Telling. In Kuhse H, Singer PA (Eds.), A Companion to Bioethics. Blackwell, Oxford, pp. 432.
...

p.000141: choice in competent international and supra-national fora.
p.000141:
p.000141: c) Treatment
p.000141: The treatment of those infected should also be based on informed con- sent. Forced treatment is not justified in
p.000141: principle, except in “emergency situations”.
p.000141: When the number of medical and nursing staff or the available treat- ments do not suffice to ensure care to
p.000141: all those infected (especially in case an infection spreads rapidly) the Commission stresses that the government must
p.000141: establish in advance general priority rules for access to treatment. The basic priority criteria should preferably be
p.000141: prescribed by law. By way of indi- cation, such priority criteria may include the severity of symptoms, the age of the
p.000141: patient and the definition of relevant vulnerable groups.
p.000141:
p.000141: 2. Limits to autonomy on public health grounds
p.000141:
p.000141: a) General rule
p.000141: Limits to the general autonomy of patients -especially the freedom of movement and establishment- are
p.000141: justified only if they are absolutely in- dispensable to protect public health pursuant to the Constitution
p.000141: (arts. 5 [4], 25 [1]). The principle of proportionality as discussed above applies in all circumstances. For
p.000141: example, hospitalized patients should be restricted in specially contained facilities.
p.000141:
p.000141: b) The risk of social stigma
p.000141: The Commission stresses the risk of social stigma that may arise from the isolation (“ghetto-ing”) of specific
p.000141: sub-populations with distinctive cultural characteristics or ways of living when an infectious disease erupts
p.000141: within such groups.
p.000141:
p.000141:
p.000141:
p.000141:
p.000142: 142
p.000142:
p.000142: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000142: OPINION
p.000142:
p.000142: Such cases must be dealt with by personalized medical care and social welfare measures especially as
p.000142: regards the improvement of hygiene in their living conditions.
p.000142:
p.000142: c) Illegal immigrants
p.000142: In case of manifestation of infectious disease or in cases when preven- tive measures (e.g. vaccination) need to
p.000142: be applied on illegal immigrants, the government must ensure that immigrants would be addressed to the
...

Searching for indicator hospitalizedXpatients:

(return to top)
p.000125: (it was associated with the auto-immune syn- drome of Guillain-Barré). Such examples justify the reluctance to
p.000125: participate and the ethical duty to society as a whole cannot remain as strong if weighed against an
p.000125: increased likelihood of unknown side-effects from the vaccine.
p.000125:
p.000125: 5. Patients in hospitals - The case of ICUs
p.000125:
p.000125: Implementing the model of consent in hospitals is met with certain limits to patient autonomy.
p.000125: First of all, the hospitalized patient is situated in a public environment which does not allow full freedom
p.000125: of movement, expression and communi- cation while drastically restricting privacy and family life. In these
p.000125: circum-
p.000125:
p.000125:
p.000126: 126
p.000126:
p.000126: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000126: REPORT
p.000126:
p.000126: stances, patients are particularly vulnerable. Especially in the ICU, these re- strictions are much more
p.000126: encroaching; moreover, patients are under psy- chological stress due to their critical condition. Taking into
p.000126: account that the potential for a sober appraisal of the situation by the patient -and in exten- sion, for a rational
p.000126: decision on the course of treatment- is significantly cur- tailed by the hospital environment, the role of the medical
p.000126: and nursing staff becomes even more decisive.
p.000126: Hospitalized patients, however, even patients in the ICU, are usually ca- pable to give an informed consent. This means
p.000126: that physicians remain fully liable for allowing patients to participate in the course of the particular
p.000126: treatment and may not legitimately act alone. In conditions of “internment”
p.000126: -especially in ICUs- the risks of manipulation of the patient’s will by the phy- sician are increased. Patients can be
p.000126: easily forced into accepting things for they are understandably eager to have their health restored as soon as pos-
p.000126: sible in order to return to the freedom of everyday life and recover the full exercise of their autonomy.
p.000126: At this point we must underline that physicians have a heightened ethi- cal duty to provide complete information.
p.000126: The more comprehensive the information, the greater the likelihood for an independent appraisal of the situation
p.000126: -and decision-making- by a de facto vulnerable will. By contrast, limited information can more easily lead to
p.000126: manipulation of the patient by the physician since the patient is called upon to evaluate and decide in an unfamiliar
p.000126: environment of internment, more prone to “blind obedience” rather than genuine exercise of autonomy.
p.000126:
p.000126: 6. Incapacity to consent
p.000126:
...

Health / ill

Searching for indicator ill:

(return to top)
p.000118:
p.000118:
p.000118:
p.000118:
p.000118: 7 This broad concept of fault is upheld today in Germany, France and the US, see Fountedakis (2003) p.
p.000118: 210-211 who accepts the distinction between “medical error” and “information error” (p. 216).
p.000118: 8 The preferred criterion for the assessment of prior information in the context of medical liability is
p.000118: the “average rational person”, see Androulidakis-Dimitriades (1993) p. 273. Typical in the case-law is the case
p.000118: Canterbury v. Spence. (464 F.2d 772 [D.C. Cir. 1972]) which changed the initial approach of American tribunals.
p.000118:
p.000119: 119
p.000119:
p.000119: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000119: REPORT
p.000119:
p.000119: 1. Extent of information
p.000119:
p.000119: As mentioned earlier, our national legislation (CME) requires informed consent prior to every medical act
p.000119: unless patients refuse the information by exercising their right not to know. But patient information is not limited to
p.000119: those cases where patients need to consent to a medical act. It also includes the patient’s right to know the
p.000119: state of his/her condition to the extent he/she so wishes. This knowledge will eventually help patients to make
p.000119: all sorts of decisions about their lives and satisfy their need for sound medical information on their condition,
p.000119: regardless of whether they will use this in- formation to make medical decisions.
p.000119: What is the usual practice, however? Do physicians actually inform will- ing patients on their condition, and the
p.000119: diagnosis and prognosis of their ill- ness? Are patients willing to be informed, even when the diagnosis is about a
p.000119: serious, or even incurable, disease or do they rather not know? Is it ac- ceptable that physicians
p.000119: inform the relatives first and then the patient? What is appropriate information in terms of its content
p.000119: and the way it is imparted and how well trained are physicians and nurses to convey this in- formation to those
p.000119: concerned?
p.000119: These questions do not always have easy answers and have being debat- ed for years by physicians, philosophers,
p.000119: jurists, sociologists and other ex- perts. The “best” answers -as will become evident below- often vary accord- ing
p.000119: to the particular conditions of countries, the cultural traditions of social groups within the same country and the
p.000119: personality, age, gender and educa- tion of patients themselves.
p.000119: There is plenty of international literature both on what patients want and on the perceptions of the
p.000119: medical community on honesty and infor- mation (review by Herbert et al., 1997; Tuckett, 2004). This
p.000119: literature is based on research conducted on different severe or incurable diseases in various countries,
p.000119: age groups and nationalities. The most frequently used example is the attitude of patients and physicians to
p.000119: disclosure of diagnosis in case of cancer. Other entities have also been investigated like Alzheimer’s and multiple
p.000119: sclerosis.
p.000119:
p.000119:
p.000119:
p.000119:
p.000119:
p.000120: 120
p.000120:
...

p.000127: control over one’s health.
p.000127: In the case of minors, it would be more appropriate to recognize their capacity for self-consent after a certain
p.000127: age (thus precluding consent by the minor’s legal representatives) for there is an objective presumption of suffi-
p.000127: cient maturity in contemporary societal life that can hardly be put in ques- tion (e.g. from the age 15 years).
p.000127: Meanwhile the assent of minors must be given considerable weight in relevant decisions, especially if coinciding with
p.000127: the physician’s advice, even when the parents disagree.
p.000127: For adults, it is difficult to assume a similar objective presumption. Therefore, the view of the concerned
p.000127: person must be given particular atten- tion (as must the appropriateness of prior information) and evaluated on a
p.000127: case-by-case basis although the power of legal representatives to decide cannot be questioned.
p.000127: The problem of advance directives is a much harder nut to crack. The event of becoming incompetent to
p.000127: consent often leads people to issue di- rections on how they wish to be treated ahead of time. These directions are
p.000127: usually addressed to close relatives or close friends, or even to the physi- cian, if one is already ill.
p.000127: They are usually informal (oral and eventually with no witnesses) but some countries have provided a modality to
p.000127: safeguard the validity of their will (“living wills”). Usually, these directions are about the refusal of
p.000127: certain unpleasant or painful treatments (e.g. haemodialysis, car-
p.000127:
p.000127: decisions by patients capable to consent and on the mental faculties, which are criti- cal for consent (Elliot, 2001).
p.000127:
p.000128: 128
p.000128:
p.000128: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000128: REPORT
p.000128:
p.000128: diopulmonary resuscitation)11 or even the interruption of artificial life sup- port (e.g. refusal of feeding,
p.000128: hydration, etc.)12.
p.000128: Bearing in mind the fact that the law in our country is ambiguous13 the question is what happens when a physician is
p.000128: aware of such directions and the legal representatives of the patient, who by law are responsible to give their
p.000128: consent, disagree.
p.000128: In ethical terms, it is certain that these directions must, in principle, be communicated to the patient’s relatives in
p.000128: the context of prior information to them. If they still disagree after that, again the physician may not wholly
p.000128: disregard the patient’s wishes. For insofar as there is a presumed authentic manifestation of the patient’s autonomy -
p.000128: even if expressed ahead of time - the “substitute” consent of the patient’s legal representatives appears weak.
...

Health / patients in emergency situations

Searching for indicator emergencies:

(return to top)
p.000122: sure to relatives may isolate the sufferer from his/her surroundings.
p.000122: The opposite, however, can also be argued: that in some cases complete information may be detrimental to certain
p.000122: patients and have a negative psy- chological and physical impact. A compromise between these contradictions can be
p.000122: reached if we admit that there is no single “correct” approach to the issue of honesty but every patient must be dealt
p.000122: with according to his/her needs. To meet this goal, it is important to dedicate time to the develop- ment
p.000122: of a relationship of communication between the physician and the patient such that the former will understand
p.000122: the needs of the latter and the patient will feel free to express his/her wishes. Appropriate training on
p.000122: communication with patients and on ways to announce an ominous diagno- sis is equally important for an efficient
p.000122: physician-patient relationship. The lack of such training is stressed by many Greek authors who have investigat- ed
p.000122: honesty and patient information (Mystakidou et al., 1996; Rigatos, 1997).
p.000122:
p.000122:
p.000123: 123
p.000123:
p.000123: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000123: REPORT
p.000123:
p.000123: 2. The problem of time
p.000123:
p.000123: According to a frequent argument, it is difficult to implement the model of consent in the limited time available
p.000123: to case management. Experience shows that this time shortage is due either to the nature of the case itself
p.000123: (“emergencies”) or to the inadequate organization of health services espe- cially when faced with occasional peaks of
p.000123: demand.
p.000123: It is worth noting that, in the first case, it is generally admitted -and ex- pressly stipulated by the law- that
p.000123: physicians may act alone, namely “in- formed consent” does not apply. The notion of “emergency” is very broad and
p.000123: needs to be further specified. Assuming that its use must be regarded as exceptional, its scope is limited to: i)
p.000123: cases posing an immediate threat against the patient’s life, or, ii) cases where even the slightest delay in
p.000123: ef- fecting the indicated medical act will definitely cause serious harm to health. Thus, moderate harm to health, even
p.000123: when demanding immediate action, or serious but chronic pathological conditions (e.g. many forms of cancer, dia- betes,
p.000123: etc.) cannot qualify as “emergencies”. In-between these two ex- tremes, there is an area in which the
p.000123: rule of consent must apply with the necessary adjustments to the available margins of time9.
p.000123: As far as inadequate organization of health services is concerned, the possibility to allocate the required
p.000123: time depends mostly on objective, often non-elastic, parameters (e.g. restricted resources to employ additional med-
p.000123: ical staff). Especially here, however, the issue of appropriate training and sensitization of civil health
p.000123: services to patient autonomy is crucial. For, if patient consent is not to be considered a “luxury” but an
p.000123: essential condition for the protection of health and, ultimately, for quality of life, then this re- quirement
p.000123: obviously affects the priorities of the organization of services in a way that makes finding the required time
p.000123: feasible.
p.000123:
p.000123: 3. Education - Training
p.000123:
p.000123: Among the reasons invoked by physicians to justify the concealment of diagnosis from their patients in Greece, as well
p.000123: as in other countries which
p.000123:
p.000123: 9 However, for a discussion on whether summary information provided to a patient capable to consent qualifies as
p.000123: “appropriate” in emergency circumstances see also Young, 2001.
p.000123:
p.000124: 124
p.000124:
...

p.000149: The health of others being directly at
p.000149:
p.000149:
p.000150: 150
p.000150:
p.000150: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000150: REPORT
p.000150:
p.000150: stake, the freedom to deny treatment does not enjoy the ethical justifica- tion acknowledged in different
p.000150: circumstances.
p.000150: Hence, forced treatment or prevention (e.g. mandatory vaccination) may be considered as option, especially if this is
p.000150: the only way to restore the gen- eral autonomy of the affected person (the subject of restrictions).
p.000150: The same can be argued about the extent of (personal) information and the availability of alternative treatments which
p.000150: are also limited by the emer- gency and time constraints of an epidemic.
p.000150: One may object that forced treatment is not the only option when a pa- tient denies therapy. Besides, insofar as it
p.000150: involves a direct intervention on the latter’s body, its compatibility with the respect for human value is ques-
p.000150: tionable, given that the affected person is used as a common “means” to protect society. The alternative
p.000150: -should this objection be sustained- would be to impose other restrictions to protect others, e.g. limits to the
p.000150: freedom of circulation and installation, not involving forced treatment. A solution more compatible with
p.000150: autonomy in view of the above would be to leave the choice of preferred option to the one concerned.
p.000150: At any rate, with the exception of emergencies which leave no time for government intervention -in which case it is
p.000150: ethically justified to leave the initiative to physicians- autonomy does not evaporate before public interest.
p.000150: Particularly in case of mild diseases or hard to transmit diseases, the obliga- tion to respect autonomy remains fully
p.000150: effective.
p.000150:
p.000150: 3. Scope of medical duty
p.000150:
p.000150: When public health is at risk from a contagious disease, objective pa- rameters -time, in particular- often
p.000150: prevent the unhindered practice of med- icine. In such cases, physicians must set health care priorities,
p.000150: which may result in depriving certain people from care. The availability of physicians is obviously an external sine
p.000150: qua non for exercising patient autonomy.
p.000150: The necessities of war can offer a precedent for such prioritization. Since World War I, a three-fold division of the
p.000150: population in terms of priority (“tri- age”), based on the probability of cure is generally accepted: those
p.000150: in im- mediate need of help come first; next follow those who can be transported to a hospital even if more seriously
p.000150: hurt, and last are those with minor inju- ries or few chances of survival. But one may think of other
p.000150: considerations
p.000150:
p.000150:
p.000151: 151
p.000151:
p.000151: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
...

Health / stem cells

Searching for indicator stem cells:

(return to top)
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000038: 38
p.000038:
p.000038:
p.000038:
p.000038:
p.000038:
p.000002: 2
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000002:
p.000002:
p.000002:
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p.000002:
p.000002:
p.000039: 39
p.000039:
p.000039:
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p.000040: 40
p.000040:
p.000040: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000040: OPINION
p.000040:
p.000040: O P I N I O N
p.000040:
p.000040: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000040:
p.000040: The National Bioethics Commission has considered the issue of the re- spect of moral values by
p.000040: contemporary biological research in repeated meetings. In several of its earlier opinions the Commission
p.000040: dealt with the issue of ethics in specific research areas (stem cells, clinical trials, use of an- imals in research)
p.000040: identifying the serious implications of the development of biological applications on the values of modern society. The
p.000040: present opinion emphasizes a dimension that cuts across all fields of biological research: the ethics of “procedure” of
p.000040: research.
p.000040: The Commission believes that this dimension is crucial and requires con- sideration both by the scientific community
p.000040: and by the authorities, in par- ticular in the light of the implementation of the new national legal frame- work for
p.000040: research (Law 3653/2008).
p.000040:
p.000040: I. General remarks
p.000040:
p.000040: A. Identifying the issues
p.000040:
p.000040: Generally speaking, the terms and conditions of contemporary research are significantly different from the past. The
p.000040: main characteristics of research during the last decades are the following: a) it is conducted by research
p.000040: teams in large-scale facilities and international networks of co-operation and b) it is closely linked to the
p.000040: economy.
p.000040: 1. Nowadays research does not rely on the individual activity of isolated scientists. The production of new knowledge
p.000040: requires complex organization and co-ordination of collective effort, a research environment that ensures high quality
p.000040: infrastructure and the corresponding funds as well as interna- tional co-operation.
p.000040: 2. Modern economy is particularly interested in innovation; therefore, it is closely connected to research, especially
p.000040: in the area of new technologies. As a result research is usually orientated to the market, it becomes familiar with the
...

p.000056: embryos or in biological material) en- dangers fundamental rights (privacy, personal data, health) and
p.000056: general principles (human value, equality). Research in other species (e.g. biotech- nology) is connected with
p.000056: environmental protection, public health, even the respect we owe to these species (e.g. lab animals, rare species).
p.000056: When such interests are put at risk it becomes all the more indispensa- ble to ensure credibility and to comply with
p.000056: research ethics in both the aims and the methods used.
p.000056:
p.000056: Issues of ethics in biological research
p.000056:
p.000056: As mentioned above, the basic criteria of assessment of biological re- search are publications,
p.000056: co-operation between scientists and scientific teams and adequate funding. The urge to publish and to raise
p.000056: funds, in par- ticular, has occasionally led to misconduct and fraud. In addition, the use of research findings in
p.000056: policy-making is a source of pressure on researchers from sponsors or other players with vested interests.
p.000056: The publication of research findings is necessary to diffuse knowledge. However, the pressure exerted on
p.000056: researchers for more and more publica- tions in highly respected journals can lead to unethical misconduct that has
p.000056: gone as far as fabricating the results. A recent case of fraud that hit the headlines was a publication
p.000056: by the Korean Woo Suk Hwang and co-workers in Science on the alleged successful cloning of human stem cells. This
p.000056: publi- cation made Hwang quite famous and, had the fraud not been revealed, he would certainly have been rocketed
p.000056: to summits of professional celebrity. This case exemplified issues of ethics and review of the validity of research
p.000056: results as well as the inextricable link between ethics and the quality of sci- entific research (Resnik et al., 2006).
p.000056: Not only is private financing seen as welcome but the increase of private funding figures among the goals of most
p.000056: national policies for research and technology worldwide (European Commission, 2007a). It has promoted pro- gress in
p.000056: science and technology and has often made up for the inability of the state to provide adequate funds to all scientific
p.000056: fields. The decoding of
p.000056:
p.000056:
p.000057: 57
p.000057:
p.000057: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000057: REPORT
p.000057:
p.000057: the human genome, for instance, was made possible by a partnership of private and public bodies.
p.000057: The source of financing, however, can affect the validity of research find- ings especially if the sponsor has a
p.000057: vested interest in the outcome of the research. One example is clinical trials financed by pharmaceutical compa-
p.000057: nies. It has been reported that trials of new drugs used in oncology and fi- nanced by the pharmaceutical company which
p.000057: is going to produce the drugs are eight times more likely not to reach negative results compared to inde- pendently
p.000057: funded trials (Friedberg et al., 1999). Similar cases of manipulated research have been reported in other clinical and
...

p.000234:
p.000234:
p.000234:
p.000234:
p.000235: 235
p.000235:
p.000235: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT REPORT
p.000235:
p.000235: Table I. Interventions applied to both treatment and human enhancement.
p.000235:
p.000235: Treatment Human enhancement Pharmaceutical substances
p.000235:
p.000235: Growth hormone Developmental problems in
p.000235: children
p.000235: Enhancing appearance Enhancing athletic performance
p.000235: Insulin growth factor Muscular dystrophy Increasing muscle mass Enhancing athletic
p.000235: performance
p.000235:
p.000235: Rimonabant and sibutramine
p.000235: Obesity Enhancing appearance Increase strength in patients
p.000235:
p.000235: Erythropoietin
p.000235: undergoing chemotherapy and present with anemia
p.000235: Enhancing athletic performance
p.000235: Modafinil Sleep disorders e.g. narcolepsy Enhancing attention, vigilance,
p.000235: memory
p.000235:
p.000235: Ritalin Attention Deficit Hyperactivity Disorder
p.000235:
p.000235: Prozac Antidepressant
p.000235: Enhancing concentration Enhancing emotions
p.000235: Reducing social characteristics e.g. shame
p.000235: Sildenafil (Viagra) Erectile dysfunction Enhancing sexual ability, stamina
p.000235: Techniques of genetic intervention
p.000235:
p.000235: Genetic testing (in various genes)
p.000235:
p.000235: In somatic cells
p.000235:
p.000235:
p.000235: In gametes
p.000235: Disease diagnosis Disease prevention Effective treatment Stem cell treatment
p.000235: StemXcells to generate tissue and organs
p.000235: Correcting or avoiding abnormal genes
p.000235: Avoiding sex-linked diseases
p.000235: Increasing life expectancy Selection of “better children” Enhancing athletic performance
p.000235:
p.000235: Increasing life expectancy
p.000235:
p.000235: Enhancing non-pathological genes Enhancing skills, stamina, intelligence, memory, metabolism, etc.
p.000235: Regenerative medicine
p.000235:
p.000235:
p.000235: Tissue/organ regeneration
p.000235: Restoration of organ function Restoration of sports injuries
p.000235: Increasing life expectancy Enhancing athletic performance
p.000235:
p.000235:
p.000235: Platelet rich plasma
p.000235: Scar repair after accidents or burns Enhancing appearance
p.000235: Restoration of anterior cruciate
p.000235:
p.000235: (gel)
p.000235: Restoration of joints with
p.000235: osteoarthritis
p.000235: Enhancing athletic performance
p.000235:
p.000235:
p.000235:
p.000235:
p.000235:
p.000236: 236
p.000236:
p.000236: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT REPORT
p.000236:
p.000236: Table I (continued). Interventions applied to both treatment and human enhancement.
p.000236:
p.000236: Treatment Human enhancement Technological interventions
p.000236:
p.000236:
p.000236:
p.000236: Artificial implants
p.000236: Early and accurate diagnosis Effective and targeted drug therapy Restoration of joints, organs
p.000236:
p.000236: Enhancing athletic performance Increasing life expectancy
p.000236:
p.000236:
p.000236:
p.000236: Implants - sensors
p.000236:
p.000236:
p.000236:
p.000236: Brain implants
p.000236: Diagnosis and treatment of diseases
...

Health / substance use

Searching for indicator substance use:

(return to top)
p.000282: opportunities offered in competitive environments (Farah et al., 423) and, secondly, with improvement
p.000282: of our lifestyle. This is an issue of concern which is similar to that of enhancing physical abilities
p.000282: (e.g. doping in sports).
p.000282: Here, enhancement is usually associated with memory or concentration, especially during challenges in education or
p.000282: work. The general principle that wants to prevent distortion of rivalry is valid here, but it constitutes a
p.000282: “defensive” attitude. Equal access means, mainly, that anyone who desires it is able to use substances, under the two
p.000282: reservations mentioned above.
p.000282: An objection here would be that equal access does not exist anyway, regarding the conventional ways to
p.000282: enhance cognitive performance, namely through education or training. Pupils, students or employees have strongly
p.000282: differentiated possibilities of access to adequate education, mainly because of the economic inequality, which
p.000282: significantly affects their opportunities. Generally, equal opportunities presuppose equality to
p.000282: material means, which is practically impossible.
p.000282: On the other hand, one could argue that substance use may be an option to restore the general inequality of access to
p.000282: conventional means. Thus, for example, a student with artificially enhanced memory capacity and
p.000282: concentration could cover gaps with his/her own effort, gaps that his/her socially and economically
p.000282: “'privileged'” classmates cover with expensive teaching methods. The same applies to an employee who is a candidate
p.000282: for a better position, and objectively cannot devote the same time to study compared to a well-trained
p.000282: new candidate for the same position. Nevertheless, this argument would not be convincing. For the reason
p.000282: that, on the one hand, one cannot prevent the use of substances by “privileged” people and therefore restoring
p.000282: inequality, and on the other hand, one would encourage the easy, but temporary, way of going
p.000282: through meritocratic procedures instead of constantly trying to cultivate cognitive abilities (Farah et al.,
p.000282: 424). In fact, the concern of doping in sports applies here as well.
p.000282: In general, one must not overlook that -at least with the current data- the use of enhancement substances
p.000282: has temporary effects and does not
p.000282:
p.000282:
p.000283: 283
p.000283:
p.000283: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000283: REPORT
p.000283:
p.000283: replace the solid acquisition of knowledge through education. But overall, the use of such substances
p.000283: that aim to obtain cognitive balance or psychological well-being appears at present as an
p.000283: easy substitute for education. In a sense, one could consider that the emergence of this alternative
p.000283: choice is a failure of the educational and cultural mission of the State, and a substitute for fundamental
p.000283: deficiencies. Therefore, the issue constitutes a motivation for reflection on the wider environment that forms a
p.000283: personality. Persistence on the actions that change this environment - particularly in the areas of
p.000283: education (including continuous effort for real equality in opportunities) and culture- seems to acquire a
p.000283: timely, moral significance so that enhancement substances will stop being an option.
p.000283:
p.000283: ΙΙΙ. The law
p.000283:
p.000283: In terms of law, the general framework for dealing with enhancement of cognitive and mental characteristics does not
p.000283: differ from that of enhancing physical characteristics. On one hand, the constitutional provisions for the
p.000283: development of a personality (Art. 5 § 1) and the right to health (Art. 5 § 5) (in view of which, substance use for
p.000283: enhancement purposes is, in principle, permissible) and on the other hand, the protection of health (Art. 21
p.000283: § 3) (which highlights the responsibility of the state in controlling the use of substances or implants
p.000283: that are not intended for therapeutic purposes) are essential here.
p.000283: The EU legislation on the use of implants (Directive 93/42, incorporated with JMD DY8d/GP. Oik.130648/2.10.2009,
p.000283: Directive 90/385, incorporated by JMD DY8d/GP. Oik.130644/2.10.2009) and the Regulation 726/2004, regarding
p.000283: the centralized authorization procedure of substances at the EU level (STOA, 136) also apply here.
p.000283: In a more specific level, the use of the above mentioned substances or implants is subjected to the provisions of Law
p.000283: 3418/2005 (Code of Medical Ethics), regarding the responsibility of the physician who gives the
p.000283: prescription. There is no doubt that the physician performs a medical act, which is covered by the
p.000283: provisions of CME (equivalent to aesthetic surgery), although enhancement is not explicitly mentioned in
p.000283: the legislative definition of “medical act”.
p.000283: In addition, the legislation on the liability of physicians, pharmacists and
p.000283:
p.000283:
p.000284: 284
p.000284:
p.000284: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000284: REPORT
p.000284:
p.000284: traders, which is controlled by the National Organization for Medicines (Directive 2001/1983, as
p.000284: incorporated by DYG 3a/83657/24.1.2006, Law 1316/83, as in force, Decree 96/1973, as in force) also apply here,
...

Health / visual impairment

Searching for indicator blind:

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p.000126: account that the potential for a sober appraisal of the situation by the patient -and in exten- sion, for a rational
p.000126: decision on the course of treatment- is significantly cur- tailed by the hospital environment, the role of the medical
p.000126: and nursing staff becomes even more decisive.
p.000126: Hospitalized patients, however, even patients in the ICU, are usually ca- pable to give an informed consent. This means
p.000126: that physicians remain fully liable for allowing patients to participate in the course of the particular
p.000126: treatment and may not legitimately act alone. In conditions of “internment”
p.000126: -especially in ICUs- the risks of manipulation of the patient’s will by the phy- sician are increased. Patients can be
p.000126: easily forced into accepting things for they are understandably eager to have their health restored as soon as pos-
p.000126: sible in order to return to the freedom of everyday life and recover the full exercise of their autonomy.
p.000126: At this point we must underline that physicians have a heightened ethi- cal duty to provide complete information.
p.000126: The more comprehensive the information, the greater the likelihood for an independent appraisal of the situation
p.000126: -and decision-making- by a de facto vulnerable will. By contrast, limited information can more easily lead to
p.000126: manipulation of the patient by the physician since the patient is called upon to evaluate and decide in an unfamiliar
p.000126: environment of internment, more prone to “blind obedience” rather than genuine exercise of autonomy.
p.000126:
p.000126: 6. Incapacity to consent
p.000126:
p.000126: The legal capacity to consent must be distinguished from the corre- sponding physical capacity. Patients
p.000126: with full legal competence to consent may suffer a temporary disorder of their mental functions which
p.000126: prevents the forming and expression of free will (e.g. under the influence of alcohol or narcotics or in state of
p.000126: shock because of an accident or the announce- ment of a serious disease, etc.)10.
p.000126:
p.000126:
p.000126: 10 This is a case for the application of art. 131 CC which stipulates the nullity of ex- pression of will in such
p.000126: circumstances. See generally on the problem of “irrational”
p.000126:
p.000127: 127
p.000127:
p.000127: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000127: REPORT
p.000127:
p.000127: In these circumstances acting alone is again not justified for physicians except in emergency situations. They must
p.000127: concentrate their efforts on the speedy recovery of the patient’s mental lucidity so that the patient can be informed
p.000127: in time and decide about treatment by himself/herself. Besides, it is not legitimate to substitute the patient’s
...

p.000275: narcolepsy. However, studies in healthy subjects showed that Modafinil improves memory10, as well as the levels
p.000275: of wakefulness and alertness in physicians11 and pilots12, making
p.000275:
p.000275: 6Warburton DM (1992). Nicotine as a cognitive enhancer. Progress in Neuro- Psychopharmacology and
p.000275: Biological Psychiatry, 16, 181-191.
p.000275: 7Newhouse PA, Potter A & Singh A (2004). Effects of nicotinic stimulation on cognitive performance. Current Opinion in
p.000275: Pharmacology, 4, 36-46.
p.000275: 8Teter CJ, McCabe SE, Boyd CJ, Guthrie SK (2003). Illicit methylphenidate use in an undergraduate student
p.000275: sample: Prevalence and risk factors. Pharmacotherapy 23, 609-17.
p.000275: 9McCabe SE, Teter CJ, Boyd CJ (2006). Medical use, illicit use and diversion of pre- scription stimulant
p.000275: medication. J Psychoactive Drugs 38, 43-56.
p.000275: 10Müller U, Steffenhagen N, Regenthal R, Bublak P (2004). Effects of modafinil on working memory processes
p.000275: in humans. Psychopharmacology (Berl) 177, 161-9.
p.000275: 11Gill M, Haerich P, Westcott K, et al., (2006). Cognitive performance following modafinil versus placebo
p.000275: in sleep-deprived emergency physicians: A double-blind randomized crossover study. Acad Emerg Med 13, 158-65.
p.000275: 12Caldwell JA Jr, Caldwell JL, Smythe NK 3rd, Hall KK (2000). A double-blind, placebo- controlled investigation of the
p.000275: efficacy of modafinil for sustaining the alertness and
p.000275:
p.000276: 276
p.000276:
p.000276: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000276: REPORT
p.000276:
p.000276: modafinil a substance capable of enhancing cognitive functions in humans.
p.000276:
p.000276: b. Enhancement of mental characteristics and mood
p.000276:
p.000276: At this point, it would be impossible not to mention other pharmaceutical substances,
p.000276: the use of which aims to relieve from phobias and addictions, and could well be used to improve mental
p.000276: characteristics. Illustrative examples are propranolol, which seems to have a preventive effect on
p.000276: post-traumatic stress13 and D-cycloserine, which reduces fear in individuals with phobias14and social anxiety
p.000276: disorder15.
p.000276: Finally, mood enhancers used to enhance a person’s mood, are an issue of concern. Selective Serotonin Reuptake
p.000276: Inhibitors (SSRIs), such as Prozac, Zoloft and other antidepressants are administered in mood and anxiety
p.000276: disorders. In his book “Listening to Prozac” the psychiatrist Peter Kramer reports discussions that he
p.000276: had with patients but also with people not suffering from depression, who all used Prozac to enhance their
p.000276: confidence and self-esteem and felt “better” and “socially more attractive”16. Nevertheless,
p.000276: consequent reviews of the book focused mainly on the subjectivity of diagnosing the symptoms and the
...

p.000285: movement? A mini review. Front Hum Neurosci 8, 124.
p.000285: Andersen R (2012). Why cognitive enhancement is in your future (and your past). The Atlantic.
p.000285: Bostrom N, Sandberg A (2009). Cognitive enhancement: Methods, ethics, regulatory challenges. Sci Eng Ethics 15,
p.000285: 311-41.
p.000285: Cakic V (2009). Smart drugs for cognitive enhancement: Ethical and pragmatic considerations in the
p.000285: era of cosmetic neurology. J Med Ethics 35, 611-615.
p.000285: de Jongh R, Bolt I, Schermer M, Olivier B (2008). Botox for the brain: En- hancement of cognition, mood
p.000285: and pro-social behavior and blunting of un- wanted memories. Neurosci Biobehav Rev, 32, 760-76.
p.000285: European Parliament, Science and Technology Options Assessment (STOA) (2009). Human Enhancement Study, Brussels.
p.000285: Farah MJ, Illes J, Cook-Deegan R, Gardner H, Kandel E, King P, Parens E, Sa- hakian B, Root Wolpe P (2004).
p.000285: Neurocognitive enhancement: What can we do and what should we do? Nature 5, 421-425.
p.000285: Glannon W (2006). Psychopharmacology and memory. J Med Ethics 32, 74- 78.
p.000285: Racine E & Forlini C (2010). Cognitive enhancement, lifestyle choice or misuse of prescription drugs?
p.000285: Ethics blind spots in current debates. Neuroethics, 3, 1-4.
p.000285: Rose, S (2005). “No Way To Treat The Mind” (www.nootropics.com).
p.000285:
p.000285:
p.000285:
p.000285:
p.000285:
p.000285:
p.000285:
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p.000287: 287
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...

Searching for indicator necessities:

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p.000150: tionable, given that the affected person is used as a common “means” to protect society. The alternative
p.000150: -should this objection be sustained- would be to impose other restrictions to protect others, e.g. limits to the
p.000150: freedom of circulation and installation, not involving forced treatment. A solution more compatible with
p.000150: autonomy in view of the above would be to leave the choice of preferred option to the one concerned.
p.000150: At any rate, with the exception of emergencies which leave no time for government intervention -in which case it is
p.000150: ethically justified to leave the initiative to physicians- autonomy does not evaporate before public interest.
p.000150: Particularly in case of mild diseases or hard to transmit diseases, the obliga- tion to respect autonomy remains fully
p.000150: effective.
p.000150:
p.000150: 3. Scope of medical duty
p.000150:
p.000150: When public health is at risk from a contagious disease, objective pa- rameters -time, in particular- often
p.000150: prevent the unhindered practice of med- icine. In such cases, physicians must set health care priorities,
p.000150: which may result in depriving certain people from care. The availability of physicians is obviously an external sine
p.000150: qua non for exercising patient autonomy.
p.000150: The necessities of war can offer a precedent for such prioritization. Since World War I, a three-fold division of the
p.000150: population in terms of priority (“tri- age”), based on the probability of cure is generally accepted: those
p.000150: in im- mediate need of help come first; next follow those who can be transported to a hospital even if more seriously
p.000150: hurt, and last are those with minor inju- ries or few chances of survival. But one may think of other
p.000150: considerations
p.000150:
p.000150:
p.000151: 151
p.000151:
p.000151: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000151: REPORT
p.000151:
p.000151: (e.g. priority to those who will treat others, to the young or the elderly, even a “first come first served” approach).
p.000151: Although “triage” is mostly associated with war (and natural disasters or train derailments) its core concept can be of
p.000151: use also in case of epidemics.
p.000151: At all events, health care priorities must be set by public authorities in advance on the basis of fixed rules in
p.000151: order to prevent physicians from hav- ing to make so many ethically questionable judgments.
p.000151:
p.000151: 4. Special issues: Clinical trials, patents
p.000151:
p.000151: The urgent need for prevention and treatment in times of epidemics painfully illustrates the question of
p.000151: the adverse effects of trials of new treatments (medicines, vaccines) to contain the risk.
p.000151: Given that clinical trials are now subjected to a specific control proce- dure, ensuring the safety of
...

Searching for indicator social welfare:

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p.000141:
p.000141: 2. Limits to autonomy on public health grounds
p.000141:
p.000141: a) General rule
p.000141: Limits to the general autonomy of patients -especially the freedom of movement and establishment- are
p.000141: justified only if they are absolutely in- dispensable to protect public health pursuant to the Constitution
p.000141: (arts. 5 [4], 25 [1]). The principle of proportionality as discussed above applies in all circumstances. For
p.000141: example, hospitalized patients should be restricted in specially contained facilities.
p.000141:
p.000141: b) The risk of social stigma
p.000141: The Commission stresses the risk of social stigma that may arise from the isolation (“ghetto-ing”) of specific
p.000141: sub-populations with distinctive cultural characteristics or ways of living when an infectious disease erupts
p.000141: within such groups.
p.000141:
p.000141:
p.000141:
p.000141:
p.000142: 142
p.000142:
p.000142: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000142: OPINION
p.000142:
p.000142: Such cases must be dealt with by personalized medical care and social welfare measures especially as
p.000142: regards the improvement of hygiene in their living conditions.
p.000142:
p.000142: c) Illegal immigrants
p.000142: In case of manifestation of infectious disease or in cases when preven- tive measures (e.g. vaccination) need to
p.000142: be applied on illegal immigrants, the government must ensure that immigrants would be addressed to the
p.000142: health services. The access of immigrants to health services should be un- hindered and independent on their
p.000142: immigration status; otherwise the risks for public health in general will be multiplied.
p.000142:
p.000142: d) HIV/AIDS
p.000142: This particular disease presents a set of peculiar problems. Even though the spread of the virus is in general
p.000142: relatively difficult, the disease is very severe despite progress in treatment in the recent years. Moreover, social
p.000142: perceptions -especially regarding high risk vulnerable groups- remain ex- tremely negative in our country. The
p.000142: following call for attention:
...

Searching for indicator access:

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p.000009: sickness. The difference, at the moment, of genetic as against medical predisposition markers is that the
p.000009: association between most genetic markers and the probability of disease is not well-documented compared to
p.000009: medical mark- ers.
p.000009:
p.000009: 3. Ethical issues
p.000009:
p.000009: a. Protection of personality and economic freedom
p.000009: In view of the above, the first emerging ethical issue consists in weighing protection of personality for insurance
p.000009: applicants against freedom of busi- ness for insurers.
p.000009: Disclosure of genetic information -similarly to other health-related in- formation- as a requirement for
p.000009: contracting insurance or as a factor in the
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000010: OPINION
p.000010:
p.000010: calculation of premium goes to the core of personality since this information constitutes sensitive personal data.
p.000010: Considering that genetic data is in prin- ciple unchangeable, to reveal a predisposition for a disease may lead to
p.000010: life- long “stigmatization” of the applicant, a serious infringement on personality that may take the form of unfair
p.000010: social discrimination.
p.000010: On the other hand, freedom of business for the insurer is apparently restricted if access to genetic data
p.000010: known to the other party may affect sig- nificantly the insurer’s business risk. In the context of freedom of contract,
p.000010: barring access to information which is relevant to the object of the specific insurance could be seen as unfair to
p.000010: insurers since they are exposed to a risk they ignore whereas the other party is aware (and perhaps takes advantage)
p.000010: of.
p.000010:
p.000010: b. The value of genetic data and the risk of “genetic determinism”
p.000010: Genetic data is a very useful tool in contemporary medicine. In the con- text of personalized medicine and
p.000010: pharmacogenomics, in particular, person- al genetic data is becoming increasingly important for determining
p.000010: thera- peutic treatment. It is therefore of paramount importance that the collec- tion of genetic data,
p.000010: which can contribute to improvement of individual health, is not obstructed for non-medical reasons.
p.000010: The collection of genetic data for research aiming to identify links be- tween diseases and genetic
p.000010: causes with the ultimate goal to identify new treatment targets is crucial for the advancement of science and,
p.000010: in the long run, for the protection of public health. In this case also, it is critical that
p.000010: participation in such research is not discouraged for fear of use of genetic data or of the findings of research to
p.000010: the detriment of participants.
...

p.000026: refuse to underwrite certain conditions.
p.000026: This line of thinking leads to an absolute ban on disclosure of genetic information to insurers and,
p.000026: needless to say, precludes insurers from requir- ing genetic testing as a condition to a life or health insurance
p.000026: contract.
p.000026: From the viewpoint of bioethics, the issue here is whether the economic freedom of the insurer puts the principle of
p.000026: equality at risk for the insured or, seen in the opposite, if concealment of genetic data by the insured cre- ates
p.000026: inequality between the parties in the context of freedom of contract.
p.000026: With regards to the above, it is worth noting the following:
p.000026: a) From the discussion in the first chapter, we concluded that genetic information actually has little
p.000026: predictive value as to the certainty of disease manifestation. It makes a more accurate prediction about the likelihood
p.000026: of disease but, on the other hand, allows preventive measures to limit this like- lihood. The detection of specific
p.000026: mutations in one’s genome that are known to be associated with disease, does not mean, in most cases, that the dis-
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000027: REPORT
p.000027:
p.000027: ease will actually be manifested during the life-span of an individual. The only exception is a number of
p.000027: single-gene diseases (e.g. Huntington’s cho- rea).
p.000027: b) This means that, compared to other medical information, a greater interest from insurers to have access to
p.000027: genetic information is not necessari- ly justified. Nevertheless, such an interest is widely based on overestimates of
p.000027: the power of genetic data, i.e. on the erroneous perception that has been cultivated, regarding their increased
p.000027: predictive value for the future health of an individual (HGC Minute 2007: 3.3). This is actually a version of “genetic
p.000027: determinism”, a popular belief nowadays, which is due to inaccurate infor- mation. The consequences of this misleading
p.000027: perception are not to be over- looked: the emergence of unfavourable discrimination against specific popu- lation
p.000027: groups based on their genetic traits, in violation of the principle of equality, is seen in this light, as
p.000027: an existing problem.
p.000027: c) It is a fact that an absolute prohibition of access of insurers to all in- formation, which may be critical for a
p.000027: particular type of insurance contract, can only increase their business risk. First of all, it does not seem fair that
p.000027: health information that is known to the insured should be withheld from the other party (regardless of its worthy
p.000027: protection as sensitive personal data). Besides, it should not escape our attention that such a prohibition may sus-
p.000027: tain the overrating of genetic information and the related perception of ge- netic determinism and, on the other
p.000027: hand, the increased risk assumed by insurers may lead them to a generalized reaction of raising premiums
p.000027: at least for those diseases for which a genetic predisposition can be inferred indirectly i.e. without
p.000027: carrying out any genetic testing.
p.000027: The above three points seem to us to be important for evaluating the interests of the parties to an
p.000027: insurance relationship.
p.000027:
p.000027: B. A collective interest involved
p.000027:
p.000027: However, there is an additional dimension to this debate: the protection of health as a collective interest.
p.000027: The diffuse perception of genetic determinism that inspires concerns about illegitimate uses of genetic
p.000027: information seems to have created a gen- eral reluctance among the public to undergo genetic testing for health rea-
p.000027: sons (Nationaler Ethikrat 2007:30, HGC Minute 2007:3.8).
p.000027:
p.000027:
p.000028: 28
p.000028:
...

p.000030: issued an authorization.
p.000030: Thus, a distinction must be drawn:
p.000030: - If the subject is aware of genetic data that are critical for insurance, the insurer may request such data but
p.000030: only under the provisions of Law 2472/1997.
p.000030: - If the subject is not aware of such genetic data, the insurer may not re- quest genetic testing because of the “not
p.000030: -to-be-informed” right which is safeguarded by the Oviedo Convention.
p.000030:
p.000030: SUMMARY - CONCLUSIONS
p.000030:
p.000030: 1. There are genetic tests for a significant number of disorders with a genetic component that determine
p.000030: the probability of manifestation of dis- ease with greater accuracy compared to medical testing. The degree
p.000030: of complexity of the evaluation of the results varies depending on individual case, and can be difficult even
p.000030: for experts. Therefore, the concern about the management of genetic data in life and health insurance is a legitimate
p.000030: one.
p.000030:
p.000030:
p.000030:
p.000030: 23 See Law 2496/1997, arts 189-225 Code of Commerce, 400/1970 (public supervision of insurance companies), p.d.
p.000030: 252/1996 (adaptation to relevant community law).
p.000030:
p.000031: 31
p.000031:
p.000031: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000031: REPORT
p.000031:
p.000031: 2. There are racial groups with greater incidence of certain genetic dis- orders; hence there is a risk of racial
p.000031: discrimination based on genetic data.
p.000031: 3. An extensive bioethical debate has developed with regard to access of insurance companies to the genetic data of the
p.000031: insured or of insurance ap- plicants. This debate mainly revolves around two axes: a fair calculation of risk based on
p.000031: the principle of reciprocity, on the one hand, and protection of personality from discrimination and stigmatization on
p.000031: the grounds of genet- ic data, on the other hand.
p.000031: 4. Another issue to consider is the fact that the management of genetic information with regards to access by insurance
p.000031: companies directly affects public support for genetic research. This has implications for the funding of research and
p.000031: the participation of volunteers in clinical trials, both indispen- sable to achieve progress in genetics. It mainly
p.000031: leads to avoidance of testing with injurious effects on the health of insurance applicants.
p.000031: 5. Greek legislation has not adopted specialised regulation for the use of genetic data in life and health
p.000031: insurance. Likewise no regulation exists for the operation of genetic laboratories that are the source of this
p.000031: information. In view of the above we recommend the adoption of special legislation ac- cording to the model
p.000031: followed by other countries. This legislation must strike a balance between the legitimate interests of
p.000031: the insurers and the insured guided by fundamental human rights.
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000032: 32
p.000032:
p.000032: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000032: REPORT
p.000032:
p.000032: SUGGESTED LITERATURE
p.000032:
p.000032: Andrews L (1987). Medical genetics: A legal frontier. American Bar Founda- tion, Chicago.
p.000032: Ashcroft, R (2007). Should genetic information be disclosed to insurers? No. BMJ 334, 1197.
p.000032: Bird TD (1999). Early-Onset Familial Alzheimer Disease. In: Gene Reviews at GeneTests: Medical Genetics Information
p.000032: Resource.
p.000032: Burke W (2002). Genetic Testing, N Engl J Med 347, 1867-1875.
p.000032: European Commission (2005). Survey on national legislation and activities in the field of genetic testing in EU
...

p.000104: of the Nazi regime among others- this model of medical “self-commitment” was seriously questioned. It was realized
p.000104: that self-commitment on the part of physicians does not en- sure the protection of patients. It became obvious that the
p.000104: participation of patients themselves in the course of treatment as active agents at all stages is the best safeguard
p.000104: for their well-being.
p.000104:
p.000104:
p.000105: 105
p.000105:
p.000105: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000105: OPINION
p.000105:
p.000105: But first and foremost, the development of medicine itself has made the active involvement of patients a practical
p.000105: necessity in view of the fragmen- tation in the provision of health services brought about by increasing medi- cal
p.000105: specialization and the broad introduction of new technologies that mul- tiply possible alternative treatments.
p.000105: It is almost certain that no treatment is free of adverse effects. There- fore, the classical principle of “doing
p.000105: good or not doing harm” is no longer sufficient to determine treatment. Patients need to be involved to
p.000105: deter- mine the treatment whose likely adverse effects are more acceptable to them. Especially in our
p.000105: country, the need for this involvement becomes all the more urgent due to the absence, until now, of a single
p.000105: registration sys- tem to record the complete history of patients which deprives physicians from unmediated
p.000105: access to consistent and reliable data.
p.000105: The adoption of “informed consent” presupposes that patients are in- formed by physicians and in principle,
p.000105: they consent prior to all medical acts. In this way, they can consider their condition in the context of their general
p.000105: way of living not as passive recipients but as independent agents who are involved in the whole process as much as
p.000105: possible. A good knowledge of the values and needs a patient would like the physician to take into account
p.000105: when determining treatment is an essential part of this process. It is worth noting that the requirement of
p.000105: participation is complied with even when patients express the wish to follow the suggested treatment without
p.000105: further information (right to ignorance).
p.000105:
p.000105: B. The law
p.000105:
p.000105: Initially, the new model of “informed consent” appeared in codes of eth- ics on clinical trials (Nuremberg Code,
p.000105: Helsinki Declaration) because, on this occasion, the risks for the volunteers are greater. Gradually, however,
p.000105: its effects were recognized in all areas of medical practice.
p.000105: The Oviedo Convention on Human Rights and Biomedicine is the first example of binding international law
p.000105: incorporating “informed consent” in all medical acts. In addition to the Convention, express provisions in
...

p.000112: argues that when the physician analyses the present condition of the patient and what he foretells for the future in
p.000112: the presence of the patient the latter will find it easier to believe that the physician is well acquainted
p.000112: with the situation and will have more confidence in him (Hippocrates, Prognostics, introduction to the
p.000112: text).
p.000112:
p.000113: 113
p.000113:
p.000113: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000113: REPORT
p.000113:
p.000113: the conditions in which it operates which affect the relationship physician- patient can be summarized as follows:
p.000113: 1. Medicine is divided into several specialties and one physician alone is no longer able to treat all the health
p.000113: problems of an individual.
p.000113: 2. The physicians of different specialties as involved to consult in the course of his/her life will
p.000113: not necessarily work together; therefore, the patient is the only one with a complete picture of his/her medical
p.000113: history. It should be noted also that in Greece, records of medical his- tory are not kept for each patient.
p.000113: 3. Medicine has progressed in such a way that there is no single indicat- ed treatment for each particular condition.
p.000113: 4. The level of education in our country has been improved in recent decades. As a result, most patients
p.000113: are able to understand the medi- cal facts of their condition and are seeking more detailed infor- mation.
p.000113: Furthermore, the lay public enjoys greater, if fragmentary, access to medical information from a variety of
p.000113: sources.
p.000113: 5. People do not trust the motives of physicians unreservedly. This is mainly because the practice of
p.000113: medicine is sometimes known to be influenced by varying interests not necessarily compatible with the patient’s
p.000113: interests.
p.000113: 6. Citizens demand more from the health system as regards the quality of services, the medical outcome and the
p.000113: conditions in which these services are provided. The provision of high quality services is consid- ered by citizens as
p.000113: an utmost priority in our country.
p.000113: 7. It is now acknowledged that the way of living and the religious or other philosophical beliefs of
p.000113: patients must be taken into considera- tion when determining treatment. There is an increasing awareness of the right
p.000113: to autonomy and of respect for dignity in medicine.
p.000113:
p.000113: B. LEGAL ISSUES
p.000113:
p.000113: In general
p.000113:
p.000113: The “Code of Medical Ethics” (CME, Law 3418/2005) has put in place a modern legal framework for the relationship
p.000113: physician-patient in Greek
p.000113:
p.000113:
p.000113:
p.000114: 114
p.000114:
p.000114: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000114: REPORT
p.000114:
p.000114: law2. The main characteristic of this law is the explicit introduction of “in- formed consent” albeit
p.000114: maintaining provisions which reflect the former “pa- ternalistic” approach.
...

p.000140: not to be excluded, especially for those who are highly probable to become carriers and transmit the
p.000140: infection due to the nature of their occupation. They should be offered, however, the option of changing duties. The
p.000140: established scientific requirements for clinical trials of new treatments (vaccines or medicines) may not be
p.000140: bypassed in order to
p.000140:
p.000140:
p.000140:
p.000141: 141
p.000141:
p.000141: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000141: OPINION
p.000141:
p.000141: accelerate the availability of such treatments to the public. Otherwise their efficacy will remain uncertain and
p.000141: citizens will be misinformed as a result.
p.000141: In addition, the Commission thinks that in the exceptional circumstances of epidemics or pandemics, limits to
p.000141: patents on new treatments could be justified to the extent possible. Such limits could be argued as a legal/policy
p.000141: choice in competent international and supra-national fora.
p.000141:
p.000141: c) Treatment
p.000141: The treatment of those infected should also be based on informed con- sent. Forced treatment is not justified in
p.000141: principle, except in “emergency situations”.
p.000141: When the number of medical and nursing staff or the available treat- ments do not suffice to ensure care to
p.000141: all those infected (especially in case an infection spreads rapidly) the Commission stresses that the government must
p.000141: establish in advance general priority rules for access to treatment. The basic priority criteria should preferably be
p.000141: prescribed by law. By way of indi- cation, such priority criteria may include the severity of symptoms, the age of the
p.000141: patient and the definition of relevant vulnerable groups.
p.000141:
p.000141: 2. Limits to autonomy on public health grounds
p.000141:
p.000141: a) General rule
p.000141: Limits to the general autonomy of patients -especially the freedom of movement and establishment- are
p.000141: justified only if they are absolutely in- dispensable to protect public health pursuant to the Constitution
p.000141: (arts. 5 [4], 25 [1]). The principle of proportionality as discussed above applies in all circumstances. For
p.000141: example, hospitalized patients should be restricted in specially contained facilities.
p.000141:
p.000141: b) The risk of social stigma
p.000141: The Commission stresses the risk of social stigma that may arise from the isolation (“ghetto-ing”) of specific
p.000141: sub-populations with distinctive cultural characteristics or ways of living when an infectious disease erupts
p.000141: within such groups.
p.000141:
p.000141:
p.000141:
p.000141:
p.000142: 142
p.000142:
p.000142: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000142: OPINION
p.000142:
p.000142: Such cases must be dealt with by personalized medical care and social welfare measures especially as
p.000142: regards the improvement of hygiene in their living conditions.
p.000142:
p.000142: c) Illegal immigrants
p.000142: In case of manifestation of infectious disease or in cases when preven- tive measures (e.g. vaccination) need to
p.000142: be applied on illegal immigrants, the government must ensure that immigrants would be addressed to the
p.000142: health services. The access of immigrants to health services should be un- hindered and independent on their
p.000142: immigration status; otherwise the risks for public health in general will be multiplied.
p.000142:
p.000142: d) HIV/AIDS
p.000142: This particular disease presents a set of peculiar problems. Even though the spread of the virus is in general
p.000142: relatively difficult, the disease is very severe despite progress in treatment in the recent years. Moreover, social
p.000142: perceptions -especially regarding high risk vulnerable groups- remain ex- tremely negative in our country. The
p.000142: following call for attention:
p.000142: The autonomy of HIV seropositives or HIV patients can be restricted in view of public health protection only if the
p.000142: particular setting of social con- tact is prone to the transmission of the disease. Thus, although mandatory testing
p.000142: for seropositivity is not justified in the absence of qualifying circum- stances, it can be legitimate for certain
p.000142: occupations like physicians or nurs- es or for participation in certain social activities such as sports. In
p.000142: these cases, a positive test result justifies the removal of the seropositive, but just from this
p.000142: particular social context. By contrast, social environments, which are not prone to the transmission of the
...

p.000147:
p.000147: II. Ethical issues
p.000147:
p.000147: In case of contagious diseases the scope of personal autonomy is defined by the legitimate interests of others or of
p.000147: society as a whole. Limits to au- tonomy are of two natures: those imposed by the necessity of medical in- tervention
p.000147: (diagnosis, prevention or treatment) and those imposed by the autonomy of others.
p.000147: Transmissible diseases, like other risks to public health, affect the latter category. The following questions arise in
p.000147: this respect:
p.000147: - To what extent are limits to personal autonomy justified on public health grounds (1)?
p.000147: - What is the effect of informed consent when public health is at risk (2)?
p.000147: To these questions, we must add the implications of the “doing good, not harm” principle, that is the
p.000147: scope of medical duty in case of health- threatening (perhaps also life-threatening) situations for entire
p.000147: populations since, in this event, the exercise of autonomy by patients is de facto affected (3).
p.000147: Finally, two related issues call for special consideration: clinical trials and respective patents for vaccines and
p.000147: medicines, for they also raise important ethical questions. On one hand, these are associated with the provision of
p.000147: accurate information to patients, and on the other hand with access of pa- tients to treatments in the context of
p.000147: exercising autonomy (4).
p.000147:
p.000147: 1. General autonomy and public health: Restrictions and the risk of stigma- tization
p.000147:
p.000147: The legitimate objective of protection of the health of others sets the grounds for imposing restrictions on
p.000147: the general autonomy of those infect- ed, especially in regard to movement and social contact.
p.000147: This calls for a number of qualifications. Indeed, not all transmissible diseases justify the same
p.000147: restrictions. Distinctions are necessary between
p.000147:
p.000147:
p.000147:
p.000148: 148
p.000148:
p.000148: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000148: REPORT
p.000148:
p.000148: easily and less easily transmitted diseases as well as between mild and seri- ous diseases (influenza versus HIV, for
p.000148: example).
p.000148: Mild diseases, even when easily transmitted, do not justify such re- strictions to general autonomy; the same
p.000148: is true of serious diseases that are hard to contract. Of course, there are many variations of these
p.000148: combina- tions, which prevent the formulation of more specific rules of universal ef- fect.
...

p.000151: use also in case of epidemics.
p.000151: At all events, health care priorities must be set by public authorities in advance on the basis of fixed rules in
p.000151: order to prevent physicians from hav- ing to make so many ethically questionable judgments.
p.000151:
p.000151: 4. Special issues: Clinical trials, patents
p.000151:
p.000151: The urgent need for prevention and treatment in times of epidemics painfully illustrates the question of
p.000151: the adverse effects of trials of new treatments (medicines, vaccines) to contain the risk.
p.000151: Given that clinical trials are now subjected to a specific control proce- dure, ensuring the safety of
p.000151: volunteering participants and of the end- product before it becomes available to the public, at issue is
p.000151: whether this procedure should be relativized in case of an urgent need to supply new cures. Since the
p.000151: pursuit of absolute safety, even in normal circumstances, obviously undermines the effort to find new cures (as
p.000151: being too time- and resource-consuming) the debate on the “maximization of risk” is not with- out cause. The criteria
p.000151: of socially acceptable risks from a new medicine or vaccine are ultimately a matter for bioethics, and must
p.000151: be considered as such.
p.000151: Similar arguments can be made on the scope of patents -and, with that, on the scope of trade prerogative- on new
p.000151: treatments in case of emergency. Here too, limiting the duration of privilege of the patent holder for the sake of
p.000151: providing easier (and cheaper) access to a highly needed drug or vaccine is a matter for bioethics.
p.000151:
p.000151: III. The legal dimension
p.000151:
p.000151: 1. International law
p.000151:
p.000151: Public health is considered as a remit of national sovereignty. As a result, there are no international policies
p.000151: underpinned by international rules for the moment on the protection from epidemics except from trade in food-
p.000151:
p.000151:
p.000152: 152
p.000152:
p.000152: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000152: REPORT
p.000152:
p.000152: stuffs and animal feed. To this, we must add the reluctance of developed countries to effectively combat
p.000152: serious transmissible diseases, which are endemic in developing countries (e.g. malaria, tuberculosis, HIV).
p.000152: Nevertheless, provisions on international protection from epidemics exist in the form of guidelines (IHRS)
p.000152: issued by WHO. These guidelines are not legally binding, of course, but non-compliance can lead to other types of
p.000152: sanctions (e.g. WHO travel alerts). Considering that international move- ments, immigration flows and trade
p.000152: have become easier with globalization and with the recent experiences of wide-spreading transmissible diseases in mind,
p.000152: proposals are under discussion with a view to developing internation- al instruments in this field.
p.000152:
p.000152: 2. Greek law
p.000152:
...

p.000153:
p.000153: Based on the above discussion a number of conclusions can be drawn to assist the Commission in issuing an opinion.
p.000153: 1. Personal decisions on health matters may have critical implications for the health of others, as the example of
p.000153: transmissible infectious diseas- es typically demonstrates. Therefore, the exercise of autonomy in this
p.000153:
p.000153:
p.000154: 154
p.000154:
p.000154: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000154: REPORT
p.000154:
p.000154: area must take public interest into account -i.e., the protection of pub- lic health- and, in all terms, is determined
p.000154: by such interest.
p.000154: 2. The above statement does not imply that personal autonomy may be “brought to tatters” -or virtually eliminated- by
p.000154: policy choices to pro- tect public health. Autonomy is still the rule, even in case of epidemics or pandemics, which
p.000154: means that any encroaching measures are always exceptional and can be justified only to the extent that they
p.000154: are de- monstrably appropriate for the objective they serve (principle of pro- portionality). It is, therefore,
p.000154: indispensable to distinguish between in- fectious diseases depending on the level of risk and their transmissibil-
p.000154: ity.
p.000154: 3. The adoption of general rules in advance -if possible in periods of “normality”- both in terms of
p.000154: restrictions as well as of access to sani- tary authorities in times of epidemics or pandemics not only safe-
p.000154: guards the efficacy of prevention or treatment, but also strengthens the feeling of fair distribution of
p.000154: resources and means in emergency situations as imposed by the respect for human value.
p.000154: 4. The potential of social stigma against persons or groups under the pre- text of public health protection is very
p.000154: potent in situations calling for measures. This risk can be addressed only with constant vigilance based on
p.000154: valid and accurate information, a task pertaining mostly to public authorities and institutions. Public health
p.000154: cannot be allowed to inspire phobic reflexes in a modern democratic society.
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
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p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000155: 155
p.000155:
p.000155: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000155: REPORT
p.000155:
p.000155: SUGGESTED LITERATURE
p.000155:
p.000155: Beauchamp DE (1988). The health of the republic: Epidemics, medicine, and moralism as challenges to democracy. Temple
p.000155: UP, Philadelphia PA.
p.000155: Brandt AM (1987). No magic bullet: A social history of veneral disease in the United States since 1880. Oxford U. P.,
p.000155: N. York.
p.000155: Breslow L, Duffy J, Beauchamp DE, Soskolne CL (2004). Public health, in: Post SG (ed.) Encyclopedia of bioethics. v. 4,
p.000155: 3d ed. McMillan Reference, N. York, p. 2202-2221.
p.000155: Bruce LI and Phelan JC (2006). Stigma and its public health implications, Lan- cet 367, 528-529.
p.000155: Dagtoglou PD (1991). Constitutional law, individual rights I. eds. A. N. Sak- koulas, Athens-Komotini.
p.000155: Emmanouelides D, Papaiannes I (2000). The social entitlement to health, Human Rights.
p.000155: Encyclopedia of public health. Edited by Lester Breslow, online access.
p.000155: Evans RJ (2004). Epidemics, in: Post SG (ed.), Encyclopedia of bioethics. v. 2, 3d ed. McMillan Reference, N. York, p.
p.000155: 789-794.
p.000155: Gostin L (2004). The international health regulations and beyond. Lancet, Infectious Diseases 4, p. 606-607.
p.000155: Grad FP, Beauchamp DE (2004). Public health law, in: Post SG (ed.), Encyclo- pedia of bioethics. v. 4, 3d ed. McMillan
p.000155: Reference, N. York, p. 2222-2234.
p.000155: Kenneth VI and Moskop JC (2007). Triage in medicine, Part I: Concept, histo- ry, and types. Annals of Emergency
p.000155: Medicine 49, 275-281.
p.000155: Kontiades X (1997). Welfare State and social rights. eds. A. N. Sakkoulas, Athens-Komotini.
p.000155:
p.000155:
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p.000006: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
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p.000161: disclosure by each researcher stating any possible working relationship with the company/sponsor or any possi- ble
p.000161: income or other kind or association, such as receiving company’s products, gifts, travel expenditure coverage
p.000161: etc. This disclosure should also be submitted to the responsible authorities of the State which are authorized to
p.000161: control the research, prior to the start of the clinical re- search, but also to every participating patient. In
p.000161: addition, publication of the relevant research results must be accompanied by a notification to the editorial boards
p.000161: of national scientific journals, and submitted conference abstracts must be accompanied by a notification
p.000161: to the conference organizing committees. Members of the control bodies also ought to submit a similar disclosure, as
p.000161: well as the research institutes on the assumption that there is any financial relationship (sponsor- ships,
p.000161: dividend payments of commercial products in the research etc.), including the company/sponsor.
p.000161: - The establishment of a regular education to raise the researchers’ awareness of potential conflict of
p.000161: interest, and inform about the means of control (e.g. in the context of introductory information pro- vide to a
p.000161: research group by their head or the ethics committee of the research institute, as well as by organizing special
p.000161: seminars).
p.000161:
p.000161:
p.000161:
p.000162: 162
p.000162:
p.000162: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000162: OPINION
p.000162:
p.000162: Finally, the Commission supports the right to access control mechanisms by whoever participates in a certain clinical
p.000162: study and invokes evidence of misconduct.
p.000162:
p.000162:
p.000162: Athens, 5 July 2011
p.000162:
p.000162:
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p.000163: 163
p.000163:
p.000163: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000163: OPINION
p.000163:
p.000163: COMPOSITION AND PERSONELL
p.000163: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000163: Chairman: John Papadimitriou, Emeritus Professor of Surgery, Medical School, University of Athens.
p.000163:
p.000163: Deputy Chairman: George Maniatis, Emeritus Professor of Biology, Medical School, University of Patras.
p.000163:
p.000163: Members:
p.000163: Julia Iliopoulou-Stranga, Professor of Constitutional Law, Law School, Uni- versity of Athens.
p.000163: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000163: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000163: Athens.
p.000163: Evangelos Moutsopoulos, Member of the Academy of Athens, Emeritus Professor of Philosophy, University of
p.000163: Athens.
p.000163: Athanasios Papachristou, Professor of Civil Law, Law School, University of Athens.
...

p.000193:
p.000193:
p.000193:
p.000193:
p.000193:
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p.000193:
p.000193:
p.000193:
p.000194: 194
p.000194:
p.000194: DIRECT-TO-CONSUMER GENETIC TESTING
p.000194: OPINION
p.000194:
p.000194: O P I N I O N
p.000194:
p.000194: DIRECT-TO-CONSUMER GENETIC TESTING
p.000194:
p.000194: The Hellenic National Bioethics Commission met repeatedly upon invita- tion by the President in order to consider the
p.000194: ethical issues within its juris- diction regarding Direct-to-consumer (DTC) genetic testing, available in
p.000194: pharmacies or via the internet.
p.000194: The term “DTC genetic testing” refers to any genetic test detecting DNA changes and is directly available to the public
p.000194: as a kit. It is based on the con- sumer’s own will to be examined for genetic diseases or predisposition to
p.000194: diseases -and, mainly, without prior recommendation by a doctor, medical geneticist or biologist-geneticist- or to
p.000194: genetically identify an individual. The term does not include genetic tests recommended by an expert, after exam- ining
p.000194: the clinical data and the family history of a patient, aiming to diagnose or identify the patients risk to a disease.
p.000194: “DTC genetic testing” refers to tests carried out for health reasons, pre- natal diagnosis or genetic identification of
p.000194: a person (especially the so-called “paternity tests”). A common component to all tests is that the public has direct
p.000194: access to them, without the mediation of counseling (in the first two cases) or legal authorization (judicial
p.000194: permission in the case of genetic iden- tification). Consequently, there is a rapid development of a new
p.000194: “market” for genetic services, which is already advertised to a significant extend in our country.
p.000194: The above mentioned new market is favored by the continuous progress in technology, the human genome project and the
p.000194: extensive research eluci- dating specific gene functions. At present, the technological and scientific
p.000194: progress makes methods of detecting genetic risk factors, even for serious diseases, affordable. However, specific
p.000194: sensitive ethical and social issues, associated with the way such services are provided, emerge and must
p.000194: re- ceive special attention by the involved individuals and the State.
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000195: 195
p.000195:
p.000195: DIRECT-TO-CONSUMER GENETIC TESTING
p.000195: OPINION
p.000195:
p.000195: I. The facts
p.000195:
p.000195: Genetic tests which are directly available to the public detect DNA se- quence changes. Most frequently, the
p.000195: DNA changes are associated with the etiology, diagnosis, treatment or prevention of hereditary diseases. In
p.000195: the case of monogenic disorders, a single gene is responsible for the disease and therefore DNA changes associated
p.000195: with the disease are easier to identify. However, this is not the case for complex (polygenic) diseases,
...

p.000197: tests for health purposes.
p.000197: In prenatal genetic tests, article 14 of the same Convention prohibits selection of an embryo for non-health
p.000197: reasons.
p.000197: Finally, for genetic tests undertaken to identify a person, judicial authori- zation is required under the current
p.000197: legislation (e.g. articles 1477 Civil Code, 615 Code of Civil Procedure).
p.000197: Moreover, the provisions concerning the economic freedom and its con- straints (article 5, paragraph 1 Constitution),
p.000197: especially those aiming to pro-
p.000197:
p.000197:
p.000197:
p.000198: 198
p.000198:
p.000198: DIRECT-TO-CONSUMER GENETIC TESTING
p.000198: OPINION
p.000198:
p.000198: tect the consumer (Law 2251/1994) are applied in all types of genetic test- ing.
p.000198: However, one must not overlook that the above mentioned provisions are broad, and there is no special
p.000198: legislation governing this specific activity, both in Greece and most European countries. Absence of a
p.000198: relative law means that anyone can offer DTC genetic services in an unrestricted and uncontainable manner,
p.000198: without being subjected to any kind of preventive quality control. The legislation stated above,
p.000198: partially covers the need of such a control and is unable to monitor the dynamics of a developing new market.
p.000198:
p.000198: III. Recommendations
p.000198:
p.000198: 1. General principles
p.000198:
p.000198: The Commission believes that an important aspect of autonomy in health matters is the unrestricted access
p.000198: to health information, including genetic information. Especially, however, regarding genetic tests which pre- dict
p.000198: the risk to develop a disease, the Commission considers that it is equally important to provide genetic information
p.000198: after the appropriate instructions, preferably, by an expert-physician, clinical geneticist or biologist-geneticist.
p.000198: The Commission notes that it is important to maintain the balance be- tween free access to health information and
p.000198: protection of vulnerable people who are subjected to inappropriate or unnecessary genetic testing. This per- spective
p.000198: is supported by the particular nature of genetic information and by the misleading impression about “genetic
p.000198: determinism”, which tends to dominate the public consciousness. Specifically, genetic data provide an
p.000198: element of predisposition to common complex diseases (cancer, cardiovas- cular disease, diabetes etc.) classifying
p.000198: (or not) an individual in a high risk group, without a definite result that he/she will develop the
p.000198: disease. The Commission believes that it is critical to emphasize that genetic data must not be overvalued, as
p.000198: erroneously and commonly presented.
p.000198: In regard to prenatal genetic tests, the Commission reiterates its position that they must not be performed for eugenic
p.000198: purposes. It notes the danger especially in the case of DTC genetic tests, where genetic counseling is ab- sent.
p.000198:
p.000198:
p.000199: 199
p.000199:
p.000199: DIRECT-TO-CONSUMER GENETIC TESTING
p.000199: OPINION
p.000199:
p.000199: Finally, the Commission considers that genetic tests revealing a person’s identity definitely presuppose consent from
p.000199: all the involved parties. Other- wise such genetic tests require a relevant judicial licensing.
p.000199:
p.000199: 2. Special issues
p.000199:
p.000199: In the context of the above mentioned general principles, the Commis- sion notes:
...

p.000202: detecting genetic causes of specific phenotypes and especially serious diseases, encountered the parallel
p.000202: progress of com- puter science and particularly, web applications. As a result, a new business activity emerged,
p.000202: aiming to provide genetic testing directly to any interested individual. The term “Direct-to-Consumer (DTC) Genetic
p.000202: Testing” is used to describe genetic testing taking place upon an individual’s request, without the mediation of an
p.000202: expert, i.e. clinical geneticist (medical geneticist or biol- ogist geneticist).
p.000202: Practically, this means that any individual (hereinafter referred to as “consumer”) can choose to undergo
p.000202: genetic testing offered by special com- mercial websites, After sending a biological sample and subsequent DNA
p.000202: analysis, the consumer can obtain results concerning possible predisposition to diseases such as diabetes,
p.000202: cardiovascular disease, cancer, etc. In case the DNA analysis is combined with data concerning the consumer’s lifestyle
p.000202: (di- etary habits, working conditions, smoking, exercise etc.), the end result may be a kind of specialized counseling
p.000202: on how to protect his/her health, which can be provided in an automatic way without always the mediation of
p.000202: an expert.
p.000202: The present report attempts to present the bioethical aspect of similar activities that provide genetic testing
p.000202: services directly to the public, as such activities are increasingly spreading in our country as well. In Europe, as
p.000202: well as in the USA, official concerns have already been expressed about setting a limit on a person’s access to genetic
p.000202: data concerning him/herself or a third party, without the adequate guarantees of validity and reliability. The pre-
p.000202:
p.000202:
p.000203: 203
p.000203:
p.000203: DIRECT-TO-CONSUMER GENETIC TESTING
p.000203: REPORT
p.000203:
p.000203: sent report aims to set a frame for the redaction of a relevant Opinion by the Commission.
p.000203:
p.000203:
p.000203: THE FACTS
p.000203:
p.000203: Genetic tests
p.000203:
p.000203: Genetic tests are based on the study of genetic material in order to iden- tify changes in the DNA sequence.
p.000203: These changes are either mutations, which cause a disease, or polymorphisms that constitute normal variations among
p.000203: individuals. Polymorphisms, however, can be associated with a dis- ease, i.e. if an individual carries specific
p.000203: DNA polymorphisms, he/she may have increased risk (predisposition) to develop a disease.
p.000203: In the case of monogenic disorders (e.g. thalassaemia, cystic fibrosis, familial hypercholesterolemia),
p.000203: mutations in a single gene can cause the disease. For this reason, it is relatively easy to detect the genetic
p.000203: causes of a single-gene disease. However, this is not the case for complex (multifactori- al) diseases (e.g.
p.000203: cardiovascular disease, cancer, diabetes etc.). Complex diseases can result from mutations and/or polymorphisms in
p.000203: more than one genes and/or environmental factors (e.g. smoking, diet, obesity, exercise etc.). Therefore,
p.000203: genetic tests for complex diseases cannot give a certain answer on whether an individual will develop the
p.000203: disease, but they can only estimate the relative risk to develop the condition.
p.000203: Until recently, genetic testing for health reasons was usually conducted after mandate of an expert (clinical
p.000203: geneticist). The expert in charge as- sessed the individual’s clinical phenotype and family history, and
p.000203: recom- mended or not subsequent genetic testing. The biological material was col- lected either by a physician or
p.000203: a member of the medical personnel in the genetic centre where the tests would be performed.
p.000203:
p.000203: The new trend: Direct access to genetic testing
p.000203:
p.000203: Nowadays, the way genetic testing is provided tends to change, primarily due to the great advances in molecular
p.000203: technology and genetics. This change was mainly due to:
p.000203:
p.000203:
p.000204: 204
p.000204:
p.000204: DIRECT-TO-CONSUMER GENETIC TESTING
p.000204: REPORT
p.000204:
p.000204: Α. The constant discovery of genes associated with, not just single-gene, but also complex diseases
p.000204: More specifically, the human genome project and genome-wide associa- tion studies produced a large amount of
p.000204: genetic data and associations of genetic polymorphisms with several diseases. In addition, DNA samples from
p.000204: many patients were also available, further facilitating the production of genetic data. Based on such type of
p.000204: studies, companies that provide ge- netic services promise to estimate an individual’s chances to develop a dis- ease.
p.000204: This means that the reasons why someone would undergo genetic testing are multiplied, so that any person
p.000204: can be informed of his/her own genetic profile and the family’s genetic profile as well.
p.000204: Β. The introduction of new tools in genome analysis, such as DNA micro- arrays, thanks to which high throughput
p.000204: analysis is possible (DNA analysis from several individuals simultaneously, in a short period of time)
p.000204: This enables companies to offer commercial methods to the public, in a relatively affordable price. The result is an
p.000204: emerging new market of private companies providing genetic testing.
p.000204: C. The physicians’ and the public’s growing interest for the importance of genetic information in preventive medicine
...

p.000204: to them by personal interest and/or worry about their health, or out of curiosity. The offered tests cover a wide range
p.000204: of:
p.000204: a) Diagnostic tests confirming or not a disease (single-gene diseas- es),
p.000204: b) pre-symptomatic tests that calculate a person’s chances of devel- oping a disease (multifactorial diseases),
p.000204: c) prenatal tests that determine the embryo’s gender,
p.000204: d) pharmacogenetic tests that estimate the right dosage, effective- ness and side effects of certain drugs for an
p.000204: individual,
p.000204:
p.000204:
p.000205: 205
p.000205:
p.000205: DIRECT-TO-CONSUMER GENETIC TESTING
p.000205: REPORT
p.000205:
p.000205: e) paternity tests that confirm or not paternity,
p.000205: f) kinship tests that confirm or not relationship and the degree of relationship,
p.000205: g) ancestry tests that determine the family’s origin (genealogical roots),
p.000205: h) metabolic and nutritional genomics tests that estimate predispo- sition to obesity,
p.000205: i) anti-ageing tests that study the genes affecting ageing,
p.000205: j) athletic performance tests that determine someone’s potential for athletic performance.
p.000205: Typically, the consumer receives a kit, which includes instructions to col- lect his/her own biological material
p.000205: (usually saliva or buccal mucosa swabs), and this kit is subsequently sent for analysis to the laboratory by post. The
p.000205: consumer is notified of the results by telephone, post, e-mail or a safe web- site, to which access is being
p.000205: granted. Tests requiring blood are accompa- nied by a kit to be used by a physician, who will safely collect a
p.000205: blood sample (e.g. to screen for mutations in the BRCA1 and 2 genes causing breast can- cer).
p.000205: Often, the commercial companies simply communicate the results of the genetic tests, without giving information about
p.000205: their usefulness to the inter- ested parties (genetic counseling). Other companies combine genetic results with data
p.000205: derived from a questionnaire (filled in by the consumer), providing more individualized information. Essentially, this
p.000205: is a type of genetic coun- seling, both for the recommended genetic test and the interpretation of the results. In the
p.000205: second case, counseling services are usually offered at an ex- tra charge, as a special service upon request.
p.000205: Counseling may be provided by telephone, without direct contact of the counsellor with the user of the ser- vice. In
p.000205: some cases, however, the company recommends that the results are communicated to the consumer’s physician, who will
p.000205: evaluate them.
p.000205: A completely “impersonal” way of communication is rather usual, on the basis of a fully standardised, online process.
p.000205: Even the interpretation of the results is being conducted through algorithms and special software (“rules engine”),
p.000205: which combine genetic data with the information provided by the consumer (questionnaire), in order to determine
p.000205: personal “recommenda- tions”. In the majority of cases, the users of the service end up with a huge
p.000205:
p.000205:
p.000205:
p.000206: 206
p.000206:
p.000206: DIRECT-TO-CONSUMER GENETIC TESTING
p.000206: REPORT
p.000206:
p.000206: amount of genetic data at their disposal that they cannot use or compre- hend.
...

p.000210: environmental factors (e.g. cystic fibrosis, thalas- saemia, familial hypercholesterolemia, muscular dystrophy,
p.000210: Alzheimer’s disease, Huntington’s Chorea)- are comparatively few and, most prominent- ly, rare, in order to
p.000210: justify a commercial interest in the market of genetic testing.
p.000210: The restricted value of genetic data in protecting our health, could lead a non-expert to draw erroneous or, at least,
p.000210: uncertain conclusions. For exam- ple, if an individual has no interest in following a healthy diet he/she may
p.000210: develop cardiovascular disease despite the fact that there is no genetic cause. In addition, it is possible
p.000210: that serious psychological distress is caused in individuals who overestimate the importance of genetic
p.000210: predisposition,
p.000210: e.g. for cancer, by accepting “genetic determinism” and ignoring the multi- factorial nature of the specific disease.
p.000210: This is the reason why a mediating expert, who will be able to evaluate the necessity of genetic testing and the
p.000210: results for a particular individual with known medical record and “social” profile, seems to guarantee the
p.000210: proper use of genetic testing.
p.000210: But, is the expert’s involvement always justified? For example, is the intervention necessary for tests
p.000210: provided via the internet that intend to reg- ulate the dietary habits of the recipient and are generally
p.000210: considered as harmless? And generally: to what extend is a person’s autonomy in health issues affected, when the
p.000210: expert’s mediation is presupposed in every case, in order that the person could have access to simple diagnostic tests?
p.000210: This main concern is enhanced by some “peripheral” issues that need to be addressed. The most serious issue is of
p.000210: course the management and pro- tection of personal data, in the context of a relevant business activity -
p.000210: whether it concerns tests intended to protect health or tests designed to
p.000210:
p.000210:
p.000211: 211
p.000211:
p.000211: DIRECT-TO-CONSUMER GENETIC TESTING
p.000211: REPORT
p.000211:
p.000211: reveal a person’s identity. The extend of financial freedom is also a critical issue in cases where the business object
p.000211: involves information derived from our biological constitution. Additionally, a possible regulation -legislative or
p.000211: other type- intending to regulate the distinct market of DTC genetic services and balance the values, should be
p.000211: considered.
p.000211:
p.000211: The ethical dilemmas
p.000211:
p.000211: In an attempt to highlight the ethical dilemmas arising from DTC genetic testing, one would conclude the following:
p.000211:
p.000211: Consent without counseling
p.000211: Does personal autonomy in health issues include “informed consent” without the intervention of a medical
p.000211: counsellor?
p.000211: In other words, is a person able to make decisions for his/her health, relying exclusively on whoever
p.000211: offers -and advertises- diagnostic services or even pharmaceutical products, considering that an expert’s involvement
p.000211: is “meaningless”?
p.000211: The question can be further extended: are there diagnostic services that provide reliable information directly to
...

p.000224: In this case, the ethical principles and rules of law, as outlined in a previ- ous Opinion of the Commission ("Consent
p.000224: in the patient-physician relation- ship," 2010) are entirely valid. The authentic will of the person him/herself is the
p.000224: determining factor here, in view of the right of personality. However, since there is a particularly
p.000224: sensitive issue of autonomy, it is right to allow for a period of time between the initial decision and the plastic
p.000224: surgery pro- cedure, during which the person concerned receives psychological and med- ical counseling.
p.000224:
p.000224:
p.000224:
p.000225: 225
p.000225:
p.000225: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000225: OPINION
p.000225:
p.000225: According to the Commission, if prenatal testing results in ambiguous results about the gender identity of a
p.000225: foetus, an artificial termination of the pregnancy is not justified, especially since there are the
p.000225: aforementioned reconstructive options after birth. However, given that persons in this cate- gory (seeking plastic
p.000225: surgery to alter gender specific features or gender re- assignment) belong to vulnerable social groups that
p.000225: generally suffer from social discrimination, access to relevant treatment must be ensured. For example,
p.000225: based on the principle of equality and the social right to health, the State may possibly develop counseling
p.000225: programs, but also provide ther- apy possibilities within the National Health System.
p.000225:
p.000225: 4. Face transplants
p.000225:
p.000225: Reconstructive face transplantation (e.g. in case of severe deformities caused by an accident) is, in
p.000225: principle, an acceptable alteration of the recipi- ent’s characteristics. However, it must be carried out in such a
p.000225: manner that it does not affect respect for the body of the (dead) donor. The relevant principle that rules
p.000225: transplants from a deceased donor is absolutely valid in this case too.
p.000225:
p.000225: 5. The physician’s role
p.000225:
p.000225: According to the Commission, the physician who carries out cosmetic plastic surgery has a particular
p.000225: responsibility, since he/she does not act in order to prevent a threat to a patient’s health (or life).
p.000225: Unquestionably, the consent of the person interested is a prerequisite for any relevant medical intervention. However,
p.000225: it should be noted that in the case of cosmetic plas- tic surgery, the following particularities must be taken into
p.000225: account:
p.000225: a) The physician has an increased responsibility to fully inform the person concerned as to the expected outcome
p.000225: and particularly the possible side effects on his/her health. This increased responsibility is explained
p.000225: by the need to prevent "easy" decisions by the person concerned, often influenced by obsessions with his/her body
...

p.000227: providing complete and accurate information to consumers regarding any possible side effects.
p.000227: For substances administered after prompt (either by sports medicine physicians, or gymnasts, trainers etc.),
p.000227: the relevant responsibility -moral, but also legal- belongs primarily to those who recommend the substance
p.000227: use. Regarding the apportionment of responsibility, it should not be overlooked that the interested persons that use
p.000227: them are more vulnerable to inaccurate or misleading information, as they often choose to enhance their
p.000227: physical abilities and performance and consider that such enhancement is, by de- fault, desired and
p.000227: "innocent", with no special consideration of the potential health effects.
p.000227:
p.000227: 3. The interest of third parties, particularly in sport
p.000227:
p.000227: The Commission also dealt with the case of enhancing abilities through doping, in order to participate in athletic
p.000227: contests. The Commission pointed out that the use of relevant substances must be controlled, not only in order to
p.000227: preserve equality in competition, but also to protect the athletes’ health.
p.000227: In particular, the following points are exceptionally significant:
p.000227: i) Prohibition of the use of certain substances in sport is not only related to the impressive results concerning
p.000227: the primacy of the athlete that uses them, but also to the serious risks to his/her health. This means that, even
p.000227: if one assumes that all sport participants can have equal access to such sub- stances, the use of the latter
p.000227: would still be unfair, not for reasons of fair- ness, but because the endangerment of health is incompatible
p.000227: with the very notion of rivalry.
p.000227: ii) Enhancing physical abilities by other means (e.g. strenuous exercise in particular environmental conditions) could
p.000227: also be equated with substance
p.000227:
p.000227:
p.000228: 228
p.000228:
p.000228: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000228: OPINION
p.000228:
p.000228: use, provided that the risks for one’s health were equally serious. As long as these risks are not established, the
p.000228: conditions of rivalry should not be con- sidered as adulterated for this reason alone.
p.000228: iii) New genetic technologies, such as gene therapy or gene transfer in athletes, are forms of doping, which are not
p.000228: currently detectable. In cases of gene doping, the risk to the athletes’ health is even greater, due to the nov- el and
p.000228: often experimental methods applied. However, it should be empha- sized that -according to the latest scientific data-
p.000228: such methods are at a re- search stage, even when they are used to treat patients.
p.000228: Based on the above considerations, the Commission notes the necessity of constant vigilance by the anti-doping
p.000228: authorities in our country, especially after the repeated cases during the last years.
p.000228: The Commission points out the special role of the Hellenic National Anti- Doping Council (ESKAN) for the prevention and
p.000228: fight against doping. It would be appropriate for ESKAN to acquire organizational independence (in the form of
...

p.000235: Enhancing non-pathological genes Enhancing skills, stamina, intelligence, memory, metabolism, etc.
p.000235: Regenerative medicine
p.000235:
p.000235:
p.000235: Tissue/organ regeneration
p.000235: Restoration of organ function Restoration of sports injuries
p.000235: Increasing life expectancy Enhancing athletic performance
p.000235:
p.000235:
p.000235: Platelet rich plasma
p.000235: Scar repair after accidents or burns Enhancing appearance
p.000235: Restoration of anterior cruciate
p.000235:
p.000235: (gel)
p.000235: Restoration of joints with
p.000235: osteoarthritis
p.000235: Enhancing athletic performance
p.000235:
p.000235:
p.000235:
p.000235:
p.000235:
p.000236: 236
p.000236:
p.000236: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT REPORT
p.000236:
p.000236: Table I (continued). Interventions applied to both treatment and human enhancement.
p.000236:
p.000236: Treatment Human enhancement Technological interventions
p.000236:
p.000236:
p.000236:
p.000236: Artificial implants
p.000236: Early and accurate diagnosis Effective and targeted drug therapy Restoration of joints, organs
p.000236:
p.000236: Enhancing athletic performance Increasing life expectancy
p.000236:
p.000236:
p.000236:
p.000236: Implants - sensors
p.000236:
p.000236:
p.000236:
p.000236: Brain implants
p.000236: Diagnosis and treatment of diseases
p.000236: e.g. sensor of sugar levels and use of insulin
p.000236:
p.000236: Increasing memory in patients with neurodegenerative diseases Restoration of mobility in paralyzed patients
p.000236:
p.000236: Enhancing athletic performance
p.000236:
p.000236: Enhancing senses, memory, intelligence
p.000236: Free access and opportunity to intervene in the physical world by thought
p.000236: Increasing life expectancy
p.000236:
p.000236: Nanotechnology Targeted therapy e.g. targeting cancer cells
p.000236:
p.000236: Aesthetic (surgical) interventions
p.000236: Reducing the vulnerability of soldiers by controlling their metabolism
p.000236: Skin graft Patients with severe burns Enhancing appearance and signs of
p.000236: aging
p.000236:
p.000236: Reconstructive surgery
p.000236: Scar repair after accidents or burns Restoration of anterior cruciate
p.000236: Enhancing appearance and signs of aging
p.000236: Liposuction Reducing the risk of obesity Enhancing appearance
p.000236:
p.000236: Gender change Agreement of physical and sexual
p.000236: identity
p.000236: Breast implants Breast reconstruction after total mastectomy
p.000236: Enhancing gender characteristics
p.000236:
p.000236: Enhancing appearance
p.000236:
p.000236: Breast size reduction
p.000236: Treatment of dermatitis Decrease neck pain
p.000236: Enhancing appearance Enhancing athletic performance
p.000236:
p.000236:
p.000236:
p.000236:
p.000236:
p.000236:
p.000236:
p.000236:
p.000237: 237
p.000237:
p.000237: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000237: REPORT
p.000237:
p.000237: c) The “business” of enhancement
p.000237:
p.000237: Human enhancement technologies are an opportunity for businesses to invest in, and may soon become a
p.000237: lucrative industry. Pharmaceutical companies, research institutes, universities and even governments spent
p.000237: and continue to spend huge amounts on drug research and human enhancement technologies. Similarly
p.000237: to the development of pharmaceutical drugs, for which companies invest in research with the ultimate aim to
p.000237: obtain approval and, consequently, to profit from drug sales, research in human enhancement comprises an
p.000237: area for business development. The growing demand for enhancing human characteristics is inseparable linked to the
p.000237: production and supply of such substances and technologies.
p.000237: Typical examples are the drugs Prozac (antidepressant) and Ritalin (prescribed in cases of
p.000237: attention deficit hyperactivity disorder), for which the demand is growing with equivalent profits for the
p.000237: companies producing them, as well as the increasing demand for plastic surgery with corre- sponding
p.000237: economic benefits for those who provide such services (AAAS, 2006). It is certain that non-invasive methods of
p.000237: human enhance-ment, such as drug use, will attract more future investments considering that people are more
p.000237: receptive to them, access is easier through the internet, and they are not regulated as stringent in all countries.
p.000237:
p.000237: 3. The dimension of ethics
p.000237:
p.000237: The possibility of changing properties of the human body by medical means, in order to seek some kind
p.000237: of “enhancement” (as the person interested understands it), poses, in principle, a general
p.000237: question: is “enhancement” a morally acceptable reason for medical interventions within the body or,
p.000237: on the contrary, does it exceed what we mean by “health care”?
p.000237: The affirmative answer to this question could be based on the above mentioned broad definition of
p.000237: health, adopted by WHO. According to this definition, any intervention aiming at the “full development” of
p.000237: human abilities is justified, even if nothing pathological is being treated, i.e. when the organism does not
p.000237: suffer from a disease or accident. In this context,
p.000237:
p.000237:
p.000237:
p.000238: 238
p.000238:
p.000238: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000238: REPORT
p.000238:
p.000238: “enhancement” is part of “health”1.
p.000238: A negative answer to the above posed question is linked to the standard aim of medicine, which is to treat the disease
p.000238: (and generally any damage of the organism). This approach accepts a more moderate definition of health, considering
p.000238: healthy anyone living in a balanced physical state, without presenting with any damages or threatened by
p.000238: -unforeseen or not- damages of the organism. In this context, health is not connected with the
p.000238: development of physical abilities -let alone with any desired change in external features- but simply
...

p.000239: “enhancement” a right of the person who wishes it? Namely, does enhancement fall within the realm of biological
p.000239: autonomy, and indeed, is it an aspect of the fundamental right to health? Regardless of the legal dimension of such
p.000239: issues, the moral concern, here, is actually our ability to treat our body and to intervene freely in its’
p.000239: constitution or not. Even if we answer affirmatively to this freedom on our body, we must wonder to what
p.000239: extent: a) is it binding for the physician to whom we refer (particularly when an enhancement intervention may have
p.000239: adverse effects), and, b) does it allow us to apply enhancement in the field of childcare?
p.000239: Finally, another question concerns our relationships with others, or else, justice. Frequently, enhancement is
p.000239: attempted by someone in order to deal with the various requirements of social environments, especially in
p.000239: rivalry relationships (sports, education, fashion, etc.). Is there a limit imposed by justice? The answer is,
p.000239: of course, affirmative, but it is not clear whether for example, using pharmaceutical agents is fundamentally
p.000239: different from an intensive workout in sports, or the consumption of natural stimulants (coffee, etc.)
p.000239: during class exams.
p.000239: Moreover, the issue of justice relates to the objection expressed for enhancement interventions which are
p.000239: costly, and for which equal access cannot be ensured. If such interventions significantly enhance physical
p.000239: abilities, then, marginally, they may possibly result in unequal opportunities (mainly professional) in social
p.000239: life. Ultimately, individuals who can afford such enhancement interventions may acquire privileged
p.000239: positions. The
p.000239:
p.000239:
p.000240: 240
p.000240:
p.000240: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000240: REPORT
p.000240:
p.000240: option to resolve the problem by covering the enhancement costs through social insurance is not feasible, not only due
p.000240: to the overall, worldwide crisis of the social insurance systems -which, in many cases, led to cuts in
p.000240: absolutely essential coverage- but mainly because the ambiguity of the term “enhancement” (the subjectivity of needs)
p.000240: does not offer a safe ground to plan social services for the general population.
p.000240:
p.000240: 4. The position of Law
p.000240:
p.000240: The general principles concerning human enhancement are identified, firstly, in the constitutional
p.000240: provisions and the provisions of the European Convention on Human Rights (ECHR).
p.000240: The right to develop freely a personality (art. 5 p.1 Constitution), may be considered as the most certain
p.000240: constitutional basis for human enhance- ment, provided that one concludes that the individual right to health (art.
p.000005: 5
p.000005: p. 5 Constitution) covers, in principle, the “narrow” definition of health (see above). However, it would not
p.000005: be unfounded, to cover the issue of enhancement by the right to privacy (art. 9 p.1 section b Constitution,
p.000005: art. 8
p.000005: p.1 ECHR), arguing that human enhancement is related to changes in the core personality.
...

p.000248:
p.000248: The history of conducting experiments in order to enhance the performance of soldiers started
p.000248: almost a century ago. After the use of yperite (also known as mustard gas) during the First World War, there
p.000248: were reports of yperite trials on soldiers in the USA that examined resistance to yperite depending on race. It was
p.000248: just five decades later, in 1991, that the USA government admitted these experiments (Smith, 2008). Reports of
p.000248: experiments with nuclear energy and psychotropic drugs then followed (Parasidis, 2012).
p.000248: However, enhancement of military performance has evolved due to the
p.000248:
p.000248:
p.000249: 249
p.000249:
p.000249: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000249: REPORT
p.000249:
p.000249: possibilities offered by biomedicine and biotechnology. For example, the
p.000249: U.S. Department of Defense and the Advanced Research Projects Agency Defense (DARPA) fund research on
p.000249: pharmaceutical agents that keep soldiers alert, reducing the need for sleep. Research is also conducted on
p.000249: nutrient preparations that fulfill the nutritional needs of soldiers for several days. DARPA’s program
p.000249: “Persistence in Combat” includes the development of a vaccine that would block pain, accelerate wound healing
p.000249: and stop bleeding soon after wounding (Parasidis, 2012).
p.000249:
p.000249: d) Enhancing athletic performance
p.000249:
p.000249: During their preparation, athletes are trained by qualified coaches, they follow a special diet that includes
p.000249: supplements and they have access to physiotherapy in order to improve their athletic performance. However,
p.000249: since professionalism came to be part of sports, the pressure for better athletic performance, imposed by
p.000249: either the athletes’ personal ambitions or by their athletic clubs including their coaches, is stronger.
p.000249: Thus, hard training, even from an early age, seems to be insufficient, and consequently, athletes turn to doping
p.000249: in order to enhance their athletic performance. “Doping” is the most common and oldest form of
p.000249: enhancing sports performance, while nowadays, it has many aspects, e.g. drug doping, gene doping, etc. “Doping” is
p.000249: defined as the use of prohibited substances or methods intended to artificially enhance the sports-racing
p.000249: skills of athletes, both during a game and during the preparation for a game.
p.000249: In 1928, the International Amateur Athletic Federation set the first official ban of substances that
p.000249: enhance athletic performance, despite the lack of relevant methods to detect the substances (House of
p.000249: Commons, Select Committee on Culture, Media and Sport, 2004). In 1967, the International Olympic
p.000249: Committee (IOC) created the Medical Commission aiming to supervise and deal with the problem of doping
p.000249: in the Olympic Games. In 2004, the World Anti-Doping Agency (WADA) undertook the role of the main anti-doping
p.000249: coordinator at an international level. Since then, the banned substances and methods are defined by the List
p.000249: of Prohibited Substances and Methods, which is reviewed annually by WADA and applies to all sports and all
...

p.000253:
p.000253: The use of pharmaceutical agents to enhance physical abilities is associated with both the likelihood
p.000253: of putting the athlete’s health in danger and the corruption of justice in athletic games (doping) or tests.
p.000253: As to the first issue, a person’s autonomy in his/her health is in principle absolute. The imposition of a moral “duty”
p.000253: to take care of the good state of our health and avoid risks, for reasons related to collective interests
p.000253: (the good of our family, our productivity at work, public health or even to avoid extra burden on the public
p.000253: health insurance systems), does not seem justified. On the one hand, such an obligation would drastically restrict
p.000253: the enjoyment of many freedoms (especially in the context of professional and private life). On the other hand,
p.000253: endangerment is a structural feature of today's “risk society”, to the point that it becomes impossible
p.000253: to lead a
p.000253:
p.000253:
p.000254: 254
p.000254:
p.000254: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000254: REPORT
p.000254:
p.000254: “healthy” life. In this sense, there is no essential ethical basis in the criticism of “self-destruction”, at least as
p.000254: far as the concept of autonomy presuppo- ses the rational -and non-arbitrary- use of our freedom.
p.000254: As to the second issue, our relations with third parties set limits on the enhancement of physical abilities by
p.000254: using pharmaceutical agents. Ideally, ensuring equal access to any mean that can enhance performance is a
p.000254: characteristic of justice. If this is not possible, the prohibition of specific means is, in principle,
p.000254: legitimate, in competing procedures (e.g. in education or in sports -especially championship games, where the
p.000254: interests of third parties is stronger).
p.000254: In contrast to pharmaceutical enhancement, interventions in an indi- vidual’s genome are “with no return”,
p.000254: namely they generate permanent effects on the organism. As long as there are relevant applications (as
p.000254: already discussed for championships), the concerns are stronger here, since many gene functions remain mostly
p.000254: unknown. Therefore, genetic mani- pulation imposes a greater risk on the state of the organism. Precisely due to
p.000254: this uncertainty, it is ethically questionable whether genetic manipulation methods are justifiable (“protective
p.000254: principle”) as a form of acceptable options within a person’s autonomy, because under such circumstances the
p.000254: “rational” use of freedom proves problematic. Certainly, however, the matter of providing the necessary and
p.000254: accurate information concerning the use of genetic manipulation methods is crucial.
p.000254:
p.000254: 3. The law
p.000254:
p.000254: Drug administration is subjected to the provisions of the pharmaceutical legislation (Directive 2001/1983, as
p.000254: incorporated by the Ministerial decision DYG 3a/83657/24.1.2006, Law 1316/83, as in force, Law 96/1973, as in
...

p.000268:
p.000268: HUMAN ENHANCEMENT -
p.000268: EFFECT ON COGNITIVE AND MENTAL STATE
p.000268:
p.000268: The Hellenic National Bioethics Commission, as previously announced, continued to examine the issue of “human
p.000268: enhancement”, focusing on the effects of enhancement methods on the cognitive and mental state of the human organism.
p.000268: To study the issue, the Commission held relevant hearings of Dr. G. Christodoulou, Emeritus Professor of
p.000268: Psychiatry, Medical School, Athens University and Honorary President of the Greek Psychiatric Association and Dr. G.
p.000268: Kolaitis, Associate Professor of Child Psychiatry, Medical School, Ath- ens University.
p.000268:
p.000268: I. The data
p.000268:
p.000268: Modern science enabled the development of specific interventions for the “cognitive" functions of the human
p.000268: body, with a main purpose to treat mental illnesses and disorders. However, the possibilities offered by modern science
p.000268: highlight the problem of whether it is legitimate to use such meth- ods in healthy organisms, aiming to enhance the
p.000268: mental or emotional condi- tion.
p.000268: Such methods are particularly: a) selective stimulation of brain regions, with electrical or magnetic signals, and b)
p.000268: drug use. In the future, it is likely that these methods are enriched by targeted genetic modification of genes
p.000268: associated with cognitive functions, as well as by brain/computer interfaces, which is expected to allow access
p.000268: to electronic information -and generally use of computer programs- by just activating certain cognitive functions.
p.000268: The Commission notices that there is internationally, a widespread use of substances by healthy individuals
p.000268: (nicotine, caffeine) or even prescription drugs, with the aim to further enhance their cognitive functions.
p.000268: Users mainly pursue memory and attention enhancement, but also to treat nor- mal hyperactivity, which occurs
p.000268: particularly in children. In addition, the ap- pearance of anxiety or phobias, typical elements of everyday life in a
p.000268: mod-
p.000268:
p.000268:
p.000269: 269
p.000269:
p.000269: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000269: OPINION
p.000269:
p.000269: ern social context, puts pressure on healthy individuals to use sedatives, antianxiety and antidepressant
p.000269: drugs.
p.000269: The Commission considers that, as in the case of enhancing physical characteristics, the autonomy of a
p.000269: healthy person includes options for en- hancing the cognitive or mental state of the human body. This enhancement
p.000269: is part of the right to develop freely a personality.
p.000269:
p.000269: II. Suggestions
p.000269:
p.000269: However, the aforementioned principle must be supplemented with necessary remarks.
...

p.000278: accurate in recording signals, the invasive method poses risks since electrodes are implanted in the brain
p.000278: cortex with possibilities of infection and brain damage.
p.000278: The main objective of brain-computer interfaces is to replace or restore function in patients suffering from
p.000278: neuromuscular diseases, by controlling the movement of prosthetic limbs or a wheelchair. However, such te-
p.000278: chnologies may also be applied to control robots, military vehicles and airplanes, games and virtual
p.000278: environments. According to brain-computer interface experiments, paralyzed patients can control a computer
p.000278: cursor using electrodes28,29,30, allowing the use of brain-computer interfaces for
p.000278:
p.000278: 26Tang YP, Shimizu E, Dube GR, et al. (1999). Genetic enhancement of learning and memory in mice. Nature 401, 63-9.
p.000278: 27Nicolas-Alonso LF, Gomez-Gil J (2012). Brain computer interfaces, a review. Sensors (Basel) 12, 1211-79.
p.000278: 28Hochberg LR, Bacher D, Jarosiewicz B, et al. (2012). Reach and grasp by people with tetraplegia using a neurally
p.000278: controlled robotic arm. Nature 485, 372-5.
p.000278: 29Pereira CA, Bolliger Neto R, et al. (2009). Development and evaluation of a head- controlled human-computer
p.000278: interface with mouse-like functions for physically disa- bled users. Clinics (Sao Paulo) 64, 975-81.
p.000278:
p.000279: 279
p.000279:
p.000279: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000279: REPORT
p.000279:
p.000279: continuous access to the internet, databases and information processing systems, which can enhance the
p.000279: abilities of human mind. Although these technologies are notable, however they must progress in order to
p.000279: achieve precision in manipulating external devices after stimulation of specific brain cells31.
p.000279:
p.000279: ΙΙ. The dimension of ethics
p.000279:
p.000279: 1. Overview
p.000279:
p.000279: Setting aside the general bioethics concern about human enhancement, for enhancement of cognitive and mental
p.000279: characteristics, in particular, it is worth insisting on three issues: a) the safety of interventions on
p.000279: memory functions, b) the safety in a wider range of cognitive and mental functions, and, c) the prospect of equal
p.000279: access to means of enhancement.
p.000279: These specific issues presuppose the general premise that enhancement is a legitimate pursuit for the development of a
p.000279: personality, in the context of self-determination, as long as goods of other people are not put at risk.
p.000279:
p.000279: 2. Memory enhancement
p.000279:
p.000279: Drug use aiming at enhancing specific memory functions, may be challenged as unsafe, when there may
p.000279: be uncertain consequences for other memory functions. There are data showing that, for evolutionary reasons,
p.000279: the various memory functions are not independent, but instead, they are closely linked. Thus, for
p.000279: example, the progressive memory loss of remote events appears to be associated with the speed to recall most
p.000279: recent events, in order to facilitate decision making. In addition, it seems that the ability of symbolic memory, may
p.000279: affect the ability of imaging memory or event memory (Glannon, 76-77).
p.000279: This means that the artificial increase of memory contents is likely to
p.000279:
p.000279: 30Kim SP, Simeral JD, Hochberg LR, et al. (2008). Neural control of computer cursor velocity by decoding motor
p.000279: cortical spiking activity in humans with tetraplegia. J Neu- ral Eng 5, 455-76.
p.000279: 31Robinson JT, Jorgolli M, Park H (2013). Nanowire electrodes for high-density stimu- lation and measurement of neural
p.000279: circuits. Front Neural Circuits 7, 38.
p.000279:
p.000280: 280
p.000280:
p.000280: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000280: REPORT
p.000280:
...

p.000281: choice, given the primacy of personal autonomy (Racine & Forlini, 3).
p.000281: However, two reservations remain:
p.000281: - The consequences of drug use do not cause damage to goods of a third party (e.g. in the context of
p.000281: family life or working environment of the user). Thus, for example, drug use that leads to indifference or threat for
p.000281: the user’s children or creates tension with colleagues etc., is illegitimate).
p.000281: - The user has actually made the decision freely, i.e. after providing the appropriate information to him/her, with
p.000281: all the potential risks being identified (Cakic, 613-614, Racine & Forlini, 3, Farah et al., 423). This is not certain,
p.000281: especially when the drugs are administered without a prescription or, at least, without consulting a physician.
p.000281: The re- sponsibility of the latter, here, is certainly increased, as it is about enhancing cognitive or
p.000281: mental characteristics and not about restoring relevant health damage.
p.000281:
p.000281:
p.000282: 282
p.000282:
p.000282: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000282: REPORT
p.000282:
p.000282: 4. Equal access
p.000282:
p.000282: The issue of equal access to means of cognitive or mental enhancement is mainly associated with the
p.000282: opportunities offered in competitive environments (Farah et al., 423) and, secondly, with improvement
p.000282: of our lifestyle. This is an issue of concern which is similar to that of enhancing physical abilities
p.000282: (e.g. doping in sports).
p.000282: Here, enhancement is usually associated with memory or concentration, especially during challenges in education or
p.000282: work. The general principle that wants to prevent distortion of rivalry is valid here, but it constitutes a
p.000282: “defensive” attitude. Equal access means, mainly, that anyone who desires it is able to use substances, under the two
p.000282: reservations mentioned above.
p.000282: An objection here would be that equal access does not exist anyway, regarding the conventional ways to
p.000282: enhance cognitive performance, namely through education or training. Pupils, students or employees have strongly
p.000282: differentiated possibilities of access to adequate education, mainly because of the economic inequality, which
p.000282: significantly affects their opportunities. Generally, equal opportunities presuppose equality to
p.000282: material means, which is practically impossible.
p.000282: On the other hand, one could argue that substance use may be an option to restore the general inequality of access to
p.000282: conventional means. Thus, for example, a student with artificially enhanced memory capacity and
p.000282: concentration could cover gaps with his/her own effort, gaps that his/her socially and economically
p.000282: “'privileged'” classmates cover with expensive teaching methods. The same applies to an employee who is a candidate
p.000282: for a better position, and objectively cannot devote the same time to study compared to a well-trained
p.000282: new candidate for the same position. Nevertheless, this argument would not be convincing. For the reason
p.000282: that, on the one hand, one cannot prevent the use of substances by “privileged” people and therefore restoring
p.000282: inequality, and on the other hand, one would encourage the easy, but temporary, way of going
p.000282: through meritocratic procedures instead of constantly trying to cultivate cognitive abilities (Farah et al.,
p.000282: 424). In fact, the concern of doping in sports applies here as well.
p.000282: In general, one must not overlook that -at least with the current data- the use of enhancement substances
p.000282: has temporary effects and does not
p.000282:
p.000282:
p.000283: 283
p.000283:
p.000283: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000283: REPORT
p.000283:
p.000283: replace the solid acquisition of knowledge through education. But overall, the use of such substances
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p.000009: medical mark- ers.
p.000009:
p.000009: 3. Ethical issues
p.000009:
p.000009: a. Protection of personality and economic freedom
p.000009: In view of the above, the first emerging ethical issue consists in weighing protection of personality for insurance
p.000009: applicants against freedom of busi- ness for insurers.
p.000009: Disclosure of genetic information -similarly to other health-related in- formation- as a requirement for
p.000009: contracting insurance or as a factor in the
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000010: OPINION
p.000010:
p.000010: calculation of premium goes to the core of personality since this information constitutes sensitive personal data.
p.000010: Considering that genetic data is in prin- ciple unchangeable, to reveal a predisposition for a disease may lead to
p.000010: life- long “stigmatization” of the applicant, a serious infringement on personality that may take the form of unfair
p.000010: social discrimination.
p.000010: On the other hand, freedom of business for the insurer is apparently restricted if access to genetic data
p.000010: known to the other party may affect sig- nificantly the insurer’s business risk. In the context of freedom of contract,
p.000010: barring access to information which is relevant to the object of the specific insurance could be seen as unfair to
p.000010: insurers since they are exposed to a risk they ignore whereas the other party is aware (and perhaps takes advantage)
p.000010: of.
p.000010:
p.000010: b. The value of genetic data and the risk of “genetic determinism”
p.000010: Genetic data is a very useful tool in contemporary medicine. In the con- text of personalized medicine and
p.000010: pharmacogenomics, in particular, person- al genetic data is becoming increasingly important for determining
p.000010: thera- peutic treatment. It is therefore of paramount importance that the collec- tion of genetic data,
p.000010: which can contribute to improvement of individual health, is not obstructed for non-medical reasons.
p.000010: The collection of genetic data for research aiming to identify links be- tween diseases and genetic
p.000010: causes with the ultimate goal to identify new treatment targets is crucial for the advancement of science and,
p.000010: in the long run, for the protection of public health. In this case also, it is critical that
p.000010: participation in such research is not discouraged for fear of use of genetic data or of the findings of research to
p.000010: the detriment of participants.
p.000010: Despite the significance of genetic data for both personal and public health, its prognostic value should
p.000010: not be overrated in order to avoid the impression that genetic tests are decisive for the individual. The use
p.000010: of ge- netic data in insurance would reinforce the misleading notion of “genetic determinism”, i.e. the
...

p.000196: These specific companies are content with a simple disclosure of the test results. Frequently, there is an
p.000196: impersonal interpretation of the findings
p.000196:
p.000196:
p.000197: 197
p.000197:
p.000197: DIRECT-TO-CONSUMER GENETIC TESTING
p.000197: OPINION
p.000197:
p.000197: using special algorithms and softwares, which take into account the litera- ture and the lifestyle information provided
p.000197: by the consumer after complet- ing a questionnaire. Occasionally, the companies offer genetic counseling by demand and
p.000197: at an additional cost. In that case, genetic counseling is provid- ed without direct contact with the counselor,
p.000197: whereas in a few cases the companies recommend disclosure of the results to the person’s doctor, who will evaluate
p.000197: the findings. Thus, in many cases a huge amount of information is available to the users or recipients of the genetic
p.000197: service, who are unable to utilize or even understand the findings.
p.000197: Most of the companies do not specify the fate of the genetic samples,
p.000197: i.e. whether they are destroyed or stored after completing the genetic anal- ysis, or even whether they are used for
p.000197: other purposes, such as research. In some cases, the genetic tests are offered with a discount, provided that the
p.000197: person will consent to use his/her genetic data for research purposes.
p.000197:
p.000197:
p.000197: II. The law
p.000197:
p.000197: The Commission notes the complexity of the legal framework governing DTC genetic testing.
p.000197: In genetic tests for medical reasons, applicable provisions are those con- cerning the constitutional right to health,
p.000197: which allows to everybody to have free access to information concerning his/her health (article 5, paragraph 5
p.000197: Constitution), as well as the provisions implementing this right in order to protect an individual (adequate
p.000197: information, protection of sensitive data according to the Law 2472/1997). In addition, article 12 of the
p.000197: Convention on Human Rights and Biomedicine (Law 2619/1998), which requires genetic counseling, also applies in genetic
p.000197: tests for health purposes.
p.000197: In prenatal genetic tests, article 14 of the same Convention prohibits selection of an embryo for non-health
p.000197: reasons.
p.000197: Finally, for genetic tests undertaken to identify a person, judicial authori- zation is required under the current
p.000197: legislation (e.g. articles 1477 Civil Code, 615 Code of Civil Procedure).
p.000197: Moreover, the provisions concerning the economic freedom and its con- straints (article 5, paragraph 1 Constitution),
p.000197: especially those aiming to pro-
p.000197:
p.000197:
p.000197:
p.000198: 198
p.000198:
p.000198: DIRECT-TO-CONSUMER GENETIC TESTING
p.000198: OPINION
p.000198:
p.000198: tect the consumer (Law 2251/1994) are applied in all types of genetic test- ing.
p.000198: However, one must not overlook that the above mentioned provisions are broad, and there is no special
p.000198: legislation governing this specific activity, both in Greece and most European countries. Absence of a
p.000198: relative law means that anyone can offer DTC genetic services in an unrestricted and uncontainable manner,
...

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p.000017: European populations (except among the Finns). The incidence is significantly lower in Japan, China and black
p.000017: Africans (Warby, Graham and Hayden, Table 2). The HD (IT15) gene is involved in this condition and the disease is
p.000017: inherited in an autosomal8 and dominant man- ner. The available genetic test detects the alleles of gene HD9 in the
p.000017: person undergoing the test.
p.000017: In the case of Huntington’s disease, genetic testing can answer with near certainty to whether someone, with relevant
p.000017: family history, will develop the
p.000017:
p.000017: 8 The responsible gene for the disease is situated in an autosomal, not a sexual, chromosome. Therefore,
p.000017: there is no difference in heredity between the sexes. See report on genetic data.
p.000017: 9 The test is based on DNA analysis with the PCR or the Southern hybridization meth- od and the number of repeats
p.000017: in a nucleotide triplet. The penetrance of the allele depends on the number of repeats. HD alleles are
p.000017: classified into three categories: Normal, intermediate and HD-causing.
p.000017:
p.000018: 18
p.000018:
p.000018: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000018: REPORT
p.000018:
p.000018: disease or not. The available genetic test detects the disease-causing alleles with an accuracy of 100%. However,
p.000018: it cannot predict with certainty the time of disease onset. Since there is currently no treatment for this condi-
p.000018: tion, identifying someone as a carrier has no prophylactic value.
p.000018:
p.000018: ii. Early Onset Familial Alzheimer, EOFAD
p.000018: The early onset alzheimer, like common Alzheimer, is a form of slow- progressing dementia, manifested prior
p.000018: to the age of 65 and represents less than 3% of all Alzheimer cases (Bird, 2007, Table 2). The genetic association for
p.000018: the disease seems strong since, of all the early onset alzheimer cases, 61% of patients have relevant family
p.000018: history and 13% have relatives in three generations that developed the disease. Early onset alzheimer is manifested in
p.000018: 41.2/100,000 people aged 40-59.
p.000018: The involvement of three genes has been identified, PSEN1, PSEN2, APP (Table 2). In all EOFAD cases heredity is
p.000018: autosomal and dominant. Genetic tests have been developed and are used clinically to detect disease-causing mutations
p.000018: for all three genes. The highest numbers of positive scores in EOFAD patients are achieved by tests
p.000018: detecting mutations in the PSEN1 gene. The evaluation of genetic tests for EOFAD is not as simple as
p.000018: in the test for Huntington’s disease since the available tests do not detect all the mutations and in some patients
p.000018: the test yields a negative score. Neverthe- less, penetrance of PSEN1 gene (AD3) mutations is complete whereas pene-
p.000018: trance of PSEN2 (AD4) mutations is 95%, i.e. if one of the disease-causing mutations is identified in a
p.000018: healthy subject the manifestation of the disease is almost certain.
p.000018:
p.000018: iii. BRCA1 and BRCA2 Hereditary Breast/Ovarian Cancer
p.000018: Mutations in BRCA1 and BRCA2 genes have been found to predispose for breast, ovarian, prostate and other cancers
p.000018: (Pertucelli et al., 2007, Table 2). There are genetic tests that detect mutations in these genes but the reliabil- ity
p.000018: of the test and the evaluation of the results are complex, more so than in the case of EOFAD mentioned above. Due to a
p.000018: multitude of disease-causing mutations for both genes, there is no single test capable of detecting all of them.
p.000018: For a healthy individual with a family history of this category of cancers it is important to know which mutation
p.000018: occurred in those family members that
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000019: REPORT
p.000019:
p.000019: developed cancer. Calculation of the penetrance of the mutations of genes BRCA1 and BRCA2 is not a simple task, as
p.000019: different mutations have different penetrance and the likelihood of cancer varies in different age groups. For example,
p.000019: the probability of breast cancer in BRCA1 mutations ranges from 3.2% (at the age of 30) to 85% (at the age of 70). The
p.000019: probability is similar for BRCA2 mutations.
p.000019: The likelihood of ovarian cancer is lower. The availability of several calcu- lation models for the probability of
p.000019: cancer in case disease-causing mutations are detected, which vary significantly in their predictions, is a
p.000019: sign of the complexity of the evaluation of the test results. Another important factor is that a negative score in
p.000019: the genetic test does not mean that the subject will not develop the specific cancers, only that the risk is not higher
p.000019: as compared with the general population. Finally, a positive score in a healthy subject practically means
p.000019: that the person in question must undergo more frequent examinations but it makes no difference in terms of
p.000019: treatment if cancer does occur.
p.000019: In brief, testing for BRCA1/2 gene mutations is complicated and great caution is required in the choice of
p.000019: the detection method as well as in the evaluation of the result.
p.000019: In conclusion, although most genetic tests cannot predict the manifesta- tion of a genetic disease with certainty, they
p.000019: have considerable prophylactic value for the person undergoing the test. By identifying a predisposition for cancer,
p.000019: for example, one can be protected by regular medical examinations for early identification and treatment of tumors. It
p.000019: is well documented that early diagnosis saves lives in such situations.
p.000019:
p.000019: B. Genetic testing laboratories
p.000019:
p.000019: There are at least 611 certified genetic laboratories worldwide that are registered with the reliable network GeneTest.
p.000019: Greece has one certified ge- netic laboratory10. However, other public or private laboratories carry out
...

p.000024: b) Are there any collective interests, aside from the individual interests of the two parties that should be taken into
p.000024: account in this balancing?
p.000024:
p.000024:
p.000025: 25
p.000025:
p.000025: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000025: REPORT
p.000025:
p.000025: A. Business risk and protection of personality
p.000025:
p.000025: 1. In general, private insurance is a business activity governed by the principle of reciprocity. The basic
p.000025: idea consists in sharing the risk by a group of individuals who are equally likely to suffer damage which would be
p.000025: unaf- fordable to the individual person: by paying premiums, a large number of insured cover the expenses
p.000025: the insurer will have to bear for the harm suf- fered by one of the insured in question (and underwritten by the
p.000025: insurer). This idea presupposes that the insurer -just as any other businessman- also assumes part of the risk arising
p.000025: from the occurrence of unpredicted events.
p.000025: With regards to life and health insurance in particular (including insur- ance for professional
p.000025: incompetence), the insurer’s risk consists in the occur- rence of damage from disease or accident to the insured. In
p.000025: these cases, the calculation of the premium by the insurer is based on statistics on the prob- ability of risk in
p.000025: population groups with common characteristics (e.g. sex, age, lifestyle). Such data include information on
p.000025: health, which the insurer requests from the insured. This information consists of the medical history (of the
p.000025: individual and/or their family) and may include new medical tests. The more accurate the information the
p.000025: more accurate the prediction. By contrast, the poorer the information, the greater the risk for the insurer. In the
p.000025: latter case, if insurance is not wholly unattractive in business terms, the insurer will try to hedge the risk by
p.000025: increasing the premium based on past data for a similar group.
p.000025: 2. But this purely economic calculation does not settle the issue, for life and health insurance cannot be
p.000025: assimilated to just any other commercial service or commodity. The nature of health information requested
p.000025: by the insurer being sensitive personal data, it goes to the core of the personality of the insured. Any illicit
p.000025: disclosure or other processing of this information may, in view of its nature, result in drastic restriction of
p.000025: individual freedoms, even in violation of human value.
p.000025: Here, we have to enter two caveats, typical of the differentiation be- tween health and other types of
p.000025: information:
p.000025: i) The “right of ignorance” pertaining to the subject of health infor- mation, i.e. a person may not
p.000025: wish to be informed of data concerning his/her health in order to go on with his/her life undisturbed
p.000025: (Nationaler Ethikrat 2007: 28-29). The disclosure of this information to the insurer as a
p.000025:
p.000025:
...

p.000035: Duchenne muscular dystrophy
p.000035:
p.000035: Epilepsy Essential tremor
p.000035: Fragile X syndrome Friedreich’s ataxia Gaucher disease Huntington diseases Lesch-Nyhan syndrome
p.000035: Maple Syrup Urine Disease Menkes syndrome Myotonic dystrophy Narcolepsy Neurofibromatosis Niemann-Pick disease
p.000035: Parkinson disease Phenylketonuria
p.000035: Prader-Willi syndrome Refsum disease
p.000035: Rett syndrome
p.000035: Spinal muscular atrophy Spinocerebellar ataxia Tangier disease
p.000035: Tay-Sachs disease Nodular sclerosis
p.000035: Von Hippel-Lindau syndrome Wilson’s Syndrome Zellweger syndrome
p.000035: Nutritional and metabolic diseas- es
p.000035: Adrenoleukodystrophy Diabetes, type 1 Gaucher disease
p.000035: Glucose galactose malabsorption Hereditary haemochromatosis Lesch-Nyhan syndrome
p.000035: Maple Syrup Urine Disease Menkes syndrome Niemann-Pick syndrome Obesity
p.000035: Pancreatic cancer Phenylketonuria Prader-Willi syndrome Porphyria
p.000035: Refsum disease Tangier disease Wilson’s disease Zellweger disease
p.000035: Respiratory diseases
p.000035: α-1-antithrypsine deficiency Asthma
p.000035: Cystic fibrosis
p.000035: Small cell lung carcinoma
p.000035: Skin and connective tissue dis- eases
p.000035: Androgenic alopecia Diastrophic dysplasia
p.000035: Ellis-van Creveld syndrome Marfan syndrome Malignant melanoma Menkes syndrome Porphyria
p.000035:
p.000036: 36
p.000036:
p.000036: USE OF GENETIC DATA IN PRIVATE INSURANCE REPORT
p.000036:
p.000036: Table 2. Examples of genetic diseases for which a genetic predisposition test exists.
p.000036:
p.000036:
p.000036:
p.000036: Disease
p.000036: Gene/s, genetic region
p.000036:
p.000036: Power
p.000036: of detection
p.000036:
p.000036: Incidence in the general Penetrance Age at onset population
p.000036:
p.000036: Cost* (euros)
p.000036:
p.000036: Huntington’s Disease
p.000036: HD
p.000036: (IT 15), 4p16.3
p.000036: 100% 3-7/100,000 (varies depending on ethnic origin)
p.000036: 36-39
p.000036: repeats: strong probability, >40
p.000036: repeats: 100%
p.000036: 35-44 165
p.000036:
p.000036: Early-Onset Alz-
p.000036: PSEN1,
p.000036: 5-70% depend- 41.2/100,000 AD3 (PSEN1): 100%,
p.000036: 40-59 490-
p.000036:
p.000036: heimer
p.000036: 14q24.3
p.000036: ing on the
p.000036: AD4 (PSEN2): 95%
p.000036: 4,400
p.000036:
p.000036: (EOFAD)
p.000036: PSEN2, 1q31- method q42 APP
p.000036: 21q21
p.000036:
p.000036: Hereditary Breast/
p.000036: BRCA1,
p.000036: >88% in fami-
p.000036: 1/500-1/1,000 carries a
p.000036: 3.2-85% Significant
p.000036: 30-70 390-
p.000036:
p.000036: Ovarian Cancer
p.000036: 17q21
p.000036: lies with
p.000036: genomic mutation (>1% differences depend-
p.000036: 1,900
p.000036:
p.000036: BRCA2, 13q12.3
p.000036: confirmed association with BRCA1/2
p.000036: in Ashkenazi Jews)
p.000036: ing on age, type of mutation, type of cancer and model of calculation
p.000036:
p.000036: Thrombosis Risk
p.000036: F5, 1q23 100% 10-15% heterozygotes
p.000036: 0.19%-0.45% per year The disease may 55
p.000036:
p.000036: Factor (Leiden V factor)
p.000036: in Greece (1/5,000 homozygotes)
p.000036: - 0.10% for non- carriers of the muta- tion
p.000036: be manifested also after 60
p.000036:
p.000036: Muscular dystro-
p.000036: DMD Xp21.2 6-85% depend- 1/5,000 births of male
p.000036: 100% in males, varies Symptoms from
p.000410: 410
p.000410:
p.000410: phies (e.g. Du- chenne, Becker)
p.000410: ing on the method
p.000410: infants
p.000410: in females (8% cardiomyopathy)
p.000410: the age of 2, immobility in adolescence. Dilative cardio- myopathy after 40 in female heterozygotes
p.000410:
p.000410: Haemochromatosis HFE, 6p21.3 60-90% 1/200-1/400 homozy-
p.000410: gotes, 11% carriers of the gene
p.000410: Depending on geno- type: from 0.5% to nearly 100%
p.000410: 40-60 (males), after menopause (females)
p.000410: 80-1,100
p.000410:
p.000410: Autosomal Domi- nant Polycystic Kidney Disease
p.000410: PKHD1, 6p21.1-p12
p.000410: 2-75% 1/20,000-2/40,000 100% From birth or childhood
p.000410: 775-
p.000410: 7,700
p.000410:
p.000410: Familial Mediterra- MEFV,
p.000410: 70-90% 1/3-1/7 carriers (they
p.000410: Unknown, probably
p.000410: 2-25 usually 290-440
p.000410:
p.000410: nean Fever
p.000410: Amyotrophic Lateral Sclerosis
p.000410: 16p13
p.000410: Many and varying
p.000410: do not manifest the disease)
p.000410: 3-20% 4-8/100,000 (90%
p.000410: without family history)
p.000410: underdiagnosed
p.000410: Unknown 40-60 400
p.000410: *From the network diagnogene (www.diagnogene.com). The cost varies depending on the number of tested mutations.
p.000410:
p.000410:
p.000410:
p.000410:
p.000410:
p.000410:
p.000410:
p.000410:
p.000410:
p.000410:
p.000037: 37
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000037:
p.000038: 38
p.000038:
...

p.000086: Convention was ratified both by the EU and our country (Law 2204/1994).
p.000086: The “precautionary principle”, in particular, places a limit to biotechno- logical research even when the risk
p.000086: against the environment or health re- mains uncertain. In this sense, this principle is different -more
p.000086: conservative- than the “prevention principle” which would impose limits only against a very high likelihood
p.000086: of risk. The precautionary principle has been broadly established especially in the law governing modern
p.000086: biotechnology.
p.000086: The scope of the Cartagena Protocol is more limited and concerns the safe traffic and use of genetically
p.000086: modified organisms for the protection of the environment and health. This instrument was ratified by
p.000086: Law 3233/2004.
p.000086:
p.000086: Other Conventions
p.000086:
p.000086: There are many binding instruments of international law covering specif- ic issues of biodiversity protection. The most
p.000086: important that are relevant to our topic are:
p.000086: - The Convention on the protection of wetlands of international im- portance (Ramsar Convention 1971,
p.000086: legislative decree 191/1974) as modified (Paris 1982, Law 1751/1988, Regina, Canada 1987, Law
p.000086: 1950/1991).
p.000086: - The Convention on the protection of world cultural and natural herit- age (Paris Convention 1972, Law 1126/1981).
p.000086:
p.000086:
p.000086:
p.000087: 87
p.000087:
p.000087: MANAGEMENT OF BIOLOGICAL WEALTH
p.000087: REPORT
p.000087:
p.000087: - The Convention on the protection of plants (Rome Convention 1951, Law 2014/1992).
p.000087: - The Agreement on tropical timber (Geneva Agreement 1983, Law 1761/1988).
p.000087: - The Convention on trade in endangered species of wild fauna and flora (Washington Convention 1973, Law 2055/1992).
p.000087: - The Convention on the conservation of European wildlife and natural habitats (Berne Convention 1979, Law
p.000087: 1335/1983).
p.000087: - The Convention on the conservation of migratory birds of wild fauna (Bonn Convention 1979, Law 2719/1999).
p.000087: Issues related to the management of biological wealth, such as the pro- tection of natural resources (water), pollution
p.000087: and the use of energy are also covered by special international Conventions.
p.000087:
p.000087: Non-binding instruments
p.000087: Significant international soft law instruments on our topic are the UN Declaration on the Environment
p.000087: (1972) which recognizes for the first time the duty to future generations, as well as the afore mentioned UNESCO
p.000087: Dec- laration on the responsibilities to future generations (1997).
p.000087:
p.000087: EU Law
p.000087: EU law (which applies as domestic law) is also extensive.
p.000087: The principle of sustainable development is enshrined explicitly in art. 6 of the EC Treaty whereas art. 174 on the
p.000087: environment declares as an objec- tive “the prudent and rational utilisation of natural resources” and refers to the
p.000087: precautionary and the preventive action principles, to the rectification of damage preferably at source and to “the
p.000087: polluter pays” principle.
...

p.000115: in connection to the condition of health or to the offered methods of treat- ment from the patient4. Two
p.000115: questions arise in this respect:
p.000115: i. If the physician believes that, by learning the “complete” truth, the patient will be either discouraged from
p.000115: receiving treatment or affect- ed to such extent that it becomes threatening for his/her condition, can the information
p.000115: be limited or -in extreme cases- may the physi- cian even misinform the patient5?
p.000115:
p.000115: 4 Insofar as the “truth” appears clear to the physician, of course. The issue here is not whether the information
p.000115: provided by the physician is true but whether the physician himself/herself consciously tries to mislead the patient,
p.000115: see Higgs (2001).
p.000115: 5 A related question is whether the “complete” truth includes the physician’s personal doubts or even a statistically
p.000115: insignificant risk of serious harm to health or of death, elements that may nevertheless have a critical impact on the
p.000115: patient’s condition.
p.000115:
p.000116: 116
p.000116:
p.000116: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000116: REPORT
p.000116:
p.000116: ii. In such event, may the physician choose to inform the patient’s rela- tives instead so that they may decide6?
p.000116: A further complication arises when the available alternatives do not clearly indicate the treatment of
p.000116: choice because they may be associated with serious side effects, critical perhaps for the overall quality of life
p.000116: of the patient (e.g. chemotherapy, radiotherapy, amputation, etc.). For patients of advanced age, in particular, even
p.000116: the normal side effects of an “aggressive” treatment may prove disproportionate in comparison with the real expected
p.000116: benefit.
p.000116: The relevant question here is whether information should be limited to a “neutral” presentation of alternatives or
p.000116: it should be accompanied by the physician’s evaluation for the particular patient. This question is again relat-
p.000116: ed to “completeness” of information in the sense of the law.
p.000116: A “neutral” presentation, if “complete”, leaves the appraisal of the situa- tion to the patient since only the patient
p.000116: can balance the benefits and losses for his/her quality of life. This burden, however, may prove difficult to bear for
p.000116: someone who is not able to think soberly about his/her condition. On the other hand, the physician’s
p.000116: evaluation may offer valuable help in the final decision by the patient; but this must necessarily arise from
p.000116: statistics - which do not take the particular patient into consideration- and, ultimately, from an “intuitive”
p.000116: perception of what is “best” in concreto, i.e. factors not immune to error.
p.000116:
p.000116: b) Problems pertaining to consent
p.000116:
p.000116: Problems pertaining to consent itself arise in the relationship physician- patient in case of incapacitated patients:
p.000116: First, as to the derogations from informed consent accepted by the CME (art. 12[3]), there is the question of
p.000116: whether a patient’s relatives may, in general, refuse treatment and to what extent are they allowed to do so. The
...

p.000119: unless patients refuse the information by exercising their right not to know. But patient information is not limited to
p.000119: those cases where patients need to consent to a medical act. It also includes the patient’s right to know the
p.000119: state of his/her condition to the extent he/she so wishes. This knowledge will eventually help patients to make
p.000119: all sorts of decisions about their lives and satisfy their need for sound medical information on their condition,
p.000119: regardless of whether they will use this in- formation to make medical decisions.
p.000119: What is the usual practice, however? Do physicians actually inform will- ing patients on their condition, and the
p.000119: diagnosis and prognosis of their ill- ness? Are patients willing to be informed, even when the diagnosis is about a
p.000119: serious, or even incurable, disease or do they rather not know? Is it ac- ceptable that physicians
p.000119: inform the relatives first and then the patient? What is appropriate information in terms of its content
p.000119: and the way it is imparted and how well trained are physicians and nurses to convey this in- formation to those
p.000119: concerned?
p.000119: These questions do not always have easy answers and have being debat- ed for years by physicians, philosophers,
p.000119: jurists, sociologists and other ex- perts. The “best” answers -as will become evident below- often vary accord- ing
p.000119: to the particular conditions of countries, the cultural traditions of social groups within the same country and the
p.000119: personality, age, gender and educa- tion of patients themselves.
p.000119: There is plenty of international literature both on what patients want and on the perceptions of the
p.000119: medical community on honesty and infor- mation (review by Herbert et al., 1997; Tuckett, 2004). This
p.000119: literature is based on research conducted on different severe or incurable diseases in various countries,
p.000119: age groups and nationalities. The most frequently used example is the attitude of patients and physicians to
p.000119: disclosure of diagnosis in case of cancer. Other entities have also been investigated like Alzheimer’s and multiple
p.000119: sclerosis.
p.000119:
p.000119:
p.000119:
p.000119:
p.000119:
p.000120: 120
p.000120:
p.000120: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000120: REPORT
p.000120:
p.000120: a) International experience
p.000120: One of the first studies attempting to record the views of the medical community on patient information
p.000120: conducted in the early ’60s in the US showed that the overwhelming majority of physicians (90% in a sample of
p.000120: 219 people) did not disclose the diagnosis of cancer to their patients (Oken, 1961). A study on the same topic carried
p.000120: out approximately 20 years later marked a radical change in the views of the US medical community. In a
p.000120: total reversal of the results of the previous study, 97% of the interviewees stated that they reveal the diagnosis to
p.000120: their patients (Novack et al., 1979). A similar turn was witnessed in the other Anglo-Saxon countries.
p.000120: This turn-about in the views of the medical community followed in time the desire of patients to know the truth. In a
p.000120: study published in 1957 involv- ing 560 cancer patients and their families, the participants in their great ma- jority
p.000120: (87%) argued that patients should be informed that they suffer from cancer (Samp and Curreri, 1957). Subsequent
p.000120: research on multiple sclerosis (before any treatment became available) (Elian and Dean, 1985) and Alz-
p.000120: heimer’s disease (Erde et al., 1988) also reported an increasing wish among participants to know the truth about their
...

p.000126: circumstances. See generally on the problem of “irrational”
p.000126:
p.000127: 127
p.000127:
p.000127: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000127: REPORT
p.000127:
p.000127: In these circumstances acting alone is again not justified for physicians except in emergency situations. They must
p.000127: concentrate their efforts on the speedy recovery of the patient’s mental lucidity so that the patient can be informed
p.000127: in time and decide about treatment by himself/herself. Besides, it is not legitimate to substitute the patient’s
p.000127: relatives for the patient’s own will for patients may disagree with their relatives’ decision once their mental
p.000127: capacities are restored.
p.000127: Respectively, persons who are legally incompetent to consent may be physically fully capable of forming and
p.000127: expressing their will on matters con- cerning their health. We already mentioned the example of minors, espe-
p.000127: cially from the beginning of adolescence; similar, however, is the situation of persons under legal guardianship
p.000127: (even full-fledged) whereas mild mental disorders or impairments do not by definition exclude the exercise of self-
p.000127: control over one’s health.
p.000127: In the case of minors, it would be more appropriate to recognize their capacity for self-consent after a certain
p.000127: age (thus precluding consent by the minor’s legal representatives) for there is an objective presumption of suffi-
p.000127: cient maturity in contemporary societal life that can hardly be put in ques- tion (e.g. from the age 15 years).
p.000127: Meanwhile the assent of minors must be given considerable weight in relevant decisions, especially if coinciding with
p.000127: the physician’s advice, even when the parents disagree.
p.000127: For adults, it is difficult to assume a similar objective presumption. Therefore, the view of the concerned
p.000127: person must be given particular atten- tion (as must the appropriateness of prior information) and evaluated on a
p.000127: case-by-case basis although the power of legal representatives to decide cannot be questioned.
p.000127: The problem of advance directives is a much harder nut to crack. The event of becoming incompetent to
p.000127: consent often leads people to issue di- rections on how they wish to be treated ahead of time. These directions are
p.000127: usually addressed to close relatives or close friends, or even to the physi- cian, if one is already ill.
p.000127: They are usually informal (oral and eventually with no witnesses) but some countries have provided a modality to
p.000127: safeguard the validity of their will (“living wills”). Usually, these directions are about the refusal of
p.000127: certain unpleasant or painful treatments (e.g. haemodialysis, car-
p.000127:
p.000127: decisions by patients capable to consent and on the mental faculties, which are criti- cal for consent (Elliot, 2001).
p.000127:
p.000128: 128
p.000128:
p.000128: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000128: REPORT
p.000128:
...

p.000140: established scientific requirements for clinical trials of new treatments (vaccines or medicines) may not be
p.000140: bypassed in order to
p.000140:
p.000140:
p.000140:
p.000141: 141
p.000141:
p.000141: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000141: OPINION
p.000141:
p.000141: accelerate the availability of such treatments to the public. Otherwise their efficacy will remain uncertain and
p.000141: citizens will be misinformed as a result.
p.000141: In addition, the Commission thinks that in the exceptional circumstances of epidemics or pandemics, limits to
p.000141: patents on new treatments could be justified to the extent possible. Such limits could be argued as a legal/policy
p.000141: choice in competent international and supra-national fora.
p.000141:
p.000141: c) Treatment
p.000141: The treatment of those infected should also be based on informed con- sent. Forced treatment is not justified in
p.000141: principle, except in “emergency situations”.
p.000141: When the number of medical and nursing staff or the available treat- ments do not suffice to ensure care to
p.000141: all those infected (especially in case an infection spreads rapidly) the Commission stresses that the government must
p.000141: establish in advance general priority rules for access to treatment. The basic priority criteria should preferably be
p.000141: prescribed by law. By way of indi- cation, such priority criteria may include the severity of symptoms, the age of the
p.000141: patient and the definition of relevant vulnerable groups.
p.000141:
p.000141: 2. Limits to autonomy on public health grounds
p.000141:
p.000141: a) General rule
p.000141: Limits to the general autonomy of patients -especially the freedom of movement and establishment- are
p.000141: justified only if they are absolutely in- dispensable to protect public health pursuant to the Constitution
p.000141: (arts. 5 [4], 25 [1]). The principle of proportionality as discussed above applies in all circumstances. For
p.000141: example, hospitalized patients should be restricted in specially contained facilities.
p.000141:
p.000141: b) The risk of social stigma
p.000141: The Commission stresses the risk of social stigma that may arise from the isolation (“ghetto-ing”) of specific
p.000141: sub-populations with distinctive cultural characteristics or ways of living when an infectious disease erupts
p.000141: within such groups.
p.000141:
p.000141:
p.000141:
p.000141:
p.000142: 142
p.000142:
p.000142: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000142: OPINION
p.000142:
...

p.000150: -should this objection be sustained- would be to impose other restrictions to protect others, e.g. limits to the
p.000150: freedom of circulation and installation, not involving forced treatment. A solution more compatible with
p.000150: autonomy in view of the above would be to leave the choice of preferred option to the one concerned.
p.000150: At any rate, with the exception of emergencies which leave no time for government intervention -in which case it is
p.000150: ethically justified to leave the initiative to physicians- autonomy does not evaporate before public interest.
p.000150: Particularly in case of mild diseases or hard to transmit diseases, the obliga- tion to respect autonomy remains fully
p.000150: effective.
p.000150:
p.000150: 3. Scope of medical duty
p.000150:
p.000150: When public health is at risk from a contagious disease, objective pa- rameters -time, in particular- often
p.000150: prevent the unhindered practice of med- icine. In such cases, physicians must set health care priorities,
p.000150: which may result in depriving certain people from care. The availability of physicians is obviously an external sine
p.000150: qua non for exercising patient autonomy.
p.000150: The necessities of war can offer a precedent for such prioritization. Since World War I, a three-fold division of the
p.000150: population in terms of priority (“tri- age”), based on the probability of cure is generally accepted: those
p.000150: in im- mediate need of help come first; next follow those who can be transported to a hospital even if more seriously
p.000150: hurt, and last are those with minor inju- ries or few chances of survival. But one may think of other
p.000150: considerations
p.000150:
p.000150:
p.000151: 151
p.000151:
p.000151: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000151: REPORT
p.000151:
p.000151: (e.g. priority to those who will treat others, to the young or the elderly, even a “first come first served” approach).
p.000151: Although “triage” is mostly associated with war (and natural disasters or train derailments) its core concept can be of
p.000151: use also in case of epidemics.
p.000151: At all events, health care priorities must be set by public authorities in advance on the basis of fixed rules in
p.000151: order to prevent physicians from hav- ing to make so many ethically questionable judgments.
p.000151:
p.000151: 4. Special issues: Clinical trials, patents
p.000151:
p.000151: The urgent need for prevention and treatment in times of epidemics painfully illustrates the question of
p.000151: the adverse effects of trials of new treatments (medicines, vaccines) to contain the risk.
p.000151: Given that clinical trials are now subjected to a specific control proce- dure, ensuring the safety of
p.000151: volunteering participants and of the end- product before it becomes available to the public, at issue is
...

p.000152: right2. Thus, a distinction is drawn between the right of the individual citizen to take care of matters pertaining to
p.000152: personal health and public health care for all. In this sense, the social en- titlement to health can be taken as
p.000152: a basis for adopting health protection measures (organizing vaccination programmes, blood donations, etc.).
p.000152:
p.000152: 1Article 5 (4) of the Constitution: “Individual administrative measures restricting the free movement or residency in
p.000152: the national territory or the free entry into or exit from it to any Greek citizen shall be prohibited. Such
p.000152: restrictive measures may be imposed only as ancillary sanctions by criminal court ruling in exceptional emergency
p.000152: circum- stances exclusively for the prevention of indictable offences as specified by Law”.
p.000152: Interpretation clause:
p.000152: Paragraph 4 does not preclude the prohibition to leave the country by order of public prosecutor due to criminal
p.000152: proceedings or measures imposed on grounds of public health protection or the protection of patients as
p.000152: specified by Law”.
p.000152: Article 21 (3) of the Constitution: “The State shall care for the health of citizens and shall adopt specific measures
p.000152: to protect youth, old age, disability and health care for indigents”.
p.000152: 2 Article 5 (5) of the Constitution: “Everyone is entitled to the protection of their health and genetic
p.000152: identity…”.
p.000152:
p.000153: 153
p.000153:
p.000153: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000153: REPORT
p.000153:
p.000153: However, both the Constitution and the ECHR acknowledge the need of re- strictive measures to protect public health.
p.000153: Thus, the art. 5(4) of the Constitution (interpretation statement) excep- tionally accepts individual administrative
p.000153: measures “on grounds of public health protection or the protection of patients as specified by Law”. It is im-
p.000153: portant to stress that such measures amount to extensive inroads into indi- vidual freedom -prohibiting “the free
p.000153: movement and residency in the na- tional territory or the entry into and exit from it”- and can be decided by any
p.000153: public authority (health authorities, police, local government, etc.), but al- ways under specific legal
p.000153: provisions.
p.000153: Along the same lines, the ECHR (convention with overriding formal effect versus ordinary legislation) accepts the
p.000153: deprivation of individual freedom such as, among other things, “… the lawful detention of a person for the pre-
p.000153: vention of the spreading of infectious diseases, …” (art. 5[1][e]), but always “in accordance with a procedure
...

p.000165: reported in the literature, and concern is expressed1 regarding the involvement of the industry in the po- tential
p.000165: illegitimate interaction of researchers or institutions with the “spon- sors”.
p.000165: Several particular questions, relevant to this subject, may arise:
p.000165: 1. What is the extend and the outcome of an illegitimate influence in- terfering?
p.000165: 2. Is it possible for the average physician and citizen to show absolute confidence in the scientific “findings” of
p.000165: a research study?
p.000165: 3. Is there a possibility that the general financial deterioration of aca- demic institutions or public
p.000165: hospitals, causing incapability to sup- port independently research programs, would lead to a lack in the complete
p.000165: control of results?
p.000165: 4. Does the search for accuracy in research results discourage spon- sors from funding, due to high cost
p.000165: (e.g. because of possible repli- cation of an experiment producing negative results)?
p.000165:
p.000165: 2. Financial data
p.000165:
p.000165: During the past years, the industry has increased respectfully the funds on clinical research. Data from the USA show
p.000165: that in the 1980s, 68% of funds for Phase II and III clinical studies derived from the government and only
p.000165: 32% from the pharmaceutical companies, whereas in 2000 the relevant per- centages were reversed, i.e. 38% of
p.000165: funds was from governmental grants and 62% from pharmaceutical companies. Similarly, in the United Kingdom, 70% of
p.000165: the research outlay stems from pharmaceutical industries and only 30% from other sources.
p.000165: It is estimated that the cost of drugs is increasing in a two-digit percent- age rate, and is already up to $162.4
p.000165: billion in the USA2. The pharmaceutical
p.000165:
p.000165: 1 Bodenheimer T (2000). Uneasy alliance-clinical investigators and the pharmaceuti- cal industry. N Engl J Med 342,
p.000165: 1539-1544.
p.000165: 2 Blumenthal D (2004). Doctors and drug companies. N Engl J Med, 351, 1885-1890.
p.000165:
p.000166: 166
p.000166:
p.000166: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000166: REPORT
p.000166:
p.000166: industries spend 35% of their income for “sale and advertising” expenses. An illustrative, extensive
p.000166: research in the USA in 2010 reported that out of 2,938 participating physicians (primary care physicians, specialized
p.000166: cardiolo- gists, anesthetists, general surgeons and psychiatrists), 83.6% declared they had some kind of
p.000166: relationship with pharmaceutical and medical-device companies, in the form of financial aid, travel expenses, meals
p.000166: and profes- sional services3. The estimated amount spent by the pharmaceutical indus- tries on “sale and advertising”
p.000166: outlay is $8,000-15,000 per physician1.
p.000166: Another study in the USA in 2004, revealed that 44 pharmaceutical com- panies spent $2.47 billion on sponsorships. The
p.000166: average production cost for a new drug is between $300-600 million. Out of the total $6 billion spent on “research”,
p.000166: $3.3 billion are actually into spent on research itself.
p.000166: The pharmaceutical companies have additional reasons to urgently seek approval of a product. It has been estimated
p.000166: that due to “industrial espio- nage”, “competitive” industries are very eager to secure the first approval of the
...

p.000206: with a kit for sampling and shipping. Through their webpages, the compa- nies promote their specialisation and
p.000206: know-how of their staff. They all ad- dress and offer genetic tests directly to consumers, except for one,
p.000206: for which sample collection and shipping is done by physicians or collaborating diagnostic centres. The range of
p.000206: genetic tests offered in Greece covers: pa- ternity tests (8/15), kinship tests (6/15), predisposition to complex
p.000206: diseases
p.000206:
p.000206:
p.000207: 207
p.000207:
p.000207: DIRECT-TO-CONSUMER GENETIC TESTING
p.000207: REPORT
p.000207:
p.000207: (7/15), pharmacogenetics for the efficiency and side effects of certain drugs (6/15), athletic performance (3/15),
p.000207: predisposition to single-gene diseases (2/15), nutritional or metabolic tests (2/15), anti-ageing tests (2/15),
p.000207: gene- alogy tests (1/15) and whole genome analysis (1/15). Only 4 out of 15 com- panies providing DTC genetic
p.000207: testing are accredited according to ISO/IEC 17025 standards for the operation of their laboratories.
p.000207: A recent study conducted by the University of Patra (Mai et al., 2011) provides information on the
p.000207: awareness of the Greek public and physicians on genetic testing. This survey included the completion of a
p.000207: questionnaire that was distributed to 1,717 members of the general public and 496 medi- cal practioners.
p.000207: The study showed that a large percentage of the general public in Greece is aware of the nature of
p.000207: DNA, genetic diseases and the potential advantages of genetic testing, although this percentage declined with age.
p.000207: A large proportion of those completing the questionnaire would be willing to undergo genetic testing, even if the cost
p.000207: is not covered by health insurance. On the other hand, only a small proportion of the public actually received
p.000207: advice in order to proceed with genetic tests, either from relatives or their physicians. In addition, this study
p.000207: demonstrated that most physicians con- sider the current legal framework about genetic testing in Greece relatively
p.000207: weak.
p.000207: A rather interesting finding is that the vast majority of the public strongly objects to DTC genetic testing, and
p.000207: that most of them would prefer being referred by a physician rather than a pharmacist. The study reaches the con-
p.000207: clusion that the Greek public holds a critical position towards genetics and genetic testing services, which could set
p.000207: a model for other European popula- tions (Mai et al., 2011).
p.000207:
p.000207: Restrictions, benefits and risks of genetic testing
p.000207:
p.000207: It is important for the public to understand that genetic testing for health reasons has some restrictions
p.000207: and benefits, but involves risks as well (Recommendations of the SACGT on Genetic Testing, 2000). The benefits
p.000207: and risks always exist in relation to the nature and the severity of the dis- ease.
p.000207: Genetic tests for health reasons have some diagnostic limits:
p.000207:
p.000207:
p.000208: 208
p.000208:
p.000208: DIRECT-TO-CONSUMER GENETIC TESTING
p.000208: REPORT
p.000208:
p.000208: 1. A test may not detect a singe mutation (a gene can bear several mutations in different parts). E.g. there are over
p.000208: 1,300 mutations in the gene causing familial hypercholesterolaemia, which are dis- tributed throughout the gene and
...

p.000212: information concerns - and also identifies - members of the family, they must be protected from such risks through
p.000212: appropriate procedures.
p.000212:
p.000212: Genetic tests in children
p.000212: Is it ethical to perform genetic tests in asymptomatic children, upon the parents’ request, and how does this affect
p.000212: the child’s right to ignorance?
p.000212: To protect genetic information, as well as the child’s right to ignorance, it is not justified to perform genetic tests
p.000212: in asymptomatic children for which there is no urgent medical need -particularly for late onset diseases.
p.000212: This does not mean that genetic tests for such diseases should never be performed in children. In the case where
p.000212: parents wish to have the child tested, without an immediate benefit for the child’s health (i.e. treatment or
p.000212: prevention), one must weigh the risks and the benefits, and genetic testing may be postponed until the child reaches a
p.000212: certain age and is able to con- tribute at the decision making process (British Society for Human Genetics, 2010).
p.000212:
p.000212:
p.000212:
p.000213: 213
p.000213:
p.000213: DIRECT-TO-CONSUMER GENETIC TESTING
p.000213: REPORT
p.000213:
p.000213: Genetic tests revealing identity
p.000213: Is it morally legitimate for someone to demand disclosure of a person’s identity, without the latter’s knowledge, in
p.000213: order to protect one’s own vital interests (i.e. with a “paternity test”)?
p.000213: The answer is, in principle, negative, in the context of the right to priva- cy. Even if there is a serious reason for
p.000213: such a practice, this must be judged (and eventually there may be a decision to disclose the identity of a
p.000213: third person) in an a priori defined legal procedure, not arbitrarily by the appli- cant him/herself.
p.000213:
p.000213: Commercialization of biological information
p.000213: Is it ethically acceptable to maintain a financial activity that involves “remote” services of biological
p.000213: information and other sensitive data by “faceless” organisations, which are based on standardized requests
p.000213: and questionnaires for anyone interested?
p.000213: On the conditions that biological data are protected and the use of bio- logical data for other purposes (e.g.
p.000213: research) is forbidden, maintaining such a financial activity does not seem, in principle, unacceptable. However, one
p.000213: must examine the way these specific services are promoted, so as to pre- vent misleading, which is
p.000213: particularly favoured by the impersonal character in such a sensitive field of individualized counseling.
p.000213:
p.000213: Legislative intervention
...

p.000248: just five decades later, in 1991, that the USA government admitted these experiments (Smith, 2008). Reports of
p.000248: experiments with nuclear energy and psychotropic drugs then followed (Parasidis, 2012).
p.000248: However, enhancement of military performance has evolved due to the
p.000248:
p.000248:
p.000249: 249
p.000249:
p.000249: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000249: REPORT
p.000249:
p.000249: possibilities offered by biomedicine and biotechnology. For example, the
p.000249: U.S. Department of Defense and the Advanced Research Projects Agency Defense (DARPA) fund research on
p.000249: pharmaceutical agents that keep soldiers alert, reducing the need for sleep. Research is also conducted on
p.000249: nutrient preparations that fulfill the nutritional needs of soldiers for several days. DARPA’s program
p.000249: “Persistence in Combat” includes the development of a vaccine that would block pain, accelerate wound healing
p.000249: and stop bleeding soon after wounding (Parasidis, 2012).
p.000249:
p.000249: d) Enhancing athletic performance
p.000249:
p.000249: During their preparation, athletes are trained by qualified coaches, they follow a special diet that includes
p.000249: supplements and they have access to physiotherapy in order to improve their athletic performance. However,
p.000249: since professionalism came to be part of sports, the pressure for better athletic performance, imposed by
p.000249: either the athletes’ personal ambitions or by their athletic clubs including their coaches, is stronger.
p.000249: Thus, hard training, even from an early age, seems to be insufficient, and consequently, athletes turn to doping
p.000249: in order to enhance their athletic performance. “Doping” is the most common and oldest form of
p.000249: enhancing sports performance, while nowadays, it has many aspects, e.g. drug doping, gene doping, etc. “Doping” is
p.000249: defined as the use of prohibited substances or methods intended to artificially enhance the sports-racing
p.000249: skills of athletes, both during a game and during the preparation for a game.
p.000249: In 1928, the International Amateur Athletic Federation set the first official ban of substances that
p.000249: enhance athletic performance, despite the lack of relevant methods to detect the substances (House of
p.000249: Commons, Select Committee on Culture, Media and Sport, 2004). In 1967, the International Olympic
p.000249: Committee (IOC) created the Medical Commission aiming to supervise and deal with the problem of doping
p.000249: in the Olympic Games. In 2004, the World Anti-Doping Agency (WADA) undertook the role of the main anti-doping
p.000249: coordinator at an international level. Since then, the banned substances and methods are defined by the List
p.000249: of Prohibited Substances and Methods, which is reviewed annually by WADA and applies to all sports and all
p.000249: countries. According to the World Anti-Doping Code “Doping is defined as the occurrence of one or more of the
p.000249: anti-doping rule
p.000249:
p.000249:
p.000250: 250
p.000250:
p.000250: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000250: REPORT
p.000250:
p.000250: violations set forth in Articles 2.1 through 2.8 of the World Anti-Doping Code”3. In Greece, the National
...

p.000256: The answer is, in principle, yes, since in this case there are -usually- no issues of modifying the human organism.
p.000256: Expanding a person’s capabilities may resemble the assistance provided by the usual mechanical means that make us enjoy
p.000256: our freedom, for example by increasing our movement (car, etc.), our senses (glasses, headphones, etc.), our
p.000256: expression (microphones etc.), and so on.
p.000256:
p.000256: 4 Design news 2005. http://www.designnews.com/document.asp?doc_id=226412&dfpPParams=ind_182,
p.000256: aid_226412&dfpLayout=article.
p.000256: 5 Cyberdyne. Inc. http://www.cyberdyne.jp/english/robotsuithal/.
p.000256:
p.000257: 257
p.000257:
p.000257: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000257: REPORT
p.000257:
p.000257: 3. The law
p.000257:
p.000257: Especially for equipment that requires interventions in the organism of the person concerned, the legislation
p.000257: about medical products (Directive 93/42, incorporated by JMD DY8d/GP. οik.130648/2.10.2009, Directive
p.000257: 90/385, incorporated by JMD DY8d/GP. oik.130644/2.10.2009) contains provisions for secure application of
p.000257: implants. Therefore, it also involves the technological interventions that aim, for example, at the
p.000257: musculoskeletal support.
p.000257:
p.000257: ΙV. Prolongation of life
p.000257:
p.000257: 1. The data
p.000257:
p.000257: The idea of longevity or eternal youth has always been fascinating for mankind, regardless of the era,
p.000257: culture and religion. This interest derives mainly from man’s fear about the diseases presented in old
p.000257: age but also from the death itself, as well as the quest for youth. It is a fact that, the best social and economic
p.000257: living conditions as well as better medical care increase the average lifespan of humans.
p.000257: Over the past two centuries, human life expectancy is more than dou- bled, from 25 years to 65 for men and
p.000257: 70 for women, while some estimate that for some populations this number will reach 100 years in six decades (Oeppen
p.000257: and Vaupel, 2002). In the European Union particularly, life expec- tancy has risen by an average of 10 years over the
p.000257: last fifty years6. According to statistics in 2009, the average life expectancy in the EU of 27 states is
p.000257: 79.4 years (76.4 for men and 82.4 for women). In Greece, the average age is
p.000257: 80.2 years for the total population (77.8 for men and 82.7 for women). But why this constant increase in life
p.000257: expectancy?
p.000257: Genetic factors, such as the HLA-DRw9 and HLA-DR1 alleles in the Japa- nese population (Takata et al., 1987) and the e4
p.000257: allele of the APOE gene in Finnish (Schachter et al., 1994) and the French population (Louhija et al.,
p.000257: 1994), are associated with increased life expectancy.
p.000257:
p.000257: 6 Eurostat. Mortality and life expectancy statistics. Data from October 2011.
p.000257: http://epp.eurostat.ec.europa.eu/statistics_explained/index.php/Mortality_and_life_ expectancy_statistics.
p.000257:
p.000258: 258
p.000258:
p.000258: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000258: REPORT
p.000258:
p.000258: Environmental factors, such as smoking, alcohol consumption and diet have not been proven to reduce the average
p.000258: life expectancy but their effect on the development of diseases, such as cancer and cardiovascular disease indirectly
p.000258: reduces life expectancy. In addition, the way the social status, wealth and educational level can affect
p.000258: life expectancy, is not clear (Chris- tensen & Vaupel, 1996).
p.000258: Demographic and geographical studies showed that the increase in life expectancy is, in part, due to the advances in
p.000258: Medicine and geriatrics that study the diseases of old age, such as cancer and cardiovascular disease,
p.000258: aiming at prevention and better management of common diseases (Chris- tensen & Vaupel, 1996).
p.000258: However, along with the best medical care, modern biomedical research offers insights that allow humans to understand
p.000258: and intervene in the aging mechanisms. Biogerontology studies the aging mechanisms and provides information to
p.000258: reduce the rate of aging and prolong life beyond 122 years, which is the maximum limit today7. A typical example is the
p.000258: discovery that the enzyme telomerase can be used to increase cell divisions and delay their aging (Hayflick, 2003),
p.000258: and that substances that stimulate a calorie- restricted diet can increase life expectancy by 30%
p.000258: in mice (Ingram et al, 2004).
p.000258: In this context, intervening in the aging process is scientifically feasible, while man has a special interest in the
p.000258: existing possibility to extend lifespan by using biomedical technologies. As mentioned in the introduction to this
p.000258: Report, taking into account the distinction between therapy and enhancement, intervening in
p.000258: the aging mechanisms in order to extend lifespan beyond the upper limit constitutes human
p.000258: enhancement, not prevention or treatment of diseases presented in old age that aim to increase average
p.000258: lifespan.
p.000258: The use of biomedical technologies is expected to further increase the average lifespan or the maximum
p.000258: age reached, a fact that fuels debates about the bioethical issues raised from life prolongation as a
p.000258: form of enhancing human characteristics, by means which are already available or that will be available in
p.000258: the future.
p.000258: The aging process is characterized by a slow reduction in normal body
p.000258:
p.000258:
p.000258: 7 The Guinness Book of Records, 1999 edition, p.102.
p.000258:
p.000259: 259
p.000259:
p.000259: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000259: REPORT
p.000259:
p.000259: rhythms, progressive loss of functionality, reduced fertility, increased sus- ceptibility to most diseases and
p.000259: significant mortality. Technological interven- tions that affect the process of aging and can be considered
p.000259: as enhance- ment of human characteristics include (Barazetti and Reichlin, 2011):
p.000259: Restricting caloric intake, hormone administration or replacement, re- duction of oxidative stress and
p.000259: activation of telomerase (Barazetti and Reichlin, 2011). Studies in various species showed that these
p.000259: interventions are possible to increase life expectancy and delay the aging process. Howev- er, these studies do not
p.000259: provide convincing data that can be applied to hu- mans.
p.000259: Life expectancy predictions vary. A study with 60 participants including demographers, gerontologists and
p.000259: researchers of aging, showed that life expectancy for a person born in 2100 is on average 292 years,
p.000259: while the range of predictions was large. Half of the predictions see humans not to exceed 100 years,
p.000259: while the more optimistic ones, which are the minority, predict that man will live up to 500 to 5,000 years
...

p.000259: autonomy, as, indeed, it is legitimate to treat any cause that leads the body to weakness and ultimately
p.000259: to death. Therefore the relative ethical issues do not differ substantially from the issues raised by the other
p.000259: forms of physical enhancement.
p.000259: However, a crucial issue that remains is the future social consequences of a dramatic increase in life
p.000259: expectancy, as demographic data already confirm serious effects e.g. on the sustainability of
p.000259: health insurance systems, even on the adequacy of natural resources.
p.000259: Assuming that these data reflect the limited strength of modern societies, not only in a broader
p.000259: macrosocial scale but even in the scale of a
p.000259:
p.000259:
p.000260: 260
p.000260:
p.000260: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000260: REPORT
p.000260:
p.000260: family, it is possible that maintenance of a “fourth” generation of ancestors will be against human reproduction.
p.000260: Indeed, this generation will continue to burden the family budget, effectively discouraging child bearing, which will
p.000260: marginally lead to a progressive aging of societies. In this case, the effects on the viability of societies will be
p.000260: unknown.
p.000260:
p.000260: 3. The law
p.000260:
p.000260: It is difficult to detect law restrictions regarding the fundamental rights of personality development and health (5
p.000260: par. 1 and 5, Constitution) in this specific field.
p.000260: If the reservation relates elusively to the future interest of societies in age renewal, the only
p.000260: reference that could be made concerns our responsibility towards the future generations. This
p.000260: responsibility - is mainly mentioned in the non-binding environmental law (see Report in the Opinion of the NBC
p.000260: “Management of biological wealth”, 2009) - however, an ethical issue still remains: this responsibility will lead
p.000260: us to accept our biological limits (hence the finite of our lives), which could not be determined by legal rules.
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000261: 261
p.000261:
p.000261: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000261: REPORT
p.000261:
p.000261: SUGGESTED LITERATURE
p.000261:
p.000261: AAAS invitational workshop on human enhancement (2006). AAAS Human enhancement and the means of achieving it.
p.000261: Washington, DC.
p.000261: Barazzetti G, Reichlin M (2011). Life-extension: A biomedical goal? Scientific prospects, ethical concerns. Swiss Med
p.000261: Wkly 141, w13181.
p.000261: Barton-Davis ER, Shoturma DI, Musaro A, Rosenthal N, Lee Sweeney H (1998). “Viral mediated expression of
p.000261: insulin-like growth factor i blocks the aging-related loss of skeletal muscle function.” PNAS 95, 15603-5607.
p.000261: Baylis F, Robert JS (2004). The inevitability of genetic enhancement technologies. Bioethics, p. 7.
p.000261: Birch K (2008). Neoliberalising bioethics: Bias, enhancement and economistic ethics. Genomics,
p.000261: Society and Policy, 4, 1-10.
p.000261: Bostrom N (2005). In defense of posthuman dignity. Bioethics 2005, p. 202.
...

p.000261: Crerand CE, Franklin ME, Sarwer DB (2006). Body dysmorphic disorder and cosmetic surgery. Plast Reconstr Surg 118,
p.000261: 167e-80e.
p.000261: Crerand CE, Menard W, Phillips KA (2010). Surgical and minimally invasive cosmetic procedures among
p.000261: persons with body dysmorphic disorder. Ann Plast Surg 65, 11-6.
p.000261:
p.000261:
p.000262: 262
p.000262:
p.000262: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000262: REPORT
p.000262:
p.000262: Crerand CE, Phillips KA, Menard W, Fay C (2005). Nonpsychiatric medical treatment of body dysmorphic
p.000262: disorder. Psychosomatics 46, 549-55.
p.000262: European Group on Ethics (EGE) (1999). Ethical aspects arising from doping in sport, Opinion No 14, 1.6, 2.10.
p.000262: Farah MJ (2005). Neuroethics: The practical and the philosophical trends in cognitive sciences, p. 34.
p.000262: Fukuyama F (2002). Our posthuman future: Consequences of the biotechnology revolution, Farrar,
p.000262: Strauss and Giroux, N. York.
p.000262: Garcia-Verdugo M (2005). Medio fondo y fondo. La preparacion del corridor de resistencia. Atletismo 4. Madrid. RFEA.
p.000262: GIRES (Gender Identity Research and Education Society) (2008). Gender var- iance (dysphoria) (www.gires.org.uk).
p.000262: Hayflick L (2003). Living forever and dying in the attempt. Exp Gerontol 38, 1231-1241.
p.000262: Hildt E (2005). Living longer: Ethical aspects of age-retardation, Paper presented at the 19th European
p.000262: Conference on Philosophy of Medicine and Health Care and 22nd EACME Conference “Ethics and Philosophy of Emerging
p.000262: Medical Technologies”, Barcelona.
p.000262: House of Commons, Select Committee on Culture, Media and Sport (2004). Seventh Report of Session 2003-2004, UK
p.000262: Parliament, HC 499-I.
p.000262: Huxtable R, Woodley J (2005). Gaining face or losing face? Framing the debate on face transplants.
p.000262: Bioethics, p. 505.
p.000262: Ingram DK, Anson RM, De Cabo R, Mamczarz J, Zhu M, Mattison JA, Lane MA, Roth GS (2004). Development of
p.000262: calorie restriction mimetics as a pro- longevity strategy. Ann NY Acad Sci 1019, 412-423.
p.000262: Kriari-Katrani I (2001). The constitutional protection of genetic identity. A first approach. DtA 2001, p.347.
p.000262: Lo HS, Xie SQ (2012). Exoskeleton robots for upper-limb rehabilitation: State of the art and future prospects. Med Eng
p.000262: Phys 34, 261-8.
p.000262:
p.000262:
p.000262:
p.000263: 263
p.000263:
p.000263: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000263: REPORT
p.000263:
p.000263: Louhija J, Miettinen HE, Kontula K, Tikkanen MJ, Miettinen TA, Tilvis RS (1985). Aging and genetic variation
p.000263: of plasma lipoproteins. Oldest old: New perspectives and evidence. Milbank Mem Fund Quart 63, 177-251.
p.000263: Morcel K, Camborieux L, Programme de Recherches sur les Aplasies Mülléri- ennes, Guerrier D (2007).
p.000263: Mayer-Rokitansky-Küster-Hauser (MRKH) syn- drome. Orphanet J Rare Dis 14, 2:13.
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p.000198: purposes. It notes the danger especially in the case of DTC genetic tests, where genetic counseling is ab- sent.
p.000198:
p.000198:
p.000199: 199
p.000199:
p.000199: DIRECT-TO-CONSUMER GENETIC TESTING
p.000199: OPINION
p.000199:
p.000199: Finally, the Commission considers that genetic tests revealing a person’s identity definitely presuppose consent from
p.000199: all the involved parties. Other- wise such genetic tests require a relevant judicial licensing.
p.000199:
p.000199: 2. Special issues
p.000199:
p.000199: In the context of the above mentioned general principles, the Commis- sion notes:
p.000199: A. It is recommended that DTC genetic tests for health reasons or prena- tal diagnosis must be performed following a
p.000199: suitable prescription by a liable expert physician, clinical geneticist or biologist-geneticist. The expert
p.000199: will assess the purpose of the test and will interpret the results, in order to avoid unnecessary genetic testing
p.000199: and inappropriate assessment. It is important that the consumer has the option to choose the expert. Impersonal,
p.000199: auto- mated counseling methods are discordant with the relationship of trust, which must govern health
p.000199: services.
p.000199: Exceptionally, DTC genetic testing which aims to improve dietary habits or other lifestyle factors (occupation,
p.000199: exercise etc.), or to define an individu- al’s ancestry, may not be dependent on such strict rules.
p.000199: B. In order to protect genetic information and respect a child’s right to ignorance, considering that children are
p.000199: unable to decide whether they wish to know the results of a genetic test predicting a disease, DTC genetic test- ing is
p.000199: not justified in asymptomatic children for whom there is no medical emergency, especially for late onset diseases such
p.000199: as Huntington’s disease. Even in the case where an expert decides that such a test is necessary for the parent(s),
p.000199: the same genetic test must be delayed for the child until he/she is able to participate in the decision
p.000199: making process, since there is no direct value to his/her health. On the contrary, DTC genetic testing is
p.000199: ac- ceptable in cases of children with first or second degree relatives with a monogenic disorder,
p.000199: showing a clear mode of inheritance e.g. familial hy- percholesterolemia. Nonetheless, such genetic tests must
p.000199: be allowed only in the case that the results will be used for early treatment and/or prevention of the complications
p.000199: caused by the disease.
p.000199:
p.000199:
p.000199:
p.000199:
p.000200: 200
p.000200:
p.000200: DIRECT-TO-CONSUMER GENETIC TESTING
p.000200: OPINION
p.000200:
p.000200: C. The promotion campaigns of DTC genetic testing must be governed by the same rules as in the case of health services,
p.000200: i.e. to be based on precise information and the true prognostic or diagnostic value of the test.
p.000200: Misleading advertising of the alleged “prediction” of serious diseases or other phenotypes, overlook the role of other
p.000200: genetic factors which are not determined yet or the critical role of environmental factors, and lead to ge- netic
p.000200: determinism.
p.000200: D. DTC genetic tests that determine a person’s identity without his/her consent is in principle illegal, since they
p.000200: directly offend the right to privacy.
p.000200: E. In any case, providers of DTC genetic services (especially via the inter- net) need to ensure high protection of
...

p.000212: unnecessary tests which may affect the patient’s treatment or life (art. 9 par. 4, art. 11 CME).
p.000212:
p.000212: Handling sensitive data
p.000212: Are there any restrictions in the case where a person consents to disclose sensitive data, to a third party, about
p.000212: his/her health or lifestyle expecting to obtain information on possible consequences to him/herself or his/her fami-
p.000212: ly? Furthermore, are there any restrictions in the existing risk that the data are handled with no control and,
p.000212: eventually, used for other purposes?
p.000212: In principle, everybody has full power on his/her own personal, simple or sensitive, data. However, a person can only
p.000212: undertake the risk of unethical handling of such data only for him/herself, not for others. In the case where genetic
p.000212: information concerns - and also identifies - members of the family, they must be protected from such risks through
p.000212: appropriate procedures.
p.000212:
p.000212: Genetic tests in children
p.000212: Is it ethical to perform genetic tests in asymptomatic children, upon the parents’ request, and how does this affect
p.000212: the child’s right to ignorance?
p.000212: To protect genetic information, as well as the child’s right to ignorance, it is not justified to perform genetic tests
p.000212: in asymptomatic children for which there is no urgent medical need -particularly for late onset diseases.
p.000212: This does not mean that genetic tests for such diseases should never be performed in children. In the case where
p.000212: parents wish to have the child tested, without an immediate benefit for the child’s health (i.e. treatment or
p.000212: prevention), one must weigh the risks and the benefits, and genetic testing may be postponed until the child reaches a
p.000212: certain age and is able to con- tribute at the decision making process (British Society for Human Genetics, 2010).
p.000212:
p.000212:
p.000212:
p.000213: 213
p.000213:
p.000213: DIRECT-TO-CONSUMER GENETIC TESTING
p.000213: REPORT
p.000213:
p.000213: Genetic tests revealing identity
p.000213: Is it morally legitimate for someone to demand disclosure of a person’s identity, without the latter’s knowledge, in
p.000213: order to protect one’s own vital interests (i.e. with a “paternity test”)?
p.000213: The answer is, in principle, negative, in the context of the right to priva- cy. Even if there is a serious reason for
p.000213: such a practice, this must be judged (and eventually there may be a decision to disclose the identity of a
p.000213: third person) in an a priori defined legal procedure, not arbitrarily by the appli- cant him/herself.
p.000213:
p.000213: Commercialization of biological information
p.000213: Is it ethically acceptable to maintain a financial activity that involves “remote” services of biological
p.000213: information and other sensitive data by “faceless” organisations, which are based on standardized requests
p.000213: and questionnaires for anyone interested?
p.000213: On the conditions that biological data are protected and the use of bio- logical data for other purposes (e.g.
p.000213: research) is forbidden, maintaining such a financial activity does not seem, in principle, unacceptable. However, one
p.000213: must examine the way these specific services are promoted, so as to pre- vent misleading, which is
...

p.000259: to prolong lifespan and Aubrey de Grey, a biogerontologist and a great supporter of life prolongation.
p.000259:
p.000259: 2. The dimension of ethics
p.000259:
p.000259: One cannot dispute that control of the aging mechanisms and prolongation of life are within
p.000259: the limits of a person’s autonomy. In principle, it is legitimate to pursue such a thing in the context of
p.000259: autonomy, as, indeed, it is legitimate to treat any cause that leads the body to weakness and ultimately
p.000259: to death. Therefore the relative ethical issues do not differ substantially from the issues raised by the other
p.000259: forms of physical enhancement.
p.000259: However, a crucial issue that remains is the future social consequences of a dramatic increase in life
p.000259: expectancy, as demographic data already confirm serious effects e.g. on the sustainability of
p.000259: health insurance systems, even on the adequacy of natural resources.
p.000259: Assuming that these data reflect the limited strength of modern societies, not only in a broader
p.000259: macrosocial scale but even in the scale of a
p.000259:
p.000259:
p.000260: 260
p.000260:
p.000260: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000260: REPORT
p.000260:
p.000260: family, it is possible that maintenance of a “fourth” generation of ancestors will be against human reproduction.
p.000260: Indeed, this generation will continue to burden the family budget, effectively discouraging child bearing, which will
p.000260: marginally lead to a progressive aging of societies. In this case, the effects on the viability of societies will be
p.000260: unknown.
p.000260:
p.000260: 3. The law
p.000260:
p.000260: It is difficult to detect law restrictions regarding the fundamental rights of personality development and health (5
p.000260: par. 1 and 5, Constitution) in this specific field.
p.000260: If the reservation relates elusively to the future interest of societies in age renewal, the only
p.000260: reference that could be made concerns our responsibility towards the future generations. This
p.000260: responsibility - is mainly mentioned in the non-binding environmental law (see Report in the Opinion of the NBC
p.000260: “Management of biological wealth”, 2009) - however, an ethical issue still remains: this responsibility will lead
p.000260: us to accept our biological limits (hence the finite of our lives), which could not be determined by legal rules.
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
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p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000261: 261
p.000261:
p.000261: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000261: REPORT
p.000261:
p.000261: SUGGESTED LITERATURE
p.000261:
p.000261: AAAS invitational workshop on human enhancement (2006). AAAS Human enhancement and the means of achieving it.
p.000261: Washington, DC.
p.000261: Barazzetti G, Reichlin M (2011). Life-extension: A biomedical goal? Scientific prospects, ethical concerns. Swiss Med
p.000261: Wkly 141, w13181.
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p.000267: 267
p.000267:
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p.000268: 268
p.000268:
p.000268: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000268: OPINION
p.000268:
p.000268: O P I N I O N
p.000268:
p.000268: HUMAN ENHANCEMENT -
p.000268: EFFECT ON COGNITIVE AND MENTAL STATE
p.000268:
p.000268: The Hellenic National Bioethics Commission, as previously announced, continued to examine the issue of “human
p.000268: enhancement”, focusing on the effects of enhancement methods on the cognitive and mental state of the human organism.
p.000268: To study the issue, the Commission held relevant hearings of Dr. G. Christodoulou, Emeritus Professor of
p.000268: Psychiatry, Medical School, Athens University and Honorary President of the Greek Psychiatric Association and Dr. G.
p.000268: Kolaitis, Associate Professor of Child Psychiatry, Medical School, Ath- ens University.
p.000268:
p.000268: I. The data
p.000268:
p.000268: Modern science enabled the development of specific interventions for the “cognitive" functions of the human
p.000268: body, with a main purpose to treat mental illnesses and disorders. However, the possibilities offered by modern science
p.000268: highlight the problem of whether it is legitimate to use such meth- ods in healthy organisms, aiming to enhance the
p.000268: mental or emotional condi- tion.
p.000268: Such methods are particularly: a) selective stimulation of brain regions, with electrical or magnetic signals, and b)
p.000268: drug use. In the future, it is likely that these methods are enriched by targeted genetic modification of genes
p.000268: associated with cognitive functions, as well as by brain/computer interfaces, which is expected to allow access
p.000268: to electronic information -and generally use of computer programs- by just activating certain cognitive functions.
p.000268: The Commission notices that there is internationally, a widespread use of substances by healthy individuals
p.000268: (nicotine, caffeine) or even prescription drugs, with the aim to further enhance their cognitive functions.
p.000268: Users mainly pursue memory and attention enhancement, but also to treat nor- mal hyperactivity, which occurs
...

p.000280: of memory, an issue will be raised about whether it is legitimate for a person to encounter the dilemma
p.000280: of enhancing certain functions at the expense of others.
p.000280:
p.000280: 3. Balancing cognitive and psychological functions - Personality change
p.000280:
p.000280: In the case of mental characteristics, in a broader context, we encounter the same problem regarding the balance
p.000280: of increased cognitive abilities (memory, ability to concentrate, etc.). It seems that here, there is some kind of
p.000280: connection, e.g. with the emotional life of the person. Thus, enhan- cement of cognitive abilities
p.000280: that allows an employee to perform exceptionally, has been reported to negatively affect his/her
p.000280: emotional world (events of apathy, indifference, etc.), with unknown consequences for the personality (Glannon, 77-78).
p.000280: Generally, the question of changing a personality by drug use (particularly antidepressants) is a
p.000280: central concern, as does the question of whether this increases or limits autonomy (STOA, 135). There is
p.000280: no doubt that personality changes, anyway, with the assistance of external actors - particularly by
p.000280: the socialization mechanisms during childhood and adolescence- the effects of which often are not
p.000280: controlled by the person itself. Thus, a child’s personality is constantly changing under the influence of family,
p.000280: school, friends, television, internet etc. However, there are also changes during adulthood, even if
p.000280: certain characteristics are gradually stabilized, comprising foundations for the “development” of
p.000280: personality. The very term “development”, suggests “change” anyway.
p.000280: Therefore, the critical point to our subject is not whether, in general, personality development is
p.000280: legitimate, but rather whether such a change can be so radical that can lead to psychological
p.000280: pathologies, i.e. to cause damage to a person’s mental health. Besides extreme exceptions,
p.000280: mechanisms of socialization do not cause so deep “sections” in a person’s
p.000280:
p.000280:
p.000281: 281
p.000281:
p.000281: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000281: REPORT
p.000281:
p.000281: personality. On the contrary, socialization mechanisms “build” on the grounds formed in infancy,
p.000281: which are associated with inherent cognitive abilities (including perception of space, time, etc.),
p.000281: learning the mother tongue, but also the evolution of the unconscious processes (especially the libido). In
p.000281: contrast, the use of pharmaceuticals -similarly to the use of substances such as alcohol or drugs- can
p.000281: cause such sections, which may lead to serious mental illness. The main reason is that these substances have a
...

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p.000024: whilst there is some evidence on how genetic data affects insurance prior to the agreement of a contract there has been
p.000024: no consideration regarding discrimination after contract agreement, for instance, problems with compensation
p.000024: payments.
p.000024: Whether genetic data should be treated differently from medical data in insurance is an issue widely debated. Some
p.000024: advocates of excluding genetic data from insurance argue that it is unfair to “punish” people for their ge- netic make
p.000024: up, i.e. for something they cannot change. Others argue that genetic data can be more easily misunderstood or
p.000024: overestimated compared to medical data and this is sufficient grounds to treat it differently (Holm, 2007).
p.000024: By contrast, those who argue that genetic data should be treated in the same way as medical data do not believe that
p.000024: the former have a higher prognostic value nor that they are more personal or sensitive than medical data (Ashcroft,
p.000024: 2007).
p.000024: No matter what stance one takes on this, an additional issue is how to ensure the appropriate evaluation of genetic
p.000024: information in order to avoid “misplacing” people in categories of high insurance risk on the basis of inad- equately
p.000024: understood genetic information. Such genetic discrimination might be introduced, for example, against healthy subjects
p.000024: who are heterozygotic carriers of mutations that result in disease only in homozygotes. As an ex- ample we might
p.000024: cite the parents of children suffering from cystic fibrosis who carry the responsible mutation for the disease
p.000024: but are in no risk of de- veloping cystic fibrosis themselves. There have been reports of such “mis- guided”
p.000024: discrimination in the UK (Law et al., 1998).
p.000024:
p.000024: 2. ETHICAL ISSUES
p.000024:
p.000024: Genetic testing or disclosure of related results for private insurance pur- poses raise two very poignant ethical
p.000024: questions:
p.000024: a) Is disclosure of these results justified as a requirement for insurance considering that a balance must be struck
p.000024: between economic freedom for the insurer and the need to protect the personality of the insured and also the usefulness
p.000024: of these results for the latter?
p.000024: b) Are there any collective interests, aside from the individual interests of the two parties that should be taken into
p.000024: account in this balancing?
p.000024:
p.000024:
p.000025: 25
p.000025:
p.000025: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000025: REPORT
p.000025:
p.000025: A. Business risk and protection of personality
p.000025:
p.000025: 1. In general, private insurance is a business activity governed by the principle of reciprocity. The basic
p.000025: idea consists in sharing the risk by a group of individuals who are equally likely to suffer damage which would be
p.000025: unaf- fordable to the individual person: by paying premiums, a large number of insured cover the expenses
...

p.000084: biodiversity, and the wider protection of the environment are, of course, vital components of this duty.
p.000084: As stated above, our responsibility to future generations ethically justi- fies the sustainable development debate.
p.000084: The crucial question related to this issue concerns the source or foundation of this powerful ethical duty.
p.000084: At first sight, it is an “imperfect duty” (like kindness, philanthropy etc., according to the Kantian distinction).
p.000084: But perhaps this solution falls short of the powerful commitment we appear to accept.
p.000084: One could also posit a utilitarian foundation according to which our self- restraint for the sake of next generations
p.000084: eventually improves our present
p.000084:
p.000084:
p.000085: 85
p.000085:
p.000085: MANAGEMENT OF BIOLOGICAL WEALTH
p.000085: REPORT
p.000085:
p.000085: state as well, since it leads to a rational and renewable exploitation of (fi- nite) natural resources.
p.000085: A third alternative would be to further investigate the subject in the field of the theory of “rights” or, at
p.000085: least, “interests” -either finding a way to overcome the afore mentioned difficulties in recognizing
p.000085: persons, who do not yet exist, as subjects, or dilating the reflection on our own rights and interests.
p.000085: In the latter context, we may postulate, for instance, that future generations are our concern to the extent that our
p.000085: own reproduction is our concern and that sustainable development is to the interest of our children, of their own
p.000085: children, and so on and so forth ad infinitum, and as such it is an extension of our own individual interest.
p.000085: Critical in this discussion, at any rate, is to separate ethical from legal rights: the former have a far
p.000085: greater scope even if their practical implemen- tation cannot be ensured just as effectively.
p.000085: Finally, in terms of religion, the philosophy of monotheistic religions is anthropocentric for man is
p.000085: considered as the apex of Creation and the top of the pyramid of living organisms. This is basically the
p.000085: “creationist” ap- proach which often leads to the view that our species has absolute domin- ion over nature.
p.000085: Yet, many theologians construe this dominion also as a responsibility for the wise management and protection of the
p.000085: environment, mainly as a duty to future generations (Zezioulas, 1992). This approach has actually inspired some
p.000085: initiatives for a more active involvement of Christian confessions and churches, as demonstrated, for instance, by the
p.000085: example of the Ecumenical Patriarch.
p.000085:
p.000085:
p.000085: THIRD CHAPTER THE LAW
p.000085: In regard to the above issues, the law attempts to outline a few direc- tions mainly by way of international
p.000085: and national legislation. We will at- tempt to describe these directions.
p.000085:
p.000085:
p.000085:
p.000085:
p.000086: 86
p.000086:
p.000086: MANAGEMENT OF BIOLOGICAL WEALTH
p.000086: REPORT
p.000086:
p.000086: International law
p.000086:
p.000086: The Convention on Biodiversity (Rio de Janeiro Convention, 1991) and the Protocol on Biosafety (Cartagena Protocol,
p.000086: 2000).
...

p.000140: circumstances of spreading epidemics or pandemics, according to the internationally accepted definitions of
p.000140: these terms. National authorities may not arbitrarily dilate these definitions.
p.000140: In such circumstances, medics and designated health authorities do not have the obligation to ask for patient
p.000140: consent and they could act on their own initiative (self-action). The legal basis for such restrictions
p.000140: consists mainly in art. 8 of the Convention on Human Rights and Biomedicine (Ovie- do Convention), which justifies
p.000140: medical self-action in “emergency situa- tions”.
p.000140: In this context, restrictions must comply with the principle of propor- tionality, i.e. they must be
p.000140: appropriate and necessary in order to protect public health without exceeding the purpose for which they are
p.000140: adopted.
p.000140:
p.000140: b) Vaccination
p.000140: In principle, the vaccination of the population as a measure of preven- tion, particularly the vaccination of
p.000140: vulnerable groups, requires informed consent. In this context, relevant information may be also provided to the
p.000140: general public through the media. The duty of public authorities is to ensure the validity of this information by
p.000140: allocating the task exclusively to a respon- sible entity and by taking steps to avoid inaccuracies which may inspire
p.000140: dis- trust or fear. It is worth noting that 99% of children in the US are vaccinated with a minimum rate of
p.000140: complications, which proves that benefits far ex- ceed any drawbacks; therefore, it is not justified to
p.000140: spread doubts. In “emergency situations” in the above sense, the Commission feels that even mandatory vaccination is
p.000140: not to be excluded, especially for those who are highly probable to become carriers and transmit the
p.000140: infection due to the nature of their occupation. They should be offered, however, the option of changing duties. The
p.000140: established scientific requirements for clinical trials of new treatments (vaccines or medicines) may not be
p.000140: bypassed in order to
p.000140:
p.000140:
p.000140:
p.000141: 141
p.000141:
p.000141: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000141: OPINION
p.000141:
p.000141: accelerate the availability of such treatments to the public. Otherwise their efficacy will remain uncertain and
p.000141: citizens will be misinformed as a result.
p.000141: In addition, the Commission thinks that in the exceptional circumstances of epidemics or pandemics, limits to
p.000141: patents on new treatments could be justified to the extent possible. Such limits could be argued as a legal/policy
p.000141: choice in competent international and supra-national fora.
p.000141:
p.000141: c) Treatment
p.000141: The treatment of those infected should also be based on informed con- sent. Forced treatment is not justified in
p.000141: principle, except in “emergency situations”.
...

p.000146: say that the terms “epidemic” or “pandemic” do not necessarily involve an emergency situation. The risks
p.000146: posed by a disease depend on its specific characteristics, like the severity of symptoms, mortality rates and
p.000146: infectivity.
p.000146:
p.000146: 3. Preventive measures
p.000146:
p.000146: One of the most effective tools of contemporary medicine in the preven- tion of transmissible diseases is vaccination.
p.000146: To mention a typical example, smallpox was eliminated thanks to successful immunization against the dis- ease. Vaccines
p.000146: reinforce the defenses of recipients against the specific path- ogens for which they are designed, preparing the immune
p.000146: system to imme- diately recognize and effectively resist any future attacks by these patho- gens. Vaccines
p.000146: do not ensure absolute protection and people may still be infected with a disease against which they were
p.000146: vaccinated. Vaccines, how- ever, significantly reduce the probability of infection as well as the severity of symptoms
p.000146: in the event of infection.
p.000146: The success of a vaccination programme, however, depends not only on the efficacy of the vaccine but also on the rate
p.000146: of the population participat- ing in the programme. Vaccination does not reduce only the likelihood of
p.000146: infection in case of contact with the pathogen but also the likelihood of such contact itself, if sufficient numbers of
p.000146: the population are vaccinated. This is known as “indirect immunity” or “herd immunity”. Therefore, the decision to be
p.000146: vaccinated or to have one’s children vaccinated has implications for society as a whole because the vaccine
p.000146: protects not only recipients but also the rest of the population. Therefore, the decision to participate or not in a
p.000146:
p.000146:
p.000146:
p.000147: 147
p.000147:
p.000147: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000147: REPORT
p.000147:
p.000147: vaccination programme can produce a dilemma between autonomy and public interest.
p.000147:
p.000147: II. Ethical issues
p.000147:
p.000147: In case of contagious diseases the scope of personal autonomy is defined by the legitimate interests of others or of
p.000147: society as a whole. Limits to au- tonomy are of two natures: those imposed by the necessity of medical in- tervention
p.000147: (diagnosis, prevention or treatment) and those imposed by the autonomy of others.
p.000147: Transmissible diseases, like other risks to public health, affect the latter category. The following questions arise in
p.000147: this respect:
p.000147: - To what extent are limits to personal autonomy justified on public health grounds (1)?
p.000147: - What is the effect of informed consent when public health is at risk (2)?
p.000147: To these questions, we must add the implications of the “doing good, not harm” principle, that is the
p.000147: scope of medical duty in case of health- threatening (perhaps also life-threatening) situations for entire
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p.000198:
p.000198:
p.000199: 199
p.000199:
p.000199: DIRECT-TO-CONSUMER GENETIC TESTING
p.000199: OPINION
p.000199:
p.000199: Finally, the Commission considers that genetic tests revealing a person’s identity definitely presuppose consent from
p.000199: all the involved parties. Other- wise such genetic tests require a relevant judicial licensing.
p.000199:
p.000199: 2. Special issues
p.000199:
p.000199: In the context of the above mentioned general principles, the Commis- sion notes:
p.000199: A. It is recommended that DTC genetic tests for health reasons or prena- tal diagnosis must be performed following a
p.000199: suitable prescription by a liable expert physician, clinical geneticist or biologist-geneticist. The expert
p.000199: will assess the purpose of the test and will interpret the results, in order to avoid unnecessary genetic testing
p.000199: and inappropriate assessment. It is important that the consumer has the option to choose the expert. Impersonal,
p.000199: auto- mated counseling methods are discordant with the relationship of trust, which must govern health
p.000199: services.
p.000199: Exceptionally, DTC genetic testing which aims to improve dietary habits or other lifestyle factors (occupation,
p.000199: exercise etc.), or to define an individu- al’s ancestry, may not be dependent on such strict rules.
p.000199: B. In order to protect genetic information and respect a child’s right to ignorance, considering that children are
p.000199: unable to decide whether they wish to know the results of a genetic test predicting a disease, DTC genetic test- ing is
p.000199: not justified in asymptomatic children for whom there is no medical emergency, especially for late onset diseases such
p.000199: as Huntington’s disease. Even in the case where an expert decides that such a test is necessary for the parent(s),
p.000199: the same genetic test must be delayed for the child until he/she is able to participate in the decision
p.000199: making process, since there is no direct value to his/her health. On the contrary, DTC genetic testing is
p.000199: ac- ceptable in cases of children with first or second degree relatives with a monogenic disorder,
p.000199: showing a clear mode of inheritance e.g. familial hy- percholesterolemia. Nonetheless, such genetic tests must
p.000199: be allowed only in the case that the results will be used for early treatment and/or prevention of the complications
p.000199: caused by the disease.
p.000199:
p.000199:
p.000199:
p.000199:
p.000200: 200
p.000200:
p.000200: DIRECT-TO-CONSUMER GENETIC TESTING
p.000200: OPINION
p.000200:
p.000200: C. The promotion campaigns of DTC genetic testing must be governed by the same rules as in the case of health services,
p.000200: i.e. to be based on precise information and the true prognostic or diagnostic value of the test.
p.000200: Misleading advertising of the alleged “prediction” of serious diseases or other phenotypes, overlook the role of other
p.000200: genetic factors which are not determined yet or the critical role of environmental factors, and lead to ge- netic
p.000200: determinism.
p.000200: D. DTC genetic tests that determine a person’s identity without his/her consent is in principle illegal, since they
p.000200: directly offend the right to privacy.
p.000200: E. In any case, providers of DTC genetic services (especially via the inter- net) need to ensure high protection of
p.000200: the personal data that they collect and process. The Data Protection Authority must control the way that such data are
p.000200: managed by the genetic service providers.
...

p.000208: 2. In case of a negative result, the individual is relieved and freed from possible regular tests that can
p.000208: be painful and/or costly.
p.000208: 3. When it comes to pharmacogenetic testing, one can ensure a personalized, more effective treatment,
p.000208: with reduced side effects. E.g. people who suffer from Alzheimer’s disease and bear a single copy of a
p.000208: gene have no advantage with a certain
p.000208:
p.000208:
p.000209: 209
p.000209:
p.000209: DIRECT-TO-CONSUMER GENETIC TESTING
p.000209: REPORT
p.000209:
p.000209: treatment, while people with two copies of the gene demonstrate a slow progress of the disease under the same
p.000209: treatment.
p.000209: Genetic testing for health reasons involves medical, psychological or fi- nancial risks, both for the individual and
p.000209: his/her family:
p.000209: 1. Genetic tests that include sample collection of saliva, buccal mucosa swabs or blood do not involve
p.000209: physical risks for the individual. This is not however the case for prenatal genetic screening, where e.g.
p.000209: in amniocentesis the risk of miscarriage is 1 in 200-400 cases.
p.000209: 2. False positive results can cause anxiety and further unnecessary medical examinations and treatments.
p.000209: 3. False negative results cause complacency to the person or delay the diagnosis and treatment.
p.000209: 4. The results of a genetic test can affect serious decisions over a person’s life, e.g. if high risk for
p.000209: a disease is confirmed, then the person’s decision to have children may be affected. Or in the case where the genetic
p.000209: test detects a mutation that can cause breast cancer, the person might undergo a total mastectomy as an
p.000209: extreme measure of prevention.
p.000209: 5. In case of a positive result, there is always the risk of stigmatization, refusal of
p.000209: providing him/her private insurance and work.
p.000209: 6. In case of a positive result, the psychological stress imposed on the individual is severe, causing
p.000209: worries, uncertainty, confusion and, probably, despair. These consequences expand to other members of the
p.000209: family, as it is a hereditary disease.
p.000209: 7. The above (1-6) are also combined with the cost of genetic tests, which usually burdens the individual and/or
p.000209: his/her family.
p.000209:
p.000209: THE DIMENSION OF ETHICS
p.000209:
p.000209: The above mentioned highlight the main problem, which is the possibil- ity of misleading the average citizen about both
p.000209: the quality of specific ser- vices and the value of genetic tests in general.
p.000209: The Commission has repeatedly underlined the danger of overestimating the association of genetic data with a person’s
p.000209: health (Hellenic National Bio-
p.000209:
p.000209:
p.000210: 210
p.000210:
p.000210: DIRECT-TO-CONSUMER GENETIC TESTING
p.000210: REPORT
p.000210:
...

p.000212: genetic testing that he/she does not recommend?
p.000212: According to medical ethics, a physician is not obliged to insist on caring for patients who do not cooperate or bypass
p.000212: him/her. Certainly, the physi- cian must inform the patient about the risks of misleading information or
p.000212: unnecessary tests which may affect the patient’s treatment or life (art. 9 par. 4, art. 11 CME).
p.000212:
p.000212: Handling sensitive data
p.000212: Are there any restrictions in the case where a person consents to disclose sensitive data, to a third party, about
p.000212: his/her health or lifestyle expecting to obtain information on possible consequences to him/herself or his/her fami-
p.000212: ly? Furthermore, are there any restrictions in the existing risk that the data are handled with no control and,
p.000212: eventually, used for other purposes?
p.000212: In principle, everybody has full power on his/her own personal, simple or sensitive, data. However, a person can only
p.000212: undertake the risk of unethical handling of such data only for him/herself, not for others. In the case where genetic
p.000212: information concerns - and also identifies - members of the family, they must be protected from such risks through
p.000212: appropriate procedures.
p.000212:
p.000212: Genetic tests in children
p.000212: Is it ethical to perform genetic tests in asymptomatic children, upon the parents’ request, and how does this affect
p.000212: the child’s right to ignorance?
p.000212: To protect genetic information, as well as the child’s right to ignorance, it is not justified to perform genetic tests
p.000212: in asymptomatic children for which there is no urgent medical need -particularly for late onset diseases.
p.000212: This does not mean that genetic tests for such diseases should never be performed in children. In the case where
p.000212: parents wish to have the child tested, without an immediate benefit for the child’s health (i.e. treatment or
p.000212: prevention), one must weigh the risks and the benefits, and genetic testing may be postponed until the child reaches a
p.000212: certain age and is able to con- tribute at the decision making process (British Society for Human Genetics, 2010).
p.000212:
p.000212:
p.000212:
p.000213: 213
p.000213:
p.000213: DIRECT-TO-CONSUMER GENETIC TESTING
p.000213: REPORT
p.000213:
p.000213: Genetic tests revealing identity
p.000213: Is it morally legitimate for someone to demand disclosure of a person’s identity, without the latter’s knowledge, in
p.000213: order to protect one’s own vital interests (i.e. with a “paternity test”)?
p.000213: The answer is, in principle, negative, in the context of the right to priva- cy. Even if there is a serious reason for
p.000213: such a practice, this must be judged (and eventually there may be a decision to disclose the identity of a
p.000213: third person) in an a priori defined legal procedure, not arbitrarily by the appli- cant him/herself.
p.000213:
p.000213: Commercialization of biological information
p.000213: Is it ethically acceptable to maintain a financial activity that involves “remote” services of biological
...

p.000217: (Genetic Testing Registry). This registry aims at assisting patients and those in search of information for every kind
p.000217: of genet- ic test. It includes information about the purpose, methodology, accuracy and utility of every
p.000217: genetic test, along with credentials and contact infor- mation of every lab. Those submitting the
p.000217: registered information, i.e. pri- vate companies or non-profit laboratories offering relevant services, bear
p.000217: the responsibility for its accuracy. Greek companies which offer DTC genetic
p.000217:
p.000217:
p.000217:
p.000218: 218
p.000218:
p.000218: DIRECT-TO-CONSUMER GENETIC TESTING
p.000218: REPORT
p.000218:
p.000218: tests could submit them in this registry in order to facilitate every interested party.
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000218:
p.000219: 219
p.000219:
p.000219: DIRECT-TO-CONSUMER GENETIC TESTING
p.000219: REPORT
p.000219:
p.000219: SUGGESTED LITERATURE
p.000219:
p.000219: American College of Medicine Genetics (ACMG) (2004). ACMG statement on direct-to-consumer genetic testing.
p.000219: (www.acmg.net).
p.000219: Borry P (2008). Europe to ban direct-to-consumer genetic tests? Nature Bio- technology 26, 736-737.
p.000219: British Society for Human Genetics (2010). Report on the genetic testing of children.
p.000219: ESRC Genomics Forum (2006). Evaluation of genetic services - Expert Work- shop, UK.
p.000219: European Society of Human Genetics (2010). Statement of the ESHG on di- rect-to-consumer genetic testing for
p.000219: health-related purposes. European Journal of Human Genetics 18, 1271-1273.
p.000219: Genetic Testing Registry (GTR). http://www.ncbi.nlm.nih.gov/gtr/.
p.000219: Goddard KAB et al., (2007). Awareness and use of direct-to-consumer nutri- genomic tests. Genetic Medicine 9, 510-517.
p.000219: Mai Y, Koromila T, Sagia A, et al., (2011). A critical view of the general pub- lic’s awareness and physician’s opinion
p.000219: of the trends and potential pitfalls of genetic testing in Greece. Personalized Medicine 8, 551-561.
p.000219: Recommendations of the Secretary’s Advisory Committee on Genetic Test- ing (SACGT) (2000). Enhancing
p.000219: the oversight of genetic tests. (http://oba.od.nih.gov).
p.000219: STOA (Science and Technology Options Assessment) (2007). Direct to con- sumer genetic testing, European
p.000219: Parliament.
p.000219: Williams-Jones B (2003). Where there’s a web, there’s a way: Commercial genetic testing and the internet.
p.000219: Community Genetics 6, 46-57.
p.000219: Hellenic National Bioethics Commission (June 2006). Opinion on human bi- obanks.
p.000219: Hellenic National Bioethics Commission (January 2008). Opinion on genetic data in private insurance.
p.000219:
p.000219:
p.000219:
p.000220: 220
p.000220:
p.000220:
p.000220:
p.000220:
p.000220:
p.000008: 8
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: HUMAN ENHANCEMENT -
p.000008: PHYSICAL ENHANCEMENT
p.000008:
...

p.000233: state of complete physical, mental and social well-being and not merely the absence of disease or infirmity". This
p.000233: definition expands the boundaries of health, including non-medical problems such as those resulting from spe- cific
p.000233: social characteristics. The definition of normal is even more difficult if one considers that there are “natural”
p.000233: differences, not only between indi- viduals but also within the same individual at different developmental stag-
p.000233: es.
p.000233: On the other hand, the modern medical practice already applies practis- es that aim not only at the correction of
p.000233: pathological conditions and diseas- es:
p.000233: First and foremost, preventive medicine, which aims to prevent and ultimately avoid disease. Preventive medicine
p.000233: includes preventive vaccination.
p.000233: Palliative care, which is offered in order to relieve from pain and prevent the suffering of patients.
p.000233: Infertility treatments, aiming, ultimately, to reproduction.
p.000233:
p.000233:
p.000234: 234
p.000234:
p.000234: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000234: REPORT
p.000234:
p.000234: Plastic surgery, which is offered to healthy people who want to enhance or change their physical
p.000234: characteristics.
p.000234:
p.000234: b) Techniques of human enhancement
p.000234:
p.000234: Human enhancement can be achieved by various methods and techniques, including:
p.000234: Pharmaceutical substances causing for example exaltation and happiness that enhance memory, physical
p.000234: strength and stamina and cognitive abilities.
p.000234: Techniques of genetic intervention that facilitate for example the selection and creation of healthy or smarter
p.000234: children and increase life expectancy.
p.000234: Regenerative medicine, which aim to regenerate tissues and organs.
p.000234: Technological interventions that improve human capabilities. Cosmetic interventions (surgical or non-surgical) that aim
p.000234: to improve the external appearance and physical characteristics.
p.000234: Table I presents indicative examples of the above mentioned techniques, which can be applied to both treatment and
p.000234: human enhancement.
p.000234:
p.000234:
p.000234:
p.000234:
p.000234:
p.000234:
p.000234:
p.000234:
p.000234:
p.000234:
p.000234:
p.000234:
p.000234:
p.000234:
p.000234:
p.000234:
p.000234:
p.000234:
p.000234:
p.000235: 235
p.000235:
p.000235: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT REPORT
p.000235:
p.000235: Table I. Interventions applied to both treatment and human enhancement.
p.000235:
p.000235: Treatment Human enhancement Pharmaceutical substances
p.000235:
p.000235: Growth hormone Developmental problems in
p.000235: children
p.000235: Enhancing appearance Enhancing athletic performance
p.000235: Insulin growth factor Muscular dystrophy Increasing muscle mass Enhancing athletic
p.000235: performance
p.000235:
p.000235: Rimonabant and sibutramine
p.000235: Obesity Enhancing appearance Increase strength in patients
p.000235:
p.000235: Erythropoietin
p.000235: undergoing chemotherapy and present with anemia
p.000235: Enhancing athletic performance
p.000235: Modafinil Sleep disorders e.g. narcolepsy Enhancing attention, vigilance,
p.000235: memory
p.000235:
p.000235: Ritalin Attention Deficit Hyperactivity Disorder
p.000235:
p.000235: Prozac Antidepressant
p.000235: Enhancing concentration Enhancing emotions
p.000235: Reducing social characteristics e.g. shame
p.000235: Sildenafil (Viagra) Erectile dysfunction Enhancing sexual ability, stamina
p.000235: Techniques of genetic intervention
p.000235:
p.000235: Genetic testing (in various genes)
p.000235:
p.000235: In somatic cells
p.000235:
p.000235:
p.000235: In gametes
p.000235: Disease diagnosis Disease prevention Effective treatment Stem cell treatment
p.000235: StemXcells to generate tissue and organs
p.000235: Correcting or avoiding abnormal genes
p.000235: Avoiding sex-linked diseases
p.000235: Increasing life expectancy Selection of “better children” Enhancing athletic performance
p.000235:
p.000235: Increasing life expectancy
p.000235:
p.000235: Enhancing non-pathological genes Enhancing skills, stamina, intelligence, memory, metabolism, etc.
p.000235: Regenerative medicine
p.000235:
p.000235:
p.000235: Tissue/organ regeneration
p.000235: Restoration of organ function Restoration of sports injuries
p.000235: Increasing life expectancy Enhancing athletic performance
p.000235:
p.000235:
p.000235: Platelet rich plasma
p.000235: Scar repair after accidents or burns Enhancing appearance
p.000235: Restoration of anterior cruciate
p.000235:
p.000235: (gel)
p.000235: Restoration of joints with
p.000235: osteoarthritis
p.000235: Enhancing athletic performance
p.000235:
p.000235:
p.000235:
p.000235:
p.000235:
p.000236: 236
p.000236:
p.000236: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT REPORT
p.000236:
p.000236: Table I (continued). Interventions applied to both treatment and human enhancement.
p.000236:
p.000236: Treatment Human enhancement Technological interventions
p.000236:
p.000236:
p.000236:
p.000236: Artificial implants
p.000236: Early and accurate diagnosis Effective and targeted drug therapy Restoration of joints, organs
p.000236:
p.000236: Enhancing athletic performance Increasing life expectancy
p.000236:
p.000236:
p.000236:
p.000236: Implants - sensors
p.000236:
p.000236:
p.000236:
p.000236: Brain implants
p.000236: Diagnosis and treatment of diseases
p.000236: e.g. sensor of sugar levels and use of insulin
p.000236:
p.000236: Increasing memory in patients with neurodegenerative diseases Restoration of mobility in paralyzed patients
p.000236:
p.000236: Enhancing athletic performance
p.000236:
...

p.000250:
p.000251: 251
p.000251:
p.000251: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000251: REPORT
p.000251:
p.000251: Genetic manipulations can be applied in two types of cells:
p.000251: Somatic cells. Altering the genetic material in somatic cells involves only the organisms where the
p.000251: changes are made -in that case the athlete-, and such modifications are not inherited in the subsequent
p.000251: generations.
p.000251: For example, genes could be altered in somatic cells in order to create or modify muscles to become stronger.
p.000251: The insulin-growth factor helps the muscles to develop and restore injuries. Experimen- tally, the genes expressing
p.000251: insulin-growth factor can be transferred via a viral vector in mice, promoting muscle growth (Barton-Davis et al.,
p.000251: 1998). Although this specific research was conducted with the aim to treat diseases such as muscular
p.000251: dystrophy, the results could be used to enhance the muscle mass of athletes.
p.000251: Erythropoietin is also a characteristic example, which is used to enhance the strength of patients who are
p.000251: under chemotherapy and present with anemia. Athletes receive injections of erythropoietin to enhance their athletic
p.000251: performance, but they could also go under gene transfer to receive the same gene and produce more red blood cells
p.000251: (Svensson et al., 1997).
p.000251: Germ cells. Genetic modifications in the genetic material of germ cells, namely gametes, are inherited by the
p.000251: offspring.
p.000251: For example, the genes that produce insulin-growth factor may be modified in such a way that they are
p.000251: overexpressed. Parents will pass these genes on to their children who will be born with an ad- vantage in
p.000251: their muscle growth.
p.000251: Although the use of such genetic technologies is not possible at present, concerns are being expressed about the
p.000251: possibilities that will be available to create “super-athletes” in the future. Since the gene transferred to the ath-
p.000251: lete's body is inserted in his/her genome, a major question which concerns the anti-doping authorities in this
p.000251: case is how to detect genetic modifica- tions. About 10 years ago the Medicine Commission of IOC (IOC, 2001) and
p.000251: WADA launched consultations and created working groups aiming to exam- ine “gene doping” in sports, which includes gene
p.000251: therapy and gene transfer (WADA. Health, Medical and Research Committee Meeting. Minutes. 2001). Since then, WADA
p.000251: organizes meetings of expert working groups on gene doping, whereas plentiful money have been invested on
p.000251: testing for modern
p.000251:
p.000251:
p.000252: 252
p.000252:
p.000252: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000252: REPORT
p.000252:
p.000252: methods of detection that will identify athletes who will abuse this technol- ogy (WADA 2002; 2004; 2005).
p.000252: In 2003, WADA included “gene doping” for the first time on the list of prohibited substances and methods.
p.000252: More specifically, the list of prohibited substances and methods 2012 includes “The transfer of nucleic acids or nu-
p.000252: cleic acid sequences” and “The use of normal or genetically modified cells”. According to a comment on Art. 4.3.2 of
p.000252: the World Anti-Doping Code, the use of genetic technology should be prohibited as it satisfies the two criteria of
...

p.000268:
p.000268: I. The data
p.000268:
p.000268: Modern science enabled the development of specific interventions for the “cognitive" functions of the human
p.000268: body, with a main purpose to treat mental illnesses and disorders. However, the possibilities offered by modern science
p.000268: highlight the problem of whether it is legitimate to use such meth- ods in healthy organisms, aiming to enhance the
p.000268: mental or emotional condi- tion.
p.000268: Such methods are particularly: a) selective stimulation of brain regions, with electrical or magnetic signals, and b)
p.000268: drug use. In the future, it is likely that these methods are enriched by targeted genetic modification of genes
p.000268: associated with cognitive functions, as well as by brain/computer interfaces, which is expected to allow access
p.000268: to electronic information -and generally use of computer programs- by just activating certain cognitive functions.
p.000268: The Commission notices that there is internationally, a widespread use of substances by healthy individuals
p.000268: (nicotine, caffeine) or even prescription drugs, with the aim to further enhance their cognitive functions.
p.000268: Users mainly pursue memory and attention enhancement, but also to treat nor- mal hyperactivity, which occurs
p.000268: particularly in children. In addition, the ap- pearance of anxiety or phobias, typical elements of everyday life in a
p.000268: mod-
p.000268:
p.000268:
p.000269: 269
p.000269:
p.000269: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000269: OPINION
p.000269:
p.000269: ern social context, puts pressure on healthy individuals to use sedatives, antianxiety and antidepressant
p.000269: drugs.
p.000269: The Commission considers that, as in the case of enhancing physical characteristics, the autonomy of a
p.000269: healthy person includes options for en- hancing the cognitive or mental state of the human body. This enhancement
p.000269: is part of the right to develop freely a personality.
p.000269:
p.000269: II. Suggestions
p.000269:
p.000269: However, the aforementioned principle must be supplemented with necessary remarks.
p.000269: 1. The use of drugs to enhance memory or attention may adversely af- fect other cognitive functions. Due to this
p.000269: eventuality, the person concerned must be fully informed, in order to have the opportunity of an independent choice.
p.000269: 2. The issue of influencing the personality is particularly emphasized in the case of antidepressants use. The above
p.000269: mentioned influence is in princi- ple legitimate, as a fundamental right of the person, but it encloses the risk of
p.000269: uncontrolled effects on the nervous system and the general physical and mental condition of the person. The Commission
p.000269: notes the risk when chil- dren use such drugs since such a use may lead to the substitution of all the efforts made to
p.000269: integrate the person into society. A personality is developed by the gradual and smooth integration of the
p.000269: person into the social envi- ronment, owing to the family, friends or educational mechanisms that have the
p.000269: advantage of being subjected to constant scrutiny and revision, and are reversible if necessary, depending on the
p.000269: person’s maturity. For the Com- mission, this advantage is necessary to be ensured, especially in the case of
p.000269: children. For this reason, the use of substances for non-therapeutic purpos- es is not legitimate in children.
p.000269: 3. The use of enhancement methods to improve cognitive and mental functions always requires that the
p.000269: person concerned is fully informed and updated, in terms of the expected results and possible side
p.000269: effects. The Commission considers that the risk of misinformation, especially for drugs which are not
p.000269: prescribed, is serious. The promotion of these drugs to the public and the information leaflets about their
p.000269: use should be subjected to special inspection by the authorities (National Organization for Medicines,
p.000269:
p.000269:
p.000270: 270
p.000270:
p.000270: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000270: OPINION
p.000270:
p.000270: General Secretariat for Commerce, etc.). It is apparent that for prescription drugs, the physician and the pharmacist
p.000270: have an increased responsibility to properly inform the person concerned, especially since it remains doubtful whether
p.000270: the prescription for enhancement purposes falls within the medical responsibilities, such as those described in the
p.000270: Code of Medical Ethics (Law 3418/2005).
p.000270: 4. Noting the complete lack of evidence in our country, regarding the extent of use of human
p.000270: enhancement methods to improve cognitive and mental characteristics, the Commission considers that it is
p.000270: essential for re- search institutions to develop initiative to monitor the phenomenon sys- tematically, with
...

p.000274: and dihydroergotoxin (cerebrovascular vasodilator), could enhance neuron performance (Rose et al., 2005).
p.000274: Later studies in people suffering from Alzheimer's disease showed that their neurons are destroyed, especially
p.000274: neurons secreting acetylcholine. This led to the hypothesis that an increase of acetylcholine in the brain
p.000274: may result in better memory and the consequent use of drugs such as piracetam, which is a psychostimulant, as well
p.000274: as substances that interact with other neurotransmitters, such as serotonin and dopamine (Rose et al., 2005).
p.000274: Such studies in patients (with strokes or Alzheimer's disease) contributed to the development of smart drugs for
p.000274: healthy people. In contrast to technologies of brain stimulation by electrical or magnetic signals, the use of
p.000274: substances by non-patients to enhance cognitive functions is more frequent.
p.000274:
p.000274: 5 Giurgea CE, Greindl MG, Preat S (1983). Nootropic drugs and aging. Acta Psychiatr Belg 83, 349-58.
p.000274:
p.000275: 275
p.000275:
p.000275: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000275: REPORT
p.000275:
p.000275: Stimulants such as nicotine and caffeine have a proven effect on the increase of attention and memory 6,7
p.000275: and are widely used on a daily basis. However, nowadays, the use of prescription stimulants is also common.
p.000275: Methylphenidate (known under the commercial names Ritalin, Concerta, Metadate, Methylin) and amphetamine
p.000275: (commercial name Adderall) are used to treat attention deficit hyperactivity disorder (ADHD) in children.
p.000275: Nevertheless, these stimulant substances are commonly used by young people to enhance their attention and
p.000275: academic performance.
p.000275: A study in 4,580 American college students showed that 8.3% of students reported illicit use of
p.000275: prescription stimulants at least once in their lifetime, while 5.9% of them used it during the previous year.
p.000275: Of these, 75.8% used amphetamine while 24.5% used methylphenidate, with a higher rate of use among Caucasians. The
p.000275: study indicates that the most frequent incentives for stimulant use is to increase concentration, receive help during
p.000275: studying and increase attention8. These results were confirmed by similar studies9 indicating the problem
p.000275: of frequent use, especially amphetamine use, in college students.
p.000275: Modafinil is also a stimulating substance indicated for the treatment of excessive sleepiness in patients with
p.000275: narcolepsy. However, studies in healthy subjects showed that Modafinil improves memory10, as well as the levels
p.000275: of wakefulness and alertness in physicians11 and pilots12, making
p.000275:
p.000275: 6Warburton DM (1992). Nicotine as a cognitive enhancer. Progress in Neuro- Psychopharmacology and
p.000275: Biological Psychiatry, 16, 181-191.
p.000275: 7Newhouse PA, Potter A & Singh A (2004). Effects of nicotinic stimulation on cognitive performance. Current Opinion in
p.000275: Pharmacology, 4, 36-46.
...

p.000281: drug use, a person intentionally uses pharmaceutical agents, and this is done in the context of self-determination,
p.000281: even if the person is aware of the potential serious harm to his/her health. It is generally accepted that self-
p.000281: determination does not exclude choices of an even great risk or choices of “self-destruction”, since otherwise we
p.000281: must adopt paternalistic lifestyles, something that would be fundamentally in contrast to our freedom.
p.000281: Consequently, the possibility of drug use for enhancement purposes that could lead to a radical personality change (or
p.000281: to milder effects on memory capacity, emotional life, etc.), cannot be considered as an illegitimate
p.000281: choice, given the primacy of personal autonomy (Racine & Forlini, 3).
p.000281: However, two reservations remain:
p.000281: - The consequences of drug use do not cause damage to goods of a third party (e.g. in the context of
p.000281: family life or working environment of the user). Thus, for example, drug use that leads to indifference or threat for
p.000281: the user’s children or creates tension with colleagues etc., is illegitimate).
p.000281: - The user has actually made the decision freely, i.e. after providing the appropriate information to him/her, with
p.000281: all the potential risks being identified (Cakic, 613-614, Racine & Forlini, 3, Farah et al., 423). This is not certain,
p.000281: especially when the drugs are administered without a prescription or, at least, without consulting a physician.
p.000281: The re- sponsibility of the latter, here, is certainly increased, as it is about enhancing cognitive or
p.000281: mental characteristics and not about restoring relevant health damage.
p.000281:
p.000281:
p.000282: 282
p.000282:
p.000282: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000282: REPORT
p.000282:
p.000282: 4. Equal access
p.000282:
p.000282: The issue of equal access to means of cognitive or mental enhancement is mainly associated with the
p.000282: opportunities offered in competitive environments (Farah et al., 423) and, secondly, with improvement
p.000282: of our lifestyle. This is an issue of concern which is similar to that of enhancing physical abilities
p.000282: (e.g. doping in sports).
p.000282: Here, enhancement is usually associated with memory or concentration, especially during challenges in education or
p.000282: work. The general principle that wants to prevent distortion of rivalry is valid here, but it constitutes a
...

Searching for indicator elderly:

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p.000150: Particularly in case of mild diseases or hard to transmit diseases, the obliga- tion to respect autonomy remains fully
p.000150: effective.
p.000150:
p.000150: 3. Scope of medical duty
p.000150:
p.000150: When public health is at risk from a contagious disease, objective pa- rameters -time, in particular- often
p.000150: prevent the unhindered practice of med- icine. In such cases, physicians must set health care priorities,
p.000150: which may result in depriving certain people from care. The availability of physicians is obviously an external sine
p.000150: qua non for exercising patient autonomy.
p.000150: The necessities of war can offer a precedent for such prioritization. Since World War I, a three-fold division of the
p.000150: population in terms of priority (“tri- age”), based on the probability of cure is generally accepted: those
p.000150: in im- mediate need of help come first; next follow those who can be transported to a hospital even if more seriously
p.000150: hurt, and last are those with minor inju- ries or few chances of survival. But one may think of other
p.000150: considerations
p.000150:
p.000150:
p.000151: 151
p.000151:
p.000151: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000151: REPORT
p.000151:
p.000151: (e.g. priority to those who will treat others, to the young or the elderly, even a “first come first served” approach).
p.000151: Although “triage” is mostly associated with war (and natural disasters or train derailments) its core concept can be of
p.000151: use also in case of epidemics.
p.000151: At all events, health care priorities must be set by public authorities in advance on the basis of fixed rules in
p.000151: order to prevent physicians from hav- ing to make so many ethically questionable judgments.
p.000151:
p.000151: 4. Special issues: Clinical trials, patents
p.000151:
p.000151: The urgent need for prevention and treatment in times of epidemics painfully illustrates the question of
p.000151: the adverse effects of trials of new treatments (medicines, vaccines) to contain the risk.
p.000151: Given that clinical trials are now subjected to a specific control proce- dure, ensuring the safety of
p.000151: volunteering participants and of the end- product before it becomes available to the public, at issue is
p.000151: whether this procedure should be relativized in case of an urgent need to supply new cures. Since the
p.000151: pursuit of absolute safety, even in normal circumstances, obviously undermines the effort to find new cures (as
p.000151: being too time- and resource-consuming) the debate on the “maximization of risk” is not with- out cause. The criteria
p.000151: of socially acceptable risks from a new medicine or vaccine are ultimately a matter for bioethics, and must
p.000151: be considered as such.
p.000151: Similar arguments can be made on the scope of patents -and, with that, on the scope of trade prerogative- on new
...

p.000238: objective methods, this is not the case with preventive medicine, that aims at reducing risks:
p.000238: frequently, “risk” is being confused with “health damage”
p.000238:
p.000238:
p.000238: 1 In a similar direction the so-called transhumanists do not consider that distinguish- ing between therapy and human
p.000238: enhancement is important. They comprise a move- ment which claims that humans must lead their own evolution
p.000238: beyond the limits imposed by biology. Tanshumanists believe that enhancement must be addressed as treatment, i.e. to
p.000238: use freely all the possibilities provided by science and technology for enhancement purposes. Like transhumanists,
p.000238: proponents of human enhancement in general, consider that any delays in the use of technologies, such as genetic
p.000238: interven- tions to improve cognitive abilities, have harmful effects on our health, quality and life expectancy. In
p.000238: contrast, opponents of human enhancement argue that the new technologies will not solve the problems of inequality and
p.000238: social justice.
p.000238:
p.000239: 239
p.000239:
p.000239: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000239: REPORT
p.000239:
p.000239: and is amenable to medical care in order to reduce it (e.g. taking drugs to reduce glucose or cholesterol
p.000239: levels). But beyond that, the physical deterioration of the organism with the occurrence of aging is
p.000239: undoubtedly “damage” and is regularly treated with advanced medical care (in many levels), however, it leads
p.000239: to a fatal “medicalization” of the life of the elderly. But if we accept this natural decay as inevitable, we
p.000239: should define more precisely the limits of medical intervention, finding eventually a “gray zone” to the moderate
p.000239: definition of health.
p.000239: The so-called “enhancement” raises this general issue on the very own concept of health, and consequently, the nature
p.000239: of the medical profession, which are complemented by two additional ethical issues that must be addressed
p.000239: specifically.
p.000239: Firstly, there is the question of our own self-determination in health issues. In other words, is
p.000239: “enhancement” a right of the person who wishes it? Namely, does enhancement fall within the realm of biological
p.000239: autonomy, and indeed, is it an aspect of the fundamental right to health? Regardless of the legal dimension of such
p.000239: issues, the moral concern, here, is actually our ability to treat our body and to intervene freely in its’
p.000239: constitution or not. Even if we answer affirmatively to this freedom on our body, we must wonder to what
p.000239: extent: a) is it binding for the physician to whom we refer (particularly when an enhancement intervention may have
p.000239: adverse effects), and, b) does it allow us to apply enhancement in the field of childcare?
p.000239: Finally, another question concerns our relationships with others, or else, justice. Frequently, enhancement is
p.000239: attempted by someone in order to deal with the various requirements of social environments, especially in
...

Searching for indicator ethnic:

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p.000035: Parkinson disease Phenylketonuria
p.000035: Prader-Willi syndrome Refsum disease
p.000035: Rett syndrome
p.000035: Spinal muscular atrophy Spinocerebellar ataxia Tangier disease
p.000035: Tay-Sachs disease Nodular sclerosis
p.000035: Von Hippel-Lindau syndrome Wilson’s Syndrome Zellweger syndrome
p.000035: Nutritional and metabolic diseas- es
p.000035: Adrenoleukodystrophy Diabetes, type 1 Gaucher disease
p.000035: Glucose galactose malabsorption Hereditary haemochromatosis Lesch-Nyhan syndrome
p.000035: Maple Syrup Urine Disease Menkes syndrome Niemann-Pick syndrome Obesity
p.000035: Pancreatic cancer Phenylketonuria Prader-Willi syndrome Porphyria
p.000035: Refsum disease Tangier disease Wilson’s disease Zellweger disease
p.000035: Respiratory diseases
p.000035: α-1-antithrypsine deficiency Asthma
p.000035: Cystic fibrosis
p.000035: Small cell lung carcinoma
p.000035: Skin and connective tissue dis- eases
p.000035: Androgenic alopecia Diastrophic dysplasia
p.000035: Ellis-van Creveld syndrome Marfan syndrome Malignant melanoma Menkes syndrome Porphyria
p.000035:
p.000036: 36
p.000036:
p.000036: USE OF GENETIC DATA IN PRIVATE INSURANCE REPORT
p.000036:
p.000036: Table 2. Examples of genetic diseases for which a genetic predisposition test exists.
p.000036:
p.000036:
p.000036:
p.000036: Disease
p.000036: Gene/s, genetic region
p.000036:
p.000036: Power
p.000036: of detection
p.000036:
p.000036: Incidence in the general Penetrance Age at onset population
p.000036:
p.000036: Cost* (euros)
p.000036:
p.000036: Huntington’s Disease
p.000036: HD
p.000036: (IT 15), 4p16.3
p.000036: 100% 3-7/100,000 (varies depending on ethnic origin)
p.000036: 36-39
p.000036: repeats: strong probability, >40
p.000036: repeats: 100%
p.000036: 35-44 165
p.000036:
p.000036: Early-Onset Alz-
p.000036: PSEN1,
p.000036: 5-70% depend- 41.2/100,000 AD3 (PSEN1): 100%,
p.000036: 40-59 490-
p.000036:
p.000036: heimer
p.000036: 14q24.3
p.000036: ing on the
p.000036: AD4 (PSEN2): 95%
p.000036: 4,400
p.000036:
p.000036: (EOFAD)
p.000036: PSEN2, 1q31- method q42 APP
p.000036: 21q21
p.000036:
p.000036: Hereditary Breast/
p.000036: BRCA1,
p.000036: >88% in fami-
p.000036: 1/500-1/1,000 carries a
p.000036: 3.2-85% Significant
p.000036: 30-70 390-
p.000036:
p.000036: Ovarian Cancer
p.000036: 17q21
p.000036: lies with
p.000036: genomic mutation (>1% differences depend-
p.000036: 1,900
p.000036:
p.000036: BRCA2, 13q12.3
p.000036: confirmed association with BRCA1/2
p.000036: in Ashkenazi Jews)
p.000036: ing on age, type of mutation, type of cancer and model of calculation
p.000036:
p.000036: Thrombosis Risk
p.000036: F5, 1q23 100% 10-15% heterozygotes
p.000036: 0.19%-0.45% per year The disease may 55
p.000036:
p.000036: Factor (Leiden V factor)
p.000036: in Greece (1/5,000 homozygotes)
p.000036: - 0.10% for non- carriers of the muta- tion
p.000036: be manifested also after 60
p.000036:
p.000036: Muscular dystro-
p.000036: DMD Xp21.2 6-85% depend- 1/5,000 births of male
p.000036: 100% in males, varies Symptoms from
p.000410: 410
p.000410:
p.000410: phies (e.g. Du- chenne, Becker)
p.000410: ing on the method
p.000410: infants
p.000410: in females (8% cardiomyopathy)
...

p.000119: sclerosis.
p.000119:
p.000119:
p.000119:
p.000119:
p.000119:
p.000120: 120
p.000120:
p.000120: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000120: REPORT
p.000120:
p.000120: a) International experience
p.000120: One of the first studies attempting to record the views of the medical community on patient information
p.000120: conducted in the early ’60s in the US showed that the overwhelming majority of physicians (90% in a sample of
p.000120: 219 people) did not disclose the diagnosis of cancer to their patients (Oken, 1961). A study on the same topic carried
p.000120: out approximately 20 years later marked a radical change in the views of the US medical community. In a
p.000120: total reversal of the results of the previous study, 97% of the interviewees stated that they reveal the diagnosis to
p.000120: their patients (Novack et al., 1979). A similar turn was witnessed in the other Anglo-Saxon countries.
p.000120: This turn-about in the views of the medical community followed in time the desire of patients to know the truth. In a
p.000120: study published in 1957 involv- ing 560 cancer patients and their families, the participants in their great ma- jority
p.000120: (87%) argued that patients should be informed that they suffer from cancer (Samp and Curreri, 1957). Subsequent
p.000120: research on multiple sclerosis (before any treatment became available) (Elian and Dean, 1985) and Alz-
p.000120: heimer’s disease (Erde et al., 1988) also reported an increasing wish among participants to know the truth about their
p.000120: condition (83% and 90% respec- tively). It should be noted, however, that different ethnic groups seem to
p.000120: hold divergent views. For example, a related study conducted in the US rec- orded significant variation on
p.000120: preferences of information among old pa- tients of declared Mexican or Korean origin as against patients of
p.000120: European or African (African-Americans) origin (Blackhall et al., 1995).
p.000120: In contrast to Anglo-Saxon and north-European countries, in southern and eastern European countries, as
p.000120: well as in Asian countries like China, Japan, etc., this change in the attitude of physicians on the
p.000120: disclosure of truth about the diagnosis of serious diseases has not taken place yet or, to say the least, the process
p.000120: of change has not been completed. According to the results of studies, a high percentage of physicians avoid
p.000120: disclosing the diagnosis of cancer (Thomsen et al., 1993; Mystakidou et al., 2004).
p.000120: At any rate, international literature on disclosure of the diagnosis of se- rious, chronic or/and incurable conditions
p.000120: suggests that the attitude of phy- sicians depends on the likelihood of social stigmatization, prejudice or par-
p.000120: ticular emotions (metaphysical or other) associated with a particular dis- ease, the availability of treatment
p.000120: and other relevant factors that may gen- erate a feeling of “powerlessness” in the physicians themselves with regard
p.000120:
p.000120:
p.000121: 121
p.000121:
p.000121: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000121: REPORT
p.000121:
p.000121: to the disease. For example, while the disclosure of truth in case of cancer has been almost universal since the late
...

p.000242: improve their physical characteristics that were altered because of a medical/pathological condition or
p.000242: an accident. The decision to undergo plastic surgery is mainly driven by the need to restore the initial
p.000242: or normal state.
p.000242: In contrast, cosmetic procedures are offered to healthy individuals, who do not present with pathological findings or
p.000242: abnormal functions. Certainly, in this case one cannot overlook the impact of enhancing physical
p.000242: characteristics on the mental health of these individuals. There are many people who believe that
p.000242: cosmetic surgery will be the solution to the personal and social problems that they face.
p.000242: Both men and women are increasingly concerned about their appearance, looking for ways to
p.000242: enhance it through cosmetic surgery. The decision is based on several factors, which may vary between adults
p.000242: and adolescents, and include the modern obsession with the body image, the lack of self-confidence, the
p.000242: idols of each era and the icons dictated by fashion. The mass media played a crucial role in this case, by
p.000242: consolidating a global image of what is beautiful, desirable and attractive. The importance of beauty and
p.000242: physical appearance is strongly emphasized in social relationships, both professional and personal.
p.000242: For the aforementioned reasons, aesthetic surgeries pose ethical issues, which are, perhaps, greater than those
p.000242: posed by reconstructive surgeries.
p.000242: In addition, the number of the so-called "ethnic plastic (surgery) interventions" is increasing,
p.000242: and aim at removing national or racial characteristics. Such interventions are particularly popular
p.000242: in people of Asian descent who wish to obtain European features, or in African-Ame-
p.000242:
p.000242:
p.000243: 243
p.000243:
p.000243: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000243: REPORT
p.000243:
p.000243: ricans or African-Europeans who seek Caucasian characteristics.
p.000243: It is therefore necessary, in a first phase, that a plastic surgeon inve- stigates the motivations that
p.000243: lead a person to seek plastic surgery, especially an aesthetic procedure.
p.000243:
p.000243: c) Body dysmorphic disorders and plastic surgery
p.000243:
p.000243: A particular case is when individuals suffer from the so-called Body Dysmorphic Disorders (BDD) or
p.000243: otherwise dysmorphophophia (Crerand et al., 2006). BDD is a common psychiatric disorder that affects 1-2%
p.000243: of the general population and occurs with equal frequency in men and women. It is characterized by an excessive
p.000243: preoccupation of the person with imaginary or minor physical defects in various body parts. The
p.000243: condition is often associated with frequent hospitalization (48%) and high rates of depression and
p.000243: obsessive-compulsive disorders leading to suicidal tendencies and attempts (Phillips et al., 2006).
p.000243: Individuals suffering from BDD often resort to plastic surgeries in order to enhance their appearance. According
p.000243: to studies, 50%-76% of these patients seek plastic surgery, while 58%-66% of them eventually undergo
...

Searching for indicator ethnicity:

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p.000058:
p.000058: biomedical research in humans4 and animals5, research in the human ge- nome6 and for epidemiological
p.000058: research7. The International Epidemiology Association recently issued principles of correct practice and conduct in
p.000058: epi- demiological research (IEA, 2007). Some of the issues dealt with in these instruments can be summarized
p.000058: as follows (Shamoo and Resnik, 2002):
p.000058: Honesty as to the method and the findings in the publication and report- ing of scientific studies.
p.000058: Objectivity in the design of trials and the analysis of results as well as in the consideration of the work of other
p.000058: scientists.
p.000058: Integrity in the observance of promises and assumed obligations and con- sistency between word and action.
p.000058: Care to avoid inadvertent mistakes and to keep good records.
p.000058: Compliance with copyright.
p.000058: Confidentiality with regard to information obtained during private meet- ings or when considering proposals for funding
p.000058: or papers for publication, Responsible publications whose goal should be the advancement of sci- ence and
p.000058: avoidance of pointless papers that reiterate available knowledge.
p.000058: Care for the instruction of students, protection of their prosperity and recognition of their right to decide
p.000058: for themselves.
p.000058: Respect for colleagues.
p.000058: Social Responsibility, the goal must be the common good and the avoid- ance or alleviation of social problems through
p.000058: research and education of the public.
p.000058: Avoidance of discrimination based on gender, nationality, ethnicity or any other factor irrelevant to scientific
p.000058: competence and integrity.
p.000058: Preservation of professional competence through life-long training and education.
p.000058:
p.000058: 4 CIOMS international ethical guidelines for biomedical research involving human subjects
p.000058: (http://www.cioms.ch/frame_guidelines_nov_2002.htm).
p.000058: 5 1985 international guiding principles for biomedical research involving animals
p.000058: (http://www.cioms.ch/frame_1985_texts_of_guidelines.htm).
p.000058: 6 1990 declaration of inuyama on human genome mapping, genetic screening and gene therapy
p.000058: (http://www.cioms.ch/frame_1990_texts_of_guideline.htm).
p.000058: 7 1991 international guidelines for ethical review of epidemiological studies
p.000058: (http://www.cioms.ch/frame_1991_texts_of_guideline.htm).
p.000058:
p.000059: 59
p.000059:
p.000059: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000059: REPORT
p.000059:
p.000059: Legality, compliance with all laws and regulations governing the operation of research.
p.000059: Care for animals both in the design and the execution of research pro- jects.
p.000059: Protection of volunteers, limitation of risks and maximization of benefits for volunteers and respect of their
...

p.000131: data between physicians and patients on the extent of information. In their majority, the latter would rather have more
p.000131: information than the former provide.
p.000131: The most important causes -according to the view of the authors of the present report- for this divergence of
p.000131: opinion between physicians and pa- tients were identified and discussed in the previous chapters. Primary
p.000131: among them are the lack of appropriate training for physicians and the lack of time. It is important to look for
p.000131: practical solutions to implement respect for patient autonomy in practice not only as a value in itself but also as a
p.000131: safety valve for the efficiency of health services.
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000132: 132
p.000132:
p.000132: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000132: REPORT
p.000132:
p.000132: SUGGESTED LITERATURE
p.000132:
p.000132: Androulidaki-Demetriadi I (1993). The duty to inform the patient. A contri- bution to the assessment of civil
p.000132: medical liability. Eds. Sakkoulas, Athens- Komotini.
p.000132: Asveld L (2008). Mass-vaccination programmes and the value of respect for autonomy. Bioethics 22, 245-257.
p.000132: Blackhall LJ, Murphy ST, Frank G, Michel V, Azen S (1995). Ethnicity and atti- tudes toward patient autonomy. Jama
p.000132: Journal of the American Medical As- sociation 274, 820-825.
p.000132: Brokalaki EI, Sotiropoulos GC, Tsaras K, Brokalaki H (2005). Awareness of diagnosis, and information-seeking
p.000132: behavior of hospitalized cancer patients in Greece. Supportive Care in Cancer 13, 938-942.
p.000132: Dosios T, Markopoulos C, Vlahos I and Latsios P (1986). The views of Greek physicians on whether cancer patients should
p.000132: know of their illness. Medical Review of the Armed Forces 20, 9-315.
p.000132: Elian M and Dean G (1985). To tell or not to tell the diagnosis of multiple- sclerosis. Lancet 2, 27-28.
p.000132: Elliot C (2001). Patients doubtfully capable or incapable of consent. In Kuhse, H and Singer PA (Eds.). A
p.000132: Companion to Bioethics. Blackwell, Oxford, pp. 452.
p.000132: Erde EL, Nadal EC, Scholl TO (1988). On truth telling and the diagnosis of Alzheimers disease. Journal of
p.000132: Family Practice 26, 401-406.
p.000132: Fountedaki K (2003). Civil Medical Liability. General introduction - Issues of doctrine and legal policy -
p.000132: Fundamental concepts. Eds. Sakkoulas, Athens- Thessaloniki.
p.000132: Hartzband P and Groopman J (2009). Keeping the patient in the equation- humanism and health care reform. N Engl J Med
p.000132: 361, 554-555.
p.000132: Hebert PC, Hoffmaster B, Glass KC, Singer PA (1997). Bioethics for clinicians.
p.000132: 7. Truth telling. Canadian Medical Association Journal 156, 225-228.
...

Searching for indicator fetus:

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p.000148: remain rudimentary, represents a real cause of concern for the spreading of these diseases in the
p.000148: hosting countries. However, stigmatiza- tion practices -unfair treatment, “ghettos” etc.- stem rather from the idea
p.000148: of “miasma” due to lack of information or misinformation about the medical- biological particulars of disease,
p.000148: especially infectivity. Hansen’s disease (lep- rosy) and, more recently, HIV/AIDS confirm this observation
p.000148: since these
p.000148:
p.000148:
p.000149: 149
p.000149:
p.000149: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000149: REPORT
p.000149:
p.000149: population groups are stigmatized, although the disease is relatively difficult to contract.
p.000149: In case of Hansen’s disease, the exact path of transmission is still un- known, but it is accepted
p.000149: that although it can be contracted through pro- longed social contact, approximately 95% of the population are
p.000149: immune to it, though the mechanisms of immunity have not been identified. Perhaps it was this last parameter in
p.000149: combination with the deformity caused by the disease that has led to social stigma against these patients in the
p.000149: past.
p.000149: In case of HIV/AIDS, the path of transmission is known and involves ex- posure to body fluids through sexual
p.000149: intercourse or the transfusion of con- taminated blood or use of a contaminated needle. The virus can also
p.000149: be transmitted to the fetus by the mother. Mere social contact with patients or seropositives does not constitute a
p.000149: risk of transmission. Despite this, espe- cially in the early years since the appearance of the disease, but even
p.000149: today, seropositives are treated with far greater caution, even prejudice, than is justified by medical
p.000149: fact. Apart from the severity of the disease, which meant near certainty of death in the beginning,
p.000149: whereas now there are available treatments, prejudice emanates from the fact that, initially, the disease
p.000149: had a higher incidence among male homosexuals in western coun- tries. The pre-existing stigma against homosexuals
p.000149: exacerbated the stigma against HIV/AIDS patients and carriers.
p.000149: On a practical level, the difficulty here lies in the justification of re- strictions on grounds of public
p.000149: health protection. Public authorities can be motivated by non-medical parameters (e.g. systematic deprecation or
p.000149: exclu- sion of specific groups) when considering such restrictions, in particular to the freedom of movement and
p.000149: residency. Hence, the importance of having an official entity of indisputable independence, providing accurate and un-
p.000149: derstandable medical information on the disease to the wider public, be- comes crucial.
p.000149:
p.000149: 2. Autonomy and forced treatment
p.000149:
p.000149: The second serious ethical issue arises with respect to the freedom of individuals to take care of health
...

Searching for indicator foetus:

Searching for indicator restricted:

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p.000009: report), like some other types of medical da- ta, reveal a probable risk but -in most cases- not certainty of future
p.000009: sickness. The difference, at the moment, of genetic as against medical predisposition markers is that the
p.000009: association between most genetic markers and the probability of disease is not well-documented compared to
p.000009: medical mark- ers.
p.000009:
p.000009: 3. Ethical issues
p.000009:
p.000009: a. Protection of personality and economic freedom
p.000009: In view of the above, the first emerging ethical issue consists in weighing protection of personality for insurance
p.000009: applicants against freedom of busi- ness for insurers.
p.000009: Disclosure of genetic information -similarly to other health-related in- formation- as a requirement for
p.000009: contracting insurance or as a factor in the
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000010: OPINION
p.000010:
p.000010: calculation of premium goes to the core of personality since this information constitutes sensitive personal data.
p.000010: Considering that genetic data is in prin- ciple unchangeable, to reveal a predisposition for a disease may lead to
p.000010: life- long “stigmatization” of the applicant, a serious infringement on personality that may take the form of unfair
p.000010: social discrimination.
p.000010: On the other hand, freedom of business for the insurer is apparently restricted if access to genetic data
p.000010: known to the other party may affect sig- nificantly the insurer’s business risk. In the context of freedom of contract,
p.000010: barring access to information which is relevant to the object of the specific insurance could be seen as unfair to
p.000010: insurers since they are exposed to a risk they ignore whereas the other party is aware (and perhaps takes advantage)
p.000010: of.
p.000010:
p.000010: b. The value of genetic data and the risk of “genetic determinism”
p.000010: Genetic data is a very useful tool in contemporary medicine. In the con- text of personalized medicine and
p.000010: pharmacogenomics, in particular, person- al genetic data is becoming increasingly important for determining
p.000010: thera- peutic treatment. It is therefore of paramount importance that the collec- tion of genetic data,
p.000010: which can contribute to improvement of individual health, is not obstructed for non-medical reasons.
p.000010: The collection of genetic data for research aiming to identify links be- tween diseases and genetic
p.000010: causes with the ultimate goal to identify new treatment targets is crucial for the advancement of science and,
p.000010: in the long run, for the protection of public health. In this case also, it is critical that
p.000010: participation in such research is not discouraged for fear of use of genetic data or of the findings of research to
...

p.000058: 7 1991 international guidelines for ethical review of epidemiological studies
p.000058: (http://www.cioms.ch/frame_1991_texts_of_guideline.htm).
p.000058:
p.000059: 59
p.000059:
p.000059: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000059: REPORT
p.000059:
p.000059: Legality, compliance with all laws and regulations governing the operation of research.
p.000059: Care for animals both in the design and the execution of research pro- jects.
p.000059: Protection of volunteers, limitation of risks and maximization of benefits for volunteers and respect of their
p.000059: personality, especially in case of vul- nerable groups.
p.000059:
p.000059: The problem of control
p.000059:
p.000059: The issue of controlling the credibility and the ethics of research often inspires fears of a possible
p.000059: “bureaucratization”, imposition of “outside” reg- ulations and interference of mechanisms irrelevant to the
p.000059: objective. Such deviations would unavoidably cause unjustified delay and, in the end, would discourage initiative even
p.000059: if designed correctly.
p.000059: This eventuality, however, does not automatically eliminate the need for control; it merely draws our attention to the
p.000059: methods to be used. It is gen- erally accepted that if control is exercised on the initiative and according to the
p.000059: procedures of the scientific community itself (self-regulation) the extent of “bureaucratization” would be
p.000059: restricted since the parties themselves have an interest in effective control.
p.000059:
p.000059: RECOMMENDATIONS
p.000059:
p.000059: The specificities of biological research call for some general guidelines: Proposal I
p.000059: The independence of research is a public good. A society that recognizes and safeguards this principle cannot accept
p.000059: the unconditional submission of researchers to purely economic parameters.
p.000059: Therefore, some space needs to be ensured -and supported financially- for the unhindered development of research
p.000059: initiatives governed by princi- ples, rules and priorities set by science itself (the respective scientific field) even
p.000059: under the afore mentioned circumstances.
p.000059:
p.000059:
p.000059:
p.000060: 60
p.000060:
p.000060: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000060: REPORT
p.000060:
p.000060: This responsibility lies primarily with the state through the public funding of research. It is important, however,
p.000060: that non-state agencies can contribute here (e.g. non-profit organizations or charities).
p.000060:
p.000060: Proposal II
p.000060:
p.000060: The scientific community is the natural guarantor of independence of research both internationally and
p.000060: nationally. A national policy of research must be based on the community of scientists of every field
p.000060: in order to avoid the imposition of “outside” regulations. A principle similar to academ- ic freedom in higher
p.000060: education should be adopted for research.
p.000060:
p.000060: Proposal III
p.000060:
p.000060: In terms of ethics, a national policy for research must ensure:
...

p.000123: (“emergencies”) or to the inadequate organization of health services espe- cially when faced with occasional peaks of
p.000123: demand.
p.000123: It is worth noting that, in the first case, it is generally admitted -and ex- pressly stipulated by the law- that
p.000123: physicians may act alone, namely “in- formed consent” does not apply. The notion of “emergency” is very broad and
p.000123: needs to be further specified. Assuming that its use must be regarded as exceptional, its scope is limited to: i)
p.000123: cases posing an immediate threat against the patient’s life, or, ii) cases where even the slightest delay in
p.000123: ef- fecting the indicated medical act will definitely cause serious harm to health. Thus, moderate harm to health, even
p.000123: when demanding immediate action, or serious but chronic pathological conditions (e.g. many forms of cancer, dia- betes,
p.000123: etc.) cannot qualify as “emergencies”. In-between these two ex- tremes, there is an area in which the
p.000123: rule of consent must apply with the necessary adjustments to the available margins of time9.
p.000123: As far as inadequate organization of health services is concerned, the possibility to allocate the required
p.000123: time depends mostly on objective, often non-elastic, parameters (e.g. restricted resources to employ additional med-
p.000123: ical staff). Especially here, however, the issue of appropriate training and sensitization of civil health
p.000123: services to patient autonomy is crucial. For, if patient consent is not to be considered a “luxury” but an
p.000123: essential condition for the protection of health and, ultimately, for quality of life, then this re- quirement
p.000123: obviously affects the priorities of the organization of services in a way that makes finding the required time
p.000123: feasible.
p.000123:
p.000123: 3. Education - Training
p.000123:
p.000123: Among the reasons invoked by physicians to justify the concealment of diagnosis from their patients in Greece, as well
p.000123: as in other countries which
p.000123:
p.000123: 9 However, for a discussion on whether summary information provided to a patient capable to consent qualifies as
p.000123: “appropriate” in emergency circumstances see also Young, 2001.
p.000123:
p.000124: 124
p.000124:
p.000124: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000124: REPORT
p.000124:
p.000124: share the same practice, is the lack of training (Mystakidou 1996; Iconomou 2002).
p.000124: The question of deficient training of physicians in patient autonomy in Greece has at least two sides. The
p.000124: first concerns the knowledge of the rights of patients and the second the implementation of these rights and the ef-
...

p.000141: choice in competent international and supra-national fora.
p.000141:
p.000141: c) Treatment
p.000141: The treatment of those infected should also be based on informed con- sent. Forced treatment is not justified in
p.000141: principle, except in “emergency situations”.
p.000141: When the number of medical and nursing staff or the available treat- ments do not suffice to ensure care to
p.000141: all those infected (especially in case an infection spreads rapidly) the Commission stresses that the government must
p.000141: establish in advance general priority rules for access to treatment. The basic priority criteria should preferably be
p.000141: prescribed by law. By way of indi- cation, such priority criteria may include the severity of symptoms, the age of the
p.000141: patient and the definition of relevant vulnerable groups.
p.000141:
p.000141: 2. Limits to autonomy on public health grounds
p.000141:
p.000141: a) General rule
p.000141: Limits to the general autonomy of patients -especially the freedom of movement and establishment- are
p.000141: justified only if they are absolutely in- dispensable to protect public health pursuant to the Constitution
p.000141: (arts. 5 [4], 25 [1]). The principle of proportionality as discussed above applies in all circumstances. For
p.000141: example, hospitalized patients should be restricted in specially contained facilities.
p.000141:
p.000141: b) The risk of social stigma
p.000141: The Commission stresses the risk of social stigma that may arise from the isolation (“ghetto-ing”) of specific
p.000141: sub-populations with distinctive cultural characteristics or ways of living when an infectious disease erupts
p.000141: within such groups.
p.000141:
p.000141:
p.000141:
p.000141:
p.000142: 142
p.000142:
p.000142: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000142: OPINION
p.000142:
p.000142: Such cases must be dealt with by personalized medical care and social welfare measures especially as
p.000142: regards the improvement of hygiene in their living conditions.
p.000142:
p.000142: c) Illegal immigrants
p.000142: In case of manifestation of infectious disease or in cases when preven- tive measures (e.g. vaccination) need to
p.000142: be applied on illegal immigrants, the government must ensure that immigrants would be addressed to the
p.000142: health services. The access of immigrants to health services should be un- hindered and independent on their
p.000142: immigration status; otherwise the risks for public health in general will be multiplied.
p.000142:
p.000142: d) HIV/AIDS
p.000142: This particular disease presents a set of peculiar problems. Even though the spread of the virus is in general
p.000142: relatively difficult, the disease is very severe despite progress in treatment in the recent years. Moreover, social
p.000142: perceptions -especially regarding high risk vulnerable groups- remain ex- tremely negative in our country. The
p.000142: following call for attention:
p.000142: The autonomy of HIV seropositives or HIV patients can be restricted in view of public health protection only if the
p.000142: particular setting of social con- tact is prone to the transmission of the disease. Thus, although mandatory testing
p.000142: for seropositivity is not justified in the absence of qualifying circum- stances, it can be legitimate for certain
p.000142: occupations like physicians or nurs- es or for participation in certain social activities such as sports. In
p.000142: these cases, a positive test result justifies the removal of the seropositive, but just from this
p.000142: particular social context. By contrast, social environments, which are not prone to the transmission of the
p.000142: virus, do not justify devia- tions from the respect of autonomy which is generally applicable.
p.000142: Finally, special attention is required when the virus occurs in enclosed areas of mandatory containment, like
p.000142: schools, hospitals, military barracks or prisons. Any limits to autonomy which are considered indispensable
p.000142: must be combined with additional measures of supervision in order not to betray the purpose of the presence of the HIV
p.000142: seropositive in these areas (e.g. participation in common school activities, military exercises, etc.).
p.000142:
p.000142: Athens, 18 March 2011
p.000142:
p.000143: 143
p.000143:
p.000143: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000143: OPINION
p.000143:
...

p.000149: today, seropositives are treated with far greater caution, even prejudice, than is justified by medical
p.000149: fact. Apart from the severity of the disease, which meant near certainty of death in the beginning,
p.000149: whereas now there are available treatments, prejudice emanates from the fact that, initially, the disease
p.000149: had a higher incidence among male homosexuals in western coun- tries. The pre-existing stigma against homosexuals
p.000149: exacerbated the stigma against HIV/AIDS patients and carriers.
p.000149: On a practical level, the difficulty here lies in the justification of re- strictions on grounds of public
p.000149: health protection. Public authorities can be motivated by non-medical parameters (e.g. systematic deprecation or
p.000149: exclu- sion of specific groups) when considering such restrictions, in particular to the freedom of movement and
p.000149: residency. Hence, the importance of having an official entity of indisputable independence, providing accurate and un-
p.000149: derstandable medical information on the disease to the wider public, be- comes crucial.
p.000149:
p.000149: 2. Autonomy and forced treatment
p.000149:
p.000149: The second serious ethical issue arises with respect to the freedom of individuals to take care of health
p.000149: matters regarding themselves.
p.000149: Here, the principle of “informed consent” may be restricted, especially with regard to “refusal of treatment”.
p.000149: The health of others being directly at
p.000149:
p.000149:
p.000150: 150
p.000150:
p.000150: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000150: REPORT
p.000150:
p.000150: stake, the freedom to deny treatment does not enjoy the ethical justifica- tion acknowledged in different
p.000150: circumstances.
p.000150: Hence, forced treatment or prevention (e.g. mandatory vaccination) may be considered as option, especially if this is
p.000150: the only way to restore the gen- eral autonomy of the affected person (the subject of restrictions).
p.000150: The same can be argued about the extent of (personal) information and the availability of alternative treatments which
p.000150: are also limited by the emer- gency and time constraints of an epidemic.
p.000150: One may object that forced treatment is not the only option when a pa- tient denies therapy. Besides, insofar as it
p.000150: involves a direct intervention on the latter’s body, its compatibility with the respect for human value is ques-
p.000150: tionable, given that the affected person is used as a common “means” to protect society. The alternative
p.000150: -should this objection be sustained- would be to impose other restrictions to protect others, e.g. limits to the
p.000150: freedom of circulation and installation, not involving forced treatment. A solution more compatible with
p.000150: autonomy in view of the above would be to leave the choice of preferred option to the one concerned.
...

p.000209:
p.000209: The above mentioned highlight the main problem, which is the possibil- ity of misleading the average citizen about both
p.000209: the quality of specific ser- vices and the value of genetic tests in general.
p.000209: The Commission has repeatedly underlined the danger of overestimating the association of genetic data with a person’s
p.000209: health (Hellenic National Bio-
p.000209:
p.000209:
p.000210: 210
p.000210:
p.000210: DIRECT-TO-CONSUMER GENETIC TESTING
p.000210: REPORT
p.000210:
p.000210: ethics Commission 2006: Opinion on Human Biobanks par. 2a; Hellenic Na- tional Bioethics Commission 2008: Opinion on
p.000210: Genetic Data in Private Insur- ance par. 3b).
p.000210: It is sufficient, at this point, to note that although the genetic causes of many serious complex diseases have
p.000210: been detected, these reveal nothing more than mere “predisposition”. In order to develop a complex
p.000210: disease, relevant environmental factors must exist, otherwise genetic predisposition may remain inert. This category
p.000210: includes the vast majority of complex (mul- tifactorial) diseases, which comprise the main interest of a perfectly
p.000210: healthy individual, i.e. the consumer in this case. Monogenic diseases -that develop without the occurrence of
p.000210: environmental factors (e.g. cystic fibrosis, thalas- saemia, familial hypercholesterolemia, muscular dystrophy,
p.000210: Alzheimer’s disease, Huntington’s Chorea)- are comparatively few and, most prominent- ly, rare, in order to
p.000210: justify a commercial interest in the market of genetic testing.
p.000210: The restricted value of genetic data in protecting our health, could lead a non-expert to draw erroneous or, at least,
p.000210: uncertain conclusions. For exam- ple, if an individual has no interest in following a healthy diet he/she may
p.000210: develop cardiovascular disease despite the fact that there is no genetic cause. In addition, it is possible
p.000210: that serious psychological distress is caused in individuals who overestimate the importance of genetic
p.000210: predisposition,
p.000210: e.g. for cancer, by accepting “genetic determinism” and ignoring the multi- factorial nature of the specific disease.
p.000210: This is the reason why a mediating expert, who will be able to evaluate the necessity of genetic testing and the
p.000210: results for a particular individual with known medical record and “social” profile, seems to guarantee the
p.000210: proper use of genetic testing.
p.000210: But, is the expert’s involvement always justified? For example, is the intervention necessary for tests
p.000210: provided via the internet that intend to reg- ulate the dietary habits of the recipient and are generally
p.000210: considered as harmless? And generally: to what extend is a person’s autonomy in health issues affected, when the
p.000210: expert’s mediation is presupposed in every case, in order that the person could have access to simple diagnostic tests?
p.000210: This main concern is enhanced by some “peripheral” issues that need to be addressed. The most serious issue is of
p.000210: course the management and pro- tection of personal data, in the context of a relevant business activity -
p.000210: whether it concerns tests intended to protect health or tests designed to
...

p.000257:
p.000257: 6 Eurostat. Mortality and life expectancy statistics. Data from October 2011.
p.000257: http://epp.eurostat.ec.europa.eu/statistics_explained/index.php/Mortality_and_life_ expectancy_statistics.
p.000257:
p.000258: 258
p.000258:
p.000258: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000258: REPORT
p.000258:
p.000258: Environmental factors, such as smoking, alcohol consumption and diet have not been proven to reduce the average
p.000258: life expectancy but their effect on the development of diseases, such as cancer and cardiovascular disease indirectly
p.000258: reduces life expectancy. In addition, the way the social status, wealth and educational level can affect
p.000258: life expectancy, is not clear (Chris- tensen & Vaupel, 1996).
p.000258: Demographic and geographical studies showed that the increase in life expectancy is, in part, due to the advances in
p.000258: Medicine and geriatrics that study the diseases of old age, such as cancer and cardiovascular disease,
p.000258: aiming at prevention and better management of common diseases (Chris- tensen & Vaupel, 1996).
p.000258: However, along with the best medical care, modern biomedical research offers insights that allow humans to understand
p.000258: and intervene in the aging mechanisms. Biogerontology studies the aging mechanisms and provides information to
p.000258: reduce the rate of aging and prolong life beyond 122 years, which is the maximum limit today7. A typical example is the
p.000258: discovery that the enzyme telomerase can be used to increase cell divisions and delay their aging (Hayflick, 2003),
p.000258: and that substances that stimulate a calorie- restricted diet can increase life expectancy by 30%
p.000258: in mice (Ingram et al, 2004).
p.000258: In this context, intervening in the aging process is scientifically feasible, while man has a special interest in the
p.000258: existing possibility to extend lifespan by using biomedical technologies. As mentioned in the introduction to this
p.000258: Report, taking into account the distinction between therapy and enhancement, intervening in
p.000258: the aging mechanisms in order to extend lifespan beyond the upper limit constitutes human
p.000258: enhancement, not prevention or treatment of diseases presented in old age that aim to increase average
p.000258: lifespan.
p.000258: The use of biomedical technologies is expected to further increase the average lifespan or the maximum
p.000258: age reached, a fact that fuels debates about the bioethical issues raised from life prolongation as a
p.000258: form of enhancing human characteristics, by means which are already available or that will be available in
p.000258: the future.
p.000258: The aging process is characterized by a slow reduction in normal body
p.000258:
p.000258:
p.000258: 7 The Guinness Book of Records, 1999 edition, p.102.
p.000258:
p.000259: 259
p.000259:
p.000259: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000259: REPORT
p.000259:
p.000259: rhythms, progressive loss of functionality, reduced fertility, increased sus- ceptibility to most diseases and
p.000259: significant mortality. Technological interven- tions that affect the process of aging and can be considered
p.000259: as enhance- ment of human characteristics include (Barazetti and Reichlin, 2011):
...

Searching for indicator gender identity:

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p.000224: therapy used. Hermaphroditism and gen- der identity disorder fall within these cases.
p.000224: Regardless of the aetiology of a person’s mental and physical condition, which may be due to neurodevelopmental or
p.000224: genetic causes, the Commis- sion considers that such kind of procedures are essentially reconstructive and
p.000224: therapeutic, since they aim to match the psychosomatic disposition of a person with gender specific features.
p.000224: In this case, the ethical principles and rules of law, as outlined in a previ- ous Opinion of the Commission ("Consent
p.000224: in the patient-physician relation- ship," 2010) are entirely valid. The authentic will of the person him/herself is the
p.000224: determining factor here, in view of the right of personality. However, since there is a particularly
p.000224: sensitive issue of autonomy, it is right to allow for a period of time between the initial decision and the plastic
p.000224: surgery pro- cedure, during which the person concerned receives psychological and med- ical counseling.
p.000224:
p.000224:
p.000224:
p.000225: 225
p.000225:
p.000225: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000225: OPINION
p.000225:
p.000225: According to the Commission, if prenatal testing results in ambiguous results about the gender identity of a
p.000225: foetus, an artificial termination of the pregnancy is not justified, especially since there are the
p.000225: aforementioned reconstructive options after birth. However, given that persons in this cate- gory (seeking plastic
p.000225: surgery to alter gender specific features or gender re- assignment) belong to vulnerable social groups that
p.000225: generally suffer from social discrimination, access to relevant treatment must be ensured. For example,
p.000225: based on the principle of equality and the social right to health, the State may possibly develop counseling
p.000225: programs, but also provide ther- apy possibilities within the National Health System.
p.000225:
p.000225: 4. Face transplants
p.000225:
p.000225: Reconstructive face transplantation (e.g. in case of severe deformities caused by an accident) is, in
p.000225: principle, an acceptable alteration of the recipi- ent’s characteristics. However, it must be carried out in such a
p.000225: manner that it does not affect respect for the body of the (dead) donor. The relevant principle that rules
p.000225: transplants from a deceased donor is absolutely valid in this case too.
p.000225:
p.000225: 5. The physician’s role
p.000225:
p.000225: According to the Commission, the physician who carries out cosmetic plastic surgery has a particular
p.000225: responsibility, since he/she does not act in order to prevent a threat to a patient’s health (or life).
...

p.000261: Transgenderism 13:165-232.
p.000261: Comité Consultatif National d` Éthique (CCNE) (1998). Rapport sur le vieillissement, Opinion No 59.
p.000261: Comité Consultatif National d` Éthique (CCNE) (2004). L’ allotransplantation de tissu composite (ATC) au niveau de la
p.000261: face (Greffe totale ou partielle d’ un visage), Opinion No 82.
p.000261: Crerand CE, Franklin ME, Sarwer DB (2006). Body dysmorphic disorder and cosmetic surgery. Plast Reconstr Surg 118,
p.000261: 167e-80e.
p.000261: Crerand CE, Menard W, Phillips KA (2010). Surgical and minimally invasive cosmetic procedures among
p.000261: persons with body dysmorphic disorder. Ann Plast Surg 65, 11-6.
p.000261:
p.000261:
p.000262: 262
p.000262:
p.000262: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000262: REPORT
p.000262:
p.000262: Crerand CE, Phillips KA, Menard W, Fay C (2005). Nonpsychiatric medical treatment of body dysmorphic
p.000262: disorder. Psychosomatics 46, 549-55.
p.000262: European Group on Ethics (EGE) (1999). Ethical aspects arising from doping in sport, Opinion No 14, 1.6, 2.10.
p.000262: Farah MJ (2005). Neuroethics: The practical and the philosophical trends in cognitive sciences, p. 34.
p.000262: Fukuyama F (2002). Our posthuman future: Consequences of the biotechnology revolution, Farrar,
p.000262: Strauss and Giroux, N. York.
p.000262: Garcia-Verdugo M (2005). Medio fondo y fondo. La preparacion del corridor de resistencia. Atletismo 4. Madrid. RFEA.
p.000262: GIRES (Gender Identity Research and Education Society) (2008). Gender var- iance (dysphoria) (www.gires.org.uk).
p.000262: Hayflick L (2003). Living forever and dying in the attempt. Exp Gerontol 38, 1231-1241.
p.000262: Hildt E (2005). Living longer: Ethical aspects of age-retardation, Paper presented at the 19th European
p.000262: Conference on Philosophy of Medicine and Health Care and 22nd EACME Conference “Ethics and Philosophy of Emerging
p.000262: Medical Technologies”, Barcelona.
p.000262: House of Commons, Select Committee on Culture, Media and Sport (2004). Seventh Report of Session 2003-2004, UK
p.000262: Parliament, HC 499-I.
p.000262: Huxtable R, Woodley J (2005). Gaining face or losing face? Framing the debate on face transplants.
p.000262: Bioethics, p. 505.
p.000262: Ingram DK, Anson RM, De Cabo R, Mamczarz J, Zhu M, Mattison JA, Lane MA, Roth GS (2004). Development of
p.000262: calorie restriction mimetics as a pro- longevity strategy. Ann NY Acad Sci 1019, 412-423.
p.000262: Kriari-Katrani I (2001). The constitutional protection of genetic identity. A first approach. DtA 2001, p.347.
p.000262: Lo HS, Xie SQ (2012). Exoskeleton robots for upper-limb rehabilitation: State of the art and future prospects. Med Eng
p.000262: Phys 34, 261-8.
p.000262:
p.000262:
p.000262:
p.000263: 263
p.000263:
p.000263: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000263: REPORT
p.000263:
...

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p.000206: nutrition tests. Over the last years, promotion of DTC genetic testing through the in- ternet has been growing with
p.000206: even faster pace, since the service is favoured by the automated process of contacting the public via the internet and
p.000206: the development of e-commerce techniques.
p.000206: Today, advertising of genetic tests exceeds the traditional promotion to scientific audiences via medical journals, and
p.000206: even exceeds promotion to the general public via physicians. Already, direct advertising without the media- tion of an
p.000206: expert, is constantly growing (through the press, television, radio and internet), especially in the USA On one
p.000206: occasion, tests for breast cancer were advertised by operating a free phone line for the public, in case
p.000206: an individual wished to be informed on whether he/she should undergo the test. Advertising of genetic
p.000206: tests is based on preventing a disease, which could “shield” a person’s health, by protecting him/her
p.000206: from exposure to environmental risk factors and thus, balancing “bad” genetic predisposition. These methods of DTC
p.000206: advertising are often questioned, due to their similar- ity with advertising of prescribed medicines, which is
p.000206: forbidden in the E.U. This issue is related to a more general possibility of giving misleading infor- mation about
p.000206: the true value of genetic data -especially for protecting health- which will be examined in the present
p.000206: report.
p.000206:
p.000206: The Greek reality
p.000206:
p.000206: In Greece, as in other European countries, providing genetic tests direct- ly to consumers is steadily increasing. In a
p.000206: systematic search for websites in the Greek language, 15 companies were found to offer DTC genetic tests,
p.000206: with a kit for sampling and shipping. Through their webpages, the compa- nies promote their specialisation and
p.000206: know-how of their staff. They all ad- dress and offer genetic tests directly to consumers, except for one,
p.000206: for which sample collection and shipping is done by physicians or collaborating diagnostic centres. The range of
p.000206: genetic tests offered in Greece covers: pa- ternity tests (8/15), kinship tests (6/15), predisposition to complex
p.000206: diseases
p.000206:
p.000206:
p.000207: 207
p.000207:
p.000207: DIRECT-TO-CONSUMER GENETIC TESTING
p.000207: REPORT
p.000207:
p.000207: (7/15), pharmacogenetics for the efficiency and side effects of certain drugs (6/15), athletic performance (3/15),
p.000207: predisposition to single-gene diseases (2/15), nutritional or metabolic tests (2/15), anti-ageing tests (2/15),
p.000207: gene- alogy tests (1/15) and whole genome analysis (1/15). Only 4 out of 15 com- panies providing DTC genetic
p.000207: testing are accredited according to ISO/IEC 17025 standards for the operation of their laboratories.
p.000207: A recent study conducted by the University of Patra (Mai et al., 2011) provides information on the
p.000207: awareness of the Greek public and physicians on genetic testing. This survey included the completion of a
p.000207: questionnaire that was distributed to 1,717 members of the general public and 496 medi- cal practioners.
p.000207: The study showed that a large percentage of the general public in Greece is aware of the nature of
p.000207: DNA, genetic diseases and the potential advantages of genetic testing, although this percentage declined with age.
...

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p.000015: extremely useful in pharmacogenetics and in person- alized medicine1.
p.000015: Genetic and environmental factors interact in the development of dis- ease by creating a spectrum (Figure 1),
p.000015: with the so-called genetic or heredi- tary diseases associated with exclusively genetic causes (like β-thalassaemia) at
p.000015: the one end and diseases with exclusively environmental (external) caus-
p.000015:
p.000015: 1 See par. 1(C): The value of genetic information for personal health and scientific progress and the
p.000015: potential of genetic testing.
p.000015:
p.000016: 16
p.000016:
p.000016: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000016: REPORT
p.000016:
p.000016: es (like trauma) at the other end. The causes of most human pathological conditions, however, lie
p.000016: somewhere in-between, i.e. it is a combination of genetic and environmental factors that leads to
p.000016: manifestation of disease, such as diabetes or cardiovascular diseases.
p.000016: Depending on their genetic basis, genetic diseases are divided in (i) sin- gle-gene2, (ii) polygenic3, and, (iii)
p.000016: mitochondrial4 (Human Genome Project Information5). A gene’s disease-causing mutation is either dominant or re-
p.000016: cessive if one or two mutated alleles are required respectively for the mani- festation of the disease. Finally,
p.000016: the likelihood of disease depends on the penetrance6 of the allele. The evaluation of the results of a genetic
p.000016: test de- pends directly on the category of genetic disease for which the test is taken. In general, the evaluation of
p.000016: genetic testing results for single-gene diseases is simpler as compared with multifactorial diseases.
p.000016: The genetic disorders relevant to the present report are those manifest- ed after an application for insurance has been
p.000016: made, so usually after infan- cy. Genetic tests potentially of value to health and life insurance are those that can
p.000016: contribute to determining the insured risk, i.e. those able to detect mutations which are well-documented to be
p.000016: associated with a specific dis- ease(s) and their penetrance is known so that, based on the outcome of the genetic
p.000016: test, it is possible to determine the likelihood of manifestation of the disease.
p.000016: According to the reliable network GeneTests, as of today (data accurate on 4/10/2007) there are 1.175 genetic
p.000016: tests in clinical use and 282 at the experimental stage for 1.475 diseases. NCBI’s on-line database
p.000016: Genes and Disease7 provides information on the association of one or more genes with 84 groups of diseases (Table 1),
p.000016: whereas there are overall more than 6,000
p.000016:
p.000016:
p.000016: 2 They are caused by the disease-causing mutation of a single gene, e.g. Huntington’s chorea, cystic fibrosis, Marfan’s
p.000016: syndrome, etc.
p.000016: 3 More than one genes are involved in the manifestation of the disease, e.g. Alz- heimer’s disease,
p.000016: diabetes, arthritis, etc.
p.000016: 4 Mutations in the non-chromosomal DNA of the mitochondria.
p.000016: 5 http://www.ornl.gov/sci/techresources/Human_Genome/home.html.
p.000016: 6 Penetrance is complete if all the carriers of disease-causing alleles will manifest the disease or incomplete when
p.000016: only some of the carriers will develop the disease.
p.000016: 7 On-line database which collects information on genetic testing and is funded by the American National Institutes of
p.000016: Health (NIH’s) http://www.ncbi.nlm.nih.gov/.
p.000016:
p.000017: 17
p.000017:
p.000017: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000017: REPORT
p.000017:
p.000017: single-gene disorders that affect approximately 1/200 births (Human Ge- nome Project Information). Of the
p.000017: available genetic tests, those with predic- tive value concern 61 diseases as a whole. Table 2 provides selective
p.000017: infor- mation on some of the most common diseases. The available genetic tests that qualify as predictive are further
p.000017: classified according to the penetrance of the disease causing mutations into pre-symptomatic and predisposition
p.000017: tests (McPherson, 2006).
p.000017: The first category comprises tests that detect mutations with complete penetrance, where the manifestation of disease
p.000017: is certain for the carriers of disease-causing mutations, e.g. the genetic test for Huntington Disease. The second
p.000017: category includes tests that detect mutations with incomplete pene- trance. The carriers of such mutations will not
p.000017: necessarily develop the dis- ease but their chances are increased compared to the general population. Tests for cancer
p.000017: belong to this category. In this case, if the result is positive, medical testing will need to be carried out more
p.000017: frequently in the future; if negative, the likelihood of disease is the same with that of the general popu- lation, but
p.000017: not zero. Below, we provide some examples of genetic tests from both categories.
p.000017:
p.000017: i. Huntington Disease
p.000017: Huntington’s disease is a neurodegenerative condition affecting 3- 7/100,000 people in western
p.000017: European populations (except among the Finns). The incidence is significantly lower in Japan, China and black
p.000017: Africans (Warby, Graham and Hayden, Table 2). The HD (IT15) gene is involved in this condition and the disease is
p.000017: inherited in an autosomal8 and dominant man- ner. The available genetic test detects the alleles of gene HD9 in the
...

p.000018: the disease seems strong since, of all the early onset alzheimer cases, 61% of patients have relevant family
p.000018: history and 13% have relatives in three generations that developed the disease. Early onset alzheimer is manifested in
p.000018: 41.2/100,000 people aged 40-59.
p.000018: The involvement of three genes has been identified, PSEN1, PSEN2, APP (Table 2). In all EOFAD cases heredity is
p.000018: autosomal and dominant. Genetic tests have been developed and are used clinically to detect disease-causing mutations
p.000018: for all three genes. The highest numbers of positive scores in EOFAD patients are achieved by tests
p.000018: detecting mutations in the PSEN1 gene. The evaluation of genetic tests for EOFAD is not as simple as
p.000018: in the test for Huntington’s disease since the available tests do not detect all the mutations and in some patients
p.000018: the test yields a negative score. Neverthe- less, penetrance of PSEN1 gene (AD3) mutations is complete whereas pene-
p.000018: trance of PSEN2 (AD4) mutations is 95%, i.e. if one of the disease-causing mutations is identified in a
p.000018: healthy subject the manifestation of the disease is almost certain.
p.000018:
p.000018: iii. BRCA1 and BRCA2 Hereditary Breast/Ovarian Cancer
p.000018: Mutations in BRCA1 and BRCA2 genes have been found to predispose for breast, ovarian, prostate and other cancers
p.000018: (Pertucelli et al., 2007, Table 2). There are genetic tests that detect mutations in these genes but the reliabil- ity
p.000018: of the test and the evaluation of the results are complex, more so than in the case of EOFAD mentioned above. Due to a
p.000018: multitude of disease-causing mutations for both genes, there is no single test capable of detecting all of them.
p.000018: For a healthy individual with a family history of this category of cancers it is important to know which mutation
p.000018: occurred in those family members that
p.000018:
p.000018:
p.000019: 19
p.000019:
p.000019: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000019: REPORT
p.000019:
p.000019: developed cancer. Calculation of the penetrance of the mutations of genes BRCA1 and BRCA2 is not a simple task, as
p.000019: different mutations have different penetrance and the likelihood of cancer varies in different age groups. For example,
p.000019: the probability of breast cancer in BRCA1 mutations ranges from 3.2% (at the age of 30) to 85% (at the age of 70). The
p.000019: probability is similar for BRCA2 mutations.
p.000019: The likelihood of ovarian cancer is lower. The availability of several calcu- lation models for the probability of
p.000019: cancer in case disease-causing mutations are detected, which vary significantly in their predictions, is a
p.000019: sign of the complexity of the evaluation of the test results. Another important factor is that a negative score in
p.000019: the genetic test does not mean that the subject will not develop the specific cancers, only that the risk is not higher
p.000019: as compared with the general population. Finally, a positive score in a healthy subject practically means
p.000019: that the person in question must undergo more frequent examinations but it makes no difference in terms of
p.000019: treatment if cancer does occur.
...

p.000026: of a genetic predisposition). Thus it might very well be that, in the future, the cost of health care is reduced
p.000026: for those not found to have any predisposition and increased for the rest, or that insurers might even
p.000026: refuse to underwrite certain conditions.
p.000026: This line of thinking leads to an absolute ban on disclosure of genetic information to insurers and,
p.000026: needless to say, precludes insurers from requir- ing genetic testing as a condition to a life or health insurance
p.000026: contract.
p.000026: From the viewpoint of bioethics, the issue here is whether the economic freedom of the insurer puts the principle of
p.000026: equality at risk for the insured or, seen in the opposite, if concealment of genetic data by the insured cre- ates
p.000026: inequality between the parties in the context of freedom of contract.
p.000026: With regards to the above, it is worth noting the following:
p.000026: a) From the discussion in the first chapter, we concluded that genetic information actually has little
p.000026: predictive value as to the certainty of disease manifestation. It makes a more accurate prediction about the likelihood
p.000026: of disease but, on the other hand, allows preventive measures to limit this like- lihood. The detection of specific
p.000026: mutations in one’s genome that are known to be associated with disease, does not mean, in most cases, that the dis-
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000027: REPORT
p.000027:
p.000027: ease will actually be manifested during the life-span of an individual. The only exception is a number of
p.000027: single-gene diseases (e.g. Huntington’s cho- rea).
p.000027: b) This means that, compared to other medical information, a greater interest from insurers to have access to
p.000027: genetic information is not necessari- ly justified. Nevertheless, such an interest is widely based on overestimates of
p.000027: the power of genetic data, i.e. on the erroneous perception that has been cultivated, regarding their increased
p.000027: predictive value for the future health of an individual (HGC Minute 2007: 3.3). This is actually a version of “genetic
p.000027: determinism”, a popular belief nowadays, which is due to inaccurate infor- mation. The consequences of this misleading
p.000027: perception are not to be over- looked: the emergence of unfavourable discrimination against specific popu- lation
p.000027: groups based on their genetic traits, in violation of the principle of equality, is seen in this light, as
p.000027: an existing problem.
p.000027: c) It is a fact that an absolute prohibition of access of insurers to all in- formation, which may be critical for a
p.000027: particular type of insurance contract, can only increase their business risk. First of all, it does not seem fair that
p.000027: health information that is known to the insured should be withheld from the other party (regardless of its worthy
p.000027: protection as sensitive personal data). Besides, it should not escape our attention that such a prohibition may sus-
...

p.000032: AJLM 28, 1-76.
p.000032: GeneTests: Medical Genetics Information Resource (database online). Seat- tle. 1993-2007. http://www.genetests.org.
p.000032: Goldman BR (2005). Pharmacogenomics: Privacy in the era of personalized medicine. Northwestern Journal of Technology
p.000032: and Intellectual Property 4, 83-99.
p.000032: Hall MA and Rich SS (2000). Laws restricting health insurers' use of genetic information: Impact on genetic
p.000032: discrimination. Am J Hum Genet 66, 293- 307.
p.000032: Holm S (2007). Should genetic information be disclosed to insurers? Yes. BMJ 334, 1196.
p.000032: Holtzman NA, Watson MS (1999). Promoting safe and effective genetic test- ing in the United States: Final report of the
p.000032: Task Force on Genetic Testing. Baltimore: Johns Hopkins University Press.
p.000032: Kriari-Katrani I (1999). Genetic technology and fundamental rights. The Con- stitutional protection of genetic data,
p.000032: Athens-Thessaloniki.
p.000032:
p.000032:
p.000032:
p.000033: 33
p.000033:
p.000033: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000033: REPORT
p.000033:
p.000033: Lemmens T (2003). Genetics and insurance discrimination: Comparative legislative, regulatory and policy
p.000033: developments and Canadian options, Health Law Journal 41-86.
p.000033: Low L, King S, Wilkie T (1998). Genetic discrimination in life insurance: Em- pirical evidence from a cross sectional
p.000033: survey of genetic support groups in the United Kingdom. BMJ 317, 1632-1635.
p.000033: McPherson E (2006). Genetic diagnosis and testing in clinical practice, Clini- cal Medicine & Research 4, 123-129.
p.000033: Minute of the Meeting between HGC and the Single Equality Bill Team (2007). Wellington House, (HGC Minute
p.000033: 2007).
p.000033: Nationaler Ethikrat (2007). Predictive health information in the conclusion of insurance contracts. Opinion,
p.000033: Berlin.
p.000033: Pertucelli N, Daly MB, Bars Culver JO, Feldman GL (1998). BRCA1 and BRCA2 hereditary breast/ovarian cancer. In:
p.000033: GeneReviews at GeneTests: Medical Genetics Information Resource.
p.000033: Pfeffer NL, Veach PM, LeRoy BS (2003). An investigation of genetic counse- lors' discussion of genetic discrimination
p.000033: with cancer risk patients. J Genet Couns 12, 419-438.
p.000033: Rothenberg KH and Terry SF (2002). Before it’s too late-Addressing fear of genetic information, Science 297, 196-197.
p.000033: Warby SC, Graham RK, Hayden MR (1998). Huntington Disease. In: GeneRe- views at GeneTests: Medical Genetics Information
p.000033: Resource.
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000033:
p.000034: 34
p.000034:
p.000034: USE OF GENETIC DATA IN PRIVATE INSURANCE REPORT
p.000034:
p.000034: ANNEX: FIGURES AND TABLES
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034: Figure 1. Schematic representation of the spectrum of genetic and environmental causes of human diseases.
p.000034: Adapted from GeneTests (http://www.genetests.org/).
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.001400: 1400
p.001400:
p.001300: 1300
p.001300:
p.001200: 1200
p.001200:
p.001100: 1100
p.001100:
p.001000: 1000
p.001000:
p.000900: 900
p.000900:
p.000800: 800
p.000800:
p.000700: 700
p.000700:
p.000600: 600
p.000600:
p.000500: 500
...

p.000104: patients.
p.000104: Following the end of World War II -and spurred by the dismal experience of the experiments performed on the prisoners
p.000104: of the Nazi regime among others- this model of medical “self-commitment” was seriously questioned. It was realized
p.000104: that self-commitment on the part of physicians does not en- sure the protection of patients. It became obvious that the
p.000104: participation of patients themselves in the course of treatment as active agents at all stages is the best safeguard
p.000104: for their well-being.
p.000104:
p.000104:
p.000105: 105
p.000105:
p.000105: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000105: OPINION
p.000105:
p.000105: But first and foremost, the development of medicine itself has made the active involvement of patients a practical
p.000105: necessity in view of the fragmen- tation in the provision of health services brought about by increasing medi- cal
p.000105: specialization and the broad introduction of new technologies that mul- tiply possible alternative treatments.
p.000105: It is almost certain that no treatment is free of adverse effects. There- fore, the classical principle of “doing
p.000105: good or not doing harm” is no longer sufficient to determine treatment. Patients need to be involved to
p.000105: deter- mine the treatment whose likely adverse effects are more acceptable to them. Especially in our
p.000105: country, the need for this involvement becomes all the more urgent due to the absence, until now, of a single
p.000105: registration sys- tem to record the complete history of patients which deprives physicians from unmediated
p.000105: access to consistent and reliable data.
p.000105: The adoption of “informed consent” presupposes that patients are in- formed by physicians and in principle,
p.000105: they consent prior to all medical acts. In this way, they can consider their condition in the context of their general
p.000105: way of living not as passive recipients but as independent agents who are involved in the whole process as much as
p.000105: possible. A good knowledge of the values and needs a patient would like the physician to take into account
p.000105: when determining treatment is an essential part of this process. It is worth noting that the requirement of
p.000105: participation is complied with even when patients express the wish to follow the suggested treatment without
p.000105: further information (right to ignorance).
p.000105:
p.000105: B. The law
p.000105:
p.000105: Initially, the new model of “informed consent” appeared in codes of eth- ics on clinical trials (Nuremberg Code,
p.000105: Helsinki Declaration) because, on this occasion, the risks for the volunteers are greater. Gradually, however,
p.000105: its effects were recognized in all areas of medical practice.
p.000105: The Oviedo Convention on Human Rights and Biomedicine is the first example of binding international law
...

p.000112: 1Although the so-called “paternalistic” model of the relationship patient-physician is attributed to Hippocrates or to
p.000112: his followers, in the extant Hippocratic texts the au- thor considers as a virtue of the physician that “he makes sure
p.000112: to foresee and foretell to the sick their present condition, what preceded it and what will happen in the fu- ture”.
p.000112: He considers also that “any irrational thing that happens needs to be dis- cussed” (Rigatos, 1997) while he
p.000112: argues that when the physician analyses the present condition of the patient and what he foretells for the future in
p.000112: the presence of the patient the latter will find it easier to believe that the physician is well acquainted
p.000112: with the situation and will have more confidence in him (Hippocrates, Prognostics, introduction to the
p.000112: text).
p.000112:
p.000113: 113
p.000113:
p.000113: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000113: REPORT
p.000113:
p.000113: the conditions in which it operates which affect the relationship physician- patient can be summarized as follows:
p.000113: 1. Medicine is divided into several specialties and one physician alone is no longer able to treat all the health
p.000113: problems of an individual.
p.000113: 2. The physicians of different specialties as involved to consult in the course of his/her life will
p.000113: not necessarily work together; therefore, the patient is the only one with a complete picture of his/her medical
p.000113: history. It should be noted also that in Greece, records of medical his- tory are not kept for each patient.
p.000113: 3. Medicine has progressed in such a way that there is no single indicat- ed treatment for each particular condition.
p.000113: 4. The level of education in our country has been improved in recent decades. As a result, most patients
p.000113: are able to understand the medi- cal facts of their condition and are seeking more detailed infor- mation.
p.000113: Furthermore, the lay public enjoys greater, if fragmentary, access to medical information from a variety of
p.000113: sources.
p.000113: 5. People do not trust the motives of physicians unreservedly. This is mainly because the practice of
p.000113: medicine is sometimes known to be influenced by varying interests not necessarily compatible with the patient’s
p.000113: interests.
p.000113: 6. Citizens demand more from the health system as regards the quality of services, the medical outcome and the
p.000113: conditions in which these services are provided. The provision of high quality services is consid- ered by citizens as
p.000113: an utmost priority in our country.
p.000113: 7. It is now acknowledged that the way of living and the religious or other philosophical beliefs of
p.000113: patients must be taken into considera- tion when determining treatment. There is an increasing awareness of the right
p.000113: to autonomy and of respect for dignity in medicine.
p.000113:
p.000113: B. LEGAL ISSUES
p.000113:
p.000113: In general
p.000113:
p.000113: The “Code of Medical Ethics” (CME, Law 3418/2005) has put in place a modern legal framework for the relationship
p.000113: physician-patient in Greek
p.000113:
p.000113:
p.000113:
p.000114: 114
p.000114:
...

p.000122: 15.5% of the patients who participated in rele- vant research knew they suffered from cancer (Lavrentiadis et al.,
p.000122: 1988).
p.000122: All the above show a considerable distance in our country between a wish by patients to receive more
p.000122: information and the attitude of physicians. The causes of this divergence, in particular, the reasons leading
p.000122: physicians to hide the truth from their patients, need to be investigated in order to develop guidelines
p.000122: based on the patients’ interests.
p.000122:
p.000122: c) Honesty in the physician-patient relationship
p.000122: There is disagreement as to the usefulness of honesty in the relationship physician-patient, especially when disclosing
p.000122: the diagnosis of serious diseas- es. A lot of international literature supports the view that honesty and in-
p.000122: formation are beneficial to patients because they strengthen their confi- dence in the physician, increase the
p.000122: chances of compliance, reduce pain and suffering from medical interventions, increase satisfaction for the provided
p.000122: medical care and reduce the chances of change of physician (review by Hebert et al., 1997). By contrast, the
p.000122: concealment of truth from the patient may lead to an attitude of suspicion vis-à-vis the physician while its disclo-
p.000122: sure to relatives may isolate the sufferer from his/her surroundings.
p.000122: The opposite, however, can also be argued: that in some cases complete information may be detrimental to certain
p.000122: patients and have a negative psy- chological and physical impact. A compromise between these contradictions can be
p.000122: reached if we admit that there is no single “correct” approach to the issue of honesty but every patient must be dealt
p.000122: with according to his/her needs. To meet this goal, it is important to dedicate time to the develop- ment
p.000122: of a relationship of communication between the physician and the patient such that the former will understand
p.000122: the needs of the latter and the patient will feel free to express his/her wishes. Appropriate training on
p.000122: communication with patients and on ways to announce an ominous diagno- sis is equally important for an efficient
p.000122: physician-patient relationship. The lack of such training is stressed by many Greek authors who have investigat- ed
p.000122: honesty and patient information (Mystakidou et al., 1996; Rigatos, 1997).
p.000122:
p.000122:
p.000123: 123
p.000123:
p.000123: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000123: REPORT
p.000123:
p.000123: 2. The problem of time
p.000123:
p.000123: According to a frequent argument, it is difficult to implement the model of consent in the limited time available
p.000123: to case management. Experience shows that this time shortage is due either to the nature of the case itself
p.000123: (“emergencies”) or to the inadequate organization of health services espe- cially when faced with occasional peaks of
p.000123: demand.
p.000123: It is worth noting that, in the first case, it is generally admitted -and ex- pressly stipulated by the law- that
p.000123: physicians may act alone, namely “in- formed consent” does not apply. The notion of “emergency” is very broad and
...

p.000006:
p.000006:
p.000006:
p.000006:
p.000157: 157
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000158: 158
p.000158:
p.000158: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000158: OPINION
p.000158:
p.000158: O P I N I O N
p.000158:
p.000158: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000158:
p.000158: The Hellenic National Bioethics Commission met repeatedly upon invita- tion by the President in order to consider the
p.000158: ethical and social issues within its jurisdiction with regard to conflict of interest in clinical research,
p.000158: espe- cially in clinical trials of pharmaceutical agents. Dealing with this issue is a continuance of the already
p.000158: issued expert opinions on clinical trials on human subjects (2004), the establishment of ethics committees that
p.000158: review bio- medical research (2005) and research ethics in the biological sciences (2008). The timeliness
p.000158: of the matter is due to the usual criticism on the ac- countability of clinical trials of pharmaceutical agents
p.000158: or biomedical tech- nology appliances that are funded by the pharmaceutical industry. The ac- countability of
p.000158: clinical studies is crucial for public health, as it remains the single guarantee for drug efficiency and
p.000158: non-hazardous research products directed to the public.
p.000158:
p.000158: 1. General principle
p.000158: The Commission believes that the collaboration between the private sector and hospitals or research
p.000158: institutes is desirable because it ensures innovation, but under the strict condition that the ethical
p.000158: integrity of re- search is protected.
p.000158: In this context, “conflict of interest” may emerge between pursuing the truth, which is the aim of scientific research,
p.000158: and the financial profit antici- pated by the research sponsors.
p.000158:
p.000158: a) The relationship between researcher/sponsor: The duty to reveal the truth
p.000158: In clinical studies, the person that primarily encounters conflict of inter- est is the researcher who realizes
p.000158: that the research results may not be of financial benefit to the sponsor, and faces the dilemma of
p.000158: revealing the truth or defending the financial interest.
p.000158: The Commission believes that the researcher has always the moral duty to search for and reveal the truth, even
p.000158: when this is unfavorable to the sponsor. Serving health via the accuracy of the results of clinical studies is
p.000158:
p.000159: 159
p.000159:
p.000159: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000159: OPINION
p.000159:
p.000159: absolutely preceding, even in the case that this is discouraging for funding research in the future. The Commission
p.000159: feels that the risk of such discour- agement should be undertaken by the scientific community, due to the sig-
p.000159: nificance of protecting public health.
p.000159:
...

p.000179: c) Salaries or compensations for services provided for research by the Institution, and are provided in the relevant
p.000179: contract.
p.000179: d) Financial aids-sponsorships by the State or non-profit charitable or- ganizations.
p.000179: “Donations” are examined by the Committee with scrutiny, since they may fall within the relevant prohibitions.
p.000179: The Institution must establish: a) the responsible authority where the CIC will refer to in a case of
p.000179: conflict of interest and, b) a procedure to be followed when members of the administration have a relationship
p.000179: that may
p.000179:
p.000179:
p.000179:
p.000179: 37 Equity holding, Equity interest, Mutual funds, Stock options etc.
p.000179:
p.000180: 180
p.000180:
p.000180: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000180: REPORT
p.000180:
p.000180: compromise their judgment. Cases where conflict of interest may emerge from a private company sponsorship to
p.000180: an Institution include:
p.000180: a) Sponsorships from companies to the Institution, independent from the undertaken research.
p.000180: b) Dividends from investments resulting from licensing and commer- cialization of research products of >$50,000.
p.000180:
p.000180: 7. Collaborative clinical studies
p.000180:
p.000180: Over the past years, there is an extensive discussion about collabora- tive clinical studies, i.e. studies in which
p.000180: two or more companies cooperate to test the efficacy and safety of biomedical products with similar action. With this
p.000180: approach, the companies share the expenses, patient recruit- ment/participation is faster (patients are not
p.000180: divided into separated clinical studies by different companies), a single control group is necessary, the
p.000180: duration of the clinical study is reduced, and the use of a common protocol with well defined parameters allows direct
p.000180: comparison and production of robust and convincing results38.
p.000180: Such collaborative studies may be conducted in order to test similar therapies by different pharmaceutical
p.000180: companies against the same dis- ease, or a combination of different therapies that detect different
p.000180: path- ways or mechanisms of disease. A good example in the recent literature is the “Cardiac Arrhythmia Suppression
p.000180: Trial”, which was funded by the Na- tional Institutes of Health. During this study there was a direct comparison of
p.000180: three antiarrhythmic drugs from different companies, testing their effi- cacy to reduce arrhythmic death after a
p.000180: myocardial infarction39. It was proved that two out of the three approved drugs are associated with in- creased
p.000180: mortality instead of decreasing it. If three different clinical studies were conducted, more time would be necessary
p.000180: for completing the stud- ies, they would cost more and it would be impossible to reach such a clear result.
p.000180: Collaborative clinical studies are advantageous not only for faster
p.000180:
p.000180: 38 Moss AJ, Francis CW, Ryan D (2001). Collaborative clinical trials. N Engl J Med 364, 789-791.
p.000180: 39 Echt DS, Liebson PR, Mitchell LB et al. (1991). Mortality and morbidity in patients receiving encainide, flecainide,
p.000180: or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med 324, 781-788.
p.000180:
p.000181: 181
p.000181:
p.000181: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000181: REPORT
p.000181:
...

p.000194: a person (especially the so-called “paternity tests”). A common component to all tests is that the public has direct
p.000194: access to them, without the mediation of counseling (in the first two cases) or legal authorization (judicial
p.000194: permission in the case of genetic iden- tification). Consequently, there is a rapid development of a new
p.000194: “market” for genetic services, which is already advertised to a significant extend in our country.
p.000194: The above mentioned new market is favored by the continuous progress in technology, the human genome project and the
p.000194: extensive research eluci- dating specific gene functions. At present, the technological and scientific
p.000194: progress makes methods of detecting genetic risk factors, even for serious diseases, affordable. However, specific
p.000194: sensitive ethical and social issues, associated with the way such services are provided, emerge and must
p.000194: re- ceive special attention by the involved individuals and the State.
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000194:
p.000195: 195
p.000195:
p.000195: DIRECT-TO-CONSUMER GENETIC TESTING
p.000195: OPINION
p.000195:
p.000195: I. The facts
p.000195:
p.000195: Genetic tests which are directly available to the public detect DNA se- quence changes. Most frequently, the
p.000195: DNA changes are associated with the etiology, diagnosis, treatment or prevention of hereditary diseases. In
p.000195: the case of monogenic disorders, a single gene is responsible for the disease and therefore DNA changes associated
p.000195: with the disease are easier to identify. However, this is not the case for complex (polygenic) diseases,
p.000195: comprising the largest proportion of the most common diseases, such as cardiovascular disease, cancer and diabetes.
p.000195: Complex diseases are caused by the combined action of many genes as well as environmental factors.
p.000195: Up to the present time, the person interested in genetic testing consult- ed an expert. Based on the clinical data and
p.000195: the family history of the patient, the expert decided whether he/she would receive a suitable biologic sample from the
p.000195: patient and request a specific genetic test for a disease. Subse- quently, specialized genetic
p.000195: laboratories, with suitable biomedical equip- ment and certified, specialized personnel, would perform genetic
p.000195: testing.
p.000195: The current genetic services are constantly modified. On the one hand, this is due to the relatively recent progress in
p.000195: molecular biology and genet- ics, and on the other hand, due to the fact that the public becomes increas- ingly
p.000195: interested in genetic testing. Important factors contributing to such changes in genetic services are:
p.000195:
p.000195: A. The detection of genetic factors associated with monogenic and com- plex diseases, as well as the human genome
p.000195: project
p.000195: Specifically, genome wide association studies lead to the assumption that DNA sequence variations among
p.000195: individuals are associated with most common diseases. These studies examine DNA sequence variations in spe- cific
...

p.000202: an expert.
p.000202: The present report attempts to present the bioethical aspect of similar activities that provide genetic testing
p.000202: services directly to the public, as such activities are increasingly spreading in our country as well. In Europe, as
p.000202: well as in the USA, official concerns have already been expressed about setting a limit on a person’s access to genetic
p.000202: data concerning him/herself or a third party, without the adequate guarantees of validity and reliability. The pre-
p.000202:
p.000202:
p.000203: 203
p.000203:
p.000203: DIRECT-TO-CONSUMER GENETIC TESTING
p.000203: REPORT
p.000203:
p.000203: sent report aims to set a frame for the redaction of a relevant Opinion by the Commission.
p.000203:
p.000203:
p.000203: THE FACTS
p.000203:
p.000203: Genetic tests
p.000203:
p.000203: Genetic tests are based on the study of genetic material in order to iden- tify changes in the DNA sequence.
p.000203: These changes are either mutations, which cause a disease, or polymorphisms that constitute normal variations among
p.000203: individuals. Polymorphisms, however, can be associated with a dis- ease, i.e. if an individual carries specific
p.000203: DNA polymorphisms, he/she may have increased risk (predisposition) to develop a disease.
p.000203: In the case of monogenic disorders (e.g. thalassaemia, cystic fibrosis, familial hypercholesterolemia),
p.000203: mutations in a single gene can cause the disease. For this reason, it is relatively easy to detect the genetic
p.000203: causes of a single-gene disease. However, this is not the case for complex (multifactori- al) diseases (e.g.
p.000203: cardiovascular disease, cancer, diabetes etc.). Complex diseases can result from mutations and/or polymorphisms in
p.000203: more than one genes and/or environmental factors (e.g. smoking, diet, obesity, exercise etc.). Therefore,
p.000203: genetic tests for complex diseases cannot give a certain answer on whether an individual will develop the
p.000203: disease, but they can only estimate the relative risk to develop the condition.
p.000203: Until recently, genetic testing for health reasons was usually conducted after mandate of an expert (clinical
p.000203: geneticist). The expert in charge as- sessed the individual’s clinical phenotype and family history, and
p.000203: recom- mended or not subsequent genetic testing. The biological material was col- lected either by a physician or
p.000203: a member of the medical personnel in the genetic centre where the tests would be performed.
p.000203:
p.000203: The new trend: Direct access to genetic testing
p.000203:
p.000203: Nowadays, the way genetic testing is provided tends to change, primarily due to the great advances in molecular
p.000203: technology and genetics. This change was mainly due to:
p.000203:
p.000203:
p.000204: 204
p.000204:
p.000204: DIRECT-TO-CONSUMER GENETIC TESTING
p.000204: REPORT
p.000204:
p.000204: Α. The constant discovery of genes associated with, not just single-gene, but also complex diseases
p.000204: More specifically, the human genome project and genome-wide associa- tion studies produced a large amount of
p.000204: genetic data and associations of genetic polymorphisms with several diseases. In addition, DNA samples from
p.000204: many patients were also available, further facilitating the production of genetic data. Based on such type of
p.000204: studies, companies that provide ge- netic services promise to estimate an individual’s chances to develop a dis- ease.
p.000204: This means that the reasons why someone would undergo genetic testing are multiplied, so that any person
p.000204: can be informed of his/her own genetic profile and the family’s genetic profile as well.
p.000204: Β. The introduction of new tools in genome analysis, such as DNA micro- arrays, thanks to which high throughput
p.000204: analysis is possible (DNA analysis from several individuals simultaneously, in a short period of time)
p.000204: This enables companies to offer commercial methods to the public, in a relatively affordable price. The result is an
p.000204: emerging new market of private companies providing genetic testing.
p.000204: C. The physicians’ and the public’s growing interest for the importance of genetic information in preventive medicine
p.000204: This interest lies in adopting an appropriate lifestyle that will help to prevent a disease, for which
p.000204: predisposition has been defined by genetic testing. The prospect of such a “shield” against possible
p.000204: future diseases is expected to consistently attract more consumers to get tested -especially if genetic testing is
p.000204: easy and doesn’t cost much- even if the cost is not covered by public insurance.
p.000204: In this context, companies offering genetic tests directly to the public emerged. Consumers are usually drawn
p.000204: to them by personal interest and/or worry about their health, or out of curiosity. The offered tests cover a wide range
p.000204: of:
p.000204: a) Diagnostic tests confirming or not a disease (single-gene diseas- es),
p.000204: b) pre-symptomatic tests that calculate a person’s chances of devel- oping a disease (multifactorial diseases),
p.000204: c) prenatal tests that determine the embryo’s gender,
p.000204: d) pharmacogenetic tests that estimate the right dosage, effective- ness and side effects of certain drugs for an
p.000204: individual,
p.000204:
p.000204:
p.000205: 205
p.000205:
p.000205: DIRECT-TO-CONSUMER GENETIC TESTING
p.000205: REPORT
p.000205:
p.000205: e) paternity tests that confirm or not paternity,
p.000205: f) kinship tests that confirm or not relationship and the degree of relationship,
p.000205: g) ancestry tests that determine the family’s origin (genealogical roots),
p.000205: h) metabolic and nutritional genomics tests that estimate predispo- sition to obesity,
p.000205: i) anti-ageing tests that study the genes affecting ageing,
p.000205: j) athletic performance tests that determine someone’s potential for athletic performance.
p.000205: Typically, the consumer receives a kit, which includes instructions to col- lect his/her own biological material
p.000205: (usually saliva or buccal mucosa swabs), and this kit is subsequently sent for analysis to the laboratory by post. The
p.000205: consumer is notified of the results by telephone, post, e-mail or a safe web- site, to which access is being
p.000205: granted. Tests requiring blood are accompa- nied by a kit to be used by a physician, who will safely collect a
p.000205: blood sample (e.g. to screen for mutations in the BRCA1 and 2 genes causing breast can- cer).
...

p.000206: tests is based on preventing a disease, which could “shield” a person’s health, by protecting him/her
p.000206: from exposure to environmental risk factors and thus, balancing “bad” genetic predisposition. These methods of DTC
p.000206: advertising are often questioned, due to their similar- ity with advertising of prescribed medicines, which is
p.000206: forbidden in the E.U. This issue is related to a more general possibility of giving misleading infor- mation about
p.000206: the true value of genetic data -especially for protecting health- which will be examined in the present
p.000206: report.
p.000206:
p.000206: The Greek reality
p.000206:
p.000206: In Greece, as in other European countries, providing genetic tests direct- ly to consumers is steadily increasing. In a
p.000206: systematic search for websites in the Greek language, 15 companies were found to offer DTC genetic tests,
p.000206: with a kit for sampling and shipping. Through their webpages, the compa- nies promote their specialisation and
p.000206: know-how of their staff. They all ad- dress and offer genetic tests directly to consumers, except for one,
p.000206: for which sample collection and shipping is done by physicians or collaborating diagnostic centres. The range of
p.000206: genetic tests offered in Greece covers: pa- ternity tests (8/15), kinship tests (6/15), predisposition to complex
p.000206: diseases
p.000206:
p.000206:
p.000207: 207
p.000207:
p.000207: DIRECT-TO-CONSUMER GENETIC TESTING
p.000207: REPORT
p.000207:
p.000207: (7/15), pharmacogenetics for the efficiency and side effects of certain drugs (6/15), athletic performance (3/15),
p.000207: predisposition to single-gene diseases (2/15), nutritional or metabolic tests (2/15), anti-ageing tests (2/15),
p.000207: gene- alogy tests (1/15) and whole genome analysis (1/15). Only 4 out of 15 com- panies providing DTC genetic
p.000207: testing are accredited according to ISO/IEC 17025 standards for the operation of their laboratories.
p.000207: A recent study conducted by the University of Patra (Mai et al., 2011) provides information on the
p.000207: awareness of the Greek public and physicians on genetic testing. This survey included the completion of a
p.000207: questionnaire that was distributed to 1,717 members of the general public and 496 medi- cal practioners.
p.000207: The study showed that a large percentage of the general public in Greece is aware of the nature of
p.000207: DNA, genetic diseases and the potential advantages of genetic testing, although this percentage declined with age.
p.000207: A large proportion of those completing the questionnaire would be willing to undergo genetic testing, even if the cost
p.000207: is not covered by health insurance. On the other hand, only a small proportion of the public actually received
p.000207: advice in order to proceed with genetic tests, either from relatives or their physicians. In addition, this study
p.000207: demonstrated that most physicians con- sider the current legal framework about genetic testing in Greece relatively
p.000207: weak.
p.000207: A rather interesting finding is that the vast majority of the public strongly objects to DTC genetic testing, and
p.000207: that most of them would prefer being referred by a physician rather than a pharmacist. The study reaches the con-
p.000207: clusion that the Greek public holds a critical position towards genetics and genetic testing services, which could set
...

p.000208: it.
p.000208: 3. Often, data produced by genetic tests are not directly related to the treatment of the disease or on certain
p.000208: occasions, there are no available treatments. Pharmacogenetic tests are an exception, since they provide
p.000208: information about drug response and side ef- fects based on a person’s genetic composition.
p.000208: The benefits of genetic testing are mainly related to the health and psy- chology of the individual or his/her family:
p.000208: 1. In case of a family history which is confirmed by genetic testing, the individual has a chance of
p.000208: responsible guidance by the geneticist, aiming at prevention. E.g. if a person has a family history of
p.000208: colon cancer, genetic tests detecting a mutation or predisposition will put an end to his worries and may
p.000208: become the start for regular tests which may detect precancerous polyps and even prevent death by this cause.
p.000208: Respectively, other members of the family who share the same genetic profile may also benefit.
p.000208: 2. In case of a negative result, the individual is relieved and freed from possible regular tests that can
p.000208: be painful and/or costly.
p.000208: 3. When it comes to pharmacogenetic testing, one can ensure a personalized, more effective treatment,
p.000208: with reduced side effects. E.g. people who suffer from Alzheimer’s disease and bear a single copy of a
p.000208: gene have no advantage with a certain
p.000208:
p.000208:
p.000209: 209
p.000209:
p.000209: DIRECT-TO-CONSUMER GENETIC TESTING
p.000209: REPORT
p.000209:
p.000209: treatment, while people with two copies of the gene demonstrate a slow progress of the disease under the same
p.000209: treatment.
p.000209: Genetic testing for health reasons involves medical, psychological or fi- nancial risks, both for the individual and
p.000209: his/her family:
p.000209: 1. Genetic tests that include sample collection of saliva, buccal mucosa swabs or blood do not involve
p.000209: physical risks for the individual. This is not however the case for prenatal genetic screening, where e.g.
p.000209: in amniocentesis the risk of miscarriage is 1 in 200-400 cases.
p.000209: 2. False positive results can cause anxiety and further unnecessary medical examinations and treatments.
p.000209: 3. False negative results cause complacency to the person or delay the diagnosis and treatment.
p.000209: 4. The results of a genetic test can affect serious decisions over a person’s life, e.g. if high risk for
p.000209: a disease is confirmed, then the person’s decision to have children may be affected. Or in the case where the genetic
p.000209: test detects a mutation that can cause breast cancer, the person might undergo a total mastectomy as an
p.000209: extreme measure of prevention.
p.000209: 5. In case of a positive result, there is always the risk of stigmatization, refusal of
...

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p.000088: of biological resources. The major part of relevant Greek legislation, however, transposes interna- tional or
p.000088: community law.
p.000088: Numerous problems arise in the practical implementation of this legisla- tion as demonstrated formally in the
p.000088: case-law of the Environmental Panel
p.000088: (V) of the Judicial Review Court6 and in related reports of the Ombudsman’s Environmental Department. The Proposals of
p.000088: the present report make spe- cific reference to these problems.
p.000088:
p.000088: FOURTH CHAPTER
p.000088:
p.000088: ENVIRONMENT, SOCIETY, GOVERNMENT
p.000088:
p.000088: The social parameter
p.000088:
p.000088: The relationship between human beings and nature directly affects the planning, social acceptance and efficacy of any
p.000088: policy on the protection of biodiversity and the environment. The place occupied by the environment in the personal
p.000088: scale of values and the minds of individuals determines their attitude in respect to proposed policies. This
p.000088: relationship is not one and the same for everyone but common characteristics can be traced in particular
p.000088:
p.000088: 6 Strictly by way of indication, see JRC 2304/95 (national parks), 4950-4953/95 (wild flora/fauna), 1184/96
p.000088: (vulnerable ecosystems), 1821/95, 3067/01, 3135/02, 2601- 2603/05 (protection of the caretta-caretta turtle) etc.
p.000088:
p.000089: 89
p.000089:
p.000089: MANAGEMENT OF BIOLOGICAL WEALTH
p.000089: REPORT
p.000089:
p.000089: groups which are determined by residence, occupation, environment- related choices in everyday life and
p.000089: the reasons leading to such choices. The place of the environment and biodiversity in the individual’s scale of values
p.000089: and the individual’s relationship with nature in general is reflected both in professional choices and in everyday life
p.000089: (choice of intensive, integrated or biological agriculture) as well as in the different motives leading to
p.000089: such choices (e.g. the use of more efficient irrigation systems in agriculture may be due to a conscious effort to
p.000089: protect water resources or to apply for sub- sidies).
p.000089: According to the Eurobarometer, Greeks are highly concerned with the environment. However, there is great
p.000089: difference between word and prac- tice. The causes that relegate the environment to a lesser position in
p.000089: the minds of citizens in practice have to be investigated and analysed.
p.000089: However this may be, at the level of civil society, the activity of Non- Governmental Organizations of
p.000089: environmental denomination in Greece is particularly important for raising awareness among citizens and
p.000089: bringing pressure to bear on governments.
p.000089: After the devastating fires of 2007 and their tragic toll there is a sharp increase in the number of volunteers
p.000089: and the quality of volunteer activity and activism (as estimated by the WWF). A great number of NGOs are oper-
p.000089: ating in our country7 which are either wide in scope (e.g. WWF, Greenpeace, etc.) or focus on the protection of
p.000089: specific species or areas (Arctouros, Callis- to, etc.).
p.000089:
...

p.000140: consists mainly in art. 8 of the Convention on Human Rights and Biomedicine (Ovie- do Convention), which justifies
p.000140: medical self-action in “emergency situa- tions”.
p.000140: In this context, restrictions must comply with the principle of propor- tionality, i.e. they must be
p.000140: appropriate and necessary in order to protect public health without exceeding the purpose for which they are
p.000140: adopted.
p.000140:
p.000140: b) Vaccination
p.000140: In principle, the vaccination of the population as a measure of preven- tion, particularly the vaccination of
p.000140: vulnerable groups, requires informed consent. In this context, relevant information may be also provided to the
p.000140: general public through the media. The duty of public authorities is to ensure the validity of this information by
p.000140: allocating the task exclusively to a respon- sible entity and by taking steps to avoid inaccuracies which may inspire
p.000140: dis- trust or fear. It is worth noting that 99% of children in the US are vaccinated with a minimum rate of
p.000140: complications, which proves that benefits far ex- ceed any drawbacks; therefore, it is not justified to
p.000140: spread doubts. In “emergency situations” in the above sense, the Commission feels that even mandatory vaccination is
p.000140: not to be excluded, especially for those who are highly probable to become carriers and transmit the
p.000140: infection due to the nature of their occupation. They should be offered, however, the option of changing duties. The
p.000140: established scientific requirements for clinical trials of new treatments (vaccines or medicines) may not be
p.000140: bypassed in order to
p.000140:
p.000140:
p.000140:
p.000141: 141
p.000141:
p.000141: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000141: OPINION
p.000141:
p.000141: accelerate the availability of such treatments to the public. Otherwise their efficacy will remain uncertain and
p.000141: citizens will be misinformed as a result.
p.000141: In addition, the Commission thinks that in the exceptional circumstances of epidemics or pandemics, limits to
p.000141: patents on new treatments could be justified to the extent possible. Such limits could be argued as a legal/policy
p.000141: choice in competent international and supra-national fora.
p.000141:
p.000141: c) Treatment
p.000141: The treatment of those infected should also be based on informed con- sent. Forced treatment is not justified in
p.000141: principle, except in “emergency situations”.
p.000141: When the number of medical and nursing staff or the available treat- ments do not suffice to ensure care to
p.000141: all those infected (especially in case an infection spreads rapidly) the Commission stresses that the government must
p.000141: establish in advance general priority rules for access to treatment. The basic priority criteria should preferably be
p.000141: prescribed by law. By way of indi- cation, such priority criteria may include the severity of symptoms, the age of the
...

p.000195: his/her lifestyle in such a way that he/she will
p.000195:
p.000195:
p.000196: 196
p.000196:
p.000196: DIRECT-TO-CONSUMER GENETIC TESTING
p.000196: OPINION
p.000196:
p.000196: reduce the probability of developing the disease. This fact may lead more people to undergo genetic testing
p.000196: aiming at prevention.
p.000196:
p.000196: C. Novel molecular technologies for large scale genetic analysis (simulta- neous analysis of genetic samples from
p.000196: different persons) in a relatively short time
p.000196: Large scale genetic analysis facilitates the offer of DTC genetic tests at a lower price compared to the past, and
p.000196: consequently, the development of a new market of genetic services.
p.000196: In this context, companies offering DTC genetic testing emerged. The specific genetic tests cover a wide range
p.000196: of:
p.000196: a) Diagnostic tests that may confirm a disease, e.g. β-thalassaemia,
p.000196: b) pre-symptomatic tests that estimate a person’s risk to develop a dis- ease, e.g. cancer,
p.000196: c) prenatal diagnosis tests that define the baby’s gender,
p.000196: d) pharmacogenetic tests that estimate the best dosage, efficiency and side effects of specific drugs, e.g.
p.000196: anticoagulants,
p.000196: e) paternity tests that confirm or not the paternity of the alleged father,
p.000196: f) relationship tests that assess specific degrees of relationships,
p.000196: g) genealogy tests that define an individual’s ancestry,
p.000196: h) and tests examining a person’s “lifestyle” regarding diet, occupation, exercise etc.
p.000196: Genetic tests which are directly available to the public are sold in con- ventional points of sale (pharmacies,
p.000196: beauty shops, etc.), through healthcare professionals, via the internet or by phone. The most common practice
p.000196: is that the consumer contacts the company via the internet.
p.000196: Regardless of the approach used for contact, the above mentioned ge- netic tests are offered as a kit. The kit
p.000196: contains directions for biologic sample collection by the consumer him/herself (usually saliva or a buccal swab) and
p.000196: the sample is subsequently sent to the genetic laboratory by post. The re- sults are disclosed by phone, letter,
p.000196: e-mail or by logging in to a secure web- site with a unique password provided to the consumer. For tests requiring
p.000196: blood collection, the kit is to be used by the consumer’s doctor in order to collect the blood safely.
p.000196: These specific companies are content with a simple disclosure of the test results. Frequently, there is an
p.000196: impersonal interpretation of the findings
p.000196:
p.000196:
p.000197: 197
p.000197:
p.000197: DIRECT-TO-CONSUMER GENETIC TESTING
p.000197: OPINION
p.000197:
p.000197: using special algorithms and softwares, which take into account the litera- ture and the lifestyle information provided
p.000197: by the consumer after complet- ing a questionnaire. Occasionally, the companies offer genetic counseling by demand and
p.000197: at an additional cost. In that case, genetic counseling is provid- ed without direct contact with the counselor,
p.000197: whereas in a few cases the companies recommend disclosure of the results to the person’s doctor, who will evaluate
...

p.000198: disease. The Commission believes that it is critical to emphasize that genetic data must not be overvalued, as
p.000198: erroneously and commonly presented.
p.000198: In regard to prenatal genetic tests, the Commission reiterates its position that they must not be performed for eugenic
p.000198: purposes. It notes the danger especially in the case of DTC genetic tests, where genetic counseling is ab- sent.
p.000198:
p.000198:
p.000199: 199
p.000199:
p.000199: DIRECT-TO-CONSUMER GENETIC TESTING
p.000199: OPINION
p.000199:
p.000199: Finally, the Commission considers that genetic tests revealing a person’s identity definitely presuppose consent from
p.000199: all the involved parties. Other- wise such genetic tests require a relevant judicial licensing.
p.000199:
p.000199: 2. Special issues
p.000199:
p.000199: In the context of the above mentioned general principles, the Commis- sion notes:
p.000199: A. It is recommended that DTC genetic tests for health reasons or prena- tal diagnosis must be performed following a
p.000199: suitable prescription by a liable expert physician, clinical geneticist or biologist-geneticist. The expert
p.000199: will assess the purpose of the test and will interpret the results, in order to avoid unnecessary genetic testing
p.000199: and inappropriate assessment. It is important that the consumer has the option to choose the expert. Impersonal,
p.000199: auto- mated counseling methods are discordant with the relationship of trust, which must govern health
p.000199: services.
p.000199: Exceptionally, DTC genetic testing which aims to improve dietary habits or other lifestyle factors (occupation,
p.000199: exercise etc.), or to define an individu- al’s ancestry, may not be dependent on such strict rules.
p.000199: B. In order to protect genetic information and respect a child’s right to ignorance, considering that children are
p.000199: unable to decide whether they wish to know the results of a genetic test predicting a disease, DTC genetic test- ing is
p.000199: not justified in asymptomatic children for whom there is no medical emergency, especially for late onset diseases such
p.000199: as Huntington’s disease. Even in the case where an expert decides that such a test is necessary for the parent(s),
p.000199: the same genetic test must be delayed for the child until he/she is able to participate in the decision
p.000199: making process, since there is no direct value to his/her health. On the contrary, DTC genetic testing is
p.000199: ac- ceptable in cases of children with first or second degree relatives with a monogenic disorder,
p.000199: showing a clear mode of inheritance e.g. familial hy- percholesterolemia. Nonetheless, such genetic tests must
p.000199: be allowed only in the case that the results will be used for early treatment and/or prevention of the complications
p.000199: caused by the disease.
p.000199:
p.000199:
p.000199:
p.000199:
p.000200: 200
p.000200:
p.000200: DIRECT-TO-CONSUMER GENETIC TESTING
...

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p.000094: The species of Greek nature are recorded only in a piecemeal and “stat- ic” way (e.g. by the NAGREF, the Goulandris
p.000094: Foundation, the Hellenic Orni- thological Society and other environmental NGOs). The YPEHODE has fund- ed related
p.000094: research but big gaps remain (especially as regards marine biodi- versity). A detailed inventory of species and
p.000094: the systematic monitoring of changes in habitats, populations, etc., are indispensable to the protection of
p.000094: biodiversity.
p.000094: Therefore, a specially designated body must take charge of the coordina- tion of the recording and monitoring of
p.000094: domestic species (an appropriate candidate would be, for instance, the Greek Centre of Biotopes/Wetlands) in
p.000094: cooperation with academic bodies and environmental organisations.
p.000094:
p.000094: Protected areas (especially Natura areas)
p.000094:
p.000094: These areas host a high density of biodiversity (flora and fauna). Two types of problems are identified:
p.000094:
p.000094: a) Normative gaps
p.000094:
p.000094: - There is a lack of clear demarcation of several such areas.
p.000094: - The inventory of sensitive marine ecosystems is largely deficient.
p.000094: - In many areas the allowed activities have not been defined which re- sults in the prevalence of totally arbitrary
p.000094: interventions.
p.000094:
p.000094:
p.000094:
p.000095: 95
p.000095:
p.000095: MANAGEMENT OF BIOLOGICAL WEALTH
p.000095: REPORT
p.000095:
p.000095: b) Problems of effective control
p.000095:
p.000095: These areas are not guarded effectively by the responsible authorities (police, forestry authorities,
p.000095: rangers, port police, etc.) especially regarding the prevention of disasters but the main problem consists in a
p.000095: lack of clearly defined control duties for management authorities. The pilot operation of a Public Prosecutor (at the
p.000095: Court of First Instance of Piraeus) especially dedi- cated to environmental issues is a case worth mentioning.
p.000095: Management authorities need to be granted a specific enforcement mandate either independently or in
p.000095: cooperation with prosecuting authori- ties (including the right to issue orders to the latter). The office
p.000095: of Public Prosecutor for the environment should be extended to general application.
p.000095:
p.000095: Impact of Farming and Stock-raising on biodiversity
p.000095:
p.000095: a) Problems from farming practices
p.000095:
p.000095: Agricultural activity, mainly due to its territorial intensity, has a major impact on biodiversity that is
p.000095: often negative because of intensive farming, particularly when the guidelines for good faming practices are not
p.000095: followed.
p.000095: A stricter control of farming practices and compliance with safety rules is required of the authorities of the Ministry
p.000095: for Agricultural Development. In addition, the Ministry for Agricultural Development must provide incentives to adopt
p.000095: practices that reduce the indirect and direct negative impact on biodiversity11. Institutions such as
p.000095: integrated management through the cer- tification of farming products and practices with the label AGRO or the pro-
p.000095: motion of biological crops and related products are steps in the right direc- tion.
p.000095:
p.000095: 11 Deviations from good farming practices and legislation are reflected on the com- plaints of citizens that reach
...

p.000152: specified by Law”.
p.000152: Article 21 (3) of the Constitution: “The State shall care for the health of citizens and shall adopt specific measures
p.000152: to protect youth, old age, disability and health care for indigents”.
p.000152: 2 Article 5 (5) of the Constitution: “Everyone is entitled to the protection of their health and genetic
p.000152: identity…”.
p.000152:
p.000153: 153
p.000153:
p.000153: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000153: REPORT
p.000153:
p.000153: However, both the Constitution and the ECHR acknowledge the need of re- strictive measures to protect public health.
p.000153: Thus, the art. 5(4) of the Constitution (interpretation statement) excep- tionally accepts individual administrative
p.000153: measures “on grounds of public health protection or the protection of patients as specified by Law”. It is im-
p.000153: portant to stress that such measures amount to extensive inroads into indi- vidual freedom -prohibiting “the free
p.000153: movement and residency in the na- tional territory or the entry into and exit from it”- and can be decided by any
p.000153: public authority (health authorities, police, local government, etc.), but al- ways under specific legal
p.000153: provisions.
p.000153: Along the same lines, the ECHR (convention with overriding formal effect versus ordinary legislation) accepts the
p.000153: deprivation of individual freedom such as, among other things, “… the lawful detention of a person for the pre-
p.000153: vention of the spreading of infectious diseases, …” (art. 5[1][e]), but always “in accordance with a procedure
p.000153: prescribed by law”.
p.000153: The above provisions seem to grant broad discretionary powers to the common legislator when adopting
p.000153: restrictions to the individual freedoms of persons affected by transmissible diseases but, in any case, the
p.000153: legislator’s powers are delineated by the Constitution. However, there are limits:
p.000153: a) In principle, the above restrictions pertain to personal freedom, not to other fundamental rights. That is,
p.000153: they are meant to protect others from contracting the disease, and not to treat the affected subject.
p.000153: Therefore, they cannot amount to forced treatment bypassing the patient’s will.
p.000153: b) Restrictions are subject to the principle of proportionality (art. 25 (1) of the Constitution). That is, they
p.000153: are justified only in the extent which is necessary to protect others.
p.000153: c) Furthermore, they cannot go as far as totally eliminating personal freedom. The “core” of the right must
p.000153: remain intact in all cases.
p.000153:
p.000153: IV. Concluding remarks
p.000153:
p.000153: Based on the above discussion a number of conclusions can be drawn to assist the Commission in issuing an opinion.
...

Searching for indicator coerced:

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p.000124: first concerns the knowledge of the rights of patients and the second the implementation of these rights and the ef-
p.000124: fective communication with patients. Typically, in the Medical School of the University of Athens, medical ethics
p.000124: remains an optional subject. The same deficit permeates all the national curricula in regard to learning how to ap-
p.000124: proach patients and develop meaningful relationships with them taking into account the whole spectrum of the patient’s
p.000124: needs and respecting his/her autonomy.
p.000124: The new model of the physician-patient relationship involves active par- ticipation on the part of the patient.
p.000124: Patients need appropriate education too, if they are to respond to this role. Therefore, education is an issue not
p.000124: only for physicians but for society as a whole.
p.000124:
p.000124: 4. Epidemiology: Vaccination
p.000124:
p.000124: In the prevention of infectious diseases, especially in the example of vac- cination, free will of the individual must
p.000124: be weighed against the interest of society as a whole. Should the Commission decide to consider the question of patient
p.000124: consent to vaccination the following observations may be of use.
p.000124: The success of mass vaccination is based on the greatest possible partic- ipation; in democratic societies,
p.000124: however, people may not be coerced to participate (Asveld, 2008). Here, the State, on the one hand, and the
p.000124: scien- tific community, on the other, while obliged to respect individual autonomy, are called upon to ensure the
p.000124: greatest possible participation, provided the benefits of vaccination and the safety of the vaccine have been
p.000124: foreseen and documented as far as possible. But individual citizens also bear a re- sponsibility to
p.000124: society, and their decision to participate or not in a vaccina- tion program cannot be based solely on the argument of
p.000124: autonomy. Individ- ual people themselves will probably not benefit directly from participating in a vaccination
p.000124: program, but they contribute to the protection of society and of vulnerable groups in particular.
p.000124: The importance of confidence in the safety of vaccines and the major role of the State and of the scientific
p.000124: community were recently illustrated in
p.000124:
p.000124:
p.000125: 125
p.000125:
p.000125: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000125: REPORT
p.000125:
p.000125: Great Britain in the MMR vaccine against measles, mumps and rubella. Be- fore the beginning of mass vaccination,
p.000125: measles cost Britain an average of 100 casualties annually. In 1988 the rate of participation in mass vaccination was
p.000125: 76%. The launching of the triple vaccine that year in replacement of the three separate ones increased the rate of
p.000125: participation to 91% until 1998. At that moment, however, fears began to spread about side-effects; autism in
...

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p.000016: genetic testing results for single-gene diseases is simpler as compared with multifactorial diseases.
p.000016: The genetic disorders relevant to the present report are those manifest- ed after an application for insurance has been
p.000016: made, so usually after infan- cy. Genetic tests potentially of value to health and life insurance are those that can
p.000016: contribute to determining the insured risk, i.e. those able to detect mutations which are well-documented to be
p.000016: associated with a specific dis- ease(s) and their penetrance is known so that, based on the outcome of the genetic
p.000016: test, it is possible to determine the likelihood of manifestation of the disease.
p.000016: According to the reliable network GeneTests, as of today (data accurate on 4/10/2007) there are 1.175 genetic
p.000016: tests in clinical use and 282 at the experimental stage for 1.475 diseases. NCBI’s on-line database
p.000016: Genes and Disease7 provides information on the association of one or more genes with 84 groups of diseases (Table 1),
p.000016: whereas there are overall more than 6,000
p.000016:
p.000016:
p.000016: 2 They are caused by the disease-causing mutation of a single gene, e.g. Huntington’s chorea, cystic fibrosis, Marfan’s
p.000016: syndrome, etc.
p.000016: 3 More than one genes are involved in the manifestation of the disease, e.g. Alz- heimer’s disease,
p.000016: diabetes, arthritis, etc.
p.000016: 4 Mutations in the non-chromosomal DNA of the mitochondria.
p.000016: 5 http://www.ornl.gov/sci/techresources/Human_Genome/home.html.
p.000016: 6 Penetrance is complete if all the carriers of disease-causing alleles will manifest the disease or incomplete when
p.000016: only some of the carriers will develop the disease.
p.000016: 7 On-line database which collects information on genetic testing and is funded by the American National Institutes of
p.000016: Health (NIH’s) http://www.ncbi.nlm.nih.gov/.
p.000016:
p.000017: 17
p.000017:
p.000017: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000017: REPORT
p.000017:
p.000017: single-gene disorders that affect approximately 1/200 births (Human Ge- nome Project Information). Of the
p.000017: available genetic tests, those with predic- tive value concern 61 diseases as a whole. Table 2 provides selective
p.000017: infor- mation on some of the most common diseases. The available genetic tests that qualify as predictive are further
p.000017: classified according to the penetrance of the disease causing mutations into pre-symptomatic and predisposition
p.000017: tests (McPherson, 2006).
p.000017: The first category comprises tests that detect mutations with complete penetrance, where the manifestation of disease
p.000017: is certain for the carriers of disease-causing mutations, e.g. the genetic test for Huntington Disease. The second
p.000017: category includes tests that detect mutations with incomplete pene- trance. The carriers of such mutations will not
p.000017: necessarily develop the dis- ease but their chances are increased compared to the general population. Tests for cancer
p.000017: belong to this category. In this case, if the result is positive, medical testing will need to be carried out more
p.000017: frequently in the future; if negative, the likelihood of disease is the same with that of the general popu- lation, but
p.000017: not zero. Below, we provide some examples of genetic tests from both categories.
...

Searching for indicator property:

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p.000031: insurance. Likewise no regulation exists for the operation of genetic laboratories that are the source of this
p.000031: information. In view of the above we recommend the adoption of special legislation ac- cording to the model
p.000031: followed by other countries. This legislation must strike a balance between the legitimate interests of
p.000031: the insurers and the insured guided by fundamental human rights.
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000032: 32
p.000032:
p.000032: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000032: REPORT
p.000032:
p.000032: SUGGESTED LITERATURE
p.000032:
p.000032: Andrews L (1987). Medical genetics: A legal frontier. American Bar Founda- tion, Chicago.
p.000032: Ashcroft, R (2007). Should genetic information be disclosed to insurers? No. BMJ 334, 1197.
p.000032: Bird TD (1999). Early-Onset Familial Alzheimer Disease. In: Gene Reviews at GeneTests: Medical Genetics Information
p.000032: Resource.
p.000032: Burke W (2002). Genetic Testing, N Engl J Med 347, 1867-1875.
p.000032: European Commission (2005). Survey on national legislation and activities in the field of genetic testing in EU
p.000032: Member States (L. Mathiessen-Guyader ed.), Brussels.
p.000032: Geetter JS (2002). Coding for change: The power of the human genome to transform the American health insurance system.
p.000032: AJLM 28, 1-76.
p.000032: GeneTests: Medical Genetics Information Resource (database online). Seat- tle. 1993-2007. http://www.genetests.org.
p.000032: Goldman BR (2005). Pharmacogenomics: Privacy in the era of personalized medicine. Northwestern Journal of Technology
p.000032: and Intellectual Property 4, 83-99.
p.000032: Hall MA and Rich SS (2000). Laws restricting health insurers' use of genetic information: Impact on genetic
p.000032: discrimination. Am J Hum Genet 66, 293- 307.
p.000032: Holm S (2007). Should genetic information be disclosed to insurers? Yes. BMJ 334, 1196.
p.000032: Holtzman NA, Watson MS (1999). Promoting safe and effective genetic test- ing in the United States: Final report of the
p.000032: Task Force on Genetic Testing. Baltimore: Johns Hopkins University Press.
p.000032: Kriari-Katrani I (1999). Genetic technology and fundamental rights. The Con- stitutional protection of genetic data,
p.000032: Athens-Thessaloniki.
p.000032:
p.000032:
p.000032:
p.000033: 33
p.000033:
p.000033: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000033: REPORT
p.000033:
p.000033: Lemmens T (2003). Genetics and insurance discrimination: Comparative legislative, regulatory and policy
p.000033: developments and Canadian options, Health Law Journal 41-86.
p.000033: Low L, King S, Wilkie T (1998). Genetic discrimination in life insurance: Em- pirical evidence from a cross sectional
p.000033: survey of genetic support groups in the United Kingdom. BMJ 317, 1632-1635.
p.000033: McPherson E (2006). Genetic diagnosis and testing in clinical practice, Clini- cal Medicine & Research 4, 123-129.
p.000033: Minute of the Meeting between HGC and the Single Equality Bill Team (2007). Wellington House, (HGC Minute
p.000033: 2007).
p.000033: Nationaler Ethikrat (2007). Predictive health information in the conclusion of insurance contracts. Opinion,
p.000033: Berlin.
p.000033: Pertucelli N, Daly MB, Bars Culver JO, Feldman GL (1998). BRCA1 and BRCA2 hereditary breast/ovarian cancer. In:
...

Searching for indicator minority:

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p.000258: age reached, a fact that fuels debates about the bioethical issues raised from life prolongation as a
p.000258: form of enhancing human characteristics, by means which are already available or that will be available in
p.000258: the future.
p.000258: The aging process is characterized by a slow reduction in normal body
p.000258:
p.000258:
p.000258: 7 The Guinness Book of Records, 1999 edition, p.102.
p.000258:
p.000259: 259
p.000259:
p.000259: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000259: REPORT
p.000259:
p.000259: rhythms, progressive loss of functionality, reduced fertility, increased sus- ceptibility to most diseases and
p.000259: significant mortality. Technological interven- tions that affect the process of aging and can be considered
p.000259: as enhance- ment of human characteristics include (Barazetti and Reichlin, 2011):
p.000259: Restricting caloric intake, hormone administration or replacement, re- duction of oxidative stress and
p.000259: activation of telomerase (Barazetti and Reichlin, 2011). Studies in various species showed that these
p.000259: interventions are possible to increase life expectancy and delay the aging process. Howev- er, these studies do not
p.000259: provide convincing data that can be applied to hu- mans.
p.000259: Life expectancy predictions vary. A study with 60 participants including demographers, gerontologists and
p.000259: researchers of aging, showed that life expectancy for a person born in 2100 is on average 292 years,
p.000259: while the range of predictions was large. Half of the predictions see humans not to exceed 100 years,
p.000259: while the more optimistic ones, which are the minority, predict that man will live up to 500 to 5,000 years
p.000259: (Richel, 2003). Partici- pants in this study were among others, Michael Fossel, researcher of the effect
p.000259: of telomerase on delaying cell aging, Roy Walford who studies the effect of limited calorie consumption
p.000259: to prolong lifespan and Aubrey de Grey, a biogerontologist and a great supporter of life prolongation.
p.000259:
p.000259: 2. The dimension of ethics
p.000259:
p.000259: One cannot dispute that control of the aging mechanisms and prolongation of life are within
p.000259: the limits of a person’s autonomy. In principle, it is legitimate to pursue such a thing in the context of
p.000259: autonomy, as, indeed, it is legitimate to treat any cause that leads the body to weakness and ultimately
p.000259: to death. Therefore the relative ethical issues do not differ substantially from the issues raised by the other
p.000259: forms of physical enhancement.
p.000259: However, a crucial issue that remains is the future social consequences of a dramatic increase in life
p.000259: expectancy, as demographic data already confirm serious effects e.g. on the sustainability of
p.000259: health insurance systems, even on the adequacy of natural resources.
p.000259: Assuming that these data reflect the limited strength of modern societies, not only in a broader
p.000259: macrosocial scale but even in the scale of a
p.000259:
p.000259:
p.000260: 260
p.000260:
p.000260: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000260: REPORT
p.000260:
...

Searching for indicator race:

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p.000248: The concept of enhancing performance includes skills, such as the physical strength, speed,
p.000248: agility, stamina, accuracy and movement co- ordination as well as dexterity. In this case,
p.000248: enhancement is mainly accomplished by the use of pharmaceutical agents, whereas in the future, one cannot
p.000248: preclude that performance enhancement will be achieved by the use of genetic technologies.
p.000248:
p.000248: b) Enhancing performance at work
p.000248:
p.000248: The wish to strengthen performance in the working environment may have significant effects on work, which
p.000248: require careful consideration by the policymakers, employers and employees themselves. Enhancement techno- logies could
p.000248: change the way people work, making it possible to work under difficult conditions (e.g. extreme climate conditions, low
p.000248: light conditions and low oxygen concentration), to increase strength and reduce physical fatigue even during
p.000248: prolonged labor or to reduce recovery and return earlier to work after illness (Academy of Medical
p.000248: Sciences, British Academy, Royal Academy of Engineering and Royal Society joint Workshop Report, 2012).
p.000248:
p.000248: c) Enhancing military performance
p.000248:
p.000248: The history of conducting experiments in order to enhance the performance of soldiers started
p.000248: almost a century ago. After the use of yperite (also known as mustard gas) during the First World War, there
p.000248: were reports of yperite trials on soldiers in the USA that examined resistance to yperite depending on race. It was
p.000248: just five decades later, in 1991, that the USA government admitted these experiments (Smith, 2008). Reports of
p.000248: experiments with nuclear energy and psychotropic drugs then followed (Parasidis, 2012).
p.000248: However, enhancement of military performance has evolved due to the
p.000248:
p.000248:
p.000249: 249
p.000249:
p.000249: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000249: REPORT
p.000249:
p.000249: possibilities offered by biomedicine and biotechnology. For example, the
p.000249: U.S. Department of Defense and the Advanced Research Projects Agency Defense (DARPA) fund research on
p.000249: pharmaceutical agents that keep soldiers alert, reducing the need for sleep. Research is also conducted on
p.000249: nutrient preparations that fulfill the nutritional needs of soldiers for several days. DARPA’s program
p.000249: “Persistence in Combat” includes the development of a vaccine that would block pain, accelerate wound healing
p.000249: and stop bleeding soon after wounding (Parasidis, 2012).
p.000249:
p.000249: d) Enhancing athletic performance
p.000249:
p.000249: During their preparation, athletes are trained by qualified coaches, they follow a special diet that includes
p.000249: supplements and they have access to physiotherapy in order to improve their athletic performance. However,
p.000249: since professionalism came to be part of sports, the pressure for better athletic performance, imposed by
p.000249: either the athletes’ personal ambitions or by their athletic clubs including their coaches, is stronger.
...

p.000263: Phillips KA, Grant J, Siniscalchi J, Albertini RS (2001). Surgical and nonpsychi- atric medical treatment of patients
p.000263: with body dysmorphic disorder. Psycho- somatics 42(6):504-10.
p.000263: Phillips KA, Menard W (2006). Suicidality in body dysmorphic disorder: A prospective study. Am J Psychiatry
p.000263: 163, 1280-2.
p.000263: Report from a joint workshop hosted by the Academy of Medical Sciences, the British Academy, the Royal Academy of
p.000263: Engineering and the Royal Socie- ty (2012). Human enhancement and the future of work.
p.000263: Richel T (2003). Will human life expectancy quadruple in the next hundred years? Sixty gerontologists say public debate
p.000263: on life-extension is necessary. J Anti-Aging Med 6, 309-14.
p.000263: Roco MC and Bainbridge WS (2002). Foundation converging technologies for improving human performance.
p.000263: Nanotechnology, biotechnology, infor- mation technology and cognitive Science. NSF/DOC-sponsored report.
p.000263: Salvi M (2003). What is Wrong in Modifying the Human Germ Line? JIB p.34.
p.000263: Sarwer DB (2002). Awareness and identification of body dysmorphic disor- der by aesthetic surgeons: Results of a
p.000263: survey of American Society for Aes- thetic Plastic Surgery Members. Aesthet Surg J 22, 531-5.
p.000263: Schachter F, Faure-Delanef L, Guénot F, Rouger H, Froguel P, Lesueur-Ginot L, Cohen D (1994). Genetic associations with
p.000263: human longevity at the APOE and ACE loci. Nature Genet 6, 29-32.
p.000263:
p.000264: 264
p.000264:
p.000264: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000264: REPORT
p.000264:
p.000264: Smith SL (2008). Mustard Gas and American Race-Based Human Experimen- tation in World War II. Journal of Law, Medicine
p.000264: & Ethics 36, 517-521.
p.000264: Svensson EC, Black HB, Dugger DL, Tripathy SK, Goldwasser E, Hao Z, Chu L, Leiden JM (1997). Long-term erythropoietin
p.000264: expression in rodents and non- human primates following intramuscular injection of a replication-defective adenoviral
p.000264: vector. Hum Gene Ther 8, 1797-806.
p.000264: Takata H, Suzuki M, Ishii T, Sekiguchi S, Iri H (1987). Influence of major histo- compatibility complex region on
p.000264: human longevity among Okinawan Japa- nese centenarians and nonagenarians. Lancet ii, 8246.
p.000264: Vidalis TK (2007). Biolaw. 1st volume. The Person. Eds. Sakkoulas 2007, p. 239.
p.000264: Wolpe PR (2002). Treatment, enhancement, and the ethics of neurotherapeutics, brain and
p.000264: cognition, p. 387.
p.000264: World Anti-Doping Agency (2001). Health, Medical and Research Committee Meeting. Minutes. Lausanne.
p.000264: World Anti-Doping Agency (2002). WADA conference sheds light on the po- tential of gene doping. Press release, World
p.000264: Anti-Doping Agency, New York.
p.000264: World Anti-Doping Agency (2003). International standard for the prohibited list 2004.
p.000264: World Anti-Doping Agency (2005). The Stockholm Declaration. Montreal: World Anti-Doping Agency.
p.000264:
p.000264:
p.000264:
p.000264:
p.000264:
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p.000265: 265
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p.000265:
p.000265:
p.000265:
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p.000265:
...

Searching for indicator racial:

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p.000021: genetics to avoid unfounded fears and also for an informed demand for a fair regulation of the protection of
p.000021: personal genetic data, to avoid discrimi- nation in life and health insurance as well as in other sectors -which fall
p.000021: out- side the scope of the present report- like employment.
p.000021:
p.000021:
p.000021: 12 George Church’s team in Harvard University endeavours to decode the genome of 100,000 people in one year at a cost
p.000021: below 1,000 dollars per person. This effort takes place in the context of the Personal Genome Pr
p.000021: (http://arep.med.harvard.edu/PGP/). Besides, the X Price Foundation launched the Archon Genomics Competition that will
p.000021: award 10 million dollars to the first team that will decode the complete genome of 100 people in 10 days at less than
p.000021: 1,000 dollars per genome.
p.000021: 13 We have seen tokens of the potential of this methodology from projects like the so- called “Iceland experiment”
p.000021: where genetic and other medical data of a big chunk of the population is filed into a database managed
p.000021: by the decode company (http://www.decode.com/) following the adoption of special legislation. This data
p.000021: has already led to significant scientific discoveries.
p.000021:
p.000022: 22
p.000022:
p.000022: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000022: REPORT
p.000022:
p.000022: D. High risk groups for genetic disorders
p.000022:
p.000022: The development of genetics and of genetic testing for specific diseases has confirmed empirical knowledge about
p.000022: the higher incidence of certain genetic disorders in particular geographic or racial groups. Examples include
p.000022: β-thalassaemia that has a higher incidence in people originating from the Eastern Mediterranean, Africa and
p.000022: Asia14 and various disorders with a high incidence in descendants of Ashkenazi Jews like the BRCA1/2 breast/ovarian
p.000022: cancer. In fact, there is a genetic test for a whole range of genetic disorders occurring more frequently in Ashkenazi
p.000022: Jews15.
p.000022: The development of genetic tests can contribute to early and accurate diagnosis of genetic conditions
p.000022: thus improving the prospects of manage- ment or treatment. Notwithstanding the medical benefits, however, there is
p.000022: an increasing risk of discrimination against these racial groups. Examples of such discrimination appeared in the US,
p.000022: for instance, in the ’70s when Afri- can-Americans, who were carriers of sickle cell anaemia, i.e. who were het-
p.000022: erozygotes and not actually sick, were either deprived of health insurance or charged with higher premiums
p.000022: (Rothenberg and Terry, 2002; Andrews, 1987). Today testing is optional and this case of “genetic” discrimination
p.000022: and stigmatization is used as an example to learn from in the findings of the American GINA Bill of Law.
p.000022: In the future, if no regulation is adopted, there is a risk that individuals belonging to high incidence groups
p.000022: for one or more genetic disorders will be required to undergo genetic testing prior to insur- ance.
p.000022:
p.000022: E. Genetic discrimination in insurance
p.000022:
p.000022: There is no clear-cut definition for the term “genetic discrimination” (Geetter, 2002). In insurance
p.000022: “genetic discrimination” means any form of differential treatment of insurance applicants or insured based on
p.000022: their ge- netic make-up. Practically, discrimination in insurance manifests either with refusal of insurance or with
p.000022: the application of increased premiums. Another form of discrimination is refusal to pay compensation (Pfeffer et al.,
p.000022: 2003).
p.000022:
p.000022:
p.000022: 14 Regions where malaria used to be endemic.
p.000022: 15 http://www.diagnogene.com/temp.php?page=laboratory<est=jew.
p.000022:
p.000023: 23
p.000023:
p.000023: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000023: REPORT
p.000023:
...

p.000030: genetic data) is prohibited as a rule, unless the subject has consented to it following appropriate infor-
p.000030: mation on the purpose of processing and on additional condition that the Authority of Data Protection has
p.000030: issued an authorization.
p.000030: Thus, a distinction must be drawn:
p.000030: - If the subject is aware of genetic data that are critical for insurance, the insurer may request such data but
p.000030: only under the provisions of Law 2472/1997.
p.000030: - If the subject is not aware of such genetic data, the insurer may not re- quest genetic testing because of the “not
p.000030: -to-be-informed” right which is safeguarded by the Oviedo Convention.
p.000030:
p.000030: SUMMARY - CONCLUSIONS
p.000030:
p.000030: 1. There are genetic tests for a significant number of disorders with a genetic component that determine
p.000030: the probability of manifestation of dis- ease with greater accuracy compared to medical testing. The degree
p.000030: of complexity of the evaluation of the results varies depending on individual case, and can be difficult even
p.000030: for experts. Therefore, the concern about the management of genetic data in life and health insurance is a legitimate
p.000030: one.
p.000030:
p.000030:
p.000030:
p.000030: 23 See Law 2496/1997, arts 189-225 Code of Commerce, 400/1970 (public supervision of insurance companies), p.d.
p.000030: 252/1996 (adaptation to relevant community law).
p.000030:
p.000031: 31
p.000031:
p.000031: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000031: REPORT
p.000031:
p.000031: 2. There are racial groups with greater incidence of certain genetic dis- orders; hence there is a risk of racial
p.000031: discrimination based on genetic data.
p.000031: 3. An extensive bioethical debate has developed with regard to access of insurance companies to the genetic data of the
p.000031: insured or of insurance ap- plicants. This debate mainly revolves around two axes: a fair calculation of risk based on
p.000031: the principle of reciprocity, on the one hand, and protection of personality from discrimination and stigmatization on
p.000031: the grounds of genet- ic data, on the other hand.
p.000031: 4. Another issue to consider is the fact that the management of genetic information with regards to access by insurance
p.000031: companies directly affects public support for genetic research. This has implications for the funding of research and
p.000031: the participation of volunteers in clinical trials, both indispen- sable to achieve progress in genetics. It mainly
p.000031: leads to avoidance of testing with injurious effects on the health of insurance applicants.
p.000031: 5. Greek legislation has not adopted specialised regulation for the use of genetic data in life and health
p.000031: insurance. Likewise no regulation exists for the operation of genetic laboratories that are the source of this
p.000031: information. In view of the above we recommend the adoption of special legislation ac- cording to the model
p.000031: followed by other countries. This legislation must strike a balance between the legitimate interests of
p.000031: the insurers and the insured guided by fundamental human rights.
p.000031:
p.000031:
p.000031:
p.000031:
...

p.000242: an accident. The decision to undergo plastic surgery is mainly driven by the need to restore the initial
p.000242: or normal state.
p.000242: In contrast, cosmetic procedures are offered to healthy individuals, who do not present with pathological findings or
p.000242: abnormal functions. Certainly, in this case one cannot overlook the impact of enhancing physical
p.000242: characteristics on the mental health of these individuals. There are many people who believe that
p.000242: cosmetic surgery will be the solution to the personal and social problems that they face.
p.000242: Both men and women are increasingly concerned about their appearance, looking for ways to
p.000242: enhance it through cosmetic surgery. The decision is based on several factors, which may vary between adults
p.000242: and adolescents, and include the modern obsession with the body image, the lack of self-confidence, the
p.000242: idols of each era and the icons dictated by fashion. The mass media played a crucial role in this case, by
p.000242: consolidating a global image of what is beautiful, desirable and attractive. The importance of beauty and
p.000242: physical appearance is strongly emphasized in social relationships, both professional and personal.
p.000242: For the aforementioned reasons, aesthetic surgeries pose ethical issues, which are, perhaps, greater than those
p.000242: posed by reconstructive surgeries.
p.000242: In addition, the number of the so-called "ethnic plastic (surgery) interventions" is increasing,
p.000242: and aim at removing national or racial characteristics. Such interventions are particularly popular
p.000242: in people of Asian descent who wish to obtain European features, or in African-Ame-
p.000242:
p.000242:
p.000243: 243
p.000243:
p.000243: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000243: REPORT
p.000243:
p.000243: ricans or African-Europeans who seek Caucasian characteristics.
p.000243: It is therefore necessary, in a first phase, that a plastic surgeon inve- stigates the motivations that
p.000243: lead a person to seek plastic surgery, especially an aesthetic procedure.
p.000243:
p.000243: c) Body dysmorphic disorders and plastic surgery
p.000243:
p.000243: A particular case is when individuals suffer from the so-called Body Dysmorphic Disorders (BDD) or
p.000243: otherwise dysmorphophophia (Crerand et al., 2006). BDD is a common psychiatric disorder that affects 1-2%
p.000243: of the general population and occurs with equal frequency in men and women. It is characterized by an excessive
p.000243: preoccupation of the person with imaginary or minor physical defects in various body parts. The
p.000243: condition is often associated with frequent hospitalization (48%) and high rates of depression and
p.000243: obsessive-compulsive disorders leading to suicidal tendencies and attempts (Phillips et al., 2006).
p.000243: Individuals suffering from BDD often resort to plastic surgeries in order to enhance their appearance. According
p.000243: to studies, 50%-76% of these patients seek plastic surgery, while 58%-66% of them eventually undergo
p.000243: plastic surgery and 26% of them undergo more than one plastic surgery (Crerand et al., 2006).
...

Searching for indicator belief:

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p.000010: insurers since they are exposed to a risk they ignore whereas the other party is aware (and perhaps takes advantage)
p.000010: of.
p.000010:
p.000010: b. The value of genetic data and the risk of “genetic determinism”
p.000010: Genetic data is a very useful tool in contemporary medicine. In the con- text of personalized medicine and
p.000010: pharmacogenomics, in particular, person- al genetic data is becoming increasingly important for determining
p.000010: thera- peutic treatment. It is therefore of paramount importance that the collec- tion of genetic data,
p.000010: which can contribute to improvement of individual health, is not obstructed for non-medical reasons.
p.000010: The collection of genetic data for research aiming to identify links be- tween diseases and genetic
p.000010: causes with the ultimate goal to identify new treatment targets is crucial for the advancement of science and,
p.000010: in the long run, for the protection of public health. In this case also, it is critical that
p.000010: participation in such research is not discouraged for fear of use of genetic data or of the findings of research to
p.000010: the detriment of participants.
p.000010: Despite the significance of genetic data for both personal and public health, its prognostic value should
p.000010: not be overrated in order to avoid the impression that genetic tests are decisive for the individual. The use
p.000010: of ge- netic data in insurance would reinforce the misleading notion of “genetic determinism”, i.e. the
p.000010: belief that an individual’s genetic make-up absolutely determines their future health or other personal
p.000010: characteristics. Therefore, it is important to safeguard genetic data so that not only genetic testing and
p.000010: participation in research, which could yield many benefits to the individual and to society as a whole, are not
p.000010: discouraged but also to avoid an errone-
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000011: OPINION
p.000011:
p.000011: ous use of these data disproportionate to their true value for disease pro- gnosis.
p.000011:
p.000011: 4. General directions
p.000011:
p.000011: a. The principle
p.000011: In view of the above analysis, the Commission believes that any settle- ment of the issue should give serious
p.000011: consideration to the following:
p.000011: i) Personal insurance is a value of public interest and not a common commodity.
p.000011: ii) Genetic data yields a statistical probability of becoming sick and not a definite prediction; therefore, it should
p.000011: not be overestimated.
p.000011: iii) Research of the human genome is primarily beneficial for human health, a fundamental societal right
p.000011: and should therefore not be dis- couraged.
p.000011:
p.000011: b. A need for regulation
p.000011: Starting from this position, the Commission believes that some form of regulation of the use of genetic data in
p.000011: insurance is needed in our country. It points out the following:
p.000011: i) The fact that Greece has an organized system of social security (where discrimination between the insured is
p.000011: inadmissible) does not diminish the relevance of the issue. For, considering the well-known weaknesses of the
...

p.000026: equality at risk for the insured or, seen in the opposite, if concealment of genetic data by the insured cre- ates
p.000026: inequality between the parties in the context of freedom of contract.
p.000026: With regards to the above, it is worth noting the following:
p.000026: a) From the discussion in the first chapter, we concluded that genetic information actually has little
p.000026: predictive value as to the certainty of disease manifestation. It makes a more accurate prediction about the likelihood
p.000026: of disease but, on the other hand, allows preventive measures to limit this like- lihood. The detection of specific
p.000026: mutations in one’s genome that are known to be associated with disease, does not mean, in most cases, that the dis-
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000027: REPORT
p.000027:
p.000027: ease will actually be manifested during the life-span of an individual. The only exception is a number of
p.000027: single-gene diseases (e.g. Huntington’s cho- rea).
p.000027: b) This means that, compared to other medical information, a greater interest from insurers to have access to
p.000027: genetic information is not necessari- ly justified. Nevertheless, such an interest is widely based on overestimates of
p.000027: the power of genetic data, i.e. on the erroneous perception that has been cultivated, regarding their increased
p.000027: predictive value for the future health of an individual (HGC Minute 2007: 3.3). This is actually a version of “genetic
p.000027: determinism”, a popular belief nowadays, which is due to inaccurate infor- mation. The consequences of this misleading
p.000027: perception are not to be over- looked: the emergence of unfavourable discrimination against specific popu- lation
p.000027: groups based on their genetic traits, in violation of the principle of equality, is seen in this light, as
p.000027: an existing problem.
p.000027: c) It is a fact that an absolute prohibition of access of insurers to all in- formation, which may be critical for a
p.000027: particular type of insurance contract, can only increase their business risk. First of all, it does not seem fair that
p.000027: health information that is known to the insured should be withheld from the other party (regardless of its worthy
p.000027: protection as sensitive personal data). Besides, it should not escape our attention that such a prohibition may sus-
p.000027: tain the overrating of genetic information and the related perception of ge- netic determinism and, on the other
p.000027: hand, the increased risk assumed by insurers may lead them to a generalized reaction of raising premiums
p.000027: at least for those diseases for which a genetic predisposition can be inferred indirectly i.e. without
p.000027: carrying out any genetic testing.
p.000027: The above three points seem to us to be important for evaluating the interests of the parties to an
p.000027: insurance relationship.
p.000027:
p.000027: B. A collective interest involved
p.000027:
...

Searching for indicator religion:

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p.000048: Higher Education Institutions 17,400.5 51.2%
p.000048: Non-profit Private Research Centres 192.6 0.6% Total staff
p.000048: employed in research in Greece 33,958.3 100%
p.000048: * FTEE: Full-time Employment Equivalents, man-years.
p.000048:
p.000048: According to the legislation in force the ESET is “an independent advisory body directly answerable to the Prime
p.000048: Minister”. Its members include inter- nationally acclaimed scientists among which the president of the
p.000048: National Council for Research and Technology (EOET) business executives and a rep- resentative of the civil sector.
p.000048: ESET formulates a proposal for the National Plan for Research and Technology (EPET) and submits proposals for the na-
p.000048: tional research strategy to DEET for approval. ESET supervises the imple- mentation of EPET.
p.000048: Greece does not have a separate independent council for the coordina- tion of research in the biological
p.000048: sciences. The ESET includes a section of Biology and Biotechnology but the role of sectors is unclear.
p.000048: The newly-legislated EOET which was created by the new “Statutory Framework for research and technology” has
p.000048: two sectors, one for basic and one for applied research, and its main mission is the “implementation and
p.000048:
p.000048: 1 a) Internal Affairs, b) Economy and Finance, c) External Affairs, d) National Defense,
p.000048: e) Development, f) Environment, Planning and Public Works, g) National Education and Religion, h) Employment
p.000048: and Social Protection, i) Health and Social Solidarity, j) Rural Development and Foodstuffs, k) Justice, l) Culture and
p.000048: m) Transport and Com- munication.
p.000048:
p.000049: 49
p.000049:
p.000049: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000049: REPORT
p.000049:
p.000049: management of actions in basic research, applied-technological research and innovation”2. In practical
p.000049: terms, EOET’s task is to support research through the management of public funds mainly in order to finance
p.000049: research projects to be carried out in national research institutions following call opening and evaluation
p.000049: of submitted proposals. The proposals will be peer reviewed by Greek or foreign scientists of international acclaim.
p.000049: EOET was established by Law 3653/21.3.2008 and was still inoperative at the time the present report was drawn up.
p.000049: Again, the law does not provide for a separate council dedicated to biological research.
p.000049: Despite their dependence on public funds, Universities and Research Centres can determine the orientation of
p.000049: their research activity by appoint- ing staff with desirable research interests and by raising non-public funds for
p.000049: research. According to data from the GSRT, the major source of non- government funding for Greek research
p.000049: centres comes from abroad, mainly the European Union.
p.000049:
p.000049: b. Financing
p.000049: The biggest provider of funds for public research in Greece is the state. In 2005, 47% of the expenditure was met with
...

p.000084: The crucial question related to this issue concerns the source or foundation of this powerful ethical duty.
p.000084: At first sight, it is an “imperfect duty” (like kindness, philanthropy etc., according to the Kantian distinction).
p.000084: But perhaps this solution falls short of the powerful commitment we appear to accept.
p.000084: One could also posit a utilitarian foundation according to which our self- restraint for the sake of next generations
p.000084: eventually improves our present
p.000084:
p.000084:
p.000085: 85
p.000085:
p.000085: MANAGEMENT OF BIOLOGICAL WEALTH
p.000085: REPORT
p.000085:
p.000085: state as well, since it leads to a rational and renewable exploitation of (fi- nite) natural resources.
p.000085: A third alternative would be to further investigate the subject in the field of the theory of “rights” or, at
p.000085: least, “interests” -either finding a way to overcome the afore mentioned difficulties in recognizing
p.000085: persons, who do not yet exist, as subjects, or dilating the reflection on our own rights and interests.
p.000085: In the latter context, we may postulate, for instance, that future generations are our concern to the extent that our
p.000085: own reproduction is our concern and that sustainable development is to the interest of our children, of their own
p.000085: children, and so on and so forth ad infinitum, and as such it is an extension of our own individual interest.
p.000085: Critical in this discussion, at any rate, is to separate ethical from legal rights: the former have a far
p.000085: greater scope even if their practical implemen- tation cannot be ensured just as effectively.
p.000085: Finally, in terms of religion, the philosophy of monotheistic religions is anthropocentric for man is
p.000085: considered as the apex of Creation and the top of the pyramid of living organisms. This is basically the
p.000085: “creationist” ap- proach which often leads to the view that our species has absolute domin- ion over nature.
p.000085: Yet, many theologians construe this dominion also as a responsibility for the wise management and protection of the
p.000085: environment, mainly as a duty to future generations (Zezioulas, 1992). This approach has actually inspired some
p.000085: initiatives for a more active involvement of Christian confessions and churches, as demonstrated, for instance, by the
p.000085: example of the Ecumenical Patriarch.
p.000085:
p.000085:
p.000085: THIRD CHAPTER THE LAW
p.000085: In regard to the above issues, the law attempts to outline a few direc- tions mainly by way of international
p.000085: and national legislation. We will at- tempt to describe these directions.
p.000085:
p.000085:
p.000085:
p.000085:
p.000086: 86
p.000086:
p.000086: MANAGEMENT OF BIOLOGICAL WEALTH
p.000086: REPORT
p.000086:
p.000086: International law
p.000086:
p.000086: The Convention on Biodiversity (Rio de Janeiro Convention, 1991) and the Protocol on Biosafety (Cartagena Protocol,
p.000086: 2000).
p.000086: The protection of global biodiversity with specific measures is the object of the Rio Convention, a fundamental
p.000086: instrument for our topic, which was adopted on the initiative of the UN.
p.000086: The Convention stipulates certain principles regarding the management of biodiversity; in particular, the
...

p.000256: is whether a person’s autonomy allows the expansion of physical capabilities beyond normal.
p.000256: The answer is, in principle, yes, since in this case there are -usually- no issues of modifying the human organism.
p.000256: Expanding a person’s capabilities may resemble the assistance provided by the usual mechanical means that make us enjoy
p.000256: our freedom, for example by increasing our movement (car, etc.), our senses (glasses, headphones, etc.), our
p.000256: expression (microphones etc.), and so on.
p.000256:
p.000256: 4 Design news 2005. http://www.designnews.com/document.asp?doc_id=226412&dfpPParams=ind_182,
p.000256: aid_226412&dfpLayout=article.
p.000256: 5 Cyberdyne. Inc. http://www.cyberdyne.jp/english/robotsuithal/.
p.000256:
p.000257: 257
p.000257:
p.000257: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000257: REPORT
p.000257:
p.000257: 3. The law
p.000257:
p.000257: Especially for equipment that requires interventions in the organism of the person concerned, the legislation
p.000257: about medical products (Directive 93/42, incorporated by JMD DY8d/GP. οik.130648/2.10.2009, Directive
p.000257: 90/385, incorporated by JMD DY8d/GP. oik.130644/2.10.2009) contains provisions for secure application of
p.000257: implants. Therefore, it also involves the technological interventions that aim, for example, at the
p.000257: musculoskeletal support.
p.000257:
p.000257: ΙV. Prolongation of life
p.000257:
p.000257: 1. The data
p.000257:
p.000257: The idea of longevity or eternal youth has always been fascinating for mankind, regardless of the era,
p.000257: culture and religion. This interest derives mainly from man’s fear about the diseases presented in old
p.000257: age but also from the death itself, as well as the quest for youth. It is a fact that, the best social and economic
p.000257: living conditions as well as better medical care increase the average lifespan of humans.
p.000257: Over the past two centuries, human life expectancy is more than dou- bled, from 25 years to 65 for men and
p.000257: 70 for women, while some estimate that for some populations this number will reach 100 years in six decades (Oeppen
p.000257: and Vaupel, 2002). In the European Union particularly, life expec- tancy has risen by an average of 10 years over the
p.000257: last fifty years6. According to statistics in 2009, the average life expectancy in the EU of 27 states is
p.000257: 79.4 years (76.4 for men and 82.4 for women). In Greece, the average age is
p.000257: 80.2 years for the total population (77.8 for men and 82.7 for women). But why this constant increase in life
p.000257: expectancy?
p.000257: Genetic factors, such as the HLA-DRw9 and HLA-DR1 alleles in the Japa- nese population (Takata et al., 1987) and the e4
p.000257: allele of the APOE gene in Finnish (Schachter et al., 1994) and the French population (Louhija et al.,
p.000257: 1994), are associated with increased life expectancy.
p.000257:
p.000257: 6 Eurostat. Mortality and life expectancy statistics. Data from October 2011.
...

Searching for indicator religious:

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p.000113: 1. Medicine is divided into several specialties and one physician alone is no longer able to treat all the health
p.000113: problems of an individual.
p.000113: 2. The physicians of different specialties as involved to consult in the course of his/her life will
p.000113: not necessarily work together; therefore, the patient is the only one with a complete picture of his/her medical
p.000113: history. It should be noted also that in Greece, records of medical his- tory are not kept for each patient.
p.000113: 3. Medicine has progressed in such a way that there is no single indicat- ed treatment for each particular condition.
p.000113: 4. The level of education in our country has been improved in recent decades. As a result, most patients
p.000113: are able to understand the medi- cal facts of their condition and are seeking more detailed infor- mation.
p.000113: Furthermore, the lay public enjoys greater, if fragmentary, access to medical information from a variety of
p.000113: sources.
p.000113: 5. People do not trust the motives of physicians unreservedly. This is mainly because the practice of
p.000113: medicine is sometimes known to be influenced by varying interests not necessarily compatible with the patient’s
p.000113: interests.
p.000113: 6. Citizens demand more from the health system as regards the quality of services, the medical outcome and the
p.000113: conditions in which these services are provided. The provision of high quality services is consid- ered by citizens as
p.000113: an utmost priority in our country.
p.000113: 7. It is now acknowledged that the way of living and the religious or other philosophical beliefs of
p.000113: patients must be taken into considera- tion when determining treatment. There is an increasing awareness of the right
p.000113: to autonomy and of respect for dignity in medicine.
p.000113:
p.000113: B. LEGAL ISSUES
p.000113:
p.000113: In general
p.000113:
p.000113: The “Code of Medical Ethics” (CME, Law 3418/2005) has put in place a modern legal framework for the relationship
p.000113: physician-patient in Greek
p.000113:
p.000113:
p.000113:
p.000114: 114
p.000114:
p.000114: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000114: REPORT
p.000114:
p.000114: law2. The main characteristic of this law is the explicit introduction of “in- formed consent” albeit
p.000114: maintaining provisions which reflect the former “pa- ternalistic” approach.
p.000114: It must be noted that “informed consent” was already embedded in Greek law, first, through the
p.000114: ratification of the Oviedo Convention on Hu- man Rights and Biomedicine (art. 5 et seq. Law 2619/1998) and,
p.000114: second, by way of express provisions in a number of laws on various medical fields3. Naturally, the
p.000114: relevant rules of the CME are more detailed. Pursuant to the CME:
p.000114: - Informed consent is always required except in case of: a) emergen- cies, b) suicide attempts, and c) refusal to
...

Searching for indicator armedXforces:

Searching for indicator military:

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p.000142: This particular disease presents a set of peculiar problems. Even though the spread of the virus is in general
p.000142: relatively difficult, the disease is very severe despite progress in treatment in the recent years. Moreover, social
p.000142: perceptions -especially regarding high risk vulnerable groups- remain ex- tremely negative in our country. The
p.000142: following call for attention:
p.000142: The autonomy of HIV seropositives or HIV patients can be restricted in view of public health protection only if the
p.000142: particular setting of social con- tact is prone to the transmission of the disease. Thus, although mandatory testing
p.000142: for seropositivity is not justified in the absence of qualifying circum- stances, it can be legitimate for certain
p.000142: occupations like physicians or nurs- es or for participation in certain social activities such as sports. In
p.000142: these cases, a positive test result justifies the removal of the seropositive, but just from this
p.000142: particular social context. By contrast, social environments, which are not prone to the transmission of the
p.000142: virus, do not justify devia- tions from the respect of autonomy which is generally applicable.
p.000142: Finally, special attention is required when the virus occurs in enclosed areas of mandatory containment, like
p.000142: schools, hospitals, military barracks or prisons. Any limits to autonomy which are considered indispensable
p.000142: must be combined with additional measures of supervision in order not to betray the purpose of the presence of the HIV
p.000142: seropositive in these areas (e.g. participation in common school activities, military exercises, etc.).
p.000142:
p.000142: Athens, 18 March 2011
p.000142:
p.000143: 143
p.000143:
p.000143: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000143: OPINION
p.000143:
p.000143: COMPOSITION AND PERSONELL
p.000143: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000143: Chairman: John Papadimitriou, Emeritus Professor of Surgery, Medical School, University of Athens.
p.000143:
p.000143: Deputy Chairman: George Maniatis, Emeritus Professor of Biology, Medical School, University of Patras.
p.000143:
p.000143: Members:
p.000143: Julia Iliopoulou-Stranga, Professor of Constitutional Law, Law School, Uni- versity of Athens.
p.000143: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000143: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000143: Athens.
p.000143: Evangelos Moutsopoulos, Member of the Academy of Athens, Emeritus Professor of Philosophy, University of
p.000143: Athens.
p.000143: Athanasios Papachristou, Professor of Civil Law, Law School, University of Athens.
p.000143: Theocharis Patargias, Emeritus Professor of Genetics, University of Athens
p.000143: Constantinos Tsoukalas, Emeritus Professor of Sociology, University of Ath- ens.
p.000143: Christos Voulgaris, Emeritus Professor of Theology, University of Athens.
p.000143:
p.000143: PERSONNEL
p.000143:
p.000143: Scientific Officers:
p.000143: Takis Vidalis, Lawyer, PhD in Law.
p.000143: Ariadne L. Hager-Theodoridou, Agronomist, PhD in Genetics.
p.000143:
p.000143: Secretariat:
...

p.000228: Based on the above considerations, the Commission notes the necessity of constant vigilance by the anti-doping
p.000228: authorities in our country, especially after the repeated cases during the last years.
p.000228: The Commission points out the special role of the Hellenic National Anti- Doping Council (ESKAN) for the prevention and
p.000228: fight against doping. It would be appropriate for ESKAN to acquire organizational independence (in the form of
p.000228: a legal entity or even of an independent authority), to apply its ju- risdiction at all levels of athletic
p.000228: contests (even in schools) and possibly complement its authority with the potentiality to impose all the
p.000228: relevant sanctions in cases of law violation.
p.000228: In addition, the Commission considers that reinforcing athletic research will contribute to inform properly the
p.000228: future athletes about their actual physical abilities, whereas underpinning the athlete’ s medical support will act
p.000228: as a deterrent to the use of doping methods.
p.000228: Finally, the Commission highlights the importance of responsible publi- cation of anti-doping test results,
p.000228: particularly by the media, in order to avoid the risk of stigmatizing sport and athletics overall. The disproportionate
p.000228: pub- licity of the offender athletes and their associates does not serve in favour of preventing the doping
p.000228: phenomenon effectively; on the contrary, it dis- courages young people from being involved in sport and
p.000228: consequently de- prives them from its indisputable benefits.
p.000228:
p.000228: 4. Physical enhancement for military purposes
p.000228:
p.000228: Physical enhancement may also be applied to a military, operational lev- el. In particular, it is not unlikely
p.000228: that one can justify the enhancement of physical characteristics of soldiers, in the name of national interest
p.000228: and na-
p.000228:
p.000228:
p.000229: 229
p.000229:
p.000229: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000229: OPINION
p.000229:
p.000229: tional security. Indeed, this may be associated with experimentation on hu- mans, which would be potentially banned in
p.000229: case the relevant research in- volved ordinary citizens.
p.000229: The Commission considers that physical enhancement of soldiers is sub- ject to the general rules of conducting
p.000229: research involving human subjects. Amongst these rules, the special informed consent of the person participat- ing
p.000229: in the process of enhancement is a necessary prerequisite. Beyond that, the Commission notes that in research
p.000229: concerning physical enhancement of soldiers, transparency is particularly important, which is, however, often in
p.000229: contrast to the confidentiality required by such cases. In this occasion, the necessary information may be available to
p.000229: a third party/organization which will ensure not only the proper conduct of research but also the confidenti- ality of
p.000229: information.
p.000229: Finally, for the military physician who participates in such a research, the Commission considers that, additionally,
p.000229: all the rules of medical ethics ap- ply, including those related to clinical research.
p.000229:
p.000229:
p.000229: Athens, 8 April 2013
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000230: 230
p.000230:
p.000230: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000230: OPINION
p.000230:
p.000230: COMPOSITION AND PERSONELL
p.000230: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000230: Chairman: John Papadimitriou, Emeritus Professor of Surgery, Medical School, University of Athens.
p.000230:
p.000230: Members:
p.000230: Julia Iliopoulou-Stranga, Professor of Constitutional Law, Law School, Uni- versity of Athens.
p.000230: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000230: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000230: Athens.
p.000230: Evangelos Moutsopoulos, Member of the Academy of Athens, Emeritus Professor of Philosophy, University of
p.000230: Athens.
p.000230: Theocharis Patargias, Emeritus Professor of Genetics, University of Athens
p.000230: Constantinos Tsoukalas, Emeritus Professor of Sociology, University of Ath- ens.
p.000230: Christos Voulgaris, Emeritus Professor of Theology, University of Athens.
p.000230:
p.000230: PERSONELL
p.000230:
p.000230: Scientific Officers:
...

p.000247: consent as the central concept here.
p.000247:
p.000247:
p.000247:
p.000247:
p.000248: 248
p.000248:
p.000248: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000248: REPORT
p.000248:
p.000248: II. Enhancing performance
p.000248:
p.000248: 1. The facts
p.000248:
p.000248: a) Overview
p.000248:
p.000248: The concept of enhancing performance includes skills, such as the physical strength, speed,
p.000248: agility, stamina, accuracy and movement co- ordination as well as dexterity. In this case,
p.000248: enhancement is mainly accomplished by the use of pharmaceutical agents, whereas in the future, one cannot
p.000248: preclude that performance enhancement will be achieved by the use of genetic technologies.
p.000248:
p.000248: b) Enhancing performance at work
p.000248:
p.000248: The wish to strengthen performance in the working environment may have significant effects on work, which
p.000248: require careful consideration by the policymakers, employers and employees themselves. Enhancement techno- logies could
p.000248: change the way people work, making it possible to work under difficult conditions (e.g. extreme climate conditions, low
p.000248: light conditions and low oxygen concentration), to increase strength and reduce physical fatigue even during
p.000248: prolonged labor or to reduce recovery and return earlier to work after illness (Academy of Medical
p.000248: Sciences, British Academy, Royal Academy of Engineering and Royal Society joint Workshop Report, 2012).
p.000248:
p.000248: c) Enhancing military performance
p.000248:
p.000248: The history of conducting experiments in order to enhance the performance of soldiers started
p.000248: almost a century ago. After the use of yperite (also known as mustard gas) during the First World War, there
p.000248: were reports of yperite trials on soldiers in the USA that examined resistance to yperite depending on race. It was
p.000248: just five decades later, in 1991, that the USA government admitted these experiments (Smith, 2008). Reports of
p.000248: experiments with nuclear energy and psychotropic drugs then followed (Parasidis, 2012).
p.000248: However, enhancement of military performance has evolved due to the
p.000248:
p.000248:
p.000249: 249
p.000249:
p.000249: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000249: REPORT
p.000249:
p.000249: possibilities offered by biomedicine and biotechnology. For example, the
p.000249: U.S. Department of Defense and the Advanced Research Projects Agency Defense (DARPA) fund research on
p.000249: pharmaceutical agents that keep soldiers alert, reducing the need for sleep. Research is also conducted on
p.000249: nutrient preparations that fulfill the nutritional needs of soldiers for several days. DARPA’s program
p.000249: “Persistence in Combat” includes the development of a vaccine that would block pain, accelerate wound healing
p.000249: and stop bleeding soon after wounding (Parasidis, 2012).
p.000249:
p.000249: d) Enhancing athletic performance
p.000249:
p.000249: During their preparation, athletes are trained by qualified coaches, they follow a special diet that includes
p.000249: supplements and they have access to physiotherapy in order to improve their athletic performance. However,
p.000249: since professionalism came to be part of sports, the pressure for better athletic performance, imposed by
p.000249: either the athletes’ personal ambitions or by their athletic clubs including their coaches, is stronger.
p.000249: Thus, hard training, even from an early age, seems to be insufficient, and consequently, athletes turn to doping
p.000249: in order to enhance their athletic performance. “Doping” is the most common and oldest form of
...

p.000255: interesting to note that athletes are permitted to use prohibited substances for therapeutic purposes. The
p.000255: first Convention was specialized in our country with the YA 3956/19.2.2012, specifying, in particular, the
p.000255: national anti-doping controls for all sports under the responsibility of ESKAN. The Anti-Doping Convention
p.000255: of the Council of Europe includes a first list of prohibited substances (with varying classifications), which has
p.000255: been updated from the relevant WADA list (included in the WADA Code 2003).
p.000255: In the field of genetic enhancement (as long as it becomes feasible, especially in sports) the
p.000255: restrictive provision of Art.13 of the Oviedo Convention is crucial, according to which interventions
p.000255: in the genome are permissible “only for preventive, diagnostic or therapeutic purposes”, and interventions
p.000255: that alter the gametes and therefore, the offspring’s genomes, are prohibited. Combined with the UNESCO Universal
p.000255: Declaration on the Human Genome and Human Rights, this provision leaves no substantial room to cover
p.000255: the interventions for pure genetic enhancement (e.g. correction of phenotypic characteristics, as long
p.000255: as it is feasible). On the contrary, this provision allows preventive interventions, through DNA
p.000255: modifications.
p.000255:
p.000255: IΙΙ. Motorized exoskeleton
p.000255:
p.000255: 1. The data
p.000255: The use of motorized means (robotic means) that assist or enhance movement and human locomotion is a
p.000255: field of research in biomedical technology, with potential medical and military applications. The motorized means
p.000255: are mechanical components or external frameworks, which require an external source of energy -at least
p.000255: partially- to operate the engine and hydraulic systems that they include. They are attached to or worn by
p.000255: an individual providing motion.
p.000255: In medicine, the use of motorized means may help to restore functi-
p.000255:
p.000256: 256
p.000256:
p.000256: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000256: REPORT
p.000256:
p.000256: onality in organs or joints, so that patients can return to a healthy or average level of function.
p.000256: Patients with neurological problems, with stroke or spinal cord injuries who present reduced mobility could benefit
p.000256: from the use of motorized exoskeletons in order to partially restore their locomotion (Lo and Xie, 2011).
p.000256: However, mechanical means often provide capabilities beyond restoration to a normal healthy state,
p.000256: favouring the acquisition of additional capabilities. A typical example is the case of Jesse Sullivan, who was given a
p.000256: robotic limb after surgery at the Rehabilitation Institute of Chicago in 2005. Jesse Sullivan not only managed to
p.000256: restore motion in his shoulder and arm, but also to perform movements that were not possible with previous
p.000256: robotic limbs4. Apart from robotic limbs, there are several companies that manufacture exoskeletons for medical
p.000256: use, for example the “robotic suit HAL” which was designed to complement or enhance human mobility5.
p.000256: In the military field, the use of motorized exoskeleton can enhance a soldier’s strength and stamina while
p.000256: carrying heavy loads. Already, several companies have designed motorized exoskeletons for military purposes,
p.000256: such as Raytheon and Lockheed Martin, and indeed often with government funding. Similar uses for motorized
p.000256: exoskeletons could be found in rescue groups, such as firemen that need to carry and rescue victims.
p.000256:
p.000256: 2. The dimension of ethics
p.000256:
p.000256: As in the case of using motorized exoskeleton for enhancement purposes, the question that arises
p.000256: is whether a person’s autonomy allows the expansion of physical capabilities beyond normal.
p.000256: The answer is, in principle, yes, since in this case there are -usually- no issues of modifying the human organism.
p.000256: Expanding a person’s capabilities may resemble the assistance provided by the usual mechanical means that make us enjoy
p.000256: our freedom, for example by increasing our movement (car, etc.), our senses (glasses, headphones, etc.), our
p.000256: expression (microphones etc.), and so on.
p.000256:
p.000256: 4 Design news 2005. http://www.designnews.com/document.asp?doc_id=226412&dfpPParams=ind_182,
p.000256: aid_226412&dfpLayout=article.
p.000256: 5 Cyberdyne. Inc. http://www.cyberdyne.jp/english/robotsuithal/.
p.000256:
p.000257: 257
p.000257:
p.000257: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000257: REPORT
p.000257:
p.000257: 3. The law
p.000257:
p.000257: Especially for equipment that requires interventions in the organism of the person concerned, the legislation
p.000257: about medical products (Directive 93/42, incorporated by JMD DY8d/GP. οik.130648/2.10.2009, Directive
p.000257: 90/385, incorporated by JMD DY8d/GP. oik.130644/2.10.2009) contains provisions for secure application of
...

p.000262: Medical Technologies”, Barcelona.
p.000262: House of Commons, Select Committee on Culture, Media and Sport (2004). Seventh Report of Session 2003-2004, UK
p.000262: Parliament, HC 499-I.
p.000262: Huxtable R, Woodley J (2005). Gaining face or losing face? Framing the debate on face transplants.
p.000262: Bioethics, p. 505.
p.000262: Ingram DK, Anson RM, De Cabo R, Mamczarz J, Zhu M, Mattison JA, Lane MA, Roth GS (2004). Development of
p.000262: calorie restriction mimetics as a pro- longevity strategy. Ann NY Acad Sci 1019, 412-423.
p.000262: Kriari-Katrani I (2001). The constitutional protection of genetic identity. A first approach. DtA 2001, p.347.
p.000262: Lo HS, Xie SQ (2012). Exoskeleton robots for upper-limb rehabilitation: State of the art and future prospects. Med Eng
p.000262: Phys 34, 261-8.
p.000262:
p.000262:
p.000262:
p.000263: 263
p.000263:
p.000263: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000263: REPORT
p.000263:
p.000263: Louhija J, Miettinen HE, Kontula K, Tikkanen MJ, Miettinen TA, Tilvis RS (1985). Aging and genetic variation
p.000263: of plasma lipoproteins. Oldest old: New perspectives and evidence. Milbank Mem Fund Quart 63, 177-251.
p.000263: Morcel K, Camborieux L, Programme de Recherches sur les Aplasies Mülléri- ennes, Guerrier D (2007).
p.000263: Mayer-Rokitansky-Küster-Hauser (MRKH) syn- drome. Orphanet J Rare Dis 14, 2:13.
p.000263: Oeppen J and Vaupel JW (2002). “Broken limits to life expectancy”. Science 296, 1029-1031.
p.000263: Parasidis E (2012). Human enhancement and experimental research in the military. Connecticut Law Review 44, 1117.
p.000263: Phillips KA, Grant J, Siniscalchi J, Albertini RS (2001). Surgical and nonpsychi- atric medical treatment of patients
p.000263: with body dysmorphic disorder. Psycho- somatics 42(6):504-10.
p.000263: Phillips KA, Menard W (2006). Suicidality in body dysmorphic disorder: A prospective study. Am J Psychiatry
p.000263: 163, 1280-2.
p.000263: Report from a joint workshop hosted by the Academy of Medical Sciences, the British Academy, the Royal Academy of
p.000263: Engineering and the Royal Socie- ty (2012). Human enhancement and the future of work.
p.000263: Richel T (2003). Will human life expectancy quadruple in the next hundred years? Sixty gerontologists say public debate
p.000263: on life-extension is necessary. J Anti-Aging Med 6, 309-14.
p.000263: Roco MC and Bainbridge WS (2002). Foundation converging technologies for improving human performance.
p.000263: Nanotechnology, biotechnology, infor- mation technology and cognitive Science. NSF/DOC-sponsored report.
p.000263: Salvi M (2003). What is Wrong in Modifying the Human Germ Line? JIB p.34.
p.000263: Sarwer DB (2002). Awareness and identification of body dysmorphic disor- der by aesthetic surgeons: Results of a
p.000263: survey of American Society for Aes- thetic Plastic Surgery Members. Aesthet Surg J 22, 531-5.
p.000263: Schachter F, Faure-Delanef L, Guénot F, Rouger H, Froguel P, Lesueur-Ginot L, Cohen D (1994). Genetic associations with
p.000263: human longevity at the APOE and ACE loci. Nature Genet 6, 29-32.
p.000263:
p.000264: 264
p.000264:
p.000264: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000264: REPORT
p.000264:
p.000264: Smith SL (2008). Mustard Gas and American Race-Based Human Experimen- tation in World War II. Journal of Law, Medicine
...

p.000278: REPORT
p.000278:
p.000278: However there are studies in animal models, particularly mice, sugge- sting new gene targets for enhancing
p.000278: intellectual and mental characteristics, with a possible extension of the use in humans. A typical example
p.000278: is the receptor subunit NR2B of the NMDA receptor, which leads to an increased learning and memory ability of mice
p.000278: when it is overexpressed after genetic modification26.
p.000278:
p.000278: 4. Human brain-computer interfaces
p.000278:
p.000278: Brain-computer interfaces refer to a number of technologies having as an ultimate aim to achieve
p.000278: interaction and communication between the human nervous system and a computer or an external device27.
p.000278: Brain- computer interfaces use the brain’s electrical activity as a command to a machine, e.g. a computer
p.000278: or a prosthetic arm, causing operation of the system directly through thoughts. Brain electrical signals are
p.000278: recorded with an electroencephalogram, either with electrodes attached to the scalp (non- invasive method) or
p.000278: with electrodes implanted in the brain (invasive method). While the non-invasive method is less
p.000278: accurate in recording signals, the invasive method poses risks since electrodes are implanted in the brain
p.000278: cortex with possibilities of infection and brain damage.
p.000278: The main objective of brain-computer interfaces is to replace or restore function in patients suffering from
p.000278: neuromuscular diseases, by controlling the movement of prosthetic limbs or a wheelchair. However, such te-
p.000278: chnologies may also be applied to control robots, military vehicles and airplanes, games and virtual
p.000278: environments. According to brain-computer interface experiments, paralyzed patients can control a computer
p.000278: cursor using electrodes28,29,30, allowing the use of brain-computer interfaces for
p.000278:
p.000278: 26Tang YP, Shimizu E, Dube GR, et al. (1999). Genetic enhancement of learning and memory in mice. Nature 401, 63-9.
p.000278: 27Nicolas-Alonso LF, Gomez-Gil J (2012). Brain computer interfaces, a review. Sensors (Basel) 12, 1211-79.
p.000278: 28Hochberg LR, Bacher D, Jarosiewicz B, et al. (2012). Reach and grasp by people with tetraplegia using a neurally
p.000278: controlled robotic arm. Nature 485, 372-5.
p.000278: 29Pereira CA, Bolliger Neto R, et al. (2009). Development and evaluation of a head- controlled human-computer
p.000278: interface with mouse-like functions for physically disa- bled users. Clinics (Sao Paulo) 64, 975-81.
p.000278:
p.000279: 279
p.000279:
p.000279: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000279: REPORT
p.000279:
p.000279: continuous access to the internet, databases and information processing systems, which can enhance the
p.000279: abilities of human mind. Although these technologies are notable, however they must progress in order to
p.000279: achieve precision in manipulating external devices after stimulation of specific brain cells31.
p.000279:
p.000279: ΙΙ. The dimension of ethics
p.000279:
p.000279: 1. Overview
p.000279:
p.000279: Setting aside the general bioethics concern about human enhancement, for enhancement of cognitive and mental
...

Searching for indicator soldier:

(return to top)
p.000255: are mechanical components or external frameworks, which require an external source of energy -at least
p.000255: partially- to operate the engine and hydraulic systems that they include. They are attached to or worn by
p.000255: an individual providing motion.
p.000255: In medicine, the use of motorized means may help to restore functi-
p.000255:
p.000256: 256
p.000256:
p.000256: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000256: REPORT
p.000256:
p.000256: onality in organs or joints, so that patients can return to a healthy or average level of function.
p.000256: Patients with neurological problems, with stroke or spinal cord injuries who present reduced mobility could benefit
p.000256: from the use of motorized exoskeletons in order to partially restore their locomotion (Lo and Xie, 2011).
p.000256: However, mechanical means often provide capabilities beyond restoration to a normal healthy state,
p.000256: favouring the acquisition of additional capabilities. A typical example is the case of Jesse Sullivan, who was given a
p.000256: robotic limb after surgery at the Rehabilitation Institute of Chicago in 2005. Jesse Sullivan not only managed to
p.000256: restore motion in his shoulder and arm, but also to perform movements that were not possible with previous
p.000256: robotic limbs4. Apart from robotic limbs, there are several companies that manufacture exoskeletons for medical
p.000256: use, for example the “robotic suit HAL” which was designed to complement or enhance human mobility5.
p.000256: In the military field, the use of motorized exoskeleton can enhance a soldier’s strength and stamina while
p.000256: carrying heavy loads. Already, several companies have designed motorized exoskeletons for military purposes,
p.000256: such as Raytheon and Lockheed Martin, and indeed often with government funding. Similar uses for motorized
p.000256: exoskeletons could be found in rescue groups, such as firemen that need to carry and rescue victims.
p.000256:
p.000256: 2. The dimension of ethics
p.000256:
p.000256: As in the case of using motorized exoskeleton for enhancement purposes, the question that arises
p.000256: is whether a person’s autonomy allows the expansion of physical capabilities beyond normal.
p.000256: The answer is, in principle, yes, since in this case there are -usually- no issues of modifying the human organism.
p.000256: Expanding a person’s capabilities may resemble the assistance provided by the usual mechanical means that make us enjoy
p.000256: our freedom, for example by increasing our movement (car, etc.), our senses (glasses, headphones, etc.), our
p.000256: expression (microphones etc.), and so on.
p.000256:
p.000256: 4 Design news 2005. http://www.designnews.com/document.asp?doc_id=226412&dfpPParams=ind_182,
p.000256: aid_226412&dfpLayout=article.
p.000256: 5 Cyberdyne. Inc. http://www.cyberdyne.jp/english/robotsuithal/.
p.000256:
p.000257: 257
p.000257:
p.000257: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000257: REPORT
p.000257:
p.000257: 3. The law
p.000257:
p.000257: Especially for equipment that requires interventions in the organism of the person concerned, the legislation
...

Searching for indicator student:

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p.000172: in a clinical study, stand in between.
p.000172: It is reasonable for researchers, specialized in implementing research projects, to be more commonly associated
p.000172: with pharmaceutical companies, compared to those who do not deal with research. This mutual relationship creates the
p.000172: conditions for conflict of interest20.
p.000172: The pharmaceutical industries have any reason to seek participation of major centers in research, because:
p.000172: a) Industries lack the necessary infrastructure and experience for such studies.
p.000172: b) Institutions ensure patient/volunteer participation.
p.000172: c) Institutions have the necessary status that will contribute to confi- dence in the pharmaceutical
p.000172: product.
p.000172:
p.000172:
p.000172: 20 Henry D, Doran E, Kerridge I, Hill S, McNeill PM, Day R (2005). Ties that bind: Mul- tiple relationships between
p.000172: clinical researchers and the pharmaceutical industry. Arch Intern Med 165, 2493-2496.
p.000172:
p.000173: 173
p.000173:
p.000173: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000173: REPORT
p.000173:
p.000173: According to some experts, the relation between academic Institutions and the pharmaceutical industries creates
p.000173: problems which become increas- ingly complex, not only to researchers but also to academic Institutions, due to the
p.000173: suspicion surrounding their moral integrity and the transparency of research21.
p.000173: “Cooperation”, may be in the form of: direct research funding from the industry, provision of technical knowledge from
p.000173: the Institution to the indus- try, academic “coverage” of the industry, student scholarships and product recognition by
p.000173: the Institutions. In 1994, the industries offered $1.5 million funding to USA Universities, for use in 6,000 research
p.000173: projects22.
p.000173: Publication of favorable research results to a high impact scientific jour- nal is a positive step towards the
p.000173: establishment of a drug or any other healthcare product. Subsequently, some companies seek “improvement” of their
p.000173: results, as indicated by the fact that 59% of pharmaceutical industries sponsored scientists who work for scientific
p.000173: societies and issue guidelines on how not to affect research results23.
p.000173: The private sector comprises the final stage in the availability of a drug. There is an increasing number of private
p.000173: healthcare physicians participating in clinical studies, either as “researchers” in non-profit centers or as patient
p.000173: providers. In the USA, the number of the above mentioned physicians is increasing24. Medical advisors
p.000173: visit more often private-sector physicians. It
p.000173:
p.000173:
p.000173:
p.000173:
p.000173: 21 Association of American Medical Colleges (2002). Task Force on Financial Conflicts of Interest in Clinical Research,
p.000173: Protecting subjects, preserving trust, promoting pro- gress. II. Principles and recommendations for oversight of
p.000173: an institution's financial interest in human subjects research. Washing-ton, D.C.
p.000173: 22 Hampson LA, Joffe S, Fowler R, Verter J, Emanuel EJ (2007). Frequency, type, and monetary value of financial
p.000173: conflicts of interest in cancer clinical research. J Clin On- col 25, 3609-3614.
...

p.000275: academic performance.
p.000275: A study in 4,580 American college students showed that 8.3% of students reported illicit use of
p.000275: prescription stimulants at least once in their lifetime, while 5.9% of them used it during the previous year.
p.000275: Of these, 75.8% used amphetamine while 24.5% used methylphenidate, with a higher rate of use among Caucasians. The
p.000275: study indicates that the most frequent incentives for stimulant use is to increase concentration, receive help during
p.000275: studying and increase attention8. These results were confirmed by similar studies9 indicating the problem
p.000275: of frequent use, especially amphetamine use, in college students.
p.000275: Modafinil is also a stimulating substance indicated for the treatment of excessive sleepiness in patients with
p.000275: narcolepsy. However, studies in healthy subjects showed that Modafinil improves memory10, as well as the levels
p.000275: of wakefulness and alertness in physicians11 and pilots12, making
p.000275:
p.000275: 6Warburton DM (1992). Nicotine as a cognitive enhancer. Progress in Neuro- Psychopharmacology and
p.000275: Biological Psychiatry, 16, 181-191.
p.000275: 7Newhouse PA, Potter A & Singh A (2004). Effects of nicotinic stimulation on cognitive performance. Current Opinion in
p.000275: Pharmacology, 4, 36-46.
p.000275: 8Teter CJ, McCabe SE, Boyd CJ, Guthrie SK (2003). Illicit methylphenidate use in an undergraduate student
p.000275: sample: Prevalence and risk factors. Pharmacotherapy 23, 609-17.
p.000275: 9McCabe SE, Teter CJ, Boyd CJ (2006). Medical use, illicit use and diversion of pre- scription stimulant
p.000275: medication. J Psychoactive Drugs 38, 43-56.
p.000275: 10Müller U, Steffenhagen N, Regenthal R, Bublak P (2004). Effects of modafinil on working memory processes
p.000275: in humans. Psychopharmacology (Berl) 177, 161-9.
p.000275: 11Gill M, Haerich P, Westcott K, et al., (2006). Cognitive performance following modafinil versus placebo
p.000275: in sleep-deprived emergency physicians: A double-blind randomized crossover study. Acad Emerg Med 13, 158-65.
p.000275: 12Caldwell JA Jr, Caldwell JL, Smythe NK 3rd, Hall KK (2000). A double-blind, placebo- controlled investigation of the
p.000275: efficacy of modafinil for sustaining the alertness and
p.000275:
p.000276: 276
p.000276:
p.000276: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000276: REPORT
p.000276:
p.000276: modafinil a substance capable of enhancing cognitive functions in humans.
p.000276:
p.000276: b. Enhancement of mental characteristics and mood
p.000276:
p.000276: At this point, it would be impossible not to mention other pharmaceutical substances,
...

p.000282: of our lifestyle. This is an issue of concern which is similar to that of enhancing physical abilities
p.000282: (e.g. doping in sports).
p.000282: Here, enhancement is usually associated with memory or concentration, especially during challenges in education or
p.000282: work. The general principle that wants to prevent distortion of rivalry is valid here, but it constitutes a
p.000282: “defensive” attitude. Equal access means, mainly, that anyone who desires it is able to use substances, under the two
p.000282: reservations mentioned above.
p.000282: An objection here would be that equal access does not exist anyway, regarding the conventional ways to
p.000282: enhance cognitive performance, namely through education or training. Pupils, students or employees have strongly
p.000282: differentiated possibilities of access to adequate education, mainly because of the economic inequality, which
p.000282: significantly affects their opportunities. Generally, equal opportunities presuppose equality to
p.000282: material means, which is practically impossible.
p.000282: On the other hand, one could argue that substance use may be an option to restore the general inequality of access to
p.000282: conventional means. Thus, for example, a student with artificially enhanced memory capacity and
p.000282: concentration could cover gaps with his/her own effort, gaps that his/her socially and economically
p.000282: “'privileged'” classmates cover with expensive teaching methods. The same applies to an employee who is a candidate
p.000282: for a better position, and objectively cannot devote the same time to study compared to a well-trained
p.000282: new candidate for the same position. Nevertheless, this argument would not be convincing. For the reason
p.000282: that, on the one hand, one cannot prevent the use of substances by “privileged” people and therefore restoring
p.000282: inequality, and on the other hand, one would encourage the easy, but temporary, way of going
p.000282: through meritocratic procedures instead of constantly trying to cultivate cognitive abilities (Farah et al.,
p.000282: 424). In fact, the concern of doping in sports applies here as well.
p.000282: In general, one must not overlook that -at least with the current data- the use of enhancement substances
p.000282: has temporary effects and does not
p.000282:
p.000282:
p.000283: 283
p.000283:
p.000283: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000283: REPORT
p.000283:
p.000283: replace the solid acquisition of knowledge through education. But overall, the use of such substances
p.000283: that aim to obtain cognitive balance or psychological well-being appears at present as an
...

Searching for indicator stigma:

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p.000141: principle, except in “emergency situations”.
p.000141: When the number of medical and nursing staff or the available treat- ments do not suffice to ensure care to
p.000141: all those infected (especially in case an infection spreads rapidly) the Commission stresses that the government must
p.000141: establish in advance general priority rules for access to treatment. The basic priority criteria should preferably be
p.000141: prescribed by law. By way of indi- cation, such priority criteria may include the severity of symptoms, the age of the
p.000141: patient and the definition of relevant vulnerable groups.
p.000141:
p.000141: 2. Limits to autonomy on public health grounds
p.000141:
p.000141: a) General rule
p.000141: Limits to the general autonomy of patients -especially the freedom of movement and establishment- are
p.000141: justified only if they are absolutely in- dispensable to protect public health pursuant to the Constitution
p.000141: (arts. 5 [4], 25 [1]). The principle of proportionality as discussed above applies in all circumstances. For
p.000141: example, hospitalized patients should be restricted in specially contained facilities.
p.000141:
p.000141: b) The risk of social stigma
p.000141: The Commission stresses the risk of social stigma that may arise from the isolation (“ghetto-ing”) of specific
p.000141: sub-populations with distinctive cultural characteristics or ways of living when an infectious disease erupts
p.000141: within such groups.
p.000141:
p.000141:
p.000141:
p.000141:
p.000142: 142
p.000142:
p.000142: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000142: OPINION
p.000142:
p.000142: Such cases must be dealt with by personalized medical care and social welfare measures especially as
p.000142: regards the improvement of hygiene in their living conditions.
p.000142:
p.000142: c) Illegal immigrants
p.000142: In case of manifestation of infectious disease or in cases when preven- tive measures (e.g. vaccination) need to
p.000142: be applied on illegal immigrants, the government must ensure that immigrants would be addressed to the
p.000142: health services. The access of immigrants to health services should be un- hindered and independent on their
p.000142: immigration status; otherwise the risks for public health in general will be multiplied.
p.000142:
p.000142: d) HIV/AIDS
...

p.000147: (diagnosis, prevention or treatment) and those imposed by the autonomy of others.
p.000147: Transmissible diseases, like other risks to public health, affect the latter category. The following questions arise in
p.000147: this respect:
p.000147: - To what extent are limits to personal autonomy justified on public health grounds (1)?
p.000147: - What is the effect of informed consent when public health is at risk (2)?
p.000147: To these questions, we must add the implications of the “doing good, not harm” principle, that is the
p.000147: scope of medical duty in case of health- threatening (perhaps also life-threatening) situations for entire
p.000147: populations since, in this event, the exercise of autonomy by patients is de facto affected (3).
p.000147: Finally, two related issues call for special consideration: clinical trials and respective patents for vaccines and
p.000147: medicines, for they also raise important ethical questions. On one hand, these are associated with the provision of
p.000147: accurate information to patients, and on the other hand with access of pa- tients to treatments in the context of
p.000147: exercising autonomy (4).
p.000147:
p.000147: 1. General autonomy and public health: Restrictions and the risk of stigma- tization
p.000147:
p.000147: The legitimate objective of protection of the health of others sets the grounds for imposing restrictions on
p.000147: the general autonomy of those infect- ed, especially in regard to movement and social contact.
p.000147: This calls for a number of qualifications. Indeed, not all transmissible diseases justify the same
p.000147: restrictions. Distinctions are necessary between
p.000147:
p.000147:
p.000147:
p.000148: 148
p.000148:
p.000148: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000148: REPORT
p.000148:
p.000148: easily and less easily transmitted diseases as well as between mild and seri- ous diseases (influenza versus HIV, for
p.000148: example).
p.000148: Mild diseases, even when easily transmitted, do not justify such re- strictions to general autonomy; the same
p.000148: is true of serious diseases that are hard to contract. Of course, there are many variations of these
p.000148: combina- tions, which prevent the formulation of more specific rules of universal ef- fect.
p.000148: Restrictions to general autonomy can lead to unfair discrimination aris- ing from a kind of “stigmatization” which
p.000148: isolates patients -even if temporar- ily- from social life. Above all, this raises a wider ethical problem. Historical-
p.000148: ly, the stigma against population groups on public health grounds has been a recurring phenomenon, from the
p.000148: persecutions and massacres of Jews dur- ing the times of “Black Death” in the Dark Ages (the plague pandemic), to the
p.000148: persecution of beggars on the same grounds in the XIX century or of prostitutes for spreading syphilis in
p.000148: World War I, to contemporary practices of discrimination against AIDS patients. In our country, stigmatization phe-
p.000148: nomena occurred in the past in the cases of leprosy and tuberculosis.
p.000148: These facts demonstrate that public health is not to be considered only as a medical problem, but involves a serious
p.000148: social and political dimension. The latter must be taken into account when adopting restrictions to general autonomy.
p.000148: Such restrictions are not justified unless accompanied by social measures aimed at minimizing the likelihood of
p.000148: transmission (e.g. housing, food, etc. for the poor or disadvantaged groups of the population) and by steps ensuring
p.000148: fair treatment (not distinguishing, for example, between prostitutes and their clients regarding the risk
p.000148: of transmission of venereal diseases).
p.000148: The current wave of immigration carries great potential of stigma on public health grounds. The fact
p.000148: that the country of origin -particularly of illegal immigrants- is often afflicted by a high prevalence
p.000148: of infectious dis- eases (especially sub-Saharan Africa and southern Asia), while local health services
p.000148: remain rudimentary, represents a real cause of concern for the spreading of these diseases in the
p.000148: hosting countries. However, stigmatiza- tion practices -unfair treatment, “ghettos” etc.- stem rather from the idea
p.000148: of “miasma” due to lack of information or misinformation about the medical- biological particulars of disease,
p.000148: especially infectivity. Hansen’s disease (lep- rosy) and, more recently, HIV/AIDS confirm this observation
p.000148: since these
p.000148:
p.000148:
p.000149: 149
p.000149:
p.000149: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000149: REPORT
p.000149:
p.000149: population groups are stigmatized, although the disease is relatively difficult to contract.
p.000149: In case of Hansen’s disease, the exact path of transmission is still un- known, but it is accepted
p.000149: that although it can be contracted through pro- longed social contact, approximately 95% of the population are
p.000149: immune to it, though the mechanisms of immunity have not been identified. Perhaps it was this last parameter in
p.000149: combination with the deformity caused by the disease that has led to social stigma against these patients in the
p.000149: past.
p.000149: In case of HIV/AIDS, the path of transmission is known and involves ex- posure to body fluids through sexual
p.000149: intercourse or the transfusion of con- taminated blood or use of a contaminated needle. The virus can also
p.000149: be transmitted to the fetus by the mother. Mere social contact with patients or seropositives does not constitute a
p.000149: risk of transmission. Despite this, espe- cially in the early years since the appearance of the disease, but even
p.000149: today, seropositives are treated with far greater caution, even prejudice, than is justified by medical
p.000149: fact. Apart from the severity of the disease, which meant near certainty of death in the beginning,
p.000149: whereas now there are available treatments, prejudice emanates from the fact that, initially, the disease
p.000149: had a higher incidence among male homosexuals in western coun- tries. The pre-existing stigma against homosexuals
p.000149: exacerbated the stigma against HIV/AIDS patients and carriers.
p.000149: On a practical level, the difficulty here lies in the justification of re- strictions on grounds of public
p.000149: health protection. Public authorities can be motivated by non-medical parameters (e.g. systematic deprecation or
p.000149: exclu- sion of specific groups) when considering such restrictions, in particular to the freedom of movement and
p.000149: residency. Hence, the importance of having an official entity of indisputable independence, providing accurate and un-
p.000149: derstandable medical information on the disease to the wider public, be- comes crucial.
p.000149:
p.000149: 2. Autonomy and forced treatment
p.000149:
p.000149: The second serious ethical issue arises with respect to the freedom of individuals to take care of health
p.000149: matters regarding themselves.
p.000149: Here, the principle of “informed consent” may be restricted, especially with regard to “refusal of treatment”.
p.000149: The health of others being directly at
p.000149:
p.000149:
p.000150: 150
p.000150:
p.000150: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000150: REPORT
p.000150:
p.000150: stake, the freedom to deny treatment does not enjoy the ethical justifica- tion acknowledged in different
p.000150: circumstances.
p.000150: Hence, forced treatment or prevention (e.g. mandatory vaccination) may be considered as option, especially if this is
...

p.000153:
p.000153:
p.000154: 154
p.000154:
p.000154: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000154: REPORT
p.000154:
p.000154: area must take public interest into account -i.e., the protection of pub- lic health- and, in all terms, is determined
p.000154: by such interest.
p.000154: 2. The above statement does not imply that personal autonomy may be “brought to tatters” -or virtually eliminated- by
p.000154: policy choices to pro- tect public health. Autonomy is still the rule, even in case of epidemics or pandemics, which
p.000154: means that any encroaching measures are always exceptional and can be justified only to the extent that they
p.000154: are de- monstrably appropriate for the objective they serve (principle of pro- portionality). It is, therefore,
p.000154: indispensable to distinguish between in- fectious diseases depending on the level of risk and their transmissibil-
p.000154: ity.
p.000154: 3. The adoption of general rules in advance -if possible in periods of “normality”- both in terms of
p.000154: restrictions as well as of access to sani- tary authorities in times of epidemics or pandemics not only safe-
p.000154: guards the efficacy of prevention or treatment, but also strengthens the feeling of fair distribution of
p.000154: resources and means in emergency situations as imposed by the respect for human value.
p.000154: 4. The potential of social stigma against persons or groups under the pre- text of public health protection is very
p.000154: potent in situations calling for measures. This risk can be addressed only with constant vigilance based on
p.000154: valid and accurate information, a task pertaining mostly to public authorities and institutions. Public health
p.000154: cannot be allowed to inspire phobic reflexes in a modern democratic society.
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000155: 155
p.000155:
p.000155: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000155: REPORT
p.000155:
p.000155: SUGGESTED LITERATURE
p.000155:
p.000155: Beauchamp DE (1988). The health of the republic: Epidemics, medicine, and moralism as challenges to democracy. Temple
p.000155: UP, Philadelphia PA.
p.000155: Brandt AM (1987). No magic bullet: A social history of veneral disease in the United States since 1880. Oxford U. P.,
p.000155: N. York.
p.000155: Breslow L, Duffy J, Beauchamp DE, Soskolne CL (2004). Public health, in: Post SG (ed.) Encyclopedia of bioethics. v. 4,
p.000155: 3d ed. McMillan Reference, N. York, p. 2202-2221.
p.000155: Bruce LI and Phelan JC (2006). Stigma and its public health implications, Lan- cet 367, 528-529.
p.000155: Dagtoglou PD (1991). Constitutional law, individual rights I. eds. A. N. Sak- koulas, Athens-Komotini.
p.000155: Emmanouelides D, Papaiannes I (2000). The social entitlement to health, Human Rights.
p.000155: Encyclopedia of public health. Edited by Lester Breslow, online access.
p.000155: Evans RJ (2004). Epidemics, in: Post SG (ed.), Encyclopedia of bioethics. v. 2, 3d ed. McMillan Reference, N. York, p.
p.000155: 789-794.
p.000155: Gostin L (2004). The international health regulations and beyond. Lancet, Infectious Diseases 4, p. 606-607.
p.000155: Grad FP, Beauchamp DE (2004). Public health law, in: Post SG (ed.), Encyclo- pedia of bioethics. v. 4, 3d ed. McMillan
p.000155: Reference, N. York, p. 2222-2234.
p.000155: Kenneth VI and Moskop JC (2007). Triage in medicine, Part I: Concept, histo- ry, and types. Annals of Emergency
p.000155: Medicine 49, 275-281.
p.000155: Kontiades X (1997). Welfare State and social rights. eds. A. N. Sakkoulas, Athens-Komotini.
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000156: 156
p.000156:
p.000156:
p.000156:
p.000156:
p.000156:
p.000006: 6
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
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p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000157: 157
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
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p.000062: http://www.niehs.nih.gov/research/resources/bioethics/whatis.cfm.
p.000062: International Epidemiological Association (2007). Good epidemiological practice (GEP): IEA guidelines for
p.000062: proper conduct of epidemiological re- search.
p.000062: Law 3536/21.3.2008: Statutory Framework for research and technology and other stipulations. Official Journal of the
p.000062: Greek Government.
p.000062: Lesser LI, Ebbeling CB, Goozner M, Wypij D, Ludwig DS (2007). Relationship between funding source and conclusion
p.000062: among nutrition-related scientific articles. PLoS Med 4, e5.
p.000062: Parascandola M (2005). Science, industry, and tobacco harm reduction: A case study of tobacco industry
p.000062: scientists' involvement in the national cancer institute's smoking and health program, 1964-1980. Public Health
p.000062: Reports 120, 338-349.
p.000062: Resnik DB (2007). What is ethics in research and why is it important? Na- tional Institute of
p.000062: Environmental Health Sciences.
p.000062: Resnik DB, Shamoo AE, Krimsky S (2006). Fraudulent human embryonic stem cell research in South Korea: Lessons learned.
p.000062: Account Res 13, 101-109.
p.000062:
p.000063: 63
p.000063:
p.000063: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000063: REPORT
p.000063:
p.000063: Rosenstock L and Lee LJ (2002). Attacks on science: The risks to evidence- based policy. American Journal
p.000063: of Public Health 92, 14-18.
p.000063: Shamoo AE and Resnik DB (2002). Responsible conduct of research. Oxford University Press.
p.000063: Tong S and Olsen J (2005). The threat to scientific integrity in environmental and occupational medicine.
p.000063: Occupational and Environmental Medicine 62, 843-846.
p.000063: Union of Concerned Scientists. Scientific integrity, Political interference.
p.000063:
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p.000064: 64
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p.000064:
p.000064:
p.000003: 3
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: MANAGEMENT OF BIOLOGICAL WEALTH
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
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p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000065: 65
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000066: 66
p.000066:
p.000066: MANAGEMENT OF BIOLOGICAL WEALTH
p.000066: OPINION
p.000066:
p.000066: O P I N I O N MANAGEMENT OF BIOLOGICAL WEALTH
...

p.000078: biodiversity both for wild and domesticated species. The consumption of water by agriculture is a major environmental
p.000078: problem as water reserves are limited and the irriga- tion systems used among the less efficient in Europe. Newly
p.000078: developed and efficient irrigation systems have not been adequately exploited and this wastefulness of water
p.000078: reserves will create serious problems for future gen- erations.
p.000078: Mass tourism, mainly directed to coastal zones, entails risks and has caused significant population
p.000078: movements and changes in land use. In par- ticular, tourism leads to increased construction in coastal areas and
p.000078: to the deterioration of aquatic ecosystems. Nevertheless, the movement of human populations and the abandonment of
p.000078: farming and stock-raising activities in favour of tourism has, on some occasions, resulted in an increase of wood-
p.000078: land. For example, a study in a limited area of western Crete which included, however, all types of Mediterranean
p.000078: ecosystems showed that between 1945 and 1989 coniferous woodland expanded and replaced other types of vege- tation
p.000078: (Papanastasis and Kazaklis, 1998). This finding illustrates the impact of overgrazing on ecosystems but also the
p.000078: potential of reversing the deterio- ration of an ecosystem when land use changes.
p.000078: The impact of industry on biodiversity consists in the contamination of natural resources, mainly air and water
p.000078: resources. The problem is accentu- ated by frequent non-compliance with environmental protection rules.
p.000078:
p.000078:
p.000078:
p.000079: 79
p.000079:
p.000079: MANAGEMENT OF BIOLOGICAL WEALTH
p.000079: REPORT
p.000079:
p.000079: Finally, a direct threat to biodiversity, in contrast to the above men- tioned indirect though significant
p.000079: threats, is hunting and species collection when conducted uncontrollably and without abiding to the relevant regula-
p.000079: tions (e.g. hunting seasons, number limitations etc.) (Hellenic Zoological Society, 1992).
p.000079:
p.000079: Scientific knowledge and research
p.000079:
p.000079: Some of the organizations that generate knowledge and can contribute more in the future are university
p.000079: departments and faculties of biological, agricultural or environmental orientation, the research institutes of the
p.000079: Na- tional Agricultural Research Foundation (NAGREF), the Hellenic Centre for Marine Research, the Institute
p.000079: of Marine Biology of Crete, the Benakeion Phytopathological Institute, NGOs like the Hellenic Zoological
p.000079: Society, the Hellenic Ornithological Society, the Goulandris Natural History Museum, WWF, Greenpeace,
p.000079: Arctouros, etc. (Legakis et al., 1998). Apart from gener- ating primary knowledge, however, it is necessary to
p.000079: systematize and use it to elaborate a protection strategy in practice.
p.000079: Despite the significant biodiversity of our country, or perhaps because of it, there are significant knowledge gaps in
p.000079: the biological (life cycles), ecologi- cal (demands of habitats) and population (size and fluctuation) characteris-
p.000079: tics of fauna and flora species. These knowledge gaps make the protection of biodiversity an arduous task. There
p.000079: is also a lack of systematization of existing knowledge into readily accessible format (data bases) that
p.000079: can be put to good use and could be further expanded.
...

p.000109: representative in writing, if possible.
p.000109: In case of patients incapable to consent who have not appointed a rep- resentative, the Commission thinks that:
p.000109: i) The legal representatives of the patient may select one of alternative treatment methods but may not refuse all
p.000109: treatments if the treating physi- cian believes that the continuation of therapy is beneficial. Only patients
p.000109: who are capable for self-consent may refuse treatment.
p.000109: ii) In case of disagreement between the legal representatives the treat- ing physician should be able to decide taking
p.000109: into account the opinion of the hospital board of ethics which must be made mandatory in our country.
p.000109: iii) The physician must take into consideration any prior directions by the patient (id est, any wishes the patient
p.000109: expressed prior to becoming incapa- ble to consent).
p.000109: iv) The opinion of mentally mature minors on issues regarding their health must be taken into account in
p.000109: order to comply with the constitutional protection of personality.
p.000109: v) In case of refusal of parents to consent to the treatment of minors - and in case of threat against their lives or
p.000109: serious harm to their health- the physician must proceed to the indicated treatment complying with the legal procedure.
p.000109: vi) In case of patients with limited capacity to consent (minors, mental patients, persons with mental
p.000109: impairments), the attitude of the physician must consist in favoring as much as possible the expression of an
p.000109: opinion by the patients themselves according to the level of their capacity to compre- hend their situation.
p.000109: Therefore, the information to be provided to the pa- tient must be adjusted accordingly in cooperation
p.000109: with their representa- tives.
p.000109:
p.000109:
p.000110: 110
p.000110:
p.000110: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000110: OPINION
p.000110:
p.000110: vii) The Commission believes that even under the circumstances of in- tensive care units physicians must not
p.000110: act alone ignoring the will of the pa- tient. On the contrary, the physician’s moral duty is to ensure the free ex-
p.000110: pression of the patient’s will by providing complete, timely and intelligible information whenever feasible.
p.000110:
p.000110: b) Right of physician to refuse treatment
p.000110: The Commission points out that physicians reserve the right to refuse a treatment which is not medically indicated in
p.000110: their view, even if the patient insists upon it.
p.000110:
p.000110:
p.000110: Athens, 29 March 2010
p.000110:
p.000110:
p.000110:
...

p.000122: of a relationship of communication between the physician and the patient such that the former will understand
p.000122: the needs of the latter and the patient will feel free to express his/her wishes. Appropriate training on
p.000122: communication with patients and on ways to announce an ominous diagno- sis is equally important for an efficient
p.000122: physician-patient relationship. The lack of such training is stressed by many Greek authors who have investigat- ed
p.000122: honesty and patient information (Mystakidou et al., 1996; Rigatos, 1997).
p.000122:
p.000122:
p.000123: 123
p.000123:
p.000123: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000123: REPORT
p.000123:
p.000123: 2. The problem of time
p.000123:
p.000123: According to a frequent argument, it is difficult to implement the model of consent in the limited time available
p.000123: to case management. Experience shows that this time shortage is due either to the nature of the case itself
p.000123: (“emergencies”) or to the inadequate organization of health services espe- cially when faced with occasional peaks of
p.000123: demand.
p.000123: It is worth noting that, in the first case, it is generally admitted -and ex- pressly stipulated by the law- that
p.000123: physicians may act alone, namely “in- formed consent” does not apply. The notion of “emergency” is very broad and
p.000123: needs to be further specified. Assuming that its use must be regarded as exceptional, its scope is limited to: i)
p.000123: cases posing an immediate threat against the patient’s life, or, ii) cases where even the slightest delay in
p.000123: ef- fecting the indicated medical act will definitely cause serious harm to health. Thus, moderate harm to health, even
p.000123: when demanding immediate action, or serious but chronic pathological conditions (e.g. many forms of cancer, dia- betes,
p.000123: etc.) cannot qualify as “emergencies”. In-between these two ex- tremes, there is an area in which the
p.000123: rule of consent must apply with the necessary adjustments to the available margins of time9.
p.000123: As far as inadequate organization of health services is concerned, the possibility to allocate the required
p.000123: time depends mostly on objective, often non-elastic, parameters (e.g. restricted resources to employ additional med-
p.000123: ical staff). Especially here, however, the issue of appropriate training and sensitization of civil health
p.000123: services to patient autonomy is crucial. For, if patient consent is not to be considered a “luxury” but an
p.000123: essential condition for the protection of health and, ultimately, for quality of life, then this re- quirement
p.000123: obviously affects the priorities of the organization of services in a way that makes finding the required time
p.000123: feasible.
p.000123:
p.000123: 3. Education - Training
p.000123:
...

p.000225: foetus, an artificial termination of the pregnancy is not justified, especially since there are the
p.000225: aforementioned reconstructive options after birth. However, given that persons in this cate- gory (seeking plastic
p.000225: surgery to alter gender specific features or gender re- assignment) belong to vulnerable social groups that
p.000225: generally suffer from social discrimination, access to relevant treatment must be ensured. For example,
p.000225: based on the principle of equality and the social right to health, the State may possibly develop counseling
p.000225: programs, but also provide ther- apy possibilities within the National Health System.
p.000225:
p.000225: 4. Face transplants
p.000225:
p.000225: Reconstructive face transplantation (e.g. in case of severe deformities caused by an accident) is, in
p.000225: principle, an acceptable alteration of the recipi- ent’s characteristics. However, it must be carried out in such a
p.000225: manner that it does not affect respect for the body of the (dead) donor. The relevant principle that rules
p.000225: transplants from a deceased donor is absolutely valid in this case too.
p.000225:
p.000225: 5. The physician’s role
p.000225:
p.000225: According to the Commission, the physician who carries out cosmetic plastic surgery has a particular
p.000225: responsibility, since he/she does not act in order to prevent a threat to a patient’s health (or life).
p.000225: Unquestionably, the consent of the person interested is a prerequisite for any relevant medical intervention. However,
p.000225: it should be noted that in the case of cosmetic plas- tic surgery, the following particularities must be taken into
p.000225: account:
p.000225: a) The physician has an increased responsibility to fully inform the person concerned as to the expected outcome
p.000225: and particularly the possible side effects on his/her health. This increased responsibility is explained
p.000225: by the need to prevent "easy" decisions by the person concerned, often influenced by obsessions with his/her body
p.000225: image, by lack of confidence, or by occa- sional fashion standards, obsessions which may put in danger the
p.000225: health of this person.
p.000225:
p.000225:
p.000225:
p.000226: 226
p.000226:
p.000226: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000226: OPINION
p.000226:
p.000226: b) As part of this responsibility, the physician must particularly consider the possibility of an underlying
p.000226: psychological or psychiatric disorder in the person concerned, and refer him/her for a psychological or
p.000226: psychiatric as- sessment. The physician should not comply with the wishes of the interest- ed person in an
p.000226: uncritical manner, since there may be defects in the per- son’s will that affect the validity of
p.000226: his/her consent. Individuals with Body Dysmorphic Disorders (BDDs or dysmorphobia) fall into this category,
p.000226: and indeed, plastic surgery offers no actual prospect of improving their condi- tion.
p.000226:
p.000226: 6. Production of a code of conduct
...

p.000281: but it is not enough to answer the question of whether the second one is legitimate or not. Similarly to alcohol or
p.000281: drug use, a person intentionally uses pharmaceutical agents, and this is done in the context of self-determination,
p.000281: even if the person is aware of the potential serious harm to his/her health. It is generally accepted that self-
p.000281: determination does not exclude choices of an even great risk or choices of “self-destruction”, since otherwise we
p.000281: must adopt paternalistic lifestyles, something that would be fundamentally in contrast to our freedom.
p.000281: Consequently, the possibility of drug use for enhancement purposes that could lead to a radical personality change (or
p.000281: to milder effects on memory capacity, emotional life, etc.), cannot be considered as an illegitimate
p.000281: choice, given the primacy of personal autonomy (Racine & Forlini, 3).
p.000281: However, two reservations remain:
p.000281: - The consequences of drug use do not cause damage to goods of a third party (e.g. in the context of
p.000281: family life or working environment of the user). Thus, for example, drug use that leads to indifference or threat for
p.000281: the user’s children or creates tension with colleagues etc., is illegitimate).
p.000281: - The user has actually made the decision freely, i.e. after providing the appropriate information to him/her, with
p.000281: all the potential risks being identified (Cakic, 613-614, Racine & Forlini, 3, Farah et al., 423). This is not certain,
p.000281: especially when the drugs are administered without a prescription or, at least, without consulting a physician.
p.000281: The re- sponsibility of the latter, here, is certainly increased, as it is about enhancing cognitive or
p.000281: mental characteristics and not about restoring relevant health damage.
p.000281:
p.000281:
p.000282: 282
p.000282:
p.000282: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000282: REPORT
p.000282:
p.000282: 4. Equal access
p.000282:
p.000282: The issue of equal access to means of cognitive or mental enhancement is mainly associated with the
p.000282: opportunities offered in competitive environments (Farah et al., 423) and, secondly, with improvement
p.000282: of our lifestyle. This is an issue of concern which is similar to that of enhancing physical abilities
p.000282: (e.g. doping in sports).
p.000282: Here, enhancement is usually associated with memory or concentration, especially during challenges in education or
p.000282: work. The general principle that wants to prevent distortion of rivalry is valid here, but it constitutes a
...

Searching for indicator stigmatization:

(return to top)
p.000009: covered for diseases not manifested prior to the conclusion of the insurance contract according to their medical
p.000009: records.
p.000009: Genetic data, and more specifically the results of predisposition tests (the main focus of the present
p.000009: report), like some other types of medical da- ta, reveal a probable risk but -in most cases- not certainty of future
p.000009: sickness. The difference, at the moment, of genetic as against medical predisposition markers is that the
p.000009: association between most genetic markers and the probability of disease is not well-documented compared to
p.000009: medical mark- ers.
p.000009:
p.000009: 3. Ethical issues
p.000009:
p.000009: a. Protection of personality and economic freedom
p.000009: In view of the above, the first emerging ethical issue consists in weighing protection of personality for insurance
p.000009: applicants against freedom of busi- ness for insurers.
p.000009: Disclosure of genetic information -similarly to other health-related in- formation- as a requirement for
p.000009: contracting insurance or as a factor in the
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000010: OPINION
p.000010:
p.000010: calculation of premium goes to the core of personality since this information constitutes sensitive personal data.
p.000010: Considering that genetic data is in prin- ciple unchangeable, to reveal a predisposition for a disease may lead to
p.000010: life- long “stigmatization” of the applicant, a serious infringement on personality that may take the form of unfair
p.000010: social discrimination.
p.000010: On the other hand, freedom of business for the insurer is apparently restricted if access to genetic data
p.000010: known to the other party may affect sig- nificantly the insurer’s business risk. In the context of freedom of contract,
p.000010: barring access to information which is relevant to the object of the specific insurance could be seen as unfair to
p.000010: insurers since they are exposed to a risk they ignore whereas the other party is aware (and perhaps takes advantage)
p.000010: of.
p.000010:
p.000010: b. The value of genetic data and the risk of “genetic determinism”
p.000010: Genetic data is a very useful tool in contemporary medicine. In the con- text of personalized medicine and
p.000010: pharmacogenomics, in particular, person- al genetic data is becoming increasingly important for determining
p.000010: thera- peutic treatment. It is therefore of paramount importance that the collec- tion of genetic data,
p.000010: which can contribute to improvement of individual health, is not obstructed for non-medical reasons.
p.000010: The collection of genetic data for research aiming to identify links be- tween diseases and genetic
p.000010: causes with the ultimate goal to identify new treatment targets is crucial for the advancement of science and,
...

p.000021:
p.000022: 22
p.000022:
p.000022: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000022: REPORT
p.000022:
p.000022: D. High risk groups for genetic disorders
p.000022:
p.000022: The development of genetics and of genetic testing for specific diseases has confirmed empirical knowledge about
p.000022: the higher incidence of certain genetic disorders in particular geographic or racial groups. Examples include
p.000022: β-thalassaemia that has a higher incidence in people originating from the Eastern Mediterranean, Africa and
p.000022: Asia14 and various disorders with a high incidence in descendants of Ashkenazi Jews like the BRCA1/2 breast/ovarian
p.000022: cancer. In fact, there is a genetic test for a whole range of genetic disorders occurring more frequently in Ashkenazi
p.000022: Jews15.
p.000022: The development of genetic tests can contribute to early and accurate diagnosis of genetic conditions
p.000022: thus improving the prospects of manage- ment or treatment. Notwithstanding the medical benefits, however, there is
p.000022: an increasing risk of discrimination against these racial groups. Examples of such discrimination appeared in the US,
p.000022: for instance, in the ’70s when Afri- can-Americans, who were carriers of sickle cell anaemia, i.e. who were het-
p.000022: erozygotes and not actually sick, were either deprived of health insurance or charged with higher premiums
p.000022: (Rothenberg and Terry, 2002; Andrews, 1987). Today testing is optional and this case of “genetic” discrimination
p.000022: and stigmatization is used as an example to learn from in the findings of the American GINA Bill of Law.
p.000022: In the future, if no regulation is adopted, there is a risk that individuals belonging to high incidence groups
p.000022: for one or more genetic disorders will be required to undergo genetic testing prior to insur- ance.
p.000022:
p.000022: E. Genetic discrimination in insurance
p.000022:
p.000022: There is no clear-cut definition for the term “genetic discrimination” (Geetter, 2002). In insurance
p.000022: “genetic discrimination” means any form of differential treatment of insurance applicants or insured based on
p.000022: their ge- netic make-up. Practically, discrimination in insurance manifests either with refusal of insurance or with
p.000022: the application of increased premiums. Another form of discrimination is refusal to pay compensation (Pfeffer et al.,
p.000022: 2003).
p.000022:
p.000022:
p.000022: 14 Regions where malaria used to be endemic.
p.000022: 15 http://www.diagnogene.com/temp.php?page=laboratory<est=jew.
p.000022:
p.000023: 23
p.000023:
p.000023: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000023: REPORT
p.000023:
p.000023: In private health insurance, particularly in individual plans (as opposed to group health plans that are governed
p.000023: by different rules), discrimination based on personal medical history or, generally, on the level of risk that the
p.000023: insured represents for the insurer is admissible. The acceptance of such dis- crimination emanates from the optional
p.000023: nature of private health insurance, the availability of social security and mainly the assumption that
...

p.000025: information:
p.000025: i) The “right of ignorance” pertaining to the subject of health infor- mation, i.e. a person may not
p.000025: wish to be informed of data concerning his/her health in order to go on with his/her life undisturbed
p.000025: (Nationaler Ethikrat 2007: 28-29). The disclosure of this information to the insurer as a
p.000025:
p.000025:
p.000026: 26
p.000026:
p.000026: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000026: REPORT
p.000026:
p.000026: precondition for insurance encroaches upon this right since the applicant is then forced to choose between taking the
p.000026: insurance and exercising this right or, alternatively, to pay higher premiums.
p.000026: ii) Medical confidentiality, the purpose of which is to keep serious health information confidential vis-à-vis third
p.000026: parties and to avoid placing one’s social life at risk. This is indeed the very reason for which medical
p.000026: confiden- tiality was put in place.
p.000026: 3. With the development of molecular genetics, the potential opened by the decoding of the human genome and the
p.000026: subsequent expansion of ge- netic applications in medicine, the importance of genetic testing, in particu- lar, has
p.000026: taken on a prominent place in this debate.
p.000026: It is pointed out by many that, by disclosing genetic data, the opportuni- ties for violation of personality are
p.000026: multiplied. Since, in principle, genetic characteristics do not change, the identification of any
p.000026: predisposition for serious diseases in one’s genome (not of an already manifested disease) may result in
p.000026: lifelong “stigmatization” and, ultimately, to unfair social dis- crimination (Nationaler Ethikrat 2007: 26-27).
p.000026: In insurance, such discrimina- tion can take the form of premium escalation (depending on the identifica- tion or not
p.000026: of a genetic predisposition). Thus it might very well be that, in the future, the cost of health care is reduced
p.000026: for those not found to have any predisposition and increased for the rest, or that insurers might even
p.000026: refuse to underwrite certain conditions.
p.000026: This line of thinking leads to an absolute ban on disclosure of genetic information to insurers and,
p.000026: needless to say, precludes insurers from requir- ing genetic testing as a condition to a life or health insurance
p.000026: contract.
p.000026: From the viewpoint of bioethics, the issue here is whether the economic freedom of the insurer puts the principle of
p.000026: equality at risk for the insured or, seen in the opposite, if concealment of genetic data by the insured cre- ates
p.000026: inequality between the parties in the context of freedom of contract.
p.000026: With regards to the above, it is worth noting the following:
p.000026: a) From the discussion in the first chapter, we concluded that genetic information actually has little
p.000026: predictive value as to the certainty of disease manifestation. It makes a more accurate prediction about the likelihood
p.000026: of disease but, on the other hand, allows preventive measures to limit this like- lihood. The detection of specific
p.000026: mutations in one’s genome that are known to be associated with disease, does not mean, in most cases, that the dis-
p.000026:
p.000026:
p.000027: 27
p.000027:
p.000027: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000027: REPORT
p.000027:
...

p.000030:
p.000030: SUMMARY - CONCLUSIONS
p.000030:
p.000030: 1. There are genetic tests for a significant number of disorders with a genetic component that determine
p.000030: the probability of manifestation of dis- ease with greater accuracy compared to medical testing. The degree
p.000030: of complexity of the evaluation of the results varies depending on individual case, and can be difficult even
p.000030: for experts. Therefore, the concern about the management of genetic data in life and health insurance is a legitimate
p.000030: one.
p.000030:
p.000030:
p.000030:
p.000030: 23 See Law 2496/1997, arts 189-225 Code of Commerce, 400/1970 (public supervision of insurance companies), p.d.
p.000030: 252/1996 (adaptation to relevant community law).
p.000030:
p.000031: 31
p.000031:
p.000031: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000031: REPORT
p.000031:
p.000031: 2. There are racial groups with greater incidence of certain genetic dis- orders; hence there is a risk of racial
p.000031: discrimination based on genetic data.
p.000031: 3. An extensive bioethical debate has developed with regard to access of insurance companies to the genetic data of the
p.000031: insured or of insurance ap- plicants. This debate mainly revolves around two axes: a fair calculation of risk based on
p.000031: the principle of reciprocity, on the one hand, and protection of personality from discrimination and stigmatization on
p.000031: the grounds of genet- ic data, on the other hand.
p.000031: 4. Another issue to consider is the fact that the management of genetic information with regards to access by insurance
p.000031: companies directly affects public support for genetic research. This has implications for the funding of research and
p.000031: the participation of volunteers in clinical trials, both indispen- sable to achieve progress in genetics. It mainly
p.000031: leads to avoidance of testing with injurious effects on the health of insurance applicants.
p.000031: 5. Greek legislation has not adopted specialised regulation for the use of genetic data in life and health
p.000031: insurance. Likewise no regulation exists for the operation of genetic laboratories that are the source of this
p.000031: information. In view of the above we recommend the adoption of special legislation ac- cording to the model
p.000031: followed by other countries. This legislation must strike a balance between the legitimate interests of
p.000031: the insurers and the insured guided by fundamental human rights.
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000031:
p.000032: 32
p.000032:
p.000032: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000032: REPORT
p.000032:
p.000032: SUGGESTED LITERATURE
p.000032:
p.000032: Andrews L (1987). Medical genetics: A legal frontier. American Bar Founda- tion, Chicago.
p.000032: Ashcroft, R (2007). Should genetic information be disclosed to insurers? No. BMJ 334, 1197.
p.000032: Bird TD (1999). Early-Onset Familial Alzheimer Disease. In: Gene Reviews at GeneTests: Medical Genetics Information
p.000032: Resource.
...

p.000120: study published in 1957 involv- ing 560 cancer patients and their families, the participants in their great ma- jority
p.000120: (87%) argued that patients should be informed that they suffer from cancer (Samp and Curreri, 1957). Subsequent
p.000120: research on multiple sclerosis (before any treatment became available) (Elian and Dean, 1985) and Alz-
p.000120: heimer’s disease (Erde et al., 1988) also reported an increasing wish among participants to know the truth about their
p.000120: condition (83% and 90% respec- tively). It should be noted, however, that different ethnic groups seem to
p.000120: hold divergent views. For example, a related study conducted in the US rec- orded significant variation on
p.000120: preferences of information among old pa- tients of declared Mexican or Korean origin as against patients of
p.000120: European or African (African-Americans) origin (Blackhall et al., 1995).
p.000120: In contrast to Anglo-Saxon and north-European countries, in southern and eastern European countries, as
p.000120: well as in Asian countries like China, Japan, etc., this change in the attitude of physicians on the
p.000120: disclosure of truth about the diagnosis of serious diseases has not taken place yet or, to say the least, the process
p.000120: of change has not been completed. According to the results of studies, a high percentage of physicians avoid
p.000120: disclosing the diagnosis of cancer (Thomsen et al., 1993; Mystakidou et al., 2004).
p.000120: At any rate, international literature on disclosure of the diagnosis of se- rious, chronic or/and incurable conditions
p.000120: suggests that the attitude of phy- sicians depends on the likelihood of social stigmatization, prejudice or par-
p.000120: ticular emotions (metaphysical or other) associated with a particular dis- ease, the availability of treatment
p.000120: and other relevant factors that may gen- erate a feeling of “powerlessness” in the physicians themselves with regard
p.000120:
p.000120:
p.000121: 121
p.000121:
p.000121: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000121: REPORT
p.000121:
p.000121: to the disease. For example, while the disclosure of truth in case of cancer has been almost universal since the late
p.000121: ’70s in the US, this was not the case with neural diseases such as multiple sclerosis (Elian M. and Dean G., 1985).
p.000121:
p.000121: b) The situation in Greece
p.000121: According to related surveys, the number of oncologists in Greece who disclose the truth to their patients
p.000121: (according to their own admissions) seems to have remained small (review by Mystakidou et al., 2005): 7%
p.000121: in 1980 (Manos and Christakis, 1980), 12.5% in 1986 (Dosios et al., 1986), 11%
p.000121: in 1996 (Mystakidou et al., 1996), 22% in 1999 (Mystakidou et al., 1999). Most surveys offer a choice
p.000121: between “almost or almost always” and “never or rarely” and their results do not vary through time. The
p.000121: comparison be- tween two surveys which offered the answer “sometimes”, however, re- veals a noticeable
p.000121: increase in the rate of physicians ticking this answer in recent research (20% in 1980, 78% in 1996).
p.000121: Thus, a change in the attitude of physicians appears to have taken place from the ’80s to the end of the ’90s in our
p.000121: country but this change does not involve all patients. It is revealing that most physicians declare that the ex- tent
...

p.000147:
p.000147: 1. General autonomy and public health: Restrictions and the risk of stigma- tization
p.000147:
p.000147: The legitimate objective of protection of the health of others sets the grounds for imposing restrictions on
p.000147: the general autonomy of those infect- ed, especially in regard to movement and social contact.
p.000147: This calls for a number of qualifications. Indeed, not all transmissible diseases justify the same
p.000147: restrictions. Distinctions are necessary between
p.000147:
p.000147:
p.000147:
p.000148: 148
p.000148:
p.000148: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000148: REPORT
p.000148:
p.000148: easily and less easily transmitted diseases as well as between mild and seri- ous diseases (influenza versus HIV, for
p.000148: example).
p.000148: Mild diseases, even when easily transmitted, do not justify such re- strictions to general autonomy; the same
p.000148: is true of serious diseases that are hard to contract. Of course, there are many variations of these
p.000148: combina- tions, which prevent the formulation of more specific rules of universal ef- fect.
p.000148: Restrictions to general autonomy can lead to unfair discrimination aris- ing from a kind of “stigmatization” which
p.000148: isolates patients -even if temporar- ily- from social life. Above all, this raises a wider ethical problem. Historical-
p.000148: ly, the stigma against population groups on public health grounds has been a recurring phenomenon, from the
p.000148: persecutions and massacres of Jews dur- ing the times of “Black Death” in the Dark Ages (the plague pandemic), to the
p.000148: persecution of beggars on the same grounds in the XIX century or of prostitutes for spreading syphilis in
p.000148: World War I, to contemporary practices of discrimination against AIDS patients. In our country, stigmatization phe-
p.000148: nomena occurred in the past in the cases of leprosy and tuberculosis.
p.000148: These facts demonstrate that public health is not to be considered only as a medical problem, but involves a serious
p.000148: social and political dimension. The latter must be taken into account when adopting restrictions to general autonomy.
p.000148: Such restrictions are not justified unless accompanied by social measures aimed at minimizing the likelihood of
p.000148: transmission (e.g. housing, food, etc. for the poor or disadvantaged groups of the population) and by steps ensuring
p.000148: fair treatment (not distinguishing, for example, between prostitutes and their clients regarding the risk
p.000148: of transmission of venereal diseases).
p.000148: The current wave of immigration carries great potential of stigma on public health grounds. The fact
p.000148: that the country of origin -particularly of illegal immigrants- is often afflicted by a high prevalence
p.000148: of infectious dis- eases (especially sub-Saharan Africa and southern Asia), while local health services
p.000148: remain rudimentary, represents a real cause of concern for the spreading of these diseases in the
p.000148: hosting countries. However, stigmatiza- tion practices -unfair treatment, “ghettos” etc.- stem rather from the idea
...

p.000208: gene have no advantage with a certain
p.000208:
p.000208:
p.000209: 209
p.000209:
p.000209: DIRECT-TO-CONSUMER GENETIC TESTING
p.000209: REPORT
p.000209:
p.000209: treatment, while people with two copies of the gene demonstrate a slow progress of the disease under the same
p.000209: treatment.
p.000209: Genetic testing for health reasons involves medical, psychological or fi- nancial risks, both for the individual and
p.000209: his/her family:
p.000209: 1. Genetic tests that include sample collection of saliva, buccal mucosa swabs or blood do not involve
p.000209: physical risks for the individual. This is not however the case for prenatal genetic screening, where e.g.
p.000209: in amniocentesis the risk of miscarriage is 1 in 200-400 cases.
p.000209: 2. False positive results can cause anxiety and further unnecessary medical examinations and treatments.
p.000209: 3. False negative results cause complacency to the person or delay the diagnosis and treatment.
p.000209: 4. The results of a genetic test can affect serious decisions over a person’s life, e.g. if high risk for
p.000209: a disease is confirmed, then the person’s decision to have children may be affected. Or in the case where the genetic
p.000209: test detects a mutation that can cause breast cancer, the person might undergo a total mastectomy as an
p.000209: extreme measure of prevention.
p.000209: 5. In case of a positive result, there is always the risk of stigmatization, refusal of
p.000209: providing him/her private insurance and work.
p.000209: 6. In case of a positive result, the psychological stress imposed on the individual is severe, causing
p.000209: worries, uncertainty, confusion and, probably, despair. These consequences expand to other members of the
p.000209: family, as it is a hereditary disease.
p.000209: 7. The above (1-6) are also combined with the cost of genetic tests, which usually burdens the individual and/or
p.000209: his/her family.
p.000209:
p.000209: THE DIMENSION OF ETHICS
p.000209:
p.000209: The above mentioned highlight the main problem, which is the possibil- ity of misleading the average citizen about both
p.000209: the quality of specific ser- vices and the value of genetic tests in general.
p.000209: The Commission has repeatedly underlined the danger of overestimating the association of genetic data with a person’s
p.000209: health (Hellenic National Bio-
p.000209:
p.000209:
p.000210: 210
p.000210:
p.000210: DIRECT-TO-CONSUMER GENETIC TESTING
p.000210: REPORT
p.000210:
p.000210: ethics Commission 2006: Opinion on Human Biobanks par. 2a; Hellenic Na- tional Bioethics Commission 2008: Opinion on
p.000210: Genetic Data in Private Insur- ance par. 3b).
p.000210: It is sufficient, at this point, to note that although the genetic causes of many serious complex diseases have
p.000210: been detected, these reveal nothing more than mere “predisposition”. In order to develop a complex
...

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p.000148: transmission (e.g. housing, food, etc. for the poor or disadvantaged groups of the population) and by steps ensuring
p.000148: fair treatment (not distinguishing, for example, between prostitutes and their clients regarding the risk
p.000148: of transmission of venereal diseases).
p.000148: The current wave of immigration carries great potential of stigma on public health grounds. The fact
p.000148: that the country of origin -particularly of illegal immigrants- is often afflicted by a high prevalence
p.000148: of infectious dis- eases (especially sub-Saharan Africa and southern Asia), while local health services
p.000148: remain rudimentary, represents a real cause of concern for the spreading of these diseases in the
p.000148: hosting countries. However, stigmatiza- tion practices -unfair treatment, “ghettos” etc.- stem rather from the idea
p.000148: of “miasma” due to lack of information or misinformation about the medical- biological particulars of disease,
p.000148: especially infectivity. Hansen’s disease (lep- rosy) and, more recently, HIV/AIDS confirm this observation
p.000148: since these
p.000148:
p.000148:
p.000149: 149
p.000149:
p.000149: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000149: REPORT
p.000149:
p.000149: population groups are stigmatized, although the disease is relatively difficult to contract.
p.000149: In case of Hansen’s disease, the exact path of transmission is still un- known, but it is accepted
p.000149: that although it can be contracted through pro- longed social contact, approximately 95% of the population are
p.000149: immune to it, though the mechanisms of immunity have not been identified. Perhaps it was this last parameter in
p.000149: combination with the deformity caused by the disease that has led to social stigma against these patients in the
p.000149: past.
p.000149: In case of HIV/AIDS, the path of transmission is known and involves ex- posure to body fluids through sexual
p.000149: intercourse or the transfusion of con- taminated blood or use of a contaminated needle. The virus can also
p.000149: be transmitted to the fetus by the mother. Mere social contact with patients or seropositives does not constitute a
p.000149: risk of transmission. Despite this, espe- cially in the early years since the appearance of the disease, but even
p.000149: today, seropositives are treated with far greater caution, even prejudice, than is justified by medical
p.000149: fact. Apart from the severity of the disease, which meant near certainty of death in the beginning,
p.000149: whereas now there are available treatments, prejudice emanates from the fact that, initially, the disease
...

Searching for indicator union:

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p.000001:
p.000001:
p.000001:
p.000001:
p.000001: Published by the Hellenic National Bioethics Commission
p.000001:
p.000001: Neofytou Vamva 6, P.C. 10674, Athens
p.000001: Tel.: (+30) 210-8847700
p.000001: Fax: (+30) 210-8847701
p.000001: E-mail: secretariat@bioethics.gr www.bioethics.gr
p.000001:
p.000001: © 2014 Hellenic National Bioethics Commission Printed by National Printing Office 2014
p.000001:
p.000001: Edited by: Dr. Vasiliki Mollaki
p.000001:
p.000001:
p.000002: 2
p.000002:
p.000002:
p.000002: PREFACE
p.000002:
p.000002: The Hellenic National Bioethics Commission was established in 1998 and, according to the founding Law (Law 2667/1998),
p.000002: is an independent advisory body of experts addressed to the Prime Minister, on matters within its com- petence.
p.000002: The biomedical advances that occurred during the last decades are, in- deed, particularly impressive and
p.000002: necessitated the operation of similar Committees, which are in position to answer critical questions that
p.000002: arise from the application of novel invasive methods and pose ethical dilemmas on matters of biology, genetics,
p.000002: biotechnology and medical sciences, as well as to inform the public on bioethical issues.
p.000002: During its operation and after an exchange of views and deep reflection, the Hellenic National Bioethics Commission
p.000002: issued more than 30 Opinions based on relevant Reports by the Scientific Associates Dr. T. Vidalis, Dr. V.
p.000002: Mollaki, Dr. S. Lymperi, Dr. A. Hager-Theodoridou and Dr. K. Manolakou, under the secretarial support of Ms.
p.000002: M. Drakopoulou, whom I thank warmly.
p.000002: The Commission is responsible to:
p.000002: 1. Coordinate similar subcommittees at a national level.
p.000002: 2. Collaborate with similar Committees of the European Union but also internationally.
p.000002: 3. Address Opinions to various public authorities upon request.
p.000002: In addition, depending on the matter examined in each case, the Com- mission took into consideration the views
p.000002: of outstanding scientists from different fields, who were invited. The Commission wishes to thank these
p.000002: scientists for their willing response.
p.000002: During its first Presidency (2000-2007), the Commission published the first volume of Opinions and Reports, in
p.000002: Greek and English. The book in hand comprises the second volume, with the Opinions and Reports from 2008-
p.000002: 2013. The entire collection of Opinions and relevant Reports is included in approximately 725 pages of these two
p.000002: volumes (“Reflections on Contempo- rary Issues, Opinions and Reports 2000-2007” and “Reflections on Contem- porary
p.000002: Issues, Opinions and Reports 2008-2013”).
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: The reader will have the chance to find that the 286 pages of the current edition include 9 issues of high interest,
p.000003: which concern the modern society.
p.000003: The current edition was edited by Dr. Vasiliki Mollaki, whom we thank.
p.000003:
p.000003:
p.000003: The President Ioannis D. Papadimitriou Emeritus Professor of Medicine
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004:
p.000004: CONTENTS
p.000004: USE OF GENETIC DATA IN PRIVATE INSURANCE 7
...

p.000048: and Social Protection, i) Health and Social Solidarity, j) Rural Development and Foodstuffs, k) Justice, l) Culture and
p.000048: m) Transport and Com- munication.
p.000048:
p.000049: 49
p.000049:
p.000049: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000049: REPORT
p.000049:
p.000049: management of actions in basic research, applied-technological research and innovation”2. In practical
p.000049: terms, EOET’s task is to support research through the management of public funds mainly in order to finance
p.000049: research projects to be carried out in national research institutions following call opening and evaluation
p.000049: of submitted proposals. The proposals will be peer reviewed by Greek or foreign scientists of international acclaim.
p.000049: EOET was established by Law 3653/21.3.2008 and was still inoperative at the time the present report was drawn up.
p.000049: Again, the law does not provide for a separate council dedicated to biological research.
p.000049: Despite their dependence on public funds, Universities and Research Centres can determine the orientation of
p.000049: their research activity by appoint- ing staff with desirable research interests and by raising non-public funds for
p.000049: research. According to data from the GSRT, the major source of non- government funding for Greek research
p.000049: centres comes from abroad, mainly the European Union.
p.000049:
p.000049: b. Financing
p.000049: The biggest provider of funds for public research in Greece is the state. In 2005, 47% of the expenditure was met with
p.000049: public funds, 31% of funds for research originated from the industry and 19% from abroad (Table 2). Re- search in
p.000049: Public Research Centres and Higher Education Institutions is fi- nanced mainly with public funds or funds
p.000049: from abroad while the domestic private sector contributes very little (Table 2).
p.000049: The largest part of foreign funding is absorbed by public research centres and universities. Research in the
p.000049: private sector absorbs one third of the overall funds most of which is self-financing. Public research
p.000049: absorbs ap- proximately 67% of the overall funds allocated for research (Table 3).
p.000049: Compared to the respective European Union average Greece spends a smaller share of its Gross Domestic
p.000049: Product (GDP) for research (0.7% as against 1.9%) whereas the contribution of the industry is even smaller (30%
p.000049: compared to 55%). The goal for 2010 is to increase the share of GDP for re- search and the contribution of the private
p.000049: sector (Table 4).
p.000049:
p.000049:
p.000049:
p.000049: 2 Article 19 (2) Law 3653 OJ A’ 49/21.3.2008: Statutory framework of science and technology and other
p.000049: stipulations (Law of Parliament, 2008).
p.000049:
p.000050: 50
p.000050:
p.000050: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES REPORT
p.000050:
p.000050: Table 2. Financing of research in Greece per source of financing and research centre. Source: GSRT, gross domestic
p.000050: expenditure for research & technological develop- ment, break-down according to source.
p.000050:
p.000050:
p.000050: Financing of Research in Greece
p.000050:
p.000050: Research Centre Total
p.000050:
p.000050:
p.000050: Source of funding
p.000050:
p.000050: Private Sector
p.000050: Public Research Centres
p.000050: Higher Education Institutions
p.000050: Non-Profit Private Re- search Centres
p.000050: Private Sector 85.4% 1.3% 8.9% 2.1% 31.0%
p.000050: State 6.3% 68.1% 65.6% 9.6%
p.000050: 47.0%
p.000050:
p.000050: Higher Education Institutions
p.000050: Non-Profit Pri- vate Research Centres
p.000050:
...

p.000056: Not only is private financing seen as welcome but the increase of private funding figures among the goals of most
p.000056: national policies for research and technology worldwide (European Commission, 2007a). It has promoted pro- gress in
p.000056: science and technology and has often made up for the inability of the state to provide adequate funds to all scientific
p.000056: fields. The decoding of
p.000056:
p.000056:
p.000057: 57
p.000057:
p.000057: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000057: REPORT
p.000057:
p.000057: the human genome, for instance, was made possible by a partnership of private and public bodies.
p.000057: The source of financing, however, can affect the validity of research find- ings especially if the sponsor has a
p.000057: vested interest in the outcome of the research. One example is clinical trials financed by pharmaceutical compa-
p.000057: nies. It has been reported that trials of new drugs used in oncology and fi- nanced by the pharmaceutical company which
p.000057: is going to produce the drugs are eight times more likely not to reach negative results compared to inde- pendently
p.000057: funded trials (Friedberg et al., 1999). Similar cases of manipulated research have been reported in other clinical and
p.000057: epidemiological trials in- cluding the notorious example of research manipulated by the tobacco in- dustry (Tong and
p.000057: Olsen, 2005; Lesser et al., 2007). Public sources of financ- ing can also be interventionist. The “Union of
p.000057: Concerned Scientists” has a list of cases of government intervention to conceal or manipulate research findings for
p.000057: political reasons.
p.000057: To give the problem its real dimensions, according to US data on re- search conducted by publicly
p.000057: funded agencies, in the last 200 years there have been 200 cases of confirmed misconduct (Resnik, 2007).
p.000057: This figure which represents approximately 0.01% of the entire research community for this period probably
p.000057: underestimates reality but implies that such phenome- na and specific cases of deliberate fraud are relatively limited.
p.000057: This, howev- er, does not mean that the problem does not require serious consideration. As the above examples
p.000057: demonstrate, the validity of biological research has a direct impact on society and often affects public health
p.000057: directly. The exist- ence of and compliance with recognized code of ethics is important not only in order to defend the
p.000057: safety and the rights of volunteers or lab animals. It is also required to ensure the quality of the results, to
p.000057: maintain public support for research, to achieve accountability to society -the source of funds- and for the
p.000057: harmonious and effective co-operation between researchers (Resnik, 2007).
p.000057: To deal with serious issues of research ethics like those mentioned above and in recognition of the
p.000057: significance of educating researchers in eth- ical topics, international scientific societies, universities and
...

p.000062: proper conduct of epidemiological re- search.
p.000062: Law 3536/21.3.2008: Statutory Framework for research and technology and other stipulations. Official Journal of the
p.000062: Greek Government.
p.000062: Lesser LI, Ebbeling CB, Goozner M, Wypij D, Ludwig DS (2007). Relationship between funding source and conclusion
p.000062: among nutrition-related scientific articles. PLoS Med 4, e5.
p.000062: Parascandola M (2005). Science, industry, and tobacco harm reduction: A case study of tobacco industry
p.000062: scientists' involvement in the national cancer institute's smoking and health program, 1964-1980. Public Health
p.000062: Reports 120, 338-349.
p.000062: Resnik DB (2007). What is ethics in research and why is it important? Na- tional Institute of
p.000062: Environmental Health Sciences.
p.000062: Resnik DB, Shamoo AE, Krimsky S (2006). Fraudulent human embryonic stem cell research in South Korea: Lessons learned.
p.000062: Account Res 13, 101-109.
p.000062:
p.000063: 63
p.000063:
p.000063: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000063: REPORT
p.000063:
p.000063: Rosenstock L and Lee LJ (2002). Attacks on science: The risks to evidence- based policy. American Journal
p.000063: of Public Health 92, 14-18.
p.000063: Shamoo AE and Resnik DB (2002). Responsible conduct of research. Oxford University Press.
p.000063: Tong S and Olsen J (2005). The threat to scientific integrity in environmental and occupational medicine.
p.000063: Occupational and Environmental Medicine 62, 843-846.
p.000063: Union of Concerned Scientists. Scientific integrity, Political interference.
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000063:
p.000064: 64
p.000064:
p.000064:
p.000064:
p.000064:
p.000064:
p.000003: 3
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: MANAGEMENT OF BIOLOGICAL WEALTH
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000065: 65
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000065:
p.000066: 66
p.000066:
p.000066: MANAGEMENT OF BIOLOGICAL WEALTH
p.000066: OPINION
p.000066:
p.000066: O P I N I O N MANAGEMENT OF BIOLOGICAL WEALTH
p.000066: The National Bioethics Commission discussed at several meetings the
p.000066: ethical aspects of biological wealth management issues that need to be con- sidered as priorities by any modern
...

p.000079: departments and faculties of biological, agricultural or environmental orientation, the research institutes of the
p.000079: Na- tional Agricultural Research Foundation (NAGREF), the Hellenic Centre for Marine Research, the Institute
p.000079: of Marine Biology of Crete, the Benakeion Phytopathological Institute, NGOs like the Hellenic Zoological
p.000079: Society, the Hellenic Ornithological Society, the Goulandris Natural History Museum, WWF, Greenpeace,
p.000079: Arctouros, etc. (Legakis et al., 1998). Apart from gener- ating primary knowledge, however, it is necessary to
p.000079: systematize and use it to elaborate a protection strategy in practice.
p.000079: Despite the significant biodiversity of our country, or perhaps because of it, there are significant knowledge gaps in
p.000079: the biological (life cycles), ecologi- cal (demands of habitats) and population (size and fluctuation) characteris-
p.000079: tics of fauna and flora species. These knowledge gaps make the protection of biodiversity an arduous task. There
p.000079: is also a lack of systematization of existing knowledge into readily accessible format (data bases) that
p.000079: can be put to good use and could be further expanded.
p.000079: With the explosion of genetics and biotechnology, field studies of flora and fauna has been sidelined for
p.000079: various reasons. Today, however, it has become apparent that there is not enough field knowledge and a conscious
p.000079: change of direction is needed. This is not so easy because the “naturalists” are threatened by extinction. The funding
p.000079: of relevant actions by the Europe- an Union is expected to provide a first incentive to revive ecological
p.000079: field studies.
p.000079: More than 100 scientists worked together successfully to compile an inventory of the areas of our country that
p.000079: meet the requirements for inclu- sion in the NATURA 2000 network because of the existence of habitat types and habitats
p.000079: of species that qualify for protection (under the European di-
p.000079:
p.000079:
p.000080: 80
p.000080:
p.000080: MANAGEMENT OF BIOLOGICAL WEALTH
p.000080: REPORT
p.000080:
p.000080: rective 92/43/EC) and to draw up a national “Scientific List”1. Unfortunately, this network of scientists was not
p.000080: put to further use. To comply with the obligations assumed by our country for the protection of
p.000080: biodiversity (by ratifying the Community directive 92/43 on habitats), the National Commit- tee “Nature” was set
p.000080: up in 20032. Its mission is to coordinate protection activities for conserved areas and could become the
p.000080: coordinator of the na- tional strategy for research in the field. A lack of funds, however, has led the Committee to
p.000080: inactivity. Recently, the General Secretariat for Research and Technology (GSRT) launched a call for tender to award
p.000080: the coordination of research in national biodiversity in the framework of EU action “LIFEWATCH: Science and Technology
p.000080: Infrastructure for Biodiversity Data and Observato- ries”.
p.000080:
p.000080: SECOND CHAPTER
p.000080:
p.000080: THE ETHICAL-SOCIAL DIMENSION
p.000080:
p.000080: In our culture, the management of biological wealth is mainly associated with three factors that set the ethical-social
...

p.000089: environmental denomination in Greece is particularly important for raising awareness among citizens and
p.000089: bringing pressure to bear on governments.
p.000089: After the devastating fires of 2007 and their tragic toll there is a sharp increase in the number of volunteers
p.000089: and the quality of volunteer activity and activism (as estimated by the WWF). A great number of NGOs are oper-
p.000089: ating in our country7 which are either wide in scope (e.g. WWF, Greenpeace, etc.) or focus on the protection of
p.000089: specific species or areas (Arctouros, Callis- to, etc.).
p.000089:
p.000089: The attitude of Government
p.000089:
p.000089: I. National policies on the protection of biodiversity
p.000089:
p.000089: In our country, environmental policy-making in general is coordinated by the Ministry for the Environment,
p.000089: Land Planning and Public Works (YPEHODE).
p.000089:
p.000089: 7 A full list of environmental NGOs is available on the website of the Ministry for the Environment. It was compiled by
p.000089: the National Centre for Social Research (EKKE) in the context of a related study that was funded by the Ministry for
p.000089: the Environment at the following address: http://www.minenv.gr/3/33/332/33201/3320113/g3320113_0.html.
p.000089:
p.000090: 90
p.000090:
p.000090: MANAGEMENT OF BIOLOGICAL WEALTH
p.000090: REPORT
p.000090:
p.000090: The coexistence of the environment and public works under the same roof is a singular case among the
p.000090: countries of the European Union. The gov- ernments of all the other member-states have independent Ministries
p.000090: for the environment sometimes including departments of rural development, fisheries or public health. This
p.000090: coexistence and the place assigned to the environment as against the other responsibilities of the
p.000090: Ministry through time tell a long story about the place of the environment in the hierarchy of governmental priorities
p.000090: as a whole.
p.000090: Within the YPEHODE, environmental policy is the remit of the General Division of the Environment which
p.000090: is headed by the Vice-Minister for the Environment. Environmental policy-making is assisted by the National Cen-
p.000090: tre for the Environment and Sustainable Development (EKPAA). The Opera- tional Program “Environment” and Sustainable
p.000090: Development (EPPERAA) for 2007-2013 outlines the objectives and the governmental strategy for the environment.
p.000090: These goals include issues of biodiversity protection.
p.000090: The Ministry for Agricultural Development and Foodstuffs (YAAT) shares in a great deal of the implementation of
p.000090: environmental policy for it is re- sponsible for laying down the rules for agricultural activity and for supervis-
p.000090: ing their implementation.
p.000090: Perhaps the main vehicle of environmental policy in agricultural produc- tion is Multiple Compliance8, a principle that
p.000090: obliges farmers to take specific measures of environmental protection to qualify for subsidies. The YAAT has also
p.000090: issued codes of Good Agricultural Practice9 which include measures for the protection of the environment and
...

p.000090: http://www.minagric.gr/greek/EPAA/INDEX%201/INDEX%201.htm.
p.000090:
p.000091: 91
p.000091:
p.000091: MANAGEMENT OF BIOLOGICAL WEALTH
p.000091: REPORT
p.000091:
p.000091: tal impact assessments to qualify as such. The products that meet the re- quirements of integrated
p.000091: management or biological farming are certified by accredited bodies. AGROCERT, the Organization of Certification and
p.000091: Supervi- sion of Agricultural Products issues specifications and supervises the certifi- cation procedure through the
p.000091: accreditation and supervision of certification bodies. The products which meet the requirements of integrated
p.000091: manage- ment receive the label AGRO and the products of biological agriculture re- ceive a similar label by accredited
p.000091: certification bodies10.
p.000091:
p.000091: II. Participation in supranational and international policy-making
p.000091:
p.000091: On the whole, our national environmental policy follows mainly the Di- rectives of the EU with no particular
p.000091: innovations or initiatives.
p.000091: Greece participates in European and other international actions on the protection of biodiversity, inter alia the
p.000091: NATURA 2000 network and the United Nations Environmental Program-Mediterranean Action Plan.
p.000091:
p.000091: a. Natura 2000 network
p.000091:
p.000091: Since the beginning of the XX century, Greece has placed certain areas of particular natural beauty or ecological
p.000091: importance under protection (mainly national reserves). The most important and systematic intervention for the
p.000091: preservation of biological wealth in recent years was envisaged by the Euro- pean Union through the aforementioned
p.000091: directives on the protection of biodiversity and the creation of the network of protected areas Natura
p.000091: 2000.
p.000091: Areas of particular “ecological value” have been mapped in the frame- work of this network, i.e. sites
p.000091: offering suitable environmental conditions for supporting certain species have been delimitated and designated as
p.000091: pro- tected areas. These sites are placed under special status and the activities allowed within are decided based
p.000091: on the protection of their specific ecologi- cal value. The aim of the EU is to stop the reduction of biodiversity in
p.000091: mem- ber-states by 2010.
p.000091:
p.000091:
p.000091: 10 Detailed lists of certification bodies and agricultural consultants are available on the website of the OPEGEP:
p.000091: http://www.agrocert.gr.
p.000091:
p.000092: 92
p.000092:
p.000092: MANAGEMENT OF BIOLOGICAL WEALTH
p.000092: REPORT
p.000092:
p.000092: b. Action Plan for the Mediterranean
p.000092:
p.000092: The conservation of Mediterranean ecosystems is paramount given that the environmental changes caused by human activity
p.000092: in this area are more dramatic than in any other area on the planet (Groves, 1998).
p.000092: Due to the importance of Mediterranean ecosystems, 16 Mediterranean countries and the European Union adopted the United
p.000092: Nations Environmen- tal Program-Mediterranean Action Plan (UNEP-MAP) in 1975 which was ini- tially aimed at the
p.000092: protection of the Mediterranean Sea from pollution. To- day 21 countries and the EU participate in the Action Plan. The
p.000092: activities of the program were extended to the integrated management of problems in coastal development zones with the
p.000092: aim to study problems and assist gov- ernments to make environmentally-friendly policies.
p.000092:
p.000092: FIFTH CHAPTER CONCLUSIONS - PROPOSALS
p.000092: General environmental policy and protection of biodiversity A Ministry for the Environment
p.000092:
p.000092: The European Union and the Greek Parliament have recognized the envi- ronment as an area of independent policy-making,
p.000092: the former by appointing a Commissioner for the Environment and the latter by setting up a Special Standing Committee
p.000092: for the Protection of the Environment. By contrast, the government has no independent Ministry for the
p.000092: environment as men- tioned earlier.
p.000092: The advantage of accommodating the current Vice-Ministry for the Envi- ronment and Land Planning in the YPEHODE is that
p.000092: it belongs to a powerful Ministry. The disadvantage is that the sector of public works has always pre- vailed in
p.000092: practice and continue to override the priorities of the Ministry.
p.000092: According to one argument, a separate Ministry for the Environment may rank low in government priorities and
p.000092: thus undermine the efficacy of initia- tives. This is not a convincing argument for it fails to consider that, already
p.000092: on the symbolic political level, environmental protection now strongly af- fects the political behaviour
p.000092: of both citizens and politicians themselves.
p.000092:
p.000092:
p.000093: 93
p.000093:
p.000093: MANAGEMENT OF BIOLOGICAL WEALTH
p.000093: REPORT
p.000093:
p.000093: With this in mind, the possibility to take initiatives that will no longer con- flict with other interests in the same
p.000093: Ministry, and a clearly defined respon- sibility for the Minister inside the cabinet must be evaluated. Taking all that
p.000093: into account, the creation of an independent Ministry for the Environment calls for immediate consideration.
p.000093:
...

p.000256:
p.000257: 257
p.000257:
p.000257: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000257: REPORT
p.000257:
p.000257: 3. The law
p.000257:
p.000257: Especially for equipment that requires interventions in the organism of the person concerned, the legislation
p.000257: about medical products (Directive 93/42, incorporated by JMD DY8d/GP. οik.130648/2.10.2009, Directive
p.000257: 90/385, incorporated by JMD DY8d/GP. oik.130644/2.10.2009) contains provisions for secure application of
p.000257: implants. Therefore, it also involves the technological interventions that aim, for example, at the
p.000257: musculoskeletal support.
p.000257:
p.000257: ΙV. Prolongation of life
p.000257:
p.000257: 1. The data
p.000257:
p.000257: The idea of longevity or eternal youth has always been fascinating for mankind, regardless of the era,
p.000257: culture and religion. This interest derives mainly from man’s fear about the diseases presented in old
p.000257: age but also from the death itself, as well as the quest for youth. It is a fact that, the best social and economic
p.000257: living conditions as well as better medical care increase the average lifespan of humans.
p.000257: Over the past two centuries, human life expectancy is more than dou- bled, from 25 years to 65 for men and
p.000257: 70 for women, while some estimate that for some populations this number will reach 100 years in six decades (Oeppen
p.000257: and Vaupel, 2002). In the European Union particularly, life expec- tancy has risen by an average of 10 years over the
p.000257: last fifty years6. According to statistics in 2009, the average life expectancy in the EU of 27 states is
p.000257: 79.4 years (76.4 for men and 82.4 for women). In Greece, the average age is
p.000257: 80.2 years for the total population (77.8 for men and 82.7 for women). But why this constant increase in life
p.000257: expectancy?
p.000257: Genetic factors, such as the HLA-DRw9 and HLA-DR1 alleles in the Japa- nese population (Takata et al., 1987) and the e4
p.000257: allele of the APOE gene in Finnish (Schachter et al., 1994) and the French population (Louhija et al.,
p.000257: 1994), are associated with increased life expectancy.
p.000257:
p.000257: 6 Eurostat. Mortality and life expectancy statistics. Data from October 2011.
p.000257: http://epp.eurostat.ec.europa.eu/statistics_explained/index.php/Mortality_and_life_ expectancy_statistics.
p.000257:
p.000258: 258
p.000258:
p.000258: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000258: REPORT
p.000258:
p.000258: Environmental factors, such as smoking, alcohol consumption and diet have not been proven to reduce the average
p.000258: life expectancy but their effect on the development of diseases, such as cancer and cardiovascular disease indirectly
p.000258: reduces life expectancy. In addition, the way the social status, wealth and educational level can affect
p.000258: life expectancy, is not clear (Chris- tensen & Vaupel, 1996).
p.000258: Demographic and geographical studies showed that the increase in life expectancy is, in part, due to the advances in
...

Searching for indicator trauma:

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p.000015: professional with appropriate training and expertise in the field of medicine involved”. Based on the definition of
p.000015: genetic testing, personal genetic information is the information that is generated by genetic testing. However, here
p.000015: as well the limits are unclear as some authors, for instance the GINA Bill of Law, include in an individual’s genetic
p.000015: information data from genetic testing and the manifestation of genetic diseases in family members. Genetic testing is
p.000015: carried out for a variety of reasons such as the diagno-
p.000015: sis of an already manifested disease, prenatal control or to determine genet- ic predisposition to specific disorders.
p.000015: The first two applications are not rel- evant to this report. Here, we are interested in genetic testing that
p.000015: identifies increased risk of disease manifestation in healthy, asymptomatic individuals. Genetic tests are also
p.000015: extremely useful in pharmacogenetics and in person- alized medicine1.
p.000015: Genetic and environmental factors interact in the development of dis- ease by creating a spectrum (Figure 1),
p.000015: with the so-called genetic or heredi- tary diseases associated with exclusively genetic causes (like β-thalassaemia) at
p.000015: the one end and diseases with exclusively environmental (external) caus-
p.000015:
p.000015: 1 See par. 1(C): The value of genetic information for personal health and scientific progress and the
p.000015: potential of genetic testing.
p.000015:
p.000016: 16
p.000016:
p.000016: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000016: REPORT
p.000016:
p.000016: es (like trauma) at the other end. The causes of most human pathological conditions, however, lie
p.000016: somewhere in-between, i.e. it is a combination of genetic and environmental factors that leads to
p.000016: manifestation of disease, such as diabetes or cardiovascular diseases.
p.000016: Depending on their genetic basis, genetic diseases are divided in (i) sin- gle-gene2, (ii) polygenic3, and, (iii)
p.000016: mitochondrial4 (Human Genome Project Information5). A gene’s disease-causing mutation is either dominant or re-
p.000016: cessive if one or two mutated alleles are required respectively for the mani- festation of the disease. Finally,
p.000016: the likelihood of disease depends on the penetrance6 of the allele. The evaluation of the results of a genetic
p.000016: test de- pends directly on the category of genetic disease for which the test is taken. In general, the evaluation of
p.000016: genetic testing results for single-gene diseases is simpler as compared with multifactorial diseases.
p.000016: The genetic disorders relevant to the present report are those manifest- ed after an application for insurance has been
p.000016: made, so usually after infan- cy. Genetic tests potentially of value to health and life insurance are those that can
p.000016: contribute to determining the insured risk, i.e. those able to detect mutations which are well-documented to be
p.000016: associated with a specific dis- ease(s) and their penetrance is known so that, based on the outcome of the genetic
p.000016: test, it is possible to determine the likelihood of manifestation of the disease.
p.000016: According to the reliable network GeneTests, as of today (data accurate on 4/10/2007) there are 1.175 genetic
...

Searching for indicator victim:

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p.000125: measles cost Britain an average of 100 casualties annually. In 1988 the rate of participation in mass vaccination was
p.000125: 76%. The launching of the triple vaccine that year in replacement of the three separate ones increased the rate of
p.000125: participation to 91% until 1998. At that moment, however, fears began to spread about side-effects; autism in
p.000125: particular. Although the vaccine had been tested for many years and there was no data commonly accepted by the
p.000125: scientific community suggesting any side effects, certain studies published by a medical researcher undermined the
p.000125: confidence of parents and participation in the vaccination program dwindled significantly after 1998. The study
p.000125: which supported the allegations of some parents about side effects proved fallacious; in fact, it contained
p.000125: fabricated data. The slump in participation rates, however, led to the loss of the so-called indirect or herd
p.000125: immunity causing an important increase in measles cases before confidence in the vaccine was restored and broad
p.000125: par- ticipation resumed (Jansen et al., 2003).
p.000125: Whereas in case of tested vaccines, the decision to abstain is not ethical- ly neutral, the example of new and
p.000125: insufficiently tested vaccines is different. The experience of mass vaccination against swine influenza in the
p.000125: US in 1976 illustrates the risks inherent in a reckless decision for extended vac- cination based on
p.000125: unfounded, as it proved, fears of a pandemics, and with inadequately tested vaccines at that. While the influenza
p.000125: claimed only one victim, the side effects from the vaccine caused 25 casualties and may have led to permanent damage
p.000125: (it was associated with the auto-immune syn- drome of Guillain-Barré). Such examples justify the reluctance to
p.000125: participate and the ethical duty to society as a whole cannot remain as strong if weighed against an
p.000125: increased likelihood of unknown side-effects from the vaccine.
p.000125:
p.000125: 5. Patients in hospitals - The case of ICUs
p.000125:
p.000125: Implementing the model of consent in hospitals is met with certain limits to patient autonomy.
p.000125: First of all, the hospitalized patient is situated in a public environment which does not allow full freedom
p.000125: of movement, expression and communi- cation while drastically restricting privacy and family life. In these
p.000125: circum-
p.000125:
p.000125:
p.000126: 126
p.000126:
p.000126: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000126: REPORT
p.000126:
p.000126: stances, patients are particularly vulnerable. Especially in the ICU, these re- strictions are much more
p.000126: encroaching; moreover, patients are under psy- chological stress due to their critical condition. Taking into
p.000126: account that the potential for a sober appraisal of the situation by the patient -and in exten- sion, for a rational
p.000126: decision on the course of treatment- is significantly cur- tailed by the hospital environment, the role of the medical
p.000126: and nursing staff becomes even more decisive.
...

Searching for indicator abuse:

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p.000250: list are:
p.000250: 1. The potential of the substance or method to enhance athletic performance.
p.000250: 2. The use of the substance or method represents an actual or potential health risk to the athlete.
p.000250: 3. The use of the substance or method violates the spirit of sport.
p.000250: If two of the three criteria are met then the substance or method is classified as prohibited. None of
p.000250: the three criteria alone is considered sufficient to establish a substance or method as prohibited.
p.000250: Although doping via drugs is systematically being checked and reviewed on a regular basis by the relevant
p.000250: international and national organizations since the 1960s, other novel technologies/methods are difficult issues
p.000250: for the anti-doping authorities.
p.000250: For example, the following may constitute enhancement of the athletic performance:
p.000250:
p.000250: i) The application of genetic technologies in athletes, such as gene therapy or gene transfer
p.000250:
p.000250: Enhancement of athletic performance by using genetic technologies is a relatively recent issue needed to be
p.000250: considered by the competent anti- doping authorities, which treat genetic interventions as a form of
p.000250: doping. The modification or intervention of genetic material is a promising method of treatment which could be very
p.000250: useful for Medicine in the future. Poten- tially, however, it is possible to abuse such methods in order to
p.000250: enhance athletic performance. Normal genes or segments of genetic material could be transferred to athletes to
p.000250: enhance the function of normal cells or to overexpress specific genes.
p.000250:
p.000250:
p.000250: 3 WADA, World anti-doping Code, 2009.
p.000250: http://www.wada-ama.org/Documents/World_Anti-Doping_Program/WADP-The- Code/WADA_Anti-Doping_CODE_2009_EN.pdf.
p.000250:
p.000251: 251
p.000251:
p.000251: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000251: REPORT
p.000251:
p.000251: Genetic manipulations can be applied in two types of cells:
p.000251: Somatic cells. Altering the genetic material in somatic cells involves only the organisms where the
p.000251: changes are made -in that case the athlete-, and such modifications are not inherited in the subsequent
p.000251: generations.
p.000251: For example, genes could be altered in somatic cells in order to create or modify muscles to become stronger.
p.000251: The insulin-growth factor helps the muscles to develop and restore injuries. Experimen- tally, the genes expressing
p.000251: insulin-growth factor can be transferred via a viral vector in mice, promoting muscle growth (Barton-Davis et al.,
p.000251: 1998). Although this specific research was conducted with the aim to treat diseases such as muscular
p.000251: dystrophy, the results could be used to enhance the muscle mass of athletes.
p.000251: Erythropoietin is also a characteristic example, which is used to enhance the strength of patients who are
p.000251: under chemotherapy and present with anemia. Athletes receive injections of erythropoietin to enhance their athletic
p.000251: performance, but they could also go under gene transfer to receive the same gene and produce more red blood cells
p.000251: (Svensson et al., 1997).
p.000251: Germ cells. Genetic modifications in the genetic material of germ cells, namely gametes, are inherited by the
p.000251: offspring.
p.000251: For example, the genes that produce insulin-growth factor may be modified in such a way that they are
p.000251: overexpressed. Parents will pass these genes on to their children who will be born with an ad- vantage in
p.000251: their muscle growth.
p.000251: Although the use of such genetic technologies is not possible at present, concerns are being expressed about the
p.000251: possibilities that will be available to create “super-athletes” in the future. Since the gene transferred to the ath-
p.000251: lete's body is inserted in his/her genome, a major question which concerns the anti-doping authorities in this
p.000251: case is how to detect genetic modifica- tions. About 10 years ago the Medicine Commission of IOC (IOC, 2001) and
p.000251: WADA launched consultations and created working groups aiming to exam- ine “gene doping” in sports, which includes gene
p.000251: therapy and gene transfer (WADA. Health, Medical and Research Committee Meeting. Minutes. 2001). Since then, WADA
p.000251: organizes meetings of expert working groups on gene doping, whereas plentiful money have been invested on
p.000251: testing for modern
p.000251:
p.000251:
p.000252: 252
p.000252:
p.000252: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000252: REPORT
p.000252:
p.000252: methods of detection that will identify athletes who will abuse this technol- ogy (WADA 2002; 2004; 2005).
p.000252: In 2003, WADA included “gene doping” for the first time on the list of prohibited substances and methods.
p.000252: More specifically, the list of prohibited substances and methods 2012 includes “The transfer of nucleic acids or nu-
p.000252: cleic acid sequences” and “The use of normal or genetically modified cells”. According to a comment on Art. 4.3.2 of
p.000252: the World Anti-Doping Code, the use of genetic technology should be prohibited as it satisfies the two criteria of
p.000252: enhancing athletic performance and violation of the spirit of sport, even if it does not represent a risk for
p.000252: the athlete’s health. However, one of the major concerns about gene doping is the impact of new -and often
p.000252: experi- mental- methods of gene transfer on the athlete’s health.
p.000252:
p.000252: ii) The use of genetic tests that assess athletic performance
p.000252:
p.000252: Specific genetic tests identify genetic markers of athletic performance and define an athlete’s predisposition
p.000252: to stamina, strength or speed based on his/her genetic profile. Although these genetic tests do not involve physi- cal
p.000252: modification or introduction of genetic material into the athlete’s body, however they may be used by scouts to choose
p.000252: “1st class” athletes. One of the conclusions reached by WADA during the meeting of the working group on gene doping in
p.000252: 2005, is that “the use of genetic information to select for or to categorize athletes must be strongly discouraged”
p.000252: (WADA 2005).
p.000252:
p.000252: iii) The use of athletic equipment with a specific design and technology that modify various conditions and enhance
p.000252: performance
p.000252:
...

Searching for indicator women:

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p.000166: and profes- sional services3. The estimated amount spent by the pharmaceutical indus- tries on “sale and advertising”
p.000166: outlay is $8,000-15,000 per physician1.
p.000166: Another study in the USA in 2004, revealed that 44 pharmaceutical com- panies spent $2.47 billion on sponsorships. The
p.000166: average production cost for a new drug is between $300-600 million. Out of the total $6 billion spent on “research”,
p.000166: $3.3 billion are actually into spent on research itself.
p.000166: The pharmaceutical companies have additional reasons to urgently seek approval of a product. It has been estimated
p.000166: that due to “industrial espio- nage”, “competitive” industries are very eager to secure the first approval of the
p.000166: product, whatever the consequences. Each day delaying the product approval costs on average $1.3 billion to the
p.000166: industry2.
p.000166: This results in rapid drug approval, without the appropriate evaluation of long-term results (on safety and efficacy),
p.000166: with whatever that implies. A re- cent example is the withdrawal of Avastatin, a drug that had been “prema- turely and
p.000166: unnecessarily” approved by the Food and Drug Association (FDA) for use by patients in an advanced stage of breast
p.000166: cancer, a drug approval that proved to be rather hasty, as showed by four subsequent clinical stud- ies examining its
p.000166: safety and efficiency. All four studies proved that this drug not only didn’t offer any advantage to women with breast
p.000166: cancer, but also, in many cases, caused adverse side effects putting the patients’ life in dan- ger.
p.000166: Suspicions are generated by the fact that when a study is funded by a non-profit Institution, the negative
p.000166: results rise up to 38%, whereas when the study is supported by private grants the figure comes up to 5%.
p.000166: Some claim that the reason why industry-sponsored research shows more positive results, derives from the
p.000166: fact that financial resources are available to conduct studies with a large number of participating
p.000166: patients
p.000166:
p.000166: 3 Campbell EG, Rao SR, DesRoches CM et al. (2010). Physician professionalism and changes in
p.000166: physician-industry relationships from 2004 to 2009. Arch Intern Med 170, 1820-1826.
p.000166:
p.000167: 167
p.000167:
p.000167: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000167: REPORT
p.000167:
p.000167: (large sample size), leading to a high possibility of finding statistically signifi- cant differences. Another
p.000167: reason is the use of preliminary data-results, al- lowing for better planning of a clinical study and increasing
p.000167: the possibility of positive results4.
p.000167: The first argument refers to the question whether a statistically signifi- cant difference is of clinical value as
p.000167: well. Regarding the second argument, we should consider that most of the preliminary data derive from laboratory animal
p.000167: studies and often cannot be directly applied to humans.
p.000167: In addition, it is surprising that different clinical studies come up with contradictory results, depending
p.000167: on the funding company. During an evalua- tion of previous clinical studies on second generation drugs used
...

p.000170:
p.000170: e. Discrepancy between results and conclusions
p.000170: Although the results reported in some studies are accurate, it is common that authors misrepresent their meaning and
p.000170: draw more favorable conclu- sions compared to what the results can really support. For instance, 19 out of 22
p.000170: clinical studies of non-steroidal, anti-inflammatory drugs (NSAIDS) concluded that the drug manufactured by the
p.000170: sponsor was less toxic com- pared to others, but in fact such a conclusion could only be drawn by the results of 12
p.000170: clinical studies15.
p.000170:
p.000170: f. “Authors on demand”
p.000170: “Authors on demand” are exclusively employed to interpret the results of a clinical study and write up
p.000170: manuscripts that are in favor of the drug manufactured by the sponsor. The company, i.e. the drug
p.000170: manufacturer, hires a prestigious academic or physician to sign the manuscript as an au- thor. When the
p.000170: manuscript reaches the publication stage, there is no refer- ence to the original role of the “author on demand”. There
p.000170: are multiple ref- erences in the literature about “authors on demand”, some of which are analyzed in the
p.000170: paper by Dunbar and Tallman16.
p.000170: “Authors on demand” are not only used in order to ensure that positive results of clinical studies are reported, but
p.000170: also to create doubts about stud- ies that showed negative results. A good example of such a case is the clini- cal
p.000170: study “Heart and Estrogen/progestin Replacement Study, (HERS)”. The study concluded that administration of
p.000170: hormones to women with coronary heart disease offered no advantage to secondary prevention17. Publication of the study
p.000170: was followed by “manuscripts on demand” which questioned
p.000170:
p.000170:
p.000170:
p.000170:
p.000170: 15 Rochon PA, Gurwitz JH, Simms RW et al., (2004). A study of manufacturer- supported trials of
p.000170: non-steroidal anti-inflammatory drugs in the treatment of arthri- tis. Arch Intern Med 154, 157-163.
p.000170: 16 Dunbar CE, Tallman MS (2009). “Ghostbusting” at blood. Blood 113, 502-503.
p.000170: 17 Hulley S, Grady D, Bush T et al., (1998). Randomized trial of estrogen plus progestin for secondary prevention of
p.000170: coronary heart disease in postmenopausal women. Heart and Estrogen/progestin Replacement Study (HERS) Research Group.
p.000170: JAMA 280, 605- 613.
p.000170:
p.000171: 171
p.000171:
p.000171: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH REPORT
p.000171:
p.000171: the results of the study, supporting that hormone therapy had a protective effect18.
p.000171:
p.000171: g. “Seeding studies”
p.000171: Finally, conducting clinical studies after a drug is approved may be an- other way of misleading the public.
p.000171: In many cases, clinical studies conducted after the drug release solely intend to establish the drug on the market -to
p.000171: be more frequently prescribed by physicians and become better known amongst patients- and not to answer a
p.000171: scientific question.
p.000171:
p.000171: 4. Types of sponsorship
p.000171: Sponsorships of clinical research can be classified into five categories (Table 1).
p.000171:
p.000171: Table 1. Categories of sponsorship.
p.000171: 1st Free pharmaceutical products
p.000171: 2nd Gifts, meals, tickets to cultural events 3rd Travel (tickets, accommodation etc.) 4th Conference
p.000171: registrations etc.
p.000171: 5th Counseling services, lecture fees
p.000171:
p.000171: Figures from 2004 and 2005 show that ¾ of researchers having a finan- cial relationship with the pharmaceutical
p.000171: industry, received sponsorships within the established limits19, i.e. below $10,000 annually. A relationship
p.000171: with a commercial company operating in healthcare is reported by 5.9%- 6.2% of researchers. In addition, when
...

p.000176: The declaration must include the following details:
p.000176: i. First name and surname of the researcher.
p.000176: ii. Name of the Institute.
p.000176: iii. Type of sponsorship.
p.000176: iv. Amount of sponsorship33.
p.000176: v. Sponsoring company/industry.
p.000176: vi. Approval of the CRC.
p.000176: A relevant study revealed that approximately 50% of Institutions accept the establishment of a declaration32. However,
p.000176: half of them wish to include it in the informed consent form, whereas the remaining prefer to inform the participating
p.000176: patients orally. In addition, unanimity does don exist on the extend of details to be disclosed, and many
p.000176: support that the sponsor’s name is adequate. Others claim that the disclosure must be complete and include, not only
p.000176: the sponsor’s name and type of sponsorship, but also the amount, and the participant must be informed of any possible
p.000176: effects of the sponsor- ship on the research outcome, suggesting an honest discussion between the researcher and the
p.000176: patient.
p.000176: A declaration must also be submitted for a 1st stage research, where there are no human participants, but is
p.000176: intended to move to the 2nd clinical stage within the next 12 months. In that case, it is within the authority of
p.000176: the “CIC” to decide on whether the rules concerning the clinical study also apply to the preclinical stage of the
p.000176: study.
p.000176:
p.000176: 32 Hulley S, Grady D, Bush T et al. (1998). Randomized trial of estrogen plus progestin for secondary prevention of
p.000176: coronary heart disease in postmenopausal women. Heart and Estrogen/progestin Replacement Study (HERS) Research Group.
p.000176: JAMA 280, 605- 613.
p.000176: 33 The US Public Health Service set the upper limit of <$10,000/annum. P.S.H. 42. CER,
p.000176: §50603.
p.000176:
p.000177: 177
p.000177:
p.000177: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000177: REPORT
p.000177:
p.000177: “Disclosure” of the relationship must be submitted to persons or author- ities outside the Institution, such as:
p.000177: - The responsible State authorities.
p.000177: - The sponsors.
p.000177: - The “editorial” board of the scientific journal where the research is submitted for publication.
p.000177: - The conference organizing or scientific committee or professional bodies, where the research is announced
p.000177: (conferences etc.).
p.000177: - Everyone participating in the study.
p.000177: Depending on the rules of each Institution, the “disclosure” may include details concerning the type and amount of
p.000177: sponsorship. The CRC could pro- vide such a document. The document must include an assurance that the
p.000177: Protocol/Disclosure has been approved by the CIC, and state that the spon- sorship does not compromise the patient’s
p.000177: health.
p.000177: An additional recommendation is that the patient participating in re- search is informed about the fact that
p.000177: the matter has been addressed and approved by the Special Ethics Committee of the Institution and that the
p.000177: research does not compromise his/her health. Therefore, the disclosure may be posted on the Institutional website.
p.000177: Compliance with the above mentioned, is mainly shown by the Academic Centers, whereas there is no clear picture of what
p.000177: is the case outside Aca- demia. It is evident that there is no unanimity especially concerning the ex- tend of
...

p.000190: Echt DS, Liebson PR, Mitchell LB et al., (1991). Mortality and morbidity in patients receiving encainide,
p.000190: flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med 324, 781-788.
p.000190: Fisher JA (2008). Practicing research ethics: Private-sector physicians & pharmaceutical clinical trials. Soc
p.000190: Sci Med 66, 2495-2505.
p.000190: Fries JF, Krishnan E (2004). Equipoise, design bias, and randomized con- trolled trials: the elusive ethics
p.000190: of new drug development. Arthritis Res Ther 6, R250-R255.
p.000190: Fugh-Berman AJ (2010). The haunting of medical journals: How ghostwriting sold "HRT". PLoS Med 7, e1000335.
p.000190: Hampson LA, Joffe S, Fowler R, Verter J, Emanuel EJ (2007). Frequency, type, and monetary value of financial
p.000190: conflicts of interest in cancer clinical re- search. J Clin Oncol 25, 3609-3614.
p.000190: Henry D, Doran E, Kerridge I, Hill S, McNeill PM, Day R (2005). Ties that bind: multiple relationships between clinical
p.000190: researchers and the pharmaceutical industry. Arch Intern Med 165, 2493-2496.
p.000190: Heres S, Davis J, Maino K, Jetzinger E, Kissling W, Leucht S (2006). Why olanzapine beats risperidone,
p.000190: risperidone beats quetiapine, and quetiapine beats olanzapine: An exploratory analysis of head-to-head comparison stud-
p.000190: ies of second-generation antipsychotics. Am J Psychiatry 163, 185-194.
p.000190: Hulley S, Grady D, Bush T et al., (1998). Randomized trial of estrogen plus progestin for secondary prevention of
p.000190: coronary heart disease in postmeno- pausal women. Heart and Estrogen/progestin Replacement Study (HERS) Re- search
p.000190: Group. JAMA 280, 605-613.
p.000190: Jorgensen AW, Maric KL, Tendal B, Faurschou A, Gotzsche PC (2008). Indus- try-supported meta-analyses compared with
p.000190: meta-analyses with non-profit or no support: Differences in methodological quality and conclusions. BMC Med Res
p.000190: Methodol 8, 60.
p.000190:
p.000190:
p.000190:
p.000191: 191
p.000191:
p.000191: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000191: REPORT
p.000191:
p.000191: McCrary SV, Anderson CB, Jakovljevic J et al., (2000). A national survey of policies on disclosure of
p.000191: conflicts of interest in biomedical research. N Engl J Med 343, 1621-1626.
p.000191: Moss AJ, Francis CW, Ryan D (2001). Collaborative clinical trials. N Engl J Med 364, 789-791.
p.000191: Perlis RH, Perlis CS, Wu Y, Hwang C, Joseph M, Nierenberg AA (2005). Indus- try sponsorship and financial conflict of
p.000191: interest in the reporting of clinical trials in psychiatry. Am J Psychiatry 162, 1957-1960.
p.000191: Resnik DB (2004). Disclosing conflicts of interest to research subjects: An ethical and legal analysis.
p.000191: Account Res 11, 141-159.
p.000191: Rights Inventions Made by non-profit Organizations and Small business Firms. Codidied at 37 CFR, Part 401.
p.000191: Rochon PA, Gurwitz JH, Simms RW et al., (2004). A study of manufacturer- supported trials of nonsteroidal
p.000191: anti-inflammatory drugs in the treatment of arthritis. Arch Intern Med 154, 157-163.
p.000191: Spielmans GI, Biehn TL, Sawrey DL (2010). A case study of salami slicing: Pooled analyses of duloxetine for
p.000191: depression. Psychother Psychosom 79, 97- 106.
p.000191: Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R (2008). Selec- tive publication of antidepressant trials and
...

p.000005: Convention). This means that most of the Convention provisions are applied here and particularly: a) the rule of
p.000005: Informed Consent (art. 5 et seq) and the protection of privacy (art. 10).
p.000005: The CME includes regulations regarding the way medicine should be applied, in the strict sense. Indeed,
p.000005: according to art. 1 CME:
p.000005: 1. A medical act aims at prevention, diagnosis, treatment and restoration of human health, by use of
p.000005: any scientific method.
p.000005: 2. Research can also be regarded as a medical act, provided that it aims at a more accurate diagnosis, restoring
p.000005: or improving human health and the promotion of science.
p.000005:
p.000005:
p.000241: 241
p.000241:
p.000241: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000241: REPORT
p.000241:
p.000241: 3. The concept of medical act also includes drug prescriptions, the order to carry out any kind of paraclinical
p.000241: examinations, issuing medical certificates and attestations and the general counseling of the
p.000241: patient.
p.000241: This is a comprehensive definition of medical acts by the legislature, which does not include enhancement
p.000241: interventions in order to improve capabilities or aesthetics.
p.000241:
p.000241: B. ENHANCEMENT OF PHYSICAL CHARACTERISTICS AND CAPABILITIES
p.000241:
p.000241: I. Plastic (surgical) procedures
p.000241:
p.000241: 1. The data
p.000241:
p.000241: a) Reconstructive and aesthetic surgery
p.000241:
p.000241: Plastic surgery is a kind of enhancement of human characteristics, which is already applied to both men and women. The
p.000241: term plastic surgery refers to the surgical repair or correction of a feature or function of the human
p.000241: body. There are two types of plastic surgery:
p.000241: 1. Reconstructive procedures. Their purpose is to repair or enhance physiological functions and
p.000241: characteristics of the body, which are altered due to accidents, diseases or birth defects.
p.000241: The most common reconstructive procedures include reconstru- ctive plastic surgery to correct scars after
p.000241: an accident or burn, restoration of cleft lip and palate and reduction of the breast size.
p.000241: 2. Aesthetic/cosmetic procedures, which are divided into surgical and non-surgical cosmetic procedures.
p.000241: Their purpose is to reconstruct characteristics of the body in order to enhance external appearance. The
p.000241: specificity of cosmetic surgery is that the person interested is physically healthy.
p.000241: The most common types of aesthetic plastic surgery is botox/ wrinkle implants, face lift to reshape
p.000241: the forehead/eyebrows, blepharoplasty, breast augmentation, tummy tuck, rhinoplasty, oto- plasty and liposuction.
p.000241: It should be taken account that in some cases, the line between reco-
p.000241:
p.000241:
p.000242: 242
p.000242:
p.000242: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000242: REPORT
p.000242:
p.000242: nstructive and cosmetic surgery is unclear. Both reconstructive and aesthetic surgeries are, basically,
p.000242: permanent, since it is not easy to reverse the changes without a second surgery (with the exception of
p.000242: botox). Therefore, the enhancement of physical characteristics in this case, is not temporary.
p.000242:
p.000242: b) Motivations and psychological profile of the persons interested
p.000242:
p.000242: The reasons that may lead a person to seek plastic surgery vary, depending on the psychological
p.000242: profile as well as the type of surgery.
p.000242: It is important to stress that reconstructive interventions are offered to persons who were patients, and aim to
p.000242: improve their physical characteristics that were altered because of a medical/pathological condition or
p.000242: an accident. The decision to undergo plastic surgery is mainly driven by the need to restore the initial
p.000242: or normal state.
p.000242: In contrast, cosmetic procedures are offered to healthy individuals, who do not present with pathological findings or
p.000242: abnormal functions. Certainly, in this case one cannot overlook the impact of enhancing physical
p.000242: characteristics on the mental health of these individuals. There are many people who believe that
p.000242: cosmetic surgery will be the solution to the personal and social problems that they face.
p.000242: Both men and women are increasingly concerned about their appearance, looking for ways to
p.000242: enhance it through cosmetic surgery. The decision is based on several factors, which may vary between adults
p.000242: and adolescents, and include the modern obsession with the body image, the lack of self-confidence, the
p.000242: idols of each era and the icons dictated by fashion. The mass media played a crucial role in this case, by
p.000242: consolidating a global image of what is beautiful, desirable and attractive. The importance of beauty and
p.000242: physical appearance is strongly emphasized in social relationships, both professional and personal.
p.000242: For the aforementioned reasons, aesthetic surgeries pose ethical issues, which are, perhaps, greater than those
p.000242: posed by reconstructive surgeries.
p.000242: In addition, the number of the so-called "ethnic plastic (surgery) interventions" is increasing,
p.000242: and aim at removing national or racial characteristics. Such interventions are particularly popular
p.000242: in people of Asian descent who wish to obtain European features, or in African-Ame-
p.000242:
p.000242:
p.000243: 243
p.000243:
p.000243: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000243: REPORT
p.000243:
p.000243: ricans or African-Europeans who seek Caucasian characteristics.
p.000243: It is therefore necessary, in a first phase, that a plastic surgeon inve- stigates the motivations that
p.000243: lead a person to seek plastic surgery, especially an aesthetic procedure.
p.000243:
p.000243: c) Body dysmorphic disorders and plastic surgery
p.000243:
p.000243: A particular case is when individuals suffer from the so-called Body Dysmorphic Disorders (BDD) or
p.000243: otherwise dysmorphophophia (Crerand et al., 2006). BDD is a common psychiatric disorder that affects 1-2%
p.000243: of the general population and occurs with equal frequency in men and women. It is characterized by an excessive
p.000243: preoccupation of the person with imaginary or minor physical defects in various body parts. The
p.000243: condition is often associated with frequent hospitalization (48%) and high rates of depression and
p.000243: obsessive-compulsive disorders leading to suicidal tendencies and attempts (Phillips et al., 2006).
p.000243: Individuals suffering from BDD often resort to plastic surgeries in order to enhance their appearance. According
p.000243: to studies, 50%-76% of these patients seek plastic surgery, while 58%-66% of them eventually undergo
p.000243: plastic surgery and 26% of them undergo more than one plastic surgery (Crerand et al., 2006).
p.000243: Nevertheless, studies show that only a small percentage of these patients -just about 2%- are eventually
p.000243: satisfied by their body image after plastic surgery, while most of them continue to have symptoms of BDD.
p.000243: In most cases, these patients showed no improvement on their symptoms, while they often threaten or even
p.000243: sue the plastic surgeon who carried out the surgery (Crerand et al., 2010).
p.000243: Unlike plastic surgery, the therapy which is indicated for individuals who suffer from BDD is the use of certain
p.000243: drugs, mainly selective serotonin re- uptake inhibitors, and psychotherapeutic methods, and in
p.000243: particular, cognitive psychotherapy (Crerand et al., 2010).
p.000243: For the aforementioned reasons, it is essential that the plastic surgeon who suspects that a person seeking
p.000243: plastic surgery may present with BDD symptoms, refers the patient to a psychiatrist for proper mental
...

p.000256:
p.000256: 4 Design news 2005. http://www.designnews.com/document.asp?doc_id=226412&dfpPParams=ind_182,
p.000256: aid_226412&dfpLayout=article.
p.000256: 5 Cyberdyne. Inc. http://www.cyberdyne.jp/english/robotsuithal/.
p.000256:
p.000257: 257
p.000257:
p.000257: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000257: REPORT
p.000257:
p.000257: 3. The law
p.000257:
p.000257: Especially for equipment that requires interventions in the organism of the person concerned, the legislation
p.000257: about medical products (Directive 93/42, incorporated by JMD DY8d/GP. οik.130648/2.10.2009, Directive
p.000257: 90/385, incorporated by JMD DY8d/GP. oik.130644/2.10.2009) contains provisions for secure application of
p.000257: implants. Therefore, it also involves the technological interventions that aim, for example, at the
p.000257: musculoskeletal support.
p.000257:
p.000257: ΙV. Prolongation of life
p.000257:
p.000257: 1. The data
p.000257:
p.000257: The idea of longevity or eternal youth has always been fascinating for mankind, regardless of the era,
p.000257: culture and religion. This interest derives mainly from man’s fear about the diseases presented in old
p.000257: age but also from the death itself, as well as the quest for youth. It is a fact that, the best social and economic
p.000257: living conditions as well as better medical care increase the average lifespan of humans.
p.000257: Over the past two centuries, human life expectancy is more than dou- bled, from 25 years to 65 for men and
p.000257: 70 for women, while some estimate that for some populations this number will reach 100 years in six decades (Oeppen
p.000257: and Vaupel, 2002). In the European Union particularly, life expec- tancy has risen by an average of 10 years over the
p.000257: last fifty years6. According to statistics in 2009, the average life expectancy in the EU of 27 states is
p.000257: 79.4 years (76.4 for men and 82.4 for women). In Greece, the average age is
p.000257: 80.2 years for the total population (77.8 for men and 82.7 for women). But why this constant increase in life
p.000257: expectancy?
p.000257: Genetic factors, such as the HLA-DRw9 and HLA-DR1 alleles in the Japa- nese population (Takata et al., 1987) and the e4
p.000257: allele of the APOE gene in Finnish (Schachter et al., 1994) and the French population (Louhija et al.,
p.000257: 1994), are associated with increased life expectancy.
p.000257:
p.000257: 6 Eurostat. Mortality and life expectancy statistics. Data from October 2011.
p.000257: http://epp.eurostat.ec.europa.eu/statistics_explained/index.php/Mortality_and_life_ expectancy_statistics.
p.000257:
p.000258: 258
p.000258:
p.000258: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000258: REPORT
p.000258:
p.000258: Environmental factors, such as smoking, alcohol consumption and diet have not been proven to reduce the average
p.000258: life expectancy but their effect on the development of diseases, such as cancer and cardiovascular disease indirectly
p.000258: reduces life expectancy. In addition, the way the social status, wealth and educational level can affect
p.000258: life expectancy, is not clear (Chris- tensen & Vaupel, 1996).
p.000258: Demographic and geographical studies showed that the increase in life expectancy is, in part, due to the advances in
p.000258: Medicine and geriatrics that study the diseases of old age, such as cancer and cardiovascular disease,
p.000258: aiming at prevention and better management of common diseases (Chris- tensen & Vaupel, 1996).
p.000258: However, along with the best medical care, modern biomedical research offers insights that allow humans to understand
p.000258: and intervene in the aging mechanisms. Biogerontology studies the aging mechanisms and provides information to
...

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p.000116:
p.000116: Problems pertaining to consent itself arise in the relationship physician- patient in case of incapacitated patients:
p.000116: First, as to the derogations from informed consent accepted by the CME (art. 12[3]), there is the question of
p.000116: whether a patient’s relatives may, in general, refuse treatment and to what extent are they allowed to do so. The
p.000116: “risk to health”, as a limit prescribed by the law, is susceptible of broad in- terpretation and needs to be
p.000116: further specified. Certainly, the discretion to “refuse treatment” is not the same for patients and
p.000116: relatives as the latter are not able to experience the disease. On the other hand, relatives may not
p.000116:
p.000116: 6 For an example of deterioration of the patient’s health because of a similar initia- tive by the physician, see Higgs
p.000116: (op. cit.) p. 435.
p.000116:
p.000117: 117
p.000117:
p.000117: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000117: REPORT
p.000117:
p.000117: be “obligated” to allow treatment for this would defeat the basic tenet of their freedom to consent on behalf of the
p.000117: patient.
p.000117: Continuing on the question of derogations, it is worth noting the differ- ent approach of the CME as compared with art.
p.000117: 1534 of the Civil Code (CC) which allows the physician to act alone in case the parents of a minor refuse to give their
p.000117: consent to treatment. The Civil Code requires authorization by the Prosecutor whereas the CME does not. The question is
p.000117: whether the pro- visions of the CME provide sufficient grounds to cover the physician’s liability vis-à-vis the
p.000117: parents especially in view of the constitutional protection of parental care (Constitution, art. 21 [1]; art. 8
p.000117: [1] ECHR) whose guarantor is precisely the judiciary and not the physician -as firmly held in legal doctrine.
p.000117: Critical also is the physician’s attitude in case of disagreement between relatives which is not unlikely since
p.000117: the law does not assign any priority among relatives with regard to their power to decide. Should an
p.000117: implicit hierarchy be inferred or is it left to the physician to decide according to his/her fundamental
p.000117: duty to the patient? Could an ethics board be of assis- tance when the patient is hospitalized? Let us recall
p.000117: at this point that our national health system is not familiar with ethics boards whereas in Europe and the US they
p.000117: are well-established -and the importance of their role is not put in question- for many years.
p.000117: An even graver issue may arise when the physician is in a position to know the patient’s wishes, which
p.000117: were expressed before the patient became incapable to consent either in written or orally and the relatives
p.000117: disagree. Since the latter have by law the right to make the final decision, the ques- tion is whether these wishes
p.000117: should be taken into account, and how. It is worth noting that both the CME (art. 2[2]) and the Oviedo
p.000117: Convention (art.
p.000117: 9) stipulate so though failing to specify the ensuing legal effects (see below). Finally, there is a wider issue with
p.000117: the consent of minors. The law totally precludes it (art. 12 [2] [b] CME) even when minors are obviously
p.000117: able to exercise control over their health given that other provisions recognize their capacity to enter into
p.000117: legal relationships (e.g. to marry). At issue here is whether the scope of this provision should be
p.000117: interpreted stricto sensu to apply only when the intellectual immaturity of the minor obviously justifies that the
p.000117: consent be given by his/her parents or custodian in order to har- monize this rule with the constitutional protection
p.000117: of personality (Constitu-
p.000117: tion, art. 5 [1]).
p.000117:
p.000117:
p.000118: 118
p.000118:
p.000118: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000118: REPORT
p.000118:
p.000118: c) Medical liability and other legal consequences
p.000118:
p.000118: In legal terms, the answers to all the above questions have an impact, first and foremost, on the extent of
p.000118: medical liability (criminal, civil and pro- fessional). Liability, in this case, is not connected with fault in the
p.000118: execution of a medical act (which is judged according to lege artis execution) but with fault at the stage preceding
p.000118: the act, i.e. during the legal procedure of deci- sion-making7.
p.000118: Thus the implementation of the Oviedo Convention and the CME provi- sions on “informed consent” (and of the provisions
p.000118: of special legislation on transplants, assisted reproduction, etc.) complement the general legislation on medical
p.000118: liability (e.g. arts. 57, 914 CC, art. 8 Law 2251/1994) and may provide grounds for particular claims in
p.000118: action8.
p.000118: Secondly, the answers may have an impact on the legal situation of third parties (hospitals, relatives) insofar as
p.000118: compliance with the principle of con- sent is associated with individual rights and obligations pertaining to them.
p.000118:
...

p.000126:
p.000127: 127
p.000127:
p.000127: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000127: REPORT
p.000127:
p.000127: In these circumstances acting alone is again not justified for physicians except in emergency situations. They must
p.000127: concentrate their efforts on the speedy recovery of the patient’s mental lucidity so that the patient can be informed
p.000127: in time and decide about treatment by himself/herself. Besides, it is not legitimate to substitute the patient’s
p.000127: relatives for the patient’s own will for patients may disagree with their relatives’ decision once their mental
p.000127: capacities are restored.
p.000127: Respectively, persons who are legally incompetent to consent may be physically fully capable of forming and
p.000127: expressing their will on matters con- cerning their health. We already mentioned the example of minors, espe-
p.000127: cially from the beginning of adolescence; similar, however, is the situation of persons under legal guardianship
p.000127: (even full-fledged) whereas mild mental disorders or impairments do not by definition exclude the exercise of self-
p.000127: control over one’s health.
p.000127: In the case of minors, it would be more appropriate to recognize their capacity for self-consent after a certain
p.000127: age (thus precluding consent by the minor’s legal representatives) for there is an objective presumption of suffi-
p.000127: cient maturity in contemporary societal life that can hardly be put in ques- tion (e.g. from the age 15 years).
p.000127: Meanwhile the assent of minors must be given considerable weight in relevant decisions, especially if coinciding with
p.000127: the physician’s advice, even when the parents disagree.
p.000127: For adults, it is difficult to assume a similar objective presumption. Therefore, the view of the concerned
p.000127: person must be given particular atten- tion (as must the appropriateness of prior information) and evaluated on a
p.000127: case-by-case basis although the power of legal representatives to decide cannot be questioned.
p.000127: The problem of advance directives is a much harder nut to crack. The event of becoming incompetent to
p.000127: consent often leads people to issue di- rections on how they wish to be treated ahead of time. These directions are
p.000127: usually addressed to close relatives or close friends, or even to the physi- cian, if one is already ill.
p.000127: They are usually informal (oral and eventually with no witnesses) but some countries have provided a modality to
p.000127: safeguard the validity of their will (“living wills”). Usually, these directions are about the refusal of
p.000127: certain unpleasant or painful treatments (e.g. haemodialysis, car-
p.000127:
p.000127: decisions by patients capable to consent and on the mental faculties, which are criti- cal for consent (Elliot, 2001).
p.000127:
...

p.000150: autonomy in view of the above would be to leave the choice of preferred option to the one concerned.
p.000150: At any rate, with the exception of emergencies which leave no time for government intervention -in which case it is
p.000150: ethically justified to leave the initiative to physicians- autonomy does not evaporate before public interest.
p.000150: Particularly in case of mild diseases or hard to transmit diseases, the obliga- tion to respect autonomy remains fully
p.000150: effective.
p.000150:
p.000150: 3. Scope of medical duty
p.000150:
p.000150: When public health is at risk from a contagious disease, objective pa- rameters -time, in particular- often
p.000150: prevent the unhindered practice of med- icine. In such cases, physicians must set health care priorities,
p.000150: which may result in depriving certain people from care. The availability of physicians is obviously an external sine
p.000150: qua non for exercising patient autonomy.
p.000150: The necessities of war can offer a precedent for such prioritization. Since World War I, a three-fold division of the
p.000150: population in terms of priority (“tri- age”), based on the probability of cure is generally accepted: those
p.000150: in im- mediate need of help come first; next follow those who can be transported to a hospital even if more seriously
p.000150: hurt, and last are those with minor inju- ries or few chances of survival. But one may think of other
p.000150: considerations
p.000150:
p.000150:
p.000151: 151
p.000151:
p.000151: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000151: REPORT
p.000151:
p.000151: (e.g. priority to those who will treat others, to the young or the elderly, even a “first come first served” approach).
p.000151: Although “triage” is mostly associated with war (and natural disasters or train derailments) its core concept can be of
p.000151: use also in case of epidemics.
p.000151: At all events, health care priorities must be set by public authorities in advance on the basis of fixed rules in
p.000151: order to prevent physicians from hav- ing to make so many ethically questionable judgments.
p.000151:
p.000151: 4. Special issues: Clinical trials, patents
p.000151:
p.000151: The urgent need for prevention and treatment in times of epidemics painfully illustrates the question of
p.000151: the adverse effects of trials of new treatments (medicines, vaccines) to contain the risk.
p.000151: Given that clinical trials are now subjected to a specific control proce- dure, ensuring the safety of
p.000151: volunteering participants and of the end- product before it becomes available to the public, at issue is
p.000151: whether this procedure should be relativized in case of an urgent need to supply new cures. Since the
p.000151: pursuit of absolute safety, even in normal circumstances, obviously undermines the effort to find new cures (as
...

p.000242: consolidating a global image of what is beautiful, desirable and attractive. The importance of beauty and
p.000242: physical appearance is strongly emphasized in social relationships, both professional and personal.
p.000242: For the aforementioned reasons, aesthetic surgeries pose ethical issues, which are, perhaps, greater than those
p.000242: posed by reconstructive surgeries.
p.000242: In addition, the number of the so-called "ethnic plastic (surgery) interventions" is increasing,
p.000242: and aim at removing national or racial characteristics. Such interventions are particularly popular
p.000242: in people of Asian descent who wish to obtain European features, or in African-Ame-
p.000242:
p.000242:
p.000243: 243
p.000243:
p.000243: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000243: REPORT
p.000243:
p.000243: ricans or African-Europeans who seek Caucasian characteristics.
p.000243: It is therefore necessary, in a first phase, that a plastic surgeon inve- stigates the motivations that
p.000243: lead a person to seek plastic surgery, especially an aesthetic procedure.
p.000243:
p.000243: c) Body dysmorphic disorders and plastic surgery
p.000243:
p.000243: A particular case is when individuals suffer from the so-called Body Dysmorphic Disorders (BDD) or
p.000243: otherwise dysmorphophophia (Crerand et al., 2006). BDD is a common psychiatric disorder that affects 1-2%
p.000243: of the general population and occurs with equal frequency in men and women. It is characterized by an excessive
p.000243: preoccupation of the person with imaginary or minor physical defects in various body parts. The
p.000243: condition is often associated with frequent hospitalization (48%) and high rates of depression and
p.000243: obsessive-compulsive disorders leading to suicidal tendencies and attempts (Phillips et al., 2006).
p.000243: Individuals suffering from BDD often resort to plastic surgeries in order to enhance their appearance. According
p.000243: to studies, 50%-76% of these patients seek plastic surgery, while 58%-66% of them eventually undergo
p.000243: plastic surgery and 26% of them undergo more than one plastic surgery (Crerand et al., 2006).
p.000243: Nevertheless, studies show that only a small percentage of these patients -just about 2%- are eventually
p.000243: satisfied by their body image after plastic surgery, while most of them continue to have symptoms of BDD.
p.000243: In most cases, these patients showed no improvement on their symptoms, while they often threaten or even
p.000243: sue the plastic surgeon who carried out the surgery (Crerand et al., 2010).
p.000243: Unlike plastic surgery, the therapy which is indicated for individuals who suffer from BDD is the use of certain
p.000243: drugs, mainly selective serotonin re- uptake inhibitors, and psychotherapeutic methods, and in
p.000243: particular, cognitive psychotherapy (Crerand et al., 2010).
p.000243: For the aforementioned reasons, it is essential that the plastic surgeon who suspects that a person seeking
p.000243: plastic surgery may present with BDD symptoms, refers the patient to a psychiatrist for proper mental
p.000243: help. However up to now, data coming from the USA show that plastic surgeons are aware of the BDD and often
...

Searching for indicator youth:

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p.000152: Under art. 21 (3), the Constitution recognizes health as a social right in addition to its recognition as an individual
p.000152: right2. Thus, a distinction is drawn between the right of the individual citizen to take care of matters pertaining to
p.000152: personal health and public health care for all. In this sense, the social en- titlement to health can be taken as
p.000152: a basis for adopting health protection measures (organizing vaccination programmes, blood donations, etc.).
p.000152:
p.000152: 1Article 5 (4) of the Constitution: “Individual administrative measures restricting the free movement or residency in
p.000152: the national territory or the free entry into or exit from it to any Greek citizen shall be prohibited. Such
p.000152: restrictive measures may be imposed only as ancillary sanctions by criminal court ruling in exceptional emergency
p.000152: circum- stances exclusively for the prevention of indictable offences as specified by Law”.
p.000152: Interpretation clause:
p.000152: Paragraph 4 does not preclude the prohibition to leave the country by order of public prosecutor due to criminal
p.000152: proceedings or measures imposed on grounds of public health protection or the protection of patients as
p.000152: specified by Law”.
p.000152: Article 21 (3) of the Constitution: “The State shall care for the health of citizens and shall adopt specific measures
p.000152: to protect youth, old age, disability and health care for indigents”.
p.000152: 2 Article 5 (5) of the Constitution: “Everyone is entitled to the protection of their health and genetic
p.000152: identity…”.
p.000152:
p.000153: 153
p.000153:
p.000153: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000153: REPORT
p.000153:
p.000153: However, both the Constitution and the ECHR acknowledge the need of re- strictive measures to protect public health.
p.000153: Thus, the art. 5(4) of the Constitution (interpretation statement) excep- tionally accepts individual administrative
p.000153: measures “on grounds of public health protection or the protection of patients as specified by Law”. It is im-
p.000153: portant to stress that such measures amount to extensive inroads into indi- vidual freedom -prohibiting “the free
p.000153: movement and residency in the na- tional territory or the entry into and exit from it”- and can be decided by any
p.000153: public authority (health authorities, police, local government, etc.), but al- ways under specific legal
p.000153: provisions.
p.000153: Along the same lines, the ECHR (convention with overriding formal effect versus ordinary legislation) accepts the
p.000153: deprivation of individual freedom such as, among other things, “… the lawful detention of a person for the pre-
...

p.000256: 2. The dimension of ethics
p.000256:
p.000256: As in the case of using motorized exoskeleton for enhancement purposes, the question that arises
p.000256: is whether a person’s autonomy allows the expansion of physical capabilities beyond normal.
p.000256: The answer is, in principle, yes, since in this case there are -usually- no issues of modifying the human organism.
p.000256: Expanding a person’s capabilities may resemble the assistance provided by the usual mechanical means that make us enjoy
p.000256: our freedom, for example by increasing our movement (car, etc.), our senses (glasses, headphones, etc.), our
p.000256: expression (microphones etc.), and so on.
p.000256:
p.000256: 4 Design news 2005. http://www.designnews.com/document.asp?doc_id=226412&dfpPParams=ind_182,
p.000256: aid_226412&dfpLayout=article.
p.000256: 5 Cyberdyne. Inc. http://www.cyberdyne.jp/english/robotsuithal/.
p.000256:
p.000257: 257
p.000257:
p.000257: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000257: REPORT
p.000257:
p.000257: 3. The law
p.000257:
p.000257: Especially for equipment that requires interventions in the organism of the person concerned, the legislation
p.000257: about medical products (Directive 93/42, incorporated by JMD DY8d/GP. οik.130648/2.10.2009, Directive
p.000257: 90/385, incorporated by JMD DY8d/GP. oik.130644/2.10.2009) contains provisions for secure application of
p.000257: implants. Therefore, it also involves the technological interventions that aim, for example, at the
p.000257: musculoskeletal support.
p.000257:
p.000257: ΙV. Prolongation of life
p.000257:
p.000257: 1. The data
p.000257:
p.000257: The idea of longevity or eternal youth has always been fascinating for mankind, regardless of the era,
p.000257: culture and religion. This interest derives mainly from man’s fear about the diseases presented in old
p.000257: age but also from the death itself, as well as the quest for youth. It is a fact that, the best social and economic
p.000257: living conditions as well as better medical care increase the average lifespan of humans.
p.000257: Over the past two centuries, human life expectancy is more than dou- bled, from 25 years to 65 for men and
p.000257: 70 for women, while some estimate that for some populations this number will reach 100 years in six decades (Oeppen
p.000257: and Vaupel, 2002). In the European Union particularly, life expec- tancy has risen by an average of 10 years over the
p.000257: last fifty years6. According to statistics in 2009, the average life expectancy in the EU of 27 states is
p.000257: 79.4 years (76.4 for men and 82.4 for women). In Greece, the average age is
p.000257: 80.2 years for the total population (77.8 for men and 82.7 for women). But why this constant increase in life
p.000257: expectancy?
p.000257: Genetic factors, such as the HLA-DRw9 and HLA-DR1 alleles in the Japa- nese population (Takata et al., 1987) and the e4
p.000257: allele of the APOE gene in Finnish (Schachter et al., 1994) and the French population (Louhija et al.,
p.000257: 1994), are associated with increased life expectancy.
p.000257:
p.000257: 6 Eurostat. Mortality and life expectancy statistics. Data from October 2011.
p.000257: http://epp.eurostat.ec.europa.eu/statistics_explained/index.php/Mortality_and_life_ expectancy_statistics.
p.000257:
p.000258: 258
p.000258:
p.000258: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000258: REPORT
p.000258:
...

Searching for indicator education:

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p.000046: been discredited and public opinion has grown suspi- cious.
p.000046: The analysis that follows presents some elements of organization of re- search (Part I), considers the ethical
p.000046: parameters and problems to be dis- cussed (Part II) and concludes with a number of proposals.
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000047: 47
p.000047:
p.000047: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000047: REPORT
p.000047:
p.000047: PART I
p.000047:
p.000047: ELEMENTS OF ORGANISATION OF RESEARCH
p.000047:
p.000047: Research provides empirical data against which theories are tested and questions are answered. It contributes to
p.000047: fulfilling the goals of Science among which gaining new knowledge, seeking scientific truth, avoiding mis- takes
p.000047: and producing technology to facilitate everyday life.
p.000047: Biological Research, its objective being the study of life, impacts directly on essential areas of human lives such as
p.000047: health and the environment. Be- sides, due to the significant breakthroughs of recent decades and the high expectations
p.000047: for producing more innovation in the future, biological re- search has come to occupy a very prominent
p.000047: position world-wide in terms of the value attributed to it by public opinion (Eurobarometer, 2007), the
p.000047: amount of funding it absorbs and the share of economic activity it gener- ates.
p.000047:
p.000047: Biological research in Greece
p.000047:
p.000047: In Greece, biological research is mainly conducted by Higher Education Institutions, Research Centres, Hospitals
p.000047: and, to a lesser extent, by the In- dustry, e.g. pharmaceutical companies, biotechnology companies, etc. Ac-
p.000047: cording to data from the General Secretariat of Research and Technology (GSRT) on research as a whole for
p.000047: 2005, 64% of science and technology re- search staff are employed in government agencies or universities (Table 1).
p.000047:
p.000047: a. Supervision of research
p.000047: In Greece, the government influences the general orientation and scope of research through the formulation of a
p.000047: national strategic plan. The extent of influence exercised by the government on the orientation of research is based on
p.000047: the management of public funds allocated to it.
p.000047: The national strategy for research and technology is approved by the Inter-Ministerial Committee for Research
p.000047: and Technology (DEET) upon pro- posal by the National Board for Research and Technology (ESET). DEET is
p.000047:
p.000047:
p.000047:
p.000047:
p.000048: 48
p.000048:
p.000048: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES REPORT
p.000048:
p.000048: comprised of the Prime Minister and the majority of government Ministers1. The President of the ESET is invited to DEET
p.000048: meetings. The participation of virtually all Ministries in the DEET testifies to the importance of research and
p.000048: technology for all sectors of public life.
p.000048:
p.000048: Table 1. Total Research Manpower in Greece in 2005. The numbers include re- searchers, technicians and
p.000048: support staff. Source: General Secretariat of Science and Technology (GSRT).
p.000048:
p.000048: Distribution of Research Manpower per sector of employment
p.000048: Man-years (FTEE)*
p.000048: Percentile
p.000048: Industry 12,020.5
p.000048: 35.4%
p.000048: Public Research Centres 4,344.8 12.8%
p.000048: Higher Education Institutions 17,400.5 51.2%
p.000048: Non-profit Private Research Centres 192.6 0.6% Total staff
p.000048: employed in research in Greece 33,958.3 100%
p.000048: * FTEE: Full-time Employment Equivalents, man-years.
p.000048:
p.000048: According to the legislation in force the ESET is “an independent advisory body directly answerable to the Prime
p.000048: Minister”. Its members include inter- nationally acclaimed scientists among which the president of the
p.000048: National Council for Research and Technology (EOET) business executives and a rep- resentative of the civil sector.
p.000048: ESET formulates a proposal for the National Plan for Research and Technology (EPET) and submits proposals for the na-
p.000048: tional research strategy to DEET for approval. ESET supervises the imple- mentation of EPET.
p.000048: Greece does not have a separate independent council for the coordina- tion of research in the biological
p.000048: sciences. The ESET includes a section of Biology and Biotechnology but the role of sectors is unclear.
p.000048: The newly-legislated EOET which was created by the new “Statutory Framework for research and technology” has
p.000048: two sectors, one for basic and one for applied research, and its main mission is the “implementation and
p.000048:
p.000048: 1 a) Internal Affairs, b) Economy and Finance, c) External Affairs, d) National Defense,
p.000048: e) Development, f) Environment, Planning and Public Works, g) National Education and Religion, h) Employment
p.000048: and Social Protection, i) Health and Social Solidarity, j) Rural Development and Foodstuffs, k) Justice, l) Culture and
p.000048: m) Transport and Com- munication.
p.000048:
p.000049: 49
p.000049:
p.000049: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000049: REPORT
p.000049:
p.000049: management of actions in basic research, applied-technological research and innovation”2. In practical
p.000049: terms, EOET’s task is to support research through the management of public funds mainly in order to finance
p.000049: research projects to be carried out in national research institutions following call opening and evaluation
p.000049: of submitted proposals. The proposals will be peer reviewed by Greek or foreign scientists of international acclaim.
p.000049: EOET was established by Law 3653/21.3.2008 and was still inoperative at the time the present report was drawn up.
p.000049: Again, the law does not provide for a separate council dedicated to biological research.
p.000049: Despite their dependence on public funds, Universities and Research Centres can determine the orientation of
p.000049: their research activity by appoint- ing staff with desirable research interests and by raising non-public funds for
p.000049: research. According to data from the GSRT, the major source of non- government funding for Greek research
p.000049: centres comes from abroad, mainly the European Union.
p.000049:
p.000049: b. Financing
p.000049: The biggest provider of funds for public research in Greece is the state. In 2005, 47% of the expenditure was met with
p.000049: public funds, 31% of funds for research originated from the industry and 19% from abroad (Table 2). Re- search in
p.000049: Public Research Centres and Higher Education Institutions is fi- nanced mainly with public funds or funds
p.000049: from abroad while the domestic private sector contributes very little (Table 2).
p.000049: The largest part of foreign funding is absorbed by public research centres and universities. Research in the
p.000049: private sector absorbs one third of the overall funds most of which is self-financing. Public research
p.000049: absorbs ap- proximately 67% of the overall funds allocated for research (Table 3).
p.000049: Compared to the respective European Union average Greece spends a smaller share of its Gross Domestic
p.000049: Product (GDP) for research (0.7% as against 1.9%) whereas the contribution of the industry is even smaller (30%
p.000049: compared to 55%). The goal for 2010 is to increase the share of GDP for re- search and the contribution of the private
p.000049: sector (Table 4).
p.000049:
p.000049:
p.000049:
p.000049: 2 Article 19 (2) Law 3653 OJ A’ 49/21.3.2008: Statutory framework of science and technology and other
p.000049: stipulations (Law of Parliament, 2008).
p.000049:
p.000050: 50
p.000050:
p.000050: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES REPORT
p.000050:
p.000050: Table 2. Financing of research in Greece per source of financing and research centre. Source: GSRT, gross domestic
p.000050: expenditure for research & technological develop- ment, break-down according to source.
p.000050:
p.000050:
p.000050: Financing of Research in Greece
p.000050:
p.000050: Research Centre Total
p.000050:
p.000050:
p.000050: Source of funding
p.000050:
p.000050: Private Sector
p.000050: Public Research Centres
p.000050: Higher Education Institutions
p.000050: Non-Profit Private Re- search Centres
p.000050: Private Sector 85.4% 1.3% 8.9% 2.1% 31.0%
p.000050: State 6.3% 68.1% 65.6% 9.6%
p.000050: 47.0%
p.000050:
p.000050: Higher Education Institutions
p.000050: Non-Profit Pri- vate Research Centres
p.000050:
p.000050: 0.3% 3.4% 1.7%
p.000050:
p.000050:
p.000050: 0.3% 0.1% 0.8% 78.8% 1.5%
p.000050: Foreign funds 7.8% 30.6% 21.3% 9.6% 18.8%
p.000050:
p.000050: Table 3. Total expenses in research per entity of research. Source: GSRT gross do- mestic expenditure for
p.000050: research & technological development, break-down accord- ing to source.
p.000050:
p.000050:
p.000050: Expenses (in mil. €)
p.000050: %
p.000050: of total
p.000050: Companies 357.0 30.9
p.000050: Public Research Institutes 233.9 20.3
p.000050: Higher Education Institutes 547.7 47.5
p.000050: Non-profit Private Law Bodies 14.6 1.3
p.000050: Total 1,153.2
p.000100: 100
p.000100:
p.000100:
p.000100:
p.000100:
p.000100:
p.000100:
p.000100:
p.000051: 51
p.000051:
p.000051: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES REPORT
p.000051:
p.000051: Table 4. Comparison of Current Expenses Greece/EU and goals for 2010. Source: GSRT *RTD: Research and
p.000051: Technological Development.
p.000051: Indicator Time EU average Greece
p.000051:
p.000051: Gross domestic expenditure for re- search & technological development in terms of GDP
p.000051: Gross domestic expenditure for re- search & technological development in terms of GDP
p.000051: Today 1.9% 0.7%(1)
p.000051: 2010 3.0% 1.5%
p.000051: Today 55% 25%(1)
p.000051: 2010 65% 40%
p.000051:
p.000051: With regards the allocation of funds per area of biological research, data from GSRT for public funding shows
p.000051: that within life sciences applied re- search is the prevalent type of research activity in terms of funds
p.000051: absorbed. In particular, in 2005 16.9% of the overall public funding for research and development went to
p.000051: applied research in the biological sciences; the respec- tive share for basic biological research was 3.3% (5 times
p.000051: smaller compared to funding for applied research). A total of 11.7% of public funds for re- search was
...

p.000052: issues of research ethics that will be discussed below.
p.000052:
p.000052:
p.000052:
p.000053: 53
p.000053:
p.000053: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000053: REPORT
p.000053:
p.000053: PART II
p.000053:
p.000053: THE ETHICAL ISSUES
p.000053:
p.000053: The value of research
p.000053:
p.000053: Scientific research is a common as well as an individual good. As a com- mon good research promotes human
p.000053: knowledge and innovation, contrib- uting to the “well-being” of society as a whole. This dimension is inextricably
p.000053: linked with the freedom of researchers without which research is inconceiv- able. In this sense research also
p.000053: represents an individual good, recognized as such in the legal system (freedom of research). The above are enshrined in
p.000053: international and constitutional instruments like the UNESCO’s declarations on Bioethics (art. 2[d], 15), on the Human
p.000053: Genome and Human Rights (pre- amble and art. 12, 14, 15, 17, 19) and the Greek Constitution (art. 16).
p.000053: Thus, all democratic societies have an interest in developing research for many reasons since:
p.000053: - Findings are expected to contribute to better quality of life for all,
p.000053: - policy-making can be based on scientific facts (Rosenstock and Lee, 2002),
p.000053: - immediate economic benefits are expected from the introduction of innovation in the production process, the
p.000053: use of patents and the crea- tion of new jobs,
p.000053: - the creativity of research manpower is enhanced,
p.000053: - research enhances education for all by renewing and enriching the content of knowledge (Tindemans 2007:24)
p.000053: especially in higher educa- tion and by nurturing a spirit of initiative, communication and co- operation
p.000053: between national entities and -in particular- respective for- eign bodies.
p.000053: Ideally, the individual and the social component of research should be harmonized. The concern for achieving
p.000053: maximum harmonization in specific actual contexts justifies the attention paid to research by modern states.
p.000053: This attention is exemplified in the constitutional protection of research, the adoption of programmatic legislation
p.000053: and the operation of specific institu- tions which draw up national strategies. The same degree of
p.000053: attention is
p.000053:
p.000053:
p.000053:
p.000054: 54
p.000054:
p.000054: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000054: REPORT
p.000054:
p.000054: seen on the supranational level in the respective institutional arrangements in the EU.
p.000054:
p.000054: The predominance of the economy and its consequences
p.000054:
p.000054: At the moment the economic parameters of the development of re- search are of particular interest as
p.000054: they tend to override all other dimen- sions. The following facts must be taken into consideration:
p.000054: a) The development of modern research in large-scale facilities. Modern research has long ceased to be driven by the
p.000054: model of the initiative and per- sonal work of isolated ingenious researchers. Today the driving forces are
p.000054: research teams which do not act in isolation but are organized in interna- tional networks of
...

p.000057: ethical principles for
p.000057:
p.000057:
p.000058: 58
p.000058:
p.000058: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000058: REPORT
p.000058:
p.000058: biomedical research in humans4 and animals5, research in the human ge- nome6 and for epidemiological
p.000058: research7. The International Epidemiology Association recently issued principles of correct practice and conduct in
p.000058: epi- demiological research (IEA, 2007). Some of the issues dealt with in these instruments can be summarized
p.000058: as follows (Shamoo and Resnik, 2002):
p.000058: Honesty as to the method and the findings in the publication and report- ing of scientific studies.
p.000058: Objectivity in the design of trials and the analysis of results as well as in the consideration of the work of other
p.000058: scientists.
p.000058: Integrity in the observance of promises and assumed obligations and con- sistency between word and action.
p.000058: Care to avoid inadvertent mistakes and to keep good records.
p.000058: Compliance with copyright.
p.000058: Confidentiality with regard to information obtained during private meet- ings or when considering proposals for funding
p.000058: or papers for publication, Responsible publications whose goal should be the advancement of sci- ence and
p.000058: avoidance of pointless papers that reiterate available knowledge.
p.000058: Care for the instruction of students, protection of their prosperity and recognition of their right to decide
p.000058: for themselves.
p.000058: Respect for colleagues.
p.000058: Social Responsibility, the goal must be the common good and the avoid- ance or alleviation of social problems through
p.000058: research and education of the public.
p.000058: Avoidance of discrimination based on gender, nationality, ethnicity or any other factor irrelevant to scientific
p.000058: competence and integrity.
p.000058: Preservation of professional competence through life-long training and education.
p.000058:
p.000058: 4 CIOMS international ethical guidelines for biomedical research involving human subjects
p.000058: (http://www.cioms.ch/frame_guidelines_nov_2002.htm).
p.000058: 5 1985 international guiding principles for biomedical research involving animals
p.000058: (http://www.cioms.ch/frame_1985_texts_of_guidelines.htm).
p.000058: 6 1990 declaration of inuyama on human genome mapping, genetic screening and gene therapy
p.000058: (http://www.cioms.ch/frame_1990_texts_of_guideline.htm).
p.000058: 7 1991 international guidelines for ethical review of epidemiological studies
p.000058: (http://www.cioms.ch/frame_1991_texts_of_guideline.htm).
p.000058:
p.000059: 59
p.000059:
p.000059: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000059: REPORT
p.000059:
p.000059: Legality, compliance with all laws and regulations governing the operation of research.
p.000059: Care for animals both in the design and the execution of research pro- jects.
p.000059: Protection of volunteers, limitation of risks and maximization of benefits for volunteers and respect of their
p.000059: personality, especially in case of vul- nerable groups.
p.000059:
p.000059: The problem of control
p.000059:
...

p.000059: procedures of the scientific community itself (self-regulation) the extent of “bureaucratization” would be
p.000059: restricted since the parties themselves have an interest in effective control.
p.000059:
p.000059: RECOMMENDATIONS
p.000059:
p.000059: The specificities of biological research call for some general guidelines: Proposal I
p.000059: The independence of research is a public good. A society that recognizes and safeguards this principle cannot accept
p.000059: the unconditional submission of researchers to purely economic parameters.
p.000059: Therefore, some space needs to be ensured -and supported financially- for the unhindered development of research
p.000059: initiatives governed by princi- ples, rules and priorities set by science itself (the respective scientific field) even
p.000059: under the afore mentioned circumstances.
p.000059:
p.000059:
p.000059:
p.000060: 60
p.000060:
p.000060: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000060: REPORT
p.000060:
p.000060: This responsibility lies primarily with the state through the public funding of research. It is important, however,
p.000060: that non-state agencies can contribute here (e.g. non-profit organizations or charities).
p.000060:
p.000060: Proposal II
p.000060:
p.000060: The scientific community is the natural guarantor of independence of research both internationally and
p.000060: nationally. A national policy of research must be based on the community of scientists of every field
p.000060: in order to avoid the imposition of “outside” regulations. A principle similar to academ- ic freedom in higher
p.000060: education should be adopted for research.
p.000060:
p.000060: Proposal III
p.000060:
p.000060: In terms of ethics, a national policy for research must ensure:
p.000060: - Transparency in the allocation of funds to research projects according to specific and preset criteria including
p.000060: active support for basic re- search. The state is responsible for developing the latter even if the re- turn to
p.000060: the economy is only indirect.
p.000060: - The independence of the community of scientists and of research insti- tutions in setting research priorities. The
p.000060: former can only be defended by a national planning board. Its members must come from the scien- tific community and
p.000060: serve for a specific mandate. The terms of estab- lishment and operation of the ESET generally meet these
p.000060: require- ments. Research bodies must be free in their planning which means that the national board can set
p.000060: only general binding frameworks.
p.000060: - Control of the accuracy and publication of all the results.
p.000060: - Accurate recording of the individual contributions of researchers in col- lective publications in scientific
p.000060: journals.
p.000060: - The investigation and publication of cases of unethical research con- ducted with public funds
p.000060: (fabrication of results, plagiarism, use of questionable methods, violation of bioethical principles, etc.).
p.000060: - The encouragement of the initiatives of young researchers and re- searchers with significant experience from
p.000060: abroad.
p.000060:
p.000060:
p.000060:
p.000060:
p.000061: 61
p.000061:
p.000061: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000061: REPORT
p.000061:
p.000061: Proposal IV
...

p.000070:
p.000070: 1. Adoption of special regulations
p.000070:
p.000070: The Commission witnesses an ever increasing interest, the last decades, for the adoption of general rules for
p.000070: the protection of biodiversity at the level of international and EU law. Instruments like the UN
p.000070: Convention on Biological Biodiversity (Rio de Janeiro) or Directive 92/43 establishing the network Natura
p.000070: 2000 for sensitive ecosystems are two important points of reference. A plethora of specific laws on the protection of
p.000070: particular cases, especially endangered species, are also in effect. This shows that the value of biodiversity is not
p.000070: merely wishful thinking but has become binding.
p.000070:
p.000070: 2. The situation in our country
p.000070:
p.000070: Our country has adopted these instruments and in addition has enacted national legislation. However, the Commission
p.000070: draws attention to views of public bodies and non-governmental organizations about a deficit of en- forcement
p.000070: of the existing regulations.
p.000070: This inadequate protection of biodiversity is due to many reasons, the main of which are limited
p.000070: knowledge about our biological wealth, lack of clearly defined land uses (especially with regards to farming,
p.000070: animal breed- ing and forest land), a misconception of the environment as a “local” issue by central government and
p.000070: the extremely limited jurisdiction of law en- forcement authorities. The underlying reason, though, is the
p.000070: absence of a modern education, focused on the importance of environmental values.
p.000070:
p.000070: III. Proposals
p.000070:
p.000070: With the above facts in mind, the Commission believes it is important that the State considers certain
p.000070: proposals on the overall management of the country’s biological wealth.
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000070:
p.000071: 71
p.000071:
p.000071: MANAGEMENT OF BIOLOGICAL WEALTH
p.000071: OPINION
p.000071:
p.000071: A. General proposals
p.000071:
p.000071: A more efficient protection of biodiversity requires the adoption of cer- tain measures of broader environmental
p.000071: protection policy. Such measures may include the following:
p.000071: 1. Environmental protection must be recognized as an essential compo- nent of national policy-making. It is a
p.000071: fact that environmental issues cut across the remit of more than one Ministry, as well as that of local authori-
p.000071: ties. For this reason and to avoid conflicts of interest and jurisdiction in deci- sion-making (e.g. environmental
p.000071: protection and public works policy) it is necessary to find a government arrangement that will ensure effective
p.000071: cen- tral planning of national environmental policy and effective intervention in order to meet the goal, which
p.000071: is the protection of biodiversity and of the environment in general.
p.000071: 2. The government needs to design specific incentives and support ac- tions for “green business” by
p.000071: developing jobs aiming (among else) on the protection of biodiversity. These actions must be long-term and
p.000071: competitive compared to traditional economic activities especially in the pressing condi- tions of the current economic
p.000071: crisis.
p.000071: 3. Enhancing environmental education and raising awareness amongst citizens of all ages but with
p.000071: emphasis on all educational levels. Non- Governmental Organizations (NGOs) involved in environmental action
p.000071: are expected to play an important role in this. The development of NGO activi- ties that promote these objectives at
p.000071: all educational institutions nationwide should be encouraged and supported.
p.000071:
p.000071: B. Special proposals
p.000071:
p.000071: In addition to general measures, the Commission proposes the following for consideration:
p.000071: 1. To coordinate and support research, particularly in monitoring chang- es in the national biological wealth, by
p.000071: assigning this responsibility to an entity and ensuring constant cooperation with universities and
p.000071: research organizations.
p.000071: 2. To produce a complete inventory and mapping of the country’s sensi- tive ecosystems (Natura areas), to
p.000071: determine the allowed activities within
p.000071:
p.000071:
p.000072: 72
p.000072:
p.000072: MANAGEMENT OF BIOLOGICAL WEALTH
p.000072: OPINION
p.000072:
p.000072: such areas without delay and to broaden the enforcement mandate of the independent management authorities.
p.000072: 3. To reinforce the mandate of control of the judiciary (e.g. broadening the application of involvement of the
p.000072: public prosecutor for the environ- ment, the availability of technical support in order to reinforce the evalua-
...

p.000084: with the new ones?
p.000084: These questions can be answered in many ways but it is worth pointing out that the value of biodiversity is seen in
p.000084: relation to our needs. Thus, bio- diversity appears to be a rather relative and not an absolute value, as might be
p.000084: argued by those who deny the “anthropocentric” approach and advocate the extension of the notion of moral subjects to
p.000084: beings other than humans.
p.000084:
p.000084: The rights of “future generations”
p.000084:
p.000084: The third consideration we are concerned with regards the so-called “rights of future generations”. The term
p.000084: underlines our responsibility vis-à- vis coming generations and binds us with the powerful notion of
p.000084: “rights”. People (or populations) that do not yet exist are thus recognized as “sub- jects of rights”. For
p.000084: this reason, the pertinence of this terminology is highly controversial since future people are considered among
p.000084: other things “re- mote in time” and “undefined” (Partridge: passim).
p.000084: Be that as it may, the ethical duty of “solidarity” between generations is not put in question. This duty is broken
p.000084: down into more special “responsibil- ities” (according to the terminology of the relevant UNESCO declaration)
p.000084: that are not related exclusively to the protection of the environment (e.g. there is a responsibility to
p.000084: maintain freedom of choice for future genera- tions at all levels, to preserve cultural difference and heritage,
p.000084: peace, devel- opment and education, to avoid social discrimination). The conservation and perpetuation of the human
p.000084: species, the protection of the diversity of the human genome, the protection of life on the planet and
p.000084: biodiversity, and the wider protection of the environment are, of course, vital components of this duty.
p.000084: As stated above, our responsibility to future generations ethically justi- fies the sustainable development debate.
p.000084: The crucial question related to this issue concerns the source or foundation of this powerful ethical duty.
p.000084: At first sight, it is an “imperfect duty” (like kindness, philanthropy etc., according to the Kantian distinction).
p.000084: But perhaps this solution falls short of the powerful commitment we appear to accept.
p.000084: One could also posit a utilitarian foundation according to which our self- restraint for the sake of next generations
p.000084: eventually improves our present
p.000084:
p.000084:
p.000085: 85
p.000085:
p.000085: MANAGEMENT OF BIOLOGICAL WEALTH
p.000085: REPORT
p.000085:
p.000085: state as well, since it leads to a rational and renewable exploitation of (fi- nite) natural resources.
p.000085: A third alternative would be to further investigate the subject in the field of the theory of “rights” or, at
p.000085: least, “interests” -either finding a way to overcome the afore mentioned difficulties in recognizing
p.000085: persons, who do not yet exist, as subjects, or dilating the reflection on our own rights and interests.
p.000085: In the latter context, we may postulate, for instance, that future generations are our concern to the extent that our
...

p.000096: protection from arbitrary interventions12. The protection of biodiversity, and of the environment in general, should be
p.000096: on an equal footing with social and economic factors which are taken into account when changing land use. This
p.000096: can be ensured only by a National Land Use Plan for the totality of the national territory.
p.000096:
p.000096: 12 Flexibility in the designation of land uses often leads to the destruction of habitats or wetlands especially if no
p.000096: special protection status applies. Typical is the case con- sidered by the JRC on an action to protect a habitat in the
p.000096: Porto settlement on the island of Tinos. In this area, the boundaries of the settlement were not clearly defined and
p.000096: the habitat was not delineated. As a result there was unauthorized building de- spite decisions by the JRC ordering the
p.000096: dismantling of constructions. Today the area is so much altered by intensive construction that it is difficult to
p.000096: recognize the proper- ties which called for its conservation (Affaire 20671/27.11.2003 JRC).
p.000096:
p.000097: 97
p.000097:
p.000097: MANAGEMENT OF BIOLOGICAL WEALTH
p.000097: REPORT
p.000097:
p.000097: V. Public awareness
p.000097:
p.000097: A mere information campaign in schools on the need to protect the envi- ronment and biodiversity is not effective
p.000097: because it fails to “mobilise” audi- ences.
p.000097: In cooperation with the Ministry for Education the YPEHODE should en- courage voluntary programs on specific
p.000097: projects that promote knowledge and protection of nature. Appropriate organizers of such initiatives are envi-
p.000097: ronmental NGOs because they rely on voluntarism themselves.
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000097:
p.000098: 98
p.000098:
p.000098: MANAGEMENT OF BIOLOGICAL WEALTH
p.000098: REPORT
p.000098:
p.000098: Acknowledgments
p.000098:
p.000098: Warm thanks are due for the very useful discussions, assistance and in- formation material provided to us by:
p.000098: Professor L. Louloudis, Vice Rector, Agricultural University of Athens, Pro- fessor Nikos Beopoulos, Department of
p.000098: Agronomic Economics, Agricultural University of Athens, Professor Anastasios Legakis, Department of Biology,
p.000098: University of Athens, Mr. M. K. Menoudakos, Deputy Presiding Judge in the JRC, Mrs. C. Hatzi, Deputy Ombudswoman
p.000098: (Department of Quality of Life), Mr. M. C. Tsaitouridis and Mrs. K. Vlahou, Senior Investigators with the Om-
p.000098: budsman, Mrs. T. Nantsou, responsible for Environmental Policy in WWF Greece, Mr. M. N. Charalambidis,
p.000098: General Director of the Greek Office of Greenpeace, Mr. M. Nikolaos Baias, Director of the Organization of
p.000098: Accredi- tation and Supervision of Agricultural Products (OPEGEP), Mr. M. Artemios Hatziathanasiou, Agronomist with
p.000098: the Division of Land Planning & Environ- mental Protection.
p.000098:
...

p.000107:
p.000107: 2 See art. 11 (1) (a).
p.000107: 3 See art. 11(2).
p.000107: 4 For a summary of this data, see the accompanying report.
p.000107:
p.000108: 108
p.000108:
p.000108: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000108: OPINION
p.000108:
p.000108: tion between physicians and families, especially in order to understand the personality and needs of patients.
p.000108:
p.000108: c) Training for physicians
p.000108: Appropriate training on the importance of autonomy for physicians and other health care professionals is a crucial
p.000108: problem.
p.000108: The procedure of consent is often viewed by physicians as a piece of bureaucracy leading them to treat
p.000108: it as a mere formality. Contrary to this practice, consent is not to be considered as a safeguard for the
p.000108: protection of physicians but as a token of respect for the patient’s autonomy. However, even when physicians are
p.000108: conscious of the need to respect patient autono- my they feel uncertain on how they should act since perceptions of
p.000108: auton- omy vary from patient to patient and from physician to physician.
p.000108: Developing relationships of cooperation and trust with patients requires appropriate education for physicians. The aim
p.000108: is not some “formal” accom- modation of the patients’ rights but to obtain the best outcome in dealing with health
p.000108: problems taking into account the values and overall way of living of patients. Seen in this light, the
p.000108: participation of patients in their treat- ment, far from being an impediment, helps to reach the best possible
p.000108: medi- cal outcome.
p.000108: In view of the above the Commission thinks that emphasis needs to be placed on ethics and its implementation in
p.000108: clinical practice both in university education and in ongoing training for physicians. Equally important is
p.000108: to ensure meaningful education in communication with patients for physicians of all specialties focusing on the
p.000108: benefits of honesty. Lifelong training of physicians on the subject-matter is also required (a relevant duty is
p.000108: stipulat- ed by the CME). Hospital boards of ethics, scientific societies and medical associations must
p.000108: arise to the task and take the initiative.
p.000108:
p.000108: d) Education and information for citizens
p.000108: The above demonstrate a need for appropriate citizen education aiming at the optimal application of the new model.
p.000108: Patients who are suitably in- formed “ahead of time” are more likely to cooperate actively, assisting phy- sicians in
p.000108: their work and enhancing the efficacy of treatment.
p.000108: Citizen education can be promoted through elementary education, in- formation campaigns by local authorities,
p.000108: local associations, regional hospi-
p.000108:
p.000108:
p.000109: 109
p.000109:
p.000109: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000109: OPINION
p.000109:
p.000109: tals and volunteer organizations. Educational programs from the media un- der the hospices of the Ministries for Health
p.000109: and Education could also be of assistance.
p.000109:
p.000109: B. Particular problems
p.000109:
p.000109: a) Power to consent and limits of autonomy
p.000109: The Commission believes that when patients who are capable to consent are committed to hospital they should appoint a
p.000109: representative in writing, if possible.
p.000109: In case of patients incapable to consent who have not appointed a rep- resentative, the Commission thinks that:
p.000109: i) The legal representatives of the patient may select one of alternative treatment methods but may not refuse all
p.000109: treatments if the treating physi- cian believes that the continuation of therapy is beneficial. Only patients
p.000109: who are capable for self-consent may refuse treatment.
p.000109: ii) In case of disagreement between the legal representatives the treat- ing physician should be able to decide taking
p.000109: into account the opinion of the hospital board of ethics which must be made mandatory in our country.
p.000109: iii) The physician must take into consideration any prior directions by the patient (id est, any wishes the patient
p.000109: expressed prior to becoming incapa- ble to consent).
p.000109: iv) The opinion of mentally mature minors on issues regarding their health must be taken into account in
...

p.000112: to foresee and foretell to the sick their present condition, what preceded it and what will happen in the fu- ture”.
p.000112: He considers also that “any irrational thing that happens needs to be dis- cussed” (Rigatos, 1997) while he
p.000112: argues that when the physician analyses the present condition of the patient and what he foretells for the future in
p.000112: the presence of the patient the latter will find it easier to believe that the physician is well acquainted
p.000112: with the situation and will have more confidence in him (Hippocrates, Prognostics, introduction to the
p.000112: text).
p.000112:
p.000113: 113
p.000113:
p.000113: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000113: REPORT
p.000113:
p.000113: the conditions in which it operates which affect the relationship physician- patient can be summarized as follows:
p.000113: 1. Medicine is divided into several specialties and one physician alone is no longer able to treat all the health
p.000113: problems of an individual.
p.000113: 2. The physicians of different specialties as involved to consult in the course of his/her life will
p.000113: not necessarily work together; therefore, the patient is the only one with a complete picture of his/her medical
p.000113: history. It should be noted also that in Greece, records of medical his- tory are not kept for each patient.
p.000113: 3. Medicine has progressed in such a way that there is no single indicat- ed treatment for each particular condition.
p.000113: 4. The level of education in our country has been improved in recent decades. As a result, most patients
p.000113: are able to understand the medi- cal facts of their condition and are seeking more detailed infor- mation.
p.000113: Furthermore, the lay public enjoys greater, if fragmentary, access to medical information from a variety of
p.000113: sources.
p.000113: 5. People do not trust the motives of physicians unreservedly. This is mainly because the practice of
p.000113: medicine is sometimes known to be influenced by varying interests not necessarily compatible with the patient’s
p.000113: interests.
p.000113: 6. Citizens demand more from the health system as regards the quality of services, the medical outcome and the
p.000113: conditions in which these services are provided. The provision of high quality services is consid- ered by citizens as
p.000113: an utmost priority in our country.
p.000113: 7. It is now acknowledged that the way of living and the religious or other philosophical beliefs of
p.000113: patients must be taken into considera- tion when determining treatment. There is an increasing awareness of the right
p.000113: to autonomy and of respect for dignity in medicine.
p.000113:
p.000113: B. LEGAL ISSUES
p.000113:
p.000113: In general
p.000113:
p.000113: The “Code of Medical Ethics” (CME, Law 3418/2005) has put in place a modern legal framework for the relationship
p.000113: physician-patient in Greek
p.000113:
p.000113:
p.000113:
p.000114: 114
p.000114:
p.000114: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000114: REPORT
p.000114:
...

p.000117:
p.000117:
p.000118: 118
p.000118:
p.000118: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000118: REPORT
p.000118:
p.000118: c) Medical liability and other legal consequences
p.000118:
p.000118: In legal terms, the answers to all the above questions have an impact, first and foremost, on the extent of
p.000118: medical liability (criminal, civil and pro- fessional). Liability, in this case, is not connected with fault in the
p.000118: execution of a medical act (which is judged according to lege artis execution) but with fault at the stage preceding
p.000118: the act, i.e. during the legal procedure of deci- sion-making7.
p.000118: Thus the implementation of the Oviedo Convention and the CME provi- sions on “informed consent” (and of the provisions
p.000118: of special legislation on transplants, assisted reproduction, etc.) complement the general legislation on medical
p.000118: liability (e.g. arts. 57, 914 CC, art. 8 Law 2251/1994) and may provide grounds for particular claims in
p.000118: action8.
p.000118: Secondly, the answers may have an impact on the legal situation of third parties (hospitals, relatives) insofar as
p.000118: compliance with the principle of con- sent is associated with individual rights and obligations pertaining to them.
p.000118:
p.000118: C. SPECIAL PROBLEMS IN THE IMPLEMENTATION OF AUTONOMY WITH EMPHASIS ON THE GREEK SITUATION
p.000118:
p.000118: The model of patient consent is based on the assumption of appropriate education on personal autonomy, on the one hand,
p.000118: and on the allocation of relatively adequate time for a sober evaluation of information, on the other. These
p.000118: assumptions rarely permit the application of the model in its pure form. As a matter of fact, special
p.000118: circumstances call for adjustments. There- fore, certain areas of medical practice must be considered separately.
p.000118:
p.000118:
p.000118:
p.000118:
p.000118: 7 This broad concept of fault is upheld today in Germany, France and the US, see Fountedakis (2003) p.
p.000118: 210-211 who accepts the distinction between “medical error” and “information error” (p. 216).
p.000118: 8 The preferred criterion for the assessment of prior information in the context of medical liability is
p.000118: the “average rational person”, see Androulidakis-Dimitriades (1993) p. 273. Typical in the case-law is the case
p.000118: Canterbury v. Spence. (464 F.2d 772 [D.C. Cir. 1972]) which changed the initial approach of American tribunals.
p.000118:
p.000119: 119
p.000119:
p.000119: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000119: REPORT
p.000119:
p.000119: 1. Extent of information
p.000119:
p.000119: As mentioned earlier, our national legislation (CME) requires informed consent prior to every medical act
p.000119: unless patients refuse the information by exercising their right not to know. But patient information is not limited to
p.000119: those cases where patients need to consent to a medical act. It also includes the patient’s right to know the
...

p.000123: ef- fecting the indicated medical act will definitely cause serious harm to health. Thus, moderate harm to health, even
p.000123: when demanding immediate action, or serious but chronic pathological conditions (e.g. many forms of cancer, dia- betes,
p.000123: etc.) cannot qualify as “emergencies”. In-between these two ex- tremes, there is an area in which the
p.000123: rule of consent must apply with the necessary adjustments to the available margins of time9.
p.000123: As far as inadequate organization of health services is concerned, the possibility to allocate the required
p.000123: time depends mostly on objective, often non-elastic, parameters (e.g. restricted resources to employ additional med-
p.000123: ical staff). Especially here, however, the issue of appropriate training and sensitization of civil health
p.000123: services to patient autonomy is crucial. For, if patient consent is not to be considered a “luxury” but an
p.000123: essential condition for the protection of health and, ultimately, for quality of life, then this re- quirement
p.000123: obviously affects the priorities of the organization of services in a way that makes finding the required time
p.000123: feasible.
p.000123:
p.000123: 3. Education - Training
p.000123:
p.000123: Among the reasons invoked by physicians to justify the concealment of diagnosis from their patients in Greece, as well
p.000123: as in other countries which
p.000123:
p.000123: 9 However, for a discussion on whether summary information provided to a patient capable to consent qualifies as
p.000123: “appropriate” in emergency circumstances see also Young, 2001.
p.000123:
p.000124: 124
p.000124:
p.000124: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000124: REPORT
p.000124:
p.000124: share the same practice, is the lack of training (Mystakidou 1996; Iconomou 2002).
p.000124: The question of deficient training of physicians in patient autonomy in Greece has at least two sides. The
p.000124: first concerns the knowledge of the rights of patients and the second the implementation of these rights and the ef-
p.000124: fective communication with patients. Typically, in the Medical School of the University of Athens, medical ethics
p.000124: remains an optional subject. The same deficit permeates all the national curricula in regard to learning how to ap-
p.000124: proach patients and develop meaningful relationships with them taking into account the whole spectrum of the patient’s
p.000124: needs and respecting his/her autonomy.
p.000124: The new model of the physician-patient relationship involves active par- ticipation on the part of the patient.
p.000124: Patients need appropriate education too, if they are to respond to this role. Therefore, education is an issue not
p.000124: only for physicians but for society as a whole.
p.000124:
p.000124: 4. Epidemiology: Vaccination
p.000124:
p.000124: In the prevention of infectious diseases, especially in the example of vac- cination, free will of the individual must
p.000124: be weighed against the interest of society as a whole. Should the Commission decide to consider the question of patient
p.000124: consent to vaccination the following observations may be of use.
p.000124: The success of mass vaccination is based on the greatest possible partic- ipation; in democratic societies,
p.000124: however, people may not be coerced to participate (Asveld, 2008). Here, the State, on the one hand, and the
p.000124: scien- tific community, on the other, while obliged to respect individual autonomy, are called upon to ensure the
p.000124: greatest possible participation, provided the benefits of vaccination and the safety of the vaccine have been
p.000124: foreseen and documented as far as possible. But individual citizens also bear a re- sponsibility to
p.000124: society, and their decision to participate or not in a vaccina- tion program cannot be based solely on the argument of
p.000124: autonomy. Individ- ual people themselves will probably not benefit directly from participating in a vaccination
p.000124: program, but they contribute to the protection of society and of vulnerable groups in particular.
p.000124: The importance of confidence in the safety of vaccines and the major role of the State and of the scientific
...

p.000161: mittees (Special Ethics Committees and Central Research Committees) must be entirely justified.
p.000161: - The initiative to promote internal procedures of research ethics in in- dustries that sponsor clinical studies,
p.000161: via their communal representa- tives (e.g. Panhellenic Association of Pharmaceutical Industry, Hellenic Federation
p.000161: of Enterprises).
p.000161: - Submission to the responsible hospital authorities where the clinical studies is conducted, of a
p.000161: disclosure by each researcher stating any possible working relationship with the company/sponsor or any possi- ble
p.000161: income or other kind or association, such as receiving company’s products, gifts, travel expenditure coverage
p.000161: etc. This disclosure should also be submitted to the responsible authorities of the State which are authorized to
p.000161: control the research, prior to the start of the clinical re- search, but also to every participating patient. In
p.000161: addition, publication of the relevant research results must be accompanied by a notification to the editorial boards
p.000161: of national scientific journals, and submitted conference abstracts must be accompanied by a notification
p.000161: to the conference organizing committees. Members of the control bodies also ought to submit a similar disclosure, as
p.000161: well as the research institutes on the assumption that there is any financial relationship (sponsor- ships,
p.000161: dividend payments of commercial products in the research etc.), including the company/sponsor.
p.000161: - The establishment of a regular education to raise the researchers’ awareness of potential conflict of
p.000161: interest, and inform about the means of control (e.g. in the context of introductory information pro- vide to a
p.000161: research group by their head or the ethics committee of the research institute, as well as by organizing special
p.000161: seminars).
p.000161:
p.000161:
p.000161:
p.000162: 162
p.000162:
p.000162: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000162: OPINION
p.000162:
p.000162: Finally, the Commission supports the right to access control mechanisms by whoever participates in a certain clinical
p.000162: study and invokes evidence of misconduct.
p.000162:
p.000162:
p.000162: Athens, 5 July 2011
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000163: 163
p.000163:
p.000163: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000163: OPINION
p.000163:
p.000163: COMPOSITION AND PERSONELL
p.000163: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000163: Chairman: John Papadimitriou, Emeritus Professor of Surgery, Medical School, University of Athens.
p.000163:
p.000163: Deputy Chairman: George Maniatis, Emeritus Professor of Biology, Medical School, University of Patras.
p.000163:
p.000163: Members:
p.000163: Julia Iliopoulou-Stranga, Professor of Constitutional Law, Law School, Uni- versity of Athens.
...

p.000216: The same applies, of course, to the new Protocol of the Oviedo Conven- tion -not yet ratified by Greece- which includes
p.000216: provisions for genetic tests for medical reasons (2008). After ratification by the Greek Parliament, this Protocol
p.000216: will be binding and will outweigh the general legislation.
p.000216: Its fundamental provisions, especially those related to DTC genetic test- ing, regardless of what it is generally
p.000216: in force (consent, protection of the incapable to consent, protection of personal data), are those demanding:
p.000216: - A high level of quality in genetic testing, according to universally accepted criteria of scientific and
p.000216: clinical accuracy (art. 5 a),
p.000216: - the appropriate experience of staff providing these services (art. 5 b),
p.000216: - regular controls of the laboratories (art. 5 c),
p.000216: - the proved clinical necessity of such a test (art. 6),
p.000216: - the essential medical counseling and examination (art. 7),
p.000216: - the adequate previous informing of the interested party (art. 8).
p.000216:
p.000216: CONCLUDING REMARKS
p.000216:
p.000216: 1. Ensuring the quality of the provided genetic tests
p.000216: The quality of genetic services primarily includes analytical and clinical accuracy of the tests, high level
p.000216: equipment of genetic centers and laborato- ries, as well as training and continuous education of their staff. Genetic
p.000216: cen- ters offering genetic testing services must have an internal system of quality control and also participate in
p.000216: external quality controls.
p.000216: The accreditation of genetic centers and tests, which could be conducted by responsible institutions (e.g. Hellenic
p.000216: Accreditation System -ESYD- which acts as the National Accreditation Body and operates within the Ministry of
p.000216: Development), safeguards the quality of genetic tests. Certified training and
p.000216:
p.000216:
p.000217: 217
p.000217:
p.000217: DIRECT-TO-CONSUMER GENETIC TESTING
p.000217: REPORT
p.000217:
p.000217: continuous education of the staff (physicians, genetic counselors, biologists and nurses) is essential. Many of the
p.000217: genetic tests offered today are based on detecting certain genetic markers which have been associated with pre-
p.000217: disposition or high risk for specific diseases, without having their prognostic value documented. The clinical utility
p.000217: and true prognostic value of a genetic test must be a fundamental criterion and, as such, provided by the genetic
p.000217: centers.
p.000217:
p.000217: 2. Special legislation for DTC genetic testing
p.000217: It is essential to adopt a special legislation for DTC genetic testing and the use of genetic data.
p.000217: The law must, primarily, include the acknowledgement and establish- ment of “Clinical Genetics” as a specialty
p.000217: or specialization, in order to ensure quality of the provided services, including genetic counseling as well. A simi-
p.000217: lar suggestion has been issued by the General Council for Health (KESY) (de- cision on “Organization and Function of
p.000217: Genetic Centers - Geneticists Quali- fications” 2/204 21.9.2006), which sets the qualifications for a Clinical
p.000217: Ge- neticist.
p.000217: The special legislation must also set the terms of use of biological mate- rial and genetic data produced by DTC
p.000217: genetic testing. Biological samples or even specific genetic data from every genetic analysis could be useful
p.000217: for science and research purposes. For this purpose, it would be appropriate to store the biological samples in
p.000217: biobanks and the genetic data in databases, under the condition that they are anonymized or that the individual has
p.000217: giv- en consent in order to use them for research purposes.
p.000217:
...

p.000239: should define more precisely the limits of medical intervention, finding eventually a “gray zone” to the moderate
p.000239: definition of health.
p.000239: The so-called “enhancement” raises this general issue on the very own concept of health, and consequently, the nature
p.000239: of the medical profession, which are complemented by two additional ethical issues that must be addressed
p.000239: specifically.
p.000239: Firstly, there is the question of our own self-determination in health issues. In other words, is
p.000239: “enhancement” a right of the person who wishes it? Namely, does enhancement fall within the realm of biological
p.000239: autonomy, and indeed, is it an aspect of the fundamental right to health? Regardless of the legal dimension of such
p.000239: issues, the moral concern, here, is actually our ability to treat our body and to intervene freely in its’
p.000239: constitution or not. Even if we answer affirmatively to this freedom on our body, we must wonder to what
p.000239: extent: a) is it binding for the physician to whom we refer (particularly when an enhancement intervention may have
p.000239: adverse effects), and, b) does it allow us to apply enhancement in the field of childcare?
p.000239: Finally, another question concerns our relationships with others, or else, justice. Frequently, enhancement is
p.000239: attempted by someone in order to deal with the various requirements of social environments, especially in
p.000239: rivalry relationships (sports, education, fashion, etc.). Is there a limit imposed by justice? The answer is,
p.000239: of course, affirmative, but it is not clear whether for example, using pharmaceutical agents is fundamentally
p.000239: different from an intensive workout in sports, or the consumption of natural stimulants (coffee, etc.)
p.000239: during class exams.
p.000239: Moreover, the issue of justice relates to the objection expressed for enhancement interventions which are
p.000239: costly, and for which equal access cannot be ensured. If such interventions significantly enhance physical
p.000239: abilities, then, marginally, they may possibly result in unequal opportunities (mainly professional) in social
p.000239: life. Ultimately, individuals who can afford such enhancement interventions may acquire privileged
p.000239: positions. The
p.000239:
p.000239:
p.000240: 240
p.000240:
p.000240: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000240: REPORT
p.000240:
p.000240: option to resolve the problem by covering the enhancement costs through social insurance is not feasible, not only due
p.000240: to the overall, worldwide crisis of the social insurance systems -which, in many cases, led to cuts in
p.000240: absolutely essential coverage- but mainly because the ambiguity of the term “enhancement” (the subjectivity of needs)
p.000240: does not offer a safe ground to plan social services for the general population.
p.000240:
p.000240: 4. The position of Law
p.000240:
p.000240: The general principles concerning human enhancement are identified, firstly, in the constitutional
p.000240: provisions and the provisions of the European Convention on Human Rights (ECHR).
...

p.000253: to take care of the good state of our health and avoid risks, for reasons related to collective interests
p.000253: (the good of our family, our productivity at work, public health or even to avoid extra burden on the public
p.000253: health insurance systems), does not seem justified. On the one hand, such an obligation would drastically restrict
p.000253: the enjoyment of many freedoms (especially in the context of professional and private life). On the other hand,
p.000253: endangerment is a structural feature of today's “risk society”, to the point that it becomes impossible
p.000253: to lead a
p.000253:
p.000253:
p.000254: 254
p.000254:
p.000254: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000254: REPORT
p.000254:
p.000254: “healthy” life. In this sense, there is no essential ethical basis in the criticism of “self-destruction”, at least as
p.000254: far as the concept of autonomy presuppo- ses the rational -and non-arbitrary- use of our freedom.
p.000254: As to the second issue, our relations with third parties set limits on the enhancement of physical abilities by
p.000254: using pharmaceutical agents. Ideally, ensuring equal access to any mean that can enhance performance is a
p.000254: characteristic of justice. If this is not possible, the prohibition of specific means is, in principle,
p.000254: legitimate, in competing procedures (e.g. in education or in sports -especially championship games, where the
p.000254: interests of third parties is stronger).
p.000254: In contrast to pharmaceutical enhancement, interventions in an indi- vidual’s genome are “with no return”,
p.000254: namely they generate permanent effects on the organism. As long as there are relevant applications (as
p.000254: already discussed for championships), the concerns are stronger here, since many gene functions remain mostly
p.000254: unknown. Therefore, genetic mani- pulation imposes a greater risk on the state of the organism. Precisely due to
p.000254: this uncertainty, it is ethically questionable whether genetic manipulation methods are justifiable (“protective
p.000254: principle”) as a form of acceptable options within a person’s autonomy, because under such circumstances the
p.000254: “rational” use of freedom proves problematic. Certainly, however, the matter of providing the necessary and
p.000254: accurate information concerning the use of genetic manipulation methods is crucial.
p.000254:
p.000254: 3. The law
p.000254:
p.000254: Drug administration is subjected to the provisions of the pharmaceutical legislation (Directive 2001/1983, as
p.000254: incorporated by the Ministerial decision DYG 3a/83657/24.1.2006, Law 1316/83, as in force, Law 96/1973, as in
p.000254: force) which are particularly relevant to the responsibility of physicians, pharmacists and traders, also
p.000254: controlled by the National Organization for Medicines (NOM). In this legislation, the prohibition of
p.000254: advertising pre- scription drugs to the public and the strict terms on the physicians’ updating about these drugs, are
p.000254: of particular importance.
p.000254: Particularly for doping in sport, both the International Convention against Doping in Sport (UNESCO,
p.000254: 2005) ratified by Law 3516/2006, and the Anti-Doping Convention (Council of Europe, 1989) ratified
p.000254: by Law
p.000254:
p.000254:
p.000255: 255
p.000255:
p.000255: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000255: REPORT
p.000255:
p.000255: 2371/1996, are applied. These legislations, are “procedural” in nature and provide control, information,
p.000255: education and transnational cooperation, but without general substantive criteria for classifying substances
p.000255: as “pro- hibited”. The characterization as “prohibited” is left to the absolute discretion of
p.000255: WADA and directly adopted from the states that ratified the aforementioned legislation. It is
p.000255: interesting to note that athletes are permitted to use prohibited substances for therapeutic purposes. The
p.000255: first Convention was specialized in our country with the YA 3956/19.2.2012, specifying, in particular, the
p.000255: national anti-doping controls for all sports under the responsibility of ESKAN. The Anti-Doping Convention
p.000255: of the Council of Europe includes a first list of prohibited substances (with varying classifications), which has
p.000255: been updated from the relevant WADA list (included in the WADA Code 2003).
p.000255: In the field of genetic enhancement (as long as it becomes feasible, especially in sports) the
p.000255: restrictive provision of Art.13 of the Oviedo Convention is crucial, according to which interventions
p.000255: in the genome are permissible “only for preventive, diagnostic or therapeutic purposes”, and interventions
p.000255: that alter the gametes and therefore, the offspring’s genomes, are prohibited. Combined with the UNESCO Universal
p.000255: Declaration on the Human Genome and Human Rights, this provision leaves no substantial room to cover
p.000255: the interventions for pure genetic enhancement (e.g. correction of phenotypic characteristics, as long
p.000255: as it is feasible). On the contrary, this provision allows preventive interventions, through DNA
p.000255: modifications.
p.000255:
...

p.000261: Comité Consultatif National d` Éthique (CCNE) (1998). Rapport sur le vieillissement, Opinion No 59.
p.000261: Comité Consultatif National d` Éthique (CCNE) (2004). L’ allotransplantation de tissu composite (ATC) au niveau de la
p.000261: face (Greffe totale ou partielle d’ un visage), Opinion No 82.
p.000261: Crerand CE, Franklin ME, Sarwer DB (2006). Body dysmorphic disorder and cosmetic surgery. Plast Reconstr Surg 118,
p.000261: 167e-80e.
p.000261: Crerand CE, Menard W, Phillips KA (2010). Surgical and minimally invasive cosmetic procedures among
p.000261: persons with body dysmorphic disorder. Ann Plast Surg 65, 11-6.
p.000261:
p.000261:
p.000262: 262
p.000262:
p.000262: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000262: REPORT
p.000262:
p.000262: Crerand CE, Phillips KA, Menard W, Fay C (2005). Nonpsychiatric medical treatment of body dysmorphic
p.000262: disorder. Psychosomatics 46, 549-55.
p.000262: European Group on Ethics (EGE) (1999). Ethical aspects arising from doping in sport, Opinion No 14, 1.6, 2.10.
p.000262: Farah MJ (2005). Neuroethics: The practical and the philosophical trends in cognitive sciences, p. 34.
p.000262: Fukuyama F (2002). Our posthuman future: Consequences of the biotechnology revolution, Farrar,
p.000262: Strauss and Giroux, N. York.
p.000262: Garcia-Verdugo M (2005). Medio fondo y fondo. La preparacion del corridor de resistencia. Atletismo 4. Madrid. RFEA.
p.000262: GIRES (Gender Identity Research and Education Society) (2008). Gender var- iance (dysphoria) (www.gires.org.uk).
p.000262: Hayflick L (2003). Living forever and dying in the attempt. Exp Gerontol 38, 1231-1241.
p.000262: Hildt E (2005). Living longer: Ethical aspects of age-retardation, Paper presented at the 19th European
p.000262: Conference on Philosophy of Medicine and Health Care and 22nd EACME Conference “Ethics and Philosophy of Emerging
p.000262: Medical Technologies”, Barcelona.
p.000262: House of Commons, Select Committee on Culture, Media and Sport (2004). Seventh Report of Session 2003-2004, UK
p.000262: Parliament, HC 499-I.
p.000262: Huxtable R, Woodley J (2005). Gaining face or losing face? Framing the debate on face transplants.
p.000262: Bioethics, p. 505.
p.000262: Ingram DK, Anson RM, De Cabo R, Mamczarz J, Zhu M, Mattison JA, Lane MA, Roth GS (2004). Development of
p.000262: calorie restriction mimetics as a pro- longevity strategy. Ann NY Acad Sci 1019, 412-423.
p.000262: Kriari-Katrani I (2001). The constitutional protection of genetic identity. A first approach. DtA 2001, p.347.
p.000262: Lo HS, Xie SQ (2012). Exoskeleton robots for upper-limb rehabilitation: State of the art and future prospects. Med Eng
p.000262: Phys 34, 261-8.
p.000262:
p.000262:
p.000262:
p.000263: 263
p.000263:
p.000263: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000263: REPORT
p.000263:
p.000263: Louhija J, Miettinen HE, Kontula K, Tikkanen MJ, Miettinen TA, Tilvis RS (1985). Aging and genetic variation
...

p.000272: Many psychiatric, neurodegenerative and neurodevelopmental disorders coexist with abnormalities in “normal”
p.000272: cognitive and mental functions. Autism, intellectual disability, attention deficit disorder,
p.000272: schizophrenia, depression but also neurodegenerative diseases, such as Alzheimer's, Parkinson's and
p.000272: Huntington's chorea, are associated with impairment of cognitive functions. Aging of the brain also leads
p.000272: to similar effects. The continuous and rapid scientific developments make it possible, to some extent, to
p.000272: intervene in the development of these diseases and delay their symptoms, mainly through pharmaceutical
p.000272: substances that aim to enhance cognitive functions. Therefore, the moral issue raised here, is whether these
p.000272: pharmaceutical substances could be used in healthy people in order to enhance their cognitive and mental
p.000272: characteristics.
p.000272: The term “cognitive” functions refers to the procedures and processes of an organism that organize information.
p.000272: This includes the acquisition, selection, clarification and recollection of information, which correspond to
p.000272: the perception, attention, understanding and memory of the organism, as well as the way these processes
p.000272: determine behavior.
p.000272:
p.000272: I. The data
p.000272:
p.000272: Unquestionably, education, consumption of certain nutrients and the use of information processing devices,
p.000272: such as calculators and computers, constitute tools to improve cognitive activity and performance. However,
p.000272: these are considered as “conventional” and are commonly accepted. New technologies such as brain stimulation,
p.000272: and new uses of older technologies such as psychotropic drugs, are the subject of discussion and reflection
p.000272: in bioethics, in the context of human enhancement.
p.000272:
p.000272:
p.000273: 273
p.000273:
p.000273: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000273: REPORT
p.000273:
p.000273: 1. Brain stimulation
p.000273:
p.000273: a. “Deep brain stimulation”
p.000273:
p.000273: The so-called “deep brain stimulation” is an invasive, research method in which electrodes are implanted in the
p.000273: brain sending electrical stimulatory signals in selected regions of the brain. This method, among others,
p.000273: has been used experimentally to treat depression, epilepsy and Parkinson's disease with relatively good
p.000273: results. Indeed, deep brain stimulation has been approved by the U.S. Food and Drug Administration (FDA) for the
p.000273: treatment of essential tremor, dystonia and Parkinson's disease. Even though this technology could be used to
p.000273: enhance human cognitive and mental abilities, nevertheless there are no reports on the use of these
p.000273: experimental technologies in healthy subjects.
p.000273:
p.000273: b. Magnetic brain stimulation
p.000273:
...

p.000281: the user’s children or creates tension with colleagues etc., is illegitimate).
p.000281: - The user has actually made the decision freely, i.e. after providing the appropriate information to him/her, with
p.000281: all the potential risks being identified (Cakic, 613-614, Racine & Forlini, 3, Farah et al., 423). This is not certain,
p.000281: especially when the drugs are administered without a prescription or, at least, without consulting a physician.
p.000281: The re- sponsibility of the latter, here, is certainly increased, as it is about enhancing cognitive or
p.000281: mental characteristics and not about restoring relevant health damage.
p.000281:
p.000281:
p.000282: 282
p.000282:
p.000282: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000282: REPORT
p.000282:
p.000282: 4. Equal access
p.000282:
p.000282: The issue of equal access to means of cognitive or mental enhancement is mainly associated with the
p.000282: opportunities offered in competitive environments (Farah et al., 423) and, secondly, with improvement
p.000282: of our lifestyle. This is an issue of concern which is similar to that of enhancing physical abilities
p.000282: (e.g. doping in sports).
p.000282: Here, enhancement is usually associated with memory or concentration, especially during challenges in education or
p.000282: work. The general principle that wants to prevent distortion of rivalry is valid here, but it constitutes a
p.000282: “defensive” attitude. Equal access means, mainly, that anyone who desires it is able to use substances, under the two
p.000282: reservations mentioned above.
p.000282: An objection here would be that equal access does not exist anyway, regarding the conventional ways to
p.000282: enhance cognitive performance, namely through education or training. Pupils, students or employees have strongly
p.000282: differentiated possibilities of access to adequate education, mainly because of the economic inequality, which
p.000282: significantly affects their opportunities. Generally, equal opportunities presuppose equality to
p.000282: material means, which is practically impossible.
p.000282: On the other hand, one could argue that substance use may be an option to restore the general inequality of access to
p.000282: conventional means. Thus, for example, a student with artificially enhanced memory capacity and
p.000282: concentration could cover gaps with his/her own effort, gaps that his/her socially and economically
p.000282: “'privileged'” classmates cover with expensive teaching methods. The same applies to an employee who is a candidate
p.000282: for a better position, and objectively cannot devote the same time to study compared to a well-trained
p.000282: new candidate for the same position. Nevertheless, this argument would not be convincing. For the reason
p.000282: that, on the one hand, one cannot prevent the use of substances by “privileged” people and therefore restoring
p.000282: inequality, and on the other hand, one would encourage the easy, but temporary, way of going
p.000282: through meritocratic procedures instead of constantly trying to cultivate cognitive abilities (Farah et al.,
p.000282: 424). In fact, the concern of doping in sports applies here as well.
p.000282: In general, one must not overlook that -at least with the current data- the use of enhancement substances
p.000282: has temporary effects and does not
p.000282:
p.000282:
p.000283: 283
p.000283:
p.000283: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000283: REPORT
p.000283:
p.000283: replace the solid acquisition of knowledge through education. But overall, the use of such substances
p.000283: that aim to obtain cognitive balance or psychological well-being appears at present as an
p.000283: easy substitute for education. In a sense, one could consider that the emergence of this alternative
p.000283: choice is a failure of the educational and cultural mission of the State, and a substitute for fundamental
p.000283: deficiencies. Therefore, the issue constitutes a motivation for reflection on the wider environment that forms a
p.000283: personality. Persistence on the actions that change this environment - particularly in the areas of
p.000283: education (including continuous effort for real equality in opportunities) and culture- seems to acquire a
p.000283: timely, moral significance so that enhancement substances will stop being an option.
p.000283:
p.000283: ΙΙΙ. The law
p.000283:
p.000283: In terms of law, the general framework for dealing with enhancement of cognitive and mental characteristics does not
p.000283: differ from that of enhancing physical characteristics. On one hand, the constitutional provisions for the
p.000283: development of a personality (Art. 5 § 1) and the right to health (Art. 5 § 5) (in view of which, substance use for
p.000283: enhancement purposes is, in principle, permissible) and on the other hand, the protection of health (Art. 21
p.000283: § 3) (which highlights the responsibility of the state in controlling the use of substances or implants
p.000283: that are not intended for therapeutic purposes) are essential here.
p.000283: The EU legislation on the use of implants (Directive 93/42, incorporated with JMD DY8d/GP. Oik.130648/2.10.2009,
p.000283: Directive 90/385, incorporated by JMD DY8d/GP. Oik.130644/2.10.2009) and the Regulation 726/2004, regarding
p.000283: the centralized authorization procedure of substances at the EU level (STOA, 136) also apply here.
p.000283: In a more specific level, the use of the above mentioned substances or implants is subjected to the provisions of Law
p.000283: 3418/2005 (Code of Medical Ethics), regarding the responsibility of the physician who gives the
p.000283: prescription. There is no doubt that the physician performs a medical act, which is covered by the
...

Searching for indicator educational:

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p.000071: protection policy. Such measures may include the following:
p.000071: 1. Environmental protection must be recognized as an essential compo- nent of national policy-making. It is a
p.000071: fact that environmental issues cut across the remit of more than one Ministry, as well as that of local authori-
p.000071: ties. For this reason and to avoid conflicts of interest and jurisdiction in deci- sion-making (e.g. environmental
p.000071: protection and public works policy) it is necessary to find a government arrangement that will ensure effective
p.000071: cen- tral planning of national environmental policy and effective intervention in order to meet the goal, which
p.000071: is the protection of biodiversity and of the environment in general.
p.000071: 2. The government needs to design specific incentives and support ac- tions for “green business” by
p.000071: developing jobs aiming (among else) on the protection of biodiversity. These actions must be long-term and
p.000071: competitive compared to traditional economic activities especially in the pressing condi- tions of the current economic
p.000071: crisis.
p.000071: 3. Enhancing environmental education and raising awareness amongst citizens of all ages but with
p.000071: emphasis on all educational levels. Non- Governmental Organizations (NGOs) involved in environmental action
p.000071: are expected to play an important role in this. The development of NGO activi- ties that promote these objectives at
p.000071: all educational institutions nationwide should be encouraged and supported.
p.000071:
p.000071: B. Special proposals
p.000071:
p.000071: In addition to general measures, the Commission proposes the following for consideration:
p.000071: 1. To coordinate and support research, particularly in monitoring chang- es in the national biological wealth, by
p.000071: assigning this responsibility to an entity and ensuring constant cooperation with universities and
p.000071: research organizations.
p.000071: 2. To produce a complete inventory and mapping of the country’s sensi- tive ecosystems (Natura areas), to
p.000071: determine the allowed activities within
p.000071:
p.000071:
p.000072: 72
p.000072:
p.000072: MANAGEMENT OF BIOLOGICAL WEALTH
p.000072: OPINION
p.000072:
p.000072: such areas without delay and to broaden the enforcement mandate of the independent management authorities.
p.000072: 3. To reinforce the mandate of control of the judiciary (e.g. broadening the application of involvement of the
p.000072: public prosecutor for the environ- ment, the availability of technical support in order to reinforce the evalua-
p.000072: tion capacity of the Judicial Review Court especially with regards to envi- ronmental impact assessments).
p.000072: 4. To adopt a policy of agricultural development based on the protection of biodiversity and of the environment in
p.000072: general by promoting sustainable farming practices that protect biodiversity and by raising environmental
p.000072: awareness in this respect.
...

p.000108: benefits of honesty. Lifelong training of physicians on the subject-matter is also required (a relevant duty is
p.000108: stipulat- ed by the CME). Hospital boards of ethics, scientific societies and medical associations must
p.000108: arise to the task and take the initiative.
p.000108:
p.000108: d) Education and information for citizens
p.000108: The above demonstrate a need for appropriate citizen education aiming at the optimal application of the new model.
p.000108: Patients who are suitably in- formed “ahead of time” are more likely to cooperate actively, assisting phy- sicians in
p.000108: their work and enhancing the efficacy of treatment.
p.000108: Citizen education can be promoted through elementary education, in- formation campaigns by local authorities,
p.000108: local associations, regional hospi-
p.000108:
p.000108:
p.000109: 109
p.000109:
p.000109: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000109: OPINION
p.000109:
p.000109: tals and volunteer organizations. Educational programs from the media un- der the hospices of the Ministries for Health
p.000109: and Education could also be of assistance.
p.000109:
p.000109: B. Particular problems
p.000109:
p.000109: a) Power to consent and limits of autonomy
p.000109: The Commission believes that when patients who are capable to consent are committed to hospital they should appoint a
p.000109: representative in writing, if possible.
p.000109: In case of patients incapable to consent who have not appointed a rep- resentative, the Commission thinks that:
p.000109: i) The legal representatives of the patient may select one of alternative treatment methods but may not refuse all
p.000109: treatments if the treating physi- cian believes that the continuation of therapy is beneficial. Only patients
p.000109: who are capable for self-consent may refuse treatment.
p.000109: ii) In case of disagreement between the legal representatives the treat- ing physician should be able to decide taking
p.000109: into account the opinion of the hospital board of ethics which must be made mandatory in our country.
p.000109: iii) The physician must take into consideration any prior directions by the patient (id est, any wishes the patient
p.000109: expressed prior to becoming incapa- ble to consent).
...

p.000257: and Vaupel, 2002). In the European Union particularly, life expec- tancy has risen by an average of 10 years over the
p.000257: last fifty years6. According to statistics in 2009, the average life expectancy in the EU of 27 states is
p.000257: 79.4 years (76.4 for men and 82.4 for women). In Greece, the average age is
p.000257: 80.2 years for the total population (77.8 for men and 82.7 for women). But why this constant increase in life
p.000257: expectancy?
p.000257: Genetic factors, such as the HLA-DRw9 and HLA-DR1 alleles in the Japa- nese population (Takata et al., 1987) and the e4
p.000257: allele of the APOE gene in Finnish (Schachter et al., 1994) and the French population (Louhija et al.,
p.000257: 1994), are associated with increased life expectancy.
p.000257:
p.000257: 6 Eurostat. Mortality and life expectancy statistics. Data from October 2011.
p.000257: http://epp.eurostat.ec.europa.eu/statistics_explained/index.php/Mortality_and_life_ expectancy_statistics.
p.000257:
p.000258: 258
p.000258:
p.000258: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000258: REPORT
p.000258:
p.000258: Environmental factors, such as smoking, alcohol consumption and diet have not been proven to reduce the average
p.000258: life expectancy but their effect on the development of diseases, such as cancer and cardiovascular disease indirectly
p.000258: reduces life expectancy. In addition, the way the social status, wealth and educational level can affect
p.000258: life expectancy, is not clear (Chris- tensen & Vaupel, 1996).
p.000258: Demographic and geographical studies showed that the increase in life expectancy is, in part, due to the advances in
p.000258: Medicine and geriatrics that study the diseases of old age, such as cancer and cardiovascular disease,
p.000258: aiming at prevention and better management of common diseases (Chris- tensen & Vaupel, 1996).
p.000258: However, along with the best medical care, modern biomedical research offers insights that allow humans to understand
p.000258: and intervene in the aging mechanisms. Biogerontology studies the aging mechanisms and provides information to
p.000258: reduce the rate of aging and prolong life beyond 122 years, which is the maximum limit today7. A typical example is the
p.000258: discovery that the enzyme telomerase can be used to increase cell divisions and delay their aging (Hayflick, 2003),
p.000258: and that substances that stimulate a calorie- restricted diet can increase life expectancy by 30%
p.000258: in mice (Ingram et al, 2004).
p.000258: In this context, intervening in the aging process is scientifically feasible, while man has a special interest in the
p.000258: existing possibility to extend lifespan by using biomedical technologies. As mentioned in the introduction to this
p.000258: Report, taking into account the distinction between therapy and enhancement, intervening in
p.000258: the aging mechanisms in order to extend lifespan beyond the upper limit constitutes human
p.000258: enhancement, not prevention or treatment of diseases presented in old age that aim to increase average
...

p.000269: drugs.
p.000269: The Commission considers that, as in the case of enhancing physical characteristics, the autonomy of a
p.000269: healthy person includes options for en- hancing the cognitive or mental state of the human body. This enhancement
p.000269: is part of the right to develop freely a personality.
p.000269:
p.000269: II. Suggestions
p.000269:
p.000269: However, the aforementioned principle must be supplemented with necessary remarks.
p.000269: 1. The use of drugs to enhance memory or attention may adversely af- fect other cognitive functions. Due to this
p.000269: eventuality, the person concerned must be fully informed, in order to have the opportunity of an independent choice.
p.000269: 2. The issue of influencing the personality is particularly emphasized in the case of antidepressants use. The above
p.000269: mentioned influence is in princi- ple legitimate, as a fundamental right of the person, but it encloses the risk of
p.000269: uncontrolled effects on the nervous system and the general physical and mental condition of the person. The Commission
p.000269: notes the risk when chil- dren use such drugs since such a use may lead to the substitution of all the efforts made to
p.000269: integrate the person into society. A personality is developed by the gradual and smooth integration of the
p.000269: person into the social envi- ronment, owing to the family, friends or educational mechanisms that have the
p.000269: advantage of being subjected to constant scrutiny and revision, and are reversible if necessary, depending on the
p.000269: person’s maturity. For the Com- mission, this advantage is necessary to be ensured, especially in the case of
p.000269: children. For this reason, the use of substances for non-therapeutic purpos- es is not legitimate in children.
p.000269: 3. The use of enhancement methods to improve cognitive and mental functions always requires that the
p.000269: person concerned is fully informed and updated, in terms of the expected results and possible side
p.000269: effects. The Commission considers that the risk of misinformation, especially for drugs which are not
p.000269: prescribed, is serious. The promotion of these drugs to the public and the information leaflets about their
p.000269: use should be subjected to special inspection by the authorities (National Organization for Medicines,
p.000269:
p.000269:
p.000270: 270
p.000270:
p.000270: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000270: OPINION
p.000270:
p.000270: General Secretariat for Commerce, etc.). It is apparent that for prescription drugs, the physician and the pharmacist
p.000270: have an increased responsibility to properly inform the person concerned, especially since it remains doubtful whether
p.000270: the prescription for enhancement purposes falls within the medical responsibilities, such as those described in the
...

p.000282: for a better position, and objectively cannot devote the same time to study compared to a well-trained
p.000282: new candidate for the same position. Nevertheless, this argument would not be convincing. For the reason
p.000282: that, on the one hand, one cannot prevent the use of substances by “privileged” people and therefore restoring
p.000282: inequality, and on the other hand, one would encourage the easy, but temporary, way of going
p.000282: through meritocratic procedures instead of constantly trying to cultivate cognitive abilities (Farah et al.,
p.000282: 424). In fact, the concern of doping in sports applies here as well.
p.000282: In general, one must not overlook that -at least with the current data- the use of enhancement substances
p.000282: has temporary effects and does not
p.000282:
p.000282:
p.000283: 283
p.000283:
p.000283: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000283: REPORT
p.000283:
p.000283: replace the solid acquisition of knowledge through education. But overall, the use of such substances
p.000283: that aim to obtain cognitive balance or psychological well-being appears at present as an
p.000283: easy substitute for education. In a sense, one could consider that the emergence of this alternative
p.000283: choice is a failure of the educational and cultural mission of the State, and a substitute for fundamental
p.000283: deficiencies. Therefore, the issue constitutes a motivation for reflection on the wider environment that forms a
p.000283: personality. Persistence on the actions that change this environment - particularly in the areas of
p.000283: education (including continuous effort for real equality in opportunities) and culture- seems to acquire a
p.000283: timely, moral significance so that enhancement substances will stop being an option.
p.000283:
p.000283: ΙΙΙ. The law
p.000283:
p.000283: In terms of law, the general framework for dealing with enhancement of cognitive and mental characteristics does not
p.000283: differ from that of enhancing physical characteristics. On one hand, the constitutional provisions for the
p.000283: development of a personality (Art. 5 § 1) and the right to health (Art. 5 § 5) (in view of which, substance use for
p.000283: enhancement purposes is, in principle, permissible) and on the other hand, the protection of health (Art. 21
p.000283: § 3) (which highlights the responsibility of the state in controlling the use of substances or implants
p.000283: that are not intended for therapeutic purposes) are essential here.
p.000283: The EU legislation on the use of implants (Directive 93/42, incorporated with JMD DY8d/GP. Oik.130648/2.10.2009,
p.000283: Directive 90/385, incorporated by JMD DY8d/GP. Oik.130644/2.10.2009) and the Regulation 726/2004, regarding
...

Searching for indicator embryo:

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p.000044: Pavlos Sourlas, Professor of Philosophy of Law, University of Athens.
p.000044: Constantinos Tsoukalas, Emeritus Professor of Sociology, University of Ath- ens.
p.000044: Ioannis Vlahoyiannis, Professor of Medicine and Nephrology, University of Patras.
p.000044:
p.000044:
p.000044:
p.000044: PERSONNEL
p.000044:
p.000044: Scientific Officers:
p.000044: Takis Vidalis, Lawyer, PhD in Law.
p.000044: Ariadne L. Hager-Theodoridou, Agronomist, PhD in Genetics.
p.000044:
p.000044: Secretariat:
p.000044: Marianna Drakopoulou, Lawyer, Head of Secretariat.
p.000044:
p.000044:
p.000044:
p.000045: 45
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000046: 46
p.000046:
p.000046: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000046: REPORT
p.000046:
p.000046: R E P O R T
p.000046:
p.000046: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000046:
p.000046: Rapporteurs: A.L. Hager-Theodoridou, T. Vidalis
p.000046: In collaboration with: P. Sourlas
p.000046:
p.000046: The present report is an attempt to identify the basic parameters of eth- ics in biological research. It is an issue
p.000046: that concerns all areas of biological research (e.g. clinical trials, research on the human embryo, research with
p.000046: human biological material, animal, plant and microorganism research). The commission has addressed ethical issues of
p.000046: specific research areas with pre- vious recommendations.
p.000046: Research ethics is of course an issue that concerns both natural sciences and humanities and is becoming increasingly
p.000046: topical within the international scientific community and international scientific organizations. An additional reason
p.000046: for discussing the issue in our country is the new legislation for pub- licly funded research that was recently
p.000046: adopted. We consider the assess- ment of the problems associated with research ethics -in particular with
p.000046: regards to safeguarding research independence and credibility- as a neces- sary condition for the effective
p.000046: implementation of the new legislation. In view of the importance that society attributes to science research
p.000046: ethics is not just an “additional” requirement for science advancement. Rather the opposite is true:
p.000046: appreciation of science by the public depends on the for- mer respecting the values of society and is constantly tested
p.000046: with every re- search initiative. Whenever science disregarded these values in the past, the scientific work has
p.000046: been discredited and public opinion has grown suspi- cious.
p.000046: The analysis that follows presents some elements of organization of re- search (Part I), considers the ethical
p.000046: parameters and problems to be dis- cussed (Part II) and concludes with a number of proposals.
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
p.000046:
...

p.000197: the findings. Thus, in many cases a huge amount of information is available to the users or recipients of the genetic
p.000197: service, who are unable to utilize or even understand the findings.
p.000197: Most of the companies do not specify the fate of the genetic samples,
p.000197: i.e. whether they are destroyed or stored after completing the genetic anal- ysis, or even whether they are used for
p.000197: other purposes, such as research. In some cases, the genetic tests are offered with a discount, provided that the
p.000197: person will consent to use his/her genetic data for research purposes.
p.000197:
p.000197:
p.000197: II. The law
p.000197:
p.000197: The Commission notes the complexity of the legal framework governing DTC genetic testing.
p.000197: In genetic tests for medical reasons, applicable provisions are those con- cerning the constitutional right to health,
p.000197: which allows to everybody to have free access to information concerning his/her health (article 5, paragraph 5
p.000197: Constitution), as well as the provisions implementing this right in order to protect an individual (adequate
p.000197: information, protection of sensitive data according to the Law 2472/1997). In addition, article 12 of the
p.000197: Convention on Human Rights and Biomedicine (Law 2619/1998), which requires genetic counseling, also applies in genetic
p.000197: tests for health purposes.
p.000197: In prenatal genetic tests, article 14 of the same Convention prohibits selection of an embryo for non-health
p.000197: reasons.
p.000197: Finally, for genetic tests undertaken to identify a person, judicial authori- zation is required under the current
p.000197: legislation (e.g. articles 1477 Civil Code, 615 Code of Civil Procedure).
p.000197: Moreover, the provisions concerning the economic freedom and its con- straints (article 5, paragraph 1 Constitution),
p.000197: especially those aiming to pro-
p.000197:
p.000197:
p.000197:
p.000198: 198
p.000198:
p.000198: DIRECT-TO-CONSUMER GENETIC TESTING
p.000198: OPINION
p.000198:
p.000198: tect the consumer (Law 2251/1994) are applied in all types of genetic test- ing.
p.000198: However, one must not overlook that the above mentioned provisions are broad, and there is no special
p.000198: legislation governing this specific activity, both in Greece and most European countries. Absence of a
p.000198: relative law means that anyone can offer DTC genetic services in an unrestricted and uncontainable manner,
p.000198: without being subjected to any kind of preventive quality control. The legislation stated above,
p.000198: partially covers the need of such a control and is unable to monitor the dynamics of a developing new market.
p.000198:
p.000198: III. Recommendations
p.000198:
p.000198: 1. General principles
p.000198:
p.000198: The Commission believes that an important aspect of autonomy in health matters is the unrestricted access
p.000198: to health information, including genetic information. Especially, however, regarding genetic tests which pre- dict
...

p.000204: can be informed of his/her own genetic profile and the family’s genetic profile as well.
p.000204: Β. The introduction of new tools in genome analysis, such as DNA micro- arrays, thanks to which high throughput
p.000204: analysis is possible (DNA analysis from several individuals simultaneously, in a short period of time)
p.000204: This enables companies to offer commercial methods to the public, in a relatively affordable price. The result is an
p.000204: emerging new market of private companies providing genetic testing.
p.000204: C. The physicians’ and the public’s growing interest for the importance of genetic information in preventive medicine
p.000204: This interest lies in adopting an appropriate lifestyle that will help to prevent a disease, for which
p.000204: predisposition has been defined by genetic testing. The prospect of such a “shield” against possible
p.000204: future diseases is expected to consistently attract more consumers to get tested -especially if genetic testing is
p.000204: easy and doesn’t cost much- even if the cost is not covered by public insurance.
p.000204: In this context, companies offering genetic tests directly to the public emerged. Consumers are usually drawn
p.000204: to them by personal interest and/or worry about their health, or out of curiosity. The offered tests cover a wide range
p.000204: of:
p.000204: a) Diagnostic tests confirming or not a disease (single-gene diseas- es),
p.000204: b) pre-symptomatic tests that calculate a person’s chances of devel- oping a disease (multifactorial diseases),
p.000204: c) prenatal tests that determine the embryo’s gender,
p.000204: d) pharmacogenetic tests that estimate the right dosage, effective- ness and side effects of certain drugs for an
p.000204: individual,
p.000204:
p.000204:
p.000205: 205
p.000205:
p.000205: DIRECT-TO-CONSUMER GENETIC TESTING
p.000205: REPORT
p.000205:
p.000205: e) paternity tests that confirm or not paternity,
p.000205: f) kinship tests that confirm or not relationship and the degree of relationship,
p.000205: g) ancestry tests that determine the family’s origin (genealogical roots),
p.000205: h) metabolic and nutritional genomics tests that estimate predispo- sition to obesity,
p.000205: i) anti-ageing tests that study the genes affecting ageing,
p.000205: j) athletic performance tests that determine someone’s potential for athletic performance.
p.000205: Typically, the consumer receives a kit, which includes instructions to col- lect his/her own biological material
p.000205: (usually saliva or buccal mucosa swabs), and this kit is subsequently sent for analysis to the laboratory by post. The
p.000205: consumer is notified of the results by telephone, post, e-mail or a safe web- site, to which access is being
p.000205: granted. Tests requiring blood are accompa- nied by a kit to be used by a physician, who will safely collect a
p.000205: blood sample (e.g. to screen for mutations in the BRCA1 and 2 genes causing breast can- cer).
p.000205: Often, the commercial companies simply communicate the results of the genetic tests, without giving information about
p.000205: their usefulness to the inter- ested parties (genetic counseling). Other companies combine genetic results with data
...

Searching for indicator employees:

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p.000247: Kingdom, 2002), even if the rule of keeping unchanged such registry documents (which serves the security of law) is
p.000247: bended, precisely because the right to freely develop a personality is a priority.
p.000247: Finally, the law for tissue transplantation (Law 3984/2011) is applicable for plastic surgery procedures, as
p.000247: long as it is not an autologous transplantation (the donor is a third party, living or not). This law
p.000247: provides special conditions aiming to protect the donor and the recipient of the transplant, with informed
p.000247: consent as the central concept here.
p.000247:
p.000247:
p.000247:
p.000247:
p.000248: 248
p.000248:
p.000248: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000248: REPORT
p.000248:
p.000248: II. Enhancing performance
p.000248:
p.000248: 1. The facts
p.000248:
p.000248: a) Overview
p.000248:
p.000248: The concept of enhancing performance includes skills, such as the physical strength, speed,
p.000248: agility, stamina, accuracy and movement co- ordination as well as dexterity. In this case,
p.000248: enhancement is mainly accomplished by the use of pharmaceutical agents, whereas in the future, one cannot
p.000248: preclude that performance enhancement will be achieved by the use of genetic technologies.
p.000248:
p.000248: b) Enhancing performance at work
p.000248:
p.000248: The wish to strengthen performance in the working environment may have significant effects on work, which
p.000248: require careful consideration by the policymakers, employers and employees themselves. Enhancement techno- logies could
p.000248: change the way people work, making it possible to work under difficult conditions (e.g. extreme climate conditions, low
p.000248: light conditions and low oxygen concentration), to increase strength and reduce physical fatigue even during
p.000248: prolonged labor or to reduce recovery and return earlier to work after illness (Academy of Medical
p.000248: Sciences, British Academy, Royal Academy of Engineering and Royal Society joint Workshop Report, 2012).
p.000248:
p.000248: c) Enhancing military performance
p.000248:
p.000248: The history of conducting experiments in order to enhance the performance of soldiers started
p.000248: almost a century ago. After the use of yperite (also known as mustard gas) during the First World War, there
p.000248: were reports of yperite trials on soldiers in the USA that examined resistance to yperite depending on race. It was
p.000248: just five decades later, in 1991, that the USA government admitted these experiments (Smith, 2008). Reports of
p.000248: experiments with nuclear energy and psychotropic drugs then followed (Parasidis, 2012).
p.000248: However, enhancement of military performance has evolved due to the
p.000248:
p.000248:
p.000249: 249
p.000249:
p.000249: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000249: REPORT
p.000249:
p.000249: possibilities offered by biomedicine and biotechnology. For example, the
p.000249: U.S. Department of Defense and the Advanced Research Projects Agency Defense (DARPA) fund research on
...

p.000281: mental characteristics and not about restoring relevant health damage.
p.000281:
p.000281:
p.000282: 282
p.000282:
p.000282: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000282: REPORT
p.000282:
p.000282: 4. Equal access
p.000282:
p.000282: The issue of equal access to means of cognitive or mental enhancement is mainly associated with the
p.000282: opportunities offered in competitive environments (Farah et al., 423) and, secondly, with improvement
p.000282: of our lifestyle. This is an issue of concern which is similar to that of enhancing physical abilities
p.000282: (e.g. doping in sports).
p.000282: Here, enhancement is usually associated with memory or concentration, especially during challenges in education or
p.000282: work. The general principle that wants to prevent distortion of rivalry is valid here, but it constitutes a
p.000282: “defensive” attitude. Equal access means, mainly, that anyone who desires it is able to use substances, under the two
p.000282: reservations mentioned above.
p.000282: An objection here would be that equal access does not exist anyway, regarding the conventional ways to
p.000282: enhance cognitive performance, namely through education or training. Pupils, students or employees have strongly
p.000282: differentiated possibilities of access to adequate education, mainly because of the economic inequality, which
p.000282: significantly affects their opportunities. Generally, equal opportunities presuppose equality to
p.000282: material means, which is practically impossible.
p.000282: On the other hand, one could argue that substance use may be an option to restore the general inequality of access to
p.000282: conventional means. Thus, for example, a student with artificially enhanced memory capacity and
p.000282: concentration could cover gaps with his/her own effort, gaps that his/her socially and economically
p.000282: “'privileged'” classmates cover with expensive teaching methods. The same applies to an employee who is a candidate
p.000282: for a better position, and objectively cannot devote the same time to study compared to a well-trained
p.000282: new candidate for the same position. Nevertheless, this argument would not be convincing. For the reason
p.000282: that, on the one hand, one cannot prevent the use of substances by “privileged” people and therefore restoring
p.000282: inequality, and on the other hand, one would encourage the easy, but temporary, way of going
p.000282: through meritocratic procedures instead of constantly trying to cultivate cognitive abilities (Farah et al.,
p.000282: 424). In fact, the concern of doping in sports applies here as well.
...

Searching for indicator gender:

(return to top)
p.000058: REPORT
p.000058:
p.000058: biomedical research in humans4 and animals5, research in the human ge- nome6 and for epidemiological
p.000058: research7. The International Epidemiology Association recently issued principles of correct practice and conduct in
p.000058: epi- demiological research (IEA, 2007). Some of the issues dealt with in these instruments can be summarized
p.000058: as follows (Shamoo and Resnik, 2002):
p.000058: Honesty as to the method and the findings in the publication and report- ing of scientific studies.
p.000058: Objectivity in the design of trials and the analysis of results as well as in the consideration of the work of other
p.000058: scientists.
p.000058: Integrity in the observance of promises and assumed obligations and con- sistency between word and action.
p.000058: Care to avoid inadvertent mistakes and to keep good records.
p.000058: Compliance with copyright.
p.000058: Confidentiality with regard to information obtained during private meet- ings or when considering proposals for funding
p.000058: or papers for publication, Responsible publications whose goal should be the advancement of sci- ence and
p.000058: avoidance of pointless papers that reiterate available knowledge.
p.000058: Care for the instruction of students, protection of their prosperity and recognition of their right to decide
p.000058: for themselves.
p.000058: Respect for colleagues.
p.000058: Social Responsibility, the goal must be the common good and the avoid- ance or alleviation of social problems through
p.000058: research and education of the public.
p.000058: Avoidance of discrimination based on gender, nationality, ethnicity or any other factor irrelevant to scientific
p.000058: competence and integrity.
p.000058: Preservation of professional competence through life-long training and education.
p.000058:
p.000058: 4 CIOMS international ethical guidelines for biomedical research involving human subjects
p.000058: (http://www.cioms.ch/frame_guidelines_nov_2002.htm).
p.000058: 5 1985 international guiding principles for biomedical research involving animals
p.000058: (http://www.cioms.ch/frame_1985_texts_of_guidelines.htm).
p.000058: 6 1990 declaration of inuyama on human genome mapping, genetic screening and gene therapy
p.000058: (http://www.cioms.ch/frame_1990_texts_of_guideline.htm).
p.000058: 7 1991 international guidelines for ethical review of epidemiological studies
p.000058: (http://www.cioms.ch/frame_1991_texts_of_guideline.htm).
p.000058:
p.000059: 59
p.000059:
p.000059: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000059: REPORT
p.000059:
p.000059: Legality, compliance with all laws and regulations governing the operation of research.
p.000059: Care for animals both in the design and the execution of research pro- jects.
...

p.000119: unless patients refuse the information by exercising their right not to know. But patient information is not limited to
p.000119: those cases where patients need to consent to a medical act. It also includes the patient’s right to know the
p.000119: state of his/her condition to the extent he/she so wishes. This knowledge will eventually help patients to make
p.000119: all sorts of decisions about their lives and satisfy their need for sound medical information on their condition,
p.000119: regardless of whether they will use this in- formation to make medical decisions.
p.000119: What is the usual practice, however? Do physicians actually inform will- ing patients on their condition, and the
p.000119: diagnosis and prognosis of their ill- ness? Are patients willing to be informed, even when the diagnosis is about a
p.000119: serious, or even incurable, disease or do they rather not know? Is it ac- ceptable that physicians
p.000119: inform the relatives first and then the patient? What is appropriate information in terms of its content
p.000119: and the way it is imparted and how well trained are physicians and nurses to convey this in- formation to those
p.000119: concerned?
p.000119: These questions do not always have easy answers and have being debat- ed for years by physicians, philosophers,
p.000119: jurists, sociologists and other ex- perts. The “best” answers -as will become evident below- often vary accord- ing
p.000119: to the particular conditions of countries, the cultural traditions of social groups within the same country and the
p.000119: personality, age, gender and educa- tion of patients themselves.
p.000119: There is plenty of international literature both on what patients want and on the perceptions of the
p.000119: medical community on honesty and infor- mation (review by Herbert et al., 1997; Tuckett, 2004). This
p.000119: literature is based on research conducted on different severe or incurable diseases in various countries,
p.000119: age groups and nationalities. The most frequently used example is the attitude of patients and physicians to
p.000119: disclosure of diagnosis in case of cancer. Other entities have also been investigated like Alzheimer’s and multiple
p.000119: sclerosis.
p.000119:
p.000119:
p.000119:
p.000119:
p.000119:
p.000120: 120
p.000120:
p.000120: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000120: REPORT
p.000120:
p.000120: a) International experience
p.000120: One of the first studies attempting to record the views of the medical community on patient information
p.000120: conducted in the early ’60s in the US showed that the overwhelming majority of physicians (90% in a sample of
p.000120: 219 people) did not disclose the diagnosis of cancer to their patients (Oken, 1961). A study on the same topic carried
p.000120: out approximately 20 years later marked a radical change in the views of the US medical community. In a
p.000120: total reversal of the results of the previous study, 97% of the interviewees stated that they reveal the diagnosis to
p.000120: their patients (Novack et al., 1979). A similar turn was witnessed in the other Anglo-Saxon countries.
p.000120: This turn-about in the views of the medical community followed in time the desire of patients to know the truth. In a
...

p.000195: use specific algorithms, claiming that they are able to predict the probability that a person will develop a disease.
p.000195:
p.000195: Β. The increasing interest of the scientific community and the public in using genetic data in preventive
p.000195: medicine
p.000195: A genetic test showing that a person has a predisposition to a disease enables that person to modify
p.000195: his/her lifestyle in such a way that he/she will
p.000195:
p.000195:
p.000196: 196
p.000196:
p.000196: DIRECT-TO-CONSUMER GENETIC TESTING
p.000196: OPINION
p.000196:
p.000196: reduce the probability of developing the disease. This fact may lead more people to undergo genetic testing
p.000196: aiming at prevention.
p.000196:
p.000196: C. Novel molecular technologies for large scale genetic analysis (simulta- neous analysis of genetic samples from
p.000196: different persons) in a relatively short time
p.000196: Large scale genetic analysis facilitates the offer of DTC genetic tests at a lower price compared to the past, and
p.000196: consequently, the development of a new market of genetic services.
p.000196: In this context, companies offering DTC genetic testing emerged. The specific genetic tests cover a wide range
p.000196: of:
p.000196: a) Diagnostic tests that may confirm a disease, e.g. β-thalassaemia,
p.000196: b) pre-symptomatic tests that estimate a person’s risk to develop a dis- ease, e.g. cancer,
p.000196: c) prenatal diagnosis tests that define the baby’s gender,
p.000196: d) pharmacogenetic tests that estimate the best dosage, efficiency and side effects of specific drugs, e.g.
p.000196: anticoagulants,
p.000196: e) paternity tests that confirm or not the paternity of the alleged father,
p.000196: f) relationship tests that assess specific degrees of relationships,
p.000196: g) genealogy tests that define an individual’s ancestry,
p.000196: h) and tests examining a person’s “lifestyle” regarding diet, occupation, exercise etc.
p.000196: Genetic tests which are directly available to the public are sold in con- ventional points of sale (pharmacies,
p.000196: beauty shops, etc.), through healthcare professionals, via the internet or by phone. The most common practice
p.000196: is that the consumer contacts the company via the internet.
p.000196: Regardless of the approach used for contact, the above mentioned ge- netic tests are offered as a kit. The kit
p.000196: contains directions for biologic sample collection by the consumer him/herself (usually saliva or a buccal swab) and
p.000196: the sample is subsequently sent to the genetic laboratory by post. The re- sults are disclosed by phone, letter,
p.000196: e-mail or by logging in to a secure web- site with a unique password provided to the consumer. For tests requiring
p.000196: blood collection, the kit is to be used by the consumer’s doctor in order to collect the blood safely.
p.000196: These specific companies are content with a simple disclosure of the test results. Frequently, there is an
p.000196: impersonal interpretation of the findings
p.000196:
p.000196:
p.000197: 197
p.000197:
p.000197: DIRECT-TO-CONSUMER GENETIC TESTING
p.000197: OPINION
p.000197:
...

p.000204: can be informed of his/her own genetic profile and the family’s genetic profile as well.
p.000204: Β. The introduction of new tools in genome analysis, such as DNA micro- arrays, thanks to which high throughput
p.000204: analysis is possible (DNA analysis from several individuals simultaneously, in a short period of time)
p.000204: This enables companies to offer commercial methods to the public, in a relatively affordable price. The result is an
p.000204: emerging new market of private companies providing genetic testing.
p.000204: C. The physicians’ and the public’s growing interest for the importance of genetic information in preventive medicine
p.000204: This interest lies in adopting an appropriate lifestyle that will help to prevent a disease, for which
p.000204: predisposition has been defined by genetic testing. The prospect of such a “shield” against possible
p.000204: future diseases is expected to consistently attract more consumers to get tested -especially if genetic testing is
p.000204: easy and doesn’t cost much- even if the cost is not covered by public insurance.
p.000204: In this context, companies offering genetic tests directly to the public emerged. Consumers are usually drawn
p.000204: to them by personal interest and/or worry about their health, or out of curiosity. The offered tests cover a wide range
p.000204: of:
p.000204: a) Diagnostic tests confirming or not a disease (single-gene diseas- es),
p.000204: b) pre-symptomatic tests that calculate a person’s chances of devel- oping a disease (multifactorial diseases),
p.000204: c) prenatal tests that determine the embryo’s gender,
p.000204: d) pharmacogenetic tests that estimate the right dosage, effective- ness and side effects of certain drugs for an
p.000204: individual,
p.000204:
p.000204:
p.000205: 205
p.000205:
p.000205: DIRECT-TO-CONSUMER GENETIC TESTING
p.000205: REPORT
p.000205:
p.000205: e) paternity tests that confirm or not paternity,
p.000205: f) kinship tests that confirm or not relationship and the degree of relationship,
p.000205: g) ancestry tests that determine the family’s origin (genealogical roots),
p.000205: h) metabolic and nutritional genomics tests that estimate predispo- sition to obesity,
p.000205: i) anti-ageing tests that study the genes affecting ageing,
p.000205: j) athletic performance tests that determine someone’s potential for athletic performance.
p.000205: Typically, the consumer receives a kit, which includes instructions to col- lect his/her own biological material
p.000205: (usually saliva or buccal mucosa swabs), and this kit is subsequently sent for analysis to the laboratory by post. The
p.000205: consumer is notified of the results by telephone, post, e-mail or a safe web- site, to which access is being
p.000205: granted. Tests requiring blood are accompa- nied by a kit to be used by a physician, who will safely collect a
p.000205: blood sample (e.g. to screen for mutations in the BRCA1 and 2 genes causing breast can- cer).
p.000205: Often, the commercial companies simply communicate the results of the genetic tests, without giving information about
p.000205: their usefulness to the inter- ested parties (genetic counseling). Other companies combine genetic results with data
p.000205: derived from a questionnaire (filled in by the consumer), providing more individualized information. Essentially, this
...

p.000223: OPINION
p.000223:
p.000223: II) enhancing physical abilities,
p.000223: III) using mechanical means of enhancement.
p.000223: To examine the issue of physical enhancement, the Commission held hearings on Dr. G. Christodoulou, Emeritus
p.000223: Professor of Psychiatry, Medical School, University of Athens and Honorary President of the Greek Psychiat- ric
p.000223: Association, Dr. A. Mandrekas, President of the Greek Association of Plas- tic, Reconstructive and Aesthetic Surgery,
p.000223: Dr. G. Creatsas, Professor of Gy- necology and Director of the 2nd Obstetrics and Gynecology Clinic, “Are-
p.000223: taieion” Hospital, Medical School, University of Athens, Dr. G. Vassilopoulos, Associate Professor of Pathology -
p.000223: Hematology, Medical School, University of Thessaly and Associate Researcher, Department of Genetics and
p.000223: Gene Therapy, Biomedical Research Foundation of the Academy of Athens, and Dr. C. Spiliopoulou,
p.000223: Associate Professor of Forensic Medicine, Medical School, University of Athens and President of the
p.000223: Hellenic National Anti- doping Council.
p.000223:
p.000223: Ι. Plastic Surgery
p.000223:
p.000223: 1. Overview
p.000223:
p.000223: Plastic surgery concerns surgical or non-surgical procedures designed either to reconstruct or to “correct”
p.000223: external body features.
p.000223: Reconstructive procedures usually follow treatment after accidents (e.g. scar revision). Cosmetic interventions are
p.000223: purely aesthetic and correspond to a person’s desire to improve the appearance of his/her face or body
p.000223: (brow lift/eyebrow, nose, breast, liposuction, etc.), regardless of health is- sues. Gender reassignment
p.000223: surgery, is a special case, which must be ad- dressed specifically.
p.000223: In principle, the Commission considers that a person’s autonomy justifies the freedom of forming external features. The
p.000223: fundamental right to person- ality development encompasses, undoubtedly, a person’s control over his/her
p.000223: external appearance. However, that does not mean that plastic sur- gery escapes from the principles and rules of law
p.000223: and medical ethics.
p.000223:
p.000223:
p.000223:
p.000223:
p.000223:
p.000224: 224
p.000224:
p.000224: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000224: OPINION
p.000224:
p.000224: 2. Altering facial features and identity confusion
p.000224:
p.000224: A person’s desire to change his/her facial features in order to cause identity confusion is a borderline
p.000224: case of self-determination, which may af- fect the public interest (e.g. in order to avoid legal prosecution). In this
p.000224: case, the Commission believes that certain restrictions on a person’s autonomy are justifiable.
p.000224: Consequently, the Commission considers that there is an issue regarding the physician’s rights and obligations. In this
p.000224: case, the physician has a duty to review the relative desire of the person interested. Under particular con- ditions,
p.000224: this review justifies that the physician may refuse to carry out a pro- cedure, however, without setting general and
p.000224: abstract rules. Ιn this case, it is required to assess each case separately. However, it is not the physician’s duty to
p.000224: report the incident to the law enforcement authorities, apart from exceptional cases in which, as the law provides, the
p.000224: offense of harboring a felon or crime concealment is constituted.
p.000224:
p.000224: 3. Plastic surgery and gender specific features
p.000224:
p.000224: In cases of altering gender specific features or even gender reassign- ment, plastic surgery is part of the
p.000224: therapy used. Hermaphroditism and gen- der identity disorder fall within these cases.
p.000224: Regardless of the aetiology of a person’s mental and physical condition, which may be due to neurodevelopmental or
p.000224: genetic causes, the Commis- sion considers that such kind of procedures are essentially reconstructive and
p.000224: therapeutic, since they aim to match the psychosomatic disposition of a person with gender specific features.
p.000224: In this case, the ethical principles and rules of law, as outlined in a previ- ous Opinion of the Commission ("Consent
p.000224: in the patient-physician relation- ship," 2010) are entirely valid. The authentic will of the person him/herself is the
p.000224: determining factor here, in view of the right of personality. However, since there is a particularly
p.000224: sensitive issue of autonomy, it is right to allow for a period of time between the initial decision and the plastic
p.000224: surgery pro- cedure, during which the person concerned receives psychological and med- ical counseling.
p.000224:
p.000224:
p.000224:
p.000225: 225
p.000225:
p.000225: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000225: OPINION
p.000225:
p.000225: According to the Commission, if prenatal testing results in ambiguous results about the gender identity of a
p.000225: foetus, an artificial termination of the pregnancy is not justified, especially since there are the
p.000225: aforementioned reconstructive options after birth. However, given that persons in this cate- gory (seeking plastic
p.000225: surgery to alter gender specific features or gender re- assignment) belong to vulnerable social groups that
p.000225: generally suffer from social discrimination, access to relevant treatment must be ensured. For example,
p.000225: based on the principle of equality and the social right to health, the State may possibly develop counseling
p.000225: programs, but also provide ther- apy possibilities within the National Health System.
p.000225:
p.000225: 4. Face transplants
p.000225:
p.000225: Reconstructive face transplantation (e.g. in case of severe deformities caused by an accident) is, in
p.000225: principle, an acceptable alteration of the recipi- ent’s characteristics. However, it must be carried out in such a
p.000225: manner that it does not affect respect for the body of the (dead) donor. The relevant principle that rules
p.000225: transplants from a deceased donor is absolutely valid in this case too.
p.000225:
p.000225: 5. The physician’s role
p.000225:
p.000225: According to the Commission, the physician who carries out cosmetic plastic surgery has a particular
p.000225: responsibility, since he/she does not act in order to prevent a threat to a patient’s health (or life).
p.000225: Unquestionably, the consent of the person interested is a prerequisite for any relevant medical intervention. However,
p.000225: it should be noted that in the case of cosmetic plas- tic surgery, the following particularities must be taken into
p.000225: account:
p.000225: a) The physician has an increased responsibility to fully inform the person concerned as to the expected outcome
...

p.000236:
p.000236: Treatment Human enhancement Technological interventions
p.000236:
p.000236:
p.000236:
p.000236: Artificial implants
p.000236: Early and accurate diagnosis Effective and targeted drug therapy Restoration of joints, organs
p.000236:
p.000236: Enhancing athletic performance Increasing life expectancy
p.000236:
p.000236:
p.000236:
p.000236: Implants - sensors
p.000236:
p.000236:
p.000236:
p.000236: Brain implants
p.000236: Diagnosis and treatment of diseases
p.000236: e.g. sensor of sugar levels and use of insulin
p.000236:
p.000236: Increasing memory in patients with neurodegenerative diseases Restoration of mobility in paralyzed patients
p.000236:
p.000236: Enhancing athletic performance
p.000236:
p.000236: Enhancing senses, memory, intelligence
p.000236: Free access and opportunity to intervene in the physical world by thought
p.000236: Increasing life expectancy
p.000236:
p.000236: Nanotechnology Targeted therapy e.g. targeting cancer cells
p.000236:
p.000236: Aesthetic (surgical) interventions
p.000236: Reducing the vulnerability of soldiers by controlling their metabolism
p.000236: Skin graft Patients with severe burns Enhancing appearance and signs of
p.000236: aging
p.000236:
p.000236: Reconstructive surgery
p.000236: Scar repair after accidents or burns Restoration of anterior cruciate
p.000236: Enhancing appearance and signs of aging
p.000236: Liposuction Reducing the risk of obesity Enhancing appearance
p.000236:
p.000236: Gender change Agreement of physical and sexual
p.000236: identity
p.000236: Breast implants Breast reconstruction after total mastectomy
p.000236: Enhancing gender characteristics
p.000236:
p.000236: Enhancing appearance
p.000236:
p.000236: Breast size reduction
p.000236: Treatment of dermatitis Decrease neck pain
p.000236: Enhancing appearance Enhancing athletic performance
p.000236:
p.000236:
p.000236:
p.000236:
p.000236:
p.000236:
p.000236:
p.000236:
p.000237: 237
p.000237:
p.000237: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000237: REPORT
p.000237:
p.000237: c) The “business” of enhancement
p.000237:
p.000237: Human enhancement technologies are an opportunity for businesses to invest in, and may soon become a
p.000237: lucrative industry. Pharmaceutical companies, research institutes, universities and even governments spent
p.000237: and continue to spend huge amounts on drug research and human enhancement technologies. Similarly
p.000237: to the development of pharmaceutical drugs, for which companies invest in research with the ultimate aim to
p.000237: obtain approval and, consequently, to profit from drug sales, research in human enhancement comprises an
p.000237: area for business development. The growing demand for enhancing human characteristics is inseparable linked to the
p.000237: production and supply of such substances and technologies.
p.000237: Typical examples are the drugs Prozac (antidepressant) and Ritalin (prescribed in cases of
p.000237: attention deficit hyperactivity disorder), for which the demand is growing with equivalent profits for the
p.000237: companies producing them, as well as the increasing demand for plastic surgery with corre- sponding
p.000237: economic benefits for those who provide such services (AAAS, 2006). It is certain that non-invasive methods of
...

p.000243: plastic surgery and 26% of them undergo more than one plastic surgery (Crerand et al., 2006).
p.000243: Nevertheless, studies show that only a small percentage of these patients -just about 2%- are eventually
p.000243: satisfied by their body image after plastic surgery, while most of them continue to have symptoms of BDD.
p.000243: In most cases, these patients showed no improvement on their symptoms, while they often threaten or even
p.000243: sue the plastic surgeon who carried out the surgery (Crerand et al., 2010).
p.000243: Unlike plastic surgery, the therapy which is indicated for individuals who suffer from BDD is the use of certain
p.000243: drugs, mainly selective serotonin re- uptake inhibitors, and psychotherapeutic methods, and in
p.000243: particular, cognitive psychotherapy (Crerand et al., 2010).
p.000243: For the aforementioned reasons, it is essential that the plastic surgeon who suspects that a person seeking
p.000243: plastic surgery may present with BDD symptoms, refers the patient to a psychiatrist for proper mental
p.000243: help. However up to now, data coming from the USA show that plastic surgeons are aware of the BDD and often
p.000243: refuse to offer plastic surgeries in these patients at a percentage ranging from 21 to 84%, depending on the
p.000243: survey
p.000243:
p.000243:
p.000244: 244
p.000244:
p.000244: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000244: REPORT
p.000244:
p.000244: (Phillips et al., 2001; Crerand et al., 2005; Sarwer 2002). Nevertheless, there are no similar studies in European
p.000244: countries.
p.000244:
p.000244: d) Gender characteristics and plastic surgery
p.000244:
p.000244: Plastic surgery is applied as a treatment to change gender characteristics in specific cases, which include:
p.000244: Gender identity disorder (or gender dysphoria). This is a neuro- developmental disorder, in which individuals
p.000244: with the phenotype of one gender have the psychism of the opposite gender (GIRES 2008). These individuals do not
p.000244: present with hermaphro-ditism. The recommended treatment in such cases is hormonal treatment or plastic
p.000244: surgery or psychotherapy, or a combination of the above. The World Professional Association for Transgender Health
p.000244: (WPATH) is an organization that provides guidelines for the care of people suffering from gender identity disorder.
p.000244: WPATH recommends standards of care that include psychiatric, psycho-logical, medical and surgical care that
p.000244: may help in these cases (Coleman et al., 2011).
p.000244: Hermaphroditism. Plastic surgery remains the treatment of choice for people who are hermaphrodites. In hermaphroditism,
p.000244: the karyotype of the individual is not in accordance with the external genitalia, which are of the opposite
p.000244: sex. In any case, for the gender selection that follows, psychological and social factors as well as the karyotype of
p.000244: the individual are taken into account.
p.000244: The Mayer-Rokitansky-Kuster-Hauser (MRKH) syndrome. It is a rare congenital malformation characterized by
p.000244: agenesis of the vagina and uterus, while the individual has a normal karyotype 46, XX. Trea- tment of the
p.000244: vaginal agenesis includes plastic surgery in order to create a vagina (Morcel et al., 2007).
p.000244:
p.000244: 2. The Greek reality
p.000244:
p.000244: According to statistics, cosmetic surgeries in Greece are particularly popular. According to the biennial
p.000244: survey of the International Society of Aesthetic Plastic Surgery (ISAPS) held in 2010, Greece occupies
p.000244: the 2nd position for cosmetic procedures, behind South Korea, after taking into
p.000244:
p.000244:
p.000245: 245
p.000245:
p.000245: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000245: REPORT
p.000245:
p.000245: account the percentage of the latter relatively to the population2. In absolute numbers, Greece
p.000245: holds the 20th position on aesthetic surgeries, among the top 25 worldwide.
p.000245: It is estimated that a total of 159,002 cosmetic procedures were held in Greece, of which 76,471 were surgical
p.000245: cosmetic procedures and 82,531 were non-surgical cosmetic procedures. Breast augmentation, eyelid surgery and
p.000245: liposuction were the most popular surgical procedures (14,300, 12,907 and 12,896, respectively) while
p.000245: interventions with hyaluronic acid, botulinum toxin type A (Botox Dysport) and autologous fat transplantation
p.000245: were the three most popular non-surgical interventions in Greece (28,171, 26,352 and 6,283, respectively). The total
...

p.000245: tissues and complete a treatment (e.g. mastectomy, reconstruction of severe burns etc.). In this context, it
p.000245: is, in principle, legitimate for an expert to select which surgeries to perform, having certain moral duty
p.000245: only for those who are therapeutic, in the above mentioned sense. Cosmetic surgery does not create a comparable
p.000245: strong commitment to the doctor, since refusal of performing an aesthetic procedure does not put
p.000245: endangers a patient’s health.
p.000245: Another issue is posed by plastic surgery procedures that alter facial features, as they may alter
p.000245: identity. Apart from the psycho-emotional consequences (an extreme form is a complete face transplant,
p.000245: which can also affect others -relatives of the donor), changes of the facial characteristics
p.000245: are associated with public interest, since the image of a
p.000245:
p.000245: 2 International Society of Aesthetic Plastic Surgery (ISAPS) Biennial Global Survey 2010.
p.000245: http://www.isaps.org/.
p.000245:
p.000246: 246
p.000246:
p.000246: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000246: REPORT
p.000246:
p.000246: person “identifies” that person in many social relations and relations with the state. On the other hand, it
p.000246: is undisputable that selecting an “image” is associated with the right to develop freely a personality, and, indeed,
p.000246: is in the core of this right. The ascertainment that our image accompanies us in any private or public relation,
p.000246: thus it affects directly our dignity and self- esteem, is a convincing argument for a person to accept a moral
p.000246: priority in the freedom of choosing an image.
p.000246: The same issue includes gender reassignment surgeries or surgeries that aim to eliminate ambiguous features
p.000246: in transsexual individuals. The singularity of these interventions -especially when compared to those that
p.000246: restore the body after accidents or serious diseases- is that, even if they do not restore “damage” of the organism,
p.000246: they “restore”, in a broad sense, the personality, mainly within the context of a normal participation in social life:
p.000246: this fact clearly distinguishes gender reassignment surgeries or surgeries that aim to eliminate ambiguous
p.000246: gender features from simple cosmetic procedures.
p.000246: In addition, a moral issue is raised by research on humans studying the effectiveness of novel plastic procedures,
p.000246: as well as by not providing adequate information to the participating individuals. The ethics
p.000246: of conducting such clinical research (which constitutes a serious legal issue too,
p.000246: e.g. in view of the Oviedo Convention), should be based on known principles, particularly: a) the
p.000246: moral assessment of the research purpose, b) the lack of alternative means of experimentation, c) the exact assessment
p.000246: of the benefits and the potential hazards for the person participating, d) the strict version of “informed
p.000246: consent” and, e) approval by the relevant ethics committee.
p.000246: As a final point, the way plastic surgery is advertised, mainly aesthetic surgery, plays an
p.000246: important role in informing the public. These advertisements cannot be equated with advertisements of
p.000246: other services or products, since they are interventions in the human organism, which are hard to reverse
p.000246: or even irreversible. Although they are not considered as illegitimate (as in the case of advertising
p.000246: therapeutic agents to the general public), these advertisements must be under tighter ethical review
p.000246: regarding the accuracy of the messages and the methods of conveyance.
p.000246:
p.000246:
p.000246:
p.000246:
p.000247: 247
p.000247:
p.000247: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000247: REPORT
p.000247:
p.000247: 4. The law
p.000247:
p.000247: According to the definition described in Law 3418/2005 (CME) art. 1, only plastic surgeries that complete
p.000247: a treatment (and therefore do not constitute “enhancement”) fall within the relevant regulations.
p.000247: On the other hand, art. 11 par. 3 CME (on the obligation to inform the patient), explicitly includes “aesthetic or
p.000247: cosmetic surgeries” in the “special surgeries”, for which intensification of attention is required during the
p.000247: process of informing the patient. From this formulation, the legislator seems to imply that these interventions
p.000247: are included in the term of medical act, even if they do not satisfy the definition of art. 1.
p.000247: The conclusion is that the latter, at least, are the only authentic enhancement interventions,
p.000247: for which the analytical CME regulations are applied, particularly regarding the rights and obligations of
p.000247: patients and physicians (art. 2-15). For all the other interventions that were mentioned above, the serious
p.000247: issue of medical liability is not covered by a specific legislation, but by the general legislation, basically
p.000247: the Criminal and the Civil Code or the Law 2251/1994 (on the liability of service providers). Essentially, the
p.000247: analogous application of the CME during the analysis of this general law, is imposed in an interpretative way,
p.000247: especially when taking into account that, in some enhancement methods, the health of the person concerned
p.000247: may be in danger.
p.000247: Plastic surgeries that change the gender and aim to restore a normal social life for the person
p.000247: involved, have been legally associated with the issue of modifying public documents and,
p.000247: particularly, registry office records. This amendment was accepted by the ECHR (decision Goodwin v. United
p.000247: Kingdom, 2002), even if the rule of keeping unchanged such registry documents (which serves the security of law) is
p.000247: bended, precisely because the right to freely develop a personality is a priority.
p.000247: Finally, the law for tissue transplantation (Law 3984/2011) is applicable for plastic surgery procedures, as
p.000247: long as it is not an autologous transplantation (the donor is a third party, living or not). This law
p.000247: provides special conditions aiming to protect the donor and the recipient of the transplant, with informed
p.000247: consent as the central concept here.
p.000247:
p.000247:
p.000247:
p.000247:
p.000248: 248
p.000248:
p.000248: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000248: REPORT
p.000248:
p.000248: II. Enhancing performance
p.000248:
p.000248: 1. The facts
p.000248:
p.000248: a) Overview
p.000248:
p.000248: The concept of enhancing performance includes skills, such as the physical strength, speed,
p.000248: agility, stamina, accuracy and movement co- ordination as well as dexterity. In this case,
p.000248: enhancement is mainly accomplished by the use of pharmaceutical agents, whereas in the future, one cannot
p.000248: preclude that performance enhancement will be achieved by the use of genetic technologies.
p.000248:
p.000248: b) Enhancing performance at work
p.000248:
...

p.000260: us to accept our biological limits (hence the finite of our lives), which could not be determined by legal rules.
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000260:
p.000261: 261
p.000261:
p.000261: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000261: REPORT
p.000261:
p.000261: SUGGESTED LITERATURE
p.000261:
p.000261: AAAS invitational workshop on human enhancement (2006). AAAS Human enhancement and the means of achieving it.
p.000261: Washington, DC.
p.000261: Barazzetti G, Reichlin M (2011). Life-extension: A biomedical goal? Scientific prospects, ethical concerns. Swiss Med
p.000261: Wkly 141, w13181.
p.000261: Barton-Davis ER, Shoturma DI, Musaro A, Rosenthal N, Lee Sweeney H (1998). “Viral mediated expression of
p.000261: insulin-like growth factor i blocks the aging-related loss of skeletal muscle function.” PNAS 95, 15603-5607.
p.000261: Baylis F, Robert JS (2004). The inevitability of genetic enhancement technologies. Bioethics, p. 7.
p.000261: Birch K (2008). Neoliberalising bioethics: Bias, enhancement and economistic ethics. Genomics,
p.000261: Society and Policy, 4, 1-10.
p.000261: Bostrom N (2005). In defense of posthuman dignity. Bioethics 2005, p. 202.
p.000261: Christensen K, Vaupel JW (1996). Determinants of longevity: Genetic, envi- ronmental and medical factors. J Intern Med
p.000261: 240, 333-41.
p.000261: Coleman E, Bockting W, Botzer M, Cohen-Kettenis P, et al., (2011). Standards of care for the
p.000261: health of transsexual, transgender, and gender- nonconforming people, Version 7. International Journal of
p.000261: Transgenderism 13:165-232.
p.000261: Comité Consultatif National d` Éthique (CCNE) (1998). Rapport sur le vieillissement, Opinion No 59.
p.000261: Comité Consultatif National d` Éthique (CCNE) (2004). L’ allotransplantation de tissu composite (ATC) au niveau de la
p.000261: face (Greffe totale ou partielle d’ un visage), Opinion No 82.
p.000261: Crerand CE, Franklin ME, Sarwer DB (2006). Body dysmorphic disorder and cosmetic surgery. Plast Reconstr Surg 118,
p.000261: 167e-80e.
p.000261: Crerand CE, Menard W, Phillips KA (2010). Surgical and minimally invasive cosmetic procedures among
p.000261: persons with body dysmorphic disorder. Ann Plast Surg 65, 11-6.
p.000261:
p.000261:
p.000262: 262
p.000262:
p.000262: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000262: REPORT
p.000262:
p.000262: Crerand CE, Phillips KA, Menard W, Fay C (2005). Nonpsychiatric medical treatment of body dysmorphic
p.000262: disorder. Psychosomatics 46, 549-55.
p.000262: European Group on Ethics (EGE) (1999). Ethical aspects arising from doping in sport, Opinion No 14, 1.6, 2.10.
p.000262: Farah MJ (2005). Neuroethics: The practical and the philosophical trends in cognitive sciences, p. 34.
p.000262: Fukuyama F (2002). Our posthuman future: Consequences of the biotechnology revolution, Farrar,
p.000262: Strauss and Giroux, N. York.
p.000262: Garcia-Verdugo M (2005). Medio fondo y fondo. La preparacion del corridor de resistencia. Atletismo 4. Madrid. RFEA.
p.000262: GIRES (Gender Identity Research and Education Society) (2008). Gender var- iance (dysphoria) (www.gires.org.uk).
p.000262: Hayflick L (2003). Living forever and dying in the attempt. Exp Gerontol 38, 1231-1241.
p.000262: Hildt E (2005). Living longer: Ethical aspects of age-retardation, Paper presented at the 19th European
p.000262: Conference on Philosophy of Medicine and Health Care and 22nd EACME Conference “Ethics and Philosophy of Emerging
p.000262: Medical Technologies”, Barcelona.
p.000262: House of Commons, Select Committee on Culture, Media and Sport (2004). Seventh Report of Session 2003-2004, UK
p.000262: Parliament, HC 499-I.
p.000262: Huxtable R, Woodley J (2005). Gaining face or losing face? Framing the debate on face transplants.
p.000262: Bioethics, p. 505.
p.000262: Ingram DK, Anson RM, De Cabo R, Mamczarz J, Zhu M, Mattison JA, Lane MA, Roth GS (2004). Development of
p.000262: calorie restriction mimetics as a pro- longevity strategy. Ann NY Acad Sci 1019, 412-423.
p.000262: Kriari-Katrani I (2001). The constitutional protection of genetic identity. A first approach. DtA 2001, p.347.
p.000262: Lo HS, Xie SQ (2012). Exoskeleton robots for upper-limb rehabilitation: State of the art and future prospects. Med Eng
p.000262: Phys 34, 261-8.
p.000262:
p.000262:
p.000262:
p.000263: 263
p.000263:
p.000263: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000263: REPORT
p.000263:
p.000263: Louhija J, Miettinen HE, Kontula K, Tikkanen MJ, Miettinen TA, Tilvis RS (1985). Aging and genetic variation
p.000263: of plasma lipoproteins. Oldest old: New perspectives and evidence. Milbank Mem Fund Quart 63, 177-251.
...

Searching for indicator genetic heritage:

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p.000028: trials for new medicines, reluctance against genetic testing has led to an actual reduction in the number of
p.000028: volunteering participants in research in tailor-made drugs (pharmacogenomics) that are thought to be very hopeful for
p.000028: the future of therapeutic medicine.
p.000028: Consequently, there is a need to take into consideration the real value of genetic information for the protection of
p.000028: health, which is just as valid as any other medical information and, for all intents and purposes, far
p.000028: removed from the pervasive overrated perceptions we noted before. At the end of the day, this need serves a
p.000028: wider social interest. Indeed, failure to use the potential of additional knowledge on health -such as genetic
p.000028: information- for fear that this knowledge may be used for illicit purposes by third parties causes more harm not only
p.000028: to the individual subject but to a more efficient organization of health care in the general population.
p.000028:
p.000028: 3. THE LEGAL DIMENSION
p.000028:
p.000028: Very few countries have adopted special legislation on the use of genetic data in insurance. As a rule, the issue is
p.000028: governed by the general laws on the protection of personal data in conjunction with insurance law.
p.000028:
p.000028: A. International law
p.000028:
p.000028: Critical from the point of view of international law is the provision of article 11 of the Oviedo
p.000028: Convention pursuant to which:
p.000028: “Any form of discrimination against a person on grounds of his or her genetic heritage is prohibited”.
p.000028: A similar provision was included in the UNESCO declaration on the Hu- man Genome.
p.000028: The Oviedo Convention does not preclude genetic testing for “health purposes” (art. 12) but recognizes
p.000028: the right “not -to-be-informed” (art. 10 [2]). Thus, it seems to refrain from taking a stance on the issue.
p.000028: Protection of the sensitive nature of personal data (with specific provi- sions on confidentiality) is embedded in
p.000028: the 3rd Protocol to the Oviedo Con-
p.000028:
p.000028:
p.000029: 29
p.000029:
p.000029: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000029: REPORT
p.000029:
p.000029: vention (Greece has not ratified it) whereas a new Protocol is going to rule on genetic testing for health reasons.
p.000029: Neither of these instruments, howe- ver, specifically mentions insurance16.
p.000029:
p.000029: B. Other jurisdictions
p.000029:
p.000029: Some European countries have enacted special prohibitory laws. Nota- bly, Austria, Denmark, Switzerland,
p.000029: Estonia, Lithuania, Luxembourg, Norway, Portugal and Belgium prohibit disclosure of genetic information to insurers
p.000029: whereas Netherlands allows it only if insurance is above a certain amount. Other European countries observe a
p.000029: moratorium, whereby insurers do not require genetic data since there is no related legislation (UK17, France, Ger-
p.000029: many, Ireland, Sweden, Finland) (European Commission 2005: passim).
p.000029: A moratorium applies also in Australia, New Zealand, South Africa and Canada (Lemmens 2003:57 sqq., European
p.000029: Commission 2005: passim).
...

Searching for indicator orphan:

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p.000183: this argumentation purely concentrates on the ethical aspect of the issue and does not relate to probable financial or
p.000183: other type of damages (e.g. legal penalties) that a business might suffer after exposing the deceit for purposes of
p.000183: profit.
p.000183: Beyond the above mentioned, however, an actual balancing between the interest of truth and the business
p.000183: interests is theoretically necessary only when during a clinical trial the researchers discover findings
p.000183: that are not crucial for the efficiency and safety of the drug tested. In this case, the business’ interest for
p.000183: concluding the trial and publishing the results prevails, even if the above findings are not included in the results.
p.000183: As a conclusion, the goal of serving health imposes, as a rule, that the researcher’s pursuit of the true
p.000183: results does not retreat before the sponsor’s business interest. In other words, the sponsor is morally obliged to
p.000183: under- take the risk that a clinical trial might lead to results that are not satisfacto-
p.000183:
p.000183:
p.000184: 184
p.000184:
p.000184: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000184: REPORT
p.000184:
p.000184: ry, with the respective cost, precisely because the specific need to serve health weighs more.
p.000184: These observations do not relate with the choice of a trial’s objective,
p.000184: i.e. whether it is ethically justifiable to prefer conducting trials for certain diseases instead of others.
p.000184: The matter is definitely critical, especially when it concerns substantial disregard of rare diseases (“orphan” drugs),
p.000184: as well as high competition in the production of drugs for specific diseases, that often leads to scientifically
p.000184: unreliable clinical trial results. However, financial free- dom does not allow a moral control on the private sector
p.000184: (pharmaceutical industry), which would result in enforcing research in certain areas of clinical trials, ignoring the
p.000184: element of business profit (and business risk respective- ly). It is basically the responsibility of the state -or the
p.000184: public funding for bi- omedical research- to satisfy similar needs, with fair criteria.
p.000184:
p.000184: 9. The law
p.000184:
p.000184: Accordingly to the above data, it is important at this point to examine the involvement of law in the
p.000184: argumentation concerning conflict of interest. The law is particularly concerned, primarily, with the issue of
p.000184: responsibil-
p.000184: ity of the physician/researcher on one hand and the financier on the other hand. Preliminarily, however, we must define
p.000184: the constitutional context, in which the matter of liability lies, especially in the field of medical research.
p.000184:
p.000184: a. The Constitutional context
p.000184: There are mainly three provisions of interest in the Constitution: art. 16 par.1 which regulates freedom of
p.000184: research (and equates with the unob- structed pursuit of truth by any scientist), art. 5 par. 1 which
p.000184: regulates fi- nancial freedom under the reservation that the “Constitution”, “the rights of others” and “public
p.000184: morals” are respected (and equates with the pursuit of financial profit by the sponsor of a trial) and moreover, art.
p.000184: 21 par. 3 which regulates health as a social right under the state’s care.
...

Searching for indicator parent:

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p.000199:
p.000199: In the context of the above mentioned general principles, the Commis- sion notes:
p.000199: A. It is recommended that DTC genetic tests for health reasons or prena- tal diagnosis must be performed following a
p.000199: suitable prescription by a liable expert physician, clinical geneticist or biologist-geneticist. The expert
p.000199: will assess the purpose of the test and will interpret the results, in order to avoid unnecessary genetic testing
p.000199: and inappropriate assessment. It is important that the consumer has the option to choose the expert. Impersonal,
p.000199: auto- mated counseling methods are discordant with the relationship of trust, which must govern health
p.000199: services.
p.000199: Exceptionally, DTC genetic testing which aims to improve dietary habits or other lifestyle factors (occupation,
p.000199: exercise etc.), or to define an individu- al’s ancestry, may not be dependent on such strict rules.
p.000199: B. In order to protect genetic information and respect a child’s right to ignorance, considering that children are
p.000199: unable to decide whether they wish to know the results of a genetic test predicting a disease, DTC genetic test- ing is
p.000199: not justified in asymptomatic children for whom there is no medical emergency, especially for late onset diseases such
p.000199: as Huntington’s disease. Even in the case where an expert decides that such a test is necessary for the parent(s),
p.000199: the same genetic test must be delayed for the child until he/she is able to participate in the decision
p.000199: making process, since there is no direct value to his/her health. On the contrary, DTC genetic testing is
p.000199: ac- ceptable in cases of children with first or second degree relatives with a monogenic disorder,
p.000199: showing a clear mode of inheritance e.g. familial hy- percholesterolemia. Nonetheless, such genetic tests must
p.000199: be allowed only in the case that the results will be used for early treatment and/or prevention of the complications
p.000199: caused by the disease.
p.000199:
p.000199:
p.000199:
p.000199:
p.000200: 200
p.000200:
p.000200: DIRECT-TO-CONSUMER GENETIC TESTING
p.000200: OPINION
p.000200:
p.000200: C. The promotion campaigns of DTC genetic testing must be governed by the same rules as in the case of health services,
p.000200: i.e. to be based on precise information and the true prognostic or diagnostic value of the test.
p.000200: Misleading advertising of the alleged “prediction” of serious diseases or other phenotypes, overlook the role of other
p.000200: genetic factors which are not determined yet or the critical role of environmental factors, and lead to ge- netic
p.000200: determinism.
p.000200: D. DTC genetic tests that determine a person’s identity without his/her consent is in principle illegal, since they
p.000200: directly offend the right to privacy.
...

Searching for indicator parents:

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p.000024: REPORT
p.000024:
p.000024: are relatively recent and their validity has not yet been evaluated by under- writers for practical purposes. Finally,
p.000024: whilst there is some evidence on how genetic data affects insurance prior to the agreement of a contract there has been
p.000024: no consideration regarding discrimination after contract agreement, for instance, problems with compensation
p.000024: payments.
p.000024: Whether genetic data should be treated differently from medical data in insurance is an issue widely debated. Some
p.000024: advocates of excluding genetic data from insurance argue that it is unfair to “punish” people for their ge- netic make
p.000024: up, i.e. for something they cannot change. Others argue that genetic data can be more easily misunderstood or
p.000024: overestimated compared to medical data and this is sufficient grounds to treat it differently (Holm, 2007).
p.000024: By contrast, those who argue that genetic data should be treated in the same way as medical data do not believe that
p.000024: the former have a higher prognostic value nor that they are more personal or sensitive than medical data (Ashcroft,
p.000024: 2007).
p.000024: No matter what stance one takes on this, an additional issue is how to ensure the appropriate evaluation of genetic
p.000024: information in order to avoid “misplacing” people in categories of high insurance risk on the basis of inad- equately
p.000024: understood genetic information. Such genetic discrimination might be introduced, for example, against healthy subjects
p.000024: who are heterozygotic carriers of mutations that result in disease only in homozygotes. As an ex- ample we might
p.000024: cite the parents of children suffering from cystic fibrosis who carry the responsible mutation for the disease
p.000024: but are in no risk of de- veloping cystic fibrosis themselves. There have been reports of such “mis- guided”
p.000024: discrimination in the UK (Law et al., 1998).
p.000024:
p.000024: 2. ETHICAL ISSUES
p.000024:
p.000024: Genetic testing or disclosure of related results for private insurance pur- poses raise two very poignant ethical
p.000024: questions:
p.000024: a) Is disclosure of these results justified as a requirement for insurance considering that a balance must be struck
p.000024: between economic freedom for the insurer and the need to protect the personality of the insured and also the usefulness
p.000024: of these results for the latter?
p.000024: b) Are there any collective interests, aside from the individual interests of the two parties that should be taken into
p.000024: account in this balancing?
p.000024:
p.000024:
p.000025: 25
p.000025:
p.000025: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000025: REPORT
p.000025:
p.000025: A. Business risk and protection of personality
p.000025:
p.000025: 1. In general, private insurance is a business activity governed by the principle of reciprocity. The basic
p.000025: idea consists in sharing the risk by a group of individuals who are equally likely to suffer damage which would be
p.000025: unaf- fordable to the individual person: by paying premiums, a large number of insured cover the expenses
...

p.000109: The Commission believes that when patients who are capable to consent are committed to hospital they should appoint a
p.000109: representative in writing, if possible.
p.000109: In case of patients incapable to consent who have not appointed a rep- resentative, the Commission thinks that:
p.000109: i) The legal representatives of the patient may select one of alternative treatment methods but may not refuse all
p.000109: treatments if the treating physi- cian believes that the continuation of therapy is beneficial. Only patients
p.000109: who are capable for self-consent may refuse treatment.
p.000109: ii) In case of disagreement between the legal representatives the treat- ing physician should be able to decide taking
p.000109: into account the opinion of the hospital board of ethics which must be made mandatory in our country.
p.000109: iii) The physician must take into consideration any prior directions by the patient (id est, any wishes the patient
p.000109: expressed prior to becoming incapa- ble to consent).
p.000109: iv) The opinion of mentally mature minors on issues regarding their health must be taken into account in
p.000109: order to comply with the constitutional protection of personality.
p.000109: v) In case of refusal of parents to consent to the treatment of minors - and in case of threat against their lives or
p.000109: serious harm to their health- the physician must proceed to the indicated treatment complying with the legal procedure.
p.000109: vi) In case of patients with limited capacity to consent (minors, mental patients, persons with mental
p.000109: impairments), the attitude of the physician must consist in favoring as much as possible the expression of an
p.000109: opinion by the patients themselves according to the level of their capacity to compre- hend their situation.
p.000109: Therefore, the information to be provided to the pa- tient must be adjusted accordingly in cooperation
p.000109: with their representa- tives.
p.000109:
p.000109:
p.000110: 110
p.000110:
p.000110: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000110: OPINION
p.000110:
p.000110: vii) The Commission believes that even under the circumstances of in- tensive care units physicians must not
p.000110: act alone ignoring the will of the pa- tient. On the contrary, the physician’s moral duty is to ensure the free ex-
p.000110: pression of the patient’s will by providing complete, timely and intelligible information whenever feasible.
p.000110:
p.000110: b) Right of physician to refuse treatment
...

p.000113: physician-patient in Greek
p.000113:
p.000113:
p.000113:
p.000114: 114
p.000114:
p.000114: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000114: REPORT
p.000114:
p.000114: law2. The main characteristic of this law is the explicit introduction of “in- formed consent” albeit
p.000114: maintaining provisions which reflect the former “pa- ternalistic” approach.
p.000114: It must be noted that “informed consent” was already embedded in Greek law, first, through the
p.000114: ratification of the Oviedo Convention on Hu- man Rights and Biomedicine (art. 5 et seq. Law 2619/1998) and,
p.000114: second, by way of express provisions in a number of laws on various medical fields3. Naturally, the
p.000114: relevant rules of the CME are more detailed. Pursuant to the CME:
p.000114: - Informed consent is always required except in case of: a) emergen- cies, b) suicide attempts, and c) refusal to
p.000114: consent by the guardian of a person incapable to consent in a life- or health-threatening situa- tion.
p.000114: - The consent must be explicit though it may be informal.
p.000114: - In case of minors, the consent is provided by their parents or custo- dian.
p.000114: - In other cases of incapacity, the consent is given by the “next of kin” or the legal guardian.
p.000114: Consent requires that the patient (or the patient’s representative in case of incapacity) must “be informed”. This
p.000114: information:
p.000114: - Must be “complete” and “intelligible”.
p.000114: - Must reflect the truth.
p.000114: - Must cover: a) the real condition of health, b) the content of the sug- gested medical act, c) the risks and likely
p.000114: side effects, d) alternative
p.000114:
p.000114:
p.000114: 2 Despite its title (“Code of Medical Ethics”) this Law was not an instance of investing with legal authority a
p.000114: pre-existing corpus of norms accumulated by the medical pro- fession in the context of self-regulation (a stricto sensu
p.000114: code of ethics). It was genuine lawmaking by the government and went through the usual pipeline of
p.000114: law- enactment (a drafting committee was set up for that purpose; its draft text was duly tabled by the responsible
p.000114: Ministry for Health to go through the parliamentary proce- dure). In that respect, the title “Code of Medical Ethics”
p.000114: is not accurate, although the same wording was also used in the previous situation enacted by the royal
p.000114: decree 25.5/6.7.1955.
p.000114: 3 See art. 10 (4) Law 2737/1999 on transplants, art. 1456 of the Civil Code (Law 3087/2002) on
...

p.000116:
p.000116: b) Problems pertaining to consent
p.000116:
p.000116: Problems pertaining to consent itself arise in the relationship physician- patient in case of incapacitated patients:
p.000116: First, as to the derogations from informed consent accepted by the CME (art. 12[3]), there is the question of
p.000116: whether a patient’s relatives may, in general, refuse treatment and to what extent are they allowed to do so. The
p.000116: “risk to health”, as a limit prescribed by the law, is susceptible of broad in- terpretation and needs to be
p.000116: further specified. Certainly, the discretion to “refuse treatment” is not the same for patients and
p.000116: relatives as the latter are not able to experience the disease. On the other hand, relatives may not
p.000116:
p.000116: 6 For an example of deterioration of the patient’s health because of a similar initia- tive by the physician, see Higgs
p.000116: (op. cit.) p. 435.
p.000116:
p.000117: 117
p.000117:
p.000117: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000117: REPORT
p.000117:
p.000117: be “obligated” to allow treatment for this would defeat the basic tenet of their freedom to consent on behalf of the
p.000117: patient.
p.000117: Continuing on the question of derogations, it is worth noting the differ- ent approach of the CME as compared with art.
p.000117: 1534 of the Civil Code (CC) which allows the physician to act alone in case the parents of a minor refuse to give their
p.000117: consent to treatment. The Civil Code requires authorization by the Prosecutor whereas the CME does not. The question is
p.000117: whether the pro- visions of the CME provide sufficient grounds to cover the physician’s liability vis-à-vis the
p.000117: parents especially in view of the constitutional protection of parental care (Constitution, art. 21 [1]; art. 8
p.000117: [1] ECHR) whose guarantor is precisely the judiciary and not the physician -as firmly held in legal doctrine.
p.000117: Critical also is the physician’s attitude in case of disagreement between relatives which is not unlikely since
p.000117: the law does not assign any priority among relatives with regard to their power to decide. Should an
p.000117: implicit hierarchy be inferred or is it left to the physician to decide according to his/her fundamental
p.000117: duty to the patient? Could an ethics board be of assis- tance when the patient is hospitalized? Let us recall
p.000117: at this point that our national health system is not familiar with ethics boards whereas in Europe and the US they
p.000117: are well-established -and the importance of their role is not put in question- for many years.
p.000117: An even graver issue may arise when the physician is in a position to know the patient’s wishes, which
p.000117: were expressed before the patient became incapable to consent either in written or orally and the relatives
p.000117: disagree. Since the latter have by law the right to make the final decision, the ques- tion is whether these wishes
p.000117: should be taken into account, and how. It is worth noting that both the CME (art. 2[2]) and the Oviedo
p.000117: Convention (art.
p.000117: 9) stipulate so though failing to specify the ensuing legal effects (see below). Finally, there is a wider issue with
p.000117: the consent of minors. The law totally precludes it (art. 12 [2] [b] CME) even when minors are obviously
p.000117: able to exercise control over their health given that other provisions recognize their capacity to enter into
p.000117: legal relationships (e.g. to marry). At issue here is whether the scope of this provision should be
p.000117: interpreted stricto sensu to apply only when the intellectual immaturity of the minor obviously justifies that the
p.000117: consent be given by his/her parents or custodian in order to har- monize this rule with the constitutional protection
p.000117: of personality (Constitu-
p.000117: tion, art. 5 [1]).
p.000117:
p.000117:
p.000118: 118
p.000118:
p.000118: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000118: REPORT
p.000118:
p.000118: c) Medical liability and other legal consequences
p.000118:
p.000118: In legal terms, the answers to all the above questions have an impact, first and foremost, on the extent of
p.000118: medical liability (criminal, civil and pro- fessional). Liability, in this case, is not connected with fault in the
p.000118: execution of a medical act (which is judged according to lege artis execution) but with fault at the stage preceding
p.000118: the act, i.e. during the legal procedure of deci- sion-making7.
p.000118: Thus the implementation of the Oviedo Convention and the CME provi- sions on “informed consent” (and of the provisions
p.000118: of special legislation on transplants, assisted reproduction, etc.) complement the general legislation on medical
p.000118: liability (e.g. arts. 57, 914 CC, art. 8 Law 2251/1994) and may provide grounds for particular claims in
p.000118: action8.
p.000118: Secondly, the answers may have an impact on the legal situation of third parties (hospitals, relatives) insofar as
p.000118: compliance with the principle of con- sent is associated with individual rights and obligations pertaining to them.
p.000118:
p.000118: C. SPECIAL PROBLEMS IN THE IMPLEMENTATION OF AUTONOMY WITH EMPHASIS ON THE GREEK SITUATION
p.000118:
...

p.000124: foreseen and documented as far as possible. But individual citizens also bear a re- sponsibility to
p.000124: society, and their decision to participate or not in a vaccina- tion program cannot be based solely on the argument of
p.000124: autonomy. Individ- ual people themselves will probably not benefit directly from participating in a vaccination
p.000124: program, but they contribute to the protection of society and of vulnerable groups in particular.
p.000124: The importance of confidence in the safety of vaccines and the major role of the State and of the scientific
p.000124: community were recently illustrated in
p.000124:
p.000124:
p.000125: 125
p.000125:
p.000125: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000125: REPORT
p.000125:
p.000125: Great Britain in the MMR vaccine against measles, mumps and rubella. Be- fore the beginning of mass vaccination,
p.000125: measles cost Britain an average of 100 casualties annually. In 1988 the rate of participation in mass vaccination was
p.000125: 76%. The launching of the triple vaccine that year in replacement of the three separate ones increased the rate of
p.000125: participation to 91% until 1998. At that moment, however, fears began to spread about side-effects; autism in
p.000125: particular. Although the vaccine had been tested for many years and there was no data commonly accepted by the
p.000125: scientific community suggesting any side effects, certain studies published by a medical researcher undermined the
p.000125: confidence of parents and participation in the vaccination program dwindled significantly after 1998. The study
p.000125: which supported the allegations of some parents about side effects proved fallacious; in fact, it contained
p.000125: fabricated data. The slump in participation rates, however, led to the loss of the so-called indirect or herd
p.000125: immunity causing an important increase in measles cases before confidence in the vaccine was restored and broad
p.000125: par- ticipation resumed (Jansen et al., 2003).
p.000125: Whereas in case of tested vaccines, the decision to abstain is not ethical- ly neutral, the example of new and
p.000125: insufficiently tested vaccines is different. The experience of mass vaccination against swine influenza in the
p.000125: US in 1976 illustrates the risks inherent in a reckless decision for extended vac- cination based on
p.000125: unfounded, as it proved, fears of a pandemics, and with inadequately tested vaccines at that. While the influenza
p.000125: claimed only one victim, the side effects from the vaccine caused 25 casualties and may have led to permanent damage
p.000125: (it was associated with the auto-immune syn- drome of Guillain-Barré). Such examples justify the reluctance to
p.000125: participate and the ethical duty to society as a whole cannot remain as strong if weighed against an
p.000125: increased likelihood of unknown side-effects from the vaccine.
p.000125:
p.000125: 5. Patients in hospitals - The case of ICUs
p.000125:
p.000125: Implementing the model of consent in hospitals is met with certain limits to patient autonomy.
p.000125: First of all, the hospitalized patient is situated in a public environment which does not allow full freedom
...

p.000127: in time and decide about treatment by himself/herself. Besides, it is not legitimate to substitute the patient’s
p.000127: relatives for the patient’s own will for patients may disagree with their relatives’ decision once their mental
p.000127: capacities are restored.
p.000127: Respectively, persons who are legally incompetent to consent may be physically fully capable of forming and
p.000127: expressing their will on matters con- cerning their health. We already mentioned the example of minors, espe-
p.000127: cially from the beginning of adolescence; similar, however, is the situation of persons under legal guardianship
p.000127: (even full-fledged) whereas mild mental disorders or impairments do not by definition exclude the exercise of self-
p.000127: control over one’s health.
p.000127: In the case of minors, it would be more appropriate to recognize their capacity for self-consent after a certain
p.000127: age (thus precluding consent by the minor’s legal representatives) for there is an objective presumption of suffi-
p.000127: cient maturity in contemporary societal life that can hardly be put in ques- tion (e.g. from the age 15 years).
p.000127: Meanwhile the assent of minors must be given considerable weight in relevant decisions, especially if coinciding with
p.000127: the physician’s advice, even when the parents disagree.
p.000127: For adults, it is difficult to assume a similar objective presumption. Therefore, the view of the concerned
p.000127: person must be given particular atten- tion (as must the appropriateness of prior information) and evaluated on a
p.000127: case-by-case basis although the power of legal representatives to decide cannot be questioned.
p.000127: The problem of advance directives is a much harder nut to crack. The event of becoming incompetent to
p.000127: consent often leads people to issue di- rections on how they wish to be treated ahead of time. These directions are
p.000127: usually addressed to close relatives or close friends, or even to the physi- cian, if one is already ill.
p.000127: They are usually informal (oral and eventually with no witnesses) but some countries have provided a modality to
p.000127: safeguard the validity of their will (“living wills”). Usually, these directions are about the refusal of
p.000127: certain unpleasant or painful treatments (e.g. haemodialysis, car-
p.000127:
p.000127: decisions by patients capable to consent and on the mental faculties, which are criti- cal for consent (Elliot, 2001).
p.000127:
p.000128: 128
p.000128:
p.000128: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000128: REPORT
p.000128:
p.000128: diopulmonary resuscitation)11 or even the interruption of artificial life sup- port (e.g. refusal of feeding,
p.000128: hydration, etc.)12.
p.000128: Bearing in mind the fact that the law in our country is ambiguous13 the question is what happens when a physician is
...

p.000212: him/her. Certainly, the physi- cian must inform the patient about the risks of misleading information or
p.000212: unnecessary tests which may affect the patient’s treatment or life (art. 9 par. 4, art. 11 CME).
p.000212:
p.000212: Handling sensitive data
p.000212: Are there any restrictions in the case where a person consents to disclose sensitive data, to a third party, about
p.000212: his/her health or lifestyle expecting to obtain information on possible consequences to him/herself or his/her fami-
p.000212: ly? Furthermore, are there any restrictions in the existing risk that the data are handled with no control and,
p.000212: eventually, used for other purposes?
p.000212: In principle, everybody has full power on his/her own personal, simple or sensitive, data. However, a person can only
p.000212: undertake the risk of unethical handling of such data only for him/herself, not for others. In the case where genetic
p.000212: information concerns - and also identifies - members of the family, they must be protected from such risks through
p.000212: appropriate procedures.
p.000212:
p.000212: Genetic tests in children
p.000212: Is it ethical to perform genetic tests in asymptomatic children, upon the parents’ request, and how does this affect
p.000212: the child’s right to ignorance?
p.000212: To protect genetic information, as well as the child’s right to ignorance, it is not justified to perform genetic tests
p.000212: in asymptomatic children for which there is no urgent medical need -particularly for late onset diseases.
p.000212: This does not mean that genetic tests for such diseases should never be performed in children. In the case where
p.000212: parents wish to have the child tested, without an immediate benefit for the child’s health (i.e. treatment or
p.000212: prevention), one must weigh the risks and the benefits, and genetic testing may be postponed until the child reaches a
p.000212: certain age and is able to con- tribute at the decision making process (British Society for Human Genetics, 2010).
p.000212:
p.000212:
p.000212:
p.000213: 213
p.000213:
p.000213: DIRECT-TO-CONSUMER GENETIC TESTING
p.000213: REPORT
p.000213:
p.000213: Genetic tests revealing identity
p.000213: Is it morally legitimate for someone to demand disclosure of a person’s identity, without the latter’s knowledge, in
p.000213: order to protect one’s own vital interests (i.e. with a “paternity test”)?
p.000213: The answer is, in principle, negative, in the context of the right to priva- cy. Even if there is a serious reason for
p.000213: such a practice, this must be judged (and eventually there may be a decision to disclose the identity of a
p.000213: third person) in an a priori defined legal procedure, not arbitrarily by the appli- cant him/herself.
p.000213:
p.000213: Commercialization of biological information
p.000213: Is it ethically acceptable to maintain a financial activity that involves “remote” services of biological
p.000213: information and other sensitive data by “faceless” organisations, which are based on standardized requests
p.000213: and questionnaires for anyone interested?
...

p.000250: http://www.wada-ama.org/Documents/World_Anti-Doping_Program/WADP-The- Code/WADA_Anti-Doping_CODE_2009_EN.pdf.
p.000250:
p.000251: 251
p.000251:
p.000251: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000251: REPORT
p.000251:
p.000251: Genetic manipulations can be applied in two types of cells:
p.000251: Somatic cells. Altering the genetic material in somatic cells involves only the organisms where the
p.000251: changes are made -in that case the athlete-, and such modifications are not inherited in the subsequent
p.000251: generations.
p.000251: For example, genes could be altered in somatic cells in order to create or modify muscles to become stronger.
p.000251: The insulin-growth factor helps the muscles to develop and restore injuries. Experimen- tally, the genes expressing
p.000251: insulin-growth factor can be transferred via a viral vector in mice, promoting muscle growth (Barton-Davis et al.,
p.000251: 1998). Although this specific research was conducted with the aim to treat diseases such as muscular
p.000251: dystrophy, the results could be used to enhance the muscle mass of athletes.
p.000251: Erythropoietin is also a characteristic example, which is used to enhance the strength of patients who are
p.000251: under chemotherapy and present with anemia. Athletes receive injections of erythropoietin to enhance their athletic
p.000251: performance, but they could also go under gene transfer to receive the same gene and produce more red blood cells
p.000251: (Svensson et al., 1997).
p.000251: Germ cells. Genetic modifications in the genetic material of germ cells, namely gametes, are inherited by the
p.000251: offspring.
p.000251: For example, the genes that produce insulin-growth factor may be modified in such a way that they are
p.000251: overexpressed. Parents will pass these genes on to their children who will be born with an ad- vantage in
p.000251: their muscle growth.
p.000251: Although the use of such genetic technologies is not possible at present, concerns are being expressed about the
p.000251: possibilities that will be available to create “super-athletes” in the future. Since the gene transferred to the ath-
p.000251: lete's body is inserted in his/her genome, a major question which concerns the anti-doping authorities in this
p.000251: case is how to detect genetic modifica- tions. About 10 years ago the Medicine Commission of IOC (IOC, 2001) and
p.000251: WADA launched consultations and created working groups aiming to exam- ine “gene doping” in sports, which includes gene
p.000251: therapy and gene transfer (WADA. Health, Medical and Research Committee Meeting. Minutes. 2001). Since then, WADA
p.000251: organizes meetings of expert working groups on gene doping, whereas plentiful money have been invested on
p.000251: testing for modern
p.000251:
p.000251:
p.000252: 252
p.000252:
p.000252: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000252: REPORT
p.000252:
p.000252: methods of detection that will identify athletes who will abuse this technol- ogy (WADA 2002; 2004; 2005).
p.000252: In 2003, WADA included “gene doping” for the first time on the list of prohibited substances and methods.
p.000252: More specifically, the list of prohibited substances and methods 2012 includes “The transfer of nucleic acids or nu-
p.000252: cleic acid sequences” and “The use of normal or genetically modified cells”. According to a comment on Art. 4.3.2 of
p.000252: the World Anti-Doping Code, the use of genetic technology should be prohibited as it satisfies the two criteria of
...

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p.000002: 3. Address Opinions to various public authorities upon request.
p.000002: In addition, depending on the matter examined in each case, the Com- mission took into consideration the views
p.000002: of outstanding scientists from different fields, who were invited. The Commission wishes to thank these
p.000002: scientists for their willing response.
p.000002: During its first Presidency (2000-2007), the Commission published the first volume of Opinions and Reports, in
p.000002: Greek and English. The book in hand comprises the second volume, with the Opinions and Reports from 2008-
p.000002: 2013. The entire collection of Opinions and relevant Reports is included in approximately 725 pages of these two
p.000002: volumes (“Reflections on Contempo- rary Issues, Opinions and Reports 2000-2007” and “Reflections on Contem- porary
p.000002: Issues, Opinions and Reports 2008-2013”).
p.000002:
p.000002:
p.000003: 3
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p.000003:
p.000003:
p.000003: The reader will have the chance to find that the 286 pages of the current edition include 9 issues of high interest,
p.000003: which concern the modern society.
p.000003: The current edition was edited by Dr. Vasiliki Mollaki, whom we thank.
p.000003:
p.000003:
p.000003: The President Ioannis D. Papadimitriou Emeritus Professor of Medicine
p.000003:
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p.000004:
p.000004: CONTENTS
p.000004: USE OF GENETIC DATA IN PRIVATE INSURANCE 7
p.000004: Opinion
p.000009: 9
p.000009: Report
p.000015: 15
p.000015: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES 39
p.000015: Opinion
p.000041: 41
p.000041: Report
p.000047: 47
p.000047: MANAGEMENT OF BIOLOGICAL WEALTH 65
p.000047: Opinion
p.000067: 67
p.000067: Report
p.000075: 75
p.000075: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN 103
p.000075: Opinion
p.000105: 105
p.000105: Report
p.000113: 113
p.000113: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND
p.000113: AUTONOMY
p.000137: 137
p.000137: Opinion
p.000139: 139
p.000139: Report
p.000145: 145
p.000145: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH 157
p.000145: Opinion
p.000159: 159
p.000159: Report
p.000165: 165
p.000165: DIRECT-TO-CONSUMER GENETIC TESTING 193
p.000165: Opinion
p.000195: 195
p.000195: Report
p.000203: 203
p.000203: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT 221
p.000203: Opinion
p.000223: 223
p.000223: Report
p.000233: 233
p.000233: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE AND MENTAL STATE 267
p.000233: Opinion
p.000269: 269
p.000269: Report
p.000273: 273
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p.000008: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000008: OPINION
p.000008:
p.000008: O P I N I O N
p.000008:
p.000008: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000008:
p.000008: The National Commission of Bioethics considered the issue of the possi- ble use of genetic data in private life
p.000008: and health insurance in several ses- sions. The Commission has already raised this issue in its recommendation
p.000008: “on the collection and use of genetic data” (2002). Today, the latest devel- opments in genetic testing and the
p.000008: activity observed in international legisla- tion justify its re-examination.
p.000008: The Commission organised hearings with Mr. Tangopoulos, President of the Committee on Life and Health Insurance of the
p.000008: Association of Insurance Companies and Mr. D. Kremezis, expert in insurance law and lawyer.
p.000008:
p.000008: 1. General comments
p.000008:
p.000008: The question of whether insurers may require insurance applicants to provide, in addition to conventional
p.000008: information on their medical history, the results of genetic testing has been a major issue for National Bioethics
p.000008: Committees and legislative action in many countries. The reason is that alt- hough genetic information reveals a mere
p.000008: predisposition for the manifesta- tion of certain diseases, it may lead to discrimination against insurance ap-
p.000008: plicants.
p.000008: There are currently three trends in relevant legislation. Some states have prohibited the use of genetic
p.000008: information with specific laws, others have decided to refrain from legislating while several have adopted a
p.000008: process of relevant consultation with the insurers during which the latter have pledged not to require nor make
p.000008: use of genetic data (moratorium). In Greece the issue has not yet been considered while the life and health
p.000008: insurance legisla- tion is incomplete.
p.000008:
p.000008: 2. Genetic data
p.000008:
p.000008: a. Definition
p.000008: Genetic data is data arising from genetic analysis, i.e. analysis of DNA, RNA, chromosomes, proteins or
p.000008: metabolites detecting gene mutations or
p.000008:
p.000009: 9
p.000009:
p.000009: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000009: OPINION
p.000009:
p.000009: chromosomal changes associated with diseases and conducted for medical reasons. According to one opinion, family
p.000009: history is also included in a per- son’s genetic data.
p.000009:
p.000009: b. Importance of genetic testing
p.000009: The number of diseases with a strong genetic link, for which genetic test- ing is available, for predisposition or
p.000009: diagnosis, is increasing. Of the available genetic tests, the most controversial with regards to their use in private
p.000009: in- surance are predisposition tests, i.e. tests capable for detecting disease- causing mutations in healthy
p.000009: individuals. The prognostic value of such tests varies significantly. Additionally, the processing and evaluation of
p.000009: the results of genetic testing is by no means a simple task as several factors need to be taken into account such as
p.000009: family history, medical history and lifestyle.
p.000009:
p.000009: c. Is genetic data different from medical data?
p.000009: Medical history is considered a legitimate criterion for dividing the in- sured into groups of equal
p.000009: risk and calculating the respective premium. Based on the current policy of insurance companies the insured are
p.000009: covered for diseases not manifested prior to the conclusion of the insurance contract according to their medical
p.000009: records.
p.000009: Genetic data, and more specifically the results of predisposition tests (the main focus of the present
p.000009: report), like some other types of medical da- ta, reveal a probable risk but -in most cases- not certainty of future
p.000009: sickness. The difference, at the moment, of genetic as against medical predisposition markers is that the
p.000009: association between most genetic markers and the probability of disease is not well-documented compared to
p.000009: medical mark- ers.
p.000009:
p.000009: 3. Ethical issues
p.000009:
p.000009: a. Protection of personality and economic freedom
p.000009: In view of the above, the first emerging ethical issue consists in weighing protection of personality for insurance
p.000009: applicants against freedom of busi- ness for insurers.
p.000009: Disclosure of genetic information -similarly to other health-related in- formation- as a requirement for
p.000009: contracting insurance or as a factor in the
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000010: OPINION
p.000010:
p.000010: calculation of premium goes to the core of personality since this information constitutes sensitive personal data.
p.000010: Considering that genetic data is in prin- ciple unchangeable, to reveal a predisposition for a disease may lead to
p.000010: life- long “stigmatization” of the applicant, a serious infringement on personality that may take the form of unfair
p.000010: social discrimination.
p.000010: On the other hand, freedom of business for the insurer is apparently restricted if access to genetic data
p.000010: known to the other party may affect sig- nificantly the insurer’s business risk. In the context of freedom of contract,
p.000010: barring access to information which is relevant to the object of the specific insurance could be seen as unfair to
p.000010: insurers since they are exposed to a risk they ignore whereas the other party is aware (and perhaps takes advantage)
p.000010: of.
p.000010:
p.000010: b. The value of genetic data and the risk of “genetic determinism”
p.000010: Genetic data is a very useful tool in contemporary medicine. In the con- text of personalized medicine and
p.000010: pharmacogenomics, in particular, person- al genetic data is becoming increasingly important for determining
p.000010: thera- peutic treatment. It is therefore of paramount importance that the collec- tion of genetic data,
p.000010: which can contribute to improvement of individual health, is not obstructed for non-medical reasons.
p.000010: The collection of genetic data for research aiming to identify links be- tween diseases and genetic
p.000010: causes with the ultimate goal to identify new treatment targets is crucial for the advancement of science and,
p.000010: in the long run, for the protection of public health. In this case also, it is critical that
p.000010: participation in such research is not discouraged for fear of use of genetic data or of the findings of research to
p.000010: the detriment of participants.
p.000010: Despite the significance of genetic data for both personal and public health, its prognostic value should
p.000010: not be overrated in order to avoid the impression that genetic tests are decisive for the individual. The use
p.000010: of ge- netic data in insurance would reinforce the misleading notion of “genetic determinism”, i.e. the
p.000010: belief that an individual’s genetic make-up absolutely determines their future health or other personal
p.000010: characteristics. Therefore, it is important to safeguard genetic data so that not only genetic testing and
p.000010: participation in research, which could yield many benefits to the individual and to society as a whole, are not
p.000010: discouraged but also to avoid an errone-
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000011: OPINION
p.000011:
p.000011: ous use of these data disproportionate to their true value for disease pro- gnosis.
p.000011:
p.000011: 4. General directions
p.000011:
p.000011: a. The principle
p.000011: In view of the above analysis, the Commission believes that any settle- ment of the issue should give serious
p.000011: consideration to the following:
p.000011: i) Personal insurance is a value of public interest and not a common commodity.
p.000011: ii) Genetic data yields a statistical probability of becoming sick and not a definite prediction; therefore, it should
p.000011: not be overestimated.
p.000011: iii) Research of the human genome is primarily beneficial for human health, a fundamental societal right
p.000011: and should therefore not be dis- couraged.
p.000011:
p.000011: b. A need for regulation
p.000011: Starting from this position, the Commission believes that some form of regulation of the use of genetic data in
p.000011: insurance is needed in our country. It points out the following:
p.000011: i) The fact that Greece has an organized system of social security (where discrimination between the insured is
p.000011: inadmissible) does not diminish the relevance of the issue. For, considering the well-known weaknesses of the
p.000011: social security system, the market of private life and health insurance is steadily expanding and is
p.000011: currently relevant to an important part of the population (11 and 16% respectively in big conurbations1). The
p.000011: same is true in other countries with well-developed social security systems that have already been studying
p.000011: the question systematically (UK, Germany).
p.000011: ii) The widespread notion of “genetic determinism” -a result of unwar- ranted overstatements in recent years
p.000011: based on the achievements of genet- ics- can easily lead to practices of unfair discrimination. The confusion
p.000011: of “predisposition” as a synonym for “manifestation” of a serious disease, even as a result of public misinformation,
p.000011: unless appropriately regulated, can cre-
p.000011:
p.000011: 1 According to data from the “Study on insurance contracts” that was commissioned to TNS-ICAP in 2007 by the
p.000011: Hellenic Association of Insurance Companies and was brought to the attention of the Commission by Mr. S.
p.000011: Tangopoulos.
p.000011:
p.000012: 12
p.000012:
p.000012: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000012: OPINION
p.000012:
p.000012: ate insurance market conditions unfavourable for the protection of human rights.
p.000012:
p.000012: c. The type of regulation
p.000012: The Commission is aware of the seriousness of the conflict between the rights and interests of citizens and
p.000012: insurers. It believes, however, that the protection of personality and avoidance of unfair discrimination against
p.000012: the insured outweighs the economic freedom of the insurers. And this because the implications of genetic -as any
p.000012: other biological- discrimination directly relate to human dignity and, consequentially, affect the quality
p.000012: of societal life and the principle of equal treatment in a democratic society. By contrast, the harm to the insurance
p.000012: market by the prohibition of genetic discrimina- tion in the risk calculation is not judged significant. The
p.000012: manifestation of a disease for which there is a predisposition (as estimated on the basis of ge- netic analysis or
p.000012: family history) is uncertain in most cases and it is impossible to determine the time of such manifestation. So,
p.000012: genetic data is not particu- larly important for the calculation of risk.
p.000012: Nevertheless, ways need to be identified that will safeguard the legiti- mate interests of insurers,
p.000012: especially the risk of wilful deception. For that purpose, it seems appropriate to adopt a moratorium
p.000012: with a reasonable duration. During this time, insurers must make specific commitments not to use genetic data and
p.000012: the State must pledge to enact legislation -following public dialogue. In the context of such dialogue, it is
p.000012: crucial to put in place a certification system for genetic laboratories and to recognize the specialty of geneticists
p.000012: in order to ensure the quality of genetic analysis and genetic counseling.
p.000012:
p.000012:
p.000012: Athens, 11 January 2008
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000013: OPINION
p.000013:
p.000013: COMPOSITION AND PERSONELL
p.000013: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000013: Deputy Chairman and Acting Chairman: George Maniatis, Emeritus Profes- sor of General Biology, University of Patras.
p.000013:
p.000013: Members:
p.000013: Savvas Agourides, Emeritus Professor of Theology, University of Athens.
p.000013: Myrto Dragona-Monachou, Emeritus Professor of Philosophy, University of Athens.
p.000013: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000013: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000013: Athens.
p.000013: Dimitrios Roupakias, Professor of Plant Breeding, University of Thessaloniki.
p.000013: Pavlos Sourlas, Professor of Philosophy of Law, University of Athens.
p.000013: Constantinos Tsoukalas, Emeritus Professor of Sociology, University of Ath- ens.
p.000013: Ioannis Vlahoyiannis, Professor of Medicine and Nephrology, University of Patras.
p.000013:
p.000013:
p.000013:
p.000013: PERSONNEL
p.000013:
p.000013: Scientific Officers:
p.000013: Takis Vidalis, Lawyer, PhD in Law.
p.000013: Ariadne L. Hager-Theodoridou, Agronomist, PhD in Genetics.
p.000013:
p.000013: Secretariat:
p.000013: Marianna Drakopoulou, Lawyer, Head of Secretariat.
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000014: REPORT
p.000014:
p.000014: R E P O R T
p.000014:
p.000014: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000014:
...

p.000019: sign of the complexity of the evaluation of the test results. Another important factor is that a negative score in
p.000019: the genetic test does not mean that the subject will not develop the specific cancers, only that the risk is not higher
p.000019: as compared with the general population. Finally, a positive score in a healthy subject practically means
p.000019: that the person in question must undergo more frequent examinations but it makes no difference in terms of
p.000019: treatment if cancer does occur.
p.000019: In brief, testing for BRCA1/2 gene mutations is complicated and great caution is required in the choice of
p.000019: the detection method as well as in the evaluation of the result.
p.000019: In conclusion, although most genetic tests cannot predict the manifesta- tion of a genetic disease with certainty, they
p.000019: have considerable prophylactic value for the person undergoing the test. By identifying a predisposition for cancer,
p.000019: for example, one can be protected by regular medical examinations for early identification and treatment of tumors. It
p.000019: is well documented that early diagnosis saves lives in such situations.
p.000019:
p.000019: B. Genetic testing laboratories
p.000019:
p.000019: There are at least 611 certified genetic laboratories worldwide that are registered with the reliable network GeneTest.
p.000019: Greece has one certified ge- netic laboratory10. However, other public or private laboratories carry out
p.000019: genetic tests without ISO certification, as there is no law regulating the op- eration of non-certified laboratories11.
p.000019:
p.000019: 10 BioAnalytic-GenoType S.A.
p.000019: 11 There is a related opinion by the Committee for Genetics to the Ministry for Health on the operation of genetic
p.000019: labs; the Committee met in 2005-2006 for this purpose.
p.000019:
p.000020: 20
p.000020:
p.000020: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000020: REPORT
p.000020:
p.000020: The multiplication of new genetic tests, the increase in genetic laborato- ry numbers (Figure 2) and the widespread
p.000020: application of genetics in medi- cine create an urgent need to ensure the quality of services offered by ge- netic
p.000020: laboratories. The operation of certified genetic laboratories is gov- erned by international certification
p.000020: rules. Among the requirements for quali- ty control according to relevant ISO regulations are the validity of method,
p.000020: the evaluation of the results by trained professionals and safeguard clauses for the protection of patient rights. With
p.000020: regards to the latter, in particular, the rules for certification require a referral by the treating physician and the
p.000020: consent of the person taking the test following comprehensive information by qualified scientists on the
p.000020: consequences of the test for those involved and their families. The anonymity of samples and the duty of
p.000020: confidentiality of the staff are also ensured. Without certification or some other kind of regulation of
p.000020: lab operation, the validity and protection of the results cannot be guaranteed.
p.000020:
p.000020: C. The value of genetic information for individual health and scientific pro- gress and the potential of genetic
p.000020: testing
p.000020:
...

p.000032: and Intellectual Property 4, 83-99.
p.000032: Hall MA and Rich SS (2000). Laws restricting health insurers' use of genetic information: Impact on genetic
p.000032: discrimination. Am J Hum Genet 66, 293- 307.
p.000032: Holm S (2007). Should genetic information be disclosed to insurers? Yes. BMJ 334, 1196.
p.000032: Holtzman NA, Watson MS (1999). Promoting safe and effective genetic test- ing in the United States: Final report of the
p.000032: Task Force on Genetic Testing. Baltimore: Johns Hopkins University Press.
p.000032: Kriari-Katrani I (1999). Genetic technology and fundamental rights. The Con- stitutional protection of genetic data,
p.000032: Athens-Thessaloniki.
p.000032:
p.000032:
p.000032:
p.000033: 33
p.000033:
p.000033: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000033: REPORT
p.000033:
p.000033: Lemmens T (2003). Genetics and insurance discrimination: Comparative legislative, regulatory and policy
p.000033: developments and Canadian options, Health Law Journal 41-86.
p.000033: Low L, King S, Wilkie T (1998). Genetic discrimination in life insurance: Em- pirical evidence from a cross sectional
p.000033: survey of genetic support groups in the United Kingdom. BMJ 317, 1632-1635.
p.000033: McPherson E (2006). Genetic diagnosis and testing in clinical practice, Clini- cal Medicine & Research 4, 123-129.
p.000033: Minute of the Meeting between HGC and the Single Equality Bill Team (2007). Wellington House, (HGC Minute
p.000033: 2007).
p.000033: Nationaler Ethikrat (2007). Predictive health information in the conclusion of insurance contracts. Opinion,
p.000033: Berlin.
p.000033: Pertucelli N, Daly MB, Bars Culver JO, Feldman GL (1998). BRCA1 and BRCA2 hereditary breast/ovarian cancer. In:
p.000033: GeneReviews at GeneTests: Medical Genetics Information Resource.
p.000033: Pfeffer NL, Veach PM, LeRoy BS (2003). An investigation of genetic counse- lors' discussion of genetic discrimination
p.000033: with cancer risk patients. J Genet Couns 12, 419-438.
p.000033: Rothenberg KH and Terry SF (2002). Before it’s too late-Addressing fear of genetic information, Science 297, 196-197.
p.000033: Warby SC, Graham RK, Hayden MR (1998). Huntington Disease. In: GeneRe- views at GeneTests: Medical Genetics Information
p.000033: Resource.
p.000033:
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p.000034: 34
p.000034:
p.000034: USE OF GENETIC DATA IN PRIVATE INSURANCE REPORT
p.000034:
p.000034: ANNEX: FIGURES AND TABLES
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.000034: Figure 1. Schematic representation of the spectrum of genetic and environmental causes of human diseases.
p.000034: Adapted from GeneTests (http://www.genetests.org/).
p.000034:
p.000034:
p.000034:
p.000034:
p.000034:
p.001400: 1400
p.001400:
p.001300: 1300
p.001300:
p.001200: 1200
p.001200:
p.001100: 1100
p.001100:
p.001000: 1000
p.001000:
p.000900: 900
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p.000400: 400
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p.000300: 300
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p.000200: 200
p.000200:
p.000100: 100
p.000100:
p.000000: 0
p.000000:
p.000000:
p.000000:
p.000000:
p.000000: Laboratories
p.000000: Diseases for which testing
p.000000:
p.000000:
...

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p.000002: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
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p.000039: 39
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p.000040: 40
p.000040:
p.000040: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000040: OPINION
p.000040:
p.000040: O P I N I O N
p.000040:
p.000040: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000040:
p.000040: The National Bioethics Commission has considered the issue of the re- spect of moral values by
p.000040: contemporary biological research in repeated meetings. In several of its earlier opinions the Commission
p.000040: dealt with the issue of ethics in specific research areas (stem cells, clinical trials, use of an- imals in research)
p.000040: identifying the serious implications of the development of biological applications on the values of modern society. The
p.000040: present opinion emphasizes a dimension that cuts across all fields of biological research: the ethics of “procedure” of
p.000040: research.
p.000040: The Commission believes that this dimension is crucial and requires con- sideration both by the scientific community
p.000040: and by the authorities, in par- ticular in the light of the implementation of the new national legal frame- work for
p.000040: research (Law 3653/2008).
p.000040:
p.000040: I. General remarks
p.000040:
p.000040: A. Identifying the issues
p.000040:
p.000040: Generally speaking, the terms and conditions of contemporary research are significantly different from the past. The
p.000040: main characteristics of research during the last decades are the following: a) it is conducted by research
p.000040: teams in large-scale facilities and international networks of co-operation and b) it is closely linked to the
p.000040: economy.
p.000040: 1. Nowadays research does not rely on the individual activity of isolated scientists. The production of new knowledge
p.000040: requires complex organization and co-ordination of collective effort, a research environment that ensures high quality
p.000040: infrastructure and the corresponding funds as well as interna- tional co-operation.
p.000040: 2. Modern economy is particularly interested in innovation; therefore, it is closely connected to research, especially
p.000040: in the area of new technologies. As a result research is usually orientated to the market, it becomes familiar with the
p.000040: workings of competition and, to a large extent, adjusts its priorities accordingly. Modern research institutions
p.000040: often operate as independent
p.000040:
p.000041: 41
p.000041:
p.000041: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000041: OPINION
p.000041:
p.000041: economic entities that do not depend on public funding and are primarily interested in applied research in
p.000041: accordance with the needs of the market. This “industrial” organization of present research directly affects the way in
p.000041: which research is carried out and developed and often restricts the freedom of researchers in the following ways:
p.000041: - Moving away from basic research in favour of prioritized commercial- ly exploitable applications,
p.000041: - intense competition between research units,
p.000041: - overdependence on sponsors,
p.000041: - preoccupation with fund raising and the management of the research institutions, often at the expense of scientific
p.000041: endeavour.
p.000041:
p.000041: B. Research in the biological sciences
p.000041:
p.000041: The Commission considers that these general remarks on the conditions of current research are particularly
p.000041: relevant to research in the biological sciences. And this because: a) a major part of the related investment is
p.000041: met by private funds on an international scale, and, b) they have direct implica- tions on fundamental principles
p.000041: (protection of human value, the environ- ment, health, privacy).
p.000041: Situations that are seen at times, such as the exclusion of useful research for rare diseases or diseases that
p.000041: affect mainly the Third World, conceal- ment of negative findings, “fabrication” of results likeable to
p.000041: sponsors, demonstrate the absolute need to safeguard the independence of research, especially biological research.
p.000041:
p.000041: C. Research as a public good - Safeguarding its independence
p.000041:
p.000041: In the Commission’s view scientific research constitutes a public good because it promotes the understanding
p.000041: of the surrounding world and con- tributes to the “well-being” of society as a whole. At the same time, howev- er, it
p.000041: is also a fundamental right, an indispensable component of freedom for the person performing research. These
p.000041: two dimensions are inextricably linked.
p.000041: Based on the above, the Commission concludes that there are mainly two safeguards for the independence of
p.000041: research:
p.000041:
p.000041:
p.000042: 42
p.000042:
p.000042: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000042: OPINION
p.000042:
p.000042: 1. The self-regulation of research ethics by the community of scientists, since researchers are the first ones who have
p.000042: an interest in protecting the credibility of their work. “Outside” regulation must take into account this
p.000042: margin of autonomy in order to avoid bureaucracy.
p.000042: 2. The State must provide adequate public funding for independent re- search so that not every research initiative is
p.000042: necessarily linked to opportun- istic economic priorities, which often operates not to the benefit of but at the cost
p.000042: of innovation.
p.000042: These safeguards need to be adopted with specific initiatives.
p.000042:
p.000042: II. Proposals
p.000042:
p.000042: Based on the above, and in view of the new national legal framework for research, the Commission suggests the
p.000042: following:
p.000042:
p.000042: To the administration
p.000042:
p.000042: a) To lay down specific rules to safeguard research ethics in publicly fi- nanced research projects.
p.000042: These rules must oblige the scientist awarded the research grant to veri- fy the accuracy of and to publish all the
p.000042: results, to report the actual contri- bution of each researcher (in related publications in scientific
p.000042: journals, in papers presented in conferences and in the activity reports of research insti- tutions) and to control
p.000042: compliance with ethical principles.
p.000042: b) To support basic research in the allocation of national grants by the responsible bodies.
p.000042:
p.000042: To the academic research community
p.000042:
p.000042: a) Research institutions of biological sciences should compile a code of research ethics. Basic issues to be
p.000042: dealt with by such a code (which must also provide for disciplinary sanctions) must include, by way of
p.000042: indication, fabrication of results, plagiarism, violation of ethical principles (e.g. inde- pendence,
p.000042: principle of “beneficence or no harm”, ethical treatment of ex- perimental animals, etc.). The Commission
p.000042: intends to present a model of principles.
p.000042:
p.000042:
p.000043: 43
p.000043:
p.000043: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000043: OPINION
p.000043:
p.000043: b) To adopt initiatives to familiarize researchers with research ethics in their field of activity.
p.000043: c) To ensure transparency as to the source of the direct and indirect fi- nancial funding of research projects and,
p.000043: generally, of the operation of re- search institutions.
p.000043:
p.000043: Athens, 19 June 2008
p.000043:
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p.000044:
p.000044: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000044: OPINION
p.000044:
p.000044: COMPOSITION AND PERSONELL
p.000044: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000044: Deputy Chairman and Acting Chairman: George Maniatis, Emeritus Profes- sor of General Biology, University of Patras.
p.000044:
p.000044: Members:
p.000044: Savvas Agourides, Emeritus Professor of Theology, University of Athens.
p.000044: Myrto Dragona-Monachou, Emeritus Professor of Philosophy, University of Athens.
p.000044: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000044: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000044: Athens.
p.000044: Dimitrios Roupakias, Professor of Plant Breeding, University of Thessaloniki.
p.000044: Pavlos Sourlas, Professor of Philosophy of Law, University of Athens.
p.000044: Constantinos Tsoukalas, Emeritus Professor of Sociology, University of Ath- ens.
p.000044: Ioannis Vlahoyiannis, Professor of Medicine and Nephrology, University of Patras.
p.000044:
p.000044:
p.000044:
p.000044: PERSONNEL
p.000044:
p.000044: Scientific Officers:
p.000044: Takis Vidalis, Lawyer, PhD in Law.
p.000044: Ariadne L. Hager-Theodoridou, Agronomist, PhD in Genetics.
p.000044:
p.000044: Secretariat:
p.000044: Marianna Drakopoulou, Lawyer, Head of Secretariat.
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p.000046:
p.000046: The present report is an attempt to identify the basic parameters of eth- ics in biological research. It is an issue
p.000046: that concerns all areas of biological research (e.g. clinical trials, research on the human embryo, research with
p.000046: human biological material, animal, plant and microorganism research). The commission has addressed ethical issues of
p.000046: specific research areas with pre- vious recommendations.
p.000046: Research ethics is of course an issue that concerns both natural sciences and humanities and is becoming increasingly
p.000046: topical within the international scientific community and international scientific organizations. An additional reason
p.000046: for discussing the issue in our country is the new legislation for pub- licly funded research that was recently
p.000046: adopted. We consider the assess- ment of the problems associated with research ethics -in particular with
p.000046: regards to safeguarding research independence and credibility- as a neces- sary condition for the effective
p.000046: implementation of the new legislation. In view of the importance that society attributes to science research
p.000046: ethics is not just an “additional” requirement for science advancement. Rather the opposite is true:
p.000046: appreciation of science by the public depends on the for- mer respecting the values of society and is constantly tested
p.000046: with every re- search initiative. Whenever science disregarded these values in the past, the scientific work has
p.000046: been discredited and public opinion has grown suspi- cious.
p.000046: The analysis that follows presents some elements of organization of re- search (Part I), considers the ethical
p.000046: parameters and problems to be dis- cussed (Part II) and concludes with a number of proposals.
p.000046:
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p.000047: 47
p.000047:
p.000047: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000047: REPORT
p.000047:
p.000047: PART I
p.000047:
p.000047: ELEMENTS OF ORGANISATION OF RESEARCH
p.000047:
p.000047: Research provides empirical data against which theories are tested and questions are answered. It contributes to
p.000047: fulfilling the goals of Science among which gaining new knowledge, seeking scientific truth, avoiding mis- takes
p.000047: and producing technology to facilitate everyday life.
p.000047: Biological Research, its objective being the study of life, impacts directly on essential areas of human lives such as
p.000047: health and the environment. Be- sides, due to the significant breakthroughs of recent decades and the high expectations
p.000047: for producing more innovation in the future, biological re- search has come to occupy a very prominent
p.000047: position world-wide in terms of the value attributed to it by public opinion (Eurobarometer, 2007), the
p.000047: amount of funding it absorbs and the share of economic activity it gener- ates.
p.000047:
p.000047: Biological research in Greece
p.000047:
p.000047: In Greece, biological research is mainly conducted by Higher Education Institutions, Research Centres, Hospitals
p.000047: and, to a lesser extent, by the In- dustry, e.g. pharmaceutical companies, biotechnology companies, etc. Ac-
p.000047: cording to data from the General Secretariat of Research and Technology (GSRT) on research as a whole for
p.000047: 2005, 64% of science and technology re- search staff are employed in government agencies or universities (Table 1).
p.000047:
p.000047: a. Supervision of research
p.000047: In Greece, the government influences the general orientation and scope of research through the formulation of a
p.000047: national strategic plan. The extent of influence exercised by the government on the orientation of research is based on
p.000047: the management of public funds allocated to it.
p.000047: The national strategy for research and technology is approved by the Inter-Ministerial Committee for Research
p.000047: and Technology (DEET) upon pro- posal by the National Board for Research and Technology (ESET). DEET is
p.000047:
p.000047:
p.000047:
p.000047:
p.000048: 48
p.000048:
p.000048: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES REPORT
p.000048:
p.000048: comprised of the Prime Minister and the majority of government Ministers1. The President of the ESET is invited to DEET
p.000048: meetings. The participation of virtually all Ministries in the DEET testifies to the importance of research and
...

p.000063: Tong S and Olsen J (2005). The threat to scientific integrity in environmental and occupational medicine.
p.000063: Occupational and Environmental Medicine 62, 843-846.
p.000063: Union of Concerned Scientists. Scientific integrity, Political interference.
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p.000066: 66
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p.000066: MANAGEMENT OF BIOLOGICAL WEALTH
p.000066: OPINION
p.000066:
p.000066: O P I N I O N MANAGEMENT OF BIOLOGICAL WEALTH
p.000066: The National Bioethics Commission discussed at several meetings the
p.000066: ethical aspects of biological wealth management issues that need to be con- sidered as priorities by any modern
p.000066: society. Here, the term “biological wealth” includes the diversity of life forms that exist at a specific place and
p.000066: time.
p.000066: The way in which the lives of other species are affected by human activi- ty is no longer evaluated based solely on
p.000066: technical and economic criteria as was the case until recently. It has now become common place that this ac- tivity
p.000066: affects the quality of the natural environment, in particular downgrad- ing and destroying sensitive ecosystems with
p.000066: direct or indirect implications on the quality of human life. This fact calls for an ethical assessment of the human
p.000066: intervention in the biosphere. The present opinion illustrates this critical approach and formulates a number
p.000066: of proposals that could contrib- ute to an ethically acceptable management of biological wealth, especially in our
p.000066: country.
p.000066:
p.000066: I. The importance of biodiversity for humanity
p.000066:
p.000066: Under the Convention on Biological Biodiversity which was the outcome of the 1992 Rio de Janeiro United Nations
p.000066: Conference on the Environment and Development, “biodiversity” was defined as the “the variability among living
p.000066: organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the
p.000066: ecological complexes of which they are part; this includes diversity within species, between species and of
p.000066: ecosys- tems”.
p.000066: According to the current prevailing scientific view, the greater the biodi- versity, the more chances for survival and
p.000066: adaptability for ecosystems that sustain human survival as well. Furthermore, new discoveries are constantly made
p.000066: using previously unknown properties of species (animals, plants or micro-organisms) able to improve the
p.000066: quality of human life, for instance, through new pharmaceutical substances or new varieties of crops or animal
p.000066: races, and in addition to protect the environment.
p.000066:
p.000067: 67
p.000067:
p.000067: MANAGEMENT OF BIOLOGICAL WEALTH
p.000067: OPINION
p.000067:
p.000067:
p.000067: Irrespective of whether there is a positive association between high di- versity and the survival of ecosystems, it is
p.000067: a fact that:
p.000067: (i) Biodiversity is significantly reduced as a result of human activity,
p.000067: (ii) we do not accurately know nor are we able to reproduce the process of its creation, and,
p.000067: (iii) we cannot predict the impact of the deterioration of ecosystems in particular when taking into account the
p.000067: changes of environmental condi- tions that are just as unpredictable.
p.000067: All the above support the need to protect biodiversity as, among else, its reduction is very likely to have
p.000067: implications on the quality of life, if not on the survival of humankind.
p.000067: A study of the geographical distribution of natural richness as reflected in the total biodiversity of a given area and
p.000067: the number of endemic species indicates specific areas of the planet as hot spots of biodiversity. The Medi- terranean
p.000067: in general, and Greek ecosystems/wetlands in particular, have been identified as such hot spot areas for
p.000067: biodiversity that require protec- tion and many areas of the country were included in the European network Natura for
p.000067: the protection of sensitive ecosystems. The management of the significant biological wealth of Greece raises a number
p.000067: of ethical issues that will be discussed below.
p.000067: Several are the dangers that threaten biodiversity. Except for the indirect repercussions of climate change, caused
p.000067: by the greenhouse effect and by pollution of the environment in general, the most significant direct threats for
p.000067: biodiversity in Greece caused by the distraction or severe changes of the ecosystems that sustain it are the following:
p.000067: (i) the luck of effective protec- tion of areas characterized as high ecological significance (e.g. areas belong- ing
p.000067: to the Natura network), (ii) agriculture, animal breeding and fisheries and in particular the high input,
p.000067: high yield practices and the practice of monoculture, (iii) the urbanisation and mass tourism, (iv) the
p.000067: flexibility in the determination of land uses and, (v) the uncontrollable industrial devel- opment.
p.000067:
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p.000068: MANAGEMENT OF BIOLOGICAL WEALTH
p.000068: OPINION
p.000068:
p.000068: II. Human responsibility for the protection of biodiversity
p.000068:
p.000068: A. The ethical context
p.000068:
p.000068: 1. The general relationship between development/environment
p.000068:
p.000068: The observation of major transformations in the natural environment mainly due to energy-consuming human
p.000068: activity (industrial, residential, agri- cultural, etc.) -like the greenhouse effect, the depletion of the ozone layer,
p.000068: causing a rapid climatic change- has inspired a discussion about combining the notion of “development” with
p.000068: environmental protection. The use of terms such as “sustainable development”, “green development”, etc.
p.000068: indi- cates an awareness of limits to the unhindered exploitation of natural re- sources and ecosystems.
p.000068: It is true that part of the scientific community considers “sustainable development” as a contradiction in
p.000068: terms arguing that any further develop- ment factually and directly undermines the conservation of life as we know it.
p.000068: Even accepting this view, however, the need for environmental protec- tion becomes all the more urgent rather
p.000068: than obsolete.
p.000068: The environment does not have unlimited resistance, therefore it cannot sustain a constantly growing development of
p.000068: our productive activities. For this reason, the environment cannot be an ethically neutral reality but
p.000068: emerges as a value, an individual and particularly a social one.
p.000068: In this sense, the Commission adopts as a starting position that, although the economic activity of the individual or
p.000068: of the society as a whole are also recognized values, they cannot endanger the environment without any con- sideration.
p.000068:
p.000068: 2. Biodiversity and responsibility to future generations
p.000068:
p.000068: These general assumptions apply to biodiversity as part of the natural environment.
p.000068: The Commission considers that the protection of biodiversity constitutes a specific environmental value mainly because
p.000068: it is associated with the re- sponsibility of the present for the future generations. Notwithstanding the fact that
p.000068: species, like individuals, have a finite life span -and as a conse-
p.000068:
p.000068:
p.000069: 69
p.000069:
p.000069: MANAGEMENT OF BIOLOGICAL WEALTH
p.000069: OPINION
p.000069:
p.000069: quence many species have regularly become extinct from the apparition of life to the present- the preservation of
p.000069: current life forms is not ethically neu- tral, particularly because the pace of extinction is significantly
p.000069: accelerated by human activity. Indeed, since the species’ variability is believed to ensure the balance of
p.000069: ecosystems, which ensure survival of our species, present generations have a moral duty to preserve it for the
p.000069: sake of future genera- tions. The objective dimension of human value -the interest in the conserva- tion of our own
p.000069: species- is the foundation of this duty, ultimately a form of intergenerational “solidarity”. This solidarity
p.000069: entails limits to the manage- ment of biological wealth and precludes the selfish maximisation of its ex-
p.000069: ploitation by present societies for economic or other purposes. Further- more, and for Greece in particular as
p.000069: it is hosting among the highest densi- ties of biodiversity relative to its territory worldwide, the protection of this
p.000069: wealth is not only a matter of solidarity to the next generations but also to the rest of the world.
p.000069:
p.000069: 3. The importance of the “precautionary principle”
p.000069:
p.000069: The impact of the extinction of species and of the alteration or destruc- tion of ecosystems on stability of life in
p.000069: general and the survival of the hu- man species in particular is not fully understood. Moreover, the impact of
p.000069: biotechnological applications, e.g. genetically modified organisms, on biodi- versity is also unclear. It is due to
p.000069: this lack of knowledge that the protection of biodiversity is best served by the precautionary principle.
p.000069: According to this principle, environmental protection measures must be taken not only when there is certainty
p.000069: of damage but also when there is a risk of damage.
p.000069: The Commission estimates that a prudent application of this principle is crucial with the provision that it promotes
p.000069: rather than discourages research aimed at the identification of risk factors. If the latter provision is not met we
p.000069: would have to accept the suspension of all research activities or techno- logical innovation, adopting a generally
p.000069: “phobic” attitude towards the de- velopment of research and technology. This would obviously be in direct
p.000069: contradiction with the values of an open society and with progress.
p.000069:
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p.000070:
p.000070: MANAGEMENT OF BIOLOGICAL WEALTH
p.000070: OPINION
p.000070:
p.000070: B. The Law
p.000070:
p.000070: 1. Adoption of special regulations
p.000070:
p.000070: The Commission witnesses an ever increasing interest, the last decades, for the adoption of general rules for
p.000070: the protection of biodiversity at the level of international and EU law. Instruments like the UN
p.000070: Convention on Biological Biodiversity (Rio de Janeiro) or Directive 92/43 establishing the network Natura
p.000070: 2000 for sensitive ecosystems are two important points of reference. A plethora of specific laws on the protection of
p.000070: particular cases, especially endangered species, are also in effect. This shows that the value of biodiversity is not
p.000070: merely wishful thinking but has become binding.
p.000070:
p.000070: 2. The situation in our country
p.000070:
p.000070: Our country has adopted these instruments and in addition has enacted national legislation. However, the Commission
p.000070: draws attention to views of public bodies and non-governmental organizations about a deficit of en- forcement
p.000070: of the existing regulations.
p.000070: This inadequate protection of biodiversity is due to many reasons, the main of which are limited
p.000070: knowledge about our biological wealth, lack of clearly defined land uses (especially with regards to farming,
p.000070: animal breed- ing and forest land), a misconception of the environment as a “local” issue by central government and
p.000070: the extremely limited jurisdiction of law en- forcement authorities. The underlying reason, though, is the
p.000070: absence of a modern education, focused on the importance of environmental values.
p.000070:
p.000070: III. Proposals
p.000070:
p.000070: With the above facts in mind, the Commission believes it is important that the State considers certain
p.000070: proposals on the overall management of the country’s biological wealth.
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p.000071: 71
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p.000071: MANAGEMENT OF BIOLOGICAL WEALTH
p.000071: OPINION
p.000071:
p.000071: A. General proposals
p.000071:
p.000071: A more efficient protection of biodiversity requires the adoption of cer- tain measures of broader environmental
p.000071: protection policy. Such measures may include the following:
p.000071: 1. Environmental protection must be recognized as an essential compo- nent of national policy-making. It is a
p.000071: fact that environmental issues cut across the remit of more than one Ministry, as well as that of local authori-
p.000071: ties. For this reason and to avoid conflicts of interest and jurisdiction in deci- sion-making (e.g. environmental
p.000071: protection and public works policy) it is necessary to find a government arrangement that will ensure effective
p.000071: cen- tral planning of national environmental policy and effective intervention in order to meet the goal, which
p.000071: is the protection of biodiversity and of the environment in general.
p.000071: 2. The government needs to design specific incentives and support ac- tions for “green business” by
p.000071: developing jobs aiming (among else) on the protection of biodiversity. These actions must be long-term and
p.000071: competitive compared to traditional economic activities especially in the pressing condi- tions of the current economic
p.000071: crisis.
p.000071: 3. Enhancing environmental education and raising awareness amongst citizens of all ages but with
p.000071: emphasis on all educational levels. Non- Governmental Organizations (NGOs) involved in environmental action
p.000071: are expected to play an important role in this. The development of NGO activi- ties that promote these objectives at
p.000071: all educational institutions nationwide should be encouraged and supported.
p.000071:
p.000071: B. Special proposals
p.000071:
p.000071: In addition to general measures, the Commission proposes the following for consideration:
p.000071: 1. To coordinate and support research, particularly in monitoring chang- es in the national biological wealth, by
p.000071: assigning this responsibility to an entity and ensuring constant cooperation with universities and
p.000071: research organizations.
p.000071: 2. To produce a complete inventory and mapping of the country’s sensi- tive ecosystems (Natura areas), to
p.000071: determine the allowed activities within
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p.000072: MANAGEMENT OF BIOLOGICAL WEALTH
p.000072: OPINION
p.000072:
p.000072: such areas without delay and to broaden the enforcement mandate of the independent management authorities.
p.000072: 3. To reinforce the mandate of control of the judiciary (e.g. broadening the application of involvement of the
p.000072: public prosecutor for the environ- ment, the availability of technical support in order to reinforce the evalua-
p.000072: tion capacity of the Judicial Review Court especially with regards to envi- ronmental impact assessments).
p.000072: 4. To adopt a policy of agricultural development based on the protection of biodiversity and of the environment in
p.000072: general by promoting sustainable farming practices that protect biodiversity and by raising environmental
p.000072: awareness in this respect.
p.000072: 5. To ensure transparency in land planning and the protection of fixed land uses and to pursue the optimal
p.000072: long-term utilisation of land depending on its properties.
p.000072:
p.000072: Athens, 25 February 2009
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p.000073: MANAGEMENT OF BIOLOGICAL WEALTH
p.000073: OPINION
p.000073:
p.000073: COMPOSITION AND PERSONELL
p.000073: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000073: Deputy Chairman and Acting Chairman: George Maniatis, Emeritus Profes- sor of General Biology, University of Patras.
p.000073:
p.000073: Members:
p.000073: Savvas Agourides, Emeritus Professor of Theology, University of Athens.
p.000073: Myrto Dragona-Monachou, Emeritus Professor of Philosophy, University of Athens.
p.000073: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000073: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000073: Athens.
p.000073: Dimitrios Roupakias, Professor of Plant Breeding, University of Thessaloniki.
p.000073: Pavlos Sourlas, Professor of Philosophy of Law, University of Athens.
p.000073: Constantinos Tsoukalas, Emeritus Professor of Sociology, University of Ath- ens.
p.000073: Ioannis Vlahoyiannis, Professor of Medicine and Nephrology, University of Patras.
p.000073:
p.000073:
p.000073:
p.000073: PERSONNEL
p.000073:
p.000073: Scientific Officers:
p.000073: Takis Vidalis, Lawyer, PhD in Law.
p.000073: Ariadne L. Hager-Theodoridou, Agronomist, PhD in Genetics.
p.000073:
p.000073: Secretariat:
p.000073: Marianna Drakopoulou, Lawyer, Head of Secretariat.
p.000073:
p.000073:
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p.000074: MANAGEMENT OF BIOLOGICAL WEALTH
p.000074: REPORT
p.000074:
p.000074: R E P O R T MANAGEMENT OF BIOLOGICAL WEALTH
p.000074: Rapporteurs: T. Vidalis, A. Hager-Theodoridou
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p.000104: OPINION
p.000104:
p.000104: O P I N I O N
p.000104:
p.000104: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000104:
p.000104: The National Bioethics Commission considered the scope of personal autonomy in the provision of medical care in
p.000104: repeated meetings. The issue arises in regard to all medical acts either preventive or therapeutic. Fur-
p.000104: thermore, it lies at the heart of a contemporary reflection in bioethics as the model of the so-called “paternalistic”
p.000104: medicine tends to be replaced world- wide by the model of “informed consent”.
p.000104: Having considered the modified approach to the relationship patient- physician brought about by this change and
p.000104: conscious of the wide scope of autonomy, the Commission thought it appropriate to highlight a number of typical
p.000104: problems and suggest solutions to address them.
p.000104:
p.000104: I. In general
p.000104:
p.000104: A. Paternalism and autonomy in medicine
p.000104:
p.000104: The ethics governing the relationship patient-physician has been going through a change of model since the
p.000104: second half of the XX Century. Histori- cally, this relationship was defined by the dominant position of the physician
p.000104: as the only one responsible to appraise the situation and to decide on the course of treatment. Patients were merely
p.000104: able to select the treating physi- cian; as for the rest, they had to rely on the latter’s knowledge and
p.000104: skills without any say in therapy. This absolute dominion of physicians did not imply any form of
p.000104: arbitrariness on their part since they pledged themselves through the Hippocratic Oath to act in the best interests of
p.000104: patients.
p.000104: Following the end of World War II -and spurred by the dismal experience of the experiments performed on the prisoners
p.000104: of the Nazi regime among others- this model of medical “self-commitment” was seriously questioned. It was realized
p.000104: that self-commitment on the part of physicians does not en- sure the protection of patients. It became obvious that the
p.000104: participation of patients themselves in the course of treatment as active agents at all stages is the best safeguard
p.000104: for their well-being.
p.000104:
p.000104:
p.000105: 105
p.000105:
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p.000105: OPINION
p.000105:
p.000105: But first and foremost, the development of medicine itself has made the active involvement of patients a practical
p.000105: necessity in view of the fragmen- tation in the provision of health services brought about by increasing medi- cal
p.000105: specialization and the broad introduction of new technologies that mul- tiply possible alternative treatments.
p.000105: It is almost certain that no treatment is free of adverse effects. There- fore, the classical principle of “doing
p.000105: good or not doing harm” is no longer sufficient to determine treatment. Patients need to be involved to
p.000105: deter- mine the treatment whose likely adverse effects are more acceptable to them. Especially in our
p.000105: country, the need for this involvement becomes all the more urgent due to the absence, until now, of a single
p.000105: registration sys- tem to record the complete history of patients which deprives physicians from unmediated
p.000105: access to consistent and reliable data.
p.000105: The adoption of “informed consent” presupposes that patients are in- formed by physicians and in principle,
p.000105: they consent prior to all medical acts. In this way, they can consider their condition in the context of their general
p.000105: way of living not as passive recipients but as independent agents who are involved in the whole process as much as
p.000105: possible. A good knowledge of the values and needs a patient would like the physician to take into account
p.000105: when determining treatment is an essential part of this process. It is worth noting that the requirement of
p.000105: participation is complied with even when patients express the wish to follow the suggested treatment without
p.000105: further information (right to ignorance).
p.000105:
p.000105: B. The law
p.000105:
p.000105: Initially, the new model of “informed consent” appeared in codes of eth- ics on clinical trials (Nuremberg Code,
p.000105: Helsinki Declaration) because, on this occasion, the risks for the volunteers are greater. Gradually, however,
p.000105: its effects were recognized in all areas of medical practice.
p.000105: The Oviedo Convention on Human Rights and Biomedicine is the first example of binding international law
p.000105: incorporating “informed consent” in all medical acts. In addition to the Convention, express provisions in
p.000105: Greece have been included both in the Code of Medical Ethics (CME, Law 3418/2005) and in
p.000105: special legislation (assisted reproduction, transplants, etc.).
p.000105:
p.000105:
p.000106: 106
p.000106:
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p.000106: OPINION
p.000106:
p.000106: Both the Oviedo Convention and the CME provide for the event of in- competence to consent (in which
p.000106: case consent is given by relatives after prior information) whereas they hold that consent does not apply in
p.000106: emer- gency situations. However, the example of the CME stipulating that: “In the exercise of medicine, physicians act
p.000106: with total freedom within the generally accepted rules and methods of medical science… They may choose the
p.000106: method of treatment which in their view is significantly better against all others for the particular
p.000106: patient based on modern rules of medical sci- ence…”1, demonstrates that the traditional model of the
p.000106: relationship pa- tient-physician has not been fully abandoned in Greece as it has in other jurisdictions.
p.000106:
p.000106: II. Problems in the implementation of autonomy and related proposals
p.000106:
p.000106: A. The problem in general
p.000106:
p.000106: Although the need for active involvement by patients in determining treatment is now widely acknowledged, it
p.000106: is often defeated in medical prac- tice. The main reasons for this failure are the following:
p.000106: - Limited time for communication between physician-patient,
p.000106: - lack of clarity on the appropriate extent of information,
p.000106: - deficient training of physicians on the relationships they need to de- velop with patients, and,
p.000106: - occasionally, lack of familiarization of the general public with the rights and possibilities of every user of
p.000106: health services to cooperate with phy- sicians in order to reach the result best suited for the patient’s way of
p.000106: living.
p.000106:
p.000106: a) Time
p.000106: Scarcity of time is, at first sight, a purely practical matter arising mostly in first aid and emergency situations.
p.000106: The Commission thinks that, even in these circumstances, understanding the needs of patients and exercise of autonomy
p.000106: should be considered as an integral part of medical acts so that the allocation of the available time -
p.000106:
p.000106:
p.000106: 1 Art. 3 (3).
p.000106:
p.000107: 107
p.000107:
p.000107: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000107: OPINION
p.000107:
p.000107: even if limited- can be adjusted accordingly insofar as full communication with the patient is possible.
p.000107:
p.000107: b) Extent of information
p.000107: Pursuant to the CME “the physician has a duty of truth to the patient”2. But the patient has the right to refuse
p.000107: information (right to ignorance) and ask the physician to inform exclusively one or more other persons to be indi-
p.000107: cated by the patient3.
p.000107: But the extent of information that qualifies as appropriate to enable the patient to decide freely remains unclear. As
p.000107: the available empirical data in- dicates4, the majority of patients in our country apparently want more ex- tensive
p.000107: and more sincere information compared to what some physicians currently provide or believe they have to
p.000107: provide.
p.000107: The Commission points out that:
p.000107: i) Unless the right to ignorance is invoked, the physician must provide all those elements that will enable the
p.000107: patient to form a full and, mainly, an intelligible picture of the situation so that he/she may be assisted in
p.000107: making a decision. Elementary information alone will not do. In any event, the in- formation must be appropriate and
p.000107: graduated according to the mental con- dition of the patient. Given that the “appropriateness” of information
p.000107: is necessarily associated with the peculiarities of each patient, dialogue be- tween patient and physician is
p.000107: indispensable.
p.000107: ii) The information must not be “neutral”. A mere description by the physician of the expected benefits
p.000107: and likely risks from treatment is not enough. An essential part of the information consists in an ad hoc
p.000107: evaluation of benefits/risks based on the particular patient. But this evaluation may not anticipate the final decision
p.000107: manipulating the will of the patient.
p.000107: iii) It is usual practice to conceal information from patients and disclose it to relatives either because the
p.000107: treating physician is afraid the information may disturb the patient’s psychological balance during therapy or
p.000107: because relatives request it. However, if the patient is capable to consent, this prac- tice disrupts the fundamental
p.000107: connection between information and consent and may cause confusion. This is not to underestimate the need of coopera-
p.000107:
p.000107: 2 See art. 11 (1) (a).
p.000107: 3 See art. 11(2).
p.000107: 4 For a summary of this data, see the accompanying report.
p.000107:
p.000108: 108
p.000108:
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p.000108: OPINION
p.000108:
p.000108: tion between physicians and families, especially in order to understand the personality and needs of patients.
p.000108:
p.000108: c) Training for physicians
p.000108: Appropriate training on the importance of autonomy for physicians and other health care professionals is a crucial
p.000108: problem.
p.000108: The procedure of consent is often viewed by physicians as a piece of bureaucracy leading them to treat
p.000108: it as a mere formality. Contrary to this practice, consent is not to be considered as a safeguard for the
p.000108: protection of physicians but as a token of respect for the patient’s autonomy. However, even when physicians are
p.000108: conscious of the need to respect patient autono- my they feel uncertain on how they should act since perceptions of
p.000108: auton- omy vary from patient to patient and from physician to physician.
p.000108: Developing relationships of cooperation and trust with patients requires appropriate education for physicians. The aim
p.000108: is not some “formal” accom- modation of the patients’ rights but to obtain the best outcome in dealing with health
p.000108: problems taking into account the values and overall way of living of patients. Seen in this light, the
p.000108: participation of patients in their treat- ment, far from being an impediment, helps to reach the best possible
p.000108: medi- cal outcome.
p.000108: In view of the above the Commission thinks that emphasis needs to be placed on ethics and its implementation in
p.000108: clinical practice both in university education and in ongoing training for physicians. Equally important is
p.000108: to ensure meaningful education in communication with patients for physicians of all specialties focusing on the
p.000108: benefits of honesty. Lifelong training of physicians on the subject-matter is also required (a relevant duty is
p.000108: stipulat- ed by the CME). Hospital boards of ethics, scientific societies and medical associations must
p.000108: arise to the task and take the initiative.
p.000108:
p.000108: d) Education and information for citizens
p.000108: The above demonstrate a need for appropriate citizen education aiming at the optimal application of the new model.
p.000108: Patients who are suitably in- formed “ahead of time” are more likely to cooperate actively, assisting phy- sicians in
p.000108: their work and enhancing the efficacy of treatment.
p.000108: Citizen education can be promoted through elementary education, in- formation campaigns by local authorities,
p.000108: local associations, regional hospi-
p.000108:
p.000108:
p.000109: 109
p.000109:
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p.000109: OPINION
p.000109:
p.000109: tals and volunteer organizations. Educational programs from the media un- der the hospices of the Ministries for Health
p.000109: and Education could also be of assistance.
p.000109:
p.000109: B. Particular problems
p.000109:
p.000109: a) Power to consent and limits of autonomy
p.000109: The Commission believes that when patients who are capable to consent are committed to hospital they should appoint a
p.000109: representative in writing, if possible.
p.000109: In case of patients incapable to consent who have not appointed a rep- resentative, the Commission thinks that:
p.000109: i) The legal representatives of the patient may select one of alternative treatment methods but may not refuse all
p.000109: treatments if the treating physi- cian believes that the continuation of therapy is beneficial. Only patients
p.000109: who are capable for self-consent may refuse treatment.
p.000109: ii) In case of disagreement between the legal representatives the treat- ing physician should be able to decide taking
p.000109: into account the opinion of the hospital board of ethics which must be made mandatory in our country.
p.000109: iii) The physician must take into consideration any prior directions by the patient (id est, any wishes the patient
p.000109: expressed prior to becoming incapa- ble to consent).
p.000109: iv) The opinion of mentally mature minors on issues regarding their health must be taken into account in
p.000109: order to comply with the constitutional protection of personality.
p.000109: v) In case of refusal of parents to consent to the treatment of minors - and in case of threat against their lives or
p.000109: serious harm to their health- the physician must proceed to the indicated treatment complying with the legal procedure.
p.000109: vi) In case of patients with limited capacity to consent (minors, mental patients, persons with mental
p.000109: impairments), the attitude of the physician must consist in favoring as much as possible the expression of an
p.000109: opinion by the patients themselves according to the level of their capacity to compre- hend their situation.
p.000109: Therefore, the information to be provided to the pa- tient must be adjusted accordingly in cooperation
p.000109: with their representa- tives.
p.000109:
p.000109:
p.000110: 110
p.000110:
p.000110: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000110: OPINION
p.000110:
p.000110: vii) The Commission believes that even under the circumstances of in- tensive care units physicians must not
p.000110: act alone ignoring the will of the pa- tient. On the contrary, the physician’s moral duty is to ensure the free ex-
p.000110: pression of the patient’s will by providing complete, timely and intelligible information whenever feasible.
p.000110:
p.000110: b) Right of physician to refuse treatment
p.000110: The Commission points out that physicians reserve the right to refuse a treatment which is not medically indicated in
p.000110: their view, even if the patient insists upon it.
p.000110:
p.000110:
p.000110: Athens, 29 March 2010
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
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p.000110:
p.000111: 111
p.000111:
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p.000111: OPINION
p.000111:
p.000111: COMPOSITION AND PERSONELL
p.000111: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000111: Chairman: John Papadimitriou, Emeritus Professor of Surgery, Medical School, University of Athens.
p.000111:
p.000111: Deputy Chairman: George Maniatis, Emeritus Professor of Biology, Medical School, University of Patras.
p.000111:
p.000111: Members:
p.000111: Julia Iliopoulou-Stranga, Professor of Constitutional Law, Law School, Uni- versity of Athens.
p.000111: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000111: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000111: Athens.
p.000111: Evangelos Moutsopoulos, Member of the Academy of Athens, Emeritus Professor of Philosophy, University of
p.000111: Athens.
p.000111: Athanasios Papachristou, Professor of Civil Law, Law School, University of Athens.
p.000111: Theocharis Patargias, Emeritus Professor of Genetics, University of Athens Constantinos Tsoukalas, Emeritus Professor
p.000111: of Sociology, University of Ath- ens.
p.000111: Christos Voulgaris, Emeritus Professor of Theology, University of Athens.
p.000111:
p.000111: PERSONNEL
p.000111:
p.000111: Scientific Officers:
p.000111: Takis Vidalis, Lawyer, PhD in Law.
p.000111: Ariadne L. Hager-Theodoridou, Agronomist, PhD in Genetics.
p.000111:
p.000111: Secretariat:
p.000111: Marianna Drakopoulou, Lawyer, Head of Secretariat.
p.000111:
p.000111:
p.000112: 112
p.000112:
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p.000128: regards medical liabil- ity.
p.000128: 14 Cf. arts. 2(5), 9(4) CME which leave room for such an attitude on the part of a phy- sician.
p.000128:
p.000129: 129
p.000129:
p.000129: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000129: REPORT
p.000129:
p.000129: mean that “informal” directions will not generate legal effects for the physi- cian or for the legal representatives of
p.000129: the patient. And this because, apart from the fact that people may freely express their wishes on the
p.000129: future management of issues regarding their health at any time -i.e. without ob- serving some official
p.000129: “form”- it must be stressed that what is at issue here is not medical liability but the physician’s moral duty. Thus,
p.000129: even though phy- sicians will be legally bound to comply with “formally” manifested directions only, in ethical terms,
p.000129: they may not disregard any directions that were ex- pressed informally by the patient.
p.000129:
p.000129: 7. The health system
p.000129:
p.000129: The health system determines the quality of provided services and has a decisive impact on the model of relationship
p.000129: developed between the patient and the patient’s physician. The primary objective is the optimal use of hu- man
p.000129: resources and material assets to meet the needs of citizens whose con- tributions finance the system’s operation. The
p.000129: operation of the health sys- tem is not, at first sight, directly connected with consent in the relationship
p.000129: patient-physician. However, we will provide some information the Commis- sion might find useful in order to
p.000129: decide whether to consider issuing an opinion on the subject.
p.000129: In 2000, in the context of a worldwide evaluation of health systems, the World Health Organization (WHO) used
p.000129: “responsibility” as the basic bench- mark (World Health Organization, 2000; Hartzband and Groopman, 2009). This
p.000129: criterion encompasses respect for the dignity of persons and their fami- lies, and the protection of their
p.000129: autonomy when making decisions about their health. Thus, the WHO places patient autonomy and medical human- ism at
p.000129: the heart of health systems.
p.000129: Apart from customizing medical care according to the needs and prefer- ences of individual persons, another
p.000129: international trend in medical practice directly linked to the objectives of health systems is “evidence-based medi-
p.000129: cine” (Timmermans et al., 2005). Evidence-based medicine is the “conscien- tious, explicit and judicious use of current
p.000129: best evidence in making decisions about the care of individual patients” (Sackett et al., 1996). Implementing
p.000129: this type of medical practice requires active medical societies in all special- ties to assist physicians by developing
p.000129: specific guidelines.
p.000129:
p.000129:
p.000130: 130
p.000130:
p.000130: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000130: REPORT
p.000130:
p.000130: At first glance, evidence-based medicine does not seem to oppose a con- cept of medicine that places the individual at
p.000130: its core insofar as the guide- lines are meant to orientate decisions towards the best scientific treatment for a
...

p.000130: autonomy. In recent decades, this rela- tionship has been changing, passing from the traditional paternalistic model
p.000130: whereby the physician is primarily responsible to decide what best serves the patient’s interest and to act
p.000130: accordingly to a new model, the model of informed consent whereby the physician and the patient are called upon to
p.000130: engage together in the making of medical decisions.
p.000130: In medical practice, respect for autonomy aims at the best possible ap- plication of modern medicine but in a way that
p.000130: respects the patient’s needs
p.000130:
p.000130:
p.000131: 131
p.000131:
p.000131: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000131: REPORT
p.000131:
p.000131: and wishes. The complexity of modern medicine and, more often than not, the uncertain borders of “what” constitute
p.000131: treatment challenge the theory that the “doctor knows better” and create a need for new relationships re- quiring
p.000131: cooperation and participation by both “parties” in order to reach the best possible outcome.
p.000131: On the other hand, patient information is indispensable for developing such a relationship of cooperation
p.000131: between physician-patient; once again, however, the boundaries of appropriate information are often blurred. One of
p.000131: the major problems with implementing autonomy in medical practice is the divergence of opinion as implied by empirical
p.000131: data between physicians and patients on the extent of information. In their majority, the latter would rather have more
p.000131: information than the former provide.
p.000131: The most important causes -according to the view of the authors of the present report- for this divergence of
p.000131: opinion between physicians and pa- tients were identified and discussed in the previous chapters. Primary
p.000131: among them are the lack of appropriate training for physicians and the lack of time. It is important to look for
p.000131: practical solutions to implement respect for patient autonomy in practice not only as a value in itself but also as a
p.000131: safety valve for the efficiency of health services.
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
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p.000131:
p.000131:
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p.000131:
p.000131:
p.000131:
p.000132: 132
p.000132:
p.000132: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000132: REPORT
p.000132:
p.000132: SUGGESTED LITERATURE
p.000132:
p.000132: Androulidaki-Demetriadi I (1993). The duty to inform the patient. A contri- bution to the assessment of civil
p.000132: medical liability. Eds. Sakkoulas, Athens- Komotini.
p.000132: Asveld L (2008). Mass-vaccination programmes and the value of respect for autonomy. Bioethics 22, 245-257.
p.000132: Blackhall LJ, Murphy ST, Frank G, Michel V, Azen S (1995). Ethnicity and atti- tudes toward patient autonomy. Jama
p.000132: Journal of the American Medical As- sociation 274, 820-825.
p.000132: Brokalaki EI, Sotiropoulos GC, Tsaras K, Brokalaki H (2005). Awareness of diagnosis, and information-seeking
p.000132: behavior of hospitalized cancer patients in Greece. Supportive Care in Cancer 13, 938-942.
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p.000005: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
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p.000138: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
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p.000138: O P I N I O N
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p.000138: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000138:
p.000138: The National Bioethics Commission considered, in repeated sessions, the issue of acceptable restrictions on
p.000138: personal autonomy to protect public health in the case of transmissible infectious diseases. This debate is a major
p.000138: concern of contemporary bioethics, which influences crucial decision- making when there is an outburst of
p.000138: an epidemic or an endemic. There are frequent examples in the news, such as the avian influenza (bird flu),
p.000138: the SARS and most recently the H1N1 virus; furthermore the spread of HIV/AIDS and the recurrence of tuberculosis are
p.000138: also arising matters.
p.000138: At the core of the problem lies the fact that free decisions about person- al health may affect the health or endanger
p.000138: the lives of others in the imme- diate or wider vicinity. This perceived conflict between the principle of au- tonomy
p.000138: and public interest invites a consideration of ethically and legally acceptable choices.
p.000138: Based on the views and assumptions of its previous Opinion on the “con- sent in the relationship
p.000138: patient-physician”, the Commission felt that the question is so important as to be considered in a
p.000138: separate Opinion. The Commission issued its opinion after consulting specialized scientists, Profes- sors G.
p.000138: Saroglou, D. Trichopoulos and A. Hatzakis.
p.000138:
p.000138:
p.000138: I. General overview
p.000138:
p.000138: 1. Transmissible infectious diseases
p.000138:
p.000138: The main characteristic of transmissible infectious diseases is that the infected person is carrier for
p.000138: the transmission of the disease to others. Therefore, unlike with other diseases, decisions by patients
p.000138: have implica- tions not only for the patients themselves but also for the health of others or of the whole community
p.000138: in general.
p.000138: This already complicates the issue of patient autonomy. The risk for the health of others justifies certain limits to
p.000138: autonomy. These limits are of two
p.000138:
p.000139: 139
p.000139:
p.000139: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000139: OPINION
p.000139:
p.000139: kinds; either to the “stricto sensu” autonomy in the strict sense regarding personal health (i.e. the right
p.000139: of everyone to decide on matters of their own health) or to the general autonomy (especially the enjoyment of
p.000139: the free- dom of movement and establishment). The possibility of the latter is stipu- lated in the international law
p.000139: and modern national legal systems, including Greece.
p.000139: As the path of transmission and the severity of infectious diseases vary significantly, the nature and extent of such
p.000139: limits require special attention.
p.000139:
p.000139: 2. The priority of the principle of autonomy
p.000139:
p.000139: In this context, the Commission confirms its Opinion on the supremacy of personal autonomy, meaning the freedom of the
p.000139: individual to decide on matters relating to the personal health and the way of living, providing that the lives of
p.000139: other people are not significantly affected.
p.000139: What this assumption primarily means is that when the medical commu- nity is called to provide advice on
p.000139: measures required to protect public health or when public authorities are called to adopt such measures, auton- omy
p.000139: should not be limited without adequate documented justification.
p.000139: In particular, the Commission believes that the general rules on the ex- ercise of autonomy in patient-physician
p.000139: relationship allow an effective man- agement of transmissible infectious diseases. For example: the appropriate
p.000139: information to patients -including, among other things, advice on self- limitation- or, exceptionally, the
p.000139: supremacy of medics to act on their own initiative in case of emergency. At any rate, the discretion
p.000139: to impose re- strictions is limited when dealing with difficultly transmitted viruses or mild infections.
p.000139:
p.000139: II. Special issues
p.000139:
p.000139: When public health is at risk due to the spreading of infectious disease the Commission considers the following:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000140: 140
p.000140:
p.000140: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000140: OPINION
p.000140:
p.000140: 1. Restrictions to autonomy relating to personal health
p.000140:
p.000140: a) Basic principles
p.000140: Preventive measures adopted by public authorities to address threats against the health of others may include
p.000140: restrictions on personal autonomy in matters of health but only in exceptional circumstances. “Exceptional” are the
p.000140: circumstances of spreading epidemics or pandemics, according to the internationally accepted definitions of
p.000140: these terms. National authorities may not arbitrarily dilate these definitions.
p.000140: In such circumstances, medics and designated health authorities do not have the obligation to ask for patient
p.000140: consent and they could act on their own initiative (self-action). The legal basis for such restrictions
p.000140: consists mainly in art. 8 of the Convention on Human Rights and Biomedicine (Ovie- do Convention), which justifies
p.000140: medical self-action in “emergency situa- tions”.
p.000140: In this context, restrictions must comply with the principle of propor- tionality, i.e. they must be
p.000140: appropriate and necessary in order to protect public health without exceeding the purpose for which they are
p.000140: adopted.
p.000140:
p.000140: b) Vaccination
p.000140: In principle, the vaccination of the population as a measure of preven- tion, particularly the vaccination of
p.000140: vulnerable groups, requires informed consent. In this context, relevant information may be also provided to the
p.000140: general public through the media. The duty of public authorities is to ensure the validity of this information by
p.000140: allocating the task exclusively to a respon- sible entity and by taking steps to avoid inaccuracies which may inspire
p.000140: dis- trust or fear. It is worth noting that 99% of children in the US are vaccinated with a minimum rate of
p.000140: complications, which proves that benefits far ex- ceed any drawbacks; therefore, it is not justified to
p.000140: spread doubts. In “emergency situations” in the above sense, the Commission feels that even mandatory vaccination is
p.000140: not to be excluded, especially for those who are highly probable to become carriers and transmit the
p.000140: infection due to the nature of their occupation. They should be offered, however, the option of changing duties. The
p.000140: established scientific requirements for clinical trials of new treatments (vaccines or medicines) may not be
p.000140: bypassed in order to
p.000140:
p.000140:
p.000140:
p.000141: 141
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p.000141: OPINION
p.000141:
p.000141: accelerate the availability of such treatments to the public. Otherwise their efficacy will remain uncertain and
p.000141: citizens will be misinformed as a result.
p.000141: In addition, the Commission thinks that in the exceptional circumstances of epidemics or pandemics, limits to
p.000141: patents on new treatments could be justified to the extent possible. Such limits could be argued as a legal/policy
p.000141: choice in competent international and supra-national fora.
p.000141:
p.000141: c) Treatment
p.000141: The treatment of those infected should also be based on informed con- sent. Forced treatment is not justified in
p.000141: principle, except in “emergency situations”.
p.000141: When the number of medical and nursing staff or the available treat- ments do not suffice to ensure care to
p.000141: all those infected (especially in case an infection spreads rapidly) the Commission stresses that the government must
p.000141: establish in advance general priority rules for access to treatment. The basic priority criteria should preferably be
p.000141: prescribed by law. By way of indi- cation, such priority criteria may include the severity of symptoms, the age of the
p.000141: patient and the definition of relevant vulnerable groups.
p.000141:
p.000141: 2. Limits to autonomy on public health grounds
p.000141:
p.000141: a) General rule
p.000141: Limits to the general autonomy of patients -especially the freedom of movement and establishment- are
p.000141: justified only if they are absolutely in- dispensable to protect public health pursuant to the Constitution
p.000141: (arts. 5 [4], 25 [1]). The principle of proportionality as discussed above applies in all circumstances. For
p.000141: example, hospitalized patients should be restricted in specially contained facilities.
p.000141:
p.000141: b) The risk of social stigma
p.000141: The Commission stresses the risk of social stigma that may arise from the isolation (“ghetto-ing”) of specific
p.000141: sub-populations with distinctive cultural characteristics or ways of living when an infectious disease erupts
p.000141: within such groups.
p.000141:
p.000141:
p.000141:
p.000141:
p.000142: 142
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p.000142: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000142: OPINION
p.000142:
p.000142: Such cases must be dealt with by personalized medical care and social welfare measures especially as
p.000142: regards the improvement of hygiene in their living conditions.
p.000142:
p.000142: c) Illegal immigrants
p.000142: In case of manifestation of infectious disease or in cases when preven- tive measures (e.g. vaccination) need to
p.000142: be applied on illegal immigrants, the government must ensure that immigrants would be addressed to the
p.000142: health services. The access of immigrants to health services should be un- hindered and independent on their
p.000142: immigration status; otherwise the risks for public health in general will be multiplied.
p.000142:
p.000142: d) HIV/AIDS
p.000142: This particular disease presents a set of peculiar problems. Even though the spread of the virus is in general
p.000142: relatively difficult, the disease is very severe despite progress in treatment in the recent years. Moreover, social
p.000142: perceptions -especially regarding high risk vulnerable groups- remain ex- tremely negative in our country. The
p.000142: following call for attention:
...

p.000142: particular setting of social con- tact is prone to the transmission of the disease. Thus, although mandatory testing
p.000142: for seropositivity is not justified in the absence of qualifying circum- stances, it can be legitimate for certain
p.000142: occupations like physicians or nurs- es or for participation in certain social activities such as sports. In
p.000142: these cases, a positive test result justifies the removal of the seropositive, but just from this
p.000142: particular social context. By contrast, social environments, which are not prone to the transmission of the
p.000142: virus, do not justify devia- tions from the respect of autonomy which is generally applicable.
p.000142: Finally, special attention is required when the virus occurs in enclosed areas of mandatory containment, like
p.000142: schools, hospitals, military barracks or prisons. Any limits to autonomy which are considered indispensable
p.000142: must be combined with additional measures of supervision in order not to betray the purpose of the presence of the HIV
p.000142: seropositive in these areas (e.g. participation in common school activities, military exercises, etc.).
p.000142:
p.000142: Athens, 18 March 2011
p.000142:
p.000143: 143
p.000143:
p.000143: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000143: OPINION
p.000143:
p.000143: COMPOSITION AND PERSONELL
p.000143: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000143: Chairman: John Papadimitriou, Emeritus Professor of Surgery, Medical School, University of Athens.
p.000143:
p.000143: Deputy Chairman: George Maniatis, Emeritus Professor of Biology, Medical School, University of Patras.
p.000143:
p.000143: Members:
p.000143: Julia Iliopoulou-Stranga, Professor of Constitutional Law, Law School, Uni- versity of Athens.
p.000143: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000143: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000143: Athens.
p.000143: Evangelos Moutsopoulos, Member of the Academy of Athens, Emeritus Professor of Philosophy, University of
p.000143: Athens.
p.000143: Athanasios Papachristou, Professor of Civil Law, Law School, University of Athens.
p.000143: Theocharis Patargias, Emeritus Professor of Genetics, University of Athens
p.000143: Constantinos Tsoukalas, Emeritus Professor of Sociology, University of Ath- ens.
p.000143: Christos Voulgaris, Emeritus Professor of Theology, University of Athens.
p.000143:
p.000143: PERSONNEL
p.000143:
p.000143: Scientific Officers:
p.000143: Takis Vidalis, Lawyer, PhD in Law.
p.000143: Ariadne L. Hager-Theodoridou, Agronomist, PhD in Genetics.
p.000143:
p.000143: Secretariat:
p.000143: Marianna Drakopoulou, Lawyer, Head of Secretariat.
p.000143:
p.000143:
p.000144: 144
p.000144:
p.000144: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
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p.000153: provisions.
p.000153: Along the same lines, the ECHR (convention with overriding formal effect versus ordinary legislation) accepts the
p.000153: deprivation of individual freedom such as, among other things, “… the lawful detention of a person for the pre-
p.000153: vention of the spreading of infectious diseases, …” (art. 5[1][e]), but always “in accordance with a procedure
p.000153: prescribed by law”.
p.000153: The above provisions seem to grant broad discretionary powers to the common legislator when adopting
p.000153: restrictions to the individual freedoms of persons affected by transmissible diseases but, in any case, the
p.000153: legislator’s powers are delineated by the Constitution. However, there are limits:
p.000153: a) In principle, the above restrictions pertain to personal freedom, not to other fundamental rights. That is,
p.000153: they are meant to protect others from contracting the disease, and not to treat the affected subject.
p.000153: Therefore, they cannot amount to forced treatment bypassing the patient’s will.
p.000153: b) Restrictions are subject to the principle of proportionality (art. 25 (1) of the Constitution). That is, they
p.000153: are justified only in the extent which is necessary to protect others.
p.000153: c) Furthermore, they cannot go as far as totally eliminating personal freedom. The “core” of the right must
p.000153: remain intact in all cases.
p.000153:
p.000153: IV. Concluding remarks
p.000153:
p.000153: Based on the above discussion a number of conclusions can be drawn to assist the Commission in issuing an opinion.
p.000153: 1. Personal decisions on health matters may have critical implications for the health of others, as the example of
p.000153: transmissible infectious diseas- es typically demonstrates. Therefore, the exercise of autonomy in this
p.000153:
p.000153:
p.000154: 154
p.000154:
p.000154: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000154: REPORT
p.000154:
p.000154: area must take public interest into account -i.e., the protection of pub- lic health- and, in all terms, is determined
p.000154: by such interest.
p.000154: 2. The above statement does not imply that personal autonomy may be “brought to tatters” -or virtually eliminated- by
p.000154: policy choices to pro- tect public health. Autonomy is still the rule, even in case of epidemics or pandemics, which
p.000154: means that any encroaching measures are always exceptional and can be justified only to the extent that they
p.000154: are de- monstrably appropriate for the objective they serve (principle of pro- portionality). It is, therefore,
p.000154: indispensable to distinguish between in- fectious diseases depending on the level of risk and their transmissibil-
p.000154: ity.
p.000154: 3. The adoption of general rules in advance -if possible in periods of “normality”- both in terms of
p.000154: restrictions as well as of access to sani- tary authorities in times of epidemics or pandemics not only safe-
...

p.000155: 789-794.
p.000155: Gostin L (2004). The international health regulations and beyond. Lancet, Infectious Diseases 4, p. 606-607.
p.000155: Grad FP, Beauchamp DE (2004). Public health law, in: Post SG (ed.), Encyclo- pedia of bioethics. v. 4, 3d ed. McMillan
p.000155: Reference, N. York, p. 2222-2234.
p.000155: Kenneth VI and Moskop JC (2007). Triage in medicine, Part I: Concept, histo- ry, and types. Annals of Emergency
p.000155: Medicine 49, 275-281.
p.000155: Kontiades X (1997). Welfare State and social rights. eds. A. N. Sakkoulas, Athens-Komotini.
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p.000158: 158
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p.000158: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000158: OPINION
p.000158:
p.000158: O P I N I O N
p.000158:
p.000158: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000158:
p.000158: The Hellenic National Bioethics Commission met repeatedly upon invita- tion by the President in order to consider the
p.000158: ethical and social issues within its jurisdiction with regard to conflict of interest in clinical research,
p.000158: espe- cially in clinical trials of pharmaceutical agents. Dealing with this issue is a continuance of the already
p.000158: issued expert opinions on clinical trials on human subjects (2004), the establishment of ethics committees that
p.000158: review bio- medical research (2005) and research ethics in the biological sciences (2008). The timeliness
p.000158: of the matter is due to the usual criticism on the ac- countability of clinical trials of pharmaceutical agents
p.000158: or biomedical tech- nology appliances that are funded by the pharmaceutical industry. The ac- countability of
p.000158: clinical studies is crucial for public health, as it remains the single guarantee for drug efficiency and
p.000158: non-hazardous research products directed to the public.
p.000158:
p.000158: 1. General principle
p.000158: The Commission believes that the collaboration between the private sector and hospitals or research
p.000158: institutes is desirable because it ensures innovation, but under the strict condition that the ethical
p.000158: integrity of re- search is protected.
p.000158: In this context, “conflict of interest” may emerge between pursuing the truth, which is the aim of scientific research,
p.000158: and the financial profit antici- pated by the research sponsors.
p.000158:
p.000158: a) The relationship between researcher/sponsor: The duty to reveal the truth
p.000158: In clinical studies, the person that primarily encounters conflict of inter- est is the researcher who realizes
p.000158: that the research results may not be of financial benefit to the sponsor, and faces the dilemma of
p.000158: revealing the truth or defending the financial interest.
p.000158: The Commission believes that the researcher has always the moral duty to search for and reveal the truth, even
p.000158: when this is unfavorable to the sponsor. Serving health via the accuracy of the results of clinical studies is
p.000158:
p.000159: 159
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p.000159: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000159: OPINION
p.000159:
p.000159: absolutely preceding, even in the case that this is discouraging for funding research in the future. The Commission
p.000159: feels that the risk of such discour- agement should be undertaken by the scientific community, due to the sig-
p.000159: nificance of protecting public health.
p.000159:
p.000159: b) Revealing the truth and the right to information
p.000159: The Commission stresses that providing the public with products result- ing from deficient or inaccurate
p.000159: biomedical research offends the personal right to appropriate information. This right is a fundamental requirement
p.000159: for self-determination of a person in health matters (informed consent).
p.000159:
p.000159: 2. Special Issues
p.000159:
p.000159: a) Promoting collaborative clinical studies
p.000159: The Commission believes that an efficient way to eliminate conflict of interest phenomena is to conduct
p.000159: collaborative clinical studies, i.e. studies in which several companies take part. As a result, it is
p.000159: possible to directly compare more products under trial, based on a common protocol. Thus, on one hand, funding from
p.000159: many sponsors diminishes data counterfeiting aim- ing at their own profit, and on the other hand, research is driven
p.000159: towards more reliable results.
p.000159:
p.000159: b) Publication of negative results
p.000159: In view of the verified practice followed by specific pharmaceutical com- panies, which attempt to obstruct publication
p.000159: of negative results concerning the product under trial, even by taking legal action1, the Commission be-
p.000159: lieves that since a clinical study shows negative results, either for the effi- ciency or the safety of the product
p.000159: which is under trial, the results must be published. In addition, it is essential to take concern in treating equally
p.000159: any possible overlapping findings for similar products. This way, both the scien- tific community and the sponsors are
p.000159: informed early enough as to decide on the rational direction of their future interest.
p.000159:
p.000159:
p.000159:
p.000159: 1 Von Elm E, Röllin Al, Blümle A, Huwiler K, Witschi M, Egger M (2008). Publication and non-publication of clinical
p.000159: trials. Swiss Med Weekly 138, 197.
p.000159:
p.000160: 160
p.000160:
p.000160: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000160: OPINION
p.000160:
p.000160: c) Freedom of research group members
p.000160: The Commission believes that the independency of the scientific opinion of each research group member must be
p.000160: absolutely consolidated. Com- plaints concerning plagiarism, falsification or conscious concealment of re-
p.000160: sults must be immediately investigated, ensuring that this will not prove detrimental to the complainants.
p.000160:
p.000160: 3. Control mechanisms
p.000160:
p.000160: The Commission reminds that the legislation in force, which is in harmo- ny with the Directive 2001/20, already
p.000160: provides control levels in conflict of interest in clinical studies, both during the approval process of the relevant
p.000160: protocol and the course of the study. Moreover, the Commission notes that, according to the Medical Ethics Act
p.000160: (3418/2005), the disciplinary bodies of Medical Associations are also responsible to prevent conflict of
p.000160: interest in doctors/researchers. The same applies to scientists of other disciplines who participate in the research
p.000160: group according to the relevant provisions of the legislation.
p.000160: Above and beyond, the Commission believes that in order to address the problem it is necessary to adopt additional
p.000160: procedures and measures, such as:
p.000160: - The establishment of Special Ethics Committees in hospitals and re- search institutes that conduct clinical
p.000160: studies, with the responsibility to control the implementation of research protocols. Intervention of such committees
p.000160: to the researcher/sponsor relationship may possibly pre- vent unethical dependencies in time.
p.000160: - Since conflict of interest may well extend in the relationships between research institutes or universities and the
p.000160: commercial companies that are active in biomedical research, establishment of a distinct control procedure
p.000160: for clinical research in the central level of the University (Central Research Committee, with members
p.000160: independent of the insti- tute’s administration), additionally to the procedure followed by the National Ethics
p.000160: Committee for Clinical Studies in the Ministry of Health (which involves university and non-university research
p.000160: groups). Found- ing the relevant control mechanism is appropriate, because of the po- tential direct relationships
p.000160: between companies and universities or
p.000160:
p.000160:
p.000161: 161
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p.000161: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000161: OPINION
p.000161:
p.000161: even members of the above mentioned committee. This novel proce- dure will emphasize the additional academic
p.000161: responsibility of university researchers to safeguard the accountability of the clinical studies they participate.
p.000161: Nevertheless, control does not involve: a) the cost of la- boratory consumables, laboratory equipment and
p.000161: salaries of external associates, b) charity donations to the research group or individual re- searchers and, c) legal
p.000161: income by previous work (e.g. patents). It is im- portant to emphasize that, the decisions reached by the control com-
p.000161: mittees (Special Ethics Committees and Central Research Committees) must be entirely justified.
p.000161: - The initiative to promote internal procedures of research ethics in in- dustries that sponsor clinical studies,
p.000161: via their communal representa- tives (e.g. Panhellenic Association of Pharmaceutical Industry, Hellenic Federation
p.000161: of Enterprises).
p.000161: - Submission to the responsible hospital authorities where the clinical studies is conducted, of a
p.000161: disclosure by each researcher stating any possible working relationship with the company/sponsor or any possi- ble
p.000161: income or other kind or association, such as receiving company’s products, gifts, travel expenditure coverage
p.000161: etc. This disclosure should also be submitted to the responsible authorities of the State which are authorized to
p.000161: control the research, prior to the start of the clinical re- search, but also to every participating patient. In
p.000161: addition, publication of the relevant research results must be accompanied by a notification to the editorial boards
p.000161: of national scientific journals, and submitted conference abstracts must be accompanied by a notification
p.000161: to the conference organizing committees. Members of the control bodies also ought to submit a similar disclosure, as
p.000161: well as the research institutes on the assumption that there is any financial relationship (sponsor- ships,
p.000161: dividend payments of commercial products in the research etc.), including the company/sponsor.
p.000161: - The establishment of a regular education to raise the researchers’ awareness of potential conflict of
p.000161: interest, and inform about the means of control (e.g. in the context of introductory information pro- vide to a
p.000161: research group by their head or the ethics committee of the research institute, as well as by organizing special
p.000161: seminars).
p.000161:
p.000161:
p.000161:
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p.000162: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000162: OPINION
p.000162:
p.000162: Finally, the Commission supports the right to access control mechanisms by whoever participates in a certain clinical
p.000162: study and invokes evidence of misconduct.
p.000162:
p.000162:
p.000162: Athens, 5 July 2011
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p.000163: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000163: OPINION
p.000163:
p.000163: COMPOSITION AND PERSONELL
p.000163: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000163: Chairman: John Papadimitriou, Emeritus Professor of Surgery, Medical School, University of Athens.
p.000163:
p.000163: Deputy Chairman: George Maniatis, Emeritus Professor of Biology, Medical School, University of Patras.
p.000163:
p.000163: Members:
p.000163: Julia Iliopoulou-Stranga, Professor of Constitutional Law, Law School, Uni- versity of Athens.
p.000163: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000163: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000163: Athens.
p.000163: Evangelos Moutsopoulos, Member of the Academy of Athens, Emeritus Professor of Philosophy, University of
p.000163: Athens.
p.000163: Athanasios Papachristou, Professor of Civil Law, Law School, University of Athens.
p.000163: Theocharis Patargias, Emeritus Professor of Genetics, University of Athens Constantinos Tsoukalas, Emeritus Professor
p.000163: of Sociology, University of Ath- ens.
p.000163: Christos Voulgaris, Emeritus Professor of Theology, University of Athens.
p.000163:
p.000163:
p.000163: PERSONNEL
p.000163:
p.000163: Scientific Officers:
p.000163: Takis Vidalis, Lawyer, PhD in Law.
p.000163: Stefania Lymperi, Biologist, PhD in Cell Biology.
p.000163:
p.000163: Secretariat:
p.000163: Marianna Drakopoulou, Lawyer, Head of Secretariat.
p.000163:
p.000164: 164
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p.000164: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000164: REPORT
p.000164:
p.000164: R E P O R T
p.000164:
p.000164: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000164:
p.000164: Rapporteurs: S. Lymperi, T. Vidalis In collaboration with: J. Papadimitriou
p.000164:
p.000164: 1. Introduction
p.000164:
p.000164: In a former Opinion the Hellenic National Bioethics Commission dealt with the ethics of drug clinical
p.000164: studies and other therapeutic procedures. Particular issues concerning the lack of credibility for several studies,
p.000164: due to the financial interests of the sponsor, were already identified in that docu- ment.
p.000164: With the present report, it is attempted to probe deep into the issue of conflict of interest, since it is a
p.000164: serious matter commonly encountered by the physician/researcher. In addition, the credibility of clinical studies
p.000164: is now at the forefront of public interest, not only due to the high cost of medical products, but also because the
p.000164: demand of rapid and effective new treat- ments is imminent (a recent example is the H1N1 influenza virus).
p.000164: Progress in biomedical technology changes medicine with an extremely high pace. In the past, biomedical research was
p.000164: mainly conducted in Univer- sities and large hospitals, as opposed to the present situation, where phar- maceutical
p.000164: companies and the pharmaceutical industry have taken the reins. Large companies eagerly convert scientific
p.000164: results into “pharmaceuti- cal products” or into biomedical materials, aiming at financial profits of course.
p.000164: Relationships between physicians and pharmaceutical industries generate -rightly or wrongly- suspicions both
p.000164: to the society and the State. The publicity -often unfounded- which is given in such a relationship has a serious
p.000164: effect on the accountability of health workers, especially when legal entanglements arise.
p.000164: Sponsoring medical research is initially desirable. There is no doubt that many of the new discoveries, both in
...

p.000191: its influence on apparent effica- cy. N Engl J Med 358, 252-260.
p.000191: USA General Accounting Office, Biomedical Research, GAO-02-89, (2001).
p.000191: von Elm E, Rollin A, Blumle A, Huwiler K, Witschi M, Egger M (2008). Publica- tion and non-publication of clinical
p.000191: trials: Longitudinal study of applications submitted to a research ethics committee. Swiss Med Wkly 138, 197-203.
p.000191: Weinfurt KP, Dinan MA, Allsbrook JS et al., (2006). Policies of academic med- ical centers for disclosing financial
p.000191: conflicts of interest to potential research participants. Acad Med 81, 113-118.
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p.000007: DIRECT-TO-CONSUMER GENETIC TESTING
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p.000194: DIRECT-TO-CONSUMER GENETIC TESTING
p.000194: OPINION
p.000194:
p.000194: O P I N I O N
p.000194:
p.000194: DIRECT-TO-CONSUMER GENETIC TESTING
p.000194:
p.000194: The Hellenic National Bioethics Commission met repeatedly upon invita- tion by the President in order to consider the
p.000194: ethical issues within its juris- diction regarding Direct-to-consumer (DTC) genetic testing, available in
p.000194: pharmacies or via the internet.
p.000194: The term “DTC genetic testing” refers to any genetic test detecting DNA changes and is directly available to the public
p.000194: as a kit. It is based on the con- sumer’s own will to be examined for genetic diseases or predisposition to
p.000194: diseases -and, mainly, without prior recommendation by a doctor, medical geneticist or biologist-geneticist- or to
p.000194: genetically identify an individual. The term does not include genetic tests recommended by an expert, after exam- ining
p.000194: the clinical data and the family history of a patient, aiming to diagnose or identify the patients risk to a disease.
p.000194: “DTC genetic testing” refers to tests carried out for health reasons, pre- natal diagnosis or genetic identification of
p.000194: a person (especially the so-called “paternity tests”). A common component to all tests is that the public has direct
p.000194: access to them, without the mediation of counseling (in the first two cases) or legal authorization (judicial
p.000194: permission in the case of genetic iden- tification). Consequently, there is a rapid development of a new
p.000194: “market” for genetic services, which is already advertised to a significant extend in our country.
p.000194: The above mentioned new market is favored by the continuous progress in technology, the human genome project and the
p.000194: extensive research eluci- dating specific gene functions. At present, the technological and scientific
p.000194: progress makes methods of detecting genetic risk factors, even for serious diseases, affordable. However, specific
p.000194: sensitive ethical and social issues, associated with the way such services are provided, emerge and must
p.000194: re- ceive special attention by the involved individuals and the State.
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p.000195: OPINION
p.000195:
p.000195: I. The facts
p.000195:
p.000195: Genetic tests which are directly available to the public detect DNA se- quence changes. Most frequently, the
p.000195: DNA changes are associated with the etiology, diagnosis, treatment or prevention of hereditary diseases. In
p.000195: the case of monogenic disorders, a single gene is responsible for the disease and therefore DNA changes associated
p.000195: with the disease are easier to identify. However, this is not the case for complex (polygenic) diseases,
p.000195: comprising the largest proportion of the most common diseases, such as cardiovascular disease, cancer and diabetes.
p.000195: Complex diseases are caused by the combined action of many genes as well as environmental factors.
p.000195: Up to the present time, the person interested in genetic testing consult- ed an expert. Based on the clinical data and
p.000195: the family history of the patient, the expert decided whether he/she would receive a suitable biologic sample from the
p.000195: patient and request a specific genetic test for a disease. Subse- quently, specialized genetic
p.000195: laboratories, with suitable biomedical equip- ment and certified, specialized personnel, would perform genetic
p.000195: testing.
p.000195: The current genetic services are constantly modified. On the one hand, this is due to the relatively recent progress in
p.000195: molecular biology and genet- ics, and on the other hand, due to the fact that the public becomes increas- ingly
p.000195: interested in genetic testing. Important factors contributing to such changes in genetic services are:
p.000195:
p.000195: A. The detection of genetic factors associated with monogenic and com- plex diseases, as well as the human genome
p.000195: project
p.000195: Specifically, genome wide association studies lead to the assumption that DNA sequence variations among
p.000195: individuals are associated with most common diseases. These studies examine DNA sequence variations in spe- cific
p.000195: genes and ultimately aim at defining a person’s risk to develop a dis- ease. Based on such data, companies
p.000195: use specific algorithms, claiming that they are able to predict the probability that a person will develop a disease.
p.000195:
p.000195: Β. The increasing interest of the scientific community and the public in using genetic data in preventive
p.000195: medicine
p.000195: A genetic test showing that a person has a predisposition to a disease enables that person to modify
p.000195: his/her lifestyle in such a way that he/she will
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p.000196: OPINION
p.000196:
p.000196: reduce the probability of developing the disease. This fact may lead more people to undergo genetic testing
p.000196: aiming at prevention.
p.000196:
p.000196: C. Novel molecular technologies for large scale genetic analysis (simulta- neous analysis of genetic samples from
p.000196: different persons) in a relatively short time
p.000196: Large scale genetic analysis facilitates the offer of DTC genetic tests at a lower price compared to the past, and
p.000196: consequently, the development of a new market of genetic services.
p.000196: In this context, companies offering DTC genetic testing emerged. The specific genetic tests cover a wide range
p.000196: of:
p.000196: a) Diagnostic tests that may confirm a disease, e.g. β-thalassaemia,
p.000196: b) pre-symptomatic tests that estimate a person’s risk to develop a dis- ease, e.g. cancer,
p.000196: c) prenatal diagnosis tests that define the baby’s gender,
p.000196: d) pharmacogenetic tests that estimate the best dosage, efficiency and side effects of specific drugs, e.g.
p.000196: anticoagulants,
p.000196: e) paternity tests that confirm or not the paternity of the alleged father,
p.000196: f) relationship tests that assess specific degrees of relationships,
p.000196: g) genealogy tests that define an individual’s ancestry,
p.000196: h) and tests examining a person’s “lifestyle” regarding diet, occupation, exercise etc.
p.000196: Genetic tests which are directly available to the public are sold in con- ventional points of sale (pharmacies,
p.000196: beauty shops, etc.), through healthcare professionals, via the internet or by phone. The most common practice
p.000196: is that the consumer contacts the company via the internet.
p.000196: Regardless of the approach used for contact, the above mentioned ge- netic tests are offered as a kit. The kit
p.000196: contains directions for biologic sample collection by the consumer him/herself (usually saliva or a buccal swab) and
p.000196: the sample is subsequently sent to the genetic laboratory by post. The re- sults are disclosed by phone, letter,
p.000196: e-mail or by logging in to a secure web- site with a unique password provided to the consumer. For tests requiring
p.000196: blood collection, the kit is to be used by the consumer’s doctor in order to collect the blood safely.
p.000196: These specific companies are content with a simple disclosure of the test results. Frequently, there is an
p.000196: impersonal interpretation of the findings
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p.000197: DIRECT-TO-CONSUMER GENETIC TESTING
p.000197: OPINION
p.000197:
p.000197: using special algorithms and softwares, which take into account the litera- ture and the lifestyle information provided
p.000197: by the consumer after complet- ing a questionnaire. Occasionally, the companies offer genetic counseling by demand and
p.000197: at an additional cost. In that case, genetic counseling is provid- ed without direct contact with the counselor,
p.000197: whereas in a few cases the companies recommend disclosure of the results to the person’s doctor, who will evaluate
p.000197: the findings. Thus, in many cases a huge amount of information is available to the users or recipients of the genetic
p.000197: service, who are unable to utilize or even understand the findings.
p.000197: Most of the companies do not specify the fate of the genetic samples,
p.000197: i.e. whether they are destroyed or stored after completing the genetic anal- ysis, or even whether they are used for
p.000197: other purposes, such as research. In some cases, the genetic tests are offered with a discount, provided that the
p.000197: person will consent to use his/her genetic data for research purposes.
p.000197:
p.000197:
p.000197: II. The law
p.000197:
p.000197: The Commission notes the complexity of the legal framework governing DTC genetic testing.
p.000197: In genetic tests for medical reasons, applicable provisions are those con- cerning the constitutional right to health,
p.000197: which allows to everybody to have free access to information concerning his/her health (article 5, paragraph 5
p.000197: Constitution), as well as the provisions implementing this right in order to protect an individual (adequate
p.000197: information, protection of sensitive data according to the Law 2472/1997). In addition, article 12 of the
p.000197: Convention on Human Rights and Biomedicine (Law 2619/1998), which requires genetic counseling, also applies in genetic
p.000197: tests for health purposes.
p.000197: In prenatal genetic tests, article 14 of the same Convention prohibits selection of an embryo for non-health
p.000197: reasons.
p.000197: Finally, for genetic tests undertaken to identify a person, judicial authori- zation is required under the current
p.000197: legislation (e.g. articles 1477 Civil Code, 615 Code of Civil Procedure).
p.000197: Moreover, the provisions concerning the economic freedom and its con- straints (article 5, paragraph 1 Constitution),
p.000197: especially those aiming to pro-
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p.000198: OPINION
p.000198:
p.000198: tect the consumer (Law 2251/1994) are applied in all types of genetic test- ing.
p.000198: However, one must not overlook that the above mentioned provisions are broad, and there is no special
p.000198: legislation governing this specific activity, both in Greece and most European countries. Absence of a
p.000198: relative law means that anyone can offer DTC genetic services in an unrestricted and uncontainable manner,
p.000198: without being subjected to any kind of preventive quality control. The legislation stated above,
p.000198: partially covers the need of such a control and is unable to monitor the dynamics of a developing new market.
p.000198:
p.000198: III. Recommendations
p.000198:
p.000198: 1. General principles
p.000198:
p.000198: The Commission believes that an important aspect of autonomy in health matters is the unrestricted access
p.000198: to health information, including genetic information. Especially, however, regarding genetic tests which pre- dict
p.000198: the risk to develop a disease, the Commission considers that it is equally important to provide genetic information
p.000198: after the appropriate instructions, preferably, by an expert-physician, clinical geneticist or biologist-geneticist.
p.000198: The Commission notes that it is important to maintain the balance be- tween free access to health information and
p.000198: protection of vulnerable people who are subjected to inappropriate or unnecessary genetic testing. This per- spective
p.000198: is supported by the particular nature of genetic information and by the misleading impression about “genetic
p.000198: determinism”, which tends to dominate the public consciousness. Specifically, genetic data provide an
p.000198: element of predisposition to common complex diseases (cancer, cardiovas- cular disease, diabetes etc.) classifying
p.000198: (or not) an individual in a high risk group, without a definite result that he/she will develop the
p.000198: disease. The Commission believes that it is critical to emphasize that genetic data must not be overvalued, as
p.000198: erroneously and commonly presented.
p.000198: In regard to prenatal genetic tests, the Commission reiterates its position that they must not be performed for eugenic
p.000198: purposes. It notes the danger especially in the case of DTC genetic tests, where genetic counseling is ab- sent.
p.000198:
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p.000199: OPINION
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p.000199: Finally, the Commission considers that genetic tests revealing a person’s identity definitely presuppose consent from
p.000199: all the involved parties. Other- wise such genetic tests require a relevant judicial licensing.
p.000199:
p.000199: 2. Special issues
p.000199:
p.000199: In the context of the above mentioned general principles, the Commis- sion notes:
p.000199: A. It is recommended that DTC genetic tests for health reasons or prena- tal diagnosis must be performed following a
p.000199: suitable prescription by a liable expert physician, clinical geneticist or biologist-geneticist. The expert
p.000199: will assess the purpose of the test and will interpret the results, in order to avoid unnecessary genetic testing
p.000199: and inappropriate assessment. It is important that the consumer has the option to choose the expert. Impersonal,
p.000199: auto- mated counseling methods are discordant with the relationship of trust, which must govern health
p.000199: services.
p.000199: Exceptionally, DTC genetic testing which aims to improve dietary habits or other lifestyle factors (occupation,
p.000199: exercise etc.), or to define an individu- al’s ancestry, may not be dependent on such strict rules.
p.000199: B. In order to protect genetic information and respect a child’s right to ignorance, considering that children are
p.000199: unable to decide whether they wish to know the results of a genetic test predicting a disease, DTC genetic test- ing is
p.000199: not justified in asymptomatic children for whom there is no medical emergency, especially for late onset diseases such
p.000199: as Huntington’s disease. Even in the case where an expert decides that such a test is necessary for the parent(s),
p.000199: the same genetic test must be delayed for the child until he/she is able to participate in the decision
p.000199: making process, since there is no direct value to his/her health. On the contrary, DTC genetic testing is
p.000199: ac- ceptable in cases of children with first or second degree relatives with a monogenic disorder,
p.000199: showing a clear mode of inheritance e.g. familial hy- percholesterolemia. Nonetheless, such genetic tests must
p.000199: be allowed only in the case that the results will be used for early treatment and/or prevention of the complications
p.000199: caused by the disease.
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p.000200: DIRECT-TO-CONSUMER GENETIC TESTING
p.000200: OPINION
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p.000200: C. The promotion campaigns of DTC genetic testing must be governed by the same rules as in the case of health services,
p.000200: i.e. to be based on precise information and the true prognostic or diagnostic value of the test.
p.000200: Misleading advertising of the alleged “prediction” of serious diseases or other phenotypes, overlook the role of other
p.000200: genetic factors which are not determined yet or the critical role of environmental factors, and lead to ge- netic
p.000200: determinism.
p.000200: D. DTC genetic tests that determine a person’s identity without his/her consent is in principle illegal, since they
p.000200: directly offend the right to privacy.
p.000200: E. In any case, providers of DTC genetic services (especially via the inter- net) need to ensure high protection of
p.000200: the personal data that they collect and process. The Data Protection Authority must control the way that such data are
p.000200: managed by the genetic service providers.
p.000200: F. Finally, the development of this commercial activity imposes yet more the need to adopt a specific legislation for
p.000200: the management of genetic in- formation and its potential use for research purposes, a need that is repeat- edly noted
p.000200: by the Commission in previous Opinions. This specific legislation must particularly include:
p.000200: a) Recognition of the specialty or specialization of “Medical Genetics” in Greece (according to the 2/204
p.000200: 21.9.2006 decision of the Central Council of Health.
p.000200: b) Establishment of a previous state license for the operation of genetic centers, where the genetic tests are
p.000200: performed according to valid cri- teria for quality certification.
p.000200: c) Requirement of a regulation governing the above mentioned centers, which will include specific warranties to
p.000200: correctly inform the con- sumers, especially concerning advertising of genetic services, accord- ing to the
p.000200: paragraph C.
p.000200: d) The potential use of the biologic materials or genetic information for research purposes, on the condition
p.000200: that they are anonymized or that the subject has given consent.
p.000200:
p.000200:
p.000200: Athens, 30 March 2012
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p.000201: OPINION
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p.000201: COMPOSITION AND PERSONELL
p.000201: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000201: Chairman: John Papadimitriou, Emeritus Professor of Surgery, Medical School, University of Athens.
p.000201: Deputy Chairman: George Maniatis, Emeritus Professor of Biology, Medical School, University of Patras.
p.000201:
p.000201: Members:
p.000201: Julia Iliopoulou-Stranga, Professor of Constitutional Law, Law School, Uni- versity of Athens.
p.000201: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000201: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000201: Athens.
p.000201: Evangelos Moutsopoulos, Member of the Academy of Athens, Emeritus Professor of Philosophy, University of
p.000201: Athens.
p.000201: Athanasios Papachristou, Professor of Civil Law, Law School, University of Athens.
p.000201: Theocharis Patargias, Emeritus Professor of Genetics, University of Athens Constantinos Tsoukalas, Emeritus Professor
p.000201: of Sociology, University of Ath- ens.
p.000201: Christos Voulgaris, Emeritus Professor of Theology, University of Athens.
p.000201:
p.000201: PERSONELL
p.000201:
p.000201: Scientific Officers:
p.000201: Takis Vidalis, Lawyer, PhD in Law.
p.000201: Vasiliki Mollaki, Geneticist, PhD in Genetics.
p.000201:
p.000201: Secretariat:
p.000201: Marianna Drakopoulou, Lawyer, Head of Secretariat.
p.000201:
p.000201:
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p.000202: DIRECT-TO-CONSUMER GENETIC TESTING
p.000202: REPORT
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p.000202: R E P O R T
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p.000202: Testing” is used to describe genetic testing taking place upon an individual’s request, without the mediation of an
p.000202: expert, i.e. clinical geneticist (medical geneticist or biol- ogist geneticist).
p.000202: Practically, this means that any individual (hereinafter referred to as “consumer”) can choose to undergo
p.000202: genetic testing offered by special com- mercial websites, After sending a biological sample and subsequent DNA
p.000202: analysis, the consumer can obtain results concerning possible predisposition to diseases such as diabetes,
p.000202: cardiovascular disease, cancer, etc. In case the DNA analysis is combined with data concerning the consumer’s lifestyle
p.000202: (di- etary habits, working conditions, smoking, exercise etc.), the end result may be a kind of specialized counseling
p.000202: on how to protect his/her health, which can be provided in an automatic way without always the mediation of
p.000202: an expert.
p.000202: The present report attempts to present the bioethical aspect of similar activities that provide genetic testing
p.000202: services directly to the public, as such activities are increasingly spreading in our country as well. In Europe, as
p.000202: well as in the USA, official concerns have already been expressed about setting a limit on a person’s access to genetic
p.000202: data concerning him/herself or a third party, without the adequate guarantees of validity and reliability. The pre-
p.000202:
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p.000203: DIRECT-TO-CONSUMER GENETIC TESTING
p.000203: REPORT
p.000203:
p.000203: sent report aims to set a frame for the redaction of a relevant Opinion by the Commission.
p.000203:
p.000203:
p.000203: THE FACTS
p.000203:
p.000203: Genetic tests
p.000203:
p.000203: Genetic tests are based on the study of genetic material in order to iden- tify changes in the DNA sequence.
p.000203: These changes are either mutations, which cause a disease, or polymorphisms that constitute normal variations among
p.000203: individuals. Polymorphisms, however, can be associated with a dis- ease, i.e. if an individual carries specific
p.000203: DNA polymorphisms, he/she may have increased risk (predisposition) to develop a disease.
p.000203: In the case of monogenic disorders (e.g. thalassaemia, cystic fibrosis, familial hypercholesterolemia),
p.000203: mutations in a single gene can cause the disease. For this reason, it is relatively easy to detect the genetic
p.000203: causes of a single-gene disease. However, this is not the case for complex (multifactori- al) diseases (e.g.
p.000203: cardiovascular disease, cancer, diabetes etc.). Complex diseases can result from mutations and/or polymorphisms in
p.000203: more than one genes and/or environmental factors (e.g. smoking, diet, obesity, exercise etc.). Therefore,
p.000203: genetic tests for complex diseases cannot give a certain answer on whether an individual will develop the
p.000203: disease, but they can only estimate the relative risk to develop the condition.
p.000203: Until recently, genetic testing for health reasons was usually conducted after mandate of an expert (clinical
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p.000209: test detects a mutation that can cause breast cancer, the person might undergo a total mastectomy as an
p.000209: extreme measure of prevention.
p.000209: 5. In case of a positive result, there is always the risk of stigmatization, refusal of
p.000209: providing him/her private insurance and work.
p.000209: 6. In case of a positive result, the psychological stress imposed on the individual is severe, causing
p.000209: worries, uncertainty, confusion and, probably, despair. These consequences expand to other members of the
p.000209: family, as it is a hereditary disease.
p.000209: 7. The above (1-6) are also combined with the cost of genetic tests, which usually burdens the individual and/or
p.000209: his/her family.
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p.000209: THE DIMENSION OF ETHICS
p.000209:
p.000209: The above mentioned highlight the main problem, which is the possibil- ity of misleading the average citizen about both
p.000209: the quality of specific ser- vices and the value of genetic tests in general.
p.000209: The Commission has repeatedly underlined the danger of overestimating the association of genetic data with a person’s
p.000209: health (Hellenic National Bio-
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p.000210: DIRECT-TO-CONSUMER GENETIC TESTING
p.000210: REPORT
p.000210:
p.000210: ethics Commission 2006: Opinion on Human Biobanks par. 2a; Hellenic Na- tional Bioethics Commission 2008: Opinion on
p.000210: Genetic Data in Private Insur- ance par. 3b).
p.000210: It is sufficient, at this point, to note that although the genetic causes of many serious complex diseases have
p.000210: been detected, these reveal nothing more than mere “predisposition”. In order to develop a complex
p.000210: disease, relevant environmental factors must exist, otherwise genetic predisposition may remain inert. This category
p.000210: includes the vast majority of complex (mul- tifactorial) diseases, which comprise the main interest of a perfectly
p.000210: healthy individual, i.e. the consumer in this case. Monogenic diseases -that develop without the occurrence of
p.000210: environmental factors (e.g. cystic fibrosis, thalas- saemia, familial hypercholesterolemia, muscular dystrophy,
p.000210: Alzheimer’s disease, Huntington’s Chorea)- are comparatively few and, most prominent- ly, rare, in order to
p.000210: justify a commercial interest in the market of genetic testing.
p.000210: The restricted value of genetic data in protecting our health, could lead a non-expert to draw erroneous or, at least,
p.000210: uncertain conclusions. For exam- ple, if an individual has no interest in following a healthy diet he/she may
p.000210: develop cardiovascular disease despite the fact that there is no genetic cause. In addition, it is possible
p.000210: that serious psychological distress is caused in individuals who overestimate the importance of genetic
p.000210: predisposition,
p.000210: e.g. for cancer, by accepting “genetic determinism” and ignoring the multi- factorial nature of the specific disease.
p.000210: This is the reason why a mediating expert, who will be able to evaluate the necessity of genetic testing and the
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p.000218: DIRECT-TO-CONSUMER GENETIC TESTING
p.000218: REPORT
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p.000218: tests could submit them in this registry in order to facilitate every interested party.
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p.000219: DIRECT-TO-CONSUMER GENETIC TESTING
p.000219: REPORT
p.000219:
p.000219: SUGGESTED LITERATURE
p.000219:
p.000219: American College of Medicine Genetics (ACMG) (2004). ACMG statement on direct-to-consumer genetic testing.
p.000219: (www.acmg.net).
p.000219: Borry P (2008). Europe to ban direct-to-consumer genetic tests? Nature Bio- technology 26, 736-737.
p.000219: British Society for Human Genetics (2010). Report on the genetic testing of children.
p.000219: ESRC Genomics Forum (2006). Evaluation of genetic services - Expert Work- shop, UK.
p.000219: European Society of Human Genetics (2010). Statement of the ESHG on di- rect-to-consumer genetic testing for
p.000219: health-related purposes. European Journal of Human Genetics 18, 1271-1273.
p.000219: Genetic Testing Registry (GTR). http://www.ncbi.nlm.nih.gov/gtr/.
p.000219: Goddard KAB et al., (2007). Awareness and use of direct-to-consumer nutri- genomic tests. Genetic Medicine 9, 510-517.
p.000219: Mai Y, Koromila T, Sagia A, et al., (2011). A critical view of the general pub- lic’s awareness and physician’s opinion
p.000219: of the trends and potential pitfalls of genetic testing in Greece. Personalized Medicine 8, 551-561.
p.000219: Recommendations of the Secretary’s Advisory Committee on Genetic Test- ing (SACGT) (2000). Enhancing
p.000219: the oversight of genetic tests. (http://oba.od.nih.gov).
p.000219: STOA (Science and Technology Options Assessment) (2007). Direct to con- sumer genetic testing, European
p.000219: Parliament.
p.000219: Williams-Jones B (2003). Where there’s a web, there’s a way: Commercial genetic testing and the internet.
p.000219: Community Genetics 6, 46-57.
p.000219: Hellenic National Bioethics Commission (June 2006). Opinion on human bi- obanks.
p.000219: Hellenic National Bioethics Commission (January 2008). Opinion on genetic data in private insurance.
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p.000008: HUMAN ENHANCEMENT -
p.000008: PHYSICAL ENHANCEMENT
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p.000222: O P I N I O N
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p.000222: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000222:
p.000222:
p.000222: Introduction
p.000222:
p.000222: The Hellenic National Bioethics Commission met repeatedly upon invita- tion by the President in order to consider the
p.000222: ethical issues within its juris- diction regarding “Human Enhancement”. This term includes medical inter- ventions on
p.000222: the healthy body, aimed at shaping desirable characteristics, basically for psychological and social
p.000222: reasons (aesthetic preferences, in- creased physical or cognitive performance, etc.).
p.000222: In view of the purpose of such interventions, which is not to treat health damages, specific issues arise
p.000222: concerning the extend of autonomy of the person interested and the appropriate approach of physicians. However,
p.000222: it is worth noting that, based on the broad definition of health provided by the World Health Organization,
p.000222: according to which “Health is a state of com- plete physical, mental and social well-being and not merely the
p.000222: absence of disease or infirmity”, such interventions are, undoubtedly, included in the practice of medicine,
p.000222: and therefore ruled by the general medical ethics.
p.000222: One can distinguish various categories of enhancing interventions, de- pending on the purpose they serve.
p.000222: Thus, there are interventions that en- hance:
p.000222: a) Physical characteristics and abilities,
p.000222: b) mental characteristics and personality, and
p.000222: c) cognitive abilities.
p.000222: The Commission considers that it is useful to issue an Opinion on the first category, which will precede
p.000222: the other two, so as to better highlight the relevant issues.
p.000222:
p.000222: Improvement of physical characteristics and abilities
p.000222:
p.000222: The category of improving physical characteristics and abilities includes, in particular, the cases of:
p.000222: Ι) Plastic surgery (surgical or non-surgical),
p.000222:
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p.000223: OPINION
p.000223:
p.000223: II) enhancing physical abilities,
p.000223: III) using mechanical means of enhancement.
p.000223: To examine the issue of physical enhancement, the Commission held hearings on Dr. G. Christodoulou, Emeritus
p.000223: Professor of Psychiatry, Medical School, University of Athens and Honorary President of the Greek Psychiat- ric
p.000223: Association, Dr. A. Mandrekas, President of the Greek Association of Plas- tic, Reconstructive and Aesthetic Surgery,
p.000223: Dr. G. Creatsas, Professor of Gy- necology and Director of the 2nd Obstetrics and Gynecology Clinic, “Are-
p.000223: taieion” Hospital, Medical School, University of Athens, Dr. G. Vassilopoulos, Associate Professor of Pathology -
p.000223: Hematology, Medical School, University of Thessaly and Associate Researcher, Department of Genetics and
p.000223: Gene Therapy, Biomedical Research Foundation of the Academy of Athens, and Dr. C. Spiliopoulou,
p.000223: Associate Professor of Forensic Medicine, Medical School, University of Athens and President of the
p.000223: Hellenic National Anti- doping Council.
p.000223:
p.000223: Ι. Plastic Surgery
p.000223:
p.000223: 1. Overview
p.000223:
p.000223: Plastic surgery concerns surgical or non-surgical procedures designed either to reconstruct or to “correct”
p.000223: external body features.
p.000223: Reconstructive procedures usually follow treatment after accidents (e.g. scar revision). Cosmetic interventions are
p.000223: purely aesthetic and correspond to a person’s desire to improve the appearance of his/her face or body
p.000223: (brow lift/eyebrow, nose, breast, liposuction, etc.), regardless of health is- sues. Gender reassignment
p.000223: surgery, is a special case, which must be ad- dressed specifically.
p.000223: In principle, the Commission considers that a person’s autonomy justifies the freedom of forming external features. The
p.000223: fundamental right to person- ality development encompasses, undoubtedly, a person’s control over his/her
p.000223: external appearance. However, that does not mean that plastic sur- gery escapes from the principles and rules of law
p.000223: and medical ethics.
p.000223:
p.000223:
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p.000224: OPINION
p.000224:
p.000224: 2. Altering facial features and identity confusion
p.000224:
p.000224: A person’s desire to change his/her facial features in order to cause identity confusion is a borderline
p.000224: case of self-determination, which may af- fect the public interest (e.g. in order to avoid legal prosecution). In this
p.000224: case, the Commission believes that certain restrictions on a person’s autonomy are justifiable.
p.000224: Consequently, the Commission considers that there is an issue regarding the physician’s rights and obligations. In this
p.000224: case, the physician has a duty to review the relative desire of the person interested. Under particular con- ditions,
p.000224: this review justifies that the physician may refuse to carry out a pro- cedure, however, without setting general and
p.000224: abstract rules. Ιn this case, it is required to assess each case separately. However, it is not the physician’s duty to
p.000224: report the incident to the law enforcement authorities, apart from exceptional cases in which, as the law provides, the
p.000224: offense of harboring a felon or crime concealment is constituted.
p.000224:
p.000224: 3. Plastic surgery and gender specific features
p.000224:
p.000224: In cases of altering gender specific features or even gender reassign- ment, plastic surgery is part of the
p.000224: therapy used. Hermaphroditism and gen- der identity disorder fall within these cases.
p.000224: Regardless of the aetiology of a person’s mental and physical condition, which may be due to neurodevelopmental or
p.000224: genetic causes, the Commis- sion considers that such kind of procedures are essentially reconstructive and
p.000224: therapeutic, since they aim to match the psychosomatic disposition of a person with gender specific features.
p.000224: In this case, the ethical principles and rules of law, as outlined in a previ- ous Opinion of the Commission ("Consent
p.000224: in the patient-physician relation- ship," 2010) are entirely valid. The authentic will of the person him/herself is the
p.000224: determining factor here, in view of the right of personality. However, since there is a particularly
p.000224: sensitive issue of autonomy, it is right to allow for a period of time between the initial decision and the plastic
p.000224: surgery pro- cedure, during which the person concerned receives psychological and med- ical counseling.
p.000224:
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p.000225: OPINION
p.000225:
p.000225: According to the Commission, if prenatal testing results in ambiguous results about the gender identity of a
p.000225: foetus, an artificial termination of the pregnancy is not justified, especially since there are the
p.000225: aforementioned reconstructive options after birth. However, given that persons in this cate- gory (seeking plastic
p.000225: surgery to alter gender specific features or gender re- assignment) belong to vulnerable social groups that
p.000225: generally suffer from social discrimination, access to relevant treatment must be ensured. For example,
p.000225: based on the principle of equality and the social right to health, the State may possibly develop counseling
p.000225: programs, but also provide ther- apy possibilities within the National Health System.
p.000225:
p.000225: 4. Face transplants
p.000225:
p.000225: Reconstructive face transplantation (e.g. in case of severe deformities caused by an accident) is, in
p.000225: principle, an acceptable alteration of the recipi- ent’s characteristics. However, it must be carried out in such a
p.000225: manner that it does not affect respect for the body of the (dead) donor. The relevant principle that rules
p.000225: transplants from a deceased donor is absolutely valid in this case too.
p.000225:
p.000225: 5. The physician’s role
p.000225:
p.000225: According to the Commission, the physician who carries out cosmetic plastic surgery has a particular
p.000225: responsibility, since he/she does not act in order to prevent a threat to a patient’s health (or life).
p.000225: Unquestionably, the consent of the person interested is a prerequisite for any relevant medical intervention. However,
p.000225: it should be noted that in the case of cosmetic plas- tic surgery, the following particularities must be taken into
p.000225: account:
p.000225: a) The physician has an increased responsibility to fully inform the person concerned as to the expected outcome
p.000225: and particularly the possible side effects on his/her health. This increased responsibility is explained
p.000225: by the need to prevent "easy" decisions by the person concerned, often influenced by obsessions with his/her body
p.000225: image, by lack of confidence, or by occa- sional fashion standards, obsessions which may put in danger the
p.000225: health of this person.
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p.000226: b) As part of this responsibility, the physician must particularly consider the possibility of an underlying
p.000226: psychological or psychiatric disorder in the person concerned, and refer him/her for a psychological or
p.000226: psychiatric as- sessment. The physician should not comply with the wishes of the interest- ed person in an
p.000226: uncritical manner, since there may be defects in the per- son’s will that affect the validity of
p.000226: his/her consent. Individuals with Body Dysmorphic Disorders (BDDs or dysmorphobia) fall into this category,
p.000226: and indeed, plastic surgery offers no actual prospect of improving their condi- tion.
p.000226:
p.000226: 6. Production of a code of conduct
p.000226:
p.000226: The Commission indicates the lack of a specific Code of Conduct for plas- tic surgery and recommends that the
p.000226: relevant scientific societies should produce such a code, with the assistance of the Ministry of Health.
p.000226: The relevant code must refer to the general obligations of physicians towards the persons interested
p.000226: -especially the increased responsibility to fully inform the person concerned- and may include specific
p.000226: chapters on different types of procedures, so that the above mentioned obligations are adjusted accordingly.
p.000226:
p.000226: ΙΙ. Enhancing physical abilities
p.000226:
p.000226: 1. Overview
p.000226:
p.000226: The enhancement of physical abilities usually includes characteristics such as physical strength, speed,
p.000226: agility, endurance, accuracy, motor coordi- nation and dexterity. The artificial enhancement is achieved mainly by
p.000226: the use of pharmaceutical substances combined with physical exercise.
p.000226: The Commission considers that, in the frame of the general right to per- sonality development, improving physical
p.000226: abilities is, in principle, a legiti- mate choice. However, the Commission notes that this choice is subject to
p.000226: restrictions, which are related both to the person him/herself and third par- ties.
p.000226:
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p.000227: OPINION
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p.000227: 2. Safe use of substances for a person’s health
p.000227:
p.000227: It is imperative to protect a person’s health from potentially harmful enhancing substances, given that
p.000227: many of them are freely available in the market, with no prescription required.
p.000227: Regardless of the autonomy of the person in various health issues, the Commission emphasizes the importance of the
p.000227: strict control over these sub- stances by the competent authorities, and particularly the importance of
p.000227: providing complete and accurate information to consumers regarding any possible side effects.
p.000227: For substances administered after prompt (either by sports medicine physicians, or gymnasts, trainers etc.),
p.000227: the relevant responsibility -moral, but also legal- belongs primarily to those who recommend the substance
p.000227: use. Regarding the apportionment of responsibility, it should not be overlooked that the interested persons that use
p.000227: them are more vulnerable to inaccurate or misleading information, as they often choose to enhance their
p.000227: physical abilities and performance and consider that such enhancement is, by de- fault, desired and
p.000227: "innocent", with no special consideration of the potential health effects.
p.000227:
p.000227: 3. The interest of third parties, particularly in sport
p.000227:
p.000227: The Commission also dealt with the case of enhancing abilities through doping, in order to participate in athletic
p.000227: contests. The Commission pointed out that the use of relevant substances must be controlled, not only in order to
p.000227: preserve equality in competition, but also to protect the athletes’ health.
p.000227: In particular, the following points are exceptionally significant:
p.000227: i) Prohibition of the use of certain substances in sport is not only related to the impressive results concerning
p.000227: the primacy of the athlete that uses them, but also to the serious risks to his/her health. This means that, even
p.000227: if one assumes that all sport participants can have equal access to such sub- stances, the use of the latter
p.000227: would still be unfair, not for reasons of fair- ness, but because the endangerment of health is incompatible
p.000227: with the very notion of rivalry.
p.000227: ii) Enhancing physical abilities by other means (e.g. strenuous exercise in particular environmental conditions) could
p.000227: also be equated with substance
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p.000228: use, provided that the risks for one’s health were equally serious. As long as these risks are not established, the
p.000228: conditions of rivalry should not be con- sidered as adulterated for this reason alone.
p.000228: iii) New genetic technologies, such as gene therapy or gene transfer in athletes, are forms of doping, which are not
p.000228: currently detectable. In cases of gene doping, the risk to the athletes’ health is even greater, due to the nov- el and
p.000228: often experimental methods applied. However, it should be empha- sized that -according to the latest scientific data-
p.000228: such methods are at a re- search stage, even when they are used to treat patients.
p.000228: Based on the above considerations, the Commission notes the necessity of constant vigilance by the anti-doping
p.000228: authorities in our country, especially after the repeated cases during the last years.
p.000228: The Commission points out the special role of the Hellenic National Anti- Doping Council (ESKAN) for the prevention and
p.000228: fight against doping. It would be appropriate for ESKAN to acquire organizational independence (in the form of
p.000228: a legal entity or even of an independent authority), to apply its ju- risdiction at all levels of athletic
p.000228: contests (even in schools) and possibly complement its authority with the potentiality to impose all the
p.000228: relevant sanctions in cases of law violation.
p.000228: In addition, the Commission considers that reinforcing athletic research will contribute to inform properly the
p.000228: future athletes about their actual physical abilities, whereas underpinning the athlete’ s medical support will act
p.000228: as a deterrent to the use of doping methods.
p.000228: Finally, the Commission highlights the importance of responsible publi- cation of anti-doping test results,
p.000228: particularly by the media, in order to avoid the risk of stigmatizing sport and athletics overall. The disproportionate
p.000228: pub- licity of the offender athletes and their associates does not serve in favour of preventing the doping
p.000228: phenomenon effectively; on the contrary, it dis- courages young people from being involved in sport and
p.000228: consequently de- prives them from its indisputable benefits.
p.000228:
p.000228: 4. Physical enhancement for military purposes
p.000228:
p.000228: Physical enhancement may also be applied to a military, operational lev- el. In particular, it is not unlikely
p.000228: that one can justify the enhancement of physical characteristics of soldiers, in the name of national interest
p.000228: and na-
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p.000229: tional security. Indeed, this may be associated with experimentation on hu- mans, which would be potentially banned in
p.000229: case the relevant research in- volved ordinary citizens.
p.000229: The Commission considers that physical enhancement of soldiers is sub- ject to the general rules of conducting
p.000229: research involving human subjects. Amongst these rules, the special informed consent of the person participat- ing
p.000229: in the process of enhancement is a necessary prerequisite. Beyond that, the Commission notes that in research
p.000229: concerning physical enhancement of soldiers, transparency is particularly important, which is, however, often in
p.000229: contrast to the confidentiality required by such cases. In this occasion, the necessary information may be available to
p.000229: a third party/organization which will ensure not only the proper conduct of research but also the confidenti- ality of
p.000229: information.
p.000229: Finally, for the military physician who participates in such a research, the Commission considers that, additionally,
p.000229: all the rules of medical ethics ap- ply, including those related to clinical research.
p.000229:
p.000229:
p.000229: Athens, 8 April 2013
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p.000230: OPINION
p.000230:
p.000230: COMPOSITION AND PERSONELL
p.000230: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000230: Chairman: John Papadimitriou, Emeritus Professor of Surgery, Medical School, University of Athens.
p.000230:
p.000230: Members:
p.000230: Julia Iliopoulou-Stranga, Professor of Constitutional Law, Law School, Uni- versity of Athens.
p.000230: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000230: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000230: Athens.
p.000230: Evangelos Moutsopoulos, Member of the Academy of Athens, Emeritus Professor of Philosophy, University of
p.000230: Athens.
p.000230: Theocharis Patargias, Emeritus Professor of Genetics, University of Athens
p.000230: Constantinos Tsoukalas, Emeritus Professor of Sociology, University of Ath- ens.
p.000230: Christos Voulgaris, Emeritus Professor of Theology, University of Athens.
p.000230:
p.000230: PERSONELL
p.000230:
p.000230: Scientific Officers:
p.000230: Takis Vidalis, Lawyer, PhD in Law.
p.000230: Vasiliki Mollaki, Geneticist, PhD in Genetics.
p.000230:
p.000230: Secretariat:
p.000230: Marianna Drakopoulou, Lawyer, Head of Secretariat.
p.000230:
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p.000259: forms of physical enhancement.
p.000259: However, a crucial issue that remains is the future social consequences of a dramatic increase in life
p.000259: expectancy, as demographic data already confirm serious effects e.g. on the sustainability of
p.000259: health insurance systems, even on the adequacy of natural resources.
p.000259: Assuming that these data reflect the limited strength of modern societies, not only in a broader
p.000259: macrosocial scale but even in the scale of a
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p.000260:
p.000260: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000260: REPORT
p.000260:
p.000260: family, it is possible that maintenance of a “fourth” generation of ancestors will be against human reproduction.
p.000260: Indeed, this generation will continue to burden the family budget, effectively discouraging child bearing, which will
p.000260: marginally lead to a progressive aging of societies. In this case, the effects on the viability of societies will be
p.000260: unknown.
p.000260:
p.000260: 3. The law
p.000260:
p.000260: It is difficult to detect law restrictions regarding the fundamental rights of personality development and health (5
p.000260: par. 1 and 5, Constitution) in this specific field.
p.000260: If the reservation relates elusively to the future interest of societies in age renewal, the only
p.000260: reference that could be made concerns our responsibility towards the future generations. This
p.000260: responsibility - is mainly mentioned in the non-binding environmental law (see Report in the Opinion of the NBC
p.000260: “Management of biological wealth”, 2009) - however, an ethical issue still remains: this responsibility will lead
p.000260: us to accept our biological limits (hence the finite of our lives), which could not be determined by legal rules.
p.000260:
p.000260:
p.000260:
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p.000261: 261
p.000261:
p.000261: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000261: REPORT
p.000261:
p.000261: SUGGESTED LITERATURE
p.000261:
p.000261: AAAS invitational workshop on human enhancement (2006). AAAS Human enhancement and the means of achieving it.
p.000261: Washington, DC.
p.000261: Barazzetti G, Reichlin M (2011). Life-extension: A biomedical goal? Scientific prospects, ethical concerns. Swiss Med
p.000261: Wkly 141, w13181.
p.000261: Barton-Davis ER, Shoturma DI, Musaro A, Rosenthal N, Lee Sweeney H (1998). “Viral mediated expression of
p.000261: insulin-like growth factor i blocks the aging-related loss of skeletal muscle function.” PNAS 95, 15603-5607.
p.000261: Baylis F, Robert JS (2004). The inevitability of genetic enhancement technologies. Bioethics, p. 7.
p.000261: Birch K (2008). Neoliberalising bioethics: Bias, enhancement and economistic ethics. Genomics,
p.000261: Society and Policy, 4, 1-10.
p.000261: Bostrom N (2005). In defense of posthuman dignity. Bioethics 2005, p. 202.
p.000261: Christensen K, Vaupel JW (1996). Determinants of longevity: Genetic, envi- ronmental and medical factors. J Intern Med
p.000261: 240, 333-41.
p.000261: Coleman E, Bockting W, Botzer M, Cohen-Kettenis P, et al., (2011). Standards of care for the
p.000261: health of transsexual, transgender, and gender- nonconforming people, Version 7. International Journal of
p.000261: Transgenderism 13:165-232.
p.000261: Comité Consultatif National d` Éthique (CCNE) (1998). Rapport sur le vieillissement, Opinion No 59.
p.000261: Comité Consultatif National d` Éthique (CCNE) (2004). L’ allotransplantation de tissu composite (ATC) au niveau de la
p.000261: face (Greffe totale ou partielle d’ un visage), Opinion No 82.
p.000261: Crerand CE, Franklin ME, Sarwer DB (2006). Body dysmorphic disorder and cosmetic surgery. Plast Reconstr Surg 118,
p.000261: 167e-80e.
p.000261: Crerand CE, Menard W, Phillips KA (2010). Surgical and minimally invasive cosmetic procedures among
p.000261: persons with body dysmorphic disorder. Ann Plast Surg 65, 11-6.
p.000261:
p.000261:
p.000262: 262
p.000262:
p.000262: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000262: REPORT
p.000262:
p.000262: Crerand CE, Phillips KA, Menard W, Fay C (2005). Nonpsychiatric medical treatment of body dysmorphic
p.000262: disorder. Psychosomatics 46, 549-55.
p.000262: European Group on Ethics (EGE) (1999). Ethical aspects arising from doping in sport, Opinion No 14, 1.6, 2.10.
p.000262: Farah MJ (2005). Neuroethics: The practical and the philosophical trends in cognitive sciences, p. 34.
p.000262: Fukuyama F (2002). Our posthuman future: Consequences of the biotechnology revolution, Farrar,
p.000262: Strauss and Giroux, N. York.
p.000262: Garcia-Verdugo M (2005). Medio fondo y fondo. La preparacion del corridor de resistencia. Atletismo 4. Madrid. RFEA.
p.000262: GIRES (Gender Identity Research and Education Society) (2008). Gender var- iance (dysphoria) (www.gires.org.uk).
p.000262: Hayflick L (2003). Living forever and dying in the attempt. Exp Gerontol 38, 1231-1241.
p.000262: Hildt E (2005). Living longer: Ethical aspects of age-retardation, Paper presented at the 19th European
p.000262: Conference on Philosophy of Medicine and Health Care and 22nd EACME Conference “Ethics and Philosophy of Emerging
p.000262: Medical Technologies”, Barcelona.
p.000262: House of Commons, Select Committee on Culture, Media and Sport (2004). Seventh Report of Session 2003-2004, UK
p.000262: Parliament, HC 499-I.
p.000262: Huxtable R, Woodley J (2005). Gaining face or losing face? Framing the debate on face transplants.
p.000262: Bioethics, p. 505.
p.000262: Ingram DK, Anson RM, De Cabo R, Mamczarz J, Zhu M, Mattison JA, Lane MA, Roth GS (2004). Development of
...

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p.000009: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE AND MENTAL STATE
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p.000268: 268
p.000268:
p.000268: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000268: OPINION
p.000268:
p.000268: O P I N I O N
p.000268:
p.000268: HUMAN ENHANCEMENT -
p.000268: EFFECT ON COGNITIVE AND MENTAL STATE
p.000268:
p.000268: The Hellenic National Bioethics Commission, as previously announced, continued to examine the issue of “human
p.000268: enhancement”, focusing on the effects of enhancement methods on the cognitive and mental state of the human organism.
p.000268: To study the issue, the Commission held relevant hearings of Dr. G. Christodoulou, Emeritus Professor of
p.000268: Psychiatry, Medical School, Athens University and Honorary President of the Greek Psychiatric Association and Dr. G.
p.000268: Kolaitis, Associate Professor of Child Psychiatry, Medical School, Ath- ens University.
p.000268:
p.000268: I. The data
p.000268:
p.000268: Modern science enabled the development of specific interventions for the “cognitive" functions of the human
p.000268: body, with a main purpose to treat mental illnesses and disorders. However, the possibilities offered by modern science
p.000268: highlight the problem of whether it is legitimate to use such meth- ods in healthy organisms, aiming to enhance the
p.000268: mental or emotional condi- tion.
p.000268: Such methods are particularly: a) selective stimulation of brain regions, with electrical or magnetic signals, and b)
p.000268: drug use. In the future, it is likely that these methods are enriched by targeted genetic modification of genes
p.000268: associated with cognitive functions, as well as by brain/computer interfaces, which is expected to allow access
p.000268: to electronic information -and generally use of computer programs- by just activating certain cognitive functions.
p.000268: The Commission notices that there is internationally, a widespread use of substances by healthy individuals
p.000268: (nicotine, caffeine) or even prescription drugs, with the aim to further enhance their cognitive functions.
p.000268: Users mainly pursue memory and attention enhancement, but also to treat nor- mal hyperactivity, which occurs
p.000268: particularly in children. In addition, the ap- pearance of anxiety or phobias, typical elements of everyday life in a
p.000268: mod-
p.000268:
p.000268:
p.000269: 269
p.000269:
p.000269: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000269: OPINION
p.000269:
p.000269: ern social context, puts pressure on healthy individuals to use sedatives, antianxiety and antidepressant
p.000269: drugs.
p.000269: The Commission considers that, as in the case of enhancing physical characteristics, the autonomy of a
p.000269: healthy person includes options for en- hancing the cognitive or mental state of the human body. This enhancement
p.000269: is part of the right to develop freely a personality.
p.000269:
p.000269: II. Suggestions
p.000269:
p.000269: However, the aforementioned principle must be supplemented with necessary remarks.
p.000269: 1. The use of drugs to enhance memory or attention may adversely af- fect other cognitive functions. Due to this
p.000269: eventuality, the person concerned must be fully informed, in order to have the opportunity of an independent choice.
p.000269: 2. The issue of influencing the personality is particularly emphasized in the case of antidepressants use. The above
p.000269: mentioned influence is in princi- ple legitimate, as a fundamental right of the person, but it encloses the risk of
p.000269: uncontrolled effects on the nervous system and the general physical and mental condition of the person. The Commission
p.000269: notes the risk when chil- dren use such drugs since such a use may lead to the substitution of all the efforts made to
p.000269: integrate the person into society. A personality is developed by the gradual and smooth integration of the
p.000269: person into the social envi- ronment, owing to the family, friends or educational mechanisms that have the
p.000269: advantage of being subjected to constant scrutiny and revision, and are reversible if necessary, depending on the
p.000269: person’s maturity. For the Com- mission, this advantage is necessary to be ensured, especially in the case of
p.000269: children. For this reason, the use of substances for non-therapeutic purpos- es is not legitimate in children.
p.000269: 3. The use of enhancement methods to improve cognitive and mental functions always requires that the
p.000269: person concerned is fully informed and updated, in terms of the expected results and possible side
p.000269: effects. The Commission considers that the risk of misinformation, especially for drugs which are not
p.000269: prescribed, is serious. The promotion of these drugs to the public and the information leaflets about their
p.000269: use should be subjected to special inspection by the authorities (National Organization for Medicines,
p.000269:
p.000269:
p.000270: 270
p.000270:
p.000270: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000270: OPINION
p.000270:
p.000270: General Secretariat for Commerce, etc.). It is apparent that for prescription drugs, the physician and the pharmacist
p.000270: have an increased responsibility to properly inform the person concerned, especially since it remains doubtful whether
p.000270: the prescription for enhancement purposes falls within the medical responsibilities, such as those described in the
p.000270: Code of Medical Ethics (Law 3418/2005).
p.000270: 4. Noting the complete lack of evidence in our country, regarding the extent of use of human
p.000270: enhancement methods to improve cognitive and mental characteristics, the Commission considers that it is
p.000270: essential for re- search institutions to develop initiative to monitor the phenomenon sys- tematically, with
p.000270: the support of the Ministry of Health.
p.000270: The increasing number or reasons causing mental disorders in the popu- lation (especially among young people), most of
p.000270: which cannot be defined as “pathological”, due to prolonged economic crisis (excessive growth of un-
p.000270: employment, underemployment, strong economic downturn, uncertainty about the future, etc.), absolutely requires a
p.000270: well-organized initiative from the State.
p.000270:
p.000270:
p.000270: Athens, 5 November 2013
p.000270:
p.000270:
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p.000271: 271
p.000271:
p.000271: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000271: OPINION
p.000271:
p.000271: COMPOSITION AND PERSONELL
p.000271: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000271: Chairman: John Papadimitriou, Emeritus Professor of Surgery, Medical School, University of Athens.
p.000271:
p.000271: Members:
p.000271: Julia Iliopoulou-Stranga, Professor of Constitutional Law, Law School, Uni- versity of Athens.
p.000271: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000271: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000271: Athens.
p.000271: Evangelos Moutsopoulos, Member of the Academy of Athens, Emeritus Professor of Philosophy, University of
p.000271: Athens.
p.000271: Theocharis Patargias, Emeritus Professor of Genetics, University of Athens
p.000271: Constantinos Tsoukalas, Emeritus Professor of Sociology, University of Ath- ens.
p.000271: Christos Voulgaris, Emeritus Professor of Theology, University of Athens.
p.000271:
p.000271: PERSONELL
p.000271:
p.000271: Scientific Officers:
p.000271: Takis Vidalis, Lawyer, PhD in Law.
p.000271: Vasiliki Mollaki, Geneticist, PhD in Genetics.
p.000271:
p.000271: Secretariat:
p.000271: Marianna Drakopoulou, Lawyer, Head of Secretariat.
p.000271:
p.000271:
p.000271:
p.000271:
p.000271:
p.000272: 272
p.000272:
p.000272: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000272: REPORT
p.000272:
p.000272: R E P O R T
p.000272:
p.000272: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE AND MENTAL STATE
p.000272:
...

p.000275: (commercial name Adderall) are used to treat attention deficit hyperactivity disorder (ADHD) in children.
p.000275: Nevertheless, these stimulant substances are commonly used by young people to enhance their attention and
p.000275: academic performance.
p.000275: A study in 4,580 American college students showed that 8.3% of students reported illicit use of
p.000275: prescription stimulants at least once in their lifetime, while 5.9% of them used it during the previous year.
p.000275: Of these, 75.8% used amphetamine while 24.5% used methylphenidate, with a higher rate of use among Caucasians. The
p.000275: study indicates that the most frequent incentives for stimulant use is to increase concentration, receive help during
p.000275: studying and increase attention8. These results were confirmed by similar studies9 indicating the problem
p.000275: of frequent use, especially amphetamine use, in college students.
p.000275: Modafinil is also a stimulating substance indicated for the treatment of excessive sleepiness in patients with
p.000275: narcolepsy. However, studies in healthy subjects showed that Modafinil improves memory10, as well as the levels
p.000275: of wakefulness and alertness in physicians11 and pilots12, making
p.000275:
p.000275: 6Warburton DM (1992). Nicotine as a cognitive enhancer. Progress in Neuro- Psychopharmacology and
p.000275: Biological Psychiatry, 16, 181-191.
p.000275: 7Newhouse PA, Potter A & Singh A (2004). Effects of nicotinic stimulation on cognitive performance. Current Opinion in
p.000275: Pharmacology, 4, 36-46.
p.000275: 8Teter CJ, McCabe SE, Boyd CJ, Guthrie SK (2003). Illicit methylphenidate use in an undergraduate student
p.000275: sample: Prevalence and risk factors. Pharmacotherapy 23, 609-17.
p.000275: 9McCabe SE, Teter CJ, Boyd CJ (2006). Medical use, illicit use and diversion of pre- scription stimulant
p.000275: medication. J Psychoactive Drugs 38, 43-56.
p.000275: 10Müller U, Steffenhagen N, Regenthal R, Bublak P (2004). Effects of modafinil on working memory processes
p.000275: in humans. Psychopharmacology (Berl) 177, 161-9.
p.000275: 11Gill M, Haerich P, Westcott K, et al., (2006). Cognitive performance following modafinil versus placebo
p.000275: in sleep-deprived emergency physicians: A double-blind randomized crossover study. Acad Emerg Med 13, 158-65.
p.000275: 12Caldwell JA Jr, Caldwell JL, Smythe NK 3rd, Hall KK (2000). A double-blind, placebo- controlled investigation of the
p.000275: efficacy of modafinil for sustaining the alertness and
p.000275:
p.000276: 276
p.000276:
p.000276: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000276: REPORT
p.000276:
p.000276: modafinil a substance capable of enhancing cognitive functions in humans.
p.000276:
...

Searching for indicator philosophy:

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p.000012: family history) is uncertain in most cases and it is impossible to determine the time of such manifestation. So,
p.000012: genetic data is not particu- larly important for the calculation of risk.
p.000012: Nevertheless, ways need to be identified that will safeguard the legiti- mate interests of insurers,
p.000012: especially the risk of wilful deception. For that purpose, it seems appropriate to adopt a moratorium
p.000012: with a reasonable duration. During this time, insurers must make specific commitments not to use genetic data and
p.000012: the State must pledge to enact legislation -following public dialogue. In the context of such dialogue, it is
p.000012: crucial to put in place a certification system for genetic laboratories and to recognize the specialty of geneticists
p.000012: in order to ensure the quality of genetic analysis and genetic counseling.
p.000012:
p.000012:
p.000012: Athens, 11 January 2008
p.000012:
p.000012:
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p.000013: 13
p.000013:
p.000013: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000013: OPINION
p.000013:
p.000013: COMPOSITION AND PERSONELL
p.000013: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000013: Deputy Chairman and Acting Chairman: George Maniatis, Emeritus Profes- sor of General Biology, University of Patras.
p.000013:
p.000013: Members:
p.000013: Savvas Agourides, Emeritus Professor of Theology, University of Athens.
p.000013: Myrto Dragona-Monachou, Emeritus Professor of Philosophy, University of Athens.
p.000013: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000013: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000013: Athens.
p.000013: Dimitrios Roupakias, Professor of Plant Breeding, University of Thessaloniki.
p.000013: Pavlos Sourlas, Professor of Philosophy of Law, University of Athens.
p.000013: Constantinos Tsoukalas, Emeritus Professor of Sociology, University of Ath- ens.
p.000013: Ioannis Vlahoyiannis, Professor of Medicine and Nephrology, University of Patras.
p.000013:
p.000013:
p.000013:
p.000013: PERSONNEL
p.000013:
p.000013: Scientific Officers:
p.000013: Takis Vidalis, Lawyer, PhD in Law.
p.000013: Ariadne L. Hager-Theodoridou, Agronomist, PhD in Genetics.
p.000013:
p.000013: Secretariat:
p.000013: Marianna Drakopoulou, Lawyer, Head of Secretariat.
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000014: REPORT
p.000014:
p.000014: R E P O R T
p.000014:
p.000014: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000014:
p.000014: Rapporteurs: T. Vidalis, A.L. Hager-Theodoridou In collaboration with: G. Maniatis
p.000014:
p.000014: Disclosure to insurers of the results of genetic testing by the insured or by insurance applicants has become a
p.000014: topic of considerable interest in re- cent years. The reason is that a person’s genetic data is associated with
p.000014: their predisposition to develop certain serious diseases which is seen by some as critical in the context of life or
p.000014: health insurance. The issue maintains its rele- vance due to constant breakthroughs in genetics and the
p.000014: decoding of the human genome, especially with regards to association of mutations or ge- netic markers of
p.000014: specific genes with manifestation of disease.
p.000014: With a previous recommendation on “Genetic Data” the Commission already raised a number of related ethical,
p.000014: legal and social questions. At the core lies the concern about an eventual establishment of some form of fa- vourable
p.000014: or unfavourable “genetic discrimination” in insurance depending on whether the insured have a genetic
...

p.000042: intends to present a model of principles.
p.000042:
p.000042:
p.000043: 43
p.000043:
p.000043: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000043: OPINION
p.000043:
p.000043: b) To adopt initiatives to familiarize researchers with research ethics in their field of activity.
p.000043: c) To ensure transparency as to the source of the direct and indirect fi- nancial funding of research projects and,
p.000043: generally, of the operation of re- search institutions.
p.000043:
p.000043: Athens, 19 June 2008
p.000043:
p.000043:
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p.000044: 44
p.000044:
p.000044: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000044: OPINION
p.000044:
p.000044: COMPOSITION AND PERSONELL
p.000044: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000044: Deputy Chairman and Acting Chairman: George Maniatis, Emeritus Profes- sor of General Biology, University of Patras.
p.000044:
p.000044: Members:
p.000044: Savvas Agourides, Emeritus Professor of Theology, University of Athens.
p.000044: Myrto Dragona-Monachou, Emeritus Professor of Philosophy, University of Athens.
p.000044: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000044: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000044: Athens.
p.000044: Dimitrios Roupakias, Professor of Plant Breeding, University of Thessaloniki.
p.000044: Pavlos Sourlas, Professor of Philosophy of Law, University of Athens.
p.000044: Constantinos Tsoukalas, Emeritus Professor of Sociology, University of Ath- ens.
p.000044: Ioannis Vlahoyiannis, Professor of Medicine and Nephrology, University of Patras.
p.000044:
p.000044:
p.000044:
p.000044: PERSONNEL
p.000044:
p.000044: Scientific Officers:
p.000044: Takis Vidalis, Lawyer, PhD in Law.
p.000044: Ariadne L. Hager-Theodoridou, Agronomist, PhD in Genetics.
p.000044:
p.000044: Secretariat:
p.000044: Marianna Drakopoulou, Lawyer, Head of Secretariat.
p.000044:
p.000044:
p.000044:
p.000045: 45
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p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000045:
p.000046: 46
p.000046:
p.000046: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000046: REPORT
p.000046:
p.000046: R E P O R T
p.000046:
p.000046: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000046:
p.000046: Rapporteurs: A.L. Hager-Theodoridou, T. Vidalis
p.000046: In collaboration with: P. Sourlas
p.000046:
p.000046: The present report is an attempt to identify the basic parameters of eth- ics in biological research. It is an issue
p.000046: that concerns all areas of biological research (e.g. clinical trials, research on the human embryo, research with
p.000046: human biological material, animal, plant and microorganism research). The commission has addressed ethical issues of
...

p.000072: public prosecutor for the environ- ment, the availability of technical support in order to reinforce the evalua-
p.000072: tion capacity of the Judicial Review Court especially with regards to envi- ronmental impact assessments).
p.000072: 4. To adopt a policy of agricultural development based on the protection of biodiversity and of the environment in
p.000072: general by promoting sustainable farming practices that protect biodiversity and by raising environmental
p.000072: awareness in this respect.
p.000072: 5. To ensure transparency in land planning and the protection of fixed land uses and to pursue the optimal
p.000072: long-term utilisation of land depending on its properties.
p.000072:
p.000072: Athens, 25 February 2009
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000072:
p.000073: 73
p.000073:
p.000073: MANAGEMENT OF BIOLOGICAL WEALTH
p.000073: OPINION
p.000073:
p.000073: COMPOSITION AND PERSONELL
p.000073: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000073: Deputy Chairman and Acting Chairman: George Maniatis, Emeritus Profes- sor of General Biology, University of Patras.
p.000073:
p.000073: Members:
p.000073: Savvas Agourides, Emeritus Professor of Theology, University of Athens.
p.000073: Myrto Dragona-Monachou, Emeritus Professor of Philosophy, University of Athens.
p.000073: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000073: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000073: Athens.
p.000073: Dimitrios Roupakias, Professor of Plant Breeding, University of Thessaloniki.
p.000073: Pavlos Sourlas, Professor of Philosophy of Law, University of Athens.
p.000073: Constantinos Tsoukalas, Emeritus Professor of Sociology, University of Ath- ens.
p.000073: Ioannis Vlahoyiannis, Professor of Medicine and Nephrology, University of Patras.
p.000073:
p.000073:
p.000073:
p.000073: PERSONNEL
p.000073:
p.000073: Scientific Officers:
p.000073: Takis Vidalis, Lawyer, PhD in Law.
p.000073: Ariadne L. Hager-Theodoridou, Agronomist, PhD in Genetics.
p.000073:
p.000073: Secretariat:
p.000073: Marianna Drakopoulou, Lawyer, Head of Secretariat.
p.000073:
p.000073:
p.000073:
p.000074: 74
p.000074:
p.000074: MANAGEMENT OF BIOLOGICAL WEALTH
p.000074: REPORT
p.000074:
p.000074: R E P O R T MANAGEMENT OF BIOLOGICAL WEALTH
p.000074: Rapporteurs: T. Vidalis, A. Hager-Theodoridou
p.000074: In collaboration with: D. Roupakias
p.000074:
p.000074: The management of biological wealth is among the most critical issues of our times. Extensive and increasingly
p.000074: intensive human intervention in the natural environment to satisfy ever expanding needs, reveal that: a)
p.000074: the future of life in any particular place or country as well as on the planet as a whole is crucially affected by
p.000074: human activity, and, b) there are limits to the tolerance of the natural environment beyond which restoration is very
p.000074: diffi- cult, if not impossible, with all which that implies for our life, and for the survival and that
p.000074: of all living organisms.
p.000074: The above observations call for an, as far as possible, rational approach to the utilisation of biological
p.000074: resources by any organized society. Every country needs to reflect on the issue and elaborate specific
p.000074: political deci- sions accordingly: decisions on the exploitation of natural resources (soil, water) and land
...

p.000084: At first sight, it is an “imperfect duty” (like kindness, philanthropy etc., according to the Kantian distinction).
p.000084: But perhaps this solution falls short of the powerful commitment we appear to accept.
p.000084: One could also posit a utilitarian foundation according to which our self- restraint for the sake of next generations
p.000084: eventually improves our present
p.000084:
p.000084:
p.000085: 85
p.000085:
p.000085: MANAGEMENT OF BIOLOGICAL WEALTH
p.000085: REPORT
p.000085:
p.000085: state as well, since it leads to a rational and renewable exploitation of (fi- nite) natural resources.
p.000085: A third alternative would be to further investigate the subject in the field of the theory of “rights” or, at
p.000085: least, “interests” -either finding a way to overcome the afore mentioned difficulties in recognizing
p.000085: persons, who do not yet exist, as subjects, or dilating the reflection on our own rights and interests.
p.000085: In the latter context, we may postulate, for instance, that future generations are our concern to the extent that our
p.000085: own reproduction is our concern and that sustainable development is to the interest of our children, of their own
p.000085: children, and so on and so forth ad infinitum, and as such it is an extension of our own individual interest.
p.000085: Critical in this discussion, at any rate, is to separate ethical from legal rights: the former have a far
p.000085: greater scope even if their practical implemen- tation cannot be ensured just as effectively.
p.000085: Finally, in terms of religion, the philosophy of monotheistic religions is anthropocentric for man is
p.000085: considered as the apex of Creation and the top of the pyramid of living organisms. This is basically the
p.000085: “creationist” ap- proach which often leads to the view that our species has absolute domin- ion over nature.
p.000085: Yet, many theologians construe this dominion also as a responsibility for the wise management and protection of the
p.000085: environment, mainly as a duty to future generations (Zezioulas, 1992). This approach has actually inspired some
p.000085: initiatives for a more active involvement of Christian confessions and churches, as demonstrated, for instance, by the
p.000085: example of the Ecumenical Patriarch.
p.000085:
p.000085:
p.000085: THIRD CHAPTER THE LAW
p.000085: In regard to the above issues, the law attempts to outline a few direc- tions mainly by way of international
p.000085: and national legislation. We will at- tempt to describe these directions.
p.000085:
p.000085:
p.000085:
p.000085:
p.000086: 86
p.000086:
p.000086: MANAGEMENT OF BIOLOGICAL WEALTH
p.000086: REPORT
p.000086:
p.000086: International law
p.000086:
p.000086: The Convention on Biodiversity (Rio de Janeiro Convention, 1991) and the Protocol on Biosafety (Cartagena Protocol,
p.000086: 2000).
p.000086: The protection of global biodiversity with specific measures is the object of the Rio Convention, a fundamental
p.000086: instrument for our topic, which was adopted on the initiative of the UN.
p.000086: The Convention stipulates certain principles regarding the management of biodiversity; in particular, the
p.000086: principle of sustainable development (ex- emplified in the well-known action program Agenda 21), the precautionary
...

p.000110: act alone ignoring the will of the pa- tient. On the contrary, the physician’s moral duty is to ensure the free ex-
p.000110: pression of the patient’s will by providing complete, timely and intelligible information whenever feasible.
p.000110:
p.000110: b) Right of physician to refuse treatment
p.000110: The Commission points out that physicians reserve the right to refuse a treatment which is not medically indicated in
p.000110: their view, even if the patient insists upon it.
p.000110:
p.000110:
p.000110: Athens, 29 March 2010
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000110:
p.000111: 111
p.000111:
p.000111: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000111: OPINION
p.000111:
p.000111: COMPOSITION AND PERSONELL
p.000111: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000111: Chairman: John Papadimitriou, Emeritus Professor of Surgery, Medical School, University of Athens.
p.000111:
p.000111: Deputy Chairman: George Maniatis, Emeritus Professor of Biology, Medical School, University of Patras.
p.000111:
p.000111: Members:
p.000111: Julia Iliopoulou-Stranga, Professor of Constitutional Law, Law School, Uni- versity of Athens.
p.000111: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000111: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000111: Athens.
p.000111: Evangelos Moutsopoulos, Member of the Academy of Athens, Emeritus Professor of Philosophy, University of
p.000111: Athens.
p.000111: Athanasios Papachristou, Professor of Civil Law, Law School, University of Athens.
p.000111: Theocharis Patargias, Emeritus Professor of Genetics, University of Athens Constantinos Tsoukalas, Emeritus Professor
p.000111: of Sociology, University of Ath- ens.
p.000111: Christos Voulgaris, Emeritus Professor of Theology, University of Athens.
p.000111:
p.000111: PERSONNEL
p.000111:
p.000111: Scientific Officers:
p.000111: Takis Vidalis, Lawyer, PhD in Law.
p.000111: Ariadne L. Hager-Theodoridou, Agronomist, PhD in Genetics.
p.000111:
p.000111: Secretariat:
p.000111: Marianna Drakopoulou, Lawyer, Head of Secretariat.
p.000111:
p.000111:
p.000112: 112
p.000112:
p.000112: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000112: REPORT
p.000112:
p.000112: R E P O R T
p.000112:
p.000112: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000112:
p.000112:
p.000112: Rapporteurs: T. Vidalis, A. Hager-Theodoridou In collaboration with: G. Maniatis, A. Papachristou
p.000112:
p.000112:
p.000112: A. INTRODUCTION: NEW DEVELOPMENTS IN MEDICAL PRACTICE
p.000112:
p.000112: Until recently the physician-patient relationship was governed by a “pa- ternalistic” model developed as a product
p.000112: of Hippocrates’ ethics subse- quently interpreted or modified by a succession of physicians-philosophers like
p.000112: Galen, in combination with the prevailing social conditions. According to this model, the physician decides on all
p.000112: matters pertaining to the patient’s treatment while the latter has little or no say in it at all1. The contemporary
p.000112: conditions of medical practice exhibit new qualities suggesting a need for a new model, different from the one which
...

p.000142: Finally, special attention is required when the virus occurs in enclosed areas of mandatory containment, like
p.000142: schools, hospitals, military barracks or prisons. Any limits to autonomy which are considered indispensable
p.000142: must be combined with additional measures of supervision in order not to betray the purpose of the presence of the HIV
p.000142: seropositive in these areas (e.g. participation in common school activities, military exercises, etc.).
p.000142:
p.000142: Athens, 18 March 2011
p.000142:
p.000143: 143
p.000143:
p.000143: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000143: OPINION
p.000143:
p.000143: COMPOSITION AND PERSONELL
p.000143: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000143: Chairman: John Papadimitriou, Emeritus Professor of Surgery, Medical School, University of Athens.
p.000143:
p.000143: Deputy Chairman: George Maniatis, Emeritus Professor of Biology, Medical School, University of Patras.
p.000143:
p.000143: Members:
p.000143: Julia Iliopoulou-Stranga, Professor of Constitutional Law, Law School, Uni- versity of Athens.
p.000143: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000143: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000143: Athens.
p.000143: Evangelos Moutsopoulos, Member of the Academy of Athens, Emeritus Professor of Philosophy, University of
p.000143: Athens.
p.000143: Athanasios Papachristou, Professor of Civil Law, Law School, University of Athens.
p.000143: Theocharis Patargias, Emeritus Professor of Genetics, University of Athens
p.000143: Constantinos Tsoukalas, Emeritus Professor of Sociology, University of Ath- ens.
p.000143: Christos Voulgaris, Emeritus Professor of Theology, University of Athens.
p.000143:
p.000143: PERSONNEL
p.000143:
p.000143: Scientific Officers:
p.000143: Takis Vidalis, Lawyer, PhD in Law.
p.000143: Ariadne L. Hager-Theodoridou, Agronomist, PhD in Genetics.
p.000143:
p.000143: Secretariat:
p.000143: Marianna Drakopoulou, Lawyer, Head of Secretariat.
p.000143:
p.000143:
p.000144: 144
p.000144:
p.000144: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000144: REPORT
p.000144:
p.000144: R E P O R T
p.000144:
p.000144: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000144:
p.000144: Rapporteurs: T. Vidalis, A. L. Hager-Theodoridou In collaboration with: G. M. Maniatis, C. Tsoukalas
p.000144:
p.000144: I. Introduction
p.000144:
p.000144: In current medical practice, patients are free to agree or decline thera- peutic interventions suggested to them by
p.000144: physicians through informed con- sent. But when their individual decisions can directly affect the health of
p.000144: other people, their personal autonomy as the only factor in making such decisions is put in question. The
p.000144: present report discusses the limits of per- sonal autonomy when a conflict with public interest arises, particularly
...

p.000161: seminars).
p.000161:
p.000161:
p.000161:
p.000162: 162
p.000162:
p.000162: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000162: OPINION
p.000162:
p.000162: Finally, the Commission supports the right to access control mechanisms by whoever participates in a certain clinical
p.000162: study and invokes evidence of misconduct.
p.000162:
p.000162:
p.000162: Athens, 5 July 2011
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000162:
p.000163: 163
p.000163:
p.000163: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000163: OPINION
p.000163:
p.000163: COMPOSITION AND PERSONELL
p.000163: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000163: Chairman: John Papadimitriou, Emeritus Professor of Surgery, Medical School, University of Athens.
p.000163:
p.000163: Deputy Chairman: George Maniatis, Emeritus Professor of Biology, Medical School, University of Patras.
p.000163:
p.000163: Members:
p.000163: Julia Iliopoulou-Stranga, Professor of Constitutional Law, Law School, Uni- versity of Athens.
p.000163: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000163: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000163: Athens.
p.000163: Evangelos Moutsopoulos, Member of the Academy of Athens, Emeritus Professor of Philosophy, University of
p.000163: Athens.
p.000163: Athanasios Papachristou, Professor of Civil Law, Law School, University of Athens.
p.000163: Theocharis Patargias, Emeritus Professor of Genetics, University of Athens Constantinos Tsoukalas, Emeritus Professor
p.000163: of Sociology, University of Ath- ens.
p.000163: Christos Voulgaris, Emeritus Professor of Theology, University of Athens.
p.000163:
p.000163:
p.000163: PERSONNEL
p.000163:
p.000163: Scientific Officers:
p.000163: Takis Vidalis, Lawyer, PhD in Law.
p.000163: Stefania Lymperi, Biologist, PhD in Cell Biology.
p.000163:
p.000163: Secretariat:
p.000163: Marianna Drakopoulou, Lawyer, Head of Secretariat.
p.000163:
p.000164: 164
p.000164:
p.000164: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000164: REPORT
p.000164:
p.000164: R E P O R T
p.000164:
p.000164: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000164:
p.000164: Rapporteurs: S. Lymperi, T. Vidalis In collaboration with: J. Papadimitriou
p.000164:
p.000164: 1. Introduction
p.000164:
p.000164: In a former Opinion the Hellenic National Bioethics Commission dealt with the ethics of drug clinical
p.000164: studies and other therapeutic procedures. Particular issues concerning the lack of credibility for several studies,
p.000164: due to the financial interests of the sponsor, were already identified in that docu- ment.
p.000164: With the present report, it is attempted to probe deep into the issue of conflict of interest, since it is a
p.000164: serious matter commonly encountered by the physician/researcher. In addition, the credibility of clinical studies
...

p.000200: 21.9.2006 decision of the Central Council of Health.
p.000200: b) Establishment of a previous state license for the operation of genetic centers, where the genetic tests are
p.000200: performed according to valid cri- teria for quality certification.
p.000200: c) Requirement of a regulation governing the above mentioned centers, which will include specific warranties to
p.000200: correctly inform the con- sumers, especially concerning advertising of genetic services, accord- ing to the
p.000200: paragraph C.
p.000200: d) The potential use of the biologic materials or genetic information for research purposes, on the condition
p.000200: that they are anonymized or that the subject has given consent.
p.000200:
p.000200:
p.000200: Athens, 30 March 2012
p.000200:
p.000200:
p.000200:
p.000201: 201
p.000201:
p.000201: DIRECT-TO-CONSUMER GENETIC TESTING
p.000201: OPINION
p.000201:
p.000201: COMPOSITION AND PERSONELL
p.000201: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000201: Chairman: John Papadimitriou, Emeritus Professor of Surgery, Medical School, University of Athens.
p.000201: Deputy Chairman: George Maniatis, Emeritus Professor of Biology, Medical School, University of Patras.
p.000201:
p.000201: Members:
p.000201: Julia Iliopoulou-Stranga, Professor of Constitutional Law, Law School, Uni- versity of Athens.
p.000201: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000201: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000201: Athens.
p.000201: Evangelos Moutsopoulos, Member of the Academy of Athens, Emeritus Professor of Philosophy, University of
p.000201: Athens.
p.000201: Athanasios Papachristou, Professor of Civil Law, Law School, University of Athens.
p.000201: Theocharis Patargias, Emeritus Professor of Genetics, University of Athens Constantinos Tsoukalas, Emeritus Professor
p.000201: of Sociology, University of Ath- ens.
p.000201: Christos Voulgaris, Emeritus Professor of Theology, University of Athens.
p.000201:
p.000201: PERSONELL
p.000201:
p.000201: Scientific Officers:
p.000201: Takis Vidalis, Lawyer, PhD in Law.
p.000201: Vasiliki Mollaki, Geneticist, PhD in Genetics.
p.000201:
p.000201: Secretariat:
p.000201: Marianna Drakopoulou, Lawyer, Head of Secretariat.
p.000201:
p.000201:
p.000201:
p.000202: 202
p.000202:
p.000202: DIRECT-TO-CONSUMER GENETIC TESTING
p.000202: REPORT
p.000202:
p.000202: R E P O R T
p.000202:
p.000202: DIRECT-TO-CONSUMER GENETIC TESTING
p.000202:
p.000202:
p.000202: Rapporteurs: Takis Vidalis, Vasiliki Mollaki
p.000202:
p.000202:
p.000202: INTRODUCTION
p.000202:
p.000202: From the late ‘90s, the progress in genetic testing technology, which increased the potential of
p.000202: detecting genetic causes of specific phenotypes and especially serious diseases, encountered the parallel
p.000202: progress of com- puter science and particularly, web applications. As a result, a new business activity emerged,
p.000202: aiming to provide genetic testing directly to any interested individual. The term “Direct-to-Consumer (DTC) Genetic
p.000202: Testing” is used to describe genetic testing taking place upon an individual’s request, without the mediation of an
p.000202: expert, i.e. clinical geneticist (medical geneticist or biol- ogist geneticist).
p.000202: Practically, this means that any individual (hereinafter referred to as “consumer”) can choose to undergo
...

p.000229: concerning physical enhancement of soldiers, transparency is particularly important, which is, however, often in
p.000229: contrast to the confidentiality required by such cases. In this occasion, the necessary information may be available to
p.000229: a third party/organization which will ensure not only the proper conduct of research but also the confidenti- ality of
p.000229: information.
p.000229: Finally, for the military physician who participates in such a research, the Commission considers that, additionally,
p.000229: all the rules of medical ethics ap- ply, including those related to clinical research.
p.000229:
p.000229:
p.000229: Athens, 8 April 2013
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000229:
p.000230: 230
p.000230:
p.000230: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000230: OPINION
p.000230:
p.000230: COMPOSITION AND PERSONELL
p.000230: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000230: Chairman: John Papadimitriou, Emeritus Professor of Surgery, Medical School, University of Athens.
p.000230:
p.000230: Members:
p.000230: Julia Iliopoulou-Stranga, Professor of Constitutional Law, Law School, Uni- versity of Athens.
p.000230: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000230: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000230: Athens.
p.000230: Evangelos Moutsopoulos, Member of the Academy of Athens, Emeritus Professor of Philosophy, University of
p.000230: Athens.
p.000230: Theocharis Patargias, Emeritus Professor of Genetics, University of Athens
p.000230: Constantinos Tsoukalas, Emeritus Professor of Sociology, University of Ath- ens.
p.000230: Christos Voulgaris, Emeritus Professor of Theology, University of Athens.
p.000230:
p.000230: PERSONELL
p.000230:
p.000230: Scientific Officers:
p.000230: Takis Vidalis, Lawyer, PhD in Law.
p.000230: Vasiliki Mollaki, Geneticist, PhD in Genetics.
p.000230:
p.000230: Secretariat:
p.000230: Marianna Drakopoulou, Lawyer, Head of Secretariat.
p.000230:
p.000230:
p.000230:
p.000230:
p.000230:
p.000231: 231
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000231:
p.000232: 232
p.000232:
p.000232: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000232: REPORT
p.000232:
p.000232: R E P O R T
p.000232:
p.000232: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000232:
p.000232: Rapporteurs: Vasiliki Mollaki, Takis Vidalis
p.000232:
p.000232: Α. ENHANCEMENT OF HUMAN CHARACTERISTICS
p.000232:
p.000232: 1. Introduction
p.000232:
p.000232: Human enhancement has emerged as a major issue in bioethics. The continuous technological and scientific
p.000232: advances enable interventions in basic, “normal” human capabilities, a fact that raises serious social and
p.000232: ethical issues. Some forms of enhancement already have practical applications, whereas other forms
p.000232: belong to the realm of science fiction.
...

p.000261: 167e-80e.
p.000261: Crerand CE, Menard W, Phillips KA (2010). Surgical and minimally invasive cosmetic procedures among
p.000261: persons with body dysmorphic disorder. Ann Plast Surg 65, 11-6.
p.000261:
p.000261:
p.000262: 262
p.000262:
p.000262: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000262: REPORT
p.000262:
p.000262: Crerand CE, Phillips KA, Menard W, Fay C (2005). Nonpsychiatric medical treatment of body dysmorphic
p.000262: disorder. Psychosomatics 46, 549-55.
p.000262: European Group on Ethics (EGE) (1999). Ethical aspects arising from doping in sport, Opinion No 14, 1.6, 2.10.
p.000262: Farah MJ (2005). Neuroethics: The practical and the philosophical trends in cognitive sciences, p. 34.
p.000262: Fukuyama F (2002). Our posthuman future: Consequences of the biotechnology revolution, Farrar,
p.000262: Strauss and Giroux, N. York.
p.000262: Garcia-Verdugo M (2005). Medio fondo y fondo. La preparacion del corridor de resistencia. Atletismo 4. Madrid. RFEA.
p.000262: GIRES (Gender Identity Research and Education Society) (2008). Gender var- iance (dysphoria) (www.gires.org.uk).
p.000262: Hayflick L (2003). Living forever and dying in the attempt. Exp Gerontol 38, 1231-1241.
p.000262: Hildt E (2005). Living longer: Ethical aspects of age-retardation, Paper presented at the 19th European
p.000262: Conference on Philosophy of Medicine and Health Care and 22nd EACME Conference “Ethics and Philosophy of Emerging
p.000262: Medical Technologies”, Barcelona.
p.000262: House of Commons, Select Committee on Culture, Media and Sport (2004). Seventh Report of Session 2003-2004, UK
p.000262: Parliament, HC 499-I.
p.000262: Huxtable R, Woodley J (2005). Gaining face or losing face? Framing the debate on face transplants.
p.000262: Bioethics, p. 505.
p.000262: Ingram DK, Anson RM, De Cabo R, Mamczarz J, Zhu M, Mattison JA, Lane MA, Roth GS (2004). Development of
p.000262: calorie restriction mimetics as a pro- longevity strategy. Ann NY Acad Sci 1019, 412-423.
p.000262: Kriari-Katrani I (2001). The constitutional protection of genetic identity. A first approach. DtA 2001, p.347.
p.000262: Lo HS, Xie SQ (2012). Exoskeleton robots for upper-limb rehabilitation: State of the art and future prospects. Med Eng
p.000262: Phys 34, 261-8.
p.000262:
p.000262:
p.000262:
p.000263: 263
p.000263:
p.000263: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000263: REPORT
p.000263:
p.000263: Louhija J, Miettinen HE, Kontula K, Tikkanen MJ, Miettinen TA, Tilvis RS (1985). Aging and genetic variation
p.000263: of plasma lipoproteins. Oldest old: New perspectives and evidence. Milbank Mem Fund Quart 63, 177-251.
p.000263: Morcel K, Camborieux L, Programme de Recherches sur les Aplasies Mülléri- ennes, Guerrier D (2007).
p.000263: Mayer-Rokitansky-Küster-Hauser (MRKH) syn- drome. Orphanet J Rare Dis 14, 2:13.
p.000263: Oeppen J and Vaupel JW (2002). “Broken limits to life expectancy”. Science 296, 1029-1031.
p.000263: Parasidis E (2012). Human enhancement and experimental research in the military. Connecticut Law Review 44, 1117.
p.000263: Phillips KA, Grant J, Siniscalchi J, Albertini RS (2001). Surgical and nonpsychi- atric medical treatment of patients
...

p.000270: essential for re- search institutions to develop initiative to monitor the phenomenon sys- tematically, with
p.000270: the support of the Ministry of Health.
p.000270: The increasing number or reasons causing mental disorders in the popu- lation (especially among young people), most of
p.000270: which cannot be defined as “pathological”, due to prolonged economic crisis (excessive growth of un-
p.000270: employment, underemployment, strong economic downturn, uncertainty about the future, etc.), absolutely requires a
p.000270: well-organized initiative from the State.
p.000270:
p.000270:
p.000270: Athens, 5 November 2013
p.000270:
p.000270:
p.000270:
p.000270:
p.000270:
p.000270:
p.000270:
p.000270:
p.000270:
p.000270:
p.000270:
p.000270:
p.000270:
p.000270:
p.000270:
p.000270:
p.000270:
p.000270:
p.000271: 271
p.000271:
p.000271: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000271: OPINION
p.000271:
p.000271: COMPOSITION AND PERSONELL
p.000271: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000271: Chairman: John Papadimitriou, Emeritus Professor of Surgery, Medical School, University of Athens.
p.000271:
p.000271: Members:
p.000271: Julia Iliopoulou-Stranga, Professor of Constitutional Law, Law School, Uni- versity of Athens.
p.000271: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000271: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000271: Athens.
p.000271: Evangelos Moutsopoulos, Member of the Academy of Athens, Emeritus Professor of Philosophy, University of
p.000271: Athens.
p.000271: Theocharis Patargias, Emeritus Professor of Genetics, University of Athens
p.000271: Constantinos Tsoukalas, Emeritus Professor of Sociology, University of Ath- ens.
p.000271: Christos Voulgaris, Emeritus Professor of Theology, University of Athens.
p.000271:
p.000271: PERSONELL
p.000271:
p.000271: Scientific Officers:
p.000271: Takis Vidalis, Lawyer, PhD in Law.
p.000271: Vasiliki Mollaki, Geneticist, PhD in Genetics.
p.000271:
p.000271: Secretariat:
p.000271: Marianna Drakopoulou, Lawyer, Head of Secretariat.
p.000271:
p.000271:
p.000271:
p.000271:
p.000271:
p.000272: 272
p.000272:
p.000272: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000272: REPORT
p.000272:
p.000272: R E P O R T
p.000272:
p.000272: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE AND MENTAL STATE
p.000272:
p.000272: Rapporteurs: Takis Vidalis, Vasiliki Mollaki
p.000272: Introduction
p.000272:
p.000272: Many psychiatric, neurodegenerative and neurodevelopmental disorders coexist with abnormalities in “normal”
p.000272: cognitive and mental functions. Autism, intellectual disability, attention deficit disorder,
p.000272: schizophrenia, depression but also neurodegenerative diseases, such as Alzheimer's, Parkinson's and
p.000272: Huntington's chorea, are associated with impairment of cognitive functions. Aging of the brain also leads
p.000272: to similar effects. The continuous and rapid scientific developments make it possible, to some extent, to
...

Economic / Economic/Poverty

Searching for indicator poor:

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p.000148: is true of serious diseases that are hard to contract. Of course, there are many variations of these
p.000148: combina- tions, which prevent the formulation of more specific rules of universal ef- fect.
p.000148: Restrictions to general autonomy can lead to unfair discrimination aris- ing from a kind of “stigmatization” which
p.000148: isolates patients -even if temporar- ily- from social life. Above all, this raises a wider ethical problem. Historical-
p.000148: ly, the stigma against population groups on public health grounds has been a recurring phenomenon, from the
p.000148: persecutions and massacres of Jews dur- ing the times of “Black Death” in the Dark Ages (the plague pandemic), to the
p.000148: persecution of beggars on the same grounds in the XIX century or of prostitutes for spreading syphilis in
p.000148: World War I, to contemporary practices of discrimination against AIDS patients. In our country, stigmatization phe-
p.000148: nomena occurred in the past in the cases of leprosy and tuberculosis.
p.000148: These facts demonstrate that public health is not to be considered only as a medical problem, but involves a serious
p.000148: social and political dimension. The latter must be taken into account when adopting restrictions to general autonomy.
p.000148: Such restrictions are not justified unless accompanied by social measures aimed at minimizing the likelihood of
p.000148: transmission (e.g. housing, food, etc. for the poor or disadvantaged groups of the population) and by steps ensuring
p.000148: fair treatment (not distinguishing, for example, between prostitutes and their clients regarding the risk
p.000148: of transmission of venereal diseases).
p.000148: The current wave of immigration carries great potential of stigma on public health grounds. The fact
p.000148: that the country of origin -particularly of illegal immigrants- is often afflicted by a high prevalence
p.000148: of infectious dis- eases (especially sub-Saharan Africa and southern Asia), while local health services
p.000148: remain rudimentary, represents a real cause of concern for the spreading of these diseases in the
p.000148: hosting countries. However, stigmatiza- tion practices -unfair treatment, “ghettos” etc.- stem rather from the idea
p.000148: of “miasma” due to lack of information or misinformation about the medical- biological particulars of disease,
p.000148: especially infectivity. Hansen’s disease (lep- rosy) and, more recently, HIV/AIDS confirm this observation
p.000148: since these
p.000148:
p.000148:
p.000149: 149
p.000149:
p.000149: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000149: REPORT
p.000149:
p.000149: population groups are stigmatized, although the disease is relatively difficult to contract.
p.000149: In case of Hansen’s disease, the exact path of transmission is still un- known, but it is accepted
...

p.000167:
p.000167: 3. Research misconduct
p.000167:
p.000167: The term research misconduct refers to:
p.000167: a) Data fabrication, i.e. creating non-existent or fictitious results during the recording or publication process.
p.000167: b) Data falsification, i.e., modification or concealment of critical results.
p.000167:
p.000167:
p.000167: 4 Fries JF, Krishnan E (2004). Equipoise, design bias, and randomized controlled trials: The elusive ethics of new drug
p.000167: development. Arthritis Res Ther 6, R250-R255.
p.000167: 5 Heres S, Davis J, Maino K, Jetzinger E, Kissling W, Leucht S (2006). Why olanzapine beats risperidone, risperidone
p.000167: beats quetiapine, and quetiapine beats olanzapine: An exploratory analysis of head-to-head comparison studies of
p.000167: second-generation anti- psychotics. Am J Psychiatry 163, 185-194.
p.000167: 6 Bero LA, Rennie D (1996). Influences on the quality of published drug studies. Int J Technol Assess Health Care 12,
p.000167: 209-237.
p.000167:
p.000168: 168
p.000168:
p.000168: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000168: REPORT
p.000168:
p.000168: c) Plagiarism, i.e. repetition of referencing results, opinions, ideas or re- search methods, without the
p.000168: appropriate reference to the person who used them or reported them originally.
p.000168:
p.000168: Specifically, it is worth noting:
p.000168:
p.000168: a. Quality of methodology
p.000168: Although some people believe that clinical studies sponsored by the pharmaceutical industry are associated
p.000168: with poor methodological quality7, most of the authors stress that research protocols sponsored by the private
p.000168: sector are no less methodological8 and in fact, show better quality of meth- odology9,10.
p.000168:
p.000168: b. Inappropriate selection of dose and administration route
p.000168: It is observed that in clinical studies where two drugs are directly com- pared, the sponsor’s drug is administered
p.000168: in high doses to show better ef- fectiveness or in low doses to show fewer side effects. Administration of
p.000168: unequal doses violates the scientific principle of “clinical equipoise”, repre- senting that a subject may be enrolled
p.000168: in a clinical study only if there is true uncertainty about which of the study arms is most likely to benefit the pa-
p.000168: tient11. For instance, in 13 studies comparing the antifungals fluconazole and
p.000168:
p.000168: 7 Jorgensen AW, Maric KL, Tendal B, Faurschou A, Gotzsche PC (2008). Industry- supported meta-analyses
p.000168: compared with meta-analyses with non-profit or no sup- port: Differences in methodological quality and
p.000168: conclusions. BMC Med Res Methodol 8, 60.
p.000168: 8 Hampson LA, Joffe S, Fowler R, Verter J, Emanuel EJ (2007). Frequency, type, and monetary value of financial
p.000168: conflicts of interest in cancer clinical research. J Clin On- col 25, 3609-3614.
p.000168: 9 Heres S, Davis J, Maino K, Jetzinger E, Kissling W, Leucht S (2006). Why olanzapine beats risperidone, risperidone
p.000168: beats quetiapine, and quetiapine beats olanzapine: An exploratory analysis of head-to-head comparison studies of
p.000168: second-generation anti- psychotics. Am J Psychiatry 163, 185-194.
p.000168: 10 Perlis RH, Perlis CS, Wu Y, Hwang C, Joseph M, Nierenberg AA (2005). Industry sponsorship and
p.000168: financial conflict of interest in the reporting of clinical trials in psy- chiatry. Am J Psychiatry 162, 1957-1960.
p.000168: 11 Djulbegovic B, Cantor A, Clarke M (2003). The importance of preservation of the ethical principle of equipoise
p.000168: in the design of clinical trials: Relative impact of the
p.000168:
p.000169: 169
p.000169:
p.000169: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000169: REPORT
p.000169:
p.000169: amphotericin B in cancer patients who are vulnerable to fungal infections due to low white blood cell counts,
p.000169: 80% of the patients had the drug admin- istered orally in suspension, which shows poor absorption, not as an injec-
p.000169: tion. Conducting such clinical studies not only leads to misinformation but is also unethical, since the lack of
p.000169: therapeutic utility, endangers the patients and prolongs their pain.
p.000169:
p.000169: c. Selective publication
p.000169: Occasionally, industries intervene and prevent publication of negative results about their product which is
p.000169: under trial. Such interference is report- ed by almost 20% of researchers12. On the contrary, industries ensure that
p.000169: clinical studies with positive results are mentioned in more than one refer- ence in the literature. An illustrative
p.000169: example is a study revealing that the results from 6 different clinical studies testing duloxetine were used in more
p.000169: than 20 publications13.
p.000169:
p.000169: d. Different interpretation of results
p.000169: It is observed that industries interpret and present the results of a clini- cal study in different ways depending on
p.000169: whether they aim to publish them or submit them to the competent authorities. According to the existing lit- erature,
p.000169: 94% of the clinical studies showed positive results, whereas accord- ing to the US Food and Drug Administration (FDA)
p.000169: only 51% of the clinical studies had positive results14.
p.000169:
p.000169:
p.000169:
p.000169:
p.000169:
p.000169: methodological quality domains on the treatment effect in randomized controlled trials. Account Res 10,
p.000169: 301-315.
p.000169: 12 12 von Elm E, Rollin A, Blumle A, Huwiler K, Witschi M, Egger M (2008). Publication and non-publication of clinical
p.000169: trials: Longitudinal study of applications submitted to a research ethics committee. Swiss Med Wkly 138, 197-203.
...

p.000181: environment. In the end, these restrictions correspond to respective values, which -under certain circum-
p.000181: stances- rule out entire areas of research activity: in this context, “truth” is believed to have an excessive
p.000181: cost to our social coexistence, so excessive that it does not worth favouring against other values.
p.000181: Nonetheless, such restrictions are rather “external” on research, enforced upon it without re- futing its value,
p.000181: setting, in a way, “geographical” boundaries on the field in which it develops.
p.000181: The financial restrictions of research have a different quality. In principle they don’t question the field of
p.000181: research -or the subject of a specific re- search- but they set limits on the resources attributed to the
p.000181: production of results. Consequently, the sponsor of a clinical study on a new pharmaceuti- cal product is interested
p.000181: in: a) attributing a certain pre-calculated amount of money for this specific research and b) having specific positive
p.000181: results from this investment, i.e. results that will allow a patent, and subsequently, launch the product in
p.000181: the market.
p.000181: Under these two facts, the value of truth is relative. Actually, exactly because the results are under
p.000181: examination, it is, by definition, impossible to estimate the cost which must be attributed so that they are
p.000181: accurate and indisputable. Therefore, possible failures due to the fact that “nature choos-
p.000181:
p.000181:
p.000182: 182
p.000182:
p.000182: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000182: REPORT
p.000182:
p.000182: es otherwise” and not because of poor execution of the research protocol, cannot be assessed in advance. It is worth
p.000182: noting that the financial commit- ments of research do not mean that possible negative results must be defi- nitely
p.000182: avoided, but they mean that the negative results cannot burden the cost. Furthermore, funding a research with negative
p.000182: results, although it can prove to be scientifically useful, it is financially unprofitable.
p.000182: The financial commitments, especially in clinical research, would not be of such an importance, if the basic funding
p.000182: resource was not the industry. It must be highlighted that research on new drugs (conventional or -even more-
p.000182: biotechnology products) requires a particularly high investment and also involves a high risk of failure.
p.000182: Under these circumstances, the private sector is nearly the only choice -if one exempts public resources
p.000182: from the
p.000182: E.U. or international organizations- as it can undertake the cost and risk. Respectively, nevertheless, it
p.000182: imposes financial commitments on the free- dom of research, which will guarantee reciprocation from the
p.000182: market, i.e. profit from the production and distribution of the final product.
p.000182: The commercial pursuits of industry, through its involvement in clinical research, are not ethically indifferent.
p.000182: Financial freedom in a democratic society is also of moral value, as it creates decisive motives for the satisfac-
p.000182: tion of needs, basic or not. This element cannot be set aside in our argu- mentation, i.e. the pursuit of
p.000182: profit from the production and distribution of innovative products cannot be considered by definition “suspicious” for
...

p.000185: study, in our case, provided that they are ignored e.g. for reasons of “accelerating” the process, in order to come up
p.000185: directly with commercially exploitable results. Thus, if there is pressure to
p.000185:
p.000185:
p.000185: 40 It is worth mentioning that explicit reference in the issue of conflict of interests is made by our legislation
p.000185: concerning the inspectors of clinical studies (art. 21 par. 7 Medical Directorate 3a/79602/2007), as well as
p.000185: the members of the National Ethics Committee (art. 3 Medical Directorate 3a69150/2004).
p.000185: 41 It is, on the other hand, connected to the physician’s disciplinary liability.
p.000185:
p.000186: 186
p.000186:
p.000186: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000186: REPORT
p.000186:
p.000186: deviate from the terms of a patient’s valid consent, the doctor’s relevant liability arises (criminal
p.000186: -depending on the case-, civil and disciplinary).
p.000186: In conclusion, the current legislation “shields” the physician’s
p.000186: /researcher’s scientific independence with liability provisions, in the sense that they can be raised
p.000186: against possible pressure from the sponsor’s part. Vice versa, the law does not justify a physician’s own
p.000186: spontaneous disregard of the rules of science and ethics in favor of financial purposes, when the later
p.000186: can result in harming the patient’s interests. In this case, there is medi- cal error, an intentional one, either due
p.000186: to a poor choice or practice of the medical action in question (according to rules of science) or due to a defi- ance
p.000186: of some rule of ethics (e.g. providing information to the patient).
p.000186:
p.000186: c. The sponsor’s liability
p.000186: Another interesting side for legislation is the liability of the sponsor, as a commercial enterprise. The general
p.000186: context is defined by the legislation concerning the liability of providers of goods and services and the consum-
p.000186: ers’ protection42.
p.000186: Based on the relevant regulations, a business trading new products in the market -as for example a
p.000186: pharmaceutical industry launching a new pharmaceutical product- is responsible for the product’s quality (i.e.
p.000186: wheth- er it responds to the need it is meant to satisfy), as well as for informing the consumer (in this case, the
p.000186: patients) adequately about the efficacy (in this case, the therapeutic factors) and the safety (in this case, the
p.000186: possible side effects of a drug). In case a business launches defective products -e.g. drugs based on misleading
p.000186: results of clinical studies or new drugs with significant differences than the established ones, also based on
p.000186: unreliable clinical trials, it can be compelled to compensate, apart from possible administrative pen- alties (fines,
p.000186: license removal).
p.000186: Therefore, from this point of view, the law opts in favor of searching for scientifically valid results in clinical
p.000186: research, independently from purely financial purposes. Indeed, it is interesting that the above mentioned legisla-
p.000186: tion concerns providers of all kinds of products and services towards the public, as consumers in general.
...

General/Other / Dependent

Searching for indicator dependent:

(return to top)
p.000198: erroneously and commonly presented.
p.000198: In regard to prenatal genetic tests, the Commission reiterates its position that they must not be performed for eugenic
p.000198: purposes. It notes the danger especially in the case of DTC genetic tests, where genetic counseling is ab- sent.
p.000198:
p.000198:
p.000199: 199
p.000199:
p.000199: DIRECT-TO-CONSUMER GENETIC TESTING
p.000199: OPINION
p.000199:
p.000199: Finally, the Commission considers that genetic tests revealing a person’s identity definitely presuppose consent from
p.000199: all the involved parties. Other- wise such genetic tests require a relevant judicial licensing.
p.000199:
p.000199: 2. Special issues
p.000199:
p.000199: In the context of the above mentioned general principles, the Commis- sion notes:
p.000199: A. It is recommended that DTC genetic tests for health reasons or prena- tal diagnosis must be performed following a
p.000199: suitable prescription by a liable expert physician, clinical geneticist or biologist-geneticist. The expert
p.000199: will assess the purpose of the test and will interpret the results, in order to avoid unnecessary genetic testing
p.000199: and inappropriate assessment. It is important that the consumer has the option to choose the expert. Impersonal,
p.000199: auto- mated counseling methods are discordant with the relationship of trust, which must govern health
p.000199: services.
p.000199: Exceptionally, DTC genetic testing which aims to improve dietary habits or other lifestyle factors (occupation,
p.000199: exercise etc.), or to define an individu- al’s ancestry, may not be dependent on such strict rules.
p.000199: B. In order to protect genetic information and respect a child’s right to ignorance, considering that children are
p.000199: unable to decide whether they wish to know the results of a genetic test predicting a disease, DTC genetic test- ing is
p.000199: not justified in asymptomatic children for whom there is no medical emergency, especially for late onset diseases such
p.000199: as Huntington’s disease. Even in the case where an expert decides that such a test is necessary for the parent(s),
p.000199: the same genetic test must be delayed for the child until he/she is able to participate in the decision
p.000199: making process, since there is no direct value to his/her health. On the contrary, DTC genetic testing is
p.000199: ac- ceptable in cases of children with first or second degree relatives with a monogenic disorder,
p.000199: showing a clear mode of inheritance e.g. familial hy- percholesterolemia. Nonetheless, such genetic tests must
p.000199: be allowed only in the case that the results will be used for early treatment and/or prevention of the complications
p.000199: caused by the disease.
p.000199:
p.000199:
p.000199:
p.000199:
p.000200: 200
p.000200:
p.000200: DIRECT-TO-CONSUMER GENETIC TESTING
p.000200: OPINION
p.000200:
...

General/Other / Developing Country

Searching for indicator third world:

(return to top)
p.000055: state, therefore, seems to dismiss its own responsibilities when it “withdraws” from the active support of
p.000055: research and invokes the interests of the market leaving the efficiency of research to be determined according to free
p.000055: market criteria. For these criteria operate unilaterally and, certainly, do not respect the value of research for
p.000055: society and for the individual, as explained above.
p.000055:
p.000055: Research in the biological sciences
p.000055:
p.000055: These general remarks are all the more relevant in the case of research in the biological sciences which is our focus.
p.000055: Certain particularities need to be stressed at this point.
p.000055:
p.000055: a) Freedom and funding of research
p.000055: The funding of research in biomedicine and biotechnology is a high risk investment because usually it requires large
p.000055: funds with a high possibility of failure. This exacerbates the difficulty of public financing especially with re- gards
p.000055: to basic research. Applied research takes an important precedence because it promises immediate returns.
p.000055:
p.000055: b) Direct impact on society
p.000055: Biological research either in human subjects or in other species has a direct impact on society because it
p.000055: is connected with sensitive values to a degree unfamiliar in other fields. The strategic orientation of
p.000055: international
p.000055:
p.000055:
p.000056: 56
p.000056:
p.000056: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000056: REPORT
p.000056:
p.000056: research is often criticized, for example, for excluding research that would be useful to the Third World or research
p.000056: in rare diseases.
p.000056: Research in human subjects (mainly clinical trials for medicines and oth- er means of treatment, research in
p.000056: embryos or in biological material) en- dangers fundamental rights (privacy, personal data, health) and
p.000056: general principles (human value, equality). Research in other species (e.g. biotech- nology) is connected with
p.000056: environmental protection, public health, even the respect we owe to these species (e.g. lab animals, rare species).
p.000056: When such interests are put at risk it becomes all the more indispensa- ble to ensure credibility and to comply with
p.000056: research ethics in both the aims and the methods used.
p.000056:
p.000056: Issues of ethics in biological research
p.000056:
p.000056: As mentioned above, the basic criteria of assessment of biological re- search are publications,
p.000056: co-operation between scientists and scientific teams and adequate funding. The urge to publish and to raise
p.000056: funds, in par- ticular, has occasionally led to misconduct and fraud. In addition, the use of research findings in
p.000056: policy-making is a source of pressure on researchers from sponsors or other players with vested interests.
p.000056: The publication of research findings is necessary to diffuse knowledge. However, the pressure exerted on
p.000056: researchers for more and more publica- tions in highly respected journals can lead to unethical misconduct that has
p.000056: gone as far as fabricating the results. A recent case of fraud that hit the headlines was a publication
...

p.000083: health, clothing, housing, etc.). It is cur- rently considered as threatened because of environmental pollution,
p.000083: urban expansion, the destruction of the habitats of certain species, and the intro- duction of alien plant or
p.000083: animal species in particular areas leading to the gradual extinction of local species5.
p.000083: It is precisely as a “wealth” of biological resources that biodiversity is seen as worthy of protection
p.000083: other than a mere fact of nature. Our culture values the conservation of current species although we know that
p.000083: in the history of our planet the content of biodiversity has been constantly chang- ing, namely that millions of
p.000083: species have disappeared or appeared -and con- tinue to disappear or appear. This is natural -an inherent
p.000083: characteristic of life and the result of changing environmental conditions- but we are aware that the action of one
p.000083: species in particular -the human species- can become critical (Markl: 38, 40). In this sense, the state of biodiversity
p.000083: inevitably de- pends on our own decisions and activities, economic, political, social, etc., and so the discussion
p.000083: about its value becomes meaningful.
p.000083: Care to maintain the wealth of biological resources is also part of sus- tainable development. Certain
p.000083: questions arise in this respect too.
p.000083: Given the other dimensions of sustainable development that may be incompatible with the conservation of
p.000083: certain species for economic (exces- sive cost for wild animal infrastructure, etc.) or social reasons (the develop-
p.000083: ment of third world countries requiring large-scale interventions in the envi- ronment, the preservation of
p.000083: traditional professions, etc.), are there limits to the preservation of biodiversity? In the same vein, can we
p.000083: envisage some kind of hierarchy in the value of species, and with which criteria?
p.000083: Given the rapid development of biotechnology, do we have unlimited freedom in changing the content of
p.000083: biodiversity by introducing new species (even wholly “unpredictable” ones using genetic engineering methods)? Are
p.000083:
p.000083:
p.000083: 5 The free circulation of genetically modified organisms (e.g. fish) has, in some cases, had the same effect.
p.000083:
p.000084: 84
p.000084:
p.000084: MANAGEMENT OF BIOLOGICAL WEALTH
p.000084: REPORT
p.000084:
p.000084: we allowed to do so even at the risk of extinction of other, naturally occur- ring species as a result of their contact
p.000084: with the new ones?
p.000084: These questions can be answered in many ways but it is worth pointing out that the value of biodiversity is seen in
p.000084: relation to our needs. Thus, bio- diversity appears to be a rather relative and not an absolute value, as might be
p.000084: argued by those who deny the “anthropocentric” approach and advocate the extension of the notion of moral subjects to
p.000084: beings other than humans.
p.000084:
p.000084: The rights of “future generations”
p.000084:
p.000084: The third consideration we are concerned with regards the so-called “rights of future generations”. The term
p.000084: underlines our responsibility vis-à- vis coming generations and binds us with the powerful notion of
p.000084: “rights”. People (or populations) that do not yet exist are thus recognized as “sub- jects of rights”. For
...

General/Other / Impaired Autonomy

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p.000003: The reader will have the chance to find that the 286 pages of the current edition include 9 issues of high interest,
p.000003: which concern the modern society.
p.000003: The current edition was edited by Dr. Vasiliki Mollaki, whom we thank.
p.000003:
p.000003:
p.000003: The President Ioannis D. Papadimitriou Emeritus Professor of Medicine
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p.000004: CONTENTS
p.000004: USE OF GENETIC DATA IN PRIVATE INSURANCE 7
p.000004: Opinion
p.000009: 9
p.000009: Report
p.000015: 15
p.000015: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES 39
p.000015: Opinion
p.000041: 41
p.000041: Report
p.000047: 47
p.000047: MANAGEMENT OF BIOLOGICAL WEALTH 65
p.000047: Opinion
p.000067: 67
p.000067: Report
p.000075: 75
p.000075: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN 103
p.000075: Opinion
p.000105: 105
p.000105: Report
p.000113: 113
p.000113: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND
p.000113: AUTONOMY
p.000137: 137
p.000137: Opinion
p.000139: 139
p.000139: Report
p.000145: 145
p.000145: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH 157
p.000145: Opinion
p.000159: 159
p.000159: Report
p.000165: 165
p.000165: DIRECT-TO-CONSUMER GENETIC TESTING 193
p.000165: Opinion
p.000195: 195
p.000195: Report
p.000203: 203
p.000203: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT 221
p.000203: Opinion
p.000223: 223
p.000223: Report
p.000233: 233
p.000233: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE AND MENTAL STATE 267
p.000233: Opinion
p.000269: 269
p.000269: Report
p.000273: 273
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p.000041: met by private funds on an international scale, and, b) they have direct implica- tions on fundamental principles
p.000041: (protection of human value, the environ- ment, health, privacy).
p.000041: Situations that are seen at times, such as the exclusion of useful research for rare diseases or diseases that
p.000041: affect mainly the Third World, conceal- ment of negative findings, “fabrication” of results likeable to
p.000041: sponsors, demonstrate the absolute need to safeguard the independence of research, especially biological research.
p.000041:
p.000041: C. Research as a public good - Safeguarding its independence
p.000041:
p.000041: In the Commission’s view scientific research constitutes a public good because it promotes the understanding
p.000041: of the surrounding world and con- tributes to the “well-being” of society as a whole. At the same time, howev- er, it
p.000041: is also a fundamental right, an indispensable component of freedom for the person performing research. These
p.000041: two dimensions are inextricably linked.
p.000041: Based on the above, the Commission concludes that there are mainly two safeguards for the independence of
p.000041: research:
p.000041:
p.000041:
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p.000042:
p.000042: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000042: OPINION
p.000042:
p.000042: 1. The self-regulation of research ethics by the community of scientists, since researchers are the first ones who have
p.000042: an interest in protecting the credibility of their work. “Outside” regulation must take into account this
p.000042: margin of autonomy in order to avoid bureaucracy.
p.000042: 2. The State must provide adequate public funding for independent re- search so that not every research initiative is
p.000042: necessarily linked to opportun- istic economic priorities, which often operates not to the benefit of but at the cost
p.000042: of innovation.
p.000042: These safeguards need to be adopted with specific initiatives.
p.000042:
p.000042: II. Proposals
p.000042:
p.000042: Based on the above, and in view of the new national legal framework for research, the Commission suggests the
p.000042: following:
p.000042:
p.000042: To the administration
p.000042:
p.000042: a) To lay down specific rules to safeguard research ethics in publicly fi- nanced research projects.
p.000042: These rules must oblige the scientist awarded the research grant to veri- fy the accuracy of and to publish all the
p.000042: results, to report the actual contri- bution of each researcher (in related publications in scientific
p.000042: journals, in papers presented in conferences and in the activity reports of research insti- tutions) and to control
p.000042: compliance with ethical principles.
p.000042: b) To support basic research in the allocation of national grants by the responsible bodies.
p.000042:
p.000042: To the academic research community
p.000042:
p.000042: a) Research institutions of biological sciences should compile a code of research ethics. Basic issues to be
p.000042: dealt with by such a code (which must also provide for disciplinary sanctions) must include, by way of
p.000042: indication, fabrication of results, plagiarism, violation of ethical principles (e.g. inde- pendence,
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p.000104: O P I N I O N
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p.000104: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000104:
p.000104: The National Bioethics Commission considered the scope of personal autonomy in the provision of medical care in
p.000104: repeated meetings. The issue arises in regard to all medical acts either preventive or therapeutic. Fur-
p.000104: thermore, it lies at the heart of a contemporary reflection in bioethics as the model of the so-called “paternalistic”
p.000104: medicine tends to be replaced world- wide by the model of “informed consent”.
p.000104: Having considered the modified approach to the relationship patient- physician brought about by this change and
p.000104: conscious of the wide scope of autonomy, the Commission thought it appropriate to highlight a number of typical
p.000104: problems and suggest solutions to address them.
p.000104:
p.000104: I. In general
p.000104:
p.000104: A. Paternalism and autonomy in medicine
p.000104:
p.000104: The ethics governing the relationship patient-physician has been going through a change of model since the
p.000104: second half of the XX Century. Histori- cally, this relationship was defined by the dominant position of the physician
p.000104: as the only one responsible to appraise the situation and to decide on the course of treatment. Patients were merely
p.000104: able to select the treating physi- cian; as for the rest, they had to rely on the latter’s knowledge and
p.000104: skills without any say in therapy. This absolute dominion of physicians did not imply any form of
p.000104: arbitrariness on their part since they pledged themselves through the Hippocratic Oath to act in the best interests of
p.000104: patients.
p.000104: Following the end of World War II -and spurred by the dismal experience of the experiments performed on the prisoners
p.000104: of the Nazi regime among others- this model of medical “self-commitment” was seriously questioned. It was realized
p.000104: that self-commitment on the part of physicians does not en- sure the protection of patients. It became obvious that the
p.000104: participation of patients themselves in the course of treatment as active agents at all stages is the best safeguard
p.000104: for their well-being.
p.000104:
p.000104:
p.000105: 105
p.000105:
p.000105: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000105: OPINION
p.000105:
p.000105: But first and foremost, the development of medicine itself has made the active involvement of patients a practical
...

p.000105: incorporating “informed consent” in all medical acts. In addition to the Convention, express provisions in
p.000105: Greece have been included both in the Code of Medical Ethics (CME, Law 3418/2005) and in
p.000105: special legislation (assisted reproduction, transplants, etc.).
p.000105:
p.000105:
p.000106: 106
p.000106:
p.000106: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000106: OPINION
p.000106:
p.000106: Both the Oviedo Convention and the CME provide for the event of in- competence to consent (in which
p.000106: case consent is given by relatives after prior information) whereas they hold that consent does not apply in
p.000106: emer- gency situations. However, the example of the CME stipulating that: “In the exercise of medicine, physicians act
p.000106: with total freedom within the generally accepted rules and methods of medical science… They may choose the
p.000106: method of treatment which in their view is significantly better against all others for the particular
p.000106: patient based on modern rules of medical sci- ence…”1, demonstrates that the traditional model of the
p.000106: relationship pa- tient-physician has not been fully abandoned in Greece as it has in other jurisdictions.
p.000106:
p.000106: II. Problems in the implementation of autonomy and related proposals
p.000106:
p.000106: A. The problem in general
p.000106:
p.000106: Although the need for active involvement by patients in determining treatment is now widely acknowledged, it
p.000106: is often defeated in medical prac- tice. The main reasons for this failure are the following:
p.000106: - Limited time for communication between physician-patient,
p.000106: - lack of clarity on the appropriate extent of information,
p.000106: - deficient training of physicians on the relationships they need to de- velop with patients, and,
p.000106: - occasionally, lack of familiarization of the general public with the rights and possibilities of every user of
p.000106: health services to cooperate with phy- sicians in order to reach the result best suited for the patient’s way of
p.000106: living.
p.000106:
p.000106: a) Time
p.000106: Scarcity of time is, at first sight, a purely practical matter arising mostly in first aid and emergency situations.
p.000106: The Commission thinks that, even in these circumstances, understanding the needs of patients and exercise of autonomy
p.000106: should be considered as an integral part of medical acts so that the allocation of the available time -
p.000106:
p.000106:
p.000106: 1 Art. 3 (3).
p.000106:
p.000107: 107
p.000107:
p.000107: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000107: OPINION
p.000107:
p.000107: even if limited- can be adjusted accordingly insofar as full communication with the patient is possible.
p.000107:
p.000107: b) Extent of information
p.000107: Pursuant to the CME “the physician has a duty of truth to the patient”2. But the patient has the right to refuse
p.000107: information (right to ignorance) and ask the physician to inform exclusively one or more other persons to be indi-
p.000107: cated by the patient3.
p.000107: But the extent of information that qualifies as appropriate to enable the patient to decide freely remains unclear. As
p.000107: the available empirical data in- dicates4, the majority of patients in our country apparently want more ex- tensive
p.000107: and more sincere information compared to what some physicians currently provide or believe they have to
p.000107: provide.
p.000107: The Commission points out that:
p.000107: i) Unless the right to ignorance is invoked, the physician must provide all those elements that will enable the
p.000107: patient to form a full and, mainly, an intelligible picture of the situation so that he/she may be assisted in
p.000107: making a decision. Elementary information alone will not do. In any event, the in- formation must be appropriate and
p.000107: graduated according to the mental con- dition of the patient. Given that the “appropriateness” of information
p.000107: is necessarily associated with the peculiarities of each patient, dialogue be- tween patient and physician is
p.000107: indispensable.
p.000107: ii) The information must not be “neutral”. A mere description by the physician of the expected benefits
p.000107: and likely risks from treatment is not enough. An essential part of the information consists in an ad hoc
p.000107: evaluation of benefits/risks based on the particular patient. But this evaluation may not anticipate the final decision
p.000107: manipulating the will of the patient.
p.000107: iii) It is usual practice to conceal information from patients and disclose it to relatives either because the
p.000107: treating physician is afraid the information may disturb the patient’s psychological balance during therapy or
p.000107: because relatives request it. However, if the patient is capable to consent, this prac- tice disrupts the fundamental
p.000107: connection between information and consent and may cause confusion. This is not to underestimate the need of coopera-
p.000107:
p.000107: 2 See art. 11 (1) (a).
p.000107: 3 See art. 11(2).
p.000107: 4 For a summary of this data, see the accompanying report.
p.000107:
p.000108: 108
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p.000108: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000108: OPINION
p.000108:
p.000108: tion between physicians and families, especially in order to understand the personality and needs of patients.
p.000108:
p.000108: c) Training for physicians
p.000108: Appropriate training on the importance of autonomy for physicians and other health care professionals is a crucial
p.000108: problem.
p.000108: The procedure of consent is often viewed by physicians as a piece of bureaucracy leading them to treat
p.000108: it as a mere formality. Contrary to this practice, consent is not to be considered as a safeguard for the
p.000108: protection of physicians but as a token of respect for the patient’s autonomy. However, even when physicians are
p.000108: conscious of the need to respect patient autono- my they feel uncertain on how they should act since perceptions of
p.000108: auton- omy vary from patient to patient and from physician to physician.
p.000108: Developing relationships of cooperation and trust with patients requires appropriate education for physicians. The aim
p.000108: is not some “formal” accom- modation of the patients’ rights but to obtain the best outcome in dealing with health
p.000108: problems taking into account the values and overall way of living of patients. Seen in this light, the
p.000108: participation of patients in their treat- ment, far from being an impediment, helps to reach the best possible
p.000108: medi- cal outcome.
p.000108: In view of the above the Commission thinks that emphasis needs to be placed on ethics and its implementation in
p.000108: clinical practice both in university education and in ongoing training for physicians. Equally important is
p.000108: to ensure meaningful education in communication with patients for physicians of all specialties focusing on the
p.000108: benefits of honesty. Lifelong training of physicians on the subject-matter is also required (a relevant duty is
p.000108: stipulat- ed by the CME). Hospital boards of ethics, scientific societies and medical associations must
p.000108: arise to the task and take the initiative.
p.000108:
p.000108: d) Education and information for citizens
p.000108: The above demonstrate a need for appropriate citizen education aiming at the optimal application of the new model.
p.000108: Patients who are suitably in- formed “ahead of time” are more likely to cooperate actively, assisting phy- sicians in
p.000108: their work and enhancing the efficacy of treatment.
p.000108: Citizen education can be promoted through elementary education, in- formation campaigns by local authorities,
p.000108: local associations, regional hospi-
p.000108:
p.000108:
p.000109: 109
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p.000109: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000109: OPINION
p.000109:
p.000109: tals and volunteer organizations. Educational programs from the media un- der the hospices of the Ministries for Health
p.000109: and Education could also be of assistance.
p.000109:
p.000109: B. Particular problems
p.000109:
p.000109: a) Power to consent and limits of autonomy
p.000109: The Commission believes that when patients who are capable to consent are committed to hospital they should appoint a
p.000109: representative in writing, if possible.
p.000109: In case of patients incapable to consent who have not appointed a rep- resentative, the Commission thinks that:
p.000109: i) The legal representatives of the patient may select one of alternative treatment methods but may not refuse all
p.000109: treatments if the treating physi- cian believes that the continuation of therapy is beneficial. Only patients
p.000109: who are capable for self-consent may refuse treatment.
p.000109: ii) In case of disagreement between the legal representatives the treat- ing physician should be able to decide taking
p.000109: into account the opinion of the hospital board of ethics which must be made mandatory in our country.
p.000109: iii) The physician must take into consideration any prior directions by the patient (id est, any wishes the patient
p.000109: expressed prior to becoming incapa- ble to consent).
p.000109: iv) The opinion of mentally mature minors on issues regarding their health must be taken into account in
p.000109: order to comply with the constitutional protection of personality.
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p.000111: Christos Voulgaris, Emeritus Professor of Theology, University of Athens.
p.000111:
p.000111: PERSONNEL
p.000111:
p.000111: Scientific Officers:
p.000111: Takis Vidalis, Lawyer, PhD in Law.
p.000111: Ariadne L. Hager-Theodoridou, Agronomist, PhD in Genetics.
p.000111:
p.000111: Secretariat:
p.000111: Marianna Drakopoulou, Lawyer, Head of Secretariat.
p.000111:
p.000111:
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p.000112: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000112: REPORT
p.000112:
p.000112: R E P O R T
p.000112:
p.000112: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000112:
p.000112:
p.000112: Rapporteurs: T. Vidalis, A. Hager-Theodoridou In collaboration with: G. Maniatis, A. Papachristou
p.000112:
p.000112:
p.000112: A. INTRODUCTION: NEW DEVELOPMENTS IN MEDICAL PRACTICE
p.000112:
p.000112: Until recently the physician-patient relationship was governed by a “pa- ternalistic” model developed as a product
p.000112: of Hippocrates’ ethics subse- quently interpreted or modified by a succession of physicians-philosophers like
p.000112: Galen, in combination with the prevailing social conditions. According to this model, the physician decides on all
p.000112: matters pertaining to the patient’s treatment while the latter has little or no say in it at all1. The contemporary
p.000112: conditions of medical practice exhibit new qualities suggesting a need for a new model, different from the one which
p.000112: prevailed over the world until the ’50s and the ’60s.
p.000112: Unlike the paternalistic model, the new one, which appears to find favor particularly with Anglo-Saxon and north
p.000112: European countries, emphasizes patient’s autonomy. In the context of this model, the relationship physician- patient
p.000112: is one of cooperation with either party having more or less equal say on the making of decisions. The new
p.000112: characteristics of medical practice and
p.000112:
p.000112:
p.000112: 1Although the so-called “paternalistic” model of the relationship patient-physician is attributed to Hippocrates or to
p.000112: his followers, in the extant Hippocratic texts the au- thor considers as a virtue of the physician that “he makes sure
p.000112: to foresee and foretell to the sick their present condition, what preceded it and what will happen in the fu- ture”.
p.000112: He considers also that “any irrational thing that happens needs to be dis- cussed” (Rigatos, 1997) while he
p.000112: argues that when the physician analyses the present condition of the patient and what he foretells for the future in
p.000112: the presence of the patient the latter will find it easier to believe that the physician is well acquainted
p.000112: with the situation and will have more confidence in him (Hippocrates, Prognostics, introduction to the
p.000112: text).
p.000112:
p.000113: 113
p.000113:
p.000113: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000113: REPORT
p.000113:
p.000113: the conditions in which it operates which affect the relationship physician- patient can be summarized as follows:
p.000113: 1. Medicine is divided into several specialties and one physician alone is no longer able to treat all the health
p.000113: problems of an individual.
p.000113: 2. The physicians of different specialties as involved to consult in the course of his/her life will
p.000113: not necessarily work together; therefore, the patient is the only one with a complete picture of his/her medical
p.000113: history. It should be noted also that in Greece, records of medical his- tory are not kept for each patient.
p.000113: 3. Medicine has progressed in such a way that there is no single indicat- ed treatment for each particular condition.
p.000113: 4. The level of education in our country has been improved in recent decades. As a result, most patients
p.000113: are able to understand the medi- cal facts of their condition and are seeking more detailed infor- mation.
p.000113: Furthermore, the lay public enjoys greater, if fragmentary, access to medical information from a variety of
p.000113: sources.
p.000113: 5. People do not trust the motives of physicians unreservedly. This is mainly because the practice of
p.000113: medicine is sometimes known to be influenced by varying interests not necessarily compatible with the patient’s
p.000113: interests.
p.000113: 6. Citizens demand more from the health system as regards the quality of services, the medical outcome and the
p.000113: conditions in which these services are provided. The provision of high quality services is consid- ered by citizens as
p.000113: an utmost priority in our country.
p.000113: 7. It is now acknowledged that the way of living and the religious or other philosophical beliefs of
p.000113: patients must be taken into considera- tion when determining treatment. There is an increasing awareness of the right
p.000113: to autonomy and of respect for dignity in medicine.
p.000113:
p.000113: B. LEGAL ISSUES
p.000113:
p.000113: In general
p.000113:
p.000113: The “Code of Medical Ethics” (CME, Law 3418/2005) has put in place a modern legal framework for the relationship
p.000113: physician-patient in Greek
p.000113:
p.000113:
p.000113:
p.000114: 114
p.000114:
p.000114: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000114: REPORT
p.000114:
p.000114: law2. The main characteristic of this law is the explicit introduction of “in- formed consent” albeit
p.000114: maintaining provisions which reflect the former “pa- ternalistic” approach.
p.000114: It must be noted that “informed consent” was already embedded in Greek law, first, through the
p.000114: ratification of the Oviedo Convention on Hu- man Rights and Biomedicine (art. 5 et seq. Law 2619/1998) and,
p.000114: second, by way of express provisions in a number of laws on various medical fields3. Naturally, the
p.000114: relevant rules of the CME are more detailed. Pursuant to the CME:
p.000114: - Informed consent is always required except in case of: a) emergen- cies, b) suicide attempts, and c) refusal to
p.000114: consent by the guardian of a person incapable to consent in a life- or health-threatening situa- tion.
...

p.000117: of personality (Constitu-
p.000117: tion, art. 5 [1]).
p.000117:
p.000117:
p.000118: 118
p.000118:
p.000118: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000118: REPORT
p.000118:
p.000118: c) Medical liability and other legal consequences
p.000118:
p.000118: In legal terms, the answers to all the above questions have an impact, first and foremost, on the extent of
p.000118: medical liability (criminal, civil and pro- fessional). Liability, in this case, is not connected with fault in the
p.000118: execution of a medical act (which is judged according to lege artis execution) but with fault at the stage preceding
p.000118: the act, i.e. during the legal procedure of deci- sion-making7.
p.000118: Thus the implementation of the Oviedo Convention and the CME provi- sions on “informed consent” (and of the provisions
p.000118: of special legislation on transplants, assisted reproduction, etc.) complement the general legislation on medical
p.000118: liability (e.g. arts. 57, 914 CC, art. 8 Law 2251/1994) and may provide grounds for particular claims in
p.000118: action8.
p.000118: Secondly, the answers may have an impact on the legal situation of third parties (hospitals, relatives) insofar as
p.000118: compliance with the principle of con- sent is associated with individual rights and obligations pertaining to them.
p.000118:
p.000118: C. SPECIAL PROBLEMS IN THE IMPLEMENTATION OF AUTONOMY WITH EMPHASIS ON THE GREEK SITUATION
p.000118:
p.000118: The model of patient consent is based on the assumption of appropriate education on personal autonomy, on the one hand,
p.000118: and on the allocation of relatively adequate time for a sober evaluation of information, on the other. These
p.000118: assumptions rarely permit the application of the model in its pure form. As a matter of fact, special
p.000118: circumstances call for adjustments. There- fore, certain areas of medical practice must be considered separately.
p.000118:
p.000118:
p.000118:
p.000118:
p.000118: 7 This broad concept of fault is upheld today in Germany, France and the US, see Fountedakis (2003) p.
p.000118: 210-211 who accepts the distinction between “medical error” and “information error” (p. 216).
p.000118: 8 The preferred criterion for the assessment of prior information in the context of medical liability is
p.000118: the “average rational person”, see Androulidakis-Dimitriades (1993) p. 273. Typical in the case-law is the case
p.000118: Canterbury v. Spence. (464 F.2d 772 [D.C. Cir. 1972]) which changed the initial approach of American tribunals.
p.000118:
p.000119: 119
p.000119:
p.000119: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000119: REPORT
p.000119:
p.000119: 1. Extent of information
p.000119:
p.000119: As mentioned earlier, our national legislation (CME) requires informed consent prior to every medical act
p.000119: unless patients refuse the information by exercising their right not to know. But patient information is not limited to
p.000119: those cases where patients need to consent to a medical act. It also includes the patient’s right to know the
p.000119: state of his/her condition to the extent he/she so wishes. This knowledge will eventually help patients to make
...

p.000123: demand.
p.000123: It is worth noting that, in the first case, it is generally admitted -and ex- pressly stipulated by the law- that
p.000123: physicians may act alone, namely “in- formed consent” does not apply. The notion of “emergency” is very broad and
p.000123: needs to be further specified. Assuming that its use must be regarded as exceptional, its scope is limited to: i)
p.000123: cases posing an immediate threat against the patient’s life, or, ii) cases where even the slightest delay in
p.000123: ef- fecting the indicated medical act will definitely cause serious harm to health. Thus, moderate harm to health, even
p.000123: when demanding immediate action, or serious but chronic pathological conditions (e.g. many forms of cancer, dia- betes,
p.000123: etc.) cannot qualify as “emergencies”. In-between these two ex- tremes, there is an area in which the
p.000123: rule of consent must apply with the necessary adjustments to the available margins of time9.
p.000123: As far as inadequate organization of health services is concerned, the possibility to allocate the required
p.000123: time depends mostly on objective, often non-elastic, parameters (e.g. restricted resources to employ additional med-
p.000123: ical staff). Especially here, however, the issue of appropriate training and sensitization of civil health
p.000123: services to patient autonomy is crucial. For, if patient consent is not to be considered a “luxury” but an
p.000123: essential condition for the protection of health and, ultimately, for quality of life, then this re- quirement
p.000123: obviously affects the priorities of the organization of services in a way that makes finding the required time
p.000123: feasible.
p.000123:
p.000123: 3. Education - Training
p.000123:
p.000123: Among the reasons invoked by physicians to justify the concealment of diagnosis from their patients in Greece, as well
p.000123: as in other countries which
p.000123:
p.000123: 9 However, for a discussion on whether summary information provided to a patient capable to consent qualifies as
p.000123: “appropriate” in emergency circumstances see also Young, 2001.
p.000123:
p.000124: 124
p.000124:
p.000124: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000124: REPORT
p.000124:
p.000124: share the same practice, is the lack of training (Mystakidou 1996; Iconomou 2002).
p.000124: The question of deficient training of physicians in patient autonomy in Greece has at least two sides. The
p.000124: first concerns the knowledge of the rights of patients and the second the implementation of these rights and the ef-
p.000124: fective communication with patients. Typically, in the Medical School of the University of Athens, medical ethics
p.000124: remains an optional subject. The same deficit permeates all the national curricula in regard to learning how to ap-
p.000124: proach patients and develop meaningful relationships with them taking into account the whole spectrum of the patient’s
p.000124: needs and respecting his/her autonomy.
p.000124: The new model of the physician-patient relationship involves active par- ticipation on the part of the patient.
p.000124: Patients need appropriate education too, if they are to respond to this role. Therefore, education is an issue not
p.000124: only for physicians but for society as a whole.
p.000124:
p.000124: 4. Epidemiology: Vaccination
p.000124:
p.000124: In the prevention of infectious diseases, especially in the example of vac- cination, free will of the individual must
p.000124: be weighed against the interest of society as a whole. Should the Commission decide to consider the question of patient
p.000124: consent to vaccination the following observations may be of use.
p.000124: The success of mass vaccination is based on the greatest possible partic- ipation; in democratic societies,
p.000124: however, people may not be coerced to participate (Asveld, 2008). Here, the State, on the one hand, and the
p.000124: scien- tific community, on the other, while obliged to respect individual autonomy, are called upon to ensure the
p.000124: greatest possible participation, provided the benefits of vaccination and the safety of the vaccine have been
p.000124: foreseen and documented as far as possible. But individual citizens also bear a re- sponsibility to
p.000124: society, and their decision to participate or not in a vaccina- tion program cannot be based solely on the argument of
p.000124: autonomy. Individ- ual people themselves will probably not benefit directly from participating in a vaccination
p.000124: program, but they contribute to the protection of society and of vulnerable groups in particular.
p.000124: The importance of confidence in the safety of vaccines and the major role of the State and of the scientific
p.000124: community were recently illustrated in
p.000124:
p.000124:
p.000125: 125
p.000125:
p.000125: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000125: REPORT
p.000125:
p.000125: Great Britain in the MMR vaccine against measles, mumps and rubella. Be- fore the beginning of mass vaccination,
p.000125: measles cost Britain an average of 100 casualties annually. In 1988 the rate of participation in mass vaccination was
p.000125: 76%. The launching of the triple vaccine that year in replacement of the three separate ones increased the rate of
p.000125: participation to 91% until 1998. At that moment, however, fears began to spread about side-effects; autism in
p.000125: particular. Although the vaccine had been tested for many years and there was no data commonly accepted by the
p.000125: scientific community suggesting any side effects, certain studies published by a medical researcher undermined the
p.000125: confidence of parents and participation in the vaccination program dwindled significantly after 1998. The study
p.000125: which supported the allegations of some parents about side effects proved fallacious; in fact, it contained
p.000125: fabricated data. The slump in participation rates, however, led to the loss of the so-called indirect or herd
p.000125: immunity causing an important increase in measles cases before confidence in the vaccine was restored and broad
p.000125: par- ticipation resumed (Jansen et al., 2003).
p.000125: Whereas in case of tested vaccines, the decision to abstain is not ethical- ly neutral, the example of new and
p.000125: insufficiently tested vaccines is different. The experience of mass vaccination against swine influenza in the
p.000125: US in 1976 illustrates the risks inherent in a reckless decision for extended vac- cination based on
p.000125: unfounded, as it proved, fears of a pandemics, and with inadequately tested vaccines at that. While the influenza
p.000125: claimed only one victim, the side effects from the vaccine caused 25 casualties and may have led to permanent damage
p.000125: (it was associated with the auto-immune syn- drome of Guillain-Barré). Such examples justify the reluctance to
p.000125: participate and the ethical duty to society as a whole cannot remain as strong if weighed against an
p.000125: increased likelihood of unknown side-effects from the vaccine.
p.000125:
p.000125: 5. Patients in hospitals - The case of ICUs
p.000125:
p.000125: Implementing the model of consent in hospitals is met with certain limits to patient autonomy.
p.000125: First of all, the hospitalized patient is situated in a public environment which does not allow full freedom
p.000125: of movement, expression and communi- cation while drastically restricting privacy and family life. In these
p.000125: circum-
p.000125:
p.000125:
p.000126: 126
p.000126:
p.000126: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000126: REPORT
p.000126:
p.000126: stances, patients are particularly vulnerable. Especially in the ICU, these re- strictions are much more
p.000126: encroaching; moreover, patients are under psy- chological stress due to their critical condition. Taking into
p.000126: account that the potential for a sober appraisal of the situation by the patient -and in exten- sion, for a rational
p.000126: decision on the course of treatment- is significantly cur- tailed by the hospital environment, the role of the medical
p.000126: and nursing staff becomes even more decisive.
p.000126: Hospitalized patients, however, even patients in the ICU, are usually ca- pable to give an informed consent. This means
p.000126: that physicians remain fully liable for allowing patients to participate in the course of the particular
p.000126: treatment and may not legitimately act alone. In conditions of “internment”
p.000126: -especially in ICUs- the risks of manipulation of the patient’s will by the phy- sician are increased. Patients can be
p.000126: easily forced into accepting things for they are understandably eager to have their health restored as soon as pos-
p.000126: sible in order to return to the freedom of everyday life and recover the full exercise of their autonomy.
p.000126: At this point we must underline that physicians have a heightened ethi- cal duty to provide complete information.
p.000126: The more comprehensive the information, the greater the likelihood for an independent appraisal of the situation
p.000126: -and decision-making- by a de facto vulnerable will. By contrast, limited information can more easily lead to
p.000126: manipulation of the patient by the physician since the patient is called upon to evaluate and decide in an unfamiliar
p.000126: environment of internment, more prone to “blind obedience” rather than genuine exercise of autonomy.
p.000126:
p.000126: 6. Incapacity to consent
p.000126:
p.000126: The legal capacity to consent must be distinguished from the corre- sponding physical capacity. Patients
p.000126: with full legal competence to consent may suffer a temporary disorder of their mental functions which
p.000126: prevents the forming and expression of free will (e.g. under the influence of alcohol or narcotics or in state of
p.000126: shock because of an accident or the announce- ment of a serious disease, etc.)10.
p.000126:
p.000126:
p.000126: 10 This is a case for the application of art. 131 CC which stipulates the nullity of ex- pression of will in such
p.000126: circumstances. See generally on the problem of “irrational”
p.000126:
p.000127: 127
p.000127:
p.000127: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000127: REPORT
p.000127:
p.000127: In these circumstances acting alone is again not justified for physicians except in emergency situations. They must
p.000127: concentrate their efforts on the speedy recovery of the patient’s mental lucidity so that the patient can be informed
p.000127: in time and decide about treatment by himself/herself. Besides, it is not legitimate to substitute the patient’s
p.000127: relatives for the patient’s own will for patients may disagree with their relatives’ decision once their mental
p.000127: capacities are restored.
...

p.000127: usually addressed to close relatives or close friends, or even to the physi- cian, if one is already ill.
p.000127: They are usually informal (oral and eventually with no witnesses) but some countries have provided a modality to
p.000127: safeguard the validity of their will (“living wills”). Usually, these directions are about the refusal of
p.000127: certain unpleasant or painful treatments (e.g. haemodialysis, car-
p.000127:
p.000127: decisions by patients capable to consent and on the mental faculties, which are criti- cal for consent (Elliot, 2001).
p.000127:
p.000128: 128
p.000128:
p.000128: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000128: REPORT
p.000128:
p.000128: diopulmonary resuscitation)11 or even the interruption of artificial life sup- port (e.g. refusal of feeding,
p.000128: hydration, etc.)12.
p.000128: Bearing in mind the fact that the law in our country is ambiguous13 the question is what happens when a physician is
p.000128: aware of such directions and the legal representatives of the patient, who by law are responsible to give their
p.000128: consent, disagree.
p.000128: In ethical terms, it is certain that these directions must, in principle, be communicated to the patient’s relatives in
p.000128: the context of prior information to them. If they still disagree after that, again the physician may not wholly
p.000128: disregard the patient’s wishes. For insofar as there is a presumed authentic manifestation of the patient’s autonomy -
p.000128: even if expressed ahead of time - the “substitute” consent of the patient’s legal representatives appears weak.
p.000128: Indeed, the representatives in this case do not decide based on “what the patient would have wanted” (since he/she have
p.000128: already expressed their wishes) but based on what they believe is best for him/her or for anyone in their situation,
p.000128: something which is substantially far removed from respect- ing the principle of autonomy even if under different
p.000128: circumstances it might be the only choice.
p.000128: In legal terms, the physician may not challenge the power of the legal representatives to decide. But the
p.000128: physician has a moral duty to discuss the patient’s wishes with them in an effort to even out disagreements
p.000128: inde- pendently of his/her own view about therapy. Nevertheless, if the physician agrees with the patient’s directions,
p.000128: he/she may give up treating the patient and let another physician take charge14.
p.000128: It is worth noting that the above will remain effective even if special leg- islation is eventually enacted on the
p.000128: validity of advance directives which will
p.000128:
p.000128:
p.000128: 11 The so-called DNR Orders (“Do-Not-Resuscitate”) are an example. To comply with these orders is to commit passive
p.000128: euthanasia.
p.000128: 12 See Vidalis (2007), p. 113 et seq., for a discussion of the issue and relevant litera- ture.
p.000128: 13 Under art. 9 of the Oviedo Convention, the physician must take such wishes “into consideration”. However, there is
p.000128: no specific legislation on a typology of such wishes from which legal consequences may be inferred, especially as
p.000128: regards medical liabil- ity.
p.000128: 14 Cf. arts. 2(5), 9(4) CME which leave room for such an attitude on the part of a phy- sician.
p.000128:
p.000129: 129
p.000129:
p.000129: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000129: REPORT
p.000129:
p.000129: mean that “informal” directions will not generate legal effects for the physi- cian or for the legal representatives of
p.000129: the patient. And this because, apart from the fact that people may freely express their wishes on the
p.000129: future management of issues regarding their health at any time -i.e. without ob- serving some official
p.000129: “form”- it must be stressed that what is at issue here is not medical liability but the physician’s moral duty. Thus,
p.000129: even though phy- sicians will be legally bound to comply with “formally” manifested directions only, in ethical terms,
p.000129: they may not disregard any directions that were ex- pressed informally by the patient.
p.000129:
p.000129: 7. The health system
p.000129:
p.000129: The health system determines the quality of provided services and has a decisive impact on the model of relationship
p.000129: developed between the patient and the patient’s physician. The primary objective is the optimal use of hu- man
p.000129: resources and material assets to meet the needs of citizens whose con- tributions finance the system’s operation. The
p.000129: operation of the health sys- tem is not, at first sight, directly connected with consent in the relationship
p.000129: patient-physician. However, we will provide some information the Commis- sion might find useful in order to
p.000129: decide whether to consider issuing an opinion on the subject.
p.000129: In 2000, in the context of a worldwide evaluation of health systems, the World Health Organization (WHO) used
p.000129: “responsibility” as the basic bench- mark (World Health Organization, 2000; Hartzband and Groopman, 2009). This
p.000129: criterion encompasses respect for the dignity of persons and their fami- lies, and the protection of their
p.000129: autonomy when making decisions about their health. Thus, the WHO places patient autonomy and medical human- ism at
p.000129: the heart of health systems.
p.000129: Apart from customizing medical care according to the needs and prefer- ences of individual persons, another
p.000129: international trend in medical practice directly linked to the objectives of health systems is “evidence-based medi-
p.000129: cine” (Timmermans et al., 2005). Evidence-based medicine is the “conscien- tious, explicit and judicious use of current
p.000129: best evidence in making decisions about the care of individual patients” (Sackett et al., 1996). Implementing
p.000129: this type of medical practice requires active medical societies in all special- ties to assist physicians by developing
p.000129: specific guidelines.
p.000129:
p.000129:
p.000130: 130
p.000130:
p.000130: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000130: REPORT
p.000130:
p.000130: At first glance, evidence-based medicine does not seem to oppose a con- cept of medicine that places the individual at
p.000130: its core insofar as the guide- lines are meant to orientate decisions towards the best scientific treatment for a
p.000130: particular patient and a particular disease and not to impose specific treatments or restrictions. In some of the
p.000130: countries where evidence-based medicine is practiced, however, its operation seems sometimes to restrict
p.000130: medical practice since the guidelines are mandatory and, in some cases, physicians are not able to disregard
p.000130: them even when they believe it would be best for their patients.
p.000130: By contrast, no such guidelines or restrictions have been established in our country. This omission may lead to
p.000130: inadequate treatments in light of the latest scientific discoveries and, eventually, to a waste of resources.
p.000130: A fair and effective use of the specific and limited resources of health systems is a fundamental request of great
p.000130: urgency in our country. The foundations for an optimal implementation of evidence-based medicine while respecting indi-
p.000130: vidual autonomy may be laid by capitalizing on international experience and analysing the advantages and the
p.000130: problems observed in other health sys- tems.
p.000130:
p.000130: D. EPILOGUE
p.000130:
p.000130: Patient autonomy is a fundamental issue in bioethics. It was, in fact, in- strumental -beginning with the study of the
p.000130: ethics of clinical trials- for the development of bioethics as an independent subject-matter of Ethics. The
p.000130: aim of the present report was to give a summary account of how patient autonomy is ensured in medical
p.000130: practice today and to identify the main problems with its application emphasizing those more relevant to Greece.
p.000130: As demonstrated in the preceding chapters, the physician-patient rela- tionship is cardinal for safeguarding
p.000130: autonomy. In recent decades, this rela- tionship has been changing, passing from the traditional paternalistic model
p.000130: whereby the physician is primarily responsible to decide what best serves the patient’s interest and to act
p.000130: accordingly to a new model, the model of informed consent whereby the physician and the patient are called upon to
p.000130: engage together in the making of medical decisions.
p.000130: In medical practice, respect for autonomy aims at the best possible ap- plication of modern medicine but in a way that
p.000130: respects the patient’s needs
p.000130:
p.000130:
p.000131: 131
p.000131:
p.000131: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000131: REPORT
p.000131:
p.000131: and wishes. The complexity of modern medicine and, more often than not, the uncertain borders of “what” constitute
p.000131: treatment challenge the theory that the “doctor knows better” and create a need for new relationships re- quiring
p.000131: cooperation and participation by both “parties” in order to reach the best possible outcome.
p.000131: On the other hand, patient information is indispensable for developing such a relationship of cooperation
p.000131: between physician-patient; once again, however, the boundaries of appropriate information are often blurred. One of
p.000131: the major problems with implementing autonomy in medical practice is the divergence of opinion as implied by empirical
p.000131: data between physicians and patients on the extent of information. In their majority, the latter would rather have more
p.000131: information than the former provide.
p.000131: The most important causes -according to the view of the authors of the present report- for this divergence of
p.000131: opinion between physicians and pa- tients were identified and discussed in the previous chapters. Primary
p.000131: among them are the lack of appropriate training for physicians and the lack of time. It is important to look for
p.000131: practical solutions to implement respect for patient autonomy in practice not only as a value in itself but also as a
p.000131: safety valve for the efficiency of health services.
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000131:
p.000132: 132
p.000132:
p.000132: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000132: REPORT
p.000132:
p.000132: SUGGESTED LITERATURE
p.000132:
p.000132: Androulidaki-Demetriadi I (1993). The duty to inform the patient. A contri- bution to the assessment of civil
p.000132: medical liability. Eds. Sakkoulas, Athens- Komotini.
p.000132: Asveld L (2008). Mass-vaccination programmes and the value of respect for autonomy. Bioethics 22, 245-257.
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p.000132: Journal of the American Medical As- sociation 274, 820-825.
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p.000132: know of their illness. Medical Review of the Armed Forces 20, 9-315.
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p.000132: Fundamental concepts. Eds. Sakkoulas, Athens- Thessaloniki.
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p.000138: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000138: OPINION
p.000138:
p.000138: O P I N I O N
p.000138:
p.000138: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000138:
p.000138: The National Bioethics Commission considered, in repeated sessions, the issue of acceptable restrictions on
p.000138: personal autonomy to protect public health in the case of transmissible infectious diseases. This debate is a major
p.000138: concern of contemporary bioethics, which influences crucial decision- making when there is an outburst of
p.000138: an epidemic or an endemic. There are frequent examples in the news, such as the avian influenza (bird flu),
p.000138: the SARS and most recently the H1N1 virus; furthermore the spread of HIV/AIDS and the recurrence of tuberculosis are
p.000138: also arising matters.
p.000138: At the core of the problem lies the fact that free decisions about person- al health may affect the health or endanger
p.000138: the lives of others in the imme- diate or wider vicinity. This perceived conflict between the principle of au- tonomy
p.000138: and public interest invites a consideration of ethically and legally acceptable choices.
p.000138: Based on the views and assumptions of its previous Opinion on the “con- sent in the relationship
p.000138: patient-physician”, the Commission felt that the question is so important as to be considered in a
p.000138: separate Opinion. The Commission issued its opinion after consulting specialized scientists, Profes- sors G.
p.000138: Saroglou, D. Trichopoulos and A. Hatzakis.
p.000138:
p.000138:
p.000138: I. General overview
p.000138:
p.000138: 1. Transmissible infectious diseases
p.000138:
p.000138: The main characteristic of transmissible infectious diseases is that the infected person is carrier for
p.000138: the transmission of the disease to others. Therefore, unlike with other diseases, decisions by patients
p.000138: have implica- tions not only for the patients themselves but also for the health of others or of the whole community
p.000138: in general.
p.000138: This already complicates the issue of patient autonomy. The risk for the health of others justifies certain limits to
p.000138: autonomy. These limits are of two
p.000138:
p.000139: 139
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p.000139: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000139: OPINION
p.000139:
p.000139: kinds; either to the “stricto sensu” autonomy in the strict sense regarding personal health (i.e. the right
p.000139: of everyone to decide on matters of their own health) or to the general autonomy (especially the enjoyment of
p.000139: the free- dom of movement and establishment). The possibility of the latter is stipu- lated in the international law
p.000139: and modern national legal systems, including Greece.
p.000139: As the path of transmission and the severity of infectious diseases vary significantly, the nature and extent of such
p.000139: limits require special attention.
p.000139:
p.000139: 2. The priority of the principle of autonomy
p.000139:
p.000139: In this context, the Commission confirms its Opinion on the supremacy of personal autonomy, meaning the freedom of the
p.000139: individual to decide on matters relating to the personal health and the way of living, providing that the lives of
p.000139: other people are not significantly affected.
p.000139: What this assumption primarily means is that when the medical commu- nity is called to provide advice on
p.000139: measures required to protect public health or when public authorities are called to adopt such measures, auton- omy
p.000139: should not be limited without adequate documented justification.
p.000139: In particular, the Commission believes that the general rules on the ex- ercise of autonomy in patient-physician
p.000139: relationship allow an effective man- agement of transmissible infectious diseases. For example: the appropriate
p.000139: information to patients -including, among other things, advice on self- limitation- or, exceptionally, the
p.000139: supremacy of medics to act on their own initiative in case of emergency. At any rate, the discretion
p.000139: to impose re- strictions is limited when dealing with difficultly transmitted viruses or mild infections.
p.000139:
p.000139: II. Special issues
p.000139:
p.000139: When public health is at risk due to the spreading of infectious disease the Commission considers the following:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000140: 140
p.000140:
p.000140: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000140: OPINION
p.000140:
p.000140: 1. Restrictions to autonomy relating to personal health
p.000140:
p.000140: a) Basic principles
p.000140: Preventive measures adopted by public authorities to address threats against the health of others may include
p.000140: restrictions on personal autonomy in matters of health but only in exceptional circumstances. “Exceptional” are the
p.000140: circumstances of spreading epidemics or pandemics, according to the internationally accepted definitions of
p.000140: these terms. National authorities may not arbitrarily dilate these definitions.
p.000140: In such circumstances, medics and designated health authorities do not have the obligation to ask for patient
p.000140: consent and they could act on their own initiative (self-action). The legal basis for such restrictions
p.000140: consists mainly in art. 8 of the Convention on Human Rights and Biomedicine (Ovie- do Convention), which justifies
p.000140: medical self-action in “emergency situa- tions”.
p.000140: In this context, restrictions must comply with the principle of propor- tionality, i.e. they must be
p.000140: appropriate and necessary in order to protect public health without exceeding the purpose for which they are
p.000140: adopted.
p.000140:
p.000140: b) Vaccination
p.000140: In principle, the vaccination of the population as a measure of preven- tion, particularly the vaccination of
p.000140: vulnerable groups, requires informed consent. In this context, relevant information may be also provided to the
p.000140: general public through the media. The duty of public authorities is to ensure the validity of this information by
p.000140: allocating the task exclusively to a respon- sible entity and by taking steps to avoid inaccuracies which may inspire
p.000140: dis- trust or fear. It is worth noting that 99% of children in the US are vaccinated with a minimum rate of
p.000140: complications, which proves that benefits far ex- ceed any drawbacks; therefore, it is not justified to
p.000140: spread doubts. In “emergency situations” in the above sense, the Commission feels that even mandatory vaccination is
p.000140: not to be excluded, especially for those who are highly probable to become carriers and transmit the
p.000140: infection due to the nature of their occupation. They should be offered, however, the option of changing duties. The
p.000140: established scientific requirements for clinical trials of new treatments (vaccines or medicines) may not be
p.000140: bypassed in order to
p.000140:
p.000140:
p.000140:
p.000141: 141
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p.000141: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000141: OPINION
p.000141:
p.000141: accelerate the availability of such treatments to the public. Otherwise their efficacy will remain uncertain and
p.000141: citizens will be misinformed as a result.
p.000141: In addition, the Commission thinks that in the exceptional circumstances of epidemics or pandemics, limits to
p.000141: patents on new treatments could be justified to the extent possible. Such limits could be argued as a legal/policy
p.000141: choice in competent international and supra-national fora.
p.000141:
p.000141: c) Treatment
p.000141: The treatment of those infected should also be based on informed con- sent. Forced treatment is not justified in
p.000141: principle, except in “emergency situations”.
p.000141: When the number of medical and nursing staff or the available treat- ments do not suffice to ensure care to
p.000141: all those infected (especially in case an infection spreads rapidly) the Commission stresses that the government must
p.000141: establish in advance general priority rules for access to treatment. The basic priority criteria should preferably be
p.000141: prescribed by law. By way of indi- cation, such priority criteria may include the severity of symptoms, the age of the
p.000141: patient and the definition of relevant vulnerable groups.
p.000141:
p.000141: 2. Limits to autonomy on public health grounds
p.000141:
p.000141: a) General rule
p.000141: Limits to the general autonomy of patients -especially the freedom of movement and establishment- are
p.000141: justified only if they are absolutely in- dispensable to protect public health pursuant to the Constitution
p.000141: (arts. 5 [4], 25 [1]). The principle of proportionality as discussed above applies in all circumstances. For
p.000141: example, hospitalized patients should be restricted in specially contained facilities.
p.000141:
p.000141: b) The risk of social stigma
p.000141: The Commission stresses the risk of social stigma that may arise from the isolation (“ghetto-ing”) of specific
p.000141: sub-populations with distinctive cultural characteristics or ways of living when an infectious disease erupts
p.000141: within such groups.
p.000141:
p.000141:
p.000141:
p.000141:
p.000142: 142
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p.000142: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000142: OPINION
p.000142:
p.000142: Such cases must be dealt with by personalized medical care and social welfare measures especially as
p.000142: regards the improvement of hygiene in their living conditions.
p.000142:
p.000142: c) Illegal immigrants
p.000142: In case of manifestation of infectious disease or in cases when preven- tive measures (e.g. vaccination) need to
p.000142: be applied on illegal immigrants, the government must ensure that immigrants would be addressed to the
p.000142: health services. The access of immigrants to health services should be un- hindered and independent on their
p.000142: immigration status; otherwise the risks for public health in general will be multiplied.
p.000142:
p.000142: d) HIV/AIDS
p.000142: This particular disease presents a set of peculiar problems. Even though the spread of the virus is in general
p.000142: relatively difficult, the disease is very severe despite progress in treatment in the recent years. Moreover, social
p.000142: perceptions -especially regarding high risk vulnerable groups- remain ex- tremely negative in our country. The
p.000142: following call for attention:
p.000142: The autonomy of HIV seropositives or HIV patients can be restricted in view of public health protection only if the
p.000142: particular setting of social con- tact is prone to the transmission of the disease. Thus, although mandatory testing
p.000142: for seropositivity is not justified in the absence of qualifying circum- stances, it can be legitimate for certain
p.000142: occupations like physicians or nurs- es or for participation in certain social activities such as sports. In
p.000142: these cases, a positive test result justifies the removal of the seropositive, but just from this
p.000142: particular social context. By contrast, social environments, which are not prone to the transmission of the
p.000142: virus, do not justify devia- tions from the respect of autonomy which is generally applicable.
p.000142: Finally, special attention is required when the virus occurs in enclosed areas of mandatory containment, like
p.000142: schools, hospitals, military barracks or prisons. Any limits to autonomy which are considered indispensable
p.000142: must be combined with additional measures of supervision in order not to betray the purpose of the presence of the HIV
p.000142: seropositive in these areas (e.g. participation in common school activities, military exercises, etc.).
p.000142:
p.000142: Athens, 18 March 2011
p.000142:
p.000143: 143
p.000143:
p.000143: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000143: OPINION
p.000143:
p.000143: COMPOSITION AND PERSONELL
p.000143: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000143: Chairman: John Papadimitriou, Emeritus Professor of Surgery, Medical School, University of Athens.
p.000143:
p.000143: Deputy Chairman: George Maniatis, Emeritus Professor of Biology, Medical School, University of Patras.
p.000143:
p.000143: Members:
p.000143: Julia Iliopoulou-Stranga, Professor of Constitutional Law, Law School, Uni- versity of Athens.
p.000143: Constantinos B. Krimbas, Member of the Academy of Athens, Professor Honoris causa of Genetics,
p.000143: Agricultural University of Athens and Emeritus Professor of History and Philosophy of Biology, University of
p.000143: Athens.
p.000143: Evangelos Moutsopoulos, Member of the Academy of Athens, Emeritus Professor of Philosophy, University of
p.000143: Athens.
p.000143: Athanasios Papachristou, Professor of Civil Law, Law School, University of Athens.
p.000143: Theocharis Patargias, Emeritus Professor of Genetics, University of Athens
p.000143: Constantinos Tsoukalas, Emeritus Professor of Sociology, University of Ath- ens.
p.000143: Christos Voulgaris, Emeritus Professor of Theology, University of Athens.
p.000143:
p.000143: PERSONNEL
p.000143:
p.000143: Scientific Officers:
p.000143: Takis Vidalis, Lawyer, PhD in Law.
p.000143: Ariadne L. Hager-Theodoridou, Agronomist, PhD in Genetics.
p.000143:
p.000143: Secretariat:
p.000143: Marianna Drakopoulou, Lawyer, Head of Secretariat.
p.000143:
p.000143:
p.000144: 144
p.000144:
p.000144: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000144: REPORT
p.000144:
p.000144: R E P O R T
p.000144:
p.000144: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000144:
p.000144: Rapporteurs: T. Vidalis, A. L. Hager-Theodoridou In collaboration with: G. M. Maniatis, C. Tsoukalas
p.000144:
p.000144: I. Introduction
p.000144:
p.000144: In current medical practice, patients are free to agree or decline thera- peutic interventions suggested to them by
p.000144: physicians through informed con- sent. But when their individual decisions can directly affect the health of
p.000144: other people, their personal autonomy as the only factor in making such decisions is put in question. The
p.000144: present report discusses the limits of per- sonal autonomy when a conflict with public interest arises, particularly
p.000144: with the protection of public health.
p.000144: Such conflict of interests becomes an issue mainly with regard to infec- tious (transmissible) diseases, which can
p.000144: spread from one person to anoth- er. Decisions on the prevention and treatment of such diseases put at stake the health
p.000144: and lives of not only the patients themselves but also of healthy individuals in their immediate or wider vicinity.
p.000144: Thus, if a person affected by a contagious disease or belonging to a high risk group decide against a diag- nostic
p.000144: test or treatment, they automatically become a certain or likely “source” of transmission of the disease.
p.000144:
p.000144: 1. Infectious diseases
p.000144:
p.000144: Infectious or transmissible diseases are caused by pathogen agents in- vading the organism (viruses,
p.000144: bacteria, fungi, parasites -monocellular or multicellular- or infectious proteins [e.g. prions in case of
p.000144: spongiform en- cephalitis]). Pathogens are transmitted in specific ways e.g. by saliva drop- lets (path of
p.000144: transmission), take hold and proliferate more or less successful- ly in young subjects (infectivity), provoking
p.000144: symptoms of varying severity or no symptoms at all (virulence), in which case they remain latent and the
p.000144: host becomes a carrier, but not actually sick.
p.000144:
p.000145: 145
p.000145:
p.000145: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000145: REPORT
p.000145:
p.000145: Usually, the disease can be transmitted by carriers as well as patients. The path of transmission,
p.000145: infectivity and virulence are critical factors when developing public health protection programmes or evaluating
p.000145: arguments for or against personal autonomy where an evaluation is required. By way of indication, a common cold -highly
p.000145: transmissible through droplets but caus- ing mild symptoms and posing little risk for life- is different from influenza
p.000145: - also highly infective but causing more severe symptoms as compared with common cold- or hepatitis B, which is harder
p.000145: to contract (by blood transfu- sion or exchange of bodily fluids containing blood), but has higher mortality rates or
p.000145: likelihood of permanent damage.
p.000145:
p.000145: 2. Epidemiology
p.000145:
p.000145: Infectious diseases can cause epidemics, i.e. a significant increase in the number of infected people within a given
p.000145: population in a given time period, beyond what might be normally expected, based on the epidemiological
p.000145: statistics for the particular disease (Encyclopedia of Public Health, on line).
p.000145: The geographical area, in which the rise in the number of infected peo- ple is observed, will determine whether it is a
p.000145: mere outbreak -when the rise concerns a relatively small area, e.g. a town-, an epidemic -when the rise in the number
p.000145: of infected people spreads over a wider area, e.g. a whole coun- try or district- or a pandemic -when a disease
p.000145: spreads significantly world- wide. The 1919 influenza and HIV/AIDS from the 1980s are examples of
p.000145: pandemics (Encyclopedia of Public Health, epidemics). After the manifesta- tion of an epidemic the disease may
p.000145: disappear or persist in the population in latent form causing occasional outbreaks or remain endemic with a steady
p.000145: number of patients.
p.000145: Nowadays, the term “epidemic” is not only used for contagious diseases. It can be used for other pathologies, currently
p.000145: on the rise, like cancer or car- diac disease, even for conditions that are not a proper disease, like obesity. This
p.000145: report, however, focuses only on transmissible diseases, since they give rise to the particularities of the
p.000145: implementation of personal autonomy in medical practice, when a conflict with public interest arises, i.e. the
p.000145: protec- tion of the healthy population from the transmission of pathogens from pa- tients or carriers.
p.000145:
p.000145:
p.000145:
p.000146: 146
p.000146:
p.000146: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000146: REPORT
p.000146:
p.000146: Measures of protection against infectious disease are taken by responsi- ble health authorities irrespective of
p.000146: outbreaks. Restrictions to personal autonomy can be applied even without an increased risk of epidemics.
p.000146: However, once a disease is qualified as epidemic or pandemic, emergency measures shall be taken. Accordingly,
p.000146: the legitimacy or illegitimacy of re- strictive measures will obviously be influenced by the level of
p.000146: risk or the manifestation of an epidemic.
p.000146: It must be noted that a disease can amount to an epidemic based on the relative, not absolute, numbers of infected
p.000146: people. Thus, a relatively small number of patients or carriers can give rise to an epidemic. This is to
p.000146: say that the terms “epidemic” or “pandemic” do not necessarily involve an emergency situation. The risks
p.000146: posed by a disease depend on its specific characteristics, like the severity of symptoms, mortality rates and
p.000146: infectivity.
p.000146:
p.000146: 3. Preventive measures
p.000146:
p.000146: One of the most effective tools of contemporary medicine in the preven- tion of transmissible diseases is vaccination.
p.000146: To mention a typical example, smallpox was eliminated thanks to successful immunization against the dis- ease. Vaccines
p.000146: reinforce the defenses of recipients against the specific path- ogens for which they are designed, preparing the immune
p.000146: system to imme- diately recognize and effectively resist any future attacks by these patho- gens. Vaccines
p.000146: do not ensure absolute protection and people may still be infected with a disease against which they were
p.000146: vaccinated. Vaccines, how- ever, significantly reduce the probability of infection as well as the severity of symptoms
p.000146: in the event of infection.
p.000146: The success of a vaccination programme, however, depends not only on the efficacy of the vaccine but also on the rate
p.000146: of the population participat- ing in the programme. Vaccination does not reduce only the likelihood of
p.000146: infection in case of contact with the pathogen but also the likelihood of such contact itself, if sufficient numbers of
p.000146: the population are vaccinated. This is known as “indirect immunity” or “herd immunity”. Therefore, the decision to be
p.000146: vaccinated or to have one’s children vaccinated has implications for society as a whole because the vaccine
p.000146: protects not only recipients but also the rest of the population. Therefore, the decision to participate or not in a
p.000146:
p.000146:
p.000146:
p.000147: 147
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p.000147: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000147: REPORT
p.000147:
p.000147: vaccination programme can produce a dilemma between autonomy and public interest.
p.000147:
p.000147: II. Ethical issues
p.000147:
p.000147: In case of contagious diseases the scope of personal autonomy is defined by the legitimate interests of others or of
p.000147: society as a whole. Limits to au- tonomy are of two natures: those imposed by the necessity of medical in- tervention
p.000147: (diagnosis, prevention or treatment) and those imposed by the autonomy of others.
p.000147: Transmissible diseases, like other risks to public health, affect the latter category. The following questions arise in
p.000147: this respect:
p.000147: - To what extent are limits to personal autonomy justified on public health grounds (1)?
p.000147: - What is the effect of informed consent when public health is at risk (2)?
p.000147: To these questions, we must add the implications of the “doing good, not harm” principle, that is the
p.000147: scope of medical duty in case of health- threatening (perhaps also life-threatening) situations for entire
p.000147: populations since, in this event, the exercise of autonomy by patients is de facto affected (3).
p.000147: Finally, two related issues call for special consideration: clinical trials and respective patents for vaccines and
p.000147: medicines, for they also raise important ethical questions. On one hand, these are associated with the provision of
p.000147: accurate information to patients, and on the other hand with access of pa- tients to treatments in the context of
p.000147: exercising autonomy (4).
p.000147:
p.000147: 1. General autonomy and public health: Restrictions and the risk of stigma- tization
p.000147:
p.000147: The legitimate objective of protection of the health of others sets the grounds for imposing restrictions on
p.000147: the general autonomy of those infect- ed, especially in regard to movement and social contact.
p.000147: This calls for a number of qualifications. Indeed, not all transmissible diseases justify the same
p.000147: restrictions. Distinctions are necessary between
p.000147:
p.000147:
p.000147:
p.000148: 148
p.000148:
p.000148: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000148: REPORT
p.000148:
p.000148: easily and less easily transmitted diseases as well as between mild and seri- ous diseases (influenza versus HIV, for
p.000148: example).
p.000148: Mild diseases, even when easily transmitted, do not justify such re- strictions to general autonomy; the same
p.000148: is true of serious diseases that are hard to contract. Of course, there are many variations of these
p.000148: combina- tions, which prevent the formulation of more specific rules of universal ef- fect.
p.000148: Restrictions to general autonomy can lead to unfair discrimination aris- ing from a kind of “stigmatization” which
p.000148: isolates patients -even if temporar- ily- from social life. Above all, this raises a wider ethical problem. Historical-
p.000148: ly, the stigma against population groups on public health grounds has been a recurring phenomenon, from the
p.000148: persecutions and massacres of Jews dur- ing the times of “Black Death” in the Dark Ages (the plague pandemic), to the
p.000148: persecution of beggars on the same grounds in the XIX century or of prostitutes for spreading syphilis in
p.000148: World War I, to contemporary practices of discrimination against AIDS patients. In our country, stigmatization phe-
p.000148: nomena occurred in the past in the cases of leprosy and tuberculosis.
p.000148: These facts demonstrate that public health is not to be considered only as a medical problem, but involves a serious
p.000148: social and political dimension. The latter must be taken into account when adopting restrictions to general autonomy.
p.000148: Such restrictions are not justified unless accompanied by social measures aimed at minimizing the likelihood of
p.000148: transmission (e.g. housing, food, etc. for the poor or disadvantaged groups of the population) and by steps ensuring
p.000148: fair treatment (not distinguishing, for example, between prostitutes and their clients regarding the risk
p.000148: of transmission of venereal diseases).
p.000148: The current wave of immigration carries great potential of stigma on public health grounds. The fact
p.000148: that the country of origin -particularly of illegal immigrants- is often afflicted by a high prevalence
p.000148: of infectious dis- eases (especially sub-Saharan Africa and southern Asia), while local health services
p.000148: remain rudimentary, represents a real cause of concern for the spreading of these diseases in the
p.000148: hosting countries. However, stigmatiza- tion practices -unfair treatment, “ghettos” etc.- stem rather from the idea
p.000148: of “miasma” due to lack of information or misinformation about the medical- biological particulars of disease,
p.000148: especially infectivity. Hansen’s disease (lep- rosy) and, more recently, HIV/AIDS confirm this observation
p.000148: since these
p.000148:
p.000148:
p.000149: 149
p.000149:
p.000149: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000149: REPORT
p.000149:
p.000149: population groups are stigmatized, although the disease is relatively difficult to contract.
p.000149: In case of Hansen’s disease, the exact path of transmission is still un- known, but it is accepted
p.000149: that although it can be contracted through pro- longed social contact, approximately 95% of the population are
p.000149: immune to it, though the mechanisms of immunity have not been identified. Perhaps it was this last parameter in
p.000149: combination with the deformity caused by the disease that has led to social stigma against these patients in the
p.000149: past.
p.000149: In case of HIV/AIDS, the path of transmission is known and involves ex- posure to body fluids through sexual
p.000149: intercourse or the transfusion of con- taminated blood or use of a contaminated needle. The virus can also
p.000149: be transmitted to the fetus by the mother. Mere social contact with patients or seropositives does not constitute a
p.000149: risk of transmission. Despite this, espe- cially in the early years since the appearance of the disease, but even
p.000149: today, seropositives are treated with far greater caution, even prejudice, than is justified by medical
p.000149: fact. Apart from the severity of the disease, which meant near certainty of death in the beginning,
p.000149: whereas now there are available treatments, prejudice emanates from the fact that, initially, the disease
p.000149: had a higher incidence among male homosexuals in western coun- tries. The pre-existing stigma against homosexuals
p.000149: exacerbated the stigma against HIV/AIDS patients and carriers.
p.000149: On a practical level, the difficulty here lies in the justification of re- strictions on grounds of public
p.000149: health protection. Public authorities can be motivated by non-medical parameters (e.g. systematic deprecation or
p.000149: exclu- sion of specific groups) when considering such restrictions, in particular to the freedom of movement and
p.000149: residency. Hence, the importance of having an official entity of indisputable independence, providing accurate and un-
p.000149: derstandable medical information on the disease to the wider public, be- comes crucial.
p.000149:
p.000149: 2. Autonomy and forced treatment
p.000149:
p.000149: The second serious ethical issue arises with respect to the freedom of individuals to take care of health
p.000149: matters regarding themselves.
p.000149: Here, the principle of “informed consent” may be restricted, especially with regard to “refusal of treatment”.
p.000149: The health of others being directly at
p.000149:
p.000149:
p.000150: 150
p.000150:
p.000150: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000150: REPORT
p.000150:
p.000150: stake, the freedom to deny treatment does not enjoy the ethical justifica- tion acknowledged in different
p.000150: circumstances.
p.000150: Hence, forced treatment or prevention (e.g. mandatory vaccination) may be considered as option, especially if this is
p.000150: the only way to restore the gen- eral autonomy of the affected person (the subject of restrictions).
p.000150: The same can be argued about the extent of (personal) information and the availability of alternative treatments which
p.000150: are also limited by the emer- gency and time constraints of an epidemic.
p.000150: One may object that forced treatment is not the only option when a pa- tient denies therapy. Besides, insofar as it
p.000150: involves a direct intervention on the latter’s body, its compatibility with the respect for human value is ques-
p.000150: tionable, given that the affected person is used as a common “means” to protect society. The alternative
p.000150: -should this objection be sustained- would be to impose other restrictions to protect others, e.g. limits to the
p.000150: freedom of circulation and installation, not involving forced treatment. A solution more compatible with
p.000150: autonomy in view of the above would be to leave the choice of preferred option to the one concerned.
p.000150: At any rate, with the exception of emergencies which leave no time for government intervention -in which case it is
p.000150: ethically justified to leave the initiative to physicians- autonomy does not evaporate before public interest.
p.000150: Particularly in case of mild diseases or hard to transmit diseases, the obliga- tion to respect autonomy remains fully
p.000150: effective.
p.000150:
p.000150: 3. Scope of medical duty
p.000150:
p.000150: When public health is at risk from a contagious disease, objective pa- rameters -time, in particular- often
p.000150: prevent the unhindered practice of med- icine. In such cases, physicians must set health care priorities,
p.000150: which may result in depriving certain people from care. The availability of physicians is obviously an external sine
p.000150: qua non for exercising patient autonomy.
p.000150: The necessities of war can offer a precedent for such prioritization. Since World War I, a three-fold division of the
p.000150: population in terms of priority (“tri- age”), based on the probability of cure is generally accepted: those
p.000150: in im- mediate need of help come first; next follow those who can be transported to a hospital even if more seriously
p.000150: hurt, and last are those with minor inju- ries or few chances of survival. But one may think of other
p.000150: considerations
p.000150:
p.000150:
p.000151: 151
p.000151:
p.000151: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000151: REPORT
p.000151:
p.000151: (e.g. priority to those who will treat others, to the young or the elderly, even a “first come first served” approach).
p.000151: Although “triage” is mostly associated with war (and natural disasters or train derailments) its core concept can be of
p.000151: use also in case of epidemics.
p.000151: At all events, health care priorities must be set by public authorities in advance on the basis of fixed rules in
p.000151: order to prevent physicians from hav- ing to make so many ethically questionable judgments.
p.000151:
p.000151: 4. Special issues: Clinical trials, patents
p.000151:
p.000151: The urgent need for prevention and treatment in times of epidemics painfully illustrates the question of
p.000151: the adverse effects of trials of new treatments (medicines, vaccines) to contain the risk.
p.000151: Given that clinical trials are now subjected to a specific control proce- dure, ensuring the safety of
p.000151: volunteering participants and of the end- product before it becomes available to the public, at issue is
p.000151: whether this procedure should be relativized in case of an urgent need to supply new cures. Since the
p.000151: pursuit of absolute safety, even in normal circumstances, obviously undermines the effort to find new cures (as
p.000151: being too time- and resource-consuming) the debate on the “maximization of risk” is not with- out cause. The criteria
p.000151: of socially acceptable risks from a new medicine or vaccine are ultimately a matter for bioethics, and must
p.000151: be considered as such.
p.000151: Similar arguments can be made on the scope of patents -and, with that, on the scope of trade prerogative- on new
p.000151: treatments in case of emergency. Here too, limiting the duration of privilege of the patent holder for the sake of
p.000151: providing easier (and cheaper) access to a highly needed drug or vaccine is a matter for bioethics.
p.000151:
p.000151: III. The legal dimension
p.000151:
p.000151: 1. International law
p.000151:
p.000151: Public health is considered as a remit of national sovereignty. As a result, there are no international policies
p.000151: underpinned by international rules for the moment on the protection from epidemics except from trade in food-
p.000151:
p.000151:
p.000152: 152
p.000152:
p.000152: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000152: REPORT
p.000152:
p.000152: stuffs and animal feed. To this, we must add the reluctance of developed countries to effectively combat
p.000152: serious transmissible diseases, which are endemic in developing countries (e.g. malaria, tuberculosis, HIV).
p.000152: Nevertheless, provisions on international protection from epidemics exist in the form of guidelines (IHRS)
p.000152: issued by WHO. These guidelines are not legally binding, of course, but non-compliance can lead to other types of
p.000152: sanctions (e.g. WHO travel alerts). Considering that international move- ments, immigration flows and trade
p.000152: have become easier with globalization and with the recent experiences of wide-spreading transmissible diseases in mind,
p.000152: proposals are under discussion with a view to developing internation- al instruments in this field.
p.000152:
p.000152: 2. Greek law
p.000152:
p.000152: The protection of the population from the transmission of contagious diseases is governed by arts. 21
p.000152: (3) and 5 (4) of the Constitution and art. 5(1)(e) of the European Convention of Human Rights (ECHR)1.
p.000152: Under art. 21 (3), the Constitution recognizes health as a social right in addition to its recognition as an individual
p.000152: right2. Thus, a distinction is drawn between the right of the individual citizen to take care of matters pertaining to
p.000152: personal health and public health care for all. In this sense, the social en- titlement to health can be taken as
...

p.000152:
p.000152: 1Article 5 (4) of the Constitution: “Individual administrative measures restricting the free movement or residency in
p.000152: the national territory or the free entry into or exit from it to any Greek citizen shall be prohibited. Such
p.000152: restrictive measures may be imposed only as ancillary sanctions by criminal court ruling in exceptional emergency
p.000152: circum- stances exclusively for the prevention of indictable offences as specified by Law”.
p.000152: Interpretation clause:
p.000152: Paragraph 4 does not preclude the prohibition to leave the country by order of public prosecutor due to criminal
p.000152: proceedings or measures imposed on grounds of public health protection or the protection of patients as
p.000152: specified by Law”.
p.000152: Article 21 (3) of the Constitution: “The State shall care for the health of citizens and shall adopt specific measures
p.000152: to protect youth, old age, disability and health care for indigents”.
p.000152: 2 Article 5 (5) of the Constitution: “Everyone is entitled to the protection of their health and genetic
p.000152: identity…”.
p.000152:
p.000153: 153
p.000153:
p.000153: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000153: REPORT
p.000153:
p.000153: However, both the Constitution and the ECHR acknowledge the need of re- strictive measures to protect public health.
p.000153: Thus, the art. 5(4) of the Constitution (interpretation statement) excep- tionally accepts individual administrative
p.000153: measures “on grounds of public health protection or the protection of patients as specified by Law”. It is im-
p.000153: portant to stress that such measures amount to extensive inroads into indi- vidual freedom -prohibiting “the free
p.000153: movement and residency in the na- tional territory or the entry into and exit from it”- and can be decided by any
p.000153: public authority (health authorities, police, local government, etc.), but al- ways under specific legal
p.000153: provisions.
p.000153: Along the same lines, the ECHR (convention with overriding formal effect versus ordinary legislation) accepts the
p.000153: deprivation of individual freedom such as, among other things, “… the lawful detention of a person for the pre-
p.000153: vention of the spreading of infectious diseases, …” (art. 5[1][e]), but always “in accordance with a procedure
p.000153: prescribed by law”.
p.000153: The above provisions seem to grant broad discretionary powers to the common legislator when adopting
p.000153: restrictions to the individual freedoms of persons affected by transmissible diseases but, in any case, the
p.000153: legislator’s powers are delineated by the Constitution. However, there are limits:
p.000153: a) In principle, the above restrictions pertain to personal freedom, not to other fundamental rights. That is,
p.000153: they are meant to protect others from contracting the disease, and not to treat the affected subject.
p.000153: Therefore, they cannot amount to forced treatment bypassing the patient’s will.
p.000153: b) Restrictions are subject to the principle of proportionality (art. 25 (1) of the Constitution). That is, they
p.000153: are justified only in the extent which is necessary to protect others.
p.000153: c) Furthermore, they cannot go as far as totally eliminating personal freedom. The “core” of the right must
p.000153: remain intact in all cases.
p.000153:
p.000153: IV. Concluding remarks
p.000153:
p.000153: Based on the above discussion a number of conclusions can be drawn to assist the Commission in issuing an opinion.
p.000153: 1. Personal decisions on health matters may have critical implications for the health of others, as the example of
p.000153: transmissible infectious diseas- es typically demonstrates. Therefore, the exercise of autonomy in this
p.000153:
p.000153:
p.000154: 154
p.000154:
p.000154: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000154: REPORT
p.000154:
p.000154: area must take public interest into account -i.e., the protection of pub- lic health- and, in all terms, is determined
p.000154: by such interest.
p.000154: 2. The above statement does not imply that personal autonomy may be “brought to tatters” -or virtually eliminated- by
p.000154: policy choices to pro- tect public health. Autonomy is still the rule, even in case of epidemics or pandemics, which
p.000154: means that any encroaching measures are always exceptional and can be justified only to the extent that they
p.000154: are de- monstrably appropriate for the objective they serve (principle of pro- portionality). It is, therefore,
p.000154: indispensable to distinguish between in- fectious diseases depending on the level of risk and their transmissibil-
p.000154: ity.
p.000154: 3. The adoption of general rules in advance -if possible in periods of “normality”- both in terms of
p.000154: restrictions as well as of access to sani- tary authorities in times of epidemics or pandemics not only safe-
p.000154: guards the efficacy of prevention or treatment, but also strengthens the feeling of fair distribution of
p.000154: resources and means in emergency situations as imposed by the respect for human value.
p.000154: 4. The potential of social stigma against persons or groups under the pre- text of public health protection is very
p.000154: potent in situations calling for measures. This risk can be addressed only with constant vigilance based on
p.000154: valid and accurate information, a task pertaining mostly to public authorities and institutions. Public health
p.000154: cannot be allowed to inspire phobic reflexes in a modern democratic society.
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000155: 155
p.000155:
p.000155: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000155: REPORT
p.000155:
p.000155: SUGGESTED LITERATURE
p.000155:
p.000155: Beauchamp DE (1988). The health of the republic: Epidemics, medicine, and moralism as challenges to democracy. Temple
p.000155: UP, Philadelphia PA.
p.000155: Brandt AM (1987). No magic bullet: A social history of veneral disease in the United States since 1880. Oxford U. P.,
p.000155: N. York.
p.000155: Breslow L, Duffy J, Beauchamp DE, Soskolne CL (2004). Public health, in: Post SG (ed.) Encyclopedia of bioethics. v. 4,
p.000155: 3d ed. McMillan Reference, N. York, p. 2202-2221.
p.000155: Bruce LI and Phelan JC (2006). Stigma and its public health implications, Lan- cet 367, 528-529.
p.000155: Dagtoglou PD (1991). Constitutional law, individual rights I. eds. A. N. Sak- koulas, Athens-Komotini.
p.000155: Emmanouelides D, Papaiannes I (2000). The social entitlement to health, Human Rights.
p.000155: Encyclopedia of public health. Edited by Lester Breslow, online access.
p.000155: Evans RJ (2004). Epidemics, in: Post SG (ed.), Encyclopedia of bioethics. v. 2, 3d ed. McMillan Reference, N. York, p.
p.000155: 789-794.
p.000155: Gostin L (2004). The international health regulations and beyond. Lancet, Infectious Diseases 4, p. 606-607.
p.000155: Grad FP, Beauchamp DE (2004). Public health law, in: Post SG (ed.), Encyclo- pedia of bioethics. v. 4, 3d ed. McMillan
p.000155: Reference, N. York, p. 2222-2234.
p.000155: Kenneth VI and Moskop JC (2007). Triage in medicine, Part I: Concept, histo- ry, and types. Annals of Emergency
p.000155: Medicine 49, 275-281.
p.000155: Kontiades X (1997). Welfare State and social rights. eds. A. N. Sakkoulas, Athens-Komotini.
p.000155:
p.000155:
...

p.000174: USA.
p.000174: 28 AAV Advisory Committee on Financial Conflicts of Interest in Human Subjects Re- search, AAMC, AAV (2008).
p.000174: Protecting Patients, Preserving Integrity, Advancing Health Report of the AAMC.
p.000174:
p.000175: 175
p.000175:
p.000175: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000175: REPORT
p.000175:
p.000175: Research, February 2008”. In 2001, the General Accounting Office (USA) addressed its concerns about the
p.000175: conflict of interest phenomena in institu- tions conducting clinical research29.
p.000175: A common component to all the above mentioned recommendations is the obligation of all individuals potentially involved
p.000175: in relevant cases during the design, conduct, assessment or announcement of research results, to disclose or
p.000175: notify of any relationship with the industry.
p.000175: A. Declaration means provision of relevant information by the “re- searcher” to the responsible internal
p.000175: authorities of the Institution, such as the “Conflict of Interest Committee” (CIC) and subsequently, notification to
p.000175: the Committee of Research Control (CRC) of the Institution.
p.000175: B. Notification (or disclosure), means notification to third parties, besides the Institution, such as the patient
p.000175: interested, the accredited responsible State authorities, the scientific societies or journals where the research
p.000175: re- sults are intended for publication.
p.000175: There are three main aims of “Declaration” and “Notification” 30:
p.000175: 1. The comprehensive knowledge of possible relationships allows the participating patients or healthy
p.000175: volunteers to exercise informed choice on the right to autonomy. A condition to exercise this right, is that the
p.000175: “Notification” includes all the details of the “reconcilia- tion”. The clarity and timeliness of the
p.000175: notification are prerequi- sites.
p.000175: 2. To protect the researcher from potential legal entanglements. Alt- hough currently there is no legal obligation
p.000175: to reveal the sponsors, nevertheless, the researchers may be involved in legal matters31. Existence of a declaration
p.000175: facilitates transparency.
p.000175:
p.000175:
p.000175:
p.000175:
p.000175:
p.000175: 29 USA General Accounting Office, Biomedical Research, GAO-02-89, (2001).
p.000175: 30 Weinfurt KP, Dinan MA, Allsbrook JS et al. (2006). Policies of academic medical centers for disclosing
p.000175: financial conflicts of interest to potential research participants. Acad Med 81, 113-118.
p.000175: 31 Resnik DB (2004). Disclosing conflicts of interest to research subjects: An ethical and legal analysis.
p.000175: Account Res 11, 141-159.
p.000175:
p.000176: 176
p.000176:
p.000176: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000176: REPORT
p.000176:
p.000176: 3. A third aim, is the moral prevention of researchers and Institutions providing health services to receive
p.000176: sponsorships, especially high subsidies32.
p.000176: The fact that a researcher submitting the Declaration/Notification feels that he/she is vulnerable to criticism over
p.000176: the “transaction”, acts as a deter- rent. Approximately half of the Academic Centers state that granting the
p.000176: declaration has become mandatory in research. This declaration may be independent or may be included in the
p.000176: informed consent form.
...

p.000178: States36.
p.000178: Especially for the CIC, it must be noted that it is composed by senior members of the Institution, who are
p.000178: experienced in their field and are inde- pendent of the Institutional administration. Two members outside the Insti-
p.000178: tution, with similar qualifications, participate in the Committee. The mem- bers themselves must not create
p.000178: conditions for conflict of interest, other- wise, they are revoked immediately. Members must also submit a
p.000178: “declara- tion”. There is close cooperation and mutual information between the CICs. The CIC is responsible for
p.000178: reporting the incident to the authorized bodies and analyzing the type of relationship in detail. In cases
p.000178: concerning the Insti- tution/industry relationship, the Committee examines whether the sponsor- ships belong to the
p.000178: provided exemptions and the extend to which it could compromise research integrity.
p.000178: The declaration is submitted to: a) the responsible State authorities, b) the Institution’ s administration, c) the
p.000178: sponsors, d) the researchers and e) the publishers of scientific press, at least once per year. Every Institution has
p.000178: the freedom to adopt its own rules, according to the principles and philoso- phy governing its operation, but it must
p.000178: aim to minimize irregularities.
p.000178: Each recommendation of the Committee, positive or negative, must be completely justified. In addition, the
p.000178: Institutional administrations are en- couraged to make available to the public, the media and the State
p.000178: the measures adopted to protect the patients and their right to autonomy.
p.000178: The CICs scrutinize every case of possible conflict of interest, but without prejudice that every sponsorship is
p.000178: necessarily reprehensible and harms the patient. The judgment takes into account: a) the amount of sponsorship, b)
p.000178:
p.000178: 35 Campbell EG, Weissman JS, Vogeli C et al. (2006). Financial relationships between institutional review board members
p.000178: and industry. N Engl J Med 355, 2321-2329.
p.000178: 36 Blumenthal D (2003). Academic-industrial relationships in the life sciences. N Engl J Med 349, 2452-2459.
p.000178:
p.000179: 179
p.000179:
p.000179: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000179: REPORT
p.000179:
p.000179: the Institution/sponsor relationship and its possible effect on research and,
p.000179: c) the researcher/sponsor relationship. Subsequently, it is decided whether the research will be continued,
p.000179: discontinued or modified.
p.000179: Institutional conflict of interest may emerge when the financial interests of the Institution or one of its members
p.000179: acting as a representative, may af- fect in any way the design, execution, assessment and announcement of
p.000179: research results. However, a study by Campbell et al. showed that 42.3% of the RCR members do not always adhere to the
p.000179: principle “Conflict of Inter- est”.
p.000179: Industrial “sponsorship” may appear in various forms such as “dona- tions”, staff training, counseling offered
p.000179: to the industry by the Institutional members, legal ownership of shares for products resulting from research as well as
p.000179: mutual bonds or interest and dividends resulting from37, or various combinations of the above mentioned.
p.000179: The CIC must be aware of which of its members implicated in research, fall within the conflict of interest provisions.
...

p.000197: Convention on Human Rights and Biomedicine (Law 2619/1998), which requires genetic counseling, also applies in genetic
p.000197: tests for health purposes.
p.000197: In prenatal genetic tests, article 14 of the same Convention prohibits selection of an embryo for non-health
p.000197: reasons.
p.000197: Finally, for genetic tests undertaken to identify a person, judicial authori- zation is required under the current
p.000197: legislation (e.g. articles 1477 Civil Code, 615 Code of Civil Procedure).
p.000197: Moreover, the provisions concerning the economic freedom and its con- straints (article 5, paragraph 1 Constitution),
p.000197: especially those aiming to pro-
p.000197:
p.000197:
p.000197:
p.000198: 198
p.000198:
p.000198: DIRECT-TO-CONSUMER GENETIC TESTING
p.000198: OPINION
p.000198:
p.000198: tect the consumer (Law 2251/1994) are applied in all types of genetic test- ing.
p.000198: However, one must not overlook that the above mentioned provisions are broad, and there is no special
p.000198: legislation governing this specific activity, both in Greece and most European countries. Absence of a
p.000198: relative law means that anyone can offer DTC genetic services in an unrestricted and uncontainable manner,
p.000198: without being subjected to any kind of preventive quality control. The legislation stated above,
p.000198: partially covers the need of such a control and is unable to monitor the dynamics of a developing new market.
p.000198:
p.000198: III. Recommendations
p.000198:
p.000198: 1. General principles
p.000198:
p.000198: The Commission believes that an important aspect of autonomy in health matters is the unrestricted access
p.000198: to health information, including genetic information. Especially, however, regarding genetic tests which pre- dict
p.000198: the risk to develop a disease, the Commission considers that it is equally important to provide genetic information
p.000198: after the appropriate instructions, preferably, by an expert-physician, clinical geneticist or biologist-geneticist.
p.000198: The Commission notes that it is important to maintain the balance be- tween free access to health information and
p.000198: protection of vulnerable people who are subjected to inappropriate or unnecessary genetic testing. This per- spective
p.000198: is supported by the particular nature of genetic information and by the misleading impression about “genetic
p.000198: determinism”, which tends to dominate the public consciousness. Specifically, genetic data provide an
p.000198: element of predisposition to common complex diseases (cancer, cardiovas- cular disease, diabetes etc.) classifying
p.000198: (or not) an individual in a high risk group, without a definite result that he/she will develop the
p.000198: disease. The Commission believes that it is critical to emphasize that genetic data must not be overvalued, as
p.000198: erroneously and commonly presented.
p.000198: In regard to prenatal genetic tests, the Commission reiterates its position that they must not be performed for eugenic
p.000198: purposes. It notes the danger especially in the case of DTC genetic tests, where genetic counseling is ab- sent.
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p.000210: healthy individual, i.e. the consumer in this case. Monogenic diseases -that develop without the occurrence of
p.000210: environmental factors (e.g. cystic fibrosis, thalas- saemia, familial hypercholesterolemia, muscular dystrophy,
p.000210: Alzheimer’s disease, Huntington’s Chorea)- are comparatively few and, most prominent- ly, rare, in order to
p.000210: justify a commercial interest in the market of genetic testing.
p.000210: The restricted value of genetic data in protecting our health, could lead a non-expert to draw erroneous or, at least,
p.000210: uncertain conclusions. For exam- ple, if an individual has no interest in following a healthy diet he/she may
p.000210: develop cardiovascular disease despite the fact that there is no genetic cause. In addition, it is possible
p.000210: that serious psychological distress is caused in individuals who overestimate the importance of genetic
p.000210: predisposition,
p.000210: e.g. for cancer, by accepting “genetic determinism” and ignoring the multi- factorial nature of the specific disease.
p.000210: This is the reason why a mediating expert, who will be able to evaluate the necessity of genetic testing and the
p.000210: results for a particular individual with known medical record and “social” profile, seems to guarantee the
p.000210: proper use of genetic testing.
p.000210: But, is the expert’s involvement always justified? For example, is the intervention necessary for tests
p.000210: provided via the internet that intend to reg- ulate the dietary habits of the recipient and are generally
p.000210: considered as harmless? And generally: to what extend is a person’s autonomy in health issues affected, when the
p.000210: expert’s mediation is presupposed in every case, in order that the person could have access to simple diagnostic tests?
p.000210: This main concern is enhanced by some “peripheral” issues that need to be addressed. The most serious issue is of
p.000210: course the management and pro- tection of personal data, in the context of a relevant business activity -
p.000210: whether it concerns tests intended to protect health or tests designed to
p.000210:
p.000210:
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p.000211:
p.000211: DIRECT-TO-CONSUMER GENETIC TESTING
p.000211: REPORT
p.000211:
p.000211: reveal a person’s identity. The extend of financial freedom is also a critical issue in cases where the business object
p.000211: involves information derived from our biological constitution. Additionally, a possible regulation -legislative or
p.000211: other type- intending to regulate the distinct market of DTC genetic services and balance the values, should be
p.000211: considered.
p.000211:
p.000211: The ethical dilemmas
p.000211:
p.000211: In an attempt to highlight the ethical dilemmas arising from DTC genetic testing, one would conclude the following:
p.000211:
p.000211: Consent without counseling
p.000211: Does personal autonomy in health issues include “informed consent” without the intervention of a medical
p.000211: counsellor?
p.000211: In other words, is a person able to make decisions for his/her health, relying exclusively on whoever
p.000211: offers -and advertises- diagnostic services or even pharmaceutical products, considering that an expert’s involvement
p.000211: is “meaningless”?
p.000211: The question can be further extended: are there diagnostic services that provide reliable information directly to
p.000211: consumers, helping them to improve their habits without compromising a regular life for themselves or their fam- ily?
p.000211: If so, is genetic counseling required in this case (STOA 2007: par. 3.1)?
p.000211: The answer must be classified according to the impact of genetic testing on the consumer’s life. Tests aiming at mild
p.000211: lifestyle changes (diet, exercise, etc.) could be accepted without a mediating expert. In contrast, tests esti- mating
p.000211: predisposition to diseases, presuppose intervention of an expert, as they may lead to serious lifestyle changes.
p.000211: In this case, protecting health means that the consumer interested in taking the test must, at least, be ap-
p.000211: propriately informed by an expert, prior to deciding whether he/she will be subjected to the test. In addition,
p.000211: protecting health means that, on comple- tion of the genetic test, the consumer is entitled to have the
p.000211: results ex- plained, to receive genetic counseling by a specialized geneticist as well as to receive adequate medical
p.000211: follow up.
p.000211:
p.000211:
p.000211:
p.000211:
p.000211:
p.000212: 212
p.000212:
p.000212: DIRECT-TO-CONSUMER GENETIC TESTING
p.000212: REPORT
p.000212:
p.000212: The physician’s position
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p.000213: (and with what criteria)?
p.000213: From the above mentioned, there is no doubt that a regulatory interven- tion is essential. The general prohibition of
p.000213: DTC genetic testing is certainly not justified. A differential approach is required, based, for example, on the impact
p.000213: of the tests on a person’s lifestyle. Hence, mild tests, such as those defining a person’s genealogy or modifying
p.000213: a person’s diet etc., are not treated in the same way as tests examining predisposition to serious diseas- es.
p.000213: Moreover, a regulatory intervention, from the legislator’s perspective, seems to be imperative to assure the
p.000213: quality standards of the relevant ser-
p.000213:
p.000213:
p.000213:
p.000214: 214
p.000214:
p.000214: DIRECT-TO-CONSUMER GENETIC TESTING
p.000214: REPORT
p.000214:
p.000214: vices, to acquire guarantees concerning their validity and to avoid mislead- ing the public on such sensitive issues.
p.000214: The above questions appear to be the most important from the stand- point of ethics, without, of course, excluding
p.000214: others. In a certain sense, the continuous development of genetic testing technologies -which leads to the
p.000214: dissemination of the relevant commercial applications- compels us to main- tain this speculation constantly open.
p.000214:
p.000214: THE LEGISLATIVE FRAMEWORK
p.000214:
p.000214: General legislation
p.000214:
p.000214: There is no special legislation dealing with these issues. The general leg- islative framework we need to take into
p.000214: account includes:
p.000214: - The constitutional right to health (art. 5 par. 5 Constitution) and the relevant to personal autonomy provisions
p.000214: of the Oviedo Convention and the Code of Medical Ethics and Deontology (Law 3418/2005), where the
p.000214: principle of “informed consent” is established, as well as the importance of genetic counseling (explicitly
p.000214: stated for genetic tests - see art. 12 Oviedo Convention).
p.000214: The provisions in these texts orientate us towards accepting that mediation of an expert before genetic testing
p.000214: but also during the interpretation of the results, is essential. Therefore, providing such services without
p.000214: mediation cannot be considered as an acceptable aspect of the person’s autonomy on health issues.
p.000214: - The constitutional right to protection of personal data (art. 9 Α Constitution) and the relevant
p.000214: Law 2472/1997, which regulate handling of genetic and medical data.
p.000214: Protection of sensitive data collected by companies must be ensured in the strict context of this legislation.
p.000214: More specifically, the consumer’s consent given to the company in order to collect and handle personal
p.000214: genetic data and information about his/her lifestyle is not enough, while a relevant permission given
p.000214: by the Data Protection Authority is required. Companies operating in our country must be supervised over this
p.000214: point.
p.000214:
p.000214:
p.000215: 215
p.000215:
p.000215: DIRECT-TO-CONSUMER GENETIC TESTING
p.000215: REPORT
p.000215:
p.000215: - The legislation for consumer protection (Law 2251/1994, as in force), which establishes certain obligations for
p.000215: anyone providing services to the general public (mostly regarding adequate information).
p.000215: This legislation is of interest mainly when it comes to advertising the companies and the way they promote genetic
p.000215: testing in general. In this context, provisions for misleading actions (art. 9 d), misleading omissions (art. 9 e) and
p.000215: misleading commercial practices (art. 9 f) are of great importance.
p.000215: - The financial freedom (art. 5 par. 1 Constitution), in the context of which the development of
...

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p.000008: HUMAN ENHANCEMENT -
p.000008: PHYSICAL ENHANCEMENT
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p.000222: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000222: OPINION
p.000222:
p.000222: O P I N I O N
p.000222:
p.000222: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000222:
p.000222:
p.000222: Introduction
p.000222:
p.000222: The Hellenic National Bioethics Commission met repeatedly upon invita- tion by the President in order to consider the
p.000222: ethical issues within its juris- diction regarding “Human Enhancement”. This term includes medical inter- ventions on
p.000222: the healthy body, aimed at shaping desirable characteristics, basically for psychological and social
p.000222: reasons (aesthetic preferences, in- creased physical or cognitive performance, etc.).
p.000222: In view of the purpose of such interventions, which is not to treat health damages, specific issues arise
p.000222: concerning the extend of autonomy of the person interested and the appropriate approach of physicians. However,
p.000222: it is worth noting that, based on the broad definition of health provided by the World Health Organization,
p.000222: according to which “Health is a state of com- plete physical, mental and social well-being and not merely the
p.000222: absence of disease or infirmity”, such interventions are, undoubtedly, included in the practice of medicine,
p.000222: and therefore ruled by the general medical ethics.
p.000222: One can distinguish various categories of enhancing interventions, de- pending on the purpose they serve.
p.000222: Thus, there are interventions that en- hance:
p.000222: a) Physical characteristics and abilities,
p.000222: b) mental characteristics and personality, and
p.000222: c) cognitive abilities.
p.000222: The Commission considers that it is useful to issue an Opinion on the first category, which will precede
p.000222: the other two, so as to better highlight the relevant issues.
p.000222:
p.000222: Improvement of physical characteristics and abilities
p.000222:
p.000222: The category of improving physical characteristics and abilities includes, in particular, the cases of:
p.000222: Ι) Plastic surgery (surgical or non-surgical),
p.000222:
p.000223: 223
p.000223:
p.000223: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000223: OPINION
p.000223:
p.000223: II) enhancing physical abilities,
p.000223: III) using mechanical means of enhancement.
p.000223: To examine the issue of physical enhancement, the Commission held hearings on Dr. G. Christodoulou, Emeritus
p.000223: Professor of Psychiatry, Medical School, University of Athens and Honorary President of the Greek Psychiat- ric
p.000223: Association, Dr. A. Mandrekas, President of the Greek Association of Plas- tic, Reconstructive and Aesthetic Surgery,
p.000223: Dr. G. Creatsas, Professor of Gy- necology and Director of the 2nd Obstetrics and Gynecology Clinic, “Are-
p.000223: taieion” Hospital, Medical School, University of Athens, Dr. G. Vassilopoulos, Associate Professor of Pathology -
p.000223: Hematology, Medical School, University of Thessaly and Associate Researcher, Department of Genetics and
p.000223: Gene Therapy, Biomedical Research Foundation of the Academy of Athens, and Dr. C. Spiliopoulou,
p.000223: Associate Professor of Forensic Medicine, Medical School, University of Athens and President of the
p.000223: Hellenic National Anti- doping Council.
p.000223:
p.000223: Ι. Plastic Surgery
p.000223:
p.000223: 1. Overview
p.000223:
p.000223: Plastic surgery concerns surgical or non-surgical procedures designed either to reconstruct or to “correct”
p.000223: external body features.
p.000223: Reconstructive procedures usually follow treatment after accidents (e.g. scar revision). Cosmetic interventions are
p.000223: purely aesthetic and correspond to a person’s desire to improve the appearance of his/her face or body
p.000223: (brow lift/eyebrow, nose, breast, liposuction, etc.), regardless of health is- sues. Gender reassignment
p.000223: surgery, is a special case, which must be ad- dressed specifically.
p.000223: In principle, the Commission considers that a person’s autonomy justifies the freedom of forming external features. The
p.000223: fundamental right to person- ality development encompasses, undoubtedly, a person’s control over his/her
p.000223: external appearance. However, that does not mean that plastic sur- gery escapes from the principles and rules of law
p.000223: and medical ethics.
p.000223:
p.000223:
p.000223:
p.000223:
p.000223:
p.000224: 224
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p.000224: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000224: OPINION
p.000224:
p.000224: 2. Altering facial features and identity confusion
p.000224:
p.000224: A person’s desire to change his/her facial features in order to cause identity confusion is a borderline
p.000224: case of self-determination, which may af- fect the public interest (e.g. in order to avoid legal prosecution). In this
p.000224: case, the Commission believes that certain restrictions on a person’s autonomy are justifiable.
p.000224: Consequently, the Commission considers that there is an issue regarding the physician’s rights and obligations. In this
p.000224: case, the physician has a duty to review the relative desire of the person interested. Under particular con- ditions,
p.000224: this review justifies that the physician may refuse to carry out a pro- cedure, however, without setting general and
p.000224: abstract rules. Ιn this case, it is required to assess each case separately. However, it is not the physician’s duty to
p.000224: report the incident to the law enforcement authorities, apart from exceptional cases in which, as the law provides, the
p.000224: offense of harboring a felon or crime concealment is constituted.
p.000224:
p.000224: 3. Plastic surgery and gender specific features
p.000224:
p.000224: In cases of altering gender specific features or even gender reassign- ment, plastic surgery is part of the
p.000224: therapy used. Hermaphroditism and gen- der identity disorder fall within these cases.
p.000224: Regardless of the aetiology of a person’s mental and physical condition, which may be due to neurodevelopmental or
p.000224: genetic causes, the Commis- sion considers that such kind of procedures are essentially reconstructive and
p.000224: therapeutic, since they aim to match the psychosomatic disposition of a person with gender specific features.
p.000224: In this case, the ethical principles and rules of law, as outlined in a previ- ous Opinion of the Commission ("Consent
p.000224: in the patient-physician relation- ship," 2010) are entirely valid. The authentic will of the person him/herself is the
p.000224: determining factor here, in view of the right of personality. However, since there is a particularly
p.000224: sensitive issue of autonomy, it is right to allow for a period of time between the initial decision and the plastic
p.000224: surgery pro- cedure, during which the person concerned receives psychological and med- ical counseling.
p.000224:
p.000224:
p.000224:
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p.000225: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000225: OPINION
p.000225:
p.000225: According to the Commission, if prenatal testing results in ambiguous results about the gender identity of a
p.000225: foetus, an artificial termination of the pregnancy is not justified, especially since there are the
p.000225: aforementioned reconstructive options after birth. However, given that persons in this cate- gory (seeking plastic
p.000225: surgery to alter gender specific features or gender re- assignment) belong to vulnerable social groups that
p.000225: generally suffer from social discrimination, access to relevant treatment must be ensured. For example,
p.000225: based on the principle of equality and the social right to health, the State may possibly develop counseling
p.000225: programs, but also provide ther- apy possibilities within the National Health System.
p.000225:
p.000225: 4. Face transplants
p.000225:
p.000225: Reconstructive face transplantation (e.g. in case of severe deformities caused by an accident) is, in
p.000225: principle, an acceptable alteration of the recipi- ent’s characteristics. However, it must be carried out in such a
...

p.000226: The relevant code must refer to the general obligations of physicians towards the persons interested
p.000226: -especially the increased responsibility to fully inform the person concerned- and may include specific
p.000226: chapters on different types of procedures, so that the above mentioned obligations are adjusted accordingly.
p.000226:
p.000226: ΙΙ. Enhancing physical abilities
p.000226:
p.000226: 1. Overview
p.000226:
p.000226: The enhancement of physical abilities usually includes characteristics such as physical strength, speed,
p.000226: agility, endurance, accuracy, motor coordi- nation and dexterity. The artificial enhancement is achieved mainly by
p.000226: the use of pharmaceutical substances combined with physical exercise.
p.000226: The Commission considers that, in the frame of the general right to per- sonality development, improving physical
p.000226: abilities is, in principle, a legiti- mate choice. However, the Commission notes that this choice is subject to
p.000226: restrictions, which are related both to the person him/herself and third par- ties.
p.000226:
p.000226:
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p.000227: OPINION
p.000227:
p.000227: 2. Safe use of substances for a person’s health
p.000227:
p.000227: It is imperative to protect a person’s health from potentially harmful enhancing substances, given that
p.000227: many of them are freely available in the market, with no prescription required.
p.000227: Regardless of the autonomy of the person in various health issues, the Commission emphasizes the importance of the
p.000227: strict control over these sub- stances by the competent authorities, and particularly the importance of
p.000227: providing complete and accurate information to consumers regarding any possible side effects.
p.000227: For substances administered after prompt (either by sports medicine physicians, or gymnasts, trainers etc.),
p.000227: the relevant responsibility -moral, but also legal- belongs primarily to those who recommend the substance
p.000227: use. Regarding the apportionment of responsibility, it should not be overlooked that the interested persons that use
p.000227: them are more vulnerable to inaccurate or misleading information, as they often choose to enhance their
p.000227: physical abilities and performance and consider that such enhancement is, by de- fault, desired and
p.000227: "innocent", with no special consideration of the potential health effects.
p.000227:
p.000227: 3. The interest of third parties, particularly in sport
p.000227:
p.000227: The Commission also dealt with the case of enhancing abilities through doping, in order to participate in athletic
p.000227: contests. The Commission pointed out that the use of relevant substances must be controlled, not only in order to
p.000227: preserve equality in competition, but also to protect the athletes’ health.
p.000227: In particular, the following points are exceptionally significant:
p.000227: i) Prohibition of the use of certain substances in sport is not only related to the impressive results concerning
...

p.000238: interven- tions to improve cognitive abilities, have harmful effects on our health, quality and life expectancy. In
p.000238: contrast, opponents of human enhancement argue that the new technologies will not solve the problems of inequality and
p.000238: social justice.
p.000238:
p.000239: 239
p.000239:
p.000239: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000239: REPORT
p.000239:
p.000239: and is amenable to medical care in order to reduce it (e.g. taking drugs to reduce glucose or cholesterol
p.000239: levels). But beyond that, the physical deterioration of the organism with the occurrence of aging is
p.000239: undoubtedly “damage” and is regularly treated with advanced medical care (in many levels), however, it leads
p.000239: to a fatal “medicalization” of the life of the elderly. But if we accept this natural decay as inevitable, we
p.000239: should define more precisely the limits of medical intervention, finding eventually a “gray zone” to the moderate
p.000239: definition of health.
p.000239: The so-called “enhancement” raises this general issue on the very own concept of health, and consequently, the nature
p.000239: of the medical profession, which are complemented by two additional ethical issues that must be addressed
p.000239: specifically.
p.000239: Firstly, there is the question of our own self-determination in health issues. In other words, is
p.000239: “enhancement” a right of the person who wishes it? Namely, does enhancement fall within the realm of biological
p.000239: autonomy, and indeed, is it an aspect of the fundamental right to health? Regardless of the legal dimension of such
p.000239: issues, the moral concern, here, is actually our ability to treat our body and to intervene freely in its’
p.000239: constitution or not. Even if we answer affirmatively to this freedom on our body, we must wonder to what
p.000239: extent: a) is it binding for the physician to whom we refer (particularly when an enhancement intervention may have
p.000239: adverse effects), and, b) does it allow us to apply enhancement in the field of childcare?
p.000239: Finally, another question concerns our relationships with others, or else, justice. Frequently, enhancement is
p.000239: attempted by someone in order to deal with the various requirements of social environments, especially in
p.000239: rivalry relationships (sports, education, fashion, etc.). Is there a limit imposed by justice? The answer is,
p.000239: of course, affirmative, but it is not clear whether for example, using pharmaceutical agents is fundamentally
p.000239: different from an intensive workout in sports, or the consumption of natural stimulants (coffee, etc.)
p.000239: during class exams.
p.000239: Moreover, the issue of justice relates to the objection expressed for enhancement interventions which are
p.000239: costly, and for which equal access cannot be ensured. If such interventions significantly enhance physical
p.000239: abilities, then, marginally, they may possibly result in unequal opportunities (mainly professional) in social
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p.000253: size reduction e.g. in female tennis athletes for better performance and laser surgery for vision
p.000253: enhancement
p.000253: e.g. in golf athletes, to more dangerous experimental surgeries to achieve quick restoration of injuries.
p.000253:
p.000253: v) Training at high altitude and the use of artificial hypoxic environment
p.000253:
p.000253: The preparation of athletes at high altitudes, amongst others, reduces blood pressure and heart rate, and an
p.000253: increase in erythropoietin, resulting in an increased number of red blood cells and acceleration in fat metabolism
p.000253: (Garcia, Verdugo, 2005). Consequently, athletes who train in low oxygen conditions aim at a better use of the
p.000253: available oxygen and enhancement of their physical stamina during the games. According to a comment on Art.
p.000253: 4.3.2 of the World Anti-Doping Code, training in high altitudes only meets the criterion of enhancing
p.000253: athletic performance, and hence, is not consid- ered a prohibited method. However, there is no specific
p.000253: reference in the Code concerning the use of artificial hypoxic environments (e.g. hypoxia chambers) that
p.000253: simulate conditions of high altitudes.
p.000253:
p.000253: 2. The dimension of ethics
p.000253:
p.000253: The use of pharmaceutical agents to enhance physical abilities is associated with both the likelihood
p.000253: of putting the athlete’s health in danger and the corruption of justice in athletic games (doping) or tests.
p.000253: As to the first issue, a person’s autonomy in his/her health is in principle absolute. The imposition of a moral “duty”
p.000253: to take care of the good state of our health and avoid risks, for reasons related to collective interests
p.000253: (the good of our family, our productivity at work, public health or even to avoid extra burden on the public
p.000253: health insurance systems), does not seem justified. On the one hand, such an obligation would drastically restrict
p.000253: the enjoyment of many freedoms (especially in the context of professional and private life). On the other hand,
p.000253: endangerment is a structural feature of today's “risk society”, to the point that it becomes impossible
p.000253: to lead a
p.000253:
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p.000254: REPORT
p.000254:
p.000254: “healthy” life. In this sense, there is no essential ethical basis in the criticism of “self-destruction”, at least as
p.000254: far as the concept of autonomy presuppo- ses the rational -and non-arbitrary- use of our freedom.
p.000254: As to the second issue, our relations with third parties set limits on the enhancement of physical abilities by
p.000254: using pharmaceutical agents. Ideally, ensuring equal access to any mean that can enhance performance is a
p.000254: characteristic of justice. If this is not possible, the prohibition of specific means is, in principle,
p.000254: legitimate, in competing procedures (e.g. in education or in sports -especially championship games, where the
p.000254: interests of third parties is stronger).
p.000254: In contrast to pharmaceutical enhancement, interventions in an indi- vidual’s genome are “with no return”,
p.000254: namely they generate permanent effects on the organism. As long as there are relevant applications (as
p.000254: already discussed for championships), the concerns are stronger here, since many gene functions remain mostly
p.000254: unknown. Therefore, genetic mani- pulation imposes a greater risk on the state of the organism. Precisely due to
p.000254: this uncertainty, it is ethically questionable whether genetic manipulation methods are justifiable (“protective
p.000254: principle”) as a form of acceptable options within a person’s autonomy, because under such circumstances the
p.000254: “rational” use of freedom proves problematic. Certainly, however, the matter of providing the necessary and
p.000254: accurate information concerning the use of genetic manipulation methods is crucial.
p.000254:
p.000254: 3. The law
p.000254:
p.000254: Drug administration is subjected to the provisions of the pharmaceutical legislation (Directive 2001/1983, as
p.000254: incorporated by the Ministerial decision DYG 3a/83657/24.1.2006, Law 1316/83, as in force, Law 96/1973, as in
p.000254: force) which are particularly relevant to the responsibility of physicians, pharmacists and traders, also
p.000254: controlled by the National Organization for Medicines (NOM). In this legislation, the prohibition of
p.000254: advertising pre- scription drugs to the public and the strict terms on the physicians’ updating about these drugs, are
p.000254: of particular importance.
p.000254: Particularly for doping in sport, both the International Convention against Doping in Sport (UNESCO,
p.000254: 2005) ratified by Law 3516/2006, and the Anti-Doping Convention (Council of Europe, 1989) ratified
p.000254: by Law
p.000254:
p.000254:
p.000255: 255
p.000255:
p.000255: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000255: REPORT
p.000255:
p.000255: 2371/1996, are applied. These legislations, are “procedural” in nature and provide control, information,
p.000255: education and transnational cooperation, but without general substantive criteria for classifying substances
p.000255: as “pro- hibited”. The characterization as “prohibited” is left to the absolute discretion of
...

p.000256: from the use of motorized exoskeletons in order to partially restore their locomotion (Lo and Xie, 2011).
p.000256: However, mechanical means often provide capabilities beyond restoration to a normal healthy state,
p.000256: favouring the acquisition of additional capabilities. A typical example is the case of Jesse Sullivan, who was given a
p.000256: robotic limb after surgery at the Rehabilitation Institute of Chicago in 2005. Jesse Sullivan not only managed to
p.000256: restore motion in his shoulder and arm, but also to perform movements that were not possible with previous
p.000256: robotic limbs4. Apart from robotic limbs, there are several companies that manufacture exoskeletons for medical
p.000256: use, for example the “robotic suit HAL” which was designed to complement or enhance human mobility5.
p.000256: In the military field, the use of motorized exoskeleton can enhance a soldier’s strength and stamina while
p.000256: carrying heavy loads. Already, several companies have designed motorized exoskeletons for military purposes,
p.000256: such as Raytheon and Lockheed Martin, and indeed often with government funding. Similar uses for motorized
p.000256: exoskeletons could be found in rescue groups, such as firemen that need to carry and rescue victims.
p.000256:
p.000256: 2. The dimension of ethics
p.000256:
p.000256: As in the case of using motorized exoskeleton for enhancement purposes, the question that arises
p.000256: is whether a person’s autonomy allows the expansion of physical capabilities beyond normal.
p.000256: The answer is, in principle, yes, since in this case there are -usually- no issues of modifying the human organism.
p.000256: Expanding a person’s capabilities may resemble the assistance provided by the usual mechanical means that make us enjoy
p.000256: our freedom, for example by increasing our movement (car, etc.), our senses (glasses, headphones, etc.), our
p.000256: expression (microphones etc.), and so on.
p.000256:
p.000256: 4 Design news 2005. http://www.designnews.com/document.asp?doc_id=226412&dfpPParams=ind_182,
p.000256: aid_226412&dfpLayout=article.
p.000256: 5 Cyberdyne. Inc. http://www.cyberdyne.jp/english/robotsuithal/.
p.000256:
p.000257: 257
p.000257:
p.000257: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000257: REPORT
p.000257:
p.000257: 3. The law
p.000257:
p.000257: Especially for equipment that requires interventions in the organism of the person concerned, the legislation
p.000257: about medical products (Directive 93/42, incorporated by JMD DY8d/GP. οik.130648/2.10.2009, Directive
p.000257: 90/385, incorporated by JMD DY8d/GP. oik.130644/2.10.2009) contains provisions for secure application of
p.000257: implants. Therefore, it also involves the technological interventions that aim, for example, at the
p.000257: musculoskeletal support.
p.000257:
p.000257: ΙV. Prolongation of life
p.000257:
p.000257: 1. The data
p.000257:
p.000257: The idea of longevity or eternal youth has always been fascinating for mankind, regardless of the era,
p.000257: culture and religion. This interest derives mainly from man’s fear about the diseases presented in old
...

p.000259: significant mortality. Technological interven- tions that affect the process of aging and can be considered
p.000259: as enhance- ment of human characteristics include (Barazetti and Reichlin, 2011):
p.000259: Restricting caloric intake, hormone administration or replacement, re- duction of oxidative stress and
p.000259: activation of telomerase (Barazetti and Reichlin, 2011). Studies in various species showed that these
p.000259: interventions are possible to increase life expectancy and delay the aging process. Howev- er, these studies do not
p.000259: provide convincing data that can be applied to hu- mans.
p.000259: Life expectancy predictions vary. A study with 60 participants including demographers, gerontologists and
p.000259: researchers of aging, showed that life expectancy for a person born in 2100 is on average 292 years,
p.000259: while the range of predictions was large. Half of the predictions see humans not to exceed 100 years,
p.000259: while the more optimistic ones, which are the minority, predict that man will live up to 500 to 5,000 years
p.000259: (Richel, 2003). Partici- pants in this study were among others, Michael Fossel, researcher of the effect
p.000259: of telomerase on delaying cell aging, Roy Walford who studies the effect of limited calorie consumption
p.000259: to prolong lifespan and Aubrey de Grey, a biogerontologist and a great supporter of life prolongation.
p.000259:
p.000259: 2. The dimension of ethics
p.000259:
p.000259: One cannot dispute that control of the aging mechanisms and prolongation of life are within
p.000259: the limits of a person’s autonomy. In principle, it is legitimate to pursue such a thing in the context of
p.000259: autonomy, as, indeed, it is legitimate to treat any cause that leads the body to weakness and ultimately
p.000259: to death. Therefore the relative ethical issues do not differ substantially from the issues raised by the other
p.000259: forms of physical enhancement.
p.000259: However, a crucial issue that remains is the future social consequences of a dramatic increase in life
p.000259: expectancy, as demographic data already confirm serious effects e.g. on the sustainability of
p.000259: health insurance systems, even on the adequacy of natural resources.
p.000259: Assuming that these data reflect the limited strength of modern societies, not only in a broader
p.000259: macrosocial scale but even in the scale of a
p.000259:
p.000259:
p.000260: 260
p.000260:
p.000260: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000260: REPORT
p.000260:
p.000260: family, it is possible that maintenance of a “fourth” generation of ancestors will be against human reproduction.
p.000260: Indeed, this generation will continue to burden the family budget, effectively discouraging child bearing, which will
p.000260: marginally lead to a progressive aging of societies. In this case, the effects on the viability of societies will be
p.000260: unknown.
p.000260:
p.000260: 3. The law
p.000260:
p.000260: It is difficult to detect law restrictions regarding the fundamental rights of personality development and health (5
p.000260: par. 1 and 5, Constitution) in this specific field.
p.000260: If the reservation relates elusively to the future interest of societies in age renewal, the only
...

p.000268: Such methods are particularly: a) selective stimulation of brain regions, with electrical or magnetic signals, and b)
p.000268: drug use. In the future, it is likely that these methods are enriched by targeted genetic modification of genes
p.000268: associated with cognitive functions, as well as by brain/computer interfaces, which is expected to allow access
p.000268: to electronic information -and generally use of computer programs- by just activating certain cognitive functions.
p.000268: The Commission notices that there is internationally, a widespread use of substances by healthy individuals
p.000268: (nicotine, caffeine) or even prescription drugs, with the aim to further enhance their cognitive functions.
p.000268: Users mainly pursue memory and attention enhancement, but also to treat nor- mal hyperactivity, which occurs
p.000268: particularly in children. In addition, the ap- pearance of anxiety or phobias, typical elements of everyday life in a
p.000268: mod-
p.000268:
p.000268:
p.000269: 269
p.000269:
p.000269: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000269: OPINION
p.000269:
p.000269: ern social context, puts pressure on healthy individuals to use sedatives, antianxiety and antidepressant
p.000269: drugs.
p.000269: The Commission considers that, as in the case of enhancing physical characteristics, the autonomy of a
p.000269: healthy person includes options for en- hancing the cognitive or mental state of the human body. This enhancement
p.000269: is part of the right to develop freely a personality.
p.000269:
p.000269: II. Suggestions
p.000269:
p.000269: However, the aforementioned principle must be supplemented with necessary remarks.
p.000269: 1. The use of drugs to enhance memory or attention may adversely af- fect other cognitive functions. Due to this
p.000269: eventuality, the person concerned must be fully informed, in order to have the opportunity of an independent choice.
p.000269: 2. The issue of influencing the personality is particularly emphasized in the case of antidepressants use. The above
p.000269: mentioned influence is in princi- ple legitimate, as a fundamental right of the person, but it encloses the risk of
p.000269: uncontrolled effects on the nervous system and the general physical and mental condition of the person. The Commission
p.000269: notes the risk when chil- dren use such drugs since such a use may lead to the substitution of all the efforts made to
p.000269: integrate the person into society. A personality is developed by the gradual and smooth integration of the
p.000269: person into the social envi- ronment, owing to the family, friends or educational mechanisms that have the
p.000269: advantage of being subjected to constant scrutiny and revision, and are reversible if necessary, depending on the
...

p.000280: memory functions. It is a situation where enhancement means can cause uncertain consequences, which may
p.000280: lead to the production of multiple problems to the user. Given the relative ignorance of many brain
p.000280: functions, there is a safety issue here. Even if we get certainty about the side effects of such drugs for other areas
p.000280: of memory, an issue will be raised about whether it is legitimate for a person to encounter the dilemma
p.000280: of enhancing certain functions at the expense of others.
p.000280:
p.000280: 3. Balancing cognitive and psychological functions - Personality change
p.000280:
p.000280: In the case of mental characteristics, in a broader context, we encounter the same problem regarding the balance
p.000280: of increased cognitive abilities (memory, ability to concentrate, etc.). It seems that here, there is some kind of
p.000280: connection, e.g. with the emotional life of the person. Thus, enhan- cement of cognitive abilities
p.000280: that allows an employee to perform exceptionally, has been reported to negatively affect his/her
p.000280: emotional world (events of apathy, indifference, etc.), with unknown consequences for the personality (Glannon, 77-78).
p.000280: Generally, the question of changing a personality by drug use (particularly antidepressants) is a
p.000280: central concern, as does the question of whether this increases or limits autonomy (STOA, 135). There is
p.000280: no doubt that personality changes, anyway, with the assistance of external actors - particularly by
p.000280: the socialization mechanisms during childhood and adolescence- the effects of which often are not
p.000280: controlled by the person itself. Thus, a child’s personality is constantly changing under the influence of family,
p.000280: school, friends, television, internet etc. However, there are also changes during adulthood, even if
p.000280: certain characteristics are gradually stabilized, comprising foundations for the “development” of
p.000280: personality. The very term “development”, suggests “change” anyway.
p.000280: Therefore, the critical point to our subject is not whether, in general, personality development is
p.000280: legitimate, but rather whether such a change can be so radical that can lead to psychological
p.000280: pathologies, i.e. to cause damage to a person’s mental health. Besides extreme exceptions,
p.000280: mechanisms of socialization do not cause so deep “sections” in a person’s
p.000280:
p.000280:
p.000281: 281
p.000281:
p.000281: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000281: REPORT
p.000281:
p.000281: personality. On the contrary, socialization mechanisms “build” on the grounds formed in infancy,
p.000281: which are associated with inherent cognitive abilities (including perception of space, time, etc.),
...

p.000281: contrast, the use of pharmaceuticals -similarly to the use of substances such as alcohol or drugs- can
p.000281: cause such sections, which may lead to serious mental illness. The main reason is that these substances have a
p.000281: strong invasive impact on the function of the nervous system, with largely unpredictable effects on the mechanisms of
p.000281: cognition.
p.000281: This point is important in order to distinguish schematically between “safe” and “unsafe” personality change,
p.000281: but it is not enough to answer the question of whether the second one is legitimate or not. Similarly to alcohol or
p.000281: drug use, a person intentionally uses pharmaceutical agents, and this is done in the context of self-determination,
p.000281: even if the person is aware of the potential serious harm to his/her health. It is generally accepted that self-
p.000281: determination does not exclude choices of an even great risk or choices of “self-destruction”, since otherwise we
p.000281: must adopt paternalistic lifestyles, something that would be fundamentally in contrast to our freedom.
p.000281: Consequently, the possibility of drug use for enhancement purposes that could lead to a radical personality change (or
p.000281: to milder effects on memory capacity, emotional life, etc.), cannot be considered as an illegitimate
p.000281: choice, given the primacy of personal autonomy (Racine & Forlini, 3).
p.000281: However, two reservations remain:
p.000281: - The consequences of drug use do not cause damage to goods of a third party (e.g. in the context of
p.000281: family life or working environment of the user). Thus, for example, drug use that leads to indifference or threat for
p.000281: the user’s children or creates tension with colleagues etc., is illegitimate).
p.000281: - The user has actually made the decision freely, i.e. after providing the appropriate information to him/her, with
p.000281: all the potential risks being identified (Cakic, 613-614, Racine & Forlini, 3, Farah et al., 423). This is not certain,
p.000281: especially when the drugs are administered without a prescription or, at least, without consulting a physician.
p.000281: The re- sponsibility of the latter, here, is certainly increased, as it is about enhancing cognitive or
p.000281: mental characteristics and not about restoring relevant health damage.
p.000281:
p.000281:
p.000282: 282
p.000282:
p.000282: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000282: REPORT
p.000282:
p.000282: 4. Equal access
p.000282:
p.000282: The issue of equal access to means of cognitive or mental enhancement is mainly associated with the
...

General/Other / Incapacitated

Searching for indicator incapacitated:

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p.000116: choice because they may be associated with serious side effects, critical perhaps for the overall quality of life
p.000116: of the patient (e.g. chemotherapy, radiotherapy, amputation, etc.). For patients of advanced age, in particular, even
p.000116: the normal side effects of an “aggressive” treatment may prove disproportionate in comparison with the real expected
p.000116: benefit.
p.000116: The relevant question here is whether information should be limited to a “neutral” presentation of alternatives or
p.000116: it should be accompanied by the physician’s evaluation for the particular patient. This question is again relat-
p.000116: ed to “completeness” of information in the sense of the law.
p.000116: A “neutral” presentation, if “complete”, leaves the appraisal of the situa- tion to the patient since only the patient
p.000116: can balance the benefits and losses for his/her quality of life. This burden, however, may prove difficult to bear for
p.000116: someone who is not able to think soberly about his/her condition. On the other hand, the physician’s
p.000116: evaluation may offer valuable help in the final decision by the patient; but this must necessarily arise from
p.000116: statistics - which do not take the particular patient into consideration- and, ultimately, from an “intuitive”
p.000116: perception of what is “best” in concreto, i.e. factors not immune to error.
p.000116:
p.000116: b) Problems pertaining to consent
p.000116:
p.000116: Problems pertaining to consent itself arise in the relationship physician- patient in case of incapacitated patients:
p.000116: First, as to the derogations from informed consent accepted by the CME (art. 12[3]), there is the question of
p.000116: whether a patient’s relatives may, in general, refuse treatment and to what extent are they allowed to do so. The
p.000116: “risk to health”, as a limit prescribed by the law, is susceptible of broad in- terpretation and needs to be
p.000116: further specified. Certainly, the discretion to “refuse treatment” is not the same for patients and
p.000116: relatives as the latter are not able to experience the disease. On the other hand, relatives may not
p.000116:
p.000116: 6 For an example of deterioration of the patient’s health because of a similar initia- tive by the physician, see Higgs
p.000116: (op. cit.) p. 435.
p.000116:
p.000117: 117
p.000117:
p.000117: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000117: REPORT
p.000117:
p.000117: be “obligated” to allow treatment for this would defeat the basic tenet of their freedom to consent on behalf of the
p.000117: patient.
p.000117: Continuing on the question of derogations, it is worth noting the differ- ent approach of the CME as compared with art.
p.000117: 1534 of the Civil Code (CC) which allows the physician to act alone in case the parents of a minor refuse to give their
p.000117: consent to treatment. The Civil Code requires authorization by the Prosecutor whereas the CME does not. The question is
...

Searching for indicator incapacity:

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p.000093: that these are really “luxury issues” that should be left aside until recovery.
p.000093: At the other side of this line of reasoning, the recession can be seen as an opportunity to redefine the notion of
p.000093: “development”. That is, to recog- nize the quality of the environment and, by extension, environmental pro- tection as
p.000093: a non-negotiable value, an indispensable aspect of development.
p.000093: To achieve this, it will be necessary to turn the spotlights more on ques- tions of environmental policy and
p.000093: related actions in order to upgrade the priority of environmental protection issues at large, and of
p.000093: biodiversity in particular. Critical here is the encouragement by government of business initiatives to take
p.000093: targeted actions to protect the environment.
p.000093:
p.000093: The problem of control
p.000093:
p.000093: The perception of environmental protection as a “local issue” -and the ensuing delegation of control mainly to
p.000093: local government agencies- does no longer respond to the urgent need to deter large-scale damage which is al- ready
p.000093: occurring with increased frequency in our country as well. Serious mismanagement practices in environmental
p.000093: questions are often seen with the connivance of local authorities. The State must take up the main respon-
p.000093: sibility of control with its central and decentralised services. In the same vein, the relevant legislation
p.000093: needs to be revised accordingly.
p.000093: On the other hand, there is the problem of the actual incapacity of Panel V of the Judicial Review Court which rules on
p.000093: environmental matters to car- ry out technical evaluations of the accuracy of environmental impact as-
p.000093: sessments submitted by public bodies (especially in regard to public works).
p.000093:
p.000093:
p.000094: 94
p.000094:
p.000094: MANAGEMENT OF BIOLOGICAL WEALTH
p.000094: REPORT
p.000094:
p.000094: These assessments include chapters on the protection of biodiversity but the Court cannot conduct technical
p.000094: verifications and limits itself to review- ing the formality of assessments.
p.000094: A deeper control could be achieved either with the assistance of “amici curiae” (technical advisors to the court
p.000094: with no voting rights from special agencies, environmental NGOs, etc.) or with a permanent experts
p.000094: division on environmental issues.
p.000094:
p.000094: Particular issues of biodiversity protection Knowledge of Greek biodiversity
p.000094: The species of Greek nature are recorded only in a piecemeal and “stat- ic” way (e.g. by the NAGREF, the Goulandris
p.000094: Foundation, the Hellenic Orni- thological Society and other environmental NGOs). The YPEHODE has fund- ed related
p.000094: research but big gaps remain (especially as regards marine biodi- versity). A detailed inventory of species and
p.000094: the systematic monitoring of changes in habitats, populations, etc., are indispensable to the protection of
p.000094: biodiversity.
p.000094: Therefore, a specially designated body must take charge of the coordina- tion of the recording and monitoring of
p.000094: domestic species (an appropriate candidate would be, for instance, the Greek Centre of Biotopes/Wetlands) in
...

p.000113: physician-patient in Greek
p.000113:
p.000113:
p.000113:
p.000114: 114
p.000114:
p.000114: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000114: REPORT
p.000114:
p.000114: law2. The main characteristic of this law is the explicit introduction of “in- formed consent” albeit
p.000114: maintaining provisions which reflect the former “pa- ternalistic” approach.
p.000114: It must be noted that “informed consent” was already embedded in Greek law, first, through the
p.000114: ratification of the Oviedo Convention on Hu- man Rights and Biomedicine (art. 5 et seq. Law 2619/1998) and,
p.000114: second, by way of express provisions in a number of laws on various medical fields3. Naturally, the
p.000114: relevant rules of the CME are more detailed. Pursuant to the CME:
p.000114: - Informed consent is always required except in case of: a) emergen- cies, b) suicide attempts, and c) refusal to
p.000114: consent by the guardian of a person incapable to consent in a life- or health-threatening situa- tion.
p.000114: - The consent must be explicit though it may be informal.
p.000114: - In case of minors, the consent is provided by their parents or custo- dian.
p.000114: - In other cases of incapacity, the consent is given by the “next of kin” or the legal guardian.
p.000114: Consent requires that the patient (or the patient’s representative in case of incapacity) must “be informed”. This
p.000114: information:
p.000114: - Must be “complete” and “intelligible”.
p.000114: - Must reflect the truth.
p.000114: - Must cover: a) the real condition of health, b) the content of the sug- gested medical act, c) the risks and likely
p.000114: side effects, d) alternative
p.000114:
p.000114:
p.000114: 2 Despite its title (“Code of Medical Ethics”) this Law was not an instance of investing with legal authority a
p.000114: pre-existing corpus of norms accumulated by the medical pro- fession in the context of self-regulation (a stricto sensu
p.000114: code of ethics). It was genuine lawmaking by the government and went through the usual pipeline of
p.000114: law- enactment (a drafting committee was set up for that purpose; its draft text was duly tabled by the responsible
p.000114: Ministry for Health to go through the parliamentary proce- dure). In that respect, the title “Code of Medical Ethics”
p.000114: is not accurate, although the same wording was also used in the previous situation enacted by the royal
p.000114: decree 25.5/6.7.1955.
p.000114: 3 See art. 10 (4) Law 2737/1999 on transplants, art. 1456 of the Civil Code (Law 3087/2002) on
p.000114: assisted reproduction, art. 3 of the Joint Ministerial Decision 89292/2003 (Directive 2001/20) on
p.000114: clinical trials.
p.000114:
p.000115: 115
p.000115:
p.000115: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000115: REPORT
p.000115:
p.000115: treatment choices, and, e) the estimated time of recovery. The aim is to enable patients to consider not only the
p.000115: medical but also the social and economic factors before reaching a decision.
p.000115: - Patients may refuse to be informed (right-to-not-know) either totally or by authorizing the physician to inform
p.000115: others.
p.000115: Even in case of incapacity, however, the law acknowledges a duty to in- form the patient “to the extent possible” and
p.000115: an effort to ensure “voluntary participation”, “active involvement” and “cooperation”, especially in pa- tients
p.000115: preserving some capacity of understanding.
p.000115:
p.000115: Ambiguities
p.000115:
p.000115: The complexity usually characterizing medical conditions combined with certain ambiguities in the provisions of the law
p.000115: raise problems of interpreta- tion, as might be expected. These are multiplied with regard to “special cas- es”
p.000115: regulated by the law mainly concerning the application of new methods of technology in medical practice (arts. 29-34).
p.000115:
p.000115: a) Problems pertaining to information
p.000115:
p.000115: The main problem here is the notion of “truth”. The law often repeats the term “complete” information. Combined
p.000115: with the “duty of truth”, this seems to imply, at a first reading, that the physician must hide nothing
p.000115: in connection to the condition of health or to the offered methods of treat- ment from the patient4. Two
p.000115: questions arise in this respect:
p.000115: i. If the physician believes that, by learning the “complete” truth, the patient will be either discouraged from
p.000115: receiving treatment or affect- ed to such extent that it becomes threatening for his/her condition, can the information
p.000115: be limited or -in extreme cases- may the physi- cian even misinform the patient5?
p.000115:
p.000115: 4 Insofar as the “truth” appears clear to the physician, of course. The issue here is not whether the information
p.000115: provided by the physician is true but whether the physician himself/herself consciously tries to mislead the patient,
p.000115: see Higgs (2001).
...

p.000126: decision on the course of treatment- is significantly cur- tailed by the hospital environment, the role of the medical
p.000126: and nursing staff becomes even more decisive.
p.000126: Hospitalized patients, however, even patients in the ICU, are usually ca- pable to give an informed consent. This means
p.000126: that physicians remain fully liable for allowing patients to participate in the course of the particular
p.000126: treatment and may not legitimately act alone. In conditions of “internment”
p.000126: -especially in ICUs- the risks of manipulation of the patient’s will by the phy- sician are increased. Patients can be
p.000126: easily forced into accepting things for they are understandably eager to have their health restored as soon as pos-
p.000126: sible in order to return to the freedom of everyday life and recover the full exercise of their autonomy.
p.000126: At this point we must underline that physicians have a heightened ethi- cal duty to provide complete information.
p.000126: The more comprehensive the information, the greater the likelihood for an independent appraisal of the situation
p.000126: -and decision-making- by a de facto vulnerable will. By contrast, limited information can more easily lead to
p.000126: manipulation of the patient by the physician since the patient is called upon to evaluate and decide in an unfamiliar
p.000126: environment of internment, more prone to “blind obedience” rather than genuine exercise of autonomy.
p.000126:
p.000126: 6. Incapacity to consent
p.000126:
p.000126: The legal capacity to consent must be distinguished from the corre- sponding physical capacity. Patients
p.000126: with full legal competence to consent may suffer a temporary disorder of their mental functions which
p.000126: prevents the forming and expression of free will (e.g. under the influence of alcohol or narcotics or in state of
p.000126: shock because of an accident or the announce- ment of a serious disease, etc.)10.
p.000126:
p.000126:
p.000126: 10 This is a case for the application of art. 131 CC which stipulates the nullity of ex- pression of will in such
p.000126: circumstances. See generally on the problem of “irrational”
p.000126:
p.000127: 127
p.000127:
p.000127: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000127: REPORT
p.000127:
p.000127: In these circumstances acting alone is again not justified for physicians except in emergency situations. They must
p.000127: concentrate their efforts on the speedy recovery of the patient’s mental lucidity so that the patient can be informed
p.000127: in time and decide about treatment by himself/herself. Besides, it is not legitimate to substitute the patient’s
p.000127: relatives for the patient’s own will for patients may disagree with their relatives’ decision once their mental
p.000127: capacities are restored.
...

General/Other / Manipulable

Searching for indicator manipulate:

Searching for indicator manipulated:

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p.000056: publi- cation made Hwang quite famous and, had the fraud not been revealed, he would certainly have been rocketed
p.000056: to summits of professional celebrity. This case exemplified issues of ethics and review of the validity of research
p.000056: results as well as the inextricable link between ethics and the quality of sci- entific research (Resnik et al., 2006).
p.000056: Not only is private financing seen as welcome but the increase of private funding figures among the goals of most
p.000056: national policies for research and technology worldwide (European Commission, 2007a). It has promoted pro- gress in
p.000056: science and technology and has often made up for the inability of the state to provide adequate funds to all scientific
p.000056: fields. The decoding of
p.000056:
p.000056:
p.000057: 57
p.000057:
p.000057: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000057: REPORT
p.000057:
p.000057: the human genome, for instance, was made possible by a partnership of private and public bodies.
p.000057: The source of financing, however, can affect the validity of research find- ings especially if the sponsor has a
p.000057: vested interest in the outcome of the research. One example is clinical trials financed by pharmaceutical compa-
p.000057: nies. It has been reported that trials of new drugs used in oncology and fi- nanced by the pharmaceutical company which
p.000057: is going to produce the drugs are eight times more likely not to reach negative results compared to inde- pendently
p.000057: funded trials (Friedberg et al., 1999). Similar cases of manipulated research have been reported in other clinical and
p.000057: epidemiological trials in- cluding the notorious example of research manipulated by the tobacco in- dustry (Tong and
p.000057: Olsen, 2005; Lesser et al., 2007). Public sources of financ- ing can also be interventionist. The “Union of
p.000057: Concerned Scientists” has a list of cases of government intervention to conceal or manipulate research findings for
p.000057: political reasons.
p.000057: To give the problem its real dimensions, according to US data on re- search conducted by publicly
p.000057: funded agencies, in the last 200 years there have been 200 cases of confirmed misconduct (Resnik, 2007).
p.000057: This figure which represents approximately 0.01% of the entire research community for this period probably
p.000057: underestimates reality but implies that such phenome- na and specific cases of deliberate fraud are relatively limited.
p.000057: This, howev- er, does not mean that the problem does not require serious consideration. As the above examples
p.000057: demonstrate, the validity of biological research has a direct impact on society and often affects public health
p.000057: directly. The exist- ence of and compliance with recognized code of ethics is important not only in order to defend the
p.000057: safety and the rights of volunteers or lab animals. It is also required to ensure the quality of the results, to
p.000057: maintain public support for research, to achieve accountability to society -the source of funds- and for the
p.000057: harmonious and effective co-operation between researchers (Resnik, 2007).
...

General/Other / Public Emergency

Searching for indicator emergency:

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p.000106: emer- gency situations. However, the example of the CME stipulating that: “In the exercise of medicine, physicians act
p.000106: with total freedom within the generally accepted rules and methods of medical science… They may choose the
p.000106: method of treatment which in their view is significantly better against all others for the particular
p.000106: patient based on modern rules of medical sci- ence…”1, demonstrates that the traditional model of the
p.000106: relationship pa- tient-physician has not been fully abandoned in Greece as it has in other jurisdictions.
p.000106:
p.000106: II. Problems in the implementation of autonomy and related proposals
p.000106:
p.000106: A. The problem in general
p.000106:
p.000106: Although the need for active involvement by patients in determining treatment is now widely acknowledged, it
p.000106: is often defeated in medical prac- tice. The main reasons for this failure are the following:
p.000106: - Limited time for communication between physician-patient,
p.000106: - lack of clarity on the appropriate extent of information,
p.000106: - deficient training of physicians on the relationships they need to de- velop with patients, and,
p.000106: - occasionally, lack of familiarization of the general public with the rights and possibilities of every user of
p.000106: health services to cooperate with phy- sicians in order to reach the result best suited for the patient’s way of
p.000106: living.
p.000106:
p.000106: a) Time
p.000106: Scarcity of time is, at first sight, a purely practical matter arising mostly in first aid and emergency situations.
p.000106: The Commission thinks that, even in these circumstances, understanding the needs of patients and exercise of autonomy
p.000106: should be considered as an integral part of medical acts so that the allocation of the available time -
p.000106:
p.000106:
p.000106: 1 Art. 3 (3).
p.000106:
p.000107: 107
p.000107:
p.000107: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000107: OPINION
p.000107:
p.000107: even if limited- can be adjusted accordingly insofar as full communication with the patient is possible.
p.000107:
p.000107: b) Extent of information
p.000107: Pursuant to the CME “the physician has a duty of truth to the patient”2. But the patient has the right to refuse
p.000107: information (right to ignorance) and ask the physician to inform exclusively one or more other persons to be indi-
p.000107: cated by the patient3.
p.000107: But the extent of information that qualifies as appropriate to enable the patient to decide freely remains unclear. As
p.000107: the available empirical data in- dicates4, the majority of patients in our country apparently want more ex- tensive
p.000107: and more sincere information compared to what some physicians currently provide or believe they have to
p.000107: provide.
p.000107: The Commission points out that:
p.000107: i) Unless the right to ignorance is invoked, the physician must provide all those elements that will enable the
p.000107: patient to form a full and, mainly, an intelligible picture of the situation so that he/she may be assisted in
p.000107: making a decision. Elementary information alone will not do. In any event, the in- formation must be appropriate and
...

p.000122: with according to his/her needs. To meet this goal, it is important to dedicate time to the develop- ment
p.000122: of a relationship of communication between the physician and the patient such that the former will understand
p.000122: the needs of the latter and the patient will feel free to express his/her wishes. Appropriate training on
p.000122: communication with patients and on ways to announce an ominous diagno- sis is equally important for an efficient
p.000122: physician-patient relationship. The lack of such training is stressed by many Greek authors who have investigat- ed
p.000122: honesty and patient information (Mystakidou et al., 1996; Rigatos, 1997).
p.000122:
p.000122:
p.000123: 123
p.000123:
p.000123: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000123: REPORT
p.000123:
p.000123: 2. The problem of time
p.000123:
p.000123: According to a frequent argument, it is difficult to implement the model of consent in the limited time available
p.000123: to case management. Experience shows that this time shortage is due either to the nature of the case itself
p.000123: (“emergencies”) or to the inadequate organization of health services espe- cially when faced with occasional peaks of
p.000123: demand.
p.000123: It is worth noting that, in the first case, it is generally admitted -and ex- pressly stipulated by the law- that
p.000123: physicians may act alone, namely “in- formed consent” does not apply. The notion of “emergency” is very broad and
p.000123: needs to be further specified. Assuming that its use must be regarded as exceptional, its scope is limited to: i)
p.000123: cases posing an immediate threat against the patient’s life, or, ii) cases where even the slightest delay in
p.000123: ef- fecting the indicated medical act will definitely cause serious harm to health. Thus, moderate harm to health, even
p.000123: when demanding immediate action, or serious but chronic pathological conditions (e.g. many forms of cancer, dia- betes,
p.000123: etc.) cannot qualify as “emergencies”. In-between these two ex- tremes, there is an area in which the
p.000123: rule of consent must apply with the necessary adjustments to the available margins of time9.
p.000123: As far as inadequate organization of health services is concerned, the possibility to allocate the required
p.000123: time depends mostly on objective, often non-elastic, parameters (e.g. restricted resources to employ additional med-
p.000123: ical staff). Especially here, however, the issue of appropriate training and sensitization of civil health
p.000123: services to patient autonomy is crucial. For, if patient consent is not to be considered a “luxury” but an
p.000123: essential condition for the protection of health and, ultimately, for quality of life, then this re- quirement
p.000123: obviously affects the priorities of the organization of services in a way that makes finding the required time
p.000123: feasible.
p.000123:
p.000123: 3. Education - Training
p.000123:
p.000123: Among the reasons invoked by physicians to justify the concealment of diagnosis from their patients in Greece, as well
p.000123: as in other countries which
p.000123:
p.000123: 9 However, for a discussion on whether summary information provided to a patient capable to consent qualifies as
p.000123: “appropriate” in emergency circumstances see also Young, 2001.
p.000123:
p.000124: 124
p.000124:
p.000124: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000124: REPORT
p.000124:
p.000124: share the same practice, is the lack of training (Mystakidou 1996; Iconomou 2002).
p.000124: The question of deficient training of physicians in patient autonomy in Greece has at least two sides. The
p.000124: first concerns the knowledge of the rights of patients and the second the implementation of these rights and the ef-
p.000124: fective communication with patients. Typically, in the Medical School of the University of Athens, medical ethics
p.000124: remains an optional subject. The same deficit permeates all the national curricula in regard to learning how to ap-
p.000124: proach patients and develop meaningful relationships with them taking into account the whole spectrum of the patient’s
p.000124: needs and respecting his/her autonomy.
p.000124: The new model of the physician-patient relationship involves active par- ticipation on the part of the patient.
p.000124: Patients need appropriate education too, if they are to respond to this role. Therefore, education is an issue not
p.000124: only for physicians but for society as a whole.
p.000124:
p.000124: 4. Epidemiology: Vaccination
p.000124:
p.000124: In the prevention of infectious diseases, especially in the example of vac- cination, free will of the individual must
p.000124: be weighed against the interest of society as a whole. Should the Commission decide to consider the question of patient
...

p.000126: manipulation of the patient by the physician since the patient is called upon to evaluate and decide in an unfamiliar
p.000126: environment of internment, more prone to “blind obedience” rather than genuine exercise of autonomy.
p.000126:
p.000126: 6. Incapacity to consent
p.000126:
p.000126: The legal capacity to consent must be distinguished from the corre- sponding physical capacity. Patients
p.000126: with full legal competence to consent may suffer a temporary disorder of their mental functions which
p.000126: prevents the forming and expression of free will (e.g. under the influence of alcohol or narcotics or in state of
p.000126: shock because of an accident or the announce- ment of a serious disease, etc.)10.
p.000126:
p.000126:
p.000126: 10 This is a case for the application of art. 131 CC which stipulates the nullity of ex- pression of will in such
p.000126: circumstances. See generally on the problem of “irrational”
p.000126:
p.000127: 127
p.000127:
p.000127: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000127: REPORT
p.000127:
p.000127: In these circumstances acting alone is again not justified for physicians except in emergency situations. They must
p.000127: concentrate their efforts on the speedy recovery of the patient’s mental lucidity so that the patient can be informed
p.000127: in time and decide about treatment by himself/herself. Besides, it is not legitimate to substitute the patient’s
p.000127: relatives for the patient’s own will for patients may disagree with their relatives’ decision once their mental
p.000127: capacities are restored.
p.000127: Respectively, persons who are legally incompetent to consent may be physically fully capable of forming and
p.000127: expressing their will on matters con- cerning their health. We already mentioned the example of minors, espe-
p.000127: cially from the beginning of adolescence; similar, however, is the situation of persons under legal guardianship
p.000127: (even full-fledged) whereas mild mental disorders or impairments do not by definition exclude the exercise of self-
p.000127: control over one’s health.
p.000127: In the case of minors, it would be more appropriate to recognize their capacity for self-consent after a certain
p.000127: age (thus precluding consent by the minor’s legal representatives) for there is an objective presumption of suffi-
p.000127: cient maturity in contemporary societal life that can hardly be put in ques- tion (e.g. from the age 15 years).
p.000127: Meanwhile the assent of minors must be given considerable weight in relevant decisions, especially if coinciding with
...

p.000139: the free- dom of movement and establishment). The possibility of the latter is stipu- lated in the international law
p.000139: and modern national legal systems, including Greece.
p.000139: As the path of transmission and the severity of infectious diseases vary significantly, the nature and extent of such
p.000139: limits require special attention.
p.000139:
p.000139: 2. The priority of the principle of autonomy
p.000139:
p.000139: In this context, the Commission confirms its Opinion on the supremacy of personal autonomy, meaning the freedom of the
p.000139: individual to decide on matters relating to the personal health and the way of living, providing that the lives of
p.000139: other people are not significantly affected.
p.000139: What this assumption primarily means is that when the medical commu- nity is called to provide advice on
p.000139: measures required to protect public health or when public authorities are called to adopt such measures, auton- omy
p.000139: should not be limited without adequate documented justification.
p.000139: In particular, the Commission believes that the general rules on the ex- ercise of autonomy in patient-physician
p.000139: relationship allow an effective man- agement of transmissible infectious diseases. For example: the appropriate
p.000139: information to patients -including, among other things, advice on self- limitation- or, exceptionally, the
p.000139: supremacy of medics to act on their own initiative in case of emergency. At any rate, the discretion
p.000139: to impose re- strictions is limited when dealing with difficultly transmitted viruses or mild infections.
p.000139:
p.000139: II. Special issues
p.000139:
p.000139: When public health is at risk due to the spreading of infectious disease the Commission considers the following:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000139:
p.000140: 140
p.000140:
p.000140: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000140: OPINION
p.000140:
p.000140: 1. Restrictions to autonomy relating to personal health
p.000140:
p.000140: a) Basic principles
p.000140: Preventive measures adopted by public authorities to address threats against the health of others may include
p.000140: restrictions on personal autonomy in matters of health but only in exceptional circumstances. “Exceptional” are the
p.000140: circumstances of spreading epidemics or pandemics, according to the internationally accepted definitions of
p.000140: these terms. National authorities may not arbitrarily dilate these definitions.
p.000140: In such circumstances, medics and designated health authorities do not have the obligation to ask for patient
p.000140: consent and they could act on their own initiative (self-action). The legal basis for such restrictions
p.000140: consists mainly in art. 8 of the Convention on Human Rights and Biomedicine (Ovie- do Convention), which justifies
p.000140: medical self-action in “emergency situa- tions”.
p.000140: In this context, restrictions must comply with the principle of propor- tionality, i.e. they must be
p.000140: appropriate and necessary in order to protect public health without exceeding the purpose for which they are
p.000140: adopted.
p.000140:
p.000140: b) Vaccination
p.000140: In principle, the vaccination of the population as a measure of preven- tion, particularly the vaccination of
p.000140: vulnerable groups, requires informed consent. In this context, relevant information may be also provided to the
p.000140: general public through the media. The duty of public authorities is to ensure the validity of this information by
p.000140: allocating the task exclusively to a respon- sible entity and by taking steps to avoid inaccuracies which may inspire
p.000140: dis- trust or fear. It is worth noting that 99% of children in the US are vaccinated with a minimum rate of
p.000140: complications, which proves that benefits far ex- ceed any drawbacks; therefore, it is not justified to
p.000140: spread doubts. In “emergency situations” in the above sense, the Commission feels that even mandatory vaccination is
p.000140: not to be excluded, especially for those who are highly probable to become carriers and transmit the
p.000140: infection due to the nature of their occupation. They should be offered, however, the option of changing duties. The
p.000140: established scientific requirements for clinical trials of new treatments (vaccines or medicines) may not be
p.000140: bypassed in order to
p.000140:
p.000140:
p.000140:
p.000141: 141
p.000141:
p.000141: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000141: OPINION
p.000141:
p.000141: accelerate the availability of such treatments to the public. Otherwise their efficacy will remain uncertain and
p.000141: citizens will be misinformed as a result.
p.000141: In addition, the Commission thinks that in the exceptional circumstances of epidemics or pandemics, limits to
p.000141: patents on new treatments could be justified to the extent possible. Such limits could be argued as a legal/policy
p.000141: choice in competent international and supra-national fora.
p.000141:
p.000141: c) Treatment
p.000141: The treatment of those infected should also be based on informed con- sent. Forced treatment is not justified in
p.000141: principle, except in “emergency situations”.
p.000141: When the number of medical and nursing staff or the available treat- ments do not suffice to ensure care to
p.000141: all those infected (especially in case an infection spreads rapidly) the Commission stresses that the government must
p.000141: establish in advance general priority rules for access to treatment. The basic priority criteria should preferably be
p.000141: prescribed by law. By way of indi- cation, such priority criteria may include the severity of symptoms, the age of the
p.000141: patient and the definition of relevant vulnerable groups.
p.000141:
p.000141: 2. Limits to autonomy on public health grounds
p.000141:
p.000141: a) General rule
p.000141: Limits to the general autonomy of patients -especially the freedom of movement and establishment- are
p.000141: justified only if they are absolutely in- dispensable to protect public health pursuant to the Constitution
p.000141: (arts. 5 [4], 25 [1]). The principle of proportionality as discussed above applies in all circumstances. For
p.000141: example, hospitalized patients should be restricted in specially contained facilities.
p.000141:
p.000141: b) The risk of social stigma
...

p.000145: spreads significantly world- wide. The 1919 influenza and HIV/AIDS from the 1980s are examples of
p.000145: pandemics (Encyclopedia of Public Health, epidemics). After the manifesta- tion of an epidemic the disease may
p.000145: disappear or persist in the population in latent form causing occasional outbreaks or remain endemic with a steady
p.000145: number of patients.
p.000145: Nowadays, the term “epidemic” is not only used for contagious diseases. It can be used for other pathologies, currently
p.000145: on the rise, like cancer or car- diac disease, even for conditions that are not a proper disease, like obesity. This
p.000145: report, however, focuses only on transmissible diseases, since they give rise to the particularities of the
p.000145: implementation of personal autonomy in medical practice, when a conflict with public interest arises, i.e. the
p.000145: protec- tion of the healthy population from the transmission of pathogens from pa- tients or carriers.
p.000145:
p.000145:
p.000145:
p.000146: 146
p.000146:
p.000146: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000146: REPORT
p.000146:
p.000146: Measures of protection against infectious disease are taken by responsi- ble health authorities irrespective of
p.000146: outbreaks. Restrictions to personal autonomy can be applied even without an increased risk of epidemics.
p.000146: However, once a disease is qualified as epidemic or pandemic, emergency measures shall be taken. Accordingly,
p.000146: the legitimacy or illegitimacy of re- strictive measures will obviously be influenced by the level of
p.000146: risk or the manifestation of an epidemic.
p.000146: It must be noted that a disease can amount to an epidemic based on the relative, not absolute, numbers of infected
p.000146: people. Thus, a relatively small number of patients or carriers can give rise to an epidemic. This is to
p.000146: say that the terms “epidemic” or “pandemic” do not necessarily involve an emergency situation. The risks
p.000146: posed by a disease depend on its specific characteristics, like the severity of symptoms, mortality rates and
p.000146: infectivity.
p.000146:
p.000146: 3. Preventive measures
p.000146:
p.000146: One of the most effective tools of contemporary medicine in the preven- tion of transmissible diseases is vaccination.
p.000146: To mention a typical example, smallpox was eliminated thanks to successful immunization against the dis- ease. Vaccines
p.000146: reinforce the defenses of recipients against the specific path- ogens for which they are designed, preparing the immune
p.000146: system to imme- diately recognize and effectively resist any future attacks by these patho- gens. Vaccines
p.000146: do not ensure absolute protection and people may still be infected with a disease against which they were
p.000146: vaccinated. Vaccines, how- ever, significantly reduce the probability of infection as well as the severity of symptoms
p.000146: in the event of infection.
p.000146: The success of a vaccination programme, however, depends not only on the efficacy of the vaccine but also on the rate
p.000146: of the population participat- ing in the programme. Vaccination does not reduce only the likelihood of
p.000146: infection in case of contact with the pathogen but also the likelihood of such contact itself, if sufficient numbers of
p.000146: the population are vaccinated. This is known as “indirect immunity” or “herd immunity”. Therefore, the decision to be
p.000146: vaccinated or to have one’s children vaccinated has implications for society as a whole because the vaccine
p.000146: protects not only recipients but also the rest of the population. Therefore, the decision to participate or not in a
p.000146:
p.000146:
...

p.000151: Although “triage” is mostly associated with war (and natural disasters or train derailments) its core concept can be of
p.000151: use also in case of epidemics.
p.000151: At all events, health care priorities must be set by public authorities in advance on the basis of fixed rules in
p.000151: order to prevent physicians from hav- ing to make so many ethically questionable judgments.
p.000151:
p.000151: 4. Special issues: Clinical trials, patents
p.000151:
p.000151: The urgent need for prevention and treatment in times of epidemics painfully illustrates the question of
p.000151: the adverse effects of trials of new treatments (medicines, vaccines) to contain the risk.
p.000151: Given that clinical trials are now subjected to a specific control proce- dure, ensuring the safety of
p.000151: volunteering participants and of the end- product before it becomes available to the public, at issue is
p.000151: whether this procedure should be relativized in case of an urgent need to supply new cures. Since the
p.000151: pursuit of absolute safety, even in normal circumstances, obviously undermines the effort to find new cures (as
p.000151: being too time- and resource-consuming) the debate on the “maximization of risk” is not with- out cause. The criteria
p.000151: of socially acceptable risks from a new medicine or vaccine are ultimately a matter for bioethics, and must
p.000151: be considered as such.
p.000151: Similar arguments can be made on the scope of patents -and, with that, on the scope of trade prerogative- on new
p.000151: treatments in case of emergency. Here too, limiting the duration of privilege of the patent holder for the sake of
p.000151: providing easier (and cheaper) access to a highly needed drug or vaccine is a matter for bioethics.
p.000151:
p.000151: III. The legal dimension
p.000151:
p.000151: 1. International law
p.000151:
p.000151: Public health is considered as a remit of national sovereignty. As a result, there are no international policies
p.000151: underpinned by international rules for the moment on the protection from epidemics except from trade in food-
p.000151:
p.000151:
p.000152: 152
p.000152:
p.000152: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000152: REPORT
p.000152:
p.000152: stuffs and animal feed. To this, we must add the reluctance of developed countries to effectively combat
p.000152: serious transmissible diseases, which are endemic in developing countries (e.g. malaria, tuberculosis, HIV).
p.000152: Nevertheless, provisions on international protection from epidemics exist in the form of guidelines (IHRS)
p.000152: issued by WHO. These guidelines are not legally binding, of course, but non-compliance can lead to other types of
p.000152: sanctions (e.g. WHO travel alerts). Considering that international move- ments, immigration flows and trade
p.000152: have become easier with globalization and with the recent experiences of wide-spreading transmissible diseases in mind,
p.000152: proposals are under discussion with a view to developing internation- al instruments in this field.
p.000152:
p.000152: 2. Greek law
p.000152:
p.000152: The protection of the population from the transmission of contagious diseases is governed by arts. 21
p.000152: (3) and 5 (4) of the Constitution and art. 5(1)(e) of the European Convention of Human Rights (ECHR)1.
p.000152: Under art. 21 (3), the Constitution recognizes health as a social right in addition to its recognition as an individual
p.000152: right2. Thus, a distinction is drawn between the right of the individual citizen to take care of matters pertaining to
p.000152: personal health and public health care for all. In this sense, the social en- titlement to health can be taken as
p.000152: a basis for adopting health protection measures (organizing vaccination programmes, blood donations, etc.).
p.000152:
p.000152: 1Article 5 (4) of the Constitution: “Individual administrative measures restricting the free movement or residency in
p.000152: the national territory or the free entry into or exit from it to any Greek citizen shall be prohibited. Such
p.000152: restrictive measures may be imposed only as ancillary sanctions by criminal court ruling in exceptional emergency
p.000152: circum- stances exclusively for the prevention of indictable offences as specified by Law”.
p.000152: Interpretation clause:
p.000152: Paragraph 4 does not preclude the prohibition to leave the country by order of public prosecutor due to criminal
p.000152: proceedings or measures imposed on grounds of public health protection or the protection of patients as
p.000152: specified by Law”.
p.000152: Article 21 (3) of the Constitution: “The State shall care for the health of citizens and shall adopt specific measures
p.000152: to protect youth, old age, disability and health care for indigents”.
p.000152: 2 Article 5 (5) of the Constitution: “Everyone is entitled to the protection of their health and genetic
p.000152: identity…”.
p.000152:
p.000153: 153
p.000153:
p.000153: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000153: REPORT
p.000153:
p.000153: However, both the Constitution and the ECHR acknowledge the need of re- strictive measures to protect public health.
p.000153: Thus, the art. 5(4) of the Constitution (interpretation statement) excep- tionally accepts individual administrative
...

p.000153: transmissible infectious diseas- es typically demonstrates. Therefore, the exercise of autonomy in this
p.000153:
p.000153:
p.000154: 154
p.000154:
p.000154: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000154: REPORT
p.000154:
p.000154: area must take public interest into account -i.e., the protection of pub- lic health- and, in all terms, is determined
p.000154: by such interest.
p.000154: 2. The above statement does not imply that personal autonomy may be “brought to tatters” -or virtually eliminated- by
p.000154: policy choices to pro- tect public health. Autonomy is still the rule, even in case of epidemics or pandemics, which
p.000154: means that any encroaching measures are always exceptional and can be justified only to the extent that they
p.000154: are de- monstrably appropriate for the objective they serve (principle of pro- portionality). It is, therefore,
p.000154: indispensable to distinguish between in- fectious diseases depending on the level of risk and their transmissibil-
p.000154: ity.
p.000154: 3. The adoption of general rules in advance -if possible in periods of “normality”- both in terms of
p.000154: restrictions as well as of access to sani- tary authorities in times of epidemics or pandemics not only safe-
p.000154: guards the efficacy of prevention or treatment, but also strengthens the feeling of fair distribution of
p.000154: resources and means in emergency situations as imposed by the respect for human value.
p.000154: 4. The potential of social stigma against persons or groups under the pre- text of public health protection is very
p.000154: potent in situations calling for measures. This risk can be addressed only with constant vigilance based on
p.000154: valid and accurate information, a task pertaining mostly to public authorities and institutions. Public health
p.000154: cannot be allowed to inspire phobic reflexes in a modern democratic society.
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000154:
p.000155: 155
p.000155:
p.000155: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000155: REPORT
p.000155:
p.000155: SUGGESTED LITERATURE
p.000155:
p.000155: Beauchamp DE (1988). The health of the republic: Epidemics, medicine, and moralism as challenges to democracy. Temple
p.000155: UP, Philadelphia PA.
p.000155: Brandt AM (1987). No magic bullet: A social history of veneral disease in the United States since 1880. Oxford U. P.,
p.000155: N. York.
p.000155: Breslow L, Duffy J, Beauchamp DE, Soskolne CL (2004). Public health, in: Post SG (ed.) Encyclopedia of bioethics. v. 4,
p.000155: 3d ed. McMillan Reference, N. York, p. 2202-2221.
p.000155: Bruce LI and Phelan JC (2006). Stigma and its public health implications, Lan- cet 367, 528-529.
p.000155: Dagtoglou PD (1991). Constitutional law, individual rights I. eds. A. N. Sak- koulas, Athens-Komotini.
p.000155: Emmanouelides D, Papaiannes I (2000). The social entitlement to health, Human Rights.
p.000155: Encyclopedia of public health. Edited by Lester Breslow, online access.
p.000155: Evans RJ (2004). Epidemics, in: Post SG (ed.), Encyclopedia of bioethics. v. 2, 3d ed. McMillan Reference, N. York, p.
p.000155: 789-794.
p.000155: Gostin L (2004). The international health regulations and beyond. Lancet, Infectious Diseases 4, p. 606-607.
p.000155: Grad FP, Beauchamp DE (2004). Public health law, in: Post SG (ed.), Encyclo- pedia of bioethics. v. 4, 3d ed. McMillan
p.000155: Reference, N. York, p. 2222-2234.
p.000155: Kenneth VI and Moskop JC (2007). Triage in medicine, Part I: Concept, histo- ry, and types. Annals of Emergency
p.000155: Medicine 49, 275-281.
p.000155: Kontiades X (1997). Welfare State and social rights. eds. A. N. Sakkoulas, Athens-Komotini.
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000155:
p.000156: 156
p.000156:
p.000156:
p.000156:
p.000156:
p.000156:
p.000006: 6
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000157: 157
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000157:
p.000158: 158
p.000158:
p.000158: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000158: OPINION
p.000158:
p.000158: O P I N I O N
p.000158:
p.000158: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000158:
p.000158: The Hellenic National Bioethics Commission met repeatedly upon invita- tion by the President in order to consider the
p.000158: ethical and social issues within its jurisdiction with regard to conflict of interest in clinical research,
p.000158: espe- cially in clinical trials of pharmaceutical agents. Dealing with this issue is a continuance of the already
...

p.000199: all the involved parties. Other- wise such genetic tests require a relevant judicial licensing.
p.000199:
p.000199: 2. Special issues
p.000199:
p.000199: In the context of the above mentioned general principles, the Commis- sion notes:
p.000199: A. It is recommended that DTC genetic tests for health reasons or prena- tal diagnosis must be performed following a
p.000199: suitable prescription by a liable expert physician, clinical geneticist or biologist-geneticist. The expert
p.000199: will assess the purpose of the test and will interpret the results, in order to avoid unnecessary genetic testing
p.000199: and inappropriate assessment. It is important that the consumer has the option to choose the expert. Impersonal,
p.000199: auto- mated counseling methods are discordant with the relationship of trust, which must govern health
p.000199: services.
p.000199: Exceptionally, DTC genetic testing which aims to improve dietary habits or other lifestyle factors (occupation,
p.000199: exercise etc.), or to define an individu- al’s ancestry, may not be dependent on such strict rules.
p.000199: B. In order to protect genetic information and respect a child’s right to ignorance, considering that children are
p.000199: unable to decide whether they wish to know the results of a genetic test predicting a disease, DTC genetic test- ing is
p.000199: not justified in asymptomatic children for whom there is no medical emergency, especially for late onset diseases such
p.000199: as Huntington’s disease. Even in the case where an expert decides that such a test is necessary for the parent(s),
p.000199: the same genetic test must be delayed for the child until he/she is able to participate in the decision
p.000199: making process, since there is no direct value to his/her health. On the contrary, DTC genetic testing is
p.000199: ac- ceptable in cases of children with first or second degree relatives with a monogenic disorder,
p.000199: showing a clear mode of inheritance e.g. familial hy- percholesterolemia. Nonetheless, such genetic tests must
p.000199: be allowed only in the case that the results will be used for early treatment and/or prevention of the complications
p.000199: caused by the disease.
p.000199:
p.000199:
p.000199:
p.000199:
p.000200: 200
p.000200:
p.000200: DIRECT-TO-CONSUMER GENETIC TESTING
p.000200: OPINION
p.000200:
p.000200: C. The promotion campaigns of DTC genetic testing must be governed by the same rules as in the case of health services,
p.000200: i.e. to be based on precise information and the true prognostic or diagnostic value of the test.
p.000200: Misleading advertising of the alleged “prediction” of serious diseases or other phenotypes, overlook the role of other
p.000200: genetic factors which are not determined yet or the critical role of environmental factors, and lead to ge- netic
p.000200: determinism.
...

p.000275: Modafinil is also a stimulating substance indicated for the treatment of excessive sleepiness in patients with
p.000275: narcolepsy. However, studies in healthy subjects showed that Modafinil improves memory10, as well as the levels
p.000275: of wakefulness and alertness in physicians11 and pilots12, making
p.000275:
p.000275: 6Warburton DM (1992). Nicotine as a cognitive enhancer. Progress in Neuro- Psychopharmacology and
p.000275: Biological Psychiatry, 16, 181-191.
p.000275: 7Newhouse PA, Potter A & Singh A (2004). Effects of nicotinic stimulation on cognitive performance. Current Opinion in
p.000275: Pharmacology, 4, 36-46.
p.000275: 8Teter CJ, McCabe SE, Boyd CJ, Guthrie SK (2003). Illicit methylphenidate use in an undergraduate student
p.000275: sample: Prevalence and risk factors. Pharmacotherapy 23, 609-17.
p.000275: 9McCabe SE, Teter CJ, Boyd CJ (2006). Medical use, illicit use and diversion of pre- scription stimulant
p.000275: medication. J Psychoactive Drugs 38, 43-56.
p.000275: 10Müller U, Steffenhagen N, Regenthal R, Bublak P (2004). Effects of modafinil on working memory processes
p.000275: in humans. Psychopharmacology (Berl) 177, 161-9.
p.000275: 11Gill M, Haerich P, Westcott K, et al., (2006). Cognitive performance following modafinil versus placebo
p.000275: in sleep-deprived emergency physicians: A double-blind randomized crossover study. Acad Emerg Med 13, 158-65.
p.000275: 12Caldwell JA Jr, Caldwell JL, Smythe NK 3rd, Hall KK (2000). A double-blind, placebo- controlled investigation of the
p.000275: efficacy of modafinil for sustaining the alertness and
p.000275:
p.000276: 276
p.000276:
p.000276: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000276: REPORT
p.000276:
p.000276: modafinil a substance capable of enhancing cognitive functions in humans.
p.000276:
p.000276: b. Enhancement of mental characteristics and mood
p.000276:
p.000276: At this point, it would be impossible not to mention other pharmaceutical substances,
p.000276: the use of which aims to relieve from phobias and addictions, and could well be used to improve mental
p.000276: characteristics. Illustrative examples are propranolol, which seems to have a preventive effect on
p.000276: post-traumatic stress13 and D-cycloserine, which reduces fear in individuals with phobias14and social anxiety
p.000276: disorder15.
p.000276: Finally, mood enhancers used to enhance a person’s mood, are an issue of concern. Selective Serotonin Reuptake
p.000276: Inhibitors (SSRIs), such as Prozac, Zoloft and other antidepressants are administered in mood and anxiety
p.000276: disorders. In his book “Listening to Prozac” the psychiatrist Peter Kramer reports discussions that he
p.000276: had with patients but also with people not suffering from depression, who all used Prozac to enhance their
...

General/Other / Relationship to Authority

Searching for indicator authority:

(return to top)
p.000029: Insurers.
p.000029: 18 See T. I., e.g. sec. 101, (a) (3) (d) (9) [ibid in other sec.].
p.000029: 19 See T. I., e.g. sec 101, (c) (1) [ibid in other sec.].
p.000029: 20 See T. I., e.g. sec 101, (c) (2) (4) [ibid in other sec.].
p.000029: 21 See T. I., e.g. sec 101, (d) (6) (7) (8) [ibid in other sec.].
p.000029: 22 See T. I., e.g. sec 101, (e) [ibid in other sec.].
p.000029:
p.000030: 30
p.000030:
p.000030: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000030: REPORT
p.000030:
p.000030: C. Greek Law
p.000030:
p.000030: The Greek Law on insurance does not specifically provide for the use of genetic data in insurance23. Relevant here
p.000030: is art. 32 Law 2496/1997 under which:
p.000030: “Unless otherwise agreed, health insurance includes diseases due to causes which did not previously exist or
p.000030: did exist but the insured justifiably ignored their existence at the time of conclusion of the insurance contract”.
p.000030: This article must be read together with the aforementioned provisions of the Oviedo Convention (Law 2619/1998),
p.000030: especially the one about the right “not -to-be-informed” and the general legal provisions on the protection of personal
p.000030: data (Law 2472/1997). Pursuant to the latter, the collection and processing of sensitive data (amongst which
p.000030: genetic data) is prohibited as a rule, unless the subject has consented to it following appropriate infor-
p.000030: mation on the purpose of processing and on additional condition that the Authority of Data Protection has
p.000030: issued an authorization.
p.000030: Thus, a distinction must be drawn:
p.000030: - If the subject is aware of genetic data that are critical for insurance, the insurer may request such data but
p.000030: only under the provisions of Law 2472/1997.
p.000030: - If the subject is not aware of such genetic data, the insurer may not re- quest genetic testing because of the “not
p.000030: -to-be-informed” right which is safeguarded by the Oviedo Convention.
p.000030:
p.000030: SUMMARY - CONCLUSIONS
p.000030:
p.000030: 1. There are genetic tests for a significant number of disorders with a genetic component that determine
p.000030: the probability of manifestation of dis- ease with greater accuracy compared to medical testing. The degree
p.000030: of complexity of the evaluation of the results varies depending on individual case, and can be difficult even
p.000030: for experts. Therefore, the concern about the management of genetic data in life and health insurance is a legitimate
p.000030: one.
p.000030:
p.000030:
p.000030:
p.000030: 23 See Law 2496/1997, arts 189-225 Code of Commerce, 400/1970 (public supervision of insurance companies), p.d.
p.000030: 252/1996 (adaptation to relevant community law).
p.000030:
p.000031: 31
p.000031:
p.000031: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000031: REPORT
p.000031:
p.000031: 2. There are racial groups with greater incidence of certain genetic dis- orders; hence there is a risk of racial
p.000031: discrimination based on genetic data.
...

p.000114: relevant rules of the CME are more detailed. Pursuant to the CME:
p.000114: - Informed consent is always required except in case of: a) emergen- cies, b) suicide attempts, and c) refusal to
p.000114: consent by the guardian of a person incapable to consent in a life- or health-threatening situa- tion.
p.000114: - The consent must be explicit though it may be informal.
p.000114: - In case of minors, the consent is provided by their parents or custo- dian.
p.000114: - In other cases of incapacity, the consent is given by the “next of kin” or the legal guardian.
p.000114: Consent requires that the patient (or the patient’s representative in case of incapacity) must “be informed”. This
p.000114: information:
p.000114: - Must be “complete” and “intelligible”.
p.000114: - Must reflect the truth.
p.000114: - Must cover: a) the real condition of health, b) the content of the sug- gested medical act, c) the risks and likely
p.000114: side effects, d) alternative
p.000114:
p.000114:
p.000114: 2 Despite its title (“Code of Medical Ethics”) this Law was not an instance of investing with legal authority a
p.000114: pre-existing corpus of norms accumulated by the medical pro- fession in the context of self-regulation (a stricto sensu
p.000114: code of ethics). It was genuine lawmaking by the government and went through the usual pipeline of
p.000114: law- enactment (a drafting committee was set up for that purpose; its draft text was duly tabled by the responsible
p.000114: Ministry for Health to go through the parliamentary proce- dure). In that respect, the title “Code of Medical Ethics”
p.000114: is not accurate, although the same wording was also used in the previous situation enacted by the royal
p.000114: decree 25.5/6.7.1955.
p.000114: 3 See art. 10 (4) Law 2737/1999 on transplants, art. 1456 of the Civil Code (Law 3087/2002) on
p.000114: assisted reproduction, art. 3 of the Joint Ministerial Decision 89292/2003 (Directive 2001/20) on
p.000114: clinical trials.
p.000114:
p.000115: 115
p.000115:
p.000115: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000115: REPORT
p.000115:
p.000115: treatment choices, and, e) the estimated time of recovery. The aim is to enable patients to consider not only the
p.000115: medical but also the social and economic factors before reaching a decision.
p.000115: - Patients may refuse to be informed (right-to-not-know) either totally or by authorizing the physician to inform
p.000115: others.
p.000115: Even in case of incapacity, however, the law acknowledges a duty to in- form the patient “to the extent possible” and
p.000115: an effort to ensure “voluntary participation”, “active involvement” and “cooperation”, especially in pa- tients
...

p.000152: specified by Law”.
p.000152: Article 21 (3) of the Constitution: “The State shall care for the health of citizens and shall adopt specific measures
p.000152: to protect youth, old age, disability and health care for indigents”.
p.000152: 2 Article 5 (5) of the Constitution: “Everyone is entitled to the protection of their health and genetic
p.000152: identity…”.
p.000152:
p.000153: 153
p.000153:
p.000153: TRANSMISSIBLE INFECTIOUS DISEASES: PUBLIC INTEREST AND AUTONOMY
p.000153: REPORT
p.000153:
p.000153: However, both the Constitution and the ECHR acknowledge the need of re- strictive measures to protect public health.
p.000153: Thus, the art. 5(4) of the Constitution (interpretation statement) excep- tionally accepts individual administrative
p.000153: measures “on grounds of public health protection or the protection of patients as specified by Law”. It is im-
p.000153: portant to stress that such measures amount to extensive inroads into indi- vidual freedom -prohibiting “the free
p.000153: movement and residency in the na- tional territory or the entry into and exit from it”- and can be decided by any
p.000153: public authority (health authorities, police, local government, etc.), but al- ways under specific legal
p.000153: provisions.
p.000153: Along the same lines, the ECHR (convention with overriding formal effect versus ordinary legislation) accepts the
p.000153: deprivation of individual freedom such as, among other things, “… the lawful detention of a person for the pre-
p.000153: vention of the spreading of infectious diseases, …” (art. 5[1][e]), but always “in accordance with a procedure
p.000153: prescribed by law”.
p.000153: The above provisions seem to grant broad discretionary powers to the common legislator when adopting
p.000153: restrictions to the individual freedoms of persons affected by transmissible diseases but, in any case, the
p.000153: legislator’s powers are delineated by the Constitution. However, there are limits:
p.000153: a) In principle, the above restrictions pertain to personal freedom, not to other fundamental rights. That is,
p.000153: they are meant to protect others from contracting the disease, and not to treat the affected subject.
p.000153: Therefore, they cannot amount to forced treatment bypassing the patient’s will.
p.000153: b) Restrictions are subject to the principle of proportionality (art. 25 (1) of the Constitution). That is, they
p.000153: are justified only in the extent which is necessary to protect others.
p.000153: c) Furthermore, they cannot go as far as totally eliminating personal freedom. The “core” of the right must
p.000153: remain intact in all cases.
p.000153:
p.000153: IV. Concluding remarks
p.000153:
...

p.000176: the “transaction”, acts as a deter- rent. Approximately half of the Academic Centers state that granting the
p.000176: declaration has become mandatory in research. This declaration may be independent or may be included in the
p.000176: informed consent form.
p.000176: The declaration must include the following details:
p.000176: i. First name and surname of the researcher.
p.000176: ii. Name of the Institute.
p.000176: iii. Type of sponsorship.
p.000176: iv. Amount of sponsorship33.
p.000176: v. Sponsoring company/industry.
p.000176: vi. Approval of the CRC.
p.000176: A relevant study revealed that approximately 50% of Institutions accept the establishment of a declaration32. However,
p.000176: half of them wish to include it in the informed consent form, whereas the remaining prefer to inform the participating
p.000176: patients orally. In addition, unanimity does don exist on the extend of details to be disclosed, and many
p.000176: support that the sponsor’s name is adequate. Others claim that the disclosure must be complete and include, not only
p.000176: the sponsor’s name and type of sponsorship, but also the amount, and the participant must be informed of any possible
p.000176: effects of the sponsor- ship on the research outcome, suggesting an honest discussion between the researcher and the
p.000176: patient.
p.000176: A declaration must also be submitted for a 1st stage research, where there are no human participants, but is
p.000176: intended to move to the 2nd clinical stage within the next 12 months. In that case, it is within the authority of
p.000176: the “CIC” to decide on whether the rules concerning the clinical study also apply to the preclinical stage of the
p.000176: study.
p.000176:
p.000176: 32 Hulley S, Grady D, Bush T et al. (1998). Randomized trial of estrogen plus progestin for secondary prevention of
p.000176: coronary heart disease in postmenopausal women. Heart and Estrogen/progestin Replacement Study (HERS) Research Group.
p.000176: JAMA 280, 605- 613.
p.000176: 33 The US Public Health Service set the upper limit of <$10,000/annum. P.S.H. 42. CER,
p.000176: §50603.
p.000176:
p.000177: 177
p.000177:
p.000177: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000177: REPORT
p.000177:
p.000177: “Disclosure” of the relationship must be submitted to persons or author- ities outside the Institution, such as:
p.000177: - The responsible State authorities.
p.000177: - The sponsors.
p.000177: - The “editorial” board of the scientific journal where the research is submitted for publication.
p.000177: - The conference organizing or scientific committee or professional bodies, where the research is announced
p.000177: (conferences etc.).
p.000177: - Everyone participating in the study.
p.000177: Depending on the rules of each Institution, the “disclosure” may include details concerning the type and amount of
p.000177: sponsorship. The CRC could pro- vide such a document. The document must include an assurance that the
p.000177: Protocol/Disclosure has been approved by the CIC, and state that the spon- sorship does not compromise the patient’s
p.000177: health.
p.000177: An additional recommendation is that the patient participating in re- search is informed about the fact that
...

p.000177: Compliance with the above mentioned, is mainly shown by the Academic Centers, whereas there is no clear picture of what
p.000177: is the case outside Aca- demia. It is evident that there is no unanimity especially concerning the ex- tend of
p.000177: disclosure. However, 89% of the Institutions suggest that the disclo- sure must include any possible participation of
p.000177: husbands/housewives, par- ents or children34. Regarding scientific journals, it is reported that 43% apply a policy of
p.000177: compulsory disclosure.
p.000177: Questions are generated by the fact that only a small proportion of sci- entific journals and non-academic hospitals
p.000177: ask for a declaration of possible sponsorships. Questions are also generated by the tendency to inform oral- ly, which
p.000177: may lead to confusion about a matter that demands complete transparency.
p.000177: Every Institution undertaking a clinical study, accepts the regulation of the applied “research policy”, which
p.000177: includes all the commitments imposed
p.000177:
p.000177: 34 McCrary SV, Anderson CB, Jakovljevic J et al. (2000). A national survey of policies on disclosure of conflicts of
p.000177: interest in biomedical research. N Engl J Med 343, 1621- 1626.
p.000177:
p.000178: 178
p.000178:
p.000178: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000178: REPORT
p.000178:
p.000178: by the State and the authorized “National Committees”. The president and the members of the control bodies (CIC and
p.000178: CRC), must also submit a disclo- sure. A study35 showed that 36% of Committee members admitted they had at least one
p.000178: relationship with the industry in the past, although 85.5% of them stated that this would not compromise their
p.000178: judgment. However, con- sidering that the control of patient safety is within the authority of the above
p.000178: mentioned Committee, its members owe to be free and above any suspicion, as laid down by law in some US
p.000178: States36.
p.000178: Especially for the CIC, it must be noted that it is composed by senior members of the Institution, who are
p.000178: experienced in their field and are inde- pendent of the Institutional administration. Two members outside the Insti-
p.000178: tution, with similar qualifications, participate in the Committee. The mem- bers themselves must not create
p.000178: conditions for conflict of interest, other- wise, they are revoked immediately. Members must also submit a
p.000178: “declara- tion”. There is close cooperation and mutual information between the CICs. The CIC is responsible for
p.000178: reporting the incident to the authorized bodies and analyzing the type of relationship in detail. In cases
p.000178: concerning the Insti- tution/industry relationship, the Committee examines whether the sponsor- ships belong to the
p.000178: provided exemptions and the extend to which it could compromise research integrity.
p.000178: The declaration is submitted to: a) the responsible State authorities, b) the Institution’ s administration, c) the
p.000178: sponsors, d) the researchers and e) the publishers of scientific press, at least once per year. Every Institution has
p.000178: the freedom to adopt its own rules, according to the principles and philoso- phy governing its operation, but it must
p.000178: aim to minimize irregularities.
p.000178: Each recommendation of the Committee, positive or negative, must be completely justified. In addition, the
p.000178: Institutional administrations are en- couraged to make available to the public, the media and the State
...

p.000179: Institutional conflict of interest may emerge when the financial interests of the Institution or one of its members
p.000179: acting as a representative, may af- fect in any way the design, execution, assessment and announcement of
p.000179: research results. However, a study by Campbell et al. showed that 42.3% of the RCR members do not always adhere to the
p.000179: principle “Conflict of Inter- est”.
p.000179: Industrial “sponsorship” may appear in various forms such as “dona- tions”, staff training, counseling offered
p.000179: to the industry by the Institutional members, legal ownership of shares for products resulting from research as well as
p.000179: mutual bonds or interest and dividends resulting from37, or various combinations of the above mentioned.
p.000179: The CIC must be aware of which of its members implicated in research, fall within the conflict of interest provisions.
p.000179: The committee must also de- termine the general policy to be followed in such cases, while it has the duty to report
p.000179: any type of sponsorship resulting form signing an agreement with the industry.
p.000179: Exceptions are:
p.000179: a) Contributions of any amount, derived from legitimate business of the Institution.
p.000179: b) Payments to the Institution, resulting from the “cost”, as provided in the contract signed between the Institution
p.000179: and the sponsor.
p.000179: c) Salaries or compensations for services provided for research by the Institution, and are provided in the relevant
p.000179: contract.
p.000179: d) Financial aids-sponsorships by the State or non-profit charitable or- ganizations.
p.000179: “Donations” are examined by the Committee with scrutiny, since they may fall within the relevant prohibitions.
p.000179: The Institution must establish: a) the responsible authority where the CIC will refer to in a case of
p.000179: conflict of interest and, b) a procedure to be followed when members of the administration have a relationship
p.000179: that may
p.000179:
p.000179:
p.000179:
p.000179: 37 Equity holding, Equity interest, Mutual funds, Stock options etc.
p.000179:
p.000180: 180
p.000180:
p.000180: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000180: REPORT
p.000180:
p.000180: compromise their judgment. Cases where conflict of interest may emerge from a private company sponsorship to
p.000180: an Institution include:
p.000180: a) Sponsorships from companies to the Institution, independent from the undertaken research.
p.000180: b) Dividends from investments resulting from licensing and commer- cialization of research products of >$50,000.
p.000180:
p.000180: 7. Collaborative clinical studies
p.000180:
p.000180: Over the past years, there is an extensive discussion about collabora- tive clinical studies, i.e. studies in which
p.000180: two or more companies cooperate to test the efficacy and safety of biomedical products with similar action. With this
p.000180: approach, the companies share the expenses, patient recruit- ment/participation is faster (patients are not
p.000180: divided into separated clinical studies by different companies), a single control group is necessary, the
p.000180: duration of the clinical study is reduced, and the use of a common protocol with well defined parameters allows direct
p.000180: comparison and production of robust and convincing results38.
p.000180: Such collaborative studies may be conducted in order to test similar therapies by different pharmaceutical
p.000180: companies against the same dis- ease, or a combination of different therapies that detect different
...

p.000199: ac- ceptable in cases of children with first or second degree relatives with a monogenic disorder,
p.000199: showing a clear mode of inheritance e.g. familial hy- percholesterolemia. Nonetheless, such genetic tests must
p.000199: be allowed only in the case that the results will be used for early treatment and/or prevention of the complications
p.000199: caused by the disease.
p.000199:
p.000199:
p.000199:
p.000199:
p.000200: 200
p.000200:
p.000200: DIRECT-TO-CONSUMER GENETIC TESTING
p.000200: OPINION
p.000200:
p.000200: C. The promotion campaigns of DTC genetic testing must be governed by the same rules as in the case of health services,
p.000200: i.e. to be based on precise information and the true prognostic or diagnostic value of the test.
p.000200: Misleading advertising of the alleged “prediction” of serious diseases or other phenotypes, overlook the role of other
p.000200: genetic factors which are not determined yet or the critical role of environmental factors, and lead to ge- netic
p.000200: determinism.
p.000200: D. DTC genetic tests that determine a person’s identity without his/her consent is in principle illegal, since they
p.000200: directly offend the right to privacy.
p.000200: E. In any case, providers of DTC genetic services (especially via the inter- net) need to ensure high protection of
p.000200: the personal data that they collect and process. The Data Protection Authority must control the way that such data are
p.000200: managed by the genetic service providers.
p.000200: F. Finally, the development of this commercial activity imposes yet more the need to adopt a specific legislation for
p.000200: the management of genetic in- formation and its potential use for research purposes, a need that is repeat- edly noted
p.000200: by the Commission in previous Opinions. This specific legislation must particularly include:
p.000200: a) Recognition of the specialty or specialization of “Medical Genetics” in Greece (according to the 2/204
p.000200: 21.9.2006 decision of the Central Council of Health.
p.000200: b) Establishment of a previous state license for the operation of genetic centers, where the genetic tests are
p.000200: performed according to valid cri- teria for quality certification.
p.000200: c) Requirement of a regulation governing the above mentioned centers, which will include specific warranties to
p.000200: correctly inform the con- sumers, especially concerning advertising of genetic services, accord- ing to the
p.000200: paragraph C.
p.000200: d) The potential use of the biologic materials or genetic information for research purposes, on the condition
p.000200: that they are anonymized or that the subject has given consent.
p.000200:
p.000200:
p.000200: Athens, 30 March 2012
p.000200:
p.000200:
p.000200:
p.000201: 201
p.000201:
p.000201: DIRECT-TO-CONSUMER GENETIC TESTING
p.000201: OPINION
p.000201:
p.000201: COMPOSITION AND PERSONELL
p.000201: OF THE HELLENIC NATIONAL BIOETHICS COMMISSION COMPOSITION
p.000201: Chairman: John Papadimitriou, Emeritus Professor of Surgery, Medical School, University of Athens.
...

p.000214: of the Oviedo Convention and the Code of Medical Ethics and Deontology (Law 3418/2005), where the
p.000214: principle of “informed consent” is established, as well as the importance of genetic counseling (explicitly
p.000214: stated for genetic tests - see art. 12 Oviedo Convention).
p.000214: The provisions in these texts orientate us towards accepting that mediation of an expert before genetic testing
p.000214: but also during the interpretation of the results, is essential. Therefore, providing such services without
p.000214: mediation cannot be considered as an acceptable aspect of the person’s autonomy on health issues.
p.000214: - The constitutional right to protection of personal data (art. 9 Α Constitution) and the relevant
p.000214: Law 2472/1997, which regulate handling of genetic and medical data.
p.000214: Protection of sensitive data collected by companies must be ensured in the strict context of this legislation.
p.000214: More specifically, the consumer’s consent given to the company in order to collect and handle personal
p.000214: genetic data and information about his/her lifestyle is not enough, while a relevant permission given
p.000214: by the Data Protection Authority is required. Companies operating in our country must be supervised over this
p.000214: point.
p.000214:
p.000214:
p.000215: 215
p.000215:
p.000215: DIRECT-TO-CONSUMER GENETIC TESTING
p.000215: REPORT
p.000215:
p.000215: - The legislation for consumer protection (Law 2251/1994, as in force), which establishes certain obligations for
p.000215: anyone providing services to the general public (mostly regarding adequate information).
p.000215: This legislation is of interest mainly when it comes to advertising the companies and the way they promote genetic
p.000215: testing in general. In this context, provisions for misleading actions (art. 9 d), misleading omissions (art. 9 e) and
p.000215: misleading commercial practices (art. 9 f) are of great importance.
p.000215: - The financial freedom (art. 5 par. 1 Constitution), in the context of which the development of
p.000215: business activities is allowed under certain conditions.
p.000215: Financial freedom needs to be combined with special provisions of the Oviedo Convention, along with legislation
p.000215: for personal data protection, so as to determine purpose legitimacy of the companies providing services and
p.000215: handle biological information. In general, however, this cannot be considered to be either a
p.000215: case of commercialization practices of the human body nor parts of it (according to art. 21 of the
p.000215: Oviedo Convention), neither some form of commercialization of personal data. Without doubt, the specific
...

p.000227: would still be unfair, not for reasons of fair- ness, but because the endangerment of health is incompatible
p.000227: with the very notion of rivalry.
p.000227: ii) Enhancing physical abilities by other means (e.g. strenuous exercise in particular environmental conditions) could
p.000227: also be equated with substance
p.000227:
p.000227:
p.000228: 228
p.000228:
p.000228: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000228: OPINION
p.000228:
p.000228: use, provided that the risks for one’s health were equally serious. As long as these risks are not established, the
p.000228: conditions of rivalry should not be con- sidered as adulterated for this reason alone.
p.000228: iii) New genetic technologies, such as gene therapy or gene transfer in athletes, are forms of doping, which are not
p.000228: currently detectable. In cases of gene doping, the risk to the athletes’ health is even greater, due to the nov- el and
p.000228: often experimental methods applied. However, it should be empha- sized that -according to the latest scientific data-
p.000228: such methods are at a re- search stage, even when they are used to treat patients.
p.000228: Based on the above considerations, the Commission notes the necessity of constant vigilance by the anti-doping
p.000228: authorities in our country, especially after the repeated cases during the last years.
p.000228: The Commission points out the special role of the Hellenic National Anti- Doping Council (ESKAN) for the prevention and
p.000228: fight against doping. It would be appropriate for ESKAN to acquire organizational independence (in the form of
p.000228: a legal entity or even of an independent authority), to apply its ju- risdiction at all levels of athletic
p.000228: contests (even in schools) and possibly complement its authority with the potentiality to impose all the
p.000228: relevant sanctions in cases of law violation.
p.000228: In addition, the Commission considers that reinforcing athletic research will contribute to inform properly the
p.000228: future athletes about their actual physical abilities, whereas underpinning the athlete’ s medical support will act
p.000228: as a deterrent to the use of doping methods.
p.000228: Finally, the Commission highlights the importance of responsible publi- cation of anti-doping test results,
p.000228: particularly by the media, in order to avoid the risk of stigmatizing sport and athletics overall. The disproportionate
p.000228: pub- licity of the offender athletes and their associates does not serve in favour of preventing the doping
p.000228: phenomenon effectively; on the contrary, it dis- courages young people from being involved in sport and
p.000228: consequently de- prives them from its indisputable benefits.
p.000228:
p.000228: 4. Physical enhancement for military purposes
p.000228:
p.000228: Physical enhancement may also be applied to a military, operational lev- el. In particular, it is not unlikely
p.000228: that one can justify the enhancement of physical characteristics of soldiers, in the name of national interest
p.000228: and na-
p.000228:
p.000228:
p.000229: 229
p.000229:
p.000229: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000229: OPINION
p.000229:
p.000229: tional security. Indeed, this may be associated with experimentation on hu- mans, which would be potentially banned in
p.000229: case the relevant research in- volved ordinary citizens.
...

General/Other / cioms guidelines

Searching for indicator cioms:

(return to top)
p.000057: funded agencies, in the last 200 years there have been 200 cases of confirmed misconduct (Resnik, 2007).
p.000057: This figure which represents approximately 0.01% of the entire research community for this period probably
p.000057: underestimates reality but implies that such phenome- na and specific cases of deliberate fraud are relatively limited.
p.000057: This, howev- er, does not mean that the problem does not require serious consideration. As the above examples
p.000057: demonstrate, the validity of biological research has a direct impact on society and often affects public health
p.000057: directly. The exist- ence of and compliance with recognized code of ethics is important not only in order to defend the
p.000057: safety and the rights of volunteers or lab animals. It is also required to ensure the quality of the results, to
p.000057: maintain public support for research, to achieve accountability to society -the source of funds- and for the
p.000057: harmonious and effective co-operation between researchers (Resnik, 2007).
p.000057: To deal with serious issues of research ethics like those mentioned above and in recognition of the
p.000057: significance of educating researchers in eth- ical topics, international scientific societies, universities and
p.000057: research cen- tres have issued codes of ethics or ethical guidelines and specialized correct research practices for
p.000057: each research field. The Council for International Or- ganizations of Medical Sciences, CIOMS) has issued
p.000057: ethical principles for
p.000057:
p.000057:
p.000058: 58
p.000058:
p.000058: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000058: REPORT
p.000058:
p.000058: biomedical research in humans4 and animals5, research in the human ge- nome6 and for epidemiological
p.000058: research7. The International Epidemiology Association recently issued principles of correct practice and conduct in
p.000058: epi- demiological research (IEA, 2007). Some of the issues dealt with in these instruments can be summarized
p.000058: as follows (Shamoo and Resnik, 2002):
p.000058: Honesty as to the method and the findings in the publication and report- ing of scientific studies.
p.000058: Objectivity in the design of trials and the analysis of results as well as in the consideration of the work of other
p.000058: scientists.
p.000058: Integrity in the observance of promises and assumed obligations and con- sistency between word and action.
p.000058: Care to avoid inadvertent mistakes and to keep good records.
p.000058: Compliance with copyright.
p.000058: Confidentiality with regard to information obtained during private meet- ings or when considering proposals for funding
p.000058: or papers for publication, Responsible publications whose goal should be the advancement of sci- ence and
p.000058: avoidance of pointless papers that reiterate available knowledge.
p.000058: Care for the instruction of students, protection of their prosperity and recognition of their right to decide
p.000058: for themselves.
p.000058: Respect for colleagues.
p.000058: Social Responsibility, the goal must be the common good and the avoid- ance or alleviation of social problems through
p.000058: research and education of the public.
p.000058: Avoidance of discrimination based on gender, nationality, ethnicity or any other factor irrelevant to scientific
p.000058: competence and integrity.
p.000058: Preservation of professional competence through life-long training and education.
p.000058:
p.000058: 4 CIOMS international ethical guidelines for biomedical research involving human subjects
p.000058: (http://www.cioms.ch/frame_guidelines_nov_2002.htm).
p.000058: 5 1985 international guiding principles for biomedical research involving animals
p.000058: (http://www.cioms.ch/frame_1985_texts_of_guidelines.htm).
p.000058: 6 1990 declaration of inuyama on human genome mapping, genetic screening and gene therapy
p.000058: (http://www.cioms.ch/frame_1990_texts_of_guideline.htm).
p.000058: 7 1991 international guidelines for ethical review of epidemiological studies
p.000058: (http://www.cioms.ch/frame_1991_texts_of_guideline.htm).
p.000058:
p.000059: 59
p.000059:
p.000059: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000059: REPORT
p.000059:
p.000059: Legality, compliance with all laws and regulations governing the operation of research.
p.000059: Care for animals both in the design and the execution of research pro- jects.
p.000059: Protection of volunteers, limitation of risks and maximization of benefits for volunteers and respect of their
p.000059: personality, especially in case of vul- nerable groups.
p.000059:
p.000059: The problem of control
p.000059:
p.000059: The issue of controlling the credibility and the ethics of research often inspires fears of a possible
p.000059: “bureaucratization”, imposition of “outside” reg- ulations and interference of mechanisms irrelevant to the
p.000059: objective. Such deviations would unavoidably cause unjustified delay and, in the end, would discourage initiative even
p.000059: if designed correctly.
p.000059: This eventuality, however, does not automatically eliminate the need for control; it merely draws our attention to the
p.000059: methods to be used. It is gen- erally accepted that if control is exercised on the initiative and according to the
p.000059: procedures of the scientific community itself (self-regulation) the extent of “bureaucratization” would be
p.000059: restricted since the parties themselves have an interest in effective control.
p.000059:
p.000059: RECOMMENDATIONS
p.000059:
...

General/Other / cultural difference

Searching for indicator cultural difference:

(return to top)
p.000084: MANAGEMENT OF BIOLOGICAL WEALTH
p.000084: REPORT
p.000084:
p.000084: we allowed to do so even at the risk of extinction of other, naturally occur- ring species as a result of their contact
p.000084: with the new ones?
p.000084: These questions can be answered in many ways but it is worth pointing out that the value of biodiversity is seen in
p.000084: relation to our needs. Thus, bio- diversity appears to be a rather relative and not an absolute value, as might be
p.000084: argued by those who deny the “anthropocentric” approach and advocate the extension of the notion of moral subjects to
p.000084: beings other than humans.
p.000084:
p.000084: The rights of “future generations”
p.000084:
p.000084: The third consideration we are concerned with regards the so-called “rights of future generations”. The term
p.000084: underlines our responsibility vis-à- vis coming generations and binds us with the powerful notion of
p.000084: “rights”. People (or populations) that do not yet exist are thus recognized as “sub- jects of rights”. For
p.000084: this reason, the pertinence of this terminology is highly controversial since future people are considered among
p.000084: other things “re- mote in time” and “undefined” (Partridge: passim).
p.000084: Be that as it may, the ethical duty of “solidarity” between generations is not put in question. This duty is broken
p.000084: down into more special “responsibil- ities” (according to the terminology of the relevant UNESCO declaration)
p.000084: that are not related exclusively to the protection of the environment (e.g. there is a responsibility to
p.000084: maintain freedom of choice for future genera- tions at all levels, to preserve cultural difference and heritage,
p.000084: peace, devel- opment and education, to avoid social discrimination). The conservation and perpetuation of the human
p.000084: species, the protection of the diversity of the human genome, the protection of life on the planet and
p.000084: biodiversity, and the wider protection of the environment are, of course, vital components of this duty.
p.000084: As stated above, our responsibility to future generations ethically justi- fies the sustainable development debate.
p.000084: The crucial question related to this issue concerns the source or foundation of this powerful ethical duty.
p.000084: At first sight, it is an “imperfect duty” (like kindness, philanthropy etc., according to the Kantian distinction).
p.000084: But perhaps this solution falls short of the powerful commitment we appear to accept.
p.000084: One could also posit a utilitarian foundation according to which our self- restraint for the sake of next generations
p.000084: eventually improves our present
p.000084:
p.000084:
p.000085: 85
p.000085:
p.000085: MANAGEMENT OF BIOLOGICAL WEALTH
p.000085: REPORT
p.000085:
p.000085: state as well, since it leads to a rational and renewable exploitation of (fi- nite) natural resources.
p.000085: A third alternative would be to further investigate the subject in the field of the theory of “rights” or, at
p.000085: least, “interests” -either finding a way to overcome the afore mentioned difficulties in recognizing
p.000085: persons, who do not yet exist, as subjects, or dilating the reflection on our own rights and interests.
...

General/Other / declaration of helsinki

Searching for indicator helsinki:

(return to top)
p.000105: good or not doing harm” is no longer sufficient to determine treatment. Patients need to be involved to
p.000105: deter- mine the treatment whose likely adverse effects are more acceptable to them. Especially in our
p.000105: country, the need for this involvement becomes all the more urgent due to the absence, until now, of a single
p.000105: registration sys- tem to record the complete history of patients which deprives physicians from unmediated
p.000105: access to consistent and reliable data.
p.000105: The adoption of “informed consent” presupposes that patients are in- formed by physicians and in principle,
p.000105: they consent prior to all medical acts. In this way, they can consider their condition in the context of their general
p.000105: way of living not as passive recipients but as independent agents who are involved in the whole process as much as
p.000105: possible. A good knowledge of the values and needs a patient would like the physician to take into account
p.000105: when determining treatment is an essential part of this process. It is worth noting that the requirement of
p.000105: participation is complied with even when patients express the wish to follow the suggested treatment without
p.000105: further information (right to ignorance).
p.000105:
p.000105: B. The law
p.000105:
p.000105: Initially, the new model of “informed consent” appeared in codes of eth- ics on clinical trials (Nuremberg Code,
p.000105: Helsinki Declaration) because, on this occasion, the risks for the volunteers are greater. Gradually, however,
p.000105: its effects were recognized in all areas of medical practice.
p.000105: The Oviedo Convention on Human Rights and Biomedicine is the first example of binding international law
p.000105: incorporating “informed consent” in all medical acts. In addition to the Convention, express provisions in
p.000105: Greece have been included both in the Code of Medical Ethics (CME, Law 3418/2005) and in
p.000105: special legislation (assisted reproduction, transplants, etc.).
p.000105:
p.000105:
p.000106: 106
p.000106:
p.000106: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000106: OPINION
p.000106:
p.000106: Both the Oviedo Convention and the CME provide for the event of in- competence to consent (in which
p.000106: case consent is given by relatives after prior information) whereas they hold that consent does not apply in
p.000106: emer- gency situations. However, the example of the CME stipulating that: “In the exercise of medicine, physicians act
p.000106: with total freedom within the generally accepted rules and methods of medical science… They may choose the
...

General/Other / oviedo

Searching for indicator oviedo:

(return to top)
p.000028: individual subjects to miss valuable information that may contribute significantly to good health. In clinical
p.000028: trials for new medicines, reluctance against genetic testing has led to an actual reduction in the number of
p.000028: volunteering participants in research in tailor-made drugs (pharmacogenomics) that are thought to be very hopeful for
p.000028: the future of therapeutic medicine.
p.000028: Consequently, there is a need to take into consideration the real value of genetic information for the protection of
p.000028: health, which is just as valid as any other medical information and, for all intents and purposes, far
p.000028: removed from the pervasive overrated perceptions we noted before. At the end of the day, this need serves a
p.000028: wider social interest. Indeed, failure to use the potential of additional knowledge on health -such as genetic
p.000028: information- for fear that this knowledge may be used for illicit purposes by third parties causes more harm not only
p.000028: to the individual subject but to a more efficient organization of health care in the general population.
p.000028:
p.000028: 3. THE LEGAL DIMENSION
p.000028:
p.000028: Very few countries have adopted special legislation on the use of genetic data in insurance. As a rule, the issue is
p.000028: governed by the general laws on the protection of personal data in conjunction with insurance law.
p.000028:
p.000028: A. International law
p.000028:
p.000028: Critical from the point of view of international law is the provision of article 11 of the Oviedo
p.000028: Convention pursuant to which:
p.000028: “Any form of discrimination against a person on grounds of his or her genetic heritage is prohibited”.
p.000028: A similar provision was included in the UNESCO declaration on the Hu- man Genome.
p.000028: The Oviedo Convention does not preclude genetic testing for “health purposes” (art. 12) but recognizes
p.000028: the right “not -to-be-informed” (art. 10 [2]). Thus, it seems to refrain from taking a stance on the issue.
p.000028: Protection of the sensitive nature of personal data (with specific provi- sions on confidentiality) is embedded in
p.000028: the 3rd Protocol to the Oviedo Con-
p.000028:
p.000028:
p.000029: 29
p.000029:
p.000029: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000029: REPORT
p.000029:
p.000029: vention (Greece has not ratified it) whereas a new Protocol is going to rule on genetic testing for health reasons.
p.000029: Neither of these instruments, howe- ver, specifically mentions insurance16.
p.000029:
p.000029: B. Other jurisdictions
p.000029:
p.000029: Some European countries have enacted special prohibitory laws. Nota- bly, Austria, Denmark, Switzerland,
p.000029: Estonia, Lithuania, Luxembourg, Norway, Portugal and Belgium prohibit disclosure of genetic information to insurers
p.000029: whereas Netherlands allows it only if insurance is above a certain amount. Other European countries observe a
p.000029: moratorium, whereby insurers do not require genetic data since there is no related legislation (UK17, France, Ger-
p.000029: many, Ireland, Sweden, Finland) (European Commission 2005: passim).
p.000029: A moratorium applies also in Australia, New Zealand, South Africa and Canada (Lemmens 2003:57 sqq., European
p.000029: Commission 2005: passim).
p.000029: In the US, several States have adopted statutory prohibitions and a de- bate is underway for a special federal law.
p.000029: Recently, a Bill of Law was passed in Parliament and is now pending in Congress. It is the Genetic Information
p.000029: Non-discrimination Act (GINA).
p.000029: This Bill of Law which represents the latest attempt at extensive regula- tion: a) prohibits any association between
p.000029: the possibility of anyone to con- tract insurance and the amount of premium with genetic information18, and,
p.000029: b) prohibits insurers from requiring insurance applicants or their relatives to undergo genetic testing19. It
p.000029: allows genetic testing for health reasons and clinical research20, expressly dissociating these tests from
p.000029: the question of insurance. The Bill contains definitions (for genetic data, genetic tests and genetic
p.000029: services)21 and lays down sanctions22.
p.000029:
p.000029:
p.000029: 16 The issue is debated during the preparation of the latter, however.
p.000029: 17 In the UK, in particular, there is a related provision in the Code of Ethics of the As- sociation of British
p.000029: Insurers.
p.000029: 18 See T. I., e.g. sec. 101, (a) (3) (d) (9) [ibid in other sec.].
p.000029: 19 See T. I., e.g. sec 101, (c) (1) [ibid in other sec.].
p.000029: 20 See T. I., e.g. sec 101, (c) (2) (4) [ibid in other sec.].
p.000029: 21 See T. I., e.g. sec 101, (d) (6) (7) (8) [ibid in other sec.].
p.000029: 22 See T. I., e.g. sec 101, (e) [ibid in other sec.].
p.000029:
p.000030: 30
p.000030:
p.000030: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000030: REPORT
p.000030:
p.000030: C. Greek Law
p.000030:
p.000030: The Greek Law on insurance does not specifically provide for the use of genetic data in insurance23. Relevant here
p.000030: is art. 32 Law 2496/1997 under which:
p.000030: “Unless otherwise agreed, health insurance includes diseases due to causes which did not previously exist or
p.000030: did exist but the insured justifiably ignored their existence at the time of conclusion of the insurance contract”.
p.000030: This article must be read together with the aforementioned provisions of the Oviedo Convention (Law 2619/1998),
p.000030: especially the one about the right “not -to-be-informed” and the general legal provisions on the protection of personal
p.000030: data (Law 2472/1997). Pursuant to the latter, the collection and processing of sensitive data (amongst which
p.000030: genetic data) is prohibited as a rule, unless the subject has consented to it following appropriate infor-
p.000030: mation on the purpose of processing and on additional condition that the Authority of Data Protection has
p.000030: issued an authorization.
p.000030: Thus, a distinction must be drawn:
p.000030: - If the subject is aware of genetic data that are critical for insurance, the insurer may request such data but
p.000030: only under the provisions of Law 2472/1997.
p.000030: - If the subject is not aware of such genetic data, the insurer may not re- quest genetic testing because of the “not
p.000030: -to-be-informed” right which is safeguarded by the Oviedo Convention.
p.000030:
p.000030: SUMMARY - CONCLUSIONS
p.000030:
p.000030: 1. There are genetic tests for a significant number of disorders with a genetic component that determine
p.000030: the probability of manifestation of dis- ease with greater accuracy compared to medical testing. The degree
p.000030: of complexity of the evaluation of the results varies depending on individual case, and can be difficult even
p.000030: for experts. Therefore, the concern about the management of genetic data in life and health insurance is a legitimate
p.000030: one.
p.000030:
p.000030:
p.000030:
p.000030: 23 See Law 2496/1997, arts 189-225 Code of Commerce, 400/1970 (public supervision of insurance companies), p.d.
p.000030: 252/1996 (adaptation to relevant community law).
p.000030:
p.000031: 31
p.000031:
p.000031: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000031: REPORT
p.000031:
p.000031: 2. There are racial groups with greater incidence of certain genetic dis- orders; hence there is a risk of racial
p.000031: discrimination based on genetic data.
p.000031: 3. An extensive bioethical debate has developed with regard to access of insurance companies to the genetic data of the
p.000031: insured or of insurance ap- plicants. This debate mainly revolves around two axes: a fair calculation of risk based on
p.000031: the principle of reciprocity, on the one hand, and protection of personality from discrimination and stigmatization on
p.000031: the grounds of genet- ic data, on the other hand.
...

p.000105: country, the need for this involvement becomes all the more urgent due to the absence, until now, of a single
p.000105: registration sys- tem to record the complete history of patients which deprives physicians from unmediated
p.000105: access to consistent and reliable data.
p.000105: The adoption of “informed consent” presupposes that patients are in- formed by physicians and in principle,
p.000105: they consent prior to all medical acts. In this way, they can consider their condition in the context of their general
p.000105: way of living not as passive recipients but as independent agents who are involved in the whole process as much as
p.000105: possible. A good knowledge of the values and needs a patient would like the physician to take into account
p.000105: when determining treatment is an essential part of this process. It is worth noting that the requirement of
p.000105: participation is complied with even when patients express the wish to follow the suggested treatment without
p.000105: further information (right to ignorance).
p.000105:
p.000105: B. The law
p.000105:
p.000105: Initially, the new model of “informed consent” appeared in codes of eth- ics on clinical trials (Nuremberg Code,
p.000105: Helsinki Declaration) because, on this occasion, the risks for the volunteers are greater. Gradually, however,
p.000105: its effects were recognized in all areas of medical practice.
p.000105: The Oviedo Convention on Human Rights and Biomedicine is the first example of binding international law
p.000105: incorporating “informed consent” in all medical acts. In addition to the Convention, express provisions in
p.000105: Greece have been included both in the Code of Medical Ethics (CME, Law 3418/2005) and in
p.000105: special legislation (assisted reproduction, transplants, etc.).
p.000105:
p.000105:
p.000106: 106
p.000106:
p.000106: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000106: OPINION
p.000106:
p.000106: Both the Oviedo Convention and the CME provide for the event of in- competence to consent (in which
p.000106: case consent is given by relatives after prior information) whereas they hold that consent does not apply in
p.000106: emer- gency situations. However, the example of the CME stipulating that: “In the exercise of medicine, physicians act
p.000106: with total freedom within the generally accepted rules and methods of medical science… They may choose the
p.000106: method of treatment which in their view is significantly better against all others for the particular
p.000106: patient based on modern rules of medical sci- ence…”1, demonstrates that the traditional model of the
p.000106: relationship pa- tient-physician has not been fully abandoned in Greece as it has in other jurisdictions.
p.000106:
p.000106: II. Problems in the implementation of autonomy and related proposals
p.000106:
p.000106: A. The problem in general
p.000106:
p.000106: Although the need for active involvement by patients in determining treatment is now widely acknowledged, it
p.000106: is often defeated in medical prac- tice. The main reasons for this failure are the following:
p.000106: - Limited time for communication between physician-patient,
p.000106: - lack of clarity on the appropriate extent of information,
p.000106: - deficient training of physicians on the relationships they need to de- velop with patients, and,
p.000106: - occasionally, lack of familiarization of the general public with the rights and possibilities of every user of
...

p.000113: medicine is sometimes known to be influenced by varying interests not necessarily compatible with the patient’s
p.000113: interests.
p.000113: 6. Citizens demand more from the health system as regards the quality of services, the medical outcome and the
p.000113: conditions in which these services are provided. The provision of high quality services is consid- ered by citizens as
p.000113: an utmost priority in our country.
p.000113: 7. It is now acknowledged that the way of living and the religious or other philosophical beliefs of
p.000113: patients must be taken into considera- tion when determining treatment. There is an increasing awareness of the right
p.000113: to autonomy and of respect for dignity in medicine.
p.000113:
p.000113: B. LEGAL ISSUES
p.000113:
p.000113: In general
p.000113:
p.000113: The “Code of Medical Ethics” (CME, Law 3418/2005) has put in place a modern legal framework for the relationship
p.000113: physician-patient in Greek
p.000113:
p.000113:
p.000113:
p.000114: 114
p.000114:
p.000114: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000114: REPORT
p.000114:
p.000114: law2. The main characteristic of this law is the explicit introduction of “in- formed consent” albeit
p.000114: maintaining provisions which reflect the former “pa- ternalistic” approach.
p.000114: It must be noted that “informed consent” was already embedded in Greek law, first, through the
p.000114: ratification of the Oviedo Convention on Hu- man Rights and Biomedicine (art. 5 et seq. Law 2619/1998) and,
p.000114: second, by way of express provisions in a number of laws on various medical fields3. Naturally, the
p.000114: relevant rules of the CME are more detailed. Pursuant to the CME:
p.000114: - Informed consent is always required except in case of: a) emergen- cies, b) suicide attempts, and c) refusal to
p.000114: consent by the guardian of a person incapable to consent in a life- or health-threatening situa- tion.
p.000114: - The consent must be explicit though it may be informal.
p.000114: - In case of minors, the consent is provided by their parents or custo- dian.
p.000114: - In other cases of incapacity, the consent is given by the “next of kin” or the legal guardian.
p.000114: Consent requires that the patient (or the patient’s representative in case of incapacity) must “be informed”. This
p.000114: information:
p.000114: - Must be “complete” and “intelligible”.
p.000114: - Must reflect the truth.
p.000114: - Must cover: a) the real condition of health, b) the content of the sug- gested medical act, c) the risks and likely
p.000114: side effects, d) alternative
p.000114:
p.000114:
...

p.000117: parents especially in view of the constitutional protection of parental care (Constitution, art. 21 [1]; art. 8
p.000117: [1] ECHR) whose guarantor is precisely the judiciary and not the physician -as firmly held in legal doctrine.
p.000117: Critical also is the physician’s attitude in case of disagreement between relatives which is not unlikely since
p.000117: the law does not assign any priority among relatives with regard to their power to decide. Should an
p.000117: implicit hierarchy be inferred or is it left to the physician to decide according to his/her fundamental
p.000117: duty to the patient? Could an ethics board be of assis- tance when the patient is hospitalized? Let us recall
p.000117: at this point that our national health system is not familiar with ethics boards whereas in Europe and the US they
p.000117: are well-established -and the importance of their role is not put in question- for many years.
p.000117: An even graver issue may arise when the physician is in a position to know the patient’s wishes, which
p.000117: were expressed before the patient became incapable to consent either in written or orally and the relatives
p.000117: disagree. Since the latter have by law the right to make the final decision, the ques- tion is whether these wishes
p.000117: should be taken into account, and how. It is worth noting that both the CME (art. 2[2]) and the Oviedo
p.000117: Convention (art.
p.000117: 9) stipulate so though failing to specify the ensuing legal effects (see below). Finally, there is a wider issue with
p.000117: the consent of minors. The law totally precludes it (art. 12 [2] [b] CME) even when minors are obviously
p.000117: able to exercise control over their health given that other provisions recognize their capacity to enter into
p.000117: legal relationships (e.g. to marry). At issue here is whether the scope of this provision should be
p.000117: interpreted stricto sensu to apply only when the intellectual immaturity of the minor obviously justifies that the
p.000117: consent be given by his/her parents or custodian in order to har- monize this rule with the constitutional protection
p.000117: of personality (Constitu-
p.000117: tion, art. 5 [1]).
p.000117:
p.000117:
p.000118: 118
p.000118:
p.000118: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000118: REPORT
p.000118:
p.000118: c) Medical liability and other legal consequences
p.000118:
p.000118: In legal terms, the answers to all the above questions have an impact, first and foremost, on the extent of
p.000118: medical liability (criminal, civil and pro- fessional). Liability, in this case, is not connected with fault in the
p.000118: execution of a medical act (which is judged according to lege artis execution) but with fault at the stage preceding
p.000118: the act, i.e. during the legal procedure of deci- sion-making7.
p.000118: Thus the implementation of the Oviedo Convention and the CME provi- sions on “informed consent” (and of the provisions
p.000118: of special legislation on transplants, assisted reproduction, etc.) complement the general legislation on medical
p.000118: liability (e.g. arts. 57, 914 CC, art. 8 Law 2251/1994) and may provide grounds for particular claims in
p.000118: action8.
p.000118: Secondly, the answers may have an impact on the legal situation of third parties (hospitals, relatives) insofar as
p.000118: compliance with the principle of con- sent is associated with individual rights and obligations pertaining to them.
p.000118:
p.000118: C. SPECIAL PROBLEMS IN THE IMPLEMENTATION OF AUTONOMY WITH EMPHASIS ON THE GREEK SITUATION
p.000118:
p.000118: The model of patient consent is based on the assumption of appropriate education on personal autonomy, on the one hand,
p.000118: and on the allocation of relatively adequate time for a sober evaluation of information, on the other. These
p.000118: assumptions rarely permit the application of the model in its pure form. As a matter of fact, special
p.000118: circumstances call for adjustments. There- fore, certain areas of medical practice must be considered separately.
p.000118:
p.000118:
p.000118:
p.000118:
p.000118: 7 This broad concept of fault is upheld today in Germany, France and the US, see Fountedakis (2003) p.
p.000118: 210-211 who accepts the distinction between “medical error” and “information error” (p. 216).
p.000118: 8 The preferred criterion for the assessment of prior information in the context of medical liability is
...

p.000128: disregard the patient’s wishes. For insofar as there is a presumed authentic manifestation of the patient’s autonomy -
p.000128: even if expressed ahead of time - the “substitute” consent of the patient’s legal representatives appears weak.
p.000128: Indeed, the representatives in this case do not decide based on “what the patient would have wanted” (since he/she have
p.000128: already expressed their wishes) but based on what they believe is best for him/her or for anyone in their situation,
p.000128: something which is substantially far removed from respect- ing the principle of autonomy even if under different
p.000128: circumstances it might be the only choice.
p.000128: In legal terms, the physician may not challenge the power of the legal representatives to decide. But the
p.000128: physician has a moral duty to discuss the patient’s wishes with them in an effort to even out disagreements
p.000128: inde- pendently of his/her own view about therapy. Nevertheless, if the physician agrees with the patient’s directions,
p.000128: he/she may give up treating the patient and let another physician take charge14.
p.000128: It is worth noting that the above will remain effective even if special leg- islation is eventually enacted on the
p.000128: validity of advance directives which will
p.000128:
p.000128:
p.000128: 11 The so-called DNR Orders (“Do-Not-Resuscitate”) are an example. To comply with these orders is to commit passive
p.000128: euthanasia.
p.000128: 12 See Vidalis (2007), p. 113 et seq., for a discussion of the issue and relevant litera- ture.
p.000128: 13 Under art. 9 of the Oviedo Convention, the physician must take such wishes “into consideration”. However, there is
p.000128: no specific legislation on a typology of such wishes from which legal consequences may be inferred, especially as
p.000128: regards medical liabil- ity.
p.000128: 14 Cf. arts. 2(5), 9(4) CME which leave room for such an attitude on the part of a phy- sician.
p.000128:
p.000129: 129
p.000129:
p.000129: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000129: REPORT
p.000129:
p.000129: mean that “informal” directions will not generate legal effects for the physi- cian or for the legal representatives of
p.000129: the patient. And this because, apart from the fact that people may freely express their wishes on the
p.000129: future management of issues regarding their health at any time -i.e. without ob- serving some official
p.000129: “form”- it must be stressed that what is at issue here is not medical liability but the physician’s moral duty. Thus,
p.000129: even though phy- sicians will be legally bound to comply with “formally” manifested directions only, in ethical terms,
p.000129: they may not disregard any directions that were ex- pressed informally by the patient.
p.000129:
p.000129: 7. The health system
p.000129:
p.000129: The health system determines the quality of provided services and has a decisive impact on the model of relationship
p.000129: developed between the patient and the patient’s physician. The primary objective is the optimal use of hu- man
p.000129: resources and material assets to meet the needs of citizens whose con- tributions finance the system’s operation. The
p.000129: operation of the health sys- tem is not, at first sight, directly connected with consent in the relationship
...

p.000184: the constitutional context, in which the matter of liability lies, especially in the field of medical research.
p.000184:
p.000184: a. The Constitutional context
p.000184: There are mainly three provisions of interest in the Constitution: art. 16 par.1 which regulates freedom of
p.000184: research (and equates with the unob- structed pursuit of truth by any scientist), art. 5 par. 1 which
p.000184: regulates fi- nancial freedom under the reservation that the “Constitution”, “the rights of others” and “public
p.000184: morals” are respected (and equates with the pursuit of financial profit by the sponsor of a trial) and moreover, art.
p.000184: 21 par. 3 which regulates health as a social right under the state’s care.
p.000184: This last provision is crucial in resolving a conflict between the previous two, a conflict of interest in clinical
p.000184: research.
p.000184:
p.000184:
p.000184:
p.000184:
p.000184:
p.000185: 185
p.000185:
p.000185: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000185: REPORT
p.000185:
p.000185: b. The physician’s/researcher’s liability
p.000185: From a legal point of view, the liability of the physician as a researcher is defined both by the general provisions
p.000185: of criminal and civil law (especially those concerning contract and torts) and by the special provisions concern- ing
p.000185: “scientific research” in the 7th (Z΄) chapter (art. 24-27) of the Medical Code of Ethics (Law 3418/2005).
p.000185: In these special provisions, apart from obli- gations concerning the planning of a clinical trial (also found in texts
p.000185: such as the Oviedo Convention or the 2001/20/EU Directive, as in force in our coun- try), other special obligations of
p.000185: the physicians/researchers are regulated:
p.000185: - Publishing the results of a trial to the medical community by priority, so that they can be subjected to scientific
p.000185: critique and,
p.000185: - revealing the sponsor of the trial.
p.000185: Law 3418/2005 completes the above with the general provision of art. 6 par. 4, which forbids the physician “to serve,
p.000185: depend on or be a part of busi- nesses which manufacture or merchandise drugs”.
p.000185: In the context of the EU Directive 2001/20, the National Committee of Ethics for Clinical Trials -among
p.000185: others- takes the researcher’s “adequacy” into account (art. 6 par. 3e Medical Directorate 3/89292/2003), along
p.000185: with the “guidelines for good medical practice”, as must be followed in that spe- cific facility and by those
p.000185: specific researchers (art. 6 par. 4 Medical Direc- torate 3a/79602/2007)40.
p.000185: These provisions result in a commitment of the physician/researcher to the medical society. This commitment, however,
p.000185: is not connected to medi- cal liability towards the patient taking part in a clinical research, i.e. it can- not be
p.000185: converted to criminal or civil liability of the physician during the rele- vant medical actions41.
p.000185: However, liability towards the patient can arise from other provisions that concern planning of a clinical
p.000185: study, in our case, provided that they are ignored e.g. for reasons of “accelerating” the process, in order to come up
p.000185: directly with commercially exploitable results. Thus, if there is pressure to
p.000185:
p.000185:
...

p.000213: From the above mentioned, there is no doubt that a regulatory interven- tion is essential. The general prohibition of
p.000213: DTC genetic testing is certainly not justified. A differential approach is required, based, for example, on the impact
p.000213: of the tests on a person’s lifestyle. Hence, mild tests, such as those defining a person’s genealogy or modifying
p.000213: a person’s diet etc., are not treated in the same way as tests examining predisposition to serious diseas- es.
p.000213: Moreover, a regulatory intervention, from the legislator’s perspective, seems to be imperative to assure the
p.000213: quality standards of the relevant ser-
p.000213:
p.000213:
p.000213:
p.000214: 214
p.000214:
p.000214: DIRECT-TO-CONSUMER GENETIC TESTING
p.000214: REPORT
p.000214:
p.000214: vices, to acquire guarantees concerning their validity and to avoid mislead- ing the public on such sensitive issues.
p.000214: The above questions appear to be the most important from the stand- point of ethics, without, of course, excluding
p.000214: others. In a certain sense, the continuous development of genetic testing technologies -which leads to the
p.000214: dissemination of the relevant commercial applications- compels us to main- tain this speculation constantly open.
p.000214:
p.000214: THE LEGISLATIVE FRAMEWORK
p.000214:
p.000214: General legislation
p.000214:
p.000214: There is no special legislation dealing with these issues. The general leg- islative framework we need to take into
p.000214: account includes:
p.000214: - The constitutional right to health (art. 5 par. 5 Constitution) and the relevant to personal autonomy provisions
p.000214: of the Oviedo Convention and the Code of Medical Ethics and Deontology (Law 3418/2005), where the
p.000214: principle of “informed consent” is established, as well as the importance of genetic counseling (explicitly
p.000214: stated for genetic tests - see art. 12 Oviedo Convention).
p.000214: The provisions in these texts orientate us towards accepting that mediation of an expert before genetic testing
p.000214: but also during the interpretation of the results, is essential. Therefore, providing such services without
p.000214: mediation cannot be considered as an acceptable aspect of the person’s autonomy on health issues.
p.000214: - The constitutional right to protection of personal data (art. 9 Α Constitution) and the relevant
p.000214: Law 2472/1997, which regulate handling of genetic and medical data.
p.000214: Protection of sensitive data collected by companies must be ensured in the strict context of this legislation.
p.000214: More specifically, the consumer’s consent given to the company in order to collect and handle personal
p.000214: genetic data and information about his/her lifestyle is not enough, while a relevant permission given
p.000214: by the Data Protection Authority is required. Companies operating in our country must be supervised over this
p.000214: point.
p.000214:
p.000214:
p.000215: 215
p.000215:
p.000215: DIRECT-TO-CONSUMER GENETIC TESTING
p.000215: REPORT
p.000215:
p.000215: - The legislation for consumer protection (Law 2251/1994, as in force), which establishes certain obligations for
p.000215: anyone providing services to the general public (mostly regarding adequate information).
p.000215: This legislation is of interest mainly when it comes to advertising the companies and the way they promote genetic
p.000215: testing in general. In this context, provisions for misleading actions (art. 9 d), misleading omissions (art. 9 e) and
p.000215: misleading commercial practices (art. 9 f) are of great importance.
p.000215: - The financial freedom (art. 5 par. 1 Constitution), in the context of which the development of
p.000215: business activities is allowed under certain conditions.
p.000215: Financial freedom needs to be combined with special provisions of the Oviedo Convention, along with legislation
p.000215: for personal data protection, so as to determine purpose legitimacy of the companies providing services and
p.000215: handle biological information. In general, however, this cannot be considered to be either a
p.000215: case of commercialization practices of the human body nor parts of it (according to art. 21 of the
p.000215: Oviedo Convention), neither some form of commercialization of personal data. Without doubt, the specific
p.000215: commercial activity involves production of sensitive data at a certain price, without usage of the biological material
p.000215: or the derived data by third parties. In this sense, this activity is regarded as an acceptable form of financial
p.000215: freedom, provided that conditions of safe handling set by law are respected.
p.000215: - The provisions of the Civil Code and the Code of Civil Procedure regarding establishment of paternity
p.000215: or its insult.
p.000215: These provisions are related to services for the revelation of people’s identity. It must be noted
p.000215: that for the typical judicial establishment of paternity or its insult through testing of genetic
p.000215: material, a specific court decision must previously be pronounced (art. 1477- CC., 615 CCP). In this sense, DTC
p.000215: genetic testing must be regulated, as there is a chance of conflict with legal interests of third parties. The
p.000215: specific court decision guarantees the protection of these interests.
p.000215:
p.000215:
p.000215:
p.000216: 216
p.000216:
p.000216: DIRECT-TO-CONSUMER GENETIC TESTING
p.000216: REPORT
p.000216:
p.000216: The importance of special international legislation
p.000216:
p.000216: For the specification of this general legislative framework, it is essential to address to certain international
p.000216: provisions of soft law, which explicitly refer to the use of human genetic material, such as the two Universal
p.000216: Decla- rations of UNESCO on the Human Genome and the Human Genetic Data, respectively. These texts are not
p.000216: legally binding, but they contribute signifi- cantly to the interpretation of general legislation, as it is
p.000216: usually the case when facing novel application in the law.
p.000216: The same applies, of course, to the new Protocol of the Oviedo Conven- tion -not yet ratified by Greece- which includes
p.000216: provisions for genetic tests for medical reasons (2008). After ratification by the Greek Parliament, this Protocol
p.000216: will be binding and will outweigh the general legislation.
p.000216: Its fundamental provisions, especially those related to DTC genetic test- ing, regardless of what it is generally
p.000216: in force (consent, protection of the incapable to consent, protection of personal data), are those demanding:
p.000216: - A high level of quality in genetic testing, according to universally accepted criteria of scientific and
p.000216: clinical accuracy (art. 5 a),
p.000216: - the appropriate experience of staff providing these services (art. 5 b),
p.000216: - regular controls of the laboratories (art. 5 c),
p.000216: - the proved clinical necessity of such a test (art. 6),
p.000216: - the essential medical counseling and examination (art. 7),
p.000216: - the adequate previous informing of the interested party (art. 8).
p.000216:
p.000216: CONCLUDING REMARKS
p.000216:
p.000216: 1. Ensuring the quality of the provided genetic tests
p.000216: The quality of genetic services primarily includes analytical and clinical accuracy of the tests, high level
p.000216: equipment of genetic centers and laborato- ries, as well as training and continuous education of their staff. Genetic
p.000216: cen- ters offering genetic testing services must have an internal system of quality control and also participate in
...

p.000239: abilities, then, marginally, they may possibly result in unequal opportunities (mainly professional) in social
p.000239: life. Ultimately, individuals who can afford such enhancement interventions may acquire privileged
p.000239: positions. The
p.000239:
p.000239:
p.000240: 240
p.000240:
p.000240: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000240: REPORT
p.000240:
p.000240: option to resolve the problem by covering the enhancement costs through social insurance is not feasible, not only due
p.000240: to the overall, worldwide crisis of the social insurance systems -which, in many cases, led to cuts in
p.000240: absolutely essential coverage- but mainly because the ambiguity of the term “enhancement” (the subjectivity of needs)
p.000240: does not offer a safe ground to plan social services for the general population.
p.000240:
p.000240: 4. The position of Law
p.000240:
p.000240: The general principles concerning human enhancement are identified, firstly, in the constitutional
p.000240: provisions and the provisions of the European Convention on Human Rights (ECHR).
p.000240: The right to develop freely a personality (art. 5 p.1 Constitution), may be considered as the most certain
p.000240: constitutional basis for human enhance- ment, provided that one concludes that the individual right to health (art.
p.000005: 5
p.000005: p. 5 Constitution) covers, in principle, the “narrow” definition of health (see above). However, it would not
p.000005: be unfounded, to cover the issue of enhancement by the right to privacy (art. 9 p.1 section b Constitution,
p.000005: art. 8
p.000005: p.1 ECHR), arguing that human enhancement is related to changes in the core personality.
p.000005: The Oviedo Convention and the Code of Medical Ethics (CME, Law 3418/2005) also include provisions which can
p.000005: be generally applied here.
p.000005: The regulatory scope of the Convention is the “application of Biology and Medicine” (art. 1). From this
p.000005: perspective, human enhancement falls within the Convention -as it is pursued by medical or biological
p.000005: methods- and is included in the concept of “health interventions” (which is encountered repeatedly in the
p.000005: Convention). This means that most of the Convention provisions are applied here and particularly: a) the rule of
p.000005: Informed Consent (art. 5 et seq) and the protection of privacy (art. 10).
p.000005: The CME includes regulations regarding the way medicine should be applied, in the strict sense. Indeed,
p.000005: according to art. 1 CME:
p.000005: 1. A medical act aims at prevention, diagnosis, treatment and restoration of human health, by use of
p.000005: any scientific method.
p.000005: 2. Research can also be regarded as a medical act, provided that it aims at a more accurate diagnosis, restoring
p.000005: or improving human health and the promotion of science.
p.000005:
p.000005:
p.000241: 241
p.000241:
p.000241: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000241: REPORT
p.000241:
p.000241: 3. The concept of medical act also includes drug prescriptions, the order to carry out any kind of paraclinical
p.000241: examinations, issuing medical certificates and attestations and the general counseling of the
p.000241: patient.
...

p.000246:
p.000246: person “identifies” that person in many social relations and relations with the state. On the other hand, it
p.000246: is undisputable that selecting an “image” is associated with the right to develop freely a personality, and, indeed,
p.000246: is in the core of this right. The ascertainment that our image accompanies us in any private or public relation,
p.000246: thus it affects directly our dignity and self- esteem, is a convincing argument for a person to accept a moral
p.000246: priority in the freedom of choosing an image.
p.000246: The same issue includes gender reassignment surgeries or surgeries that aim to eliminate ambiguous features
p.000246: in transsexual individuals. The singularity of these interventions -especially when compared to those that
p.000246: restore the body after accidents or serious diseases- is that, even if they do not restore “damage” of the organism,
p.000246: they “restore”, in a broad sense, the personality, mainly within the context of a normal participation in social life:
p.000246: this fact clearly distinguishes gender reassignment surgeries or surgeries that aim to eliminate ambiguous
p.000246: gender features from simple cosmetic procedures.
p.000246: In addition, a moral issue is raised by research on humans studying the effectiveness of novel plastic procedures,
p.000246: as well as by not providing adequate information to the participating individuals. The ethics
p.000246: of conducting such clinical research (which constitutes a serious legal issue too,
p.000246: e.g. in view of the Oviedo Convention), should be based on known principles, particularly: a) the
p.000246: moral assessment of the research purpose, b) the lack of alternative means of experimentation, c) the exact assessment
p.000246: of the benefits and the potential hazards for the person participating, d) the strict version of “informed
p.000246: consent” and, e) approval by the relevant ethics committee.
p.000246: As a final point, the way plastic surgery is advertised, mainly aesthetic surgery, plays an
p.000246: important role in informing the public. These advertisements cannot be equated with advertisements of
p.000246: other services or products, since they are interventions in the human organism, which are hard to reverse
p.000246: or even irreversible. Although they are not considered as illegitimate (as in the case of advertising
p.000246: therapeutic agents to the general public), these advertisements must be under tighter ethical review
p.000246: regarding the accuracy of the messages and the methods of conveyance.
p.000246:
p.000246:
p.000246:
p.000246:
p.000247: 247
p.000247:
p.000247: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000247: REPORT
p.000247:
p.000247: 4. The law
p.000247:
p.000247: According to the definition described in Law 3418/2005 (CME) art. 1, only plastic surgeries that complete
p.000247: a treatment (and therefore do not constitute “enhancement”) fall within the relevant regulations.
p.000247: On the other hand, art. 11 par. 3 CME (on the obligation to inform the patient), explicitly includes “aesthetic or
p.000247: cosmetic surgeries” in the “special surgeries”, for which intensification of attention is required during the
...

p.000254: of particular importance.
p.000254: Particularly for doping in sport, both the International Convention against Doping in Sport (UNESCO,
p.000254: 2005) ratified by Law 3516/2006, and the Anti-Doping Convention (Council of Europe, 1989) ratified
p.000254: by Law
p.000254:
p.000254:
p.000255: 255
p.000255:
p.000255: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000255: REPORT
p.000255:
p.000255: 2371/1996, are applied. These legislations, are “procedural” in nature and provide control, information,
p.000255: education and transnational cooperation, but without general substantive criteria for classifying substances
p.000255: as “pro- hibited”. The characterization as “prohibited” is left to the absolute discretion of
p.000255: WADA and directly adopted from the states that ratified the aforementioned legislation. It is
p.000255: interesting to note that athletes are permitted to use prohibited substances for therapeutic purposes. The
p.000255: first Convention was specialized in our country with the YA 3956/19.2.2012, specifying, in particular, the
p.000255: national anti-doping controls for all sports under the responsibility of ESKAN. The Anti-Doping Convention
p.000255: of the Council of Europe includes a first list of prohibited substances (with varying classifications), which has
p.000255: been updated from the relevant WADA list (included in the WADA Code 2003).
p.000255: In the field of genetic enhancement (as long as it becomes feasible, especially in sports) the
p.000255: restrictive provision of Art.13 of the Oviedo Convention is crucial, according to which interventions
p.000255: in the genome are permissible “only for preventive, diagnostic or therapeutic purposes”, and interventions
p.000255: that alter the gametes and therefore, the offspring’s genomes, are prohibited. Combined with the UNESCO Universal
p.000255: Declaration on the Human Genome and Human Rights, this provision leaves no substantial room to cover
p.000255: the interventions for pure genetic enhancement (e.g. correction of phenotypic characteristics, as long
p.000255: as it is feasible). On the contrary, this provision allows preventive interventions, through DNA
p.000255: modifications.
p.000255:
p.000255: IΙΙ. Motorized exoskeleton
p.000255:
p.000255: 1. The data
p.000255: The use of motorized means (robotic means) that assist or enhance movement and human locomotion is a
p.000255: field of research in biomedical technology, with potential medical and military applications. The motorized means
p.000255: are mechanical components or external frameworks, which require an external source of energy -at least
p.000255: partially- to operate the engine and hydraulic systems that they include. They are attached to or worn by
p.000255: an individual providing motion.
p.000255: In medicine, the use of motorized means may help to restore functi-
p.000255:
p.000256: 256
p.000256:
p.000256: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000256: REPORT
p.000256:
p.000256: onality in organs or joints, so that patients can return to a healthy or average level of function.
p.000256: Patients with neurological problems, with stroke or spinal cord injuries who present reduced mobility could benefit
...

General/Other / participants in a control group

Searching for indicator placebo:

(return to top)
p.000180: approach, the companies share the expenses, patient recruit- ment/participation is faster (patients are not
p.000180: divided into separated clinical studies by different companies), a single control group is necessary, the
p.000180: duration of the clinical study is reduced, and the use of a common protocol with well defined parameters allows direct
p.000180: comparison and production of robust and convincing results38.
p.000180: Such collaborative studies may be conducted in order to test similar therapies by different pharmaceutical
p.000180: companies against the same dis- ease, or a combination of different therapies that detect different
p.000180: path- ways or mechanisms of disease. A good example in the recent literature is the “Cardiac Arrhythmia Suppression
p.000180: Trial”, which was funded by the Na- tional Institutes of Health. During this study there was a direct comparison of
p.000180: three antiarrhythmic drugs from different companies, testing their effi- cacy to reduce arrhythmic death after a
p.000180: myocardial infarction39. It was proved that two out of the three approved drugs are associated with in- creased
p.000180: mortality instead of decreasing it. If three different clinical studies were conducted, more time would be necessary
p.000180: for completing the stud- ies, they would cost more and it would be impossible to reach such a clear result.
p.000180: Collaborative clinical studies are advantageous not only for faster
p.000180:
p.000180: 38 Moss AJ, Francis CW, Ryan D (2001). Collaborative clinical trials. N Engl J Med 364, 789-791.
p.000180: 39 Echt DS, Liebson PR, Mitchell LB et al. (1991). Mortality and morbidity in patients receiving encainide, flecainide,
p.000180: or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med 324, 781-788.
p.000180:
p.000181: 181
p.000181:
p.000181: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000181: REPORT
p.000181:
p.000181: and less costly research, but they could potentially limit conflict of interest, since more individuals, from different
p.000181: companies are implicated.
p.000181:
p.000181: 8. The ethical issues
p.000181:
p.000181: a. The basic values
p.000181: Pursuing the truth justifies the freedom of research from an ethical point of view. Indeed, the value of the
p.000181: later -acknowledged as a fundamental right- would be pointless if not connected to a rational method revealing the
p.000181: laws and phenomena of nature and society. The development of civilization, along with everyday human activity in
p.000181: any field, would, in reality, be un- thinkable without the pursuit of truth, i.e. without freedom of research.
p.000181: Starting with the above admission, we must however consider how the search for truth is practically organised in
p.000181: a moral-social environment, where other values also matter. It is certain, for example, that research ac- tivity is
p.000181: subject to some restrictions, such as respect of the person’s dignity, protection of public health, protection of the
p.000181: environment. In the end, these restrictions correspond to respective values, which -under certain circum-
p.000181: stances- rule out entire areas of research activity: in this context, “truth” is believed to have an excessive
p.000181: cost to our social coexistence, so excessive that it does not worth favouring against other values.
p.000181: Nonetheless, such restrictions are rather “external” on research, enforced upon it without re- futing its value,
...

p.000189: of an institution's financial interest in human subjects research. Washington, D.C.
p.000189: Bero LA, Rennie D (1996). Influences on the quality of published drug stud- ies. Int J Technol Assess Health Care 12,
p.000189: 209-237.
p.000189: Blumenthal D (2003). Academic-industrial relationships in the life sciences. N Engl J Med 349, 2452-2459.
p.000189: Blumenthal D (2004). Doctors and drug companies. N Engl J Med 351, 1885- 1890.
p.000189: Bodenheimer T (2000). Uneasy alliance-clinical investigators and the phar- maceutical industry. N Engl J Med
p.000189: 342, 1539-1544.
p.000189: Campbell EG, Rao SR, DesRoches CM et al., (2010). Physician professional- ism and changes in physician-industry
p.000189: relationships from 2004 to 2009. Arch Intern Med 170, 1820-1826.
p.000189: Campbell EG, Weissman JS, Vogeli C et al., (2006). Financial relationships be- tween institutional review board members
p.000189: and industry. N Engl J Med 355, 2321-2329.
p.000189: Djulbegovic B, Cantor A, Clarke M (2003). The importance of preservation of the ethical principle of equipoise in the
p.000189: design of clinical trials: relative im- pact of the methodological quality domains on the treatment effect in ran-
p.000189: domized controlled trials. Account Res 10, 301-315.
p.000189:
p.000189:
p.000190: 190
p.000190:
p.000190: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000190: REPORT
p.000190:
p.000190: Dunbar CE, Tallman MS (2009). “Ghostbusting” at blood. Blood 113, 502- 503.
p.000190: Echt DS, Liebson PR, Mitchell LB et al., (1991). Mortality and morbidity in patients receiving encainide,
p.000190: flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med 324, 781-788.
p.000190: Fisher JA (2008). Practicing research ethics: Private-sector physicians & pharmaceutical clinical trials. Soc
p.000190: Sci Med 66, 2495-2505.
p.000190: Fries JF, Krishnan E (2004). Equipoise, design bias, and randomized con- trolled trials: the elusive ethics
p.000190: of new drug development. Arthritis Res Ther 6, R250-R255.
p.000190: Fugh-Berman AJ (2010). The haunting of medical journals: How ghostwriting sold "HRT". PLoS Med 7, e1000335.
p.000190: Hampson LA, Joffe S, Fowler R, Verter J, Emanuel EJ (2007). Frequency, type, and monetary value of financial
p.000190: conflicts of interest in cancer clinical re- search. J Clin Oncol 25, 3609-3614.
p.000190: Henry D, Doran E, Kerridge I, Hill S, McNeill PM, Day R (2005). Ties that bind: multiple relationships between clinical
p.000190: researchers and the pharmaceutical industry. Arch Intern Med 165, 2493-2496.
p.000190: Heres S, Davis J, Maino K, Jetzinger E, Kissling W, Leucht S (2006). Why olanzapine beats risperidone,
p.000190: risperidone beats quetiapine, and quetiapine beats olanzapine: An exploratory analysis of head-to-head comparison stud-
p.000190: ies of second-generation antipsychotics. Am J Psychiatry 163, 185-194.
p.000190: Hulley S, Grady D, Bush T et al., (1998). Randomized trial of estrogen plus progestin for secondary prevention of
p.000190: coronary heart disease in postmeno- pausal women. Heart and Estrogen/progestin Replacement Study (HERS) Re- search
p.000190: Group. JAMA 280, 605-613.
...

p.000275: of frequent use, especially amphetamine use, in college students.
p.000275: Modafinil is also a stimulating substance indicated for the treatment of excessive sleepiness in patients with
p.000275: narcolepsy. However, studies in healthy subjects showed that Modafinil improves memory10, as well as the levels
p.000275: of wakefulness and alertness in physicians11 and pilots12, making
p.000275:
p.000275: 6Warburton DM (1992). Nicotine as a cognitive enhancer. Progress in Neuro- Psychopharmacology and
p.000275: Biological Psychiatry, 16, 181-191.
p.000275: 7Newhouse PA, Potter A & Singh A (2004). Effects of nicotinic stimulation on cognitive performance. Current Opinion in
p.000275: Pharmacology, 4, 36-46.
p.000275: 8Teter CJ, McCabe SE, Boyd CJ, Guthrie SK (2003). Illicit methylphenidate use in an undergraduate student
p.000275: sample: Prevalence and risk factors. Pharmacotherapy 23, 609-17.
p.000275: 9McCabe SE, Teter CJ, Boyd CJ (2006). Medical use, illicit use and diversion of pre- scription stimulant
p.000275: medication. J Psychoactive Drugs 38, 43-56.
p.000275: 10Müller U, Steffenhagen N, Regenthal R, Bublak P (2004). Effects of modafinil on working memory processes
p.000275: in humans. Psychopharmacology (Berl) 177, 161-9.
p.000275: 11Gill M, Haerich P, Westcott K, et al., (2006). Cognitive performance following modafinil versus placebo
p.000275: in sleep-deprived emergency physicians: A double-blind randomized crossover study. Acad Emerg Med 13, 158-65.
p.000275: 12Caldwell JA Jr, Caldwell JL, Smythe NK 3rd, Hall KK (2000). A double-blind, placebo- controlled investigation of the
p.000275: efficacy of modafinil for sustaining the alertness and
p.000275:
p.000276: 276
p.000276:
p.000276: HUMAN ENHANCEMENT - EFFECT ON COGNITIVE & MENTAL STATE
p.000276: REPORT
p.000276:
p.000276: modafinil a substance capable of enhancing cognitive functions in humans.
p.000276:
p.000276: b. Enhancement of mental characteristics and mood
p.000276:
p.000276: At this point, it would be impossible not to mention other pharmaceutical substances,
p.000276: the use of which aims to relieve from phobias and addictions, and could well be used to improve mental
p.000276: characteristics. Illustrative examples are propranolol, which seems to have a preventive effect on
p.000276: post-traumatic stress13 and D-cycloserine, which reduces fear in individuals with phobias14and social anxiety
p.000276: disorder15.
p.000276: Finally, mood enhancers used to enhance a person’s mood, are an issue of concern. Selective Serotonin Reuptake
p.000276: Inhibitors (SSRIs), such as Prozac, Zoloft and other antidepressants are administered in mood and anxiety
p.000276: disorders. In his book “Listening to Prozac” the psychiatrist Peter Kramer reports discussions that he
p.000276: had with patients but also with people not suffering from depression, who all used Prozac to enhance their
p.000276: confidence and self-esteem and felt “better” and “socially more attractive”16. Nevertheless,
p.000276: consequent reviews of the book focused mainly on the subjectivity of diagnosing the symptoms and the
...

Orphaned Trigger Words

p.000022: 14 Regions where malaria used to be endemic.
p.000022: 15 http://www.diagnogene.com/temp.php?page=laboratory<est=jew.
p.000022:
p.000023: 23
p.000023:
p.000023: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000023: REPORT
p.000023:
p.000023: In private health insurance, particularly in individual plans (as opposed to group health plans that are governed
p.000023: by different rules), discrimination based on personal medical history or, generally, on the level of risk that the
p.000023: insured represents for the insurer is admissible. The acceptance of such dis- crimination emanates from the optional
p.000023: nature of private health insurance, the availability of social security and mainly the assumption that
p.000023: private health insurance is governed by the principle of reciprocity (and not by the principle of social solidarity as
p.000023: in social security systems).
p.000023: It should be noted at this point that the legislation that regulates private health insurance varies significantly
p.000023: between countries with developed so- cial security systems -such as the majority of European countries-
p.000023: where private insurance plays a subsidiary role, and countries like the US where there is no social
p.000023: security system and, therefore, citizens’ needs must be met entirely by private insurance.
p.000023: With respect to genetic discrimination, three questions are raised:
p.000023: i) Whether genetic discrimination is currently occurring in health insur- ance, in our country and internationally,
p.000023: ii) Whether genetic discrimination is likely to be an issue in the future,
p.000023: iii) To what extent is genetic discrimination different from medical dis- crimination, which is admissible as
p.000023: a legitimate basis for the calculation of risk.
p.000023: There is no data on genetic discrimination in Greece due to lack of relat- ed research. International literature
p.000023: reports cases of discrimination (Low et al., 1998; Pfeffer et al., 2003), whereas according to some sources the prob-
p.000023: lem of genetic discrimination does not exist at present and represents only a theoretical risk (Hall and Rich, 2000).
p.000023: In actual fact, the identification of ge- netic discrimination cases is very difficult as is the identification of and
p.000023: ac- cess to high risk for discrimination individuals or groups. An additional diffi- culty for this kind of research is
p.000023: the subjectivity of the evaluation of discrim- ination as some cases may be misconstrued as discrimination and vice
p.000023: versa. Nevertheless, even those who argue that the problem of genetic discrimina- tion is hypothetical, agree that
p.000023: the enactment of prohibitory laws or/and the wider debate on the issue have lead to a prevailing “ethics” against
p.000023: the use of genetic data that come from genetic testing (Hall and Rich, 2000). Another reason for the
p.000023: small number of reported discrimination cases de- spite the absence of legislation is probably the fact that most
p.000023: genetic tests
p.000023:
p.000023:
p.000024: 24
p.000024:
p.000024: USE OF GENETIC DATA IN PRIVATE INSURANCE
p.000024: REPORT
p.000024:
p.000024: are relatively recent and their validity has not yet been evaluated by under- writers for practical purposes. Finally,
p.000024: whilst there is some evidence on how genetic data affects insurance prior to the agreement of a contract there has been
p.000024: no consideration regarding discrimination after contract agreement, for instance, problems with compensation
p.000024: payments.
p.000024: Whether genetic data should be treated differently from medical data in insurance is an issue widely debated. Some
p.000024: advocates of excluding genetic data from insurance argue that it is unfair to “punish” people for their ge- netic make
p.000024: up, i.e. for something they cannot change. Others argue that genetic data can be more easily misunderstood or
p.000024: overestimated compared to medical data and this is sufficient grounds to treat it differently (Holm, 2007).
p.000024: By contrast, those who argue that genetic data should be treated in the same way as medical data do not believe that
p.000024: the former have a higher prognostic value nor that they are more personal or sensitive than medical data (Ashcroft,
p.000024: 2007).
p.000024: No matter what stance one takes on this, an additional issue is how to ensure the appropriate evaluation of genetic ...

p.000051:
p.000051: Gross domestic expenditure for re- search & technological development in terms of GDP
p.000051: Gross domestic expenditure for re- search & technological development in terms of GDP
p.000051: Today 1.9% 0.7%(1)
p.000051: 2010 3.0% 1.5%
p.000051: Today 55% 25%(1)
p.000051: 2010 65% 40%
p.000051:
p.000051: With regards the allocation of funds per area of biological research, data from GSRT for public funding shows
p.000051: that within life sciences applied re- search is the prevalent type of research activity in terms of funds
p.000051: absorbed. In particular, in 2005 16.9% of the overall public funding for research and development went to
p.000051: applied research in the biological sciences; the respec- tive share for basic biological research was 3.3% (5 times
p.000051: smaller compared to funding for applied research). A total of 11.7% of public funds for re- search was
p.000051: absorbed by biological research in Universities. An important element demonstrating the wider importance of
p.000051: the Biological Sciences is the fact that they absorb almost one third (31.9%) of the overall expenses for research
p.000051: (Graph 1).
p.000051: To date the management of public funds for research in order to finance selected project proposals was the
p.000051: responsibility of the GSRT. Under the new legislation, management of these funds and the evaluation of proposals
p.000051: come under the EOET3. Although the adopted procedures for the scientific evaluation of research proposals to be
p.000051: submitted to EOET follows interna- tional standards, there is no provision for the evaluation for the
p.000051: ethical evaluation of the proposals. The evaluation of ethics is a prevailing interna- tional trend and a necessary
p.000051: requirement for financing proposals in the 7th EU Framework Program (FP7).
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051:
p.000051: 3 Article 23, Law 3653/2008.
p.000051:
p.000052: 52
p.000052:
p.000052: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000052: REPORT
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052:
p.000052: Graph 1. Break-down of research funding in the Biological Sciences (Biology, Medi- cine, Environment, Agronomics) in
p.000052: Greece for 2005. Percentages shown represent funding for each research activity as a percentage of the
p.000052: total public expenses for research and technological development. Source: GSRT, Public Funding for Research and
p.000052: Technological Development per domain and objectives.
p.000052:
p.000052: Assessment of research
p.000052:
p.000052: The assessment of quality of research is based on the number and quali- ty of publications in internationally
p.000052: accredited journals, the participation in international conferences in the respective field, the success in
p.000052: securing funding for research and the generation of innovative ideas as reflected in awarded patents. Also, the
p.000052: co-operation between research teams nationally and internationally plays a very important role for the positive
p.000052: assessment of the work of researchers and research teams.
p.000052: The professional recognition and career development of researchers depend on the positive assessment of their
p.000052: work. In addition to the personal motivation of each researcher for pursuing a career in research, publica-
p.000052: tions, cooperation and funding, as significant criteria for the evaluation of institutions and individuals,
p.000052: are currently the most prominent driving forces for research; therefore, they are expected to play a key-role in the
p.000052: issues of research ethics that will be discussed below.
p.000052:
p.000052:
p.000052: ...

p.000054: co-operation. Correspondingly the required infrastruc- ture cannot be achieved by isolated laboratories but by
p.000054: large-scale research centres usually operating as independent economic entities. These centres must ensure their
p.000054: viability through self-financing, i.e. by raising private funds since the state can only cover a minimal part of
p.000054: the required invest- ment. Therefore, they are inclined to favour projects of applied research that yield
p.000054: immediate returns to specific sectors of the economy even if -in view of their size- they also allow to some extend
p.000054: activities directed to basic research (indirect return).
p.000054: b) The link of the economy with innovation. Modern research is linked as never before with the economy as the latter
p.000054: funds innovation especially in relation to new technologies (Tindemans 2007: 24). A very competitive envi- ronment has
p.000054: emerged in this respect between the major players of world economy (USA, Japan, Europe and emerging
p.000054: economies); a fact that rein- forces this close link.
p.000054: These factors often create distortions and asphyxiating conditions for the freedom of researchers such as:
p.000054: - Limits to strategy (orientation to applied research and moving away from basic research which is the main
p.000054: contributor to the production of new knowledge),
p.000054: - limits to the scope and even the context of applied research since pri- ority is given to projects of immediate
p.000054: commercial use,
p.000054: - too much preoccupation with fund-raising and the “management” of the research unit, disregard for the main
p.000054: scientific interest,
p.000054:
p.000054:
p.000055: 55
p.000055:
p.000055: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000055: REPORT
p.000055:
p.000055: - readiness to “succumb” to the provider of funds even when the credi- bility of research suffers as a result
p.000055: (e.g. selective publication, even “fabrication” of data),
p.000055: - too much competition between research centres (even within each centre) leading to lack of transparency, at
p.000055: the expense of the necessary communication and co-operation especially in case of ambitious re- search goals.
p.000055: By restricting the freedom of research these symptoms virtually under- mine its intellectual pursuit as a rational
p.000055: endeavour to discover elements of reality of the world that surrounds us.
p.000055: Besides, if the value of research does not exclusively consist of support- ing the economy but also concerns the
p.000055: preservation of other common goods, then the role of public support of researchers is crucial. The
p.000055: state, therefore, seems to dismiss its own responsibilities when it “withdraws” from the active support of
p.000055: research and invokes the interests of the market leaving the efficiency of research to be determined according to free
p.000055: market criteria. For these criteria operate unilaterally and, certainly, do not respect the value of research for
p.000055: society and for the individual, as explained above.
p.000055:
p.000055: Research in the biological sciences
p.000055:
p.000055: These general remarks are all the more relevant in the case of research in the biological sciences which is our focus.
p.000055: Certain particularities need to be stressed at this point.
p.000055:
p.000055: a) Freedom and funding of research
p.000055: The funding of research in biomedicine and biotechnology is a high risk investment because usually it requires large ...

p.000060: Proposal III
p.000060:
p.000060: In terms of ethics, a national policy for research must ensure:
p.000060: - Transparency in the allocation of funds to research projects according to specific and preset criteria including
p.000060: active support for basic re- search. The state is responsible for developing the latter even if the re- turn to
p.000060: the economy is only indirect.
p.000060: - The independence of the community of scientists and of research insti- tutions in setting research priorities. The
p.000060: former can only be defended by a national planning board. Its members must come from the scien- tific community and
p.000060: serve for a specific mandate. The terms of estab- lishment and operation of the ESET generally meet these
p.000060: require- ments. Research bodies must be free in their planning which means that the national board can set
p.000060: only general binding frameworks.
p.000060: - Control of the accuracy and publication of all the results.
p.000060: - Accurate recording of the individual contributions of researchers in col- lective publications in scientific
p.000060: journals.
p.000060: - The investigation and publication of cases of unethical research con- ducted with public funds
p.000060: (fabrication of results, plagiarism, use of questionable methods, violation of bioethical principles, etc.).
p.000060: - The encouragement of the initiatives of young researchers and re- searchers with significant experience from
p.000060: abroad.
p.000060:
p.000060:
p.000060:
p.000060:
p.000061: 61
p.000061:
p.000061: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000061: REPORT
p.000061:
p.000061: Proposal IV
p.000061:
p.000061: Research ethics needs to become part of the training and assessment of researchers. Appropriate for this purpose
p.000061: are ethical codes issued by re- search institutes and adapted to their individual needs. The state can
p.000061: en- courage this process by providing some general principles (co-operation of ESET with the National Bioethics
p.000061: Commission).
p.000061: Besides, the alignment of research ethics with international standards is critical given that these issues are now
p.000061: being discussed in a very wide con- text (Tindemans 2007: 28). Keeping up with developments and, if possible,
p.000061: participating with proposals and initiatives from the ESET would be very welcome.
p.000061:
p.000061:
p.000061:
p.000061:
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p.000061:
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p.000062: 62
p.000062:
p.000062: RESEARCH ETHICS IN THE BIOLOGICAL SCIENCES
p.000062: REPORT
p.000062:
p.000062: SUGGESTED LITERATURE
p.000062:
p.000062: 1st World Conference on Research Integrity: Fostering responsible research (2007). Lisbon, Portugal. Final Report
p.000062: to ESF and ORI (incl. Tindemans Re- port).
p.000062: European Commission (2007a). Key Figures 2007 on Science, Technology and Innovation: Towards a European
p.000062: knowledge area.
p.000062: European Commission (2007b). Medical and health research: A special eu- robarometer public survey.
p.000062: Friedberg M, Saffran B, Stinson TJ, Nelson W, Bennett CL (1999). Evaluation of conflict of interest in economic
p.000062: analyses of new drugs used in oncology. Jama Journal of the American Medical Association 282, 1453-1457.
p.000062: General Secretariat of Research and Development, Statistics on R&D, scien- tific and technological indicators, 2007.
p.000062: http://www.niehs.nih.gov/research/resources/bioethics/whatis.cfm.
p.000062: International Epidemiological Association (2007). Good epidemiological practice (GEP): IEA guidelines for
p.000062: proper conduct of epidemiological re- search.
p.000062: Law 3536/21.3.2008: Statutory Framework for research and technology and other stipulations. Official Journal of the
p.000062: Greek Government.
p.000062: Lesser LI, Ebbeling CB, Goozner M, Wypij D, Ludwig DS (2007). Relationship between funding source and conclusion
p.000062: among nutrition-related scientific articles. PLoS Med 4, e5.
p.000062: Parascandola M (2005). Science, industry, and tobacco harm reduction: A case study of tobacco industry
p.000062: scientists' involvement in the national cancer institute's smoking and health program, 1964-1980. Public Health
p.000062: Reports 120, 338-349. ...

p.000074:
p.000074:
p.000074:
p.000074:
p.000075: 75
p.000075:
p.000075: MANAGEMENT OF BIOLOGICAL WEALTH
p.000075: REPORT
p.000075:
p.000075: FIRST CHAPTER
p.000075:
p.000075: BIOLOGICAL WEALTH IN OUR COUNTRY AND HUMAN ACTIVITY HAZARDS
p.000075:
p.000075: Biodiversity and benefits for humanity
p.000075:
p.000075: A country’s biological wealth is synonymous to the biodiversity it com- prises as a whole. Although the term
p.000075: biodiversity is widely used and consid- ered as having a commonly accepted content, there are different definitions as
p.000075: to its biological content. The most comprehensive definition is “the varie- ty of life at all levels of biological
p.000075: organization” (Gaston and Spicer, 2004). In particular, biodiversity occurs: (i) at the level of genes
p.000075: (genetic diversity which refers to the totality of the genetic characteristics of each species), (ii) at the level
p.000075: of organisms (species diversity which refers to the totality of species in an ecosystem or an area),
p.000075: and, (iii) at the level of ecosystems (ecological diversity, all the different ecosystems of a given
p.000075: area) (Gaston and Spicer, 2004).
p.000075: The value currently attributed to biodiversity by the international com- munity is reflected by the Convention on
p.000075: Biological Diversity, which was the product of the 1992 United Nations Conference for the Environment and
p.000075: Development at Rio de Janeiro. In the Convention the following definition is given: “the variability among living
p.000075: organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecologi-
p.000075: cal complexes of which they are part; [the term biodiversity] includes diver- sity within species, between species and
p.000075: of ecosystems”.
p.000075: But why has the protection of biodiversity been elevated to the level of a universal human value? In philosophical
p.000075: terms, the contribution of the “en- vironmentalist” movement has, of course, been significant. This movement advocated
p.000075: radical, if controversial, approaches such as, in particular, the recognition of rights to nature similar to
p.000075: the natural human rights (reviewed by Nas, 1989), something that is in contrast with the anthropocentricity of most
p.000075: philosophical systems.
p.000075: Irrespective of differences in philosophical approaches, however, the existence of biodiversity undeniably
p.000075: offers specific benefits to mankind which advocate in favour of its protection, some direct, economic or other, and
p.000075: some indirect and less visible (Wilson, 1988). The former include mainly
p.000075:
p.000075:
p.000076: 76
p.000076:
p.000076: MANAGEMENT OF BIOLOGICAL WEALTH
p.000076: REPORT
p.000076:
p.000076: economic benefits in agriculture, science, medicine and industry. Indeed, any living organism can
p.000076: potentially be used to improve on existing or dis- cover new crop species, pharmacological substances or new
p.000076: treatments and renewable raw materials for the manufacturing of industrial products re- spectively (in
p.000076: building, clothing, etc.). The largest the diversity of species, the more chances to discover “exploitable”
p.000076: properties among existing species. These benefits of the existence of high biological diversity to humanity will
p.000076: perhaps become more obvious if we consider that environmental conditions and human habits change overtime. As a result,
p.000076: new needs arise in farming or in health care, for instance, crop species that are productive in new cli- mate
p.000076: conditions or treatments for newly emerging diseases respectively.
p.000076: Another direct benefit of biodiversity is its aesthetic and emotional value and its positive impact on quality of life.
p.000076: Finally, biodiversity is sometimes part of national cultural heritage which adds yet another reason for its protection
p.000076: (e.g. historic trees like Plato’s ol- ive tree, Pausanias’ vine or ecosystems like the national reserve of Olympus, the
p.000076: Delta of Evros, the forest of Dadia, etc.).
p.000076: An indirect but possibly more important, compared to the above men- tioned, benefit of biodiversity is its
p.000076: contribution to the stability of ecosys- tems which ultimately sustain human life (McCann, 2000). In this case,
p.000076: the importance of each species separately is not obvious since the mechanisms and interactions between species and
p.000076: individuals that lead to the sustaina- bility of an ecosystem are not fully known. But a positive association is be-
p.000076: lieved to exist between the total biodiversity of an ecosystem or an area and their survival, stability and
p.000076: productivity.
p.000076: Finding evidence supporting this association is a task the scientific com- munity has set upon itself. The scientific
p.000076: quest began as early as in the XIX century and was initially based more on theoretical arguments rather than
p.000076: experimental data. Today, the attempt to prove it in practice is met with difficulties confirming the
p.000076: complexity of relations between various forms of life at all levels of biological organization. Generally, however, it
p.000076: is believed that the reduction of biodiversity leads to the deterioration of ecosystems (Tilman, 2000).
p.000076: Biodiversity is not limited to wild species of flora and fauna but extends to domesticated species of crop plants or
p.000076: farm animals in the form of varie- ties or races respectively. In this case, the conservation of local varieties, for
p.000076:
p.000076:
p.000077: 77
p.000077:
p.000077: MANAGEMENT OF BIOLOGICAL WEALTH
p.000077: REPORT
p.000077: ...

p.000081: the other aspects of sustainability, especially the economic one, for instance, when there is a demand to
p.000081: preserve certain natural species at all costs in countries without sufficient financial resources. Seen in a different
p.000081: light, though, the demand to combine different aspects of biodiversity creates new needs and, with that, new
p.000081: opportunities for unprecedented economic “post-industrial” initiatives with the use of information technologies4.
p.000081: Nowadays, the ubiquitous use of the term “sustainable development” and its association by the UN with a
p.000081: plethora of sectors and initiatives ex- plains the criticism that, in actual fact, the term is of little explanatory
p.000081: value, despite efforts to create systems of quantitative measurement of “sustaina- bility” with various indicators.
p.000081: This problem aside, sustainable development as an ethical-social de- mand raises questions on many levels.
p.000081: The first general question is whether it corresponds to some overarching value that would justify such a vast
p.000081: reorientation of socioeconomic activi- ties. The prevailing answer seems to be that such a value may consist in en-
p.000081: suring the survival of the human species in the future, hence some degree of responsibility to future generations.
p.000081: Another answer (given by “environ- mentalism” or the so-called “deep ecology”) proclaims the value of Nature in
p.000081: itself and proposes to abandon the anthropocentricity that has character- ized the development of societies so far.
p.000081: The second question concerns the extent of limitations sustainable de- velopment may entail. For instance, is it
p.000081: legitimate to set limits to national sovereignty, especially in developing countries, for the sake of
p.000081: conserving natural wealth (e.g. the big Amazonian forests) or natural resources (e.g.
p.000081:
p.000081: 4 Such initiatives are in fact promoted by the schools of economics of some universi- ties (e.g. Center for
p.000081: Sustainable Global Enterprise/Cornell Univ. or Erb Institute for Global Sustainable Enterprise/Univ. of
p.000081: Michigan).
p.000081:
p.000082: 82
p.000082:
p.000082: MANAGEMENT OF BIOLOGICAL WEALTH
p.000082: REPORT
p.000082:
p.000082: water) which are goods of supranational or universal values? Or, is the sur- vival of local populations to be granted
p.000082: absolute priority that would justify the unrestrained consumption of natural resources as was the case in
p.000082: the western developed countries in previous centuries?
p.000082: And by extension, can we think of some measure of justice in the alloca- tion of duties emanating from sustainable
p.000082: development, even at the level of local, or indeed individual activities? Is thus justifiable that industries
p.000082: may “purchase” pollution (“the polluter pays” principle) or that the intensive exploitation of natural
p.000082: resources by traditional agriculture may go on as it has in the past, and what are the limits in view of the
p.000082: preservation of sus- tainability?
p.000082: The third question concerns some form of regulation of the needs of contemporary societies at a global,
p.000082: national or local level. If the current conditions of globalized economy command a more or less free determina-
p.000082: tion of needs, a broad regulation -which might even lead to pre-industrial concepts of life according to ...

p.000087: 87
p.000087:
p.000087: MANAGEMENT OF BIOLOGICAL WEALTH
p.000087: REPORT
p.000087:
p.000087: - The Convention on the protection of plants (Rome Convention 1951, Law 2014/1992).
p.000087: - The Agreement on tropical timber (Geneva Agreement 1983, Law 1761/1988).
p.000087: - The Convention on trade in endangered species of wild fauna and flora (Washington Convention 1973, Law 2055/1992).
p.000087: - The Convention on the conservation of European wildlife and natural habitats (Berne Convention 1979, Law
p.000087: 1335/1983).
p.000087: - The Convention on the conservation of migratory birds of wild fauna (Bonn Convention 1979, Law 2719/1999).
p.000087: Issues related to the management of biological wealth, such as the pro- tection of natural resources (water), pollution
p.000087: and the use of energy are also covered by special international Conventions.
p.000087:
p.000087: Non-binding instruments
p.000087: Significant international soft law instruments on our topic are the UN Declaration on the Environment
p.000087: (1972) which recognizes for the first time the duty to future generations, as well as the afore mentioned UNESCO
p.000087: Dec- laration on the responsibilities to future generations (1997).
p.000087:
p.000087: EU Law
p.000087: EU law (which applies as domestic law) is also extensive.
p.000087: The principle of sustainable development is enshrined explicitly in art. 6 of the EC Treaty whereas art. 174 on the
p.000087: environment declares as an objec- tive “the prudent and rational utilisation of natural resources” and refers to the
p.000087: precautionary and the preventive action principles, to the rectification of damage preferably at source and to “the
p.000087: polluter pays” principle.
p.000087: In addition, there is ample legislation in specific areas for the protection of habitats (Directive 92/43 which
p.000087: provides the grounds for the NATURA 2000 network), species (Directive 79/409/EEC on wild birds) and the produc-
p.000087: tion and trade of genetically modified microorganisms and organisms (Regu- lations 1829, 1830/2003, Directives 98/81,
p.000087: 2001/18).
p.000087:
p.000087: Greek legislation
p.000087: Following the revision of the Constitution in 2001, art. 24 on the envi- ronment expressly stipulates
p.000087: the “principle of sustainability” (sustainable
p.000087:
p.000087:
p.000088: 88
p.000088:
p.000088: MANAGEMENT OF BIOLOGICAL WEALTH
p.000088: REPORT
p.000088:
p.000088: development) which had often been made reference to in the case-law of the Judicial Review Court as had been the
p.000088: principle of prevention from the early 1990s.
p.000088: Law 1650/1986 on the protection of the environment is the basic text of our national legislation that implements the
p.000088: instructions of our Constitution. Among other objectives the Law stipulates “ensuring the possibility of re-
p.000088: generation of natural resources and the rational utilization of non renewa- ble or rare resources”, and
p.000088: “preserving the ecological balance of natural ecosystems and ensuring their regenerative capacity”.
p.000088: This includes measures for the protection of domestic flora and fauna and the manage- ment of natural resources.
p.000088: Law 743/1977 on the marine environment and law 998/1979 on the pro- tection of forests also cover issues of management
p.000088: of biological resources. The major part of relevant Greek legislation, however, transposes interna- tional or
p.000088: community law.
p.000088: Numerous problems arise in the practical implementation of this legisla- tion as demonstrated formally in the
p.000088: case-law of the Environmental Panel
p.000088: (V) of the Judicial Review Court6 and in related reports of the Ombudsman’s Environmental Department. The Proposals of
p.000088: the present report make spe- cific reference to these problems.
p.000088:
p.000088: FOURTH CHAPTER
p.000088:
p.000088: ENVIRONMENT, SOCIETY, GOVERNMENT
p.000088:
p.000088: The social parameter
p.000088:
p.000088: The relationship between human beings and nature directly affects the planning, social acceptance and efficacy of any
p.000088: policy on the protection of biodiversity and the environment. The place occupied by the environment in the personal
p.000088: scale of values and the minds of individuals determines their attitude in respect to proposed policies. This ...

p.000095:
p.000095: Impact of Farming and Stock-raising on biodiversity
p.000095:
p.000095: a) Problems from farming practices
p.000095:
p.000095: Agricultural activity, mainly due to its territorial intensity, has a major impact on biodiversity that is
p.000095: often negative because of intensive farming, particularly when the guidelines for good faming practices are not
p.000095: followed.
p.000095: A stricter control of farming practices and compliance with safety rules is required of the authorities of the Ministry
p.000095: for Agricultural Development. In addition, the Ministry for Agricultural Development must provide incentives to adopt
p.000095: practices that reduce the indirect and direct negative impact on biodiversity11. Institutions such as
p.000095: integrated management through the cer- tification of farming products and practices with the label AGRO or the pro-
p.000095: motion of biological crops and related products are steps in the right direc- tion.
p.000095:
p.000095: 11 Deviations from good farming practices and legislation are reflected on the com- plaints of citizens that reach
p.000095: the Ombudsman at the Department Quality of Life. Among the complaints, of particular interest is the
p.000095: case of aerial spraying in Corfu against the olive fly. This treatment is forbidden by national and community
p.000095: legisla- tion and decisions of the Judicial Review Court. Aerial spraying on the island of Corfu was permitted
p.000095: exceptionally with a special, Ministerial decision for the years 1999- 2002 but the JRC ruled that this was a breach of
p.000095: law and led to serious mismanage- ment (references in JRC decisions 11327/08.11.99 and 16517/06.11.00).
p.000095:
p.000096: 96
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p.000096: MANAGEMENT OF BIOLOGICAL WEALTH
p.000096: REPORT
p.000096:
p.000096: b) Protection of agricultural biodiversity
p.000096:
p.000096: Another way to limit the negative environmental impact, especially from intensive monocultures, is by using local
p.000096: varieties and races. There is already a public bank for the conservation of local varieties at the ETHIAGE of Thes-
p.000096: saloniki as well as NGO banks (Aegean Seeds Bank at the Institute “Archipel- ago”, the Network on Biodiversity and
p.000096: Ecology in Agriculture at “Aegilopas” and the NGO “Peliti”). Moreover, there are local citizens associations on the
p.000096: exchange of seeds, the cultivation and trade of local varieties.
p.000096: Agricultural biodiversity needs to be protected by supporting the effort to identify and preserve local varieties and
p.000096: by providing incentives for their cultivation in appropriate environments. The use of existing informal net-
p.000096: works of propagation and trade of local varieties and races should also be promoted.
p.000096:
p.000096: Problems of land use
p.000096:
p.000096: A most serious problem for the protection of biodiversity consists in land use changing from forest/pasture to
p.000096: farmland and from agricultural to ur- ban. Whereas land uses are fixed, the conversion of determinate plots is a
p.000096: relatively easy procedure resulting in small or large scale changes without a strategic plan.
p.000096: A central, detailed and stable plan of land use is needed according to well-defined criteria and effective
p.000096: protection from arbitrary interventions12. The protection of biodiversity, and of the environment in general, should be
p.000096: on an equal footing with social and economic factors which are taken into account when changing land use. This
p.000096: can be ensured only by a National Land Use Plan for the totality of the national territory.
p.000096:
p.000096: 12 Flexibility in the designation of land uses often leads to the destruction of habitats or wetlands especially if no
p.000096: special protection status applies. Typical is the case con- sidered by the JRC on an action to protect a habitat in the
p.000096: Porto settlement on the island of Tinos. In this area, the boundaries of the settlement were not clearly defined and
p.000096: the habitat was not delineated. As a result there was unauthorized building de- spite decisions by the JRC ordering the
p.000096: dismantling of constructions. Today the area is so much altered by intensive construction that it is difficult to
p.000096: recognize the proper- ties which called for its conservation (Affaire 20671/27.11.2003 JRC).
p.000096:
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p.000097:
p.000097: MANAGEMENT OF BIOLOGICAL WEALTH
p.000097: REPORT
p.000097:
p.000097: V. Public awareness
p.000097: ...

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p.000103:
p.000103: ...

p.000121: increase in the rate of physicians ticking this answer in recent research (20% in 1980, 78% in 1996).
p.000121: Thus, a change in the attitude of physicians appears to have taken place from the ’80s to the end of the ’90s in our
p.000121: country but this change does not involve all patients. It is revealing that most physicians declare that the ex- tent
p.000121: of information they provide to their patients depends on the personali- ty of the patient (74%) and his/her expected
p.000121: reaction (54%) rather than on the physician’s personal views. Interestingly also, though not unexpectedly, even when
p.000121: they do inform patients of their diagnosis with cancer, most phy- sicians in Greece choose to inform the
p.000121: relatives first and then the patient (Mystakidou et al., 1996).
p.000121: This attitude as documented in surveys based on the admissions of phy- sicians themselves is confirmed in practice. A
p.000121: survey conducted in Athenian hospitals showed that most cancer patients (120 out of 203 interviewed) are unaware of
p.000121: their diagnosis (Brokalaki et al., 2005). However, the same sur- vey recorded a clear wish for more information
p.000121: on part of most patients (69%) whereas of the patients who knew their diagnosis only a small num- ber (13%) said
p.000121: that they would rather not to have been informed. Also, most patients wanted their relatives to be informed of their
p.000121: condition.
p.000121: These findings coincide with the findings of another survey conducted in a Patras hospital which also documented
p.000121: high ignorance rates among pa- tients (59%) and a wish for more information (Iconomou et al., 2002). This survey
p.000121: also investigated the quality of life and the psychological state of
p.000121:
p.000121:
p.000122: 122
p.000122:
p.000122: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000122: REPORT
p.000122:
p.000122: patients associated with their getting or not the full picture of their condi- tion and concluded that the
p.000122: patients were not affected psychologically by knowing the truth. Despite the high ignorance rates reported
p.000122: by the two surveys cited above, these were significantly lower as compared with older data according to which only
p.000122: 15.5% of the patients who participated in rele- vant research knew they suffered from cancer (Lavrentiadis et al.,
p.000122: 1988).
p.000122: All the above show a considerable distance in our country between a wish by patients to receive more
p.000122: information and the attitude of physicians. The causes of this divergence, in particular, the reasons leading
p.000122: physicians to hide the truth from their patients, need to be investigated in order to develop guidelines
p.000122: based on the patients’ interests.
p.000122:
p.000122: c) Honesty in the physician-patient relationship
p.000122: There is disagreement as to the usefulness of honesty in the relationship physician-patient, especially when disclosing
p.000122: the diagnosis of serious diseas- es. A lot of international literature supports the view that honesty and in-
p.000122: formation are beneficial to patients because they strengthen their confi- dence in the physician, increase the
p.000122: chances of compliance, reduce pain and suffering from medical interventions, increase satisfaction for the provided
p.000122: medical care and reduce the chances of change of physician (review by Hebert et al., 1997). By contrast, the
p.000122: concealment of truth from the patient may lead to an attitude of suspicion vis-à-vis the physician while its disclo-
p.000122: sure to relatives may isolate the sufferer from his/her surroundings. ...

p.000132: Fountedaki K (2003). Civil Medical Liability. General introduction - Issues of doctrine and legal policy -
p.000132: Fundamental concepts. Eds. Sakkoulas, Athens- Thessaloniki.
p.000132: Hartzband P and Groopman J (2009). Keeping the patient in the equation- humanism and health care reform. N Engl J Med
p.000132: 361, 554-555.
p.000132: Hebert PC, Hoffmaster B, Glass KC, Singer PA (1997). Bioethics for clinicians.
p.000132: 7. Truth telling. Canadian Medical Association Journal 156, 225-228.
p.000132:
p.000132:
p.000133: 133
p.000133:
p.000133: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000133: REPORT
p.000133:
p.000133: Higgs R (2001). Truth-Telling. In Kuhse H, Singer PA (Eds.), A Companion to Bioethics. Blackwell, Oxford, pp. 432.
p.000133: Iconomou G, Viha A, Koutras A, Vagenakis AG, Kalofonos HP (2002). Infor- mation needs and awareness of diagnosis in
p.000133: patients with cancer receiving chemotherapy: A report from Greece. Palliative Medicine 16, 315-321.
p.000133: Jansen VAA, Stollenwerk N, Jensen HJ, Ramsay ME, Edmunds WJ, Rhodes CJ (2003). Measles outbreaks in a population
p.000133: with declining vaccine uptake. Science 301, 804.
p.000133: Lavrentiadis G, Manos N, Christakis J, Semoglou C (1988). The Greek cancer- patients knowledge and attitudes toward his
p.000133: diagnosis and prognosis. Psy- chotherapy and Psychosomatics 49, 171-178.
p.000133: Manos N and Christakis J (1980). Attitudes of cancer specialists toward their patients in Greece. Int J Psychiatry Med
p.000133: 10, 305-313.
p.000133: Mystakidou K, Liossi C, Vlachos L, Papadimitriou J (1996). Disclosure of diag- nostic information to cancer patients in
p.000133: Greece. Palliat Med 10, 195-200.
p.000133: Mystakidou K, Parpa E, Tsilila E, Katsouda E, Vlahos L (2004). Cancer infor- mation disclosure in different
p.000133: cultural contexts. Support Care Cancer 12, 147-154.
p.000133: Mystakidou K, Tsilika E, Befon S, Kululias V, Vlahos L (1999). Quality of life as a parameter determining therapeutic
p.000133: choices in cancer care in a Greek sam- ple. Palliative Medicine 13, 385-392.
p.000133: Mystakidou K, Tsilika E, Parpa E, Katsouda E, Vlahos L (2005). Patterns and barriers in information disclosure
p.000133: between health care professionals and relatives with cancer patients in Greek society. Eur J Cancer Care (Engl )
p.000133: 14, 175-181.
p.000133: Novack DH, Plumer R, Smith RL, Ochitill H, Morrow GR, Bennett JM (1979). Changes in physicians attitudes toward
p.000133: telling the cancer patient. Jama- Journal of the American Medical Association 241, 897-900.
p.000133: Oken D (1961). What to tell cancer patients - A study of medical attitudes. Jama Journal of the American Medical
p.000133: Association 175, 1120-1128.
p.000133:
p.000133:
p.000133:
p.000134: 134
p.000134:
p.000134: CONSENT IN THE RELATIONSHIP PATIENT - PHYSICIAN
p.000134: REPORT
p.000134:
p.000134: Rigatos GA (1997). Cancer and truth-telling in Greece - Historical, statistical, and clinical data. Communication with
p.000134: the Cancer Patient: Information and Truth 809, 382-392.
p.000134: Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS (1996). Evi- dence based medicine: What it is and what it
p.000134: isn't. BMJ 312, 71-72.
p.000134: Samp RJ and Curreri AR (1957). A questionnaire survey on public cancer ed- ucation obtained from cancer patients
p.000134: and their families. Cancer 10, 382- 384.
p.000134: Thomsen OO, Wulff HR, Martin A, Singer PA (1993). What do gastroenterol- ogists in Europe tell cancer-patients. Lancet
p.000134: 341, 473-476. ...

p.000174:
p.000174: 6. Measures in the USA
p.000174:
p.000174: The cooperation-partnership between academic Institutions and the private sector is, in general, promoted by
p.000174: modern health systems22. Accord- ing to the law in the USA, researchers are encouraged to cooperate with the private
p.000174: initiative in research25.
p.000174: In order to deal with the conflict of interest phenomenon, Universities and the State have generated plans on
p.000174: establishing control mechanisms. In 2001 the Association of American Universities (AAU), expressed concerns
p.000174: about the possibility of conflict of interest phenomena, and submitted rele- vant proposals26. In parallel, in 2001 and
p.000174: 2002, the Association of American Medical Colleges (AAMC) published guidelines under the title “Protecting
p.000174: Subjects, Preserving Trust, Promoting Progress”27.
p.000174: In 2006, due to the increasing scandals concerning the NIH (National Institution of Health) in the USA, AAMC
p.000174: and AAU28 organized a Task Force to introduce management practices with which “the community conducting
p.000174: biomedical research could benefit from precise rules of priorities and values concerning conflict of interest issues
p.000174: between individuals and different Insti- tutions”.
p.000174: The Task Force, consisting of reliable and experienced members of Uni- versities and hospitals, submitted a report in
p.000174: 2008 entitled “Protecting Pa- tients, Preserving Integrity, Advancing Health: A report of the AAMC-AAU
p.000174: Advisory Committee on Financial Conflicts of Interest in Human Subjects
p.000174:
p.000174:
p.000174: 25 von Elm E, Rollin A, Blumle A, Huwiler K, Witschi M, Egger M (2008). Publication and non-publication of clinical
p.000174: trials: Longitudinal study of applications submitted to a research ethics committee. Swiss Med Wkly 138, 197-203.
p.000174: 26 Association American Universities (2001). Task Force on Research Accountability Report and Recommendation.
p.000174: USA.
p.000174: 27 Association of American Medical Colleges (2001). Protecting Subjects, Preserving Trust, Promoting Progress.
p.000174: USA.
p.000174: 28 AAV Advisory Committee on Financial Conflicts of Interest in Human Subjects Re- search, AAMC, AAV (2008).
p.000174: Protecting Patients, Preserving Integrity, Advancing Health Report of the AAMC.
p.000174:
p.000175: 175
p.000175:
p.000175: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000175: REPORT
p.000175:
p.000175: Research, February 2008”. In 2001, the General Accounting Office (USA) addressed its concerns about the
p.000175: conflict of interest phenomena in institu- tions conducting clinical research29.
p.000175: A common component to all the above mentioned recommendations is the obligation of all individuals potentially involved
p.000175: in relevant cases during the design, conduct, assessment or announcement of research results, to disclose or
p.000175: notify of any relationship with the industry.
p.000175: A. Declaration means provision of relevant information by the “re- searcher” to the responsible internal
p.000175: authorities of the Institution, such as the “Conflict of Interest Committee” (CIC) and subsequently, notification to
p.000175: the Committee of Research Control (CRC) of the Institution.
p.000175: B. Notification (or disclosure), means notification to third parties, besides the Institution, such as the patient
p.000175: interested, the accredited responsible State authorities, the scientific societies or journals where the research
p.000175: re- sults are intended for publication.
p.000175: There are three main aims of “Declaration” and “Notification” 30: ...

p.000182: avoided, but they mean that the negative results cannot burden the cost. Furthermore, funding a research with negative
p.000182: results, although it can prove to be scientifically useful, it is financially unprofitable.
p.000182: The financial commitments, especially in clinical research, would not be of such an importance, if the basic funding
p.000182: resource was not the industry. It must be highlighted that research on new drugs (conventional or -even more-
p.000182: biotechnology products) requires a particularly high investment and also involves a high risk of failure.
p.000182: Under these circumstances, the private sector is nearly the only choice -if one exempts public resources
p.000182: from the
p.000182: E.U. or international organizations- as it can undertake the cost and risk. Respectively, nevertheless, it
p.000182: imposes financial commitments on the free- dom of research, which will guarantee reciprocation from the
p.000182: market, i.e. profit from the production and distribution of the final product.
p.000182: The commercial pursuits of industry, through its involvement in clinical research, are not ethically indifferent.
p.000182: Financial freedom in a democratic society is also of moral value, as it creates decisive motives for the satisfac-
p.000182: tion of needs, basic or not. This element cannot be set aside in our argu- mentation, i.e. the pursuit of
p.000182: profit from the production and distribution of innovative products cannot be considered by definition “suspicious” for
p.000182: in- terfering with clinical studies results. Undoubtedly, undertaking the business risk is already a factor promoting
p.000182: biomedical research.
p.000182: The third value we must take under consideration at this point, is the one of health. The “pursuit of
p.000182: truth” by the researcher, along with the pur- suit of financial profit by the sponsor, does not concern any biotic
p.000182: need, but the value of health. Therefore, the new product expected by the research activity must satisfy
p.000182: -with efficacy and safety- a basic need with unquestion- able priority. Thus, it is not morally indifferent whether we
p.000182: will attempt to satisfy or not that need. In this sense, a clinical study also derives its moral status from the
p.000182: nature of its purpose -it does not constitute a kind of re- search out of scientific “curiosity” or
p.000182: simply to gain knowledge without a social meaning.
p.000182:
p.000182:
p.000182:
p.000182:
p.000183: 183
p.000183:
p.000183: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000183: REPORT
p.000183:
p.000183: Therefore, “freedom of research with simultaneous financial reciproca- tion, for a product of social
p.000183: significance” summarizes all the ethical aspects of the matter in question.
p.000183:
p.000183: b. Balancing the goods
p.000183: Certainly, extracting conclusions from a clinical trial is not compatible in any way with some extreme actions
p.000183: -e.g. withholding crucial data, con- structing positive results, concealing negative results- which might
p.000183: have been caused by the sponsor’s pressure on the researcher. In these cases, consciously misleading the
p.000183: scientific community along with the public leads to disregard of the value of scientific truth, by prioritising the
p.000183: pursuit of an economic “efficiency” based on illicit profit. ...

p.000186: results of clinical studies or new drugs with significant differences than the established ones, also based on
p.000186: unreliable clinical trials, it can be compelled to compensate, apart from possible administrative pen- alties (fines,
p.000186: license removal).
p.000186: Therefore, from this point of view, the law opts in favor of searching for scientifically valid results in clinical
p.000186: research, independently from purely financial purposes. Indeed, it is interesting that the above mentioned legisla-
p.000186: tion concerns providers of all kinds of products and services towards the public, as consumers in general.
p.000186: There is no special relevant legislation for products and services concerning health or consumers respectively
p.000186: (i.e.
p.000186:
p.000186:
p.000186: 42 See especially art. 7 of Law 2251/1994.
p.000186:
p.000187: 187
p.000187:
p.000187: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000187: REPORT
p.000187:
p.000187: mostly patients). Even so, however, the businesses’ liability is specified. De lege ferenda it could be argued
p.000187: that, in view of the Constitution’s art. 21 par. 3, it is necessary to adopt a special -stricter- legislation
p.000187: about the com- mercial liability of businesses in the field of healthcare products in order to operate -amongst others-
p.000187: as a dissuasive factor in cases of conflict of inter- est in clinical research.
p.000187:
p.000187: 10. Conclusion - Control mechanisms in our country
p.000187:
p.000187: The possibility of conflict of interest in clinical research has already been regulated by the relevant
p.000187: legislation. The Ministerial Decision of 2003, by which the 2001/20 Commission Directive about clinical studies
p.000187: of medicine was incorporated, adopts a certain form of control of this possibility by the National Ethics Committee for
p.000187: Clinical Studies, to which research protocols are submitted in order to get approval in terms of ethical adequacy43.
p.000187: Beyond that, the constant control by the appointed authorities of the National Organization for Medicines
p.000187: on the course of a clinical study in terms of scientific adequacy, may reveal unjustified gaps and
p.000187: omissions, which can lead to misleading results due to “acceleration” and financial pur- poses.
p.000187: The ethical, as well as the technical (scientific), adequacy of a clinical study are the sponsor’s
p.000187: responsibility, who therefore must be inspected by the appointed authorities of the National Organization for Medicines
p.000187: for the possibility of conflict of interest. The responsibility of inspecting the physi- cian/researcher, as a rule,
p.000187: belongs to the disciplinary powers of both the hospital where the clinical study is taking place and the
p.000187: corresponding med- ical association, mostly on the basis of provisions of Law 3418/2005 men- tioned earlier.
p.000187: It is however pointed out that the current control system does not in- clude, for the time being, the most
p.000187: crucial mechanism, i.e. the hospital re- search ethics committees, an established Institution in most
p.000187: countries, which is able to spot and deter phenomena of conflict of interest in their
p.000187:
p.000187: 43 See art. 6 par. 3 of Ministerial Decision Medical Directorate 3/89292/2003. See also art. 11 par.
p.000187: 4 of the relevant Ministerial Decision Medical Directorate 3a/7567/2008 (2003/94 Commission Directive
p.000187: for rules of good manufacturing of medicinal products).
p.000187:
p.000188: 188
p.000188:
p.000188: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000188: REPORT
p.000188:
p.000188: “source”. This Institution -in which the Hellenic National Bioethics Commis- sion has been repeatedly referred to -is
p.000188: still inactive even though it has been regulated by our legislation (Law 2071/1992).
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000188:
p.000189: 189
p.000189:
p.000189: CONFLICT OF INTEREST IN BIOMEDICAL RESEARCH
p.000189: REPORT
p.000189:
p.000189: SUGGESTED LITERATURE
p.000189:
p.000189: AAV Advisory Committee on financial conflicts of interest in human subjects research, AAMC, AAV (2008). Protecting
p.000189: patients, preserving integrity, ad- vancing health report of the AAMC.
p.000189: Association American Universities (2001). Task force on research accounta- bility report and recommendation. USA.
p.000189: Association of American Medical Colleges (2001). Protecting subjects, pre- serving trust, promoting progress.
p.000189: USA. ...

p.000244: the individual are taken into account.
p.000244: The Mayer-Rokitansky-Kuster-Hauser (MRKH) syndrome. It is a rare congenital malformation characterized by
p.000244: agenesis of the vagina and uterus, while the individual has a normal karyotype 46, XX. Trea- tment of the
p.000244: vaginal agenesis includes plastic surgery in order to create a vagina (Morcel et al., 2007).
p.000244:
p.000244: 2. The Greek reality
p.000244:
p.000244: According to statistics, cosmetic surgeries in Greece are particularly popular. According to the biennial
p.000244: survey of the International Society of Aesthetic Plastic Surgery (ISAPS) held in 2010, Greece occupies
p.000244: the 2nd position for cosmetic procedures, behind South Korea, after taking into
p.000244:
p.000244:
p.000245: 245
p.000245:
p.000245: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000245: REPORT
p.000245:
p.000245: account the percentage of the latter relatively to the population2. In absolute numbers, Greece
p.000245: holds the 20th position on aesthetic surgeries, among the top 25 worldwide.
p.000245: It is estimated that a total of 159,002 cosmetic procedures were held in Greece, of which 76,471 were surgical
p.000245: cosmetic procedures and 82,531 were non-surgical cosmetic procedures. Breast augmentation, eyelid surgery and
p.000245: liposuction were the most popular surgical procedures (14,300, 12,907 and 12,896, respectively) while
p.000245: interventions with hyaluronic acid, botulinum toxin type A (Botox Dysport) and autologous fat transplantation
p.000245: were the three most popular non-surgical interventions in Greece (28,171, 26,352 and 6,283, respectively). The total
p.000245: number of plastic surgeons (286) ranks Greece in the 20th place worldwide.
p.000245:
p.000245: 3. The dimension of ethics
p.000245:
p.000245: Although plastic surgery raises new and complex ethical dilemmas, the relevant literature is limited. The ethical
p.000245: issues arising from plastic surgery vary.
p.000245: Could a physician freely refuse such services, after judging that they are not part of his/her moral duty? The answer
p.000245: should not be taken for granted by the fact that plastic surgery is already a recognized medical specialty. The object
p.000245: of this specialty is not only to correct characteristics for aesthetic reasons, but also to repair damaged
p.000245: tissues and complete a treatment (e.g. mastectomy, reconstruction of severe burns etc.). In this context, it
p.000245: is, in principle, legitimate for an expert to select which surgeries to perform, having certain moral duty
p.000245: only for those who are therapeutic, in the above mentioned sense. Cosmetic surgery does not create a comparable
p.000245: strong commitment to the doctor, since refusal of performing an aesthetic procedure does not put
p.000245: endangers a patient’s health.
p.000245: Another issue is posed by plastic surgery procedures that alter facial features, as they may alter
p.000245: identity. Apart from the psycho-emotional consequences (an extreme form is a complete face transplant,
p.000245: which can also affect others -relatives of the donor), changes of the facial characteristics
p.000245: are associated with public interest, since the image of a
p.000245:
p.000245: 2 International Society of Aesthetic Plastic Surgery (ISAPS) Biennial Global Survey 2010.
p.000245: http://www.isaps.org/.
p.000245:
p.000246: 246
p.000246:
p.000246: HUMAN ENHANCEMENT - PHYSICAL ENHANCEMENT
p.000246: REPORT
p.000246: ...

Appendix

Indicator List

Indicator	Vulnerability
HIV	HIV/AIDS
abuse	Victim of Abuse
access	Access to Social Goods
access to information	Access to information
age	Age
armedXforces	Soldier
authority	Relationship to Authority
autonomy	Impaired Autonomy
belief	Religion
blind	visual impairment
child	Child
children	Child
cioms	cioms guidelines
coerced	Presence of Coercion
cognitive	Cognitive Impairment
crime	Illegal Activity
criminal	criminal
cultural difference	cultural difference
dependence	Drug Dependence
dependent	Dependent
disability	Mentally Disabled
drug	Drug Usage
education	education
educational	education
elderly	Elderly
embryo	embryo
emergencies	patients in emergency situations
emergency	Public Emergency
employees	employees
ethnic	Ethnicity
ethnicity	Ethnicity
family	Motherhood/Family
felon	Criminal Convictions
fetus	Fetus/Neonate
foetus	Fetus/Neonate
gender	gender
gender identity	LGBTQ+ Status
genetic heritage	genetic heritage
healthy volunteers	Healthy People
helsinki	declaration of helsinki
hiv/aids	HIV/AIDS
home	Property Ownership
hospitalized	hospitalized patients
hospitalizedXpatients	hospitalized patients
ill	ill
illegal	Illegal Activity
illness	Physically Disabled
immigrants	immigrants
impairment	Cognitive Impairment
incapable	Mentally Incapacitated
incapacitated	Incapacitated
incapacity	Incapacitated
influence	Drug Usage
language	Linguistic Proficiency
manipulate	Manipulable
manipulated	Manipulable
mentally	Mentally Disabled
military	Soldier
minor	Youth/Minors
minority	Racial Minority
nation	stateless persons
native	Indigenous
necessities	Access to Social Goods
occupation	Occupation
opinion	philosophical differences/differences of opinion
orphan	orphan
oviedo	oviedo
parent	parents
parents	parents
party	political affiliation
philosophy	philosophical differences/differences of opinion
physically	Physically Disabled
placebo	participants in a control group
police	Police Officer
political	political affiliation
poor	Economic/Poverty
prisoners	Criminal Convictions
property	Property Ownership
race	Racial Minority
racial	Racial Minority
religion	Religion
religious	Religion
restricted	Incarcerated
sick	Physically Ill
single	Marital Status
social welfare	Access to Social Goods
soldier	Soldier
stem cells	stem cells
stigma	Threat of Stigma
stigmatization	Threat of Stigma
stigmatized	Threat of Stigma
student	Student
substance	Drug Usage
substance use	substance use
third world	Developing Country
threat	Threat of Stigma
trauma	Victim of Abuse
unconscious	Unconscious People
union	Trade Union Membership
usage	Drug Usage
victim	Victim of Abuse
volunteers	Healthy People
vulnerability	vulnerable
vulnerable	vulnerable
women	Women
youth	Youth/Minors

Indicator Peers (Indicators in Same Vulnerability)

Indicator	Peers
HIV	['hiv/aids']
abuse	['trauma', 'victim']
access	['necessities', 'socialXwelfare']
armedXforces	['military', 'soldier']
belief	['religion', 'religious']
child	['children']
children	['child']
cognitive	['impairment']
crime	['illegal']
disability	['mentally']
drug	['influence', 'substance', 'usage']
education	['educational']
educational	['education']
ethnic	['ethnicity']
ethnicity	['ethnic']
felon	['prisoners']
fetus	['foetus']
foetus	['fetus']
healthy volunteers	['volunteers']
hiv/aids	['HIV']
home	['property']
hospitalized	['hospitalizedXpatients']
hospitalizedXpatients	['hospitalized']
illegal	['crime']
illness	['physically']
impairment	['cognitive']
incapacitated	['incapacity']
incapacity	['incapacitated']
influence	['drug', 'substance', 'usage']
manipulate	['manipulated']
manipulated	['manipulate']
mentally	['disability']
military	['armedXforces', 'soldier']
minor	['youth']
minority	['race', 'racial']
necessities	['socialXwelfare', 'access']
opinion	['philosophy']
parent	['parents']
parents	['parent']
party	['political']
philosophy	['opinion']
physically	['illness']
political	['party']
prisoners	['felon']
property	['home']
race	['minority', 'racial']
racial	['minority', 'race']
religion	['belief', 'religious']
religious	['belief', 'religion']
social welfare	['necessities', 'access']
soldier	['armedXforces', 'military']
stigma	['threat', 'stigmatization', 'stigmatized']
stigmatization	['stigma', 'threat', 'stigmatized']
stigmatized	['stigma', 'threat', 'stigmatization']
substance	['drug', 'influence', 'usage']
threat	['stigma', 'stigmatization', 'stigmatized']
trauma	['victim', 'abuse']
usage	['drug', 'influence', 'substance']
victim	['trauma', 'abuse']
volunteers	['healthyXvolunteers']
vulnerability	['vulnerable']
vulnerable	['vulnerability']
youth	['minor']

Trigger Words

capacity

consent

cultural

developing

ethics

exploit

harm

justice

protect

protection

risk

self-determination

sensitive

volunteer

welfare

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	Criminal Convictions	felon	1
Political	Criminal Convictions	prisoners	1
Political	Illegal Activity	crime	1
Political	Illegal Activity	illegal	5
Political	Indigenous	native	1
Political	criminal	criminal	7
Political	immigrants	immigrants	5
Political	political affiliation	party	11
Political	political affiliation	political	10
Political	stateless persons	nation	2
Political	vulnerable	vulnerable	12
Political	vulnerable	vulnerability	1
Health	Cognitive Impairment	cognitive	71
Health	Cognitive Impairment	impairment	1
Health	Drug Dependence	dependence	1
Health	Drug Usage	drug	49
Health	Drug Usage	influence	8
Health	Drug Usage	substance	10
Health	Drug Usage	usage	1
Health	HIV/AIDS	HIV	11
Health	HIV/AIDS	hiv/aids	0
Health	Healthy People	healthy volunteers	1
Health	Healthy People	volunteers	9
Health	Mentally Disabled	mentally	1
Health	Mentally Disabled	disability	2
Health	Mentally Incapacitated	incapable	5
Health	Motherhood/Family	family	31
Health	Physically Disabled	illness	4
Health	Physically Disabled	physically	3
Health	Physically Ill	sick	4
Health	Unconscious People	unconscious	1
Health	hospitalized patients	hospitalized	4
Health	hospitalized patients	hospitalizedXpatients	1
Health	ill	ill	2
Health	patients in emergency situations	emergencies	3
Health	stem cells	stem cells	3
Health	substance use	substance use	2
Health	visual impairment	blind	4
Social	Access to Social Goods	necessities	1
Social	Access to Social Goods	social welfare	1
Social	Access to Social Goods	access	37
Social	Access to information	access to information	2
Social	Age	age	28
Social	Child	child	10
Social	Child	children	23
Social	Elderly	elderly	2
Social	Ethnicity	ethnic	3
Social	Ethnicity	ethnicity	2
Social	Fetus/Neonate	fetus	1
Social	Fetus/Neonate	foetus	1
Social	Incarcerated	restricted	8
Social	LGBTQ+ Status	gender identity	2
Social	Linguistic Proficiency	language	1
Social	Marital Status	single	18
Social	Occupation	occupation	4
Social	Police Officer	police	3
Social	Presence of Coercion	coerced	1
Social	Property Ownership	home	1
Social	Property Ownership	property	1
Social	Racial Minority	minority	1
Social	Racial Minority	race	2
Social	Racial Minority	racial	5
Social	Religion	belief	2
Social	Religion	religion	3
Social	Religion	religious	1
Social	Soldier	armedXforces	1
Social	Soldier	military	12
Social	Soldier	soldier	1
Social	Student	student	3
Social	Threat of Stigma	stigma	10
Social	Threat of Stigma	threat	6
Social	Threat of Stigma	stigmatization	8
Social	Threat of Stigma	stigmatized	1
Social	Trade Union Membership	union	11
Social	Victim of Abuse	trauma	1
Social	Victim of Abuse	victim	1
Social	Victim of Abuse	abuse	2
Social	Women	women	11
Social	Youth/Minors	minor	5
Social	Youth/Minors	youth	3
Social	education	education	42
Social	education	educational	6
Social	embryo	embryo	3
Social	employees	employees	2
Social	gender	gender	27
Social	genetic heritage	genetic heritage	1
Social	orphan	orphan	1
Social	parents	parent	1
Social	parents	parents	12
Social	philosophical differences/differences of opinion	opinion	102
Social	philosophical differences/differences of opinion	philosophy	24
Economic	Economic/Poverty	poor	5
General/Other	Dependent	dependent	1
General/Other	Developing Country	third world	2
General/Other	Impaired Autonomy	autonomy	119
General/Other	Incapacitated	incapacitated	1
General/Other	Incapacitated	incapacity	5
General/Other	Manipulable	manipulate	1
General/Other	Manipulable	manipulated	2
General/Other	Public Emergency	emergency	16
General/Other	Relationship to Authority	authority	10
General/Other	cioms guidelines	cioms	6
General/Other	cultural difference	cultural difference	1
General/Other	declaration of helsinki	helsinki	1
General/Other	oviedo	oviedo	20
General/Other	participants in a control group	placebo	4

Conflict of Interest in Biomedical Research (2014)

Applicable Type / Vulnerability / Indicator Overlay for this Input

Political / Criminal Convictions

Political / Illegal Activity

Political / Indigenous

Political / criminal

Political / immigrants

Political / political affiliation

Political / stateless persons

Political / vulnerable

Health / Cognitive Impairment

Health / Drug Dependence

Health / Drug Usage

Health / HIV/AIDS

Health / Healthy People

Health / Mentally Disabled

Health / Mentally Incapacitated

Health / Motherhood/Family

Health / Physically Disabled

Health / Physically Ill

Health / Unconscious People

Health / hospitalized patients

Health / ill

Health / patients in emergency situations

Health / stem cells

Health / substance use

Health / visual impairment

Social / Access to Social Goods

Social / Access to information

Social / Age

Social / Child

Social / Elderly

Social / Ethnicity

Social / Fetus/Neonate

Social / Incarcerated

Social / LGBTQ+ Status

Social / Linguistic Proficiency

Social / Marital Status

Social / Occupation

Social / Police Officer

Social / Presence of Coercion

Social / Property Ownership

Social / Racial Minority

Social / Religion

Social / Soldier

Social / Student

Social / Threat of Stigma

Social / Trade Union Membership

Social / Victim of Abuse

Social / Women

Social / Youth/Minors

Social / education

Social / embryo

Social / employees

Social / gender

Social / genetic heritage

Social / orphan

Social / parents

Social / philosophical differences/differences of opinion

Economic / Economic/Poverty

General/Other / Dependent

General/Other / Developing Country

General/Other / Impaired Autonomy

General/Other / Incapacitated

General/Other / Manipulable

General/Other / Public Emergency

General/Other / Relationship to Authority

General/Other / cioms guidelines

General/Other / cultural difference

General/Other / declaration of helsinki

General/Other / oviedo

General/Other / participants in a control group

Orphaned Trigger Words

Appendix

Indicator List

Indicator Peers (Indicators in Same Vulnerability)

Trigger Words

Applicable Type / Vulnerability / Indicator Overlay for this Input