79C3C34C52B45572883A05D425EB0F82
Opinion No. 13: Regarding Experimentation on Man (2001)
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| 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)
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Political / Criminal Convictions
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p.000003: harm would be more suitable in the case of protocols for clinical studies.
p.000003: We think that this is a problem that concerns all local ethics committees and we are asking for the opinion of the
p.000003: Advisory Committee on Bioethics regarding the attitude to be adopted to safeguard our patients as well as possible.
p.000003: […]”.
p.000003:
p.000003: Opinion no. 13 of 9 July 2001 – Final version
p.000004: 4
p.000004:
p.000004: At its first meetings in the spring of 1998, the select committee held preliminary discussions on the basis of a
p.000004: certain number of discussion notes. At that time, its members decided to see their mission, initially, as a
p.000004: reflection on the ethical problem raised by human experimentation1 and the advisability and content of a
p.000004: normative framework in this area.
p.000004: It was in fact immediately decided to defer to another opinion the practical situations that require special
p.000004: precautions owing either to the vulnerability of the individual or to the impossibility of obtaining
p.000004: informed consent. This concerns, among other things but not exclusively, experiments on children, psychiatric
p.000004: patients and other incapable individuals, prisoners, elderly people living in homes, individuals more likely to be
p.000004: constrained (military personnel, police officers, students, laboratory staff, etc.), vulnerable groups
p.000004: (separate cultural communities, those in need, citizens of developing countries, etc.), pregnant or
p.000004: breastfeeding women (in view of the possible consequences for their unborn children), as well as studies where
p.000004: obtaining individual consent interferes with the research itself2.
p.000004: Similarly, the issue of healthy volunteers will not be covered here.
p.000004: The questions of research on embryos in vitro, material obtained during abortions and devitalised tissue
p.000004: and organs (products of operating theatres and cadavers) will not be dealt with in this opinion, either.
p.000004: The same applies for the questions raised by research into dossiers.
p.000004: Finally, the situation with regard to the issue of therapeutic innovation should be clarified. In many respects, this
p.000004: process differs from experimentation. It consist of treating a patient using a new method or a new medicinal
...
p.000007:
p.000007: In the light of these principles – as is stipulated in point 2 above – at first glance the conflict of values
p.000007: inherent in human experimentation appears to be a dilemma between scientificity (principles a and b) and the
p.000007: protection of the autonomy and integrity of individuals (principles c and d). However, experimentation also aims
p.000007: to achieve collective utility. Now, even if we are inclined to believe it owing to the credit currently accorded to
p.000007: science, this collective utility cannot be considered purely and simply an effect of the progress made in
p.000007: scientific knowledge. When they do deal with this question, which is unfortunately only too rare, texts stress
p.000007: that collective utility can only be sought by taking into account a principle of justice, that is a
p.000007: fair distribution between the advantages and the disadvantages of experimentation4.
p.000007: This principle of justice draws attention to the selection of the individuals taking part in research, both those
p.000007: who, owing to their vulnerability, may be exploited by their inclusion (for instance, those who are
p.000007: incapable of consenting, such as nurslings, children, mentally disabled people, prisoners or elderly people living
p.000007: in institutions), and those who are usually excluded, possibly to their disadvantage. In fact, it may be
p.000007: observed that drug treatment in children, for example, is based on observations made in adults, which is not
p.000007: necessarily optimal. The principle of justice also leads to the concern to offer and guarantee fair access to quality
p.000007: health care.
p.000007: For additional information, see Introductory Report, C., 4.
p.000007:
p.000007:
p.000007: C. WHAT IS THE NORMATIVE FRAMEWORK FOR HUMAN EXPERIMENTATION?
p.000007:
p.000007:
p.000007: Belgian law is incomplete as regards human experimentation.
p.000007: In addition to Belgian legislation, there are also European and international normative texts and deontological rules
p.000007: (see Introductory Report, D.).
p.000007:
p.000007: The Advisory Committee suggests:
p.000007: 1) setting up legally established local ethics committees as bodies for the assessment of human experimentation
p.000007: protocols, with clearly defined areas of competence;
p.000007: 2) harmonisation of national, European and international standards in the field of human experimentation and
p.000007: complementarity between the deontological rules and the legal rules;
p.000007: 3) a framework law containing legal rules on ethics committees, the rights and duties of
p.000007:
...
p.000028: consent". This information must include the details relating to liability and insurance in the event of an accident,
p.000028: the limits of the confidentiality of the data obtained and the opinion and comments from the ethics
p.000028: committee that examined the protocol. This information must also be updated as the experiment progresses
p.000028: when relevant new information becomes available.
p.000028:
p.000028:
p.000028: 5. CONCLUSION
p.000028:
p.000028: In addition to these general rules, there are also special rules that are not part of this opinion for
p.000028: vulnerable groups and special situations such as:
p.000028: - healthy volunteers;
p.000028: Opinion no. 13 of 9 July 2001 – Final version
p.000029: 29
p.000029:
p.000029: - individuals who are legally or de facto incapable (psychiatric patients, unconscious patients,
p.000029: underage patients);
p.000029: - the protocols of behavioural studies where obtaining consent prevents the experiment from being carried
p.000029: out at all;
p.000029:
p.000029: - socially vulnerable groups: separate cultural communities, prisoners, persons who are be likely to be
p.000029: forced (such as medical students), persons in need;
p.000029: - pregnant or breastfeeding women;
p.000029: - in vitro human embryos;
p.000029: - experiments on cadavers;
p.000029: - experiments on organs, tissue or tumours removed from patients;
p.000029: - experiments on the products of spontaneous or induced abortions.
p.000029:
p.000029: It appears that a growing number of firms are asking to keep samples with a view to carrying out subsequent genetic
p.000029: analyses. A procedure like this which may involve research carried out unbeknown to the patient poses particular
p.000029: problems and will be the subject of a separate opinion.
p.000029:
p.000029: The aspects of data confidentiality are in principle governed by the legislation on the protection of
p.000029: privacy (act of 8 December 1992 on the protection of privacy with regard to the processing of personal data
p.000029: (Moniteur belge of 18 March 1993)) and the directives of the National Council of the Order of Doctors
p.000029: concerning access to human experimentation dossiers (opinions of 22 August 1992, 17 February 1996, 13 December
p.000029: 1997, 19 September
p.000029: 1998, 24 April 1999, 15 January 2000 and 19 February 2000).
p.000029:
...
Political / criminal
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p.000008:
p.000008: Some members of the Advisory Committee believe that when the opinion of the ethics committee is negative, this must be
p.000008: binding for the investigator because they think that this is the only way to guarantee the safety of the trial subject.
p.000008:
p.000008: Other members believe that it is, of course, legitimate to require that all human experimentation
p.000008: protocols be submitted for assessment to local ethics committee, but on condition that this opinion is advisory and
p.000008: not binding (as is stipulated, moreover, by Article 70 ter of the act of 7 August 1987 on hospitals, inserted by
p.000008: Article 194 of the act of 25 January 1999 (Moniteur belge of 6 February 1999)). In fact, even if the
p.000008: reasons relating to protection of the trial subject are understandable, making a negative option binding5 has major
p.000008: disadvantages:
p.000008: 1) it could lead to the introduction of a power of censorship of the freedom to research: many major
p.000008: experiments in the history of medicine would not have been possible if a binding opinion from a ethics committee had
p.000008: been required;
p.000008: 2) it shifts the centre of liability for experimentation from the researcher to the ethics committee, the effect
p.000008: (paradoxically) being to weaken the civil and criminal liability of the researcher and correlatively to increase that
p.000008: of ethics committee members who thus risk being encouraged to issue ‘defensive’ opinions for fear of incurring
p.000008: liability, to the detriment of any hypothetical progress which the research project may permit.
p.000008: Again according to these members, protection of the trial subject could be guaranteed
p.000008:
p.000008:
p.000008: 5Because a positive opinion will never be binding, so it will never oblige an investigator to proceed with the
p.000008: experimentation.
p.000008: Opinion no. 13 of 9 July 2001 – Final version
p.000009: 9
p.000009:
p.000009: by the threefold obligation for the researcher:
p.000009: 1. to submit the research project to an ethics committee for assessment,
p.000009: 2. to note on the information document that the opinion given was, if appropriate, negative and
p.000009: 3. only to undertake the experimentation once insurance has been taken out.
p.000009:
p.000009: If the opinion is negative, however, the researcher is unlikely to find a hospital and scientific
p.000009: structure that will support his research project. Nevertheless, if only for reasons of principle he must be able to
p.000009: retain the possibility of ignoring the negative opinion of the ethics committee, while remaining aware that he is
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Political / political affiliation
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p.000011: 11
p.000011:
p.000011: These observations and comments provoke a reaction among some certain members of the Advisory Committee who see
p.000011: here not only a radical criticism of the law – by highlighting its formalist dimension – but also a
p.000011: questioning of its efficacy. In response to the question of formalism, they stress that for them, right and morals are
p.000011: not separate normative disciplines. They believe that the rules of law are often replicas of moral rules and that it is
p.000011: therefore not correct to say that observing a legal rule is merely a formal factor that can never be morally
p.000011: experienced or accepted. By making compliance with legal rules mandatory, citizens can also be educated to
p.000011: adopt responsible social behaviour. An initial stage when it is mainly the constraint of the legal rule that is felt
p.000011: and perhaps criticised, is often succeeded by a period of habituation and finally moral integration of the rule
p.000011: (such as the obligation to wear seat belt, mandatory health inspections at school, etc.). These members
p.000011: consider it obvious that the law formulates what was previously seen to be advisable by everyone: the
p.000011: regulation of relationships between human beings.
p.000011:
p.000011: Radicalising their outlooks, they think it is utopian to believe that specific bioethical questions could
p.000011: be definitively resolved outside any legal context. In fact, the trial subject is the weak participant and
p.000011: therefore the one above all who must be protected. Once this subject suffers harm owing to any dysfunction of the
p.000011: experiment whatsoever, he will seek reparation. Practice shows that the party liable usually does not wish to be called
p.000011: into question on the basis of his liability and rarely offers reparation spontaneously. The
p.000011: only option is therefore for the victim to turn to the courts in the hope of finding reparation there. However,
p.000011: appealing to the courts is only possible if this is allowed by law, that is if the experimentation is regulated by law
p.000011: and not by medical ethics. It is therefore in the very best interest of the trial subject that there are rules of law,
p.000011: as a judge can only rule on the basis of these rules.
p.000011:
p.000011: Finally, the advocates of this point of view state that for them, legislation like this does not have to be
p.000011: exhaustive, or deal with the issue in full. The law can be confined to establishing the minimum rules of
p.000011: behaviour and procedures that nevertheless guarantee the protection of trial subjects. It should also be stated that a
p.000011: law does not, by its very nature, address individual cases but is enacted for a group of individual who are
p.000011: in a similar situation. Its formulation and its content are adapted to this ‘common denominator’
p.000011: approach. So even if the preferred option is regulations that are fairly complete and binding, this
p.000011: permits complementary standards, notably in the case in point decisions taken by ethics committees.
p.000011:
p.000011: 3. A framework law
p.000011:
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Political / vulnerable
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p.000003: Advisory Committee on Bioethics regarding the attitude to be adopted to safeguard our patients as well as possible.
p.000003: […]”.
p.000003:
p.000003: Opinion no. 13 of 9 July 2001 – Final version
p.000004: 4
p.000004:
p.000004: At its first meetings in the spring of 1998, the select committee held preliminary discussions on the basis of a
p.000004: certain number of discussion notes. At that time, its members decided to see their mission, initially, as a
p.000004: reflection on the ethical problem raised by human experimentation1 and the advisability and content of a
p.000004: normative framework in this area.
p.000004: It was in fact immediately decided to defer to another opinion the practical situations that require special
p.000004: precautions owing either to the vulnerability of the individual or to the impossibility of obtaining
p.000004: informed consent. This concerns, among other things but not exclusively, experiments on children, psychiatric
p.000004: patients and other incapable individuals, prisoners, elderly people living in homes, individuals more likely to be
p.000004: constrained (military personnel, police officers, students, laboratory staff, etc.), vulnerable groups
p.000004: (separate cultural communities, those in need, citizens of developing countries, etc.), pregnant or
p.000004: breastfeeding women (in view of the possible consequences for their unborn children), as well as studies where
p.000004: obtaining individual consent interferes with the research itself2.
p.000004: Similarly, the issue of healthy volunteers will not be covered here.
p.000004: The questions of research on embryos in vitro, material obtained during abortions and devitalised tissue
p.000004: and organs (products of operating theatres and cadavers) will not be dealt with in this opinion, either.
p.000004: The same applies for the questions raised by research into dossiers.
p.000004: Finally, the situation with regard to the issue of therapeutic innovation should be clarified. In many respects, this
p.000004: process differs from experimentation. It consist of treating a patient using a new method or a new medicinal
p.000004: product and its objectives do not differ from those of ordinary therapy: there is no need to draw up an experimental
p.000004: protocol, the patient is not a trial subject and ultimate aim of the treatment remains solely the patient himself and
p.000004: his personal well-being. In fact, what is involved here is the legitimacy of the innovative medical intervention. It
...
p.000012: the fulfilment of the experiment (see Introductory Report, E., 4., c).
p.000012:
p.000012: The Advisory Committee is pleased to note, on the basis of the available data, that human experimentation
p.000012: rarely causes harm. It nevertheless believes that it is necessary to protect the trial subject and therefore recommends
p.000012: that the investigator be obliged to compensate in full anyone who may suffer harm due to the investigator,
p.000012: even in the absence of error, unless the harm is due to a cause that is not related to the experiment. Insurance must
p.000012: be taken out to cover those who take part in experiments. The law must ensure that this insurance provides sufficient
p.000012: and appropriate cover for those who lend themselves to such experiments. All these measures are intended to prevent
p.000012: individuals who suffer any harm from having to bear the weight of the procedure whereas they are undertaking an act of
p.000012: solidarity for the benefit of the community.
p.000012:
p.000012: The Advisory Committee stresses that the scope of this opinion is general and that it will be supplemented by
p.000012: specific opinions on situations that call for adjustments and additional precautions, such as
p.000012: experiments involving those who are incapable, individuals belonging to vulnerable groups or healthy
p.000012: volunteers.
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p.000012: Opinion no. 13 of 9 July 2001 – Final version
p.000013: 13
p.000013:
p.000013: The opinion was prepared in select committee 97/8, consisting of*:
p.000013:
p.000013:
p.000013: Joint chairpersons
p.000013:
p.000013: M. Bogaert
p.000013:
p.000013: Y. Galloy
p.000013:
p.000013: Joint reporters
p.000013:
p.000013: M.L. Delfosse (2000)
p.000013:
p.000013: E. Guldix
p.000013:
p.000013: Members
p.000013:
p.000013: M. Abramowicz ('96- '99)
p.000013: M. Baum
p.000013: P. Devroey
p.000013: X. Dijon (resigned '98)
p.000013: I. Liebaers ('96-'99)
p.000013: J.N. Missa (2000)
p.000013: H. Nijs
p.000013: G. Sokal ('96-'99)
p.000013: M. Somville ('96-'99)
p.000013: J. Stiennon (resigned '99)
p.000013: F. Van Neste
p.000013:
p.000013: Member of the Bureau
p.000013: Y. Englert
p.000013:
p.000013:
p.000013:
p.000013: Member of the secretariaat
p.000013:
p.000013: E. Morbé
p.000013:
p.000013:
p.000013: Permanent experts
p.000013:
p.000013: • Ms M.L. Delfosse (1996-1999), philosopher, Facultes universitaires Notre-Dame de la Paix-Faculte de
p.000013: droit, and CIDES, Namur.
p.000013: • Ms I. Liebaers (2000), lecturer, Centrum Medische Genetica, AZ-VUB, Brussels.
p.000013: • Mr J.N. Missa (1996-1999), philosopher, CRIB, director of the Institut de Philosophie at the ULB, Brussels.
p.000013:
...
p.000028: involves taking very specific precautions when the consent is obtained by the general practitioner, which
p.000028: is usually the case with human experimentation involving a patient.
p.000028:
p.000028: The validity of this information and this consent is subject to the same type of discussion as information and consent
p.000028: in the context of medical acts. As for such acts, it must be fair and complete without presenting all the eventualities
p.000028: that are theoretically possible in full, which would become a source of anxiety. Finally, as regards the condition of
p.000028: the patient, it must respect his wish to know the seriousness of his condition or not. It is generally considered
p.000028: necessary to pass on "all information that a reasonable person would deem important to take the decision to
p.000028: consent". This information must include the details relating to liability and insurance in the event of an accident,
p.000028: the limits of the confidentiality of the data obtained and the opinion and comments from the ethics
p.000028: committee that examined the protocol. This information must also be updated as the experiment progresses
p.000028: when relevant new information becomes available.
p.000028:
p.000028:
p.000028: 5. CONCLUSION
p.000028:
p.000028: In addition to these general rules, there are also special rules that are not part of this opinion for
p.000028: vulnerable groups and special situations such as:
p.000028: - healthy volunteers;
p.000028: Opinion no. 13 of 9 July 2001 – Final version
p.000029: 29
p.000029:
p.000029: - individuals who are legally or de facto incapable (psychiatric patients, unconscious patients,
p.000029: underage patients);
p.000029: - the protocols of behavioural studies where obtaining consent prevents the experiment from being carried
p.000029: out at all;
p.000029:
p.000029: - socially vulnerable groups: separate cultural communities, prisoners, persons who are be likely to be
p.000029: forced (such as medical students), persons in need;
p.000029: - pregnant or breastfeeding women;
p.000029: - in vitro human embryos;
p.000029: - experiments on cadavers;
p.000029: - experiments on organs, tissue or tumours removed from patients;
p.000029: - experiments on the products of spontaneous or induced abortions.
p.000029:
p.000029: It appears that a growing number of firms are asking to keep samples with a view to carrying out subsequent genetic
p.000029: analyses. A procedure like this which may involve research carried out unbeknown to the patient poses particular
p.000029: problems and will be the subject of a separate opinion.
p.000029:
p.000029: The aspects of data confidentiality are in principle governed by the legislation on the protection of
p.000029: privacy (act of 8 December 1992 on the protection of privacy with regard to the processing of personal data
p.000029: (Moniteur belge of 18 March 1993)) and the directives of the National Council of the Order of Doctors
p.000029: concerning access to human experimentation dossiers (opinions of 22 August 1992, 17 February 1996, 13 December
p.000029: 1997, 19 September
p.000029: 1998, 24 April 1999, 15 January 2000 and 19 February 2000).
p.000029:
...
Searching for indicator vulnerability:
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p.000003: committed, and that there is a causal link to the harm. In addition, in our legislation, the burden of proof lies with
p.000003: the victim.
p.000003:
p.000003:
p.000003: In the absence of the existence of a joint compensation fund, it seems to us that a delicate situation arises where
p.000003: patients who are the subjects of clinical trials may be inadequately protected and insurance in the event of
p.000003: harm would be more suitable in the case of protocols for clinical studies.
p.000003: We think that this is a problem that concerns all local ethics committees and we are asking for the opinion of the
p.000003: Advisory Committee on Bioethics regarding the attitude to be adopted to safeguard our patients as well as possible.
p.000003: […]”.
p.000003:
p.000003: Opinion no. 13 of 9 July 2001 – Final version
p.000004: 4
p.000004:
p.000004: At its first meetings in the spring of 1998, the select committee held preliminary discussions on the basis of a
p.000004: certain number of discussion notes. At that time, its members decided to see their mission, initially, as a
p.000004: reflection on the ethical problem raised by human experimentation1 and the advisability and content of a
p.000004: normative framework in this area.
p.000004: It was in fact immediately decided to defer to another opinion the practical situations that require special
p.000004: precautions owing either to the vulnerability of the individual or to the impossibility of obtaining
p.000004: informed consent. This concerns, among other things but not exclusively, experiments on children, psychiatric
p.000004: patients and other incapable individuals, prisoners, elderly people living in homes, individuals more likely to be
p.000004: constrained (military personnel, police officers, students, laboratory staff, etc.), vulnerable groups
p.000004: (separate cultural communities, those in need, citizens of developing countries, etc.), pregnant or
p.000004: breastfeeding women (in view of the possible consequences for their unborn children), as well as studies where
p.000004: obtaining individual consent interferes with the research itself2.
p.000004: Similarly, the issue of healthy volunteers will not be covered here.
p.000004: The questions of research on embryos in vitro, material obtained during abortions and devitalised tissue
...
p.000005: without at the same time admitting the methods and activities that make it possible to attain these advantages and
p.000005: which are far more fruitful in terms of progress in knowledge than the simple empirical trial and error
p.000005: approaches of previous centuries. Affirming the legitimacy of experimentation means accepting
p.000005: the tension inherent in all experimentation between values that are difficult to harmonise which
p.000005: will have to b
p.000005:
p.000005: 3 In Belgium, Royal Decree No 78 of 10 November 1967 on the exercising of the art of curing, the
p.000005: art of nursing, the paramedical professions and medical commissions (Moniteur belge, 14 November 1967), Article 1,
p.000005: gives legal form to this concern by assigning to the medical act a preventive, diagnostic or curative purpose.
p.000005:
p.000005: Opinion no. 13 of 9 July 2001 – Final version
p.000006: 6
p.000006:
p.000006: expressed as well as possible on a case-by-case basis. Ethics and the law both have a role to play in this respect,
p.000006: according to their own specific features. Through the rules they set out, in particular they have to watch over
p.000006: professional conscience in the face of the extension of activities involving medical experimentation.
p.000006:
p.000006: Finally, human experimentation raises the following question: how can we experiment while respecting the
p.000006: autonomy of the individuals involved and protecting them in their vulnerability? This general question in fact
p.000006: summarises several aspects which are worthy of attention and vigilance, in both ethical and in legal terms.
p.000006: The conflict relating to human experimentation cannot be reduced to an opposition between the freedom to
p.000006: research and the autonomy of the individual. It is also important to take into consideration
p.000006: beneficence and collective utility. The latter aspect can only be researched by taking into account a principle of
p.000006: justice that ensures both the fair distribution of the advantages and disadvantages of experiments conducted
p.000006: within populations and the setting up of structures that enable all citizens to have fair access to quality care.
p.000006: For more information, see Introductory Report, C., 1, 2 and 3.
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p.000006: Opinion no. 13 of 9 July 2001 – Final version
p.000007: 7
p.000007:
p.000007: 3. The reference framework of ethics committees is based on four fundamental principles
p.000007:
...
p.000007: therefore supposes that the subject has the capacities of free thought and that the doctor has the capacities
p.000007: needed to provide clear information.
p.000007:
p.000007: 4. Reflections and expansion: focus on the principle of justice
p.000007:
p.000007: In the light of these principles – as is stipulated in point 2 above – at first glance the conflict of values
p.000007: inherent in human experimentation appears to be a dilemma between scientificity (principles a and b) and the
p.000007: protection of the autonomy and integrity of individuals (principles c and d). However, experimentation also aims
p.000007: to achieve collective utility. Now, even if we are inclined to believe it owing to the credit currently accorded to
p.000007: science, this collective utility cannot be considered purely and simply an effect of the progress made in
p.000007: scientific knowledge. When they do deal with this question, which is unfortunately only too rare, texts stress
p.000007: that collective utility can only be sought by taking into account a principle of justice, that is a
p.000007: fair distribution between the advantages and the disadvantages of experimentation4.
p.000007: This principle of justice draws attention to the selection of the individuals taking part in research, both those
p.000007: who, owing to their vulnerability, may be exploited by their inclusion (for instance, those who are
p.000007: incapable of consenting, such as nurslings, children, mentally disabled people, prisoners or elderly people living
p.000007: in institutions), and those who are usually excluded, possibly to their disadvantage. In fact, it may be
p.000007: observed that drug treatment in children, for example, is based on observations made in adults, which is not
p.000007: necessarily optimal. The principle of justice also leads to the concern to offer and guarantee fair access to quality
p.000007: health care.
p.000007: For additional information, see Introductory Report, C., 4.
p.000007:
p.000007:
p.000007: C. WHAT IS THE NORMATIVE FRAMEWORK FOR HUMAN EXPERIMENTATION?
p.000007:
p.000007:
p.000007: Belgian law is incomplete as regards human experimentation.
p.000007: In addition to Belgian legislation, there are also European and international normative texts and deontological rules
p.000007: (see Introductory Report, D.).
p.000007:
p.000007: The Advisory Committee suggests:
p.000007: 1) setting up legally established local ethics committees as bodies for the assessment of human experimentation
p.000007: protocols, with clearly defined areas of competence;
...
p.000013:
p.000013: The working documents of select committee 97/8 – request for opinion, personal contributions from members,
p.000013: minutes of the meetings, documents consulted – are stored as Annexes 97/8 at the Committee’s documentation centre,
p.000013: where they may be consulted and copies.
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: * Some members took part in the work of the select committee during the Committee’s two terms of
p.000013: office (1996-1999 and 2000). The length of the term is indicated next to the name of members who took part in the work
p.000013: of the committee during a single term.
p.000013:
p.000013: Opinion no. 13 of 9 July 2001 – Final version
p.000014: 14
p.000014:
p.000014: INTRODUCTORY REPORT FOR OPINION No 13 of 9 July 2001 on human experimentation
p.000014:
p.000014:
p.000014: CONTENTS
p.000014:
p.000014: A. Objectives and method
p.000014: B. Definitions
p.000014: C. Medical-scientific research on humans – Ethical and legal problems
p.000014: 1. Legitimacy based on efficacy
p.000014: 2. Care and research
p.000014: 3. The cultural context
p.000014: 4. Problems
p.000014: a. A question of methodology
p.000014: b. Examining ethical requirements – methodology
p.000014: c. The link between autonomy and vulnerability
p.000014: d. Partnership
p.000014: e. Consent
p.000014: f. Insurance
p.000014: g. Should all experimentation protocols be submitted for assessment of by an ethics committee?
p.000014: D. The current normative framework
p.000014: E. Ethics committees
p.000014: 1. Composition
p.000014: 2. Independence
p.000014: 3. Liability and insurance
p.000014: 4. Options to be taken
p.000014: a. Need for an advisory or a binding opinion?
p.000014: b. Professionalisation of ethics committees?
p.000014: c. Restructuring ethics committees to form local committees and ‘regional’ committees?
p.000014: d. An appeal structure
p.000014: e. Forum shopping
p.000014: F. Ethical assessment of an experimental protocol – Procedures
p.000014: 1. The ethical legitimacy of the aim
p.000014: a. The scientific interest of the project
p.000014: b. Drawing up an adequate protocol
p.000014: c. The existence of prerequisites
p.000014: 2. Proportionality of means
p.000014: 3. Qualification of the investigators and the experimentation environment
p.000014: 4. Free and informed consent
p.000014: a. Prior information, essential for informed consent
p.000014: b. Obtaining consent
p.000014: 5. Conclusion
p.000014:
p.000014: A. OBJECTIVES AND METHOD
p.000014:
...
p.000015: 4. the Guidelines for Good Clinical Practice (G.C.P.) of the International Conference on
p.000015: Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH),
p.000015: 5. European Directive 2001/20/EC of 4 April 2001 on the approximation of the laws, regulations and
p.000015: administrative provisions of the Member States relating to the implementation of good clinical practice in the
p.000015: conduct of clinical trials on medicinal products for human use (O.J. 1 May 2001), and
p.000015: 6. Article ATLAN, H., “Distinctions necessaires: l’innovation therapeutique, l’expérimentation sur
p.000015: l’adulte, l’expérimentation sur l’embryon”, in the collective work “Expérimentation biomédicale et Droits de
p.000015: l’Homme”, PUF, Paris, 1988.
p.000015:
p.000015: The central concept is that of experimentation.
p.000015:
p.000015: Experimenting means submitting to a scientific test. The researcher starts from an assumption and
p.000015: wants to see whether, when confronted with the facts, this assumption is confirmed or invalidated.
p.000015: The objective of experimentation is the acquisition of general knowledge that is beneficial to the community and to
p.000015: humanity. The means used to achieve this objective is the experimental strategy.
p.000015: This report is confined to human experimentation: this is referred to by the terms:
p.000015: experimentation subject, trial subject or subject.
p.000015: It was decided to defer until a subsequent examination the practical situations that require special precautions
p.000015: owing either to the vulnerability of individual or the impossibility of obtaining informed consent, as
p.000015: expressed in the opinion.
p.000015:
p.000015: All experimentation in the medical field pursues a cognitive objective, as it always aims to acquire new knowledge.
p.000015: Consequently, there is always a cognitive objective alongside any benefit for the trial subject.
p.000015: However, some members of the Advisory Committee deem it useful to recall the distinction often made between
p.000015: cognitive experimentation, non-therapeutic experimentation and therapeutic experimentation.
p.000015: The sole aim of cognitive experimentation is to improve the state of knowledge and it is not, in principle, of any
p.000015: immediate interest for the trial subjects.
p.000015: Non-therapeutic experimentation has no therapeutic objective as regards the trial subjects and is therefore
p.000015: ultimately synonymous with cognitive experimentation. In this case, the trial subjects are often (but not
p.000015: always) volunteers in good health.
p.000015: Opinion no. 13 of 9 July 2001 – Final version
p.000016: 16
p.000016:
p.000016: Therapeutic experimentation aims to advance scientific knowledge by testing a treatment, diagnostic or prevention
p.000016: process on individuals who are likely, at the same time, to benefit directly in terms of their state of health.
...
p.000019: which, when it becomes cynical, can lead to mercantilism. This is why it is important to question the
p.000019: normative framework of experimentation which gradually came into being during the 20th century, taking care
p.000019: to ensure that the prevailing cultural context does not affect the interpretation of the principles it sets out.
p.000019:
p.000019:
p.000019: 4. PROBLEMS
p.000019:
p.000019: The basic principles on which all human experimentation is based – as set out in the attached opinion,
p.000019: that is the principles of relevance, scientific rigour, ‘no harm’, autonomy and justice – raise a certain number of
p.000019: questions.
p.000019:
p.000019: a. A QUESTION OF METHODOLOGY
p.000019:
p.000019: Some members of the Advisory Committee believe it is essential not to look at questions raised by human experimentation
p.000019: from a normative point of view (solely in the light of the principles mentioned above), but again to take as a
p.000019: basis the description of situations that could lead everyone to question again the limits of the principles on
p.000019: which their ethical judgements are based. What should we so, for example when faced with patients, such as
p.000019: certain AIDS sufferers, who want to take part in an experiment despite the risks of which they have been informed? This
p.000019: situation leads to reconsideration of the link to be established between autonomy, vulnerability and acceptable
p.000019: risk-benefit ratio.
p.000019:
p.000019:
p.000019: 6 Cf. in this respect: KENIS, Y., "Expérimentation, recherche, soins. L'expérience d'un cancerologue", in
p.000019: Le devoir d'experimenter, texts compiled by J.-N. Missa, coll. Sciences, éthiques, sociétés, Brussels, De
p.000019: Boeck University, 1996. p. 80-84.
p.000019: Opinion no. 13 of 9 July 2001 – Final version
p.000020: 20
p.000020:
p.000020: b. EXAMINING ETHICAL REQUIREMENTS - METHODOLOGY
p.000020:
p.000020: Most texts on medical ethics and deontology put forward a series of principles which are based on different ethical
p.000020: outlooks, without suggesting a link between them. This situation may lead to excesses when one of these
p.000020: principles is considered to be the sole determinant, or when the ethical interpretation of the basis for this principle
p.000020: leads to a distorted interpretation of others. To overcome this difficulty, it would be advisable to suggest a
p.000020: methodology like that now put forward by certain texts7, and accompany it with this rule: any condition
p.000020: not met releases the ethics committee from having to examine the following conditions; only protocols for which
p.000020: all the conditions examined, in order, have been given a positive assessment can be granted a favourable opinion.
p.000020:
p.000020: c. THE LINK BETWEEN AUTONOMY AND VULNERABILITY
p.000020:
p.000020: In addition to the principle of autonomy, it is also important to take account of a principle of
p.000020: vulnerability which not only expresses the condition of all individuals, but also requires particular attention
p.000020: when the experimentation concerns those who are weaker, such as those who are ill, children, the mentally
p.000020: disabled, the elderly, people in institutions or suffering from neuralgic disorders. So when an experiment involves
p.000020: those who are ill, the basic question becomes that of the link to be established between the risk accepted by the
p.000020: patient (autonomy) and the benefits the latter expects. The link between autonomy and vulnerability is
p.000020: particularly acute when experimentation is suggested as the last chance of a cure for a patient who is often
p.000020: distressed.
p.000020:
p.000020: d. PARTNERSHIP
p.000020:
p.000020: Rather than seeing consent as authorisation given by a patient or a subject to carry out an experiment on him as a
p.000020: procedure that aims to find out whether this patient or this subject illustrates the relevance of an assumption, would
p.000020: it not be better to see consent and experimentation rather as a partnership? In fact, the relationship between the
p.000020: doctor and the patient must be seen in terms of evolutive agreement that is constantly renegotiated.
p.000020: Actually obtaining informed consent implies abandoning medical paternalism. The doctor cannot decide alone
p.000020: what is good for the patient. He must take the time to correctly inform his partner-patient. The individual
p.000020: taking part freely in research is not an object being manipulated to achieve ends that have nothing to do with him.
p.000020: Ideally, he is an individual who is cooperating, to a limited but effective extent, on improving medical therapeutics
p.000020: and refining scientific knowledge of the human being. Would it not, therefore, be advisable to start from a
p.000020: position of uncertainty common to the patient and the observer?
p.000020:
p.000020: e. CONSENT
p.000020:
p.000020: Without calling into question the compulsory nature of free and informed consent, it should be pointed
...
Health / Cadavers
Searching for indicator cadavers:
(return to top)
p.000004: informed consent. This concerns, among other things but not exclusively, experiments on children, psychiatric
p.000004: patients and other incapable individuals, prisoners, elderly people living in homes, individuals more likely to be
p.000004: constrained (military personnel, police officers, students, laboratory staff, etc.), vulnerable groups
p.000004: (separate cultural communities, those in need, citizens of developing countries, etc.), pregnant or
p.000004: breastfeeding women (in view of the possible consequences for their unborn children), as well as studies where
p.000004: obtaining individual consent interferes with the research itself2.
p.000004: Similarly, the issue of healthy volunteers will not be covered here.
p.000004: The questions of research on embryos in vitro, material obtained during abortions and devitalised tissue
p.000004: and organs (products of operating theatres and cadavers) will not be dealt with in this opinion, either.
p.000004: The same applies for the questions raised by research into dossiers.
p.000004: Finally, the situation with regard to the issue of therapeutic innovation should be clarified. In many respects, this
p.000004: process differs from experimentation. It consist of treating a patient using a new method or a new medicinal
p.000004: product and its objectives do not differ from those of ordinary therapy: there is no need to draw up an experimental
p.000004: protocol, the patient is not a trial subject and ultimate aim of the treatment remains solely the patient himself and
p.000004: his personal well-being. In fact, what is involved here is the legitimacy of the innovative medical intervention. It
p.000004: has been decided that questions relating to therapeutic innovation as such will not be covered in this opinion.
p.000004:
p.000004: To sum up: the opinion concerns only adult and capable trial subjects.
p.000004:
p.000004: A more in-depth analysis of the issue is provided in the introductory report relating to the opinion.
p.000004:
p.000004:
p.000004: B. THE LEGITIMACY OF HUMAN EXPERIMENTATION
p.000004:
p.000004:
p.000004: 1. The Advisory Committee has noted the importance acquired since experimental medicine was defined in
p.000004: the late 19th century by biomedical experimentation on humans and its major impact on progress in medicine in the
p.000004: 20th century.
p.000004:
p.000004:
p.000004:
p.000004: 1 One question was repeatedly asked during the work of the select committee: how should this opinion be extended, in
...
p.000028: when relevant new information becomes available.
p.000028:
p.000028:
p.000028: 5. CONCLUSION
p.000028:
p.000028: In addition to these general rules, there are also special rules that are not part of this opinion for
p.000028: vulnerable groups and special situations such as:
p.000028: - healthy volunteers;
p.000028: Opinion no. 13 of 9 July 2001 – Final version
p.000029: 29
p.000029:
p.000029: - individuals who are legally or de facto incapable (psychiatric patients, unconscious patients,
p.000029: underage patients);
p.000029: - the protocols of behavioural studies where obtaining consent prevents the experiment from being carried
p.000029: out at all;
p.000029:
p.000029: - socially vulnerable groups: separate cultural communities, prisoners, persons who are be likely to be
p.000029: forced (such as medical students), persons in need;
p.000029: - pregnant or breastfeeding women;
p.000029: - in vitro human embryos;
p.000029: - experiments on cadavers;
p.000029: - experiments on organs, tissue or tumours removed from patients;
p.000029: - experiments on the products of spontaneous or induced abortions.
p.000029:
p.000029: It appears that a growing number of firms are asking to keep samples with a view to carrying out subsequent genetic
p.000029: analyses. A procedure like this which may involve research carried out unbeknown to the patient poses particular
p.000029: problems and will be the subject of a separate opinion.
p.000029:
p.000029: The aspects of data confidentiality are in principle governed by the legislation on the protection of
p.000029: privacy (act of 8 December 1992 on the protection of privacy with regard to the processing of personal data
p.000029: (Moniteur belge of 18 March 1993)) and the directives of the National Council of the Order of Doctors
p.000029: concerning access to human experimentation dossiers (opinions of 22 August 1992, 17 February 1996, 13 December
p.000029: 1997, 19 September
p.000029: 1998, 24 April 1999, 15 January 2000 and 19 February 2000).
p.000029:
p.000029: Finally, for some members, ethics committees should follow up the protocol (information on progress with the
p.000029: experiment, interim results, unwanted side effects), which for them constitutes an activity that is as yet
p.000029: unfamiliar. Other members, however, believe that this mission should not be entrusted to them.
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
...
Health / Cognitive Impairment
Searching for indicator cognitive:
(return to top)
p.000005: the community as a whole – and to those who are ill in particular – by enabling medical progress. Society
p.000005: owes them recognition.
p.000005:
p.000005: The legitimacy of human experimentation is closely linked to the acknowledged legitimacy of
p.000005: scientific medicine: it may even be said to depend on it. Today, the importance granted to
p.000005: evidence-based medicine or EBM, illustrates the success of this approach. In fact, experimentation
p.000005: understood to mean systematically testing assumptions by carrying out rigorously monitored and
p.000005: interpreted experiments constitutes the specific method of acquiring knowledge used for scientific medicine
p.000005: which, since the 19th century, has planned to establish its therapeutic basis as widely as possible on knowledge
p.000005: (theoretical or practical) that is validated by experiment.
p.000005:
p.000005: 2. Conflict of values linked to human experimentation
p.000005:
p.000005: Human experimentation is the scene of a conflict between the freedom to research, respect for human
p.000005: beings and the principles of beneficence and justice. This conflict comprises several aspects.
p.000005: Some members consider that by having recourse to human experimentation in order to provide a scientific basis for its
p.000005: therapeutic practices, scientific medicine moves away, in its principles, from the secular but always current
p.000005: rule laid down ever since the Hippocratic Oath: “I will consider the health of my patient to be my first concern”
p.000005: (the Geneva Oath)3. The priority given to the cognitive objective and the collective interest dimension inherent
p.000005: in all experimentation mean that – even when it may also have a beneficial effect for the patient –
p.000005: experimentation involves instrumentalising the latter as well as healthy volunteers. In fact, in
p.000005: experimentation, obtaining therapeutic benefit, when this exists, is doubly mediatised: it is linked to the pursuit
p.000005: of a cognitive objective which always takes priority; through the person involved in the experiment, a category or set
p.000005: of people are targeted. The emphasis here is placed on all the conditions that have to be fulfilled during experiments:
p.000005: the relevance of the research, the appropriateness of the methodology and the context, the attention paid to the
p.000005: risks-benefits ratio, and finally – an essential but not sufficient condition – the free and informed
p.000005: consent of the trial subjects.
p.000005:
p.000005: Other members put the emphasis more on the principle of respect for individuals understood as respect for
p.000005: their self-determination. They consider that experimentation should ideally be conceived as a form of partnership
p.000005: between doctors and the subjects involved in the research. From this point of view, the rule of informed consent plays
p.000005: a fundamental role. The genuine implementation of this rule implies abandoning medical paternalism. The doctor cannot
p.000005: decide alone what is good for the patient. He must take the time to correctly inform his partner-patient. The
p.000005: individual taking part freely in research is not an object being manipulated to achieve ends that have nothing to
p.000005: do with him. Ideally, he is an individual who is cooperating, to a limited but effective extent, in improving medical
p.000005: therapeutics and refining scientific knowledge of the human being.
p.000005:
p.000005: Notwithstanding these two views, experimentation is the scene of tension between on the one hand the freedom to
...
p.000015: 5. European Directive 2001/20/EC of 4 April 2001 on the approximation of the laws, regulations and
p.000015: administrative provisions of the Member States relating to the implementation of good clinical practice in the
p.000015: conduct of clinical trials on medicinal products for human use (O.J. 1 May 2001), and
p.000015: 6. Article ATLAN, H., “Distinctions necessaires: l’innovation therapeutique, l’expérimentation sur
p.000015: l’adulte, l’expérimentation sur l’embryon”, in the collective work “Expérimentation biomédicale et Droits de
p.000015: l’Homme”, PUF, Paris, 1988.
p.000015:
p.000015: The central concept is that of experimentation.
p.000015:
p.000015: Experimenting means submitting to a scientific test. The researcher starts from an assumption and
p.000015: wants to see whether, when confronted with the facts, this assumption is confirmed or invalidated.
p.000015: The objective of experimentation is the acquisition of general knowledge that is beneficial to the community and to
p.000015: humanity. The means used to achieve this objective is the experimental strategy.
p.000015: This report is confined to human experimentation: this is referred to by the terms:
p.000015: experimentation subject, trial subject or subject.
p.000015: It was decided to defer until a subsequent examination the practical situations that require special precautions
p.000015: owing either to the vulnerability of individual or the impossibility of obtaining informed consent, as
p.000015: expressed in the opinion.
p.000015:
p.000015: All experimentation in the medical field pursues a cognitive objective, as it always aims to acquire new knowledge.
p.000015: Consequently, there is always a cognitive objective alongside any benefit for the trial subject.
p.000015: However, some members of the Advisory Committee deem it useful to recall the distinction often made between
p.000015: cognitive experimentation, non-therapeutic experimentation and therapeutic experimentation.
p.000015: The sole aim of cognitive experimentation is to improve the state of knowledge and it is not, in principle, of any
p.000015: immediate interest for the trial subjects.
p.000015: Non-therapeutic experimentation has no therapeutic objective as regards the trial subjects and is therefore
p.000015: ultimately synonymous with cognitive experimentation. In this case, the trial subjects are often (but not
p.000015: always) volunteers in good health.
p.000015: Opinion no. 13 of 9 July 2001 – Final version
p.000016: 16
p.000016:
p.000016: Therapeutic experimentation aims to advance scientific knowledge by testing a treatment, diagnostic or prevention
p.000016: process on individuals who are likely, at the same time, to benefit directly in terms of their state of health.
p.000016: Other members reject these distinctions: they stress that as the objective of experimentation is always advance
p.000016: knowledge, all experiments are for cognitive purposes5. The "therapeutic- cognitive" distinction will not be discussed
p.000016: any further here.
p.000016:
p.000016: Therapeutic innovation (also known as new therapy or experimental therapy) is not experimentation. It
p.000016: involves treating an individual patient using a new method or a new medicinal product and its objectives are
p.000016: no different from those of ordinary therapy: it is not necessary to draw up an experimental protocol, the
p.000016: patient is not a trial subject and the ultimate aim of the treatment remains exclusively the patient himself and
p.000016: his personal well- being. In fact, the question here concerns the legitimacy of the medical intervention.
p.000016:
p.000016: The Advisory Committee feels it is important to keep in mind the successive phases of biomedical
p.000016: experimentation concerning potential medicinal substances as they show in exemplary fashion the complexity
p.000016: of an experimentation procedure. They thus make it possible to be aware of the ethical and legal problems that
p.000016: arise.
p.000016:
p.000016: This type of experimentation begins with laboratory studies, for example in the form of trials on animals, which in
p.000016: principle make it possible to study the evolution and effects of the product in a living organism.
p.000016:
p.000016: This is followed by clinical studies which consist of four successive phases.
p.000016: Phase I involves administering the product for the first time, in principle to a small number of volunteers in good
p.000016: health, in order to assess their tolerance to the product, determine the maximum dose tolerated by humans and the
p.000016: minimum active dose of the product, and study its pharmacokinetic and pharmaco-dynamic properties.
...
p.000016: so as to be able to estimate the relationship between the benefits and the disadvantages (unwanted effects and
p.000016: cost). This phase is also used to gather information which will be useful for prescribers. If it proves
p.000016: conclusive, the next step is to think about marketing the product and fulfilling the procedures required
p.000016: to obtain authorisation to place it on the market.
p.000016: Phase IV comprises the studies conducted once the product has been put on the market. These studies
p.000016: enable better knowledge of the product: the possible association with other therapies, the discovery of new actions,
p.000016: the rare or belated side effects, etc.
p.000016:
p.000016: It should be remembered that the concept of human experimentation is far broader than that of
p.000016: pharmaco-therapeutic experimentation. Without claiming to be exhaustive, it includes the fields of physiology and
p.000016: physiopathology; it may also concern screening and diagnosis techniques, or involve the assessment of new
p.000016: devices or non-medicinal treatments: new techniques, medical appliances, psychotherapy, for instance.
p.000016:
p.000016: In addition to the principle concept of experimentation, the following key concepts also require
p.000016: explanation.
p.000016:
p.000016: The trial subject is the person who, alone or as part of a group, takes part in the experiment
p.000016:
p.000016: 5 These members consider that the distinction between therapeutic experimentation and non-therapeutic
p.000016: experimentation is ultimately not decisive because in both cases, since it is a matter of
p.000016: experimentation, the cognitive objective takes precedence. From this point of view, a therapeutic objective
p.000016: which is added to the cognitive objective of an experiment can only ever be considered a secondary objective; under no
p.000016: circumstances does it annul or attenuate the experimental (and therefore primarily cognitive) nature of
p.000016: the procedure undertaken.
p.000016: Opinion no. 13 of 9 July 2001 – Final version
p.000017: 17
p.000017:
p.000017: and whose organism or mind is the subject of the research.
p.000017:
p.000017: The experimenter or investigator is the person in charge of conducting the clinical study. When the study is
p.000017: carried out by a team of people, an investigator is the head or leader of this team, in charge of the team as a whole.
p.000017: He is referred to as the principal investigator.
p.000017:
p.000017: The sponsor or body subsidising the study is the person, the company, the institution or the body that takes
p.000017: responsibility for devising, managing and funding the clinical study.
p.000017:
p.000017: The experimental protocol is a document that describes, in particular, the objectives, the procedure, the
p.000017: methodology, the statistical elements and the organisation of the study. The experimental protocol also usually
p.000017: explains the foundations of and justifications for the study, even though this information may also appear in
p.000017: other documents to which reference is made in the experimental protocol.
p.000017:
p.000017: A placebo is a tablet, an injection or a treatment which the trial subject believes will have an effect (positive or
p.000017: negative) on his state of health and which, owing to this conviction on the part of the person concerned, can actually
p.000017: have such an effect, but which the investigator is convinced is inert vis-à-vis the state of the trial subject.
p.000017:
p.000017: When, in the context of any experiment during which a treatment is compared to an acknowledged existing
...
p.000018: previous centuries. We therefore have a duty to experiment in order to provide patients with better knowledge and
p.000018: better treatments.
p.000018:
p.000018: 2. CARE AND RESEARCH
p.000018:
p.000018: Experimentation radically transforms medicine. Medicine itself is no longer seen exclusively as the art of curing. The
p.000018: aim is for this art, which remains its main objective and nature, to be able to rely on scientific knowledge,
p.000018: acquired through experimentation, of the human body, its illnesses, and diagnostic and therapeutic means. By doing
p.000018: so, it is divided into two fields of activity: care and research.
p.000018: These differ from one another in the immediate objectives pursued: care on the one hand, contribution to scientific
p.000018: knowledge on the other. Fulfilling these objectives requires the implementation of separate procedures. In
p.000018: fact, the abundance of features common to therapeutic acts, in particular those considered ‘experimental’, and to
p.000018: experiments (whether therapeutic or not) undertaken for the purpose of research cannot hide the fact that they are part
p.000018: of separate processes. An act undertaken mainly for therapeutic purposes is controlled by the characteristics of the
p.000018: patient, which may lead the doctor to diverge from standard practice in the hope of achieving greater
p.000018: efficacy. This is therefore essential a practical procedure: it involves seeking to obtain the best
p.000018: effect for a given patient. Two features should be noted: this type of act is intended for a given person; it
p.000018: seeks above all to achieve an effect. The act of experimental care is therefore identified with the
p.000018: therapeutic relationship. Experimentation undertaken for cognitive purposes may also, where
p.000018: appropriate, be polarised by the search for an effect. However, it differs from the act of
p.000018: ‘experimental’ care because it is part of an experimentation plan that aims to test an assumption,
p.000018: usually by means of a trial involving a group of people. To do this, a situation is devised and created in which
p.000018: variables deemed to be relevant will be monitored as rigorously as possible. Experimentation consists of introducing
p.000018: variations – which are also monitored – into this situation. The results are collected and interpreted; they are used
p.000018: to see whether the initial assumption can or cannot be confirmed. Consequently, there are differences,
p.000018: induced by the pursuit of different objectives. The important thing to remember is that ‘good’ scientific
p.000018: experimentation presupposes strict compliance with experimentation plan drawn up beforehand, whereas the act of
p.000018: experimental care requires constant adjustment to the needs of the patient.
p.000018: Separate procedures have to be planned with regard to ethics, deontology and the law, as they involve specific
p.000018: modalities in the relationship with patients, as with individuals in good health.
p.000018:
p.000018: The distinction between care and research is difficult to establish for a number of reasons. The procedures relating
p.000018: to the one or the other are indiscernible in material terms: same players, same places, often the same acts
p.000018: and sometimes the search for an effect in both cases. They are all marked by uncertainty; moreover in both cases, the
p.000018: term used is trial. They are very closely intertwined: practice stimulates and extends research. Finally,
...
p.000026:
p.000026: This requirement recalls that, as a matter of principle itself, rigorous scientific procedure is based on prior
p.000026: knowledge. While this is true for all scientific experimentation, it is particularly important in human
p.000026: experimentation: have all the existing data relevant for the protocol in question been examined? Do these prior
p.000026: data give legitimacy to the project? Are the prior data (especially the data gathered during animal experiments
p.000026: and previous experiments on human subjects) sufficient to move on to the planned stage in the study?
p.000026:
p.000026:
p.000026: 2. PROPORTIONALITY OF RESOURCES
p.000026:
p.000026: The concept of the proportionality of resources is a conventional if complex concept in medicine: it
p.000026: refers to the fact that all acts (a fortiori all acts of experimentation, however harmless they may appear)
p.000026: entail a risk. Does the anticipated benefit justify this risk? But also: is there an alternative, less risky
p.000026: method of answering the question asked? (We are
p.000026: Opinion no. 13 of 9 July 2001 – Final version
p.000027: 27
p.000027:
p.000027: thinking here, for instance, of the new possibilities of experimentation on isolated cells, even though at some point
p.000027: human experimentation becomes essential).
p.000027:
p.000027: With experimentation carried out for therapeutic purposes, the anticipated direct benefit for the patient may make
p.000027: a high risk acceptable, whereas in the case of purely cognitive experimentation, risk for the person taking
p.000027: part in the experimentation must be slight. On the other hand, the risk assessment must cover the entire
p.000027: experimental procedure (and therefore include, for example, the examinations necessary to assess a new
p.000027: medicinal product), the procedures for the inclusion and exclusion of trial subjects, and the procedures for
p.000027: withdrawing from the experiment and those that apply in circumstances requiring a halt to the experiment.
p.000027:
p.000027: The concept of risk, too, is complex: the risk for the individual is expressed in terms of physical and
p.000027: psychological risks, but also in social and economic terms. But other aspects of the risk also have to be taken into
p.000027: account, such as its seriousness, the probability that it will arise, its reversibility and the possibility that the
p.000027: investigator can overcome it. Overall, this is a difficult assessment, even if serious accidents appear to be
p.000027: exceptional, in any case in the field of trials of new medicinal products.
p.000027:
p.000027:
p.000027: 3. QUALIFICATION OF THE INVESTIGATORS AND EXPERIMENTATION ENVIRONMENT
p.000027:
p.000027: The need for an adequate protocol and the assessment of the risk make it necessary to consider the
p.000027: quality of the investigator (is he the most competent person to carry out the planned experiment?) and the resources
...
Health / Drug Usage
Searching for indicator drug:
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p.000007: protection of the autonomy and integrity of individuals (principles c and d). However, experimentation also aims
p.000007: to achieve collective utility. Now, even if we are inclined to believe it owing to the credit currently accorded to
p.000007: science, this collective utility cannot be considered purely and simply an effect of the progress made in
p.000007: scientific knowledge. When they do deal with this question, which is unfortunately only too rare, texts stress
p.000007: that collective utility can only be sought by taking into account a principle of justice, that is a
p.000007: fair distribution between the advantages and the disadvantages of experimentation4.
p.000007: This principle of justice draws attention to the selection of the individuals taking part in research, both those
p.000007: who, owing to their vulnerability, may be exploited by their inclusion (for instance, those who are
p.000007: incapable of consenting, such as nurslings, children, mentally disabled people, prisoners or elderly people living
p.000007: in institutions), and those who are usually excluded, possibly to their disadvantage. In fact, it may be
p.000007: observed that drug treatment in children, for example, is based on observations made in adults, which is not
p.000007: necessarily optimal. The principle of justice also leads to the concern to offer and guarantee fair access to quality
p.000007: health care.
p.000007: For additional information, see Introductory Report, C., 4.
p.000007:
p.000007:
p.000007: C. WHAT IS THE NORMATIVE FRAMEWORK FOR HUMAN EXPERIMENTATION?
p.000007:
p.000007:
p.000007: Belgian law is incomplete as regards human experimentation.
p.000007: In addition to Belgian legislation, there are also European and international normative texts and deontological rules
p.000007: (see Introductory Report, D.).
p.000007:
p.000007: The Advisory Committee suggests:
p.000007: 1) setting up legally established local ethics committees as bodies for the assessment of human experimentation
p.000007: protocols, with clearly defined areas of competence;
p.000007: 2) harmonisation of national, European and international standards in the field of human experimentation and
p.000007: complementarity between the deontological rules and the legal rules;
p.000007: 3) a framework law containing legal rules on ethics committees, the rights and duties of
p.000007:
p.000007: 4 Among others: The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research,
p.000007: The Belmont Report, 1978; Council for International Organizations of Medical Sciences (CIOMS), in collab. with World
...
Health / Healthy People
Searching for indicator healthy volunteers:
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p.000004: precautions owing either to the vulnerability of the individual or to the impossibility of obtaining
p.000004: informed consent. This concerns, among other things but not exclusively, experiments on children, psychiatric
p.000004: patients and other incapable individuals, prisoners, elderly people living in homes, individuals more likely to be
p.000004: constrained (military personnel, police officers, students, laboratory staff, etc.), vulnerable groups
p.000004: (separate cultural communities, those in need, citizens of developing countries, etc.), pregnant or
p.000004: breastfeeding women (in view of the possible consequences for their unborn children), as well as studies where
p.000004: obtaining individual consent interferes with the research itself2.
p.000004: Similarly, the issue of healthy volunteers will not be covered here.
p.000004: The questions of research on embryos in vitro, material obtained during abortions and devitalised tissue
p.000004: and organs (products of operating theatres and cadavers) will not be dealt with in this opinion, either.
p.000004: The same applies for the questions raised by research into dossiers.
p.000004: Finally, the situation with regard to the issue of therapeutic innovation should be clarified. In many respects, this
p.000004: process differs from experimentation. It consist of treating a patient using a new method or a new medicinal
p.000004: product and its objectives do not differ from those of ordinary therapy: there is no need to draw up an experimental
p.000004: protocol, the patient is not a trial subject and ultimate aim of the treatment remains solely the patient himself and
p.000004: his personal well-being. In fact, what is involved here is the legitimacy of the innovative medical intervention. It
p.000004: has been decided that questions relating to therapeutic innovation as such will not be covered in this opinion.
p.000004:
p.000004: To sum up: the opinion concerns only adult and capable trial subjects.
p.000004:
p.000004: A more in-depth analysis of the issue is provided in the introductory report relating to the opinion.
p.000004:
p.000004:
p.000004: B. THE LEGITIMACY OF HUMAN EXPERIMENTATION
p.000004:
p.000004:
p.000004: 1. The Advisory Committee has noted the importance acquired since experimental medicine was defined in
...
p.000028: is usually the case with human experimentation involving a patient.
p.000028:
p.000028: The validity of this information and this consent is subject to the same type of discussion as information and consent
p.000028: in the context of medical acts. As for such acts, it must be fair and complete without presenting all the eventualities
p.000028: that are theoretically possible in full, which would become a source of anxiety. Finally, as regards the condition of
p.000028: the patient, it must respect his wish to know the seriousness of his condition or not. It is generally considered
p.000028: necessary to pass on "all information that a reasonable person would deem important to take the decision to
p.000028: consent". This information must include the details relating to liability and insurance in the event of an accident,
p.000028: the limits of the confidentiality of the data obtained and the opinion and comments from the ethics
p.000028: committee that examined the protocol. This information must also be updated as the experiment progresses
p.000028: when relevant new information becomes available.
p.000028:
p.000028:
p.000028: 5. CONCLUSION
p.000028:
p.000028: In addition to these general rules, there are also special rules that are not part of this opinion for
p.000028: vulnerable groups and special situations such as:
p.000028: - healthy volunteers;
p.000028: Opinion no. 13 of 9 July 2001 – Final version
p.000029: 29
p.000029:
p.000029: - individuals who are legally or de facto incapable (psychiatric patients, unconscious patients,
p.000029: underage patients);
p.000029: - the protocols of behavioural studies where obtaining consent prevents the experiment from being carried
p.000029: out at all;
p.000029:
p.000029: - socially vulnerable groups: separate cultural communities, prisoners, persons who are be likely to be
p.000029: forced (such as medical students), persons in need;
p.000029: - pregnant or breastfeeding women;
p.000029: - in vitro human embryos;
p.000029: - experiments on cadavers;
p.000029: - experiments on organs, tissue or tumours removed from patients;
p.000029: - experiments on the products of spontaneous or induced abortions.
p.000029:
p.000029: It appears that a growing number of firms are asking to keep samples with a view to carrying out subsequent genetic
p.000029: analyses. A procedure like this which may involve research carried out unbeknown to the patient poses particular
p.000029: problems and will be the subject of a separate opinion.
p.000029:
...
Searching for indicator volunteers:
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p.000005: scientific medicine: it may even be said to depend on it. Today, the importance granted to
p.000005: evidence-based medicine or EBM, illustrates the success of this approach. In fact, experimentation
p.000005: understood to mean systematically testing assumptions by carrying out rigorously monitored and
p.000005: interpreted experiments constitutes the specific method of acquiring knowledge used for scientific medicine
p.000005: which, since the 19th century, has planned to establish its therapeutic basis as widely as possible on knowledge
p.000005: (theoretical or practical) that is validated by experiment.
p.000005:
p.000005: 2. Conflict of values linked to human experimentation
p.000005:
p.000005: Human experimentation is the scene of a conflict between the freedom to research, respect for human
p.000005: beings and the principles of beneficence and justice. This conflict comprises several aspects.
p.000005: Some members consider that by having recourse to human experimentation in order to provide a scientific basis for its
p.000005: therapeutic practices, scientific medicine moves away, in its principles, from the secular but always current
p.000005: rule laid down ever since the Hippocratic Oath: “I will consider the health of my patient to be my first concern”
p.000005: (the Geneva Oath)3. The priority given to the cognitive objective and the collective interest dimension inherent
p.000005: in all experimentation mean that – even when it may also have a beneficial effect for the patient –
p.000005: experimentation involves instrumentalising the latter as well as healthy volunteers. In fact, in
p.000005: experimentation, obtaining therapeutic benefit, when this exists, is doubly mediatised: it is linked to the pursuit
p.000005: of a cognitive objective which always takes priority; through the person involved in the experiment, a category or set
p.000005: of people are targeted. The emphasis here is placed on all the conditions that have to be fulfilled during experiments:
p.000005: the relevance of the research, the appropriateness of the methodology and the context, the attention paid to the
p.000005: risks-benefits ratio, and finally – an essential but not sufficient condition – the free and informed
p.000005: consent of the trial subjects.
p.000005:
p.000005: Other members put the emphasis more on the principle of respect for individuals understood as respect for
p.000005: their self-determination. They consider that experimentation should ideally be conceived as a form of partnership
p.000005: between doctors and the subjects involved in the research. From this point of view, the rule of informed consent plays
p.000005: a fundamental role. The genuine implementation of this rule implies abandoning medical paternalism. The doctor cannot
p.000005: decide alone what is good for the patient. He must take the time to correctly inform his partner-patient. The
p.000005: individual taking part freely in research is not an object being manipulated to achieve ends that have nothing to
p.000005: do with him. Ideally, he is an individual who is cooperating, to a limited but effective extent, in improving medical
...
p.000012: the fulfilment of the experiment (see Introductory Report, E., 4., c).
p.000012:
p.000012: The Advisory Committee is pleased to note, on the basis of the available data, that human experimentation
p.000012: rarely causes harm. It nevertheless believes that it is necessary to protect the trial subject and therefore recommends
p.000012: that the investigator be obliged to compensate in full anyone who may suffer harm due to the investigator,
p.000012: even in the absence of error, unless the harm is due to a cause that is not related to the experiment. Insurance must
p.000012: be taken out to cover those who take part in experiments. The law must ensure that this insurance provides sufficient
p.000012: and appropriate cover for those who lend themselves to such experiments. All these measures are intended to prevent
p.000012: individuals who suffer any harm from having to bear the weight of the procedure whereas they are undertaking an act of
p.000012: solidarity for the benefit of the community.
p.000012:
p.000012: The Advisory Committee stresses that the scope of this opinion is general and that it will be supplemented by
p.000012: specific opinions on situations that call for adjustments and additional precautions, such as
p.000012: experiments involving those who are incapable, individuals belonging to vulnerable groups or healthy
p.000012: volunteers.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: Opinion no. 13 of 9 July 2001 – Final version
p.000013: 13
p.000013:
p.000013: The opinion was prepared in select committee 97/8, consisting of*:
p.000013:
p.000013:
p.000013: Joint chairpersons
p.000013:
p.000013: M. Bogaert
p.000013:
p.000013: Y. Galloy
p.000013:
p.000013: Joint reporters
p.000013:
p.000013: M.L. Delfosse (2000)
p.000013:
p.000013: E. Guldix
p.000013:
p.000013: Members
p.000013:
p.000013: M. Abramowicz ('96- '99)
p.000013: M. Baum
p.000013: P. Devroey
p.000013: X. Dijon (resigned '98)
p.000013: I. Liebaers ('96-'99)
p.000013: J.N. Missa (2000)
p.000013: H. Nijs
p.000013: G. Sokal ('96-'99)
p.000013: M. Somville ('96-'99)
p.000013: J. Stiennon (resigned '99)
p.000013: F. Van Neste
p.000013:
p.000013: Member of the Bureau
p.000013: Y. Englert
p.000013:
p.000013:
p.000013:
p.000013: Member of the secretariaat
p.000013:
p.000013: E. Morbé
p.000013:
p.000013:
p.000013: Permanent experts
p.000013:
p.000013: • Ms M.L. Delfosse (1996-1999), philosopher, Facultes universitaires Notre-Dame de la Paix-Faculte de
p.000013: droit, and CIDES, Namur.
p.000013: • Ms I. Liebaers (2000), lecturer, Centrum Medische Genetica, AZ-VUB, Brussels.
p.000013: • Mr J.N. Missa (1996-1999), philosopher, CRIB, director of the Institut de Philosophie at the ULB, Brussels.
p.000013:
...
p.000015: This report is confined to human experimentation: this is referred to by the terms:
p.000015: experimentation subject, trial subject or subject.
p.000015: It was decided to defer until a subsequent examination the practical situations that require special precautions
p.000015: owing either to the vulnerability of individual or the impossibility of obtaining informed consent, as
p.000015: expressed in the opinion.
p.000015:
p.000015: All experimentation in the medical field pursues a cognitive objective, as it always aims to acquire new knowledge.
p.000015: Consequently, there is always a cognitive objective alongside any benefit for the trial subject.
p.000015: However, some members of the Advisory Committee deem it useful to recall the distinction often made between
p.000015: cognitive experimentation, non-therapeutic experimentation and therapeutic experimentation.
p.000015: The sole aim of cognitive experimentation is to improve the state of knowledge and it is not, in principle, of any
p.000015: immediate interest for the trial subjects.
p.000015: Non-therapeutic experimentation has no therapeutic objective as regards the trial subjects and is therefore
p.000015: ultimately synonymous with cognitive experimentation. In this case, the trial subjects are often (but not
p.000015: always) volunteers in good health.
p.000015: Opinion no. 13 of 9 July 2001 – Final version
p.000016: 16
p.000016:
p.000016: Therapeutic experimentation aims to advance scientific knowledge by testing a treatment, diagnostic or prevention
p.000016: process on individuals who are likely, at the same time, to benefit directly in terms of their state of health.
p.000016: Other members reject these distinctions: they stress that as the objective of experimentation is always advance
p.000016: knowledge, all experiments are for cognitive purposes5. The "therapeutic- cognitive" distinction will not be discussed
p.000016: any further here.
p.000016:
p.000016: Therapeutic innovation (also known as new therapy or experimental therapy) is not experimentation. It
p.000016: involves treating an individual patient using a new method or a new medicinal product and its objectives are
p.000016: no different from those of ordinary therapy: it is not necessary to draw up an experimental protocol, the
p.000016: patient is not a trial subject and the ultimate aim of the treatment remains exclusively the patient himself and
p.000016: his personal well- being. In fact, the question here concerns the legitimacy of the medical intervention.
p.000016:
p.000016: The Advisory Committee feels it is important to keep in mind the successive phases of biomedical
p.000016: experimentation concerning potential medicinal substances as they show in exemplary fashion the complexity
p.000016: of an experimentation procedure. They thus make it possible to be aware of the ethical and legal problems that
p.000016: arise.
p.000016:
p.000016: This type of experimentation begins with laboratory studies, for example in the form of trials on animals, which in
p.000016: principle make it possible to study the evolution and effects of the product in a living organism.
p.000016:
p.000016: This is followed by clinical studies which consist of four successive phases.
p.000016: Phase I involves administering the product for the first time, in principle to a small number of volunteers in good
p.000016: health, in order to assess their tolerance to the product, determine the maximum dose tolerated by humans and the
p.000016: minimum active dose of the product, and study its pharmacokinetic and pharmaco-dynamic properties.
p.000016: Phase II concerns trials on a limited group of patients suffering from the pathology for which the product is
p.000016: intended, in order to confirm its efficacy, assess its therapeutic interest, evaluate the relationship
p.000016: between the risks and the advantages linked to its administration and seek the best dose and the best means of
p.000016: administration depending on the effect sought.
p.000016: During phase III, studies are conducted on a large number of patients, usually divided into comparable groups according
p.000016: to a strict methodology (randomisation). These studies aim to examine tolerance in the medium term and efficacy,
p.000016: so as to be able to estimate the relationship between the benefits and the disadvantages (unwanted effects and
p.000016: cost). This phase is also used to gather information which will be useful for prescribers. If it proves
p.000016: conclusive, the next step is to think about marketing the product and fulfilling the procedures required
p.000016: to obtain authorisation to place it on the market.
p.000016: Phase IV comprises the studies conducted once the product has been put on the market. These studies
p.000016: enable better knowledge of the product: the possible association with other therapies, the discovery of new actions,
p.000016: the rare or belated side effects, etc.
p.000016:
p.000016: It should be remembered that the concept of human experimentation is far broader than that of
p.000016: pharmaco-therapeutic experimentation. Without claiming to be exhaustive, it includes the fields of physiology and
...
p.000020: and refining scientific knowledge of the human being. Would it not, therefore, be advisable to start from a
p.000020: position of uncertainty common to the patient and the observer?
p.000020:
p.000020: e. CONSENT
p.000020:
p.000020: Without calling into question the compulsory nature of free and informed consent, it should be pointed
p.000020: out that a careful analysis of international medical ethics and of Belgian deontology and law indicates that
p.000020: these normative sets all contain provisions that indicate a tendency to protect individuals, irrespective of
p.000020: any wish they may express. While consent must not be regarded as sacred, considered to be the sole expression of an
p.000020: individual’s autonomy – which itself is wrongly identified with the dignity of human beings – it nevertheless plays
p.000020: a central role in a view that enhances the value of partnership. It is, however, important to stress
p.000020: that irrespective of the situation as regards standards, ethics committees remain vigilant regarding related
p.000020: questions.
p.000020:
p.000020: f. INSURANCE
p.000020:
p.000020: Whatever the causes and provided it relates to the experiment, any harm suffered by trial subjects, patients or healthy
p.000020: volunteers must be covered by insurance.
p.000020: According to Article 6.3 i) of European Directive 2001/20 EC of 4 April 2001 (O.J. 1 May 2001), ethics committees must
p.000020: ensure that the experimentation is covered by insurance
p.000020:
p.000020: 7 Cf. in particular: CIOMS, International Ethical Guidelines for Biomedical Research Involving Human
p.000020: Subjects, 1993, Guideline 14, Commentary, p. 38-39.
p.000020: Opinion no. 13 of 9 July 2001 – Final version
p.000021: 21
p.000021:
p.000021: and check the clauses of this insurance.
p.000021:
p.000021: g. SHOULD ALL EXPERIMENTATION PROTOCOLS BE SUBMITTED FOR ASSESSMENT BY AN ETHICS COMMITTEE?
p.000021:
p.000021: The main aim of the rule underlying this question is to provide protection for those involved. However,
p.000021: this objective cannot be achieved. In fact, the cumbersome nature of the administrative procedure can lead to the
p.000021: planned medical activity being considered a therapeutic innovation rather than an experiment. Moreover, while the
p.000021: problem that the submission of experimentation protocols to the ethics committee is intended to resolve is that of
p.000021: the risks involved, there are many risk situations which are not collectively assessed if the doctors
p.000021: confine themselves to formal compliance with the requirements. This demonstrates the benefit of increasing
...
Health / Mentally Disabled
Searching for indicator disabled:
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p.000007:
p.000007: In the light of these principles – as is stipulated in point 2 above – at first glance the conflict of values
p.000007: inherent in human experimentation appears to be a dilemma between scientificity (principles a and b) and the
p.000007: protection of the autonomy and integrity of individuals (principles c and d). However, experimentation also aims
p.000007: to achieve collective utility. Now, even if we are inclined to believe it owing to the credit currently accorded to
p.000007: science, this collective utility cannot be considered purely and simply an effect of the progress made in
p.000007: scientific knowledge. When they do deal with this question, which is unfortunately only too rare, texts stress
p.000007: that collective utility can only be sought by taking into account a principle of justice, that is a
p.000007: fair distribution between the advantages and the disadvantages of experimentation4.
p.000007: This principle of justice draws attention to the selection of the individuals taking part in research, both those
p.000007: who, owing to their vulnerability, may be exploited by their inclusion (for instance, those who are
p.000007: incapable of consenting, such as nurslings, children, mentally disabled people, prisoners or elderly people living
p.000007: in institutions), and those who are usually excluded, possibly to their disadvantage. In fact, it may be
p.000007: observed that drug treatment in children, for example, is based on observations made in adults, which is not
p.000007: necessarily optimal. The principle of justice also leads to the concern to offer and guarantee fair access to quality
p.000007: health care.
p.000007: For additional information, see Introductory Report, C., 4.
p.000007:
p.000007:
p.000007: C. WHAT IS THE NORMATIVE FRAMEWORK FOR HUMAN EXPERIMENTATION?
p.000007:
p.000007:
p.000007: Belgian law is incomplete as regards human experimentation.
p.000007: In addition to Belgian legislation, there are also European and international normative texts and deontological rules
p.000007: (see Introductory Report, D.).
p.000007:
p.000007: The Advisory Committee suggests:
p.000007: 1) setting up legally established local ethics committees as bodies for the assessment of human experimentation
p.000007: protocols, with clearly defined areas of competence;
p.000007: 2) harmonisation of national, European and international standards in the field of human experimentation and
p.000007: complementarity between the deontological rules and the legal rules;
p.000007: 3) a framework law containing legal rules on ethics committees, the rights and duties of
p.000007:
...
p.000020: outlooks, without suggesting a link between them. This situation may lead to excesses when one of these
p.000020: principles is considered to be the sole determinant, or when the ethical interpretation of the basis for this principle
p.000020: leads to a distorted interpretation of others. To overcome this difficulty, it would be advisable to suggest a
p.000020: methodology like that now put forward by certain texts7, and accompany it with this rule: any condition
p.000020: not met releases the ethics committee from having to examine the following conditions; only protocols for which
p.000020: all the conditions examined, in order, have been given a positive assessment can be granted a favourable opinion.
p.000020:
p.000020: c. THE LINK BETWEEN AUTONOMY AND VULNERABILITY
p.000020:
p.000020: In addition to the principle of autonomy, it is also important to take account of a principle of
p.000020: vulnerability which not only expresses the condition of all individuals, but also requires particular attention
p.000020: when the experimentation concerns those who are weaker, such as those who are ill, children, the mentally
p.000020: disabled, the elderly, people in institutions or suffering from neuralgic disorders. So when an experiment involves
p.000020: those who are ill, the basic question becomes that of the link to be established between the risk accepted by the
p.000020: patient (autonomy) and the benefits the latter expects. The link between autonomy and vulnerability is
p.000020: particularly acute when experimentation is suggested as the last chance of a cure for a patient who is often
p.000020: distressed.
p.000020:
p.000020: d. PARTNERSHIP
p.000020:
p.000020: Rather than seeing consent as authorisation given by a patient or a subject to carry out an experiment on him as a
p.000020: procedure that aims to find out whether this patient or this subject illustrates the relevance of an assumption, would
p.000020: it not be better to see consent and experimentation rather as a partnership? In fact, the relationship between the
p.000020: doctor and the patient must be seen in terms of evolutive agreement that is constantly renegotiated.
p.000020: Actually obtaining informed consent implies abandoning medical paternalism. The doctor cannot decide alone
p.000020: what is good for the patient. He must take the time to correctly inform his partner-patient. The individual
...
Searching for indicator mentally:
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p.000007:
p.000007: 4. Reflections and expansion: focus on the principle of justice
p.000007:
p.000007: In the light of these principles – as is stipulated in point 2 above – at first glance the conflict of values
p.000007: inherent in human experimentation appears to be a dilemma between scientificity (principles a and b) and the
p.000007: protection of the autonomy and integrity of individuals (principles c and d). However, experimentation also aims
p.000007: to achieve collective utility. Now, even if we are inclined to believe it owing to the credit currently accorded to
p.000007: science, this collective utility cannot be considered purely and simply an effect of the progress made in
p.000007: scientific knowledge. When they do deal with this question, which is unfortunately only too rare, texts stress
p.000007: that collective utility can only be sought by taking into account a principle of justice, that is a
p.000007: fair distribution between the advantages and the disadvantages of experimentation4.
p.000007: This principle of justice draws attention to the selection of the individuals taking part in research, both those
p.000007: who, owing to their vulnerability, may be exploited by their inclusion (for instance, those who are
p.000007: incapable of consenting, such as nurslings, children, mentally disabled people, prisoners or elderly people living
p.000007: in institutions), and those who are usually excluded, possibly to their disadvantage. In fact, it may be
p.000007: observed that drug treatment in children, for example, is based on observations made in adults, which is not
p.000007: necessarily optimal. The principle of justice also leads to the concern to offer and guarantee fair access to quality
p.000007: health care.
p.000007: For additional information, see Introductory Report, C., 4.
p.000007:
p.000007:
p.000007: C. WHAT IS THE NORMATIVE FRAMEWORK FOR HUMAN EXPERIMENTATION?
p.000007:
p.000007:
p.000007: Belgian law is incomplete as regards human experimentation.
p.000007: In addition to Belgian legislation, there are also European and international normative texts and deontological rules
p.000007: (see Introductory Report, D.).
p.000007:
p.000007: The Advisory Committee suggests:
p.000007: 1) setting up legally established local ethics committees as bodies for the assessment of human experimentation
p.000007: protocols, with clearly defined areas of competence;
p.000007: 2) harmonisation of national, European and international standards in the field of human experimentation and
p.000007: complementarity between the deontological rules and the legal rules;
...
p.000020:
p.000020: Most texts on medical ethics and deontology put forward a series of principles which are based on different ethical
p.000020: outlooks, without suggesting a link between them. This situation may lead to excesses when one of these
p.000020: principles is considered to be the sole determinant, or when the ethical interpretation of the basis for this principle
p.000020: leads to a distorted interpretation of others. To overcome this difficulty, it would be advisable to suggest a
p.000020: methodology like that now put forward by certain texts7, and accompany it with this rule: any condition
p.000020: not met releases the ethics committee from having to examine the following conditions; only protocols for which
p.000020: all the conditions examined, in order, have been given a positive assessment can be granted a favourable opinion.
p.000020:
p.000020: c. THE LINK BETWEEN AUTONOMY AND VULNERABILITY
p.000020:
p.000020: In addition to the principle of autonomy, it is also important to take account of a principle of
p.000020: vulnerability which not only expresses the condition of all individuals, but also requires particular attention
p.000020: when the experimentation concerns those who are weaker, such as those who are ill, children, the mentally
p.000020: disabled, the elderly, people in institutions or suffering from neuralgic disorders. So when an experiment involves
p.000020: those who are ill, the basic question becomes that of the link to be established between the risk accepted by the
p.000020: patient (autonomy) and the benefits the latter expects. The link between autonomy and vulnerability is
p.000020: particularly acute when experimentation is suggested as the last chance of a cure for a patient who is often
p.000020: distressed.
p.000020:
p.000020: d. PARTNERSHIP
p.000020:
p.000020: Rather than seeing consent as authorisation given by a patient or a subject to carry out an experiment on him as a
p.000020: procedure that aims to find out whether this patient or this subject illustrates the relevance of an assumption, would
p.000020: it not be better to see consent and experimentation rather as a partnership? In fact, the relationship between the
p.000020: doctor and the patient must be seen in terms of evolutive agreement that is constantly renegotiated.
p.000020: Actually obtaining informed consent implies abandoning medical paternalism. The doctor cannot decide alone
p.000020: what is good for the patient. He must take the time to correctly inform his partner-patient. The individual
...
Health / Mentally Incapacitated
Searching for indicator incapable:
(return to top)
p.000003: patients who are the subjects of clinical trials may be inadequately protected and insurance in the event of
p.000003: harm would be more suitable in the case of protocols for clinical studies.
p.000003: We think that this is a problem that concerns all local ethics committees and we are asking for the opinion of the
p.000003: Advisory Committee on Bioethics regarding the attitude to be adopted to safeguard our patients as well as possible.
p.000003: […]”.
p.000003:
p.000003: Opinion no. 13 of 9 July 2001 – Final version
p.000004: 4
p.000004:
p.000004: At its first meetings in the spring of 1998, the select committee held preliminary discussions on the basis of a
p.000004: certain number of discussion notes. At that time, its members decided to see their mission, initially, as a
p.000004: reflection on the ethical problem raised by human experimentation1 and the advisability and content of a
p.000004: normative framework in this area.
p.000004: It was in fact immediately decided to defer to another opinion the practical situations that require special
p.000004: precautions owing either to the vulnerability of the individual or to the impossibility of obtaining
p.000004: informed consent. This concerns, among other things but not exclusively, experiments on children, psychiatric
p.000004: patients and other incapable individuals, prisoners, elderly people living in homes, individuals more likely to be
p.000004: constrained (military personnel, police officers, students, laboratory staff, etc.), vulnerable groups
p.000004: (separate cultural communities, those in need, citizens of developing countries, etc.), pregnant or
p.000004: breastfeeding women (in view of the possible consequences for their unborn children), as well as studies where
p.000004: obtaining individual consent interferes with the research itself2.
p.000004: Similarly, the issue of healthy volunteers will not be covered here.
p.000004: The questions of research on embryos in vitro, material obtained during abortions and devitalised tissue
p.000004: and organs (products of operating theatres and cadavers) will not be dealt with in this opinion, either.
p.000004: The same applies for the questions raised by research into dossiers.
p.000004: Finally, the situation with regard to the issue of therapeutic innovation should be clarified. In many respects, this
...
p.000007: therefore supposes that the subject has the capacities of free thought and that the doctor has the capacities
p.000007: needed to provide clear information.
p.000007:
p.000007: 4. Reflections and expansion: focus on the principle of justice
p.000007:
p.000007: In the light of these principles – as is stipulated in point 2 above – at first glance the conflict of values
p.000007: inherent in human experimentation appears to be a dilemma between scientificity (principles a and b) and the
p.000007: protection of the autonomy and integrity of individuals (principles c and d). However, experimentation also aims
p.000007: to achieve collective utility. Now, even if we are inclined to believe it owing to the credit currently accorded to
p.000007: science, this collective utility cannot be considered purely and simply an effect of the progress made in
p.000007: scientific knowledge. When they do deal with this question, which is unfortunately only too rare, texts stress
p.000007: that collective utility can only be sought by taking into account a principle of justice, that is a
p.000007: fair distribution between the advantages and the disadvantages of experimentation4.
p.000007: This principle of justice draws attention to the selection of the individuals taking part in research, both those
p.000007: who, owing to their vulnerability, may be exploited by their inclusion (for instance, those who are
p.000007: incapable of consenting, such as nurslings, children, mentally disabled people, prisoners or elderly people living
p.000007: in institutions), and those who are usually excluded, possibly to their disadvantage. In fact, it may be
p.000007: observed that drug treatment in children, for example, is based on observations made in adults, which is not
p.000007: necessarily optimal. The principle of justice also leads to the concern to offer and guarantee fair access to quality
p.000007: health care.
p.000007: For additional information, see Introductory Report, C., 4.
p.000007:
p.000007:
p.000007: C. WHAT IS THE NORMATIVE FRAMEWORK FOR HUMAN EXPERIMENTATION?
p.000007:
p.000007:
p.000007: Belgian law is incomplete as regards human experimentation.
p.000007: In addition to Belgian legislation, there are also European and international normative texts and deontological rules
p.000007: (see Introductory Report, D.).
p.000007:
p.000007: The Advisory Committee suggests:
p.000007: 1) setting up legally established local ethics committees as bodies for the assessment of human experimentation
p.000007: protocols, with clearly defined areas of competence;
p.000007: 2) harmonisation of national, European and international standards in the field of human experimentation and
p.000007: complementarity between the deontological rules and the legal rules;
...
p.000012: would take on the other task of ethics committees and remain responsible for the assessment of the local conditions for
p.000012: the fulfilment of the experiment (see Introductory Report, E., 4., c).
p.000012:
p.000012: The Advisory Committee is pleased to note, on the basis of the available data, that human experimentation
p.000012: rarely causes harm. It nevertheless believes that it is necessary to protect the trial subject and therefore recommends
p.000012: that the investigator be obliged to compensate in full anyone who may suffer harm due to the investigator,
p.000012: even in the absence of error, unless the harm is due to a cause that is not related to the experiment. Insurance must
p.000012: be taken out to cover those who take part in experiments. The law must ensure that this insurance provides sufficient
p.000012: and appropriate cover for those who lend themselves to such experiments. All these measures are intended to prevent
p.000012: individuals who suffer any harm from having to bear the weight of the procedure whereas they are undertaking an act of
p.000012: solidarity for the benefit of the community.
p.000012:
p.000012: The Advisory Committee stresses that the scope of this opinion is general and that it will be supplemented by
p.000012: specific opinions on situations that call for adjustments and additional precautions, such as
p.000012: experiments involving those who are incapable, individuals belonging to vulnerable groups or healthy
p.000012: volunteers.
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012:
p.000012: Opinion no. 13 of 9 July 2001 – Final version
p.000013: 13
p.000013:
p.000013: The opinion was prepared in select committee 97/8, consisting of*:
p.000013:
p.000013:
p.000013: Joint chairpersons
p.000013:
p.000013: M. Bogaert
p.000013:
p.000013: Y. Galloy
p.000013:
p.000013: Joint reporters
p.000013:
p.000013: M.L. Delfosse (2000)
p.000013:
p.000013: E. Guldix
p.000013:
p.000013: Members
p.000013:
p.000013: M. Abramowicz ('96- '99)
p.000013: M. Baum
p.000013: P. Devroey
p.000013: X. Dijon (resigned '98)
p.000013: I. Liebaers ('96-'99)
p.000013: J.N. Missa (2000)
p.000013: H. Nijs
p.000013: G. Sokal ('96-'99)
p.000013: M. Somville ('96-'99)
p.000013: J. Stiennon (resigned '99)
p.000013: F. Van Neste
p.000013:
p.000013: Member of the Bureau
p.000013: Y. Englert
p.000013:
p.000013:
p.000013:
p.000013: Member of the secretariaat
p.000013:
p.000013: E. Morbé
p.000013:
p.000013:
p.000013: Permanent experts
p.000013:
p.000013: • Ms M.L. Delfosse (1996-1999), philosopher, Facultes universitaires Notre-Dame de la Paix-Faculte de
p.000013: droit, and CIDES, Namur.
p.000013: • Ms I. Liebaers (2000), lecturer, Centrum Medische Genetica, AZ-VUB, Brussels.
p.000013: • Mr J.N. Missa (1996-1999), philosopher, CRIB, director of the Institut de Philosophie at the ULB, Brussels.
...
p.000028: in the context of medical acts. As for such acts, it must be fair and complete without presenting all the eventualities
p.000028: that are theoretically possible in full, which would become a source of anxiety. Finally, as regards the condition of
p.000028: the patient, it must respect his wish to know the seriousness of his condition or not. It is generally considered
p.000028: necessary to pass on "all information that a reasonable person would deem important to take the decision to
p.000028: consent". This information must include the details relating to liability and insurance in the event of an accident,
p.000028: the limits of the confidentiality of the data obtained and the opinion and comments from the ethics
p.000028: committee that examined the protocol. This information must also be updated as the experiment progresses
p.000028: when relevant new information becomes available.
p.000028:
p.000028:
p.000028: 5. CONCLUSION
p.000028:
p.000028: In addition to these general rules, there are also special rules that are not part of this opinion for
p.000028: vulnerable groups and special situations such as:
p.000028: - healthy volunteers;
p.000028: Opinion no. 13 of 9 July 2001 – Final version
p.000029: 29
p.000029:
p.000029: - individuals who are legally or de facto incapable (psychiatric patients, unconscious patients,
p.000029: underage patients);
p.000029: - the protocols of behavioural studies where obtaining consent prevents the experiment from being carried
p.000029: out at all;
p.000029:
p.000029: - socially vulnerable groups: separate cultural communities, prisoners, persons who are be likely to be
p.000029: forced (such as medical students), persons in need;
p.000029: - pregnant or breastfeeding women;
p.000029: - in vitro human embryos;
p.000029: - experiments on cadavers;
p.000029: - experiments on organs, tissue or tumours removed from patients;
p.000029: - experiments on the products of spontaneous or induced abortions.
p.000029:
p.000029: It appears that a growing number of firms are asking to keep samples with a view to carrying out subsequent genetic
p.000029: analyses. A procedure like this which may involve research carried out unbeknown to the patient poses particular
p.000029: problems and will be the subject of a separate opinion.
p.000029:
p.000029: The aspects of data confidentiality are in principle governed by the legislation on the protection of
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000007: d. The principle of autonomy
p.000007: 4. Reflections and expansion: focus on the principle of justice
p.000007:
p.000007: C. What is the normative framework for human experimentation?
p.000007:
p.000007: 1. Ethics committees as assessment bodies
p.000007: 2. Harmonisation of legal standards and complementarity of deontological and legal rules – Advocates and opponents
p.000007: a. Arguing in favour of a normative polyphony
p.000007: b. Rejection of all legal formalism
p.000007: c. Requirements beyond the law
p.000007: d. Nevertheless, legal regulations are desirable, if not essential
p.000007: 3. A framework law
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007: Opinion no. 13 of 9 July 2001 – Final version
p.000003: 3
p.000003:
p.000003: A. INTRODUCTION
p.000003:
p.000003:
p.000003: This opinion is issued further to a request dated 12 November 1997 from Professor Dr. W. BETZ, Chairman of the
p.000003: Medical Ethics Commission of the Vlaams Huisartsen Instituut – Flemish institute of general practitioners.
p.000003: This institute studies the research protocols carried out by family doctors. Professor Betz was concerned
p.000003: about certain investigators ‘shopping’ if a local ethics committee issued a negative opinion. He suggested a number
p.000003: of avenues for a solution, including the creation of a central register of projects regarding which
p.000003: requests have been submitted, or the establishment of a mandatory procedure for the exchange of information
p.000003: between ethics committees consulted successively by the researcher.
p.000003: The text of the request for an opinion was worded as follows:
p.000003:
p.000003: “I am contacting you in my capacity as Chairman of the Medical Ethics Committee of the V.H.I. (OM 071) regarding the
p.000003: following matter.
p.000003:
p.000003: Our committee regularly issues negative opinions on research projects considering, for example, that they do not
p.000003: contribute much scientific added value or have not been sufficiently well prepared. The authors of such
p.000003: projects therefore turn to ‘easy committees’ which do not take as much account of the ‘ethical reflection’ and
p.000003: therefore give the go-ahead after a fast procedure.
p.000003: In some cases, this second committee is nevertheless informed of the negative opinion of the first; consequently, I
p.000003: believe that it is necessary to establish a procedure for the mandatory exchange of data between committees. A central
p.000003: register of all projects for which a request has been submitted seems to me to be necessary.
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000004: 4
p.000004:
p.000004: At its first meetings in the spring of 1998, the select committee held preliminary discussions on the basis of a
p.000004: certain number of discussion notes. At that time, its members decided to see their mission, initially, as a
p.000004: reflection on the ethical problem raised by human experimentation1 and the advisability and content of a
p.000004: normative framework in this area.
p.000004: It was in fact immediately decided to defer to another opinion the practical situations that require special
p.000004: precautions owing either to the vulnerability of the individual or to the impossibility of obtaining
p.000004: informed consent. This concerns, among other things but not exclusively, experiments on children, psychiatric
p.000004: patients and other incapable individuals, prisoners, elderly people living in homes, individuals more likely to be
p.000004: constrained (military personnel, police officers, students, laboratory staff, etc.), vulnerable groups
p.000004: (separate cultural communities, those in need, citizens of developing countries, etc.), pregnant or
p.000004: breastfeeding women (in view of the possible consequences for their unborn children), as well as studies where
p.000004: obtaining individual consent interferes with the research itself2.
p.000004: Similarly, the issue of healthy volunteers will not be covered here.
p.000004: The questions of research on embryos in vitro, material obtained during abortions and devitalised tissue
p.000004: and organs (products of operating theatres and cadavers) will not be dealt with in this opinion, either.
p.000004: The same applies for the questions raised by research into dossiers.
p.000004: Finally, the situation with regard to the issue of therapeutic innovation should be clarified. In many respects, this
p.000004: process differs from experimentation. It consist of treating a patient using a new method or a new medicinal
p.000004: product and its objectives do not differ from those of ordinary therapy: there is no need to draw up an experimental
p.000004: protocol, the patient is not a trial subject and ultimate aim of the treatment remains solely the patient himself and
p.000004: his personal well-being. In fact, what is involved here is the legitimacy of the innovative medical intervention. It
p.000004: has been decided that questions relating to therapeutic innovation as such will not be covered in this opinion.
p.000004:
...
p.000028: the limits of the confidentiality of the data obtained and the opinion and comments from the ethics
p.000028: committee that examined the protocol. This information must also be updated as the experiment progresses
p.000028: when relevant new information becomes available.
p.000028:
p.000028:
p.000028: 5. CONCLUSION
p.000028:
p.000028: In addition to these general rules, there are also special rules that are not part of this opinion for
p.000028: vulnerable groups and special situations such as:
p.000028: - healthy volunteers;
p.000028: Opinion no. 13 of 9 July 2001 – Final version
p.000029: 29
p.000029:
p.000029: - individuals who are legally or de facto incapable (psychiatric patients, unconscious patients,
p.000029: underage patients);
p.000029: - the protocols of behavioural studies where obtaining consent prevents the experiment from being carried
p.000029: out at all;
p.000029:
p.000029: - socially vulnerable groups: separate cultural communities, prisoners, persons who are be likely to be
p.000029: forced (such as medical students), persons in need;
p.000029: - pregnant or breastfeeding women;
p.000029: - in vitro human embryos;
p.000029: - experiments on cadavers;
p.000029: - experiments on organs, tissue or tumours removed from patients;
p.000029: - experiments on the products of spontaneous or induced abortions.
p.000029:
p.000029: It appears that a growing number of firms are asking to keep samples with a view to carrying out subsequent genetic
p.000029: analyses. A procedure like this which may involve research carried out unbeknown to the patient poses particular
p.000029: problems and will be the subject of a separate opinion.
p.000029:
p.000029: The aspects of data confidentiality are in principle governed by the legislation on the protection of
p.000029: privacy (act of 8 December 1992 on the protection of privacy with regard to the processing of personal data
p.000029: (Moniteur belge of 18 March 1993)) and the directives of the National Council of the Order of Doctors
p.000029: concerning access to human experimentation dossiers (opinions of 22 August 1992, 17 February 1996, 13 December
p.000029: 1997, 19 September
p.000029: 1998, 24 April 1999, 15 January 2000 and 19 February 2000).
p.000029:
p.000029: Finally, for some members, ethics committees should follow up the protocol (information on progress with the
p.000029: experiment, interim results, unwanted side effects), which for them constitutes an activity that is as yet
...
Health / Unconscious People
Searching for indicator unconscious:
(return to top)
p.000028: in the context of medical acts. As for such acts, it must be fair and complete without presenting all the eventualities
p.000028: that are theoretically possible in full, which would become a source of anxiety. Finally, as regards the condition of
p.000028: the patient, it must respect his wish to know the seriousness of his condition or not. It is generally considered
p.000028: necessary to pass on "all information that a reasonable person would deem important to take the decision to
p.000028: consent". This information must include the details relating to liability and insurance in the event of an accident,
p.000028: the limits of the confidentiality of the data obtained and the opinion and comments from the ethics
p.000028: committee that examined the protocol. This information must also be updated as the experiment progresses
p.000028: when relevant new information becomes available.
p.000028:
p.000028:
p.000028: 5. CONCLUSION
p.000028:
p.000028: In addition to these general rules, there are also special rules that are not part of this opinion for
p.000028: vulnerable groups and special situations such as:
p.000028: - healthy volunteers;
p.000028: Opinion no. 13 of 9 July 2001 – Final version
p.000029: 29
p.000029:
p.000029: - individuals who are legally or de facto incapable (psychiatric patients, unconscious patients,
p.000029: underage patients);
p.000029: - the protocols of behavioural studies where obtaining consent prevents the experiment from being carried
p.000029: out at all;
p.000029:
p.000029: - socially vulnerable groups: separate cultural communities, prisoners, persons who are be likely to be
p.000029: forced (such as medical students), persons in need;
p.000029: - pregnant or breastfeeding women;
p.000029: - in vitro human embryos;
p.000029: - experiments on cadavers;
p.000029: - experiments on organs, tissue or tumours removed from patients;
p.000029: - experiments on the products of spontaneous or induced abortions.
p.000029:
p.000029: It appears that a growing number of firms are asking to keep samples with a view to carrying out subsequent genetic
p.000029: analyses. A procedure like this which may involve research carried out unbeknown to the patient poses particular
p.000029: problems and will be the subject of a separate opinion.
p.000029:
p.000029: The aspects of data confidentiality are in principle governed by the legislation on the protection of
p.000029: privacy (act of 8 December 1992 on the protection of privacy with regard to the processing of personal data
...
Health / breastfeeding
Searching for indicator breastfeeding:
(return to top)
p.000004: At its first meetings in the spring of 1998, the select committee held preliminary discussions on the basis of a
p.000004: certain number of discussion notes. At that time, its members decided to see their mission, initially, as a
p.000004: reflection on the ethical problem raised by human experimentation1 and the advisability and content of a
p.000004: normative framework in this area.
p.000004: It was in fact immediately decided to defer to another opinion the practical situations that require special
p.000004: precautions owing either to the vulnerability of the individual or to the impossibility of obtaining
p.000004: informed consent. This concerns, among other things but not exclusively, experiments on children, psychiatric
p.000004: patients and other incapable individuals, prisoners, elderly people living in homes, individuals more likely to be
p.000004: constrained (military personnel, police officers, students, laboratory staff, etc.), vulnerable groups
p.000004: (separate cultural communities, those in need, citizens of developing countries, etc.), pregnant or
p.000004: breastfeeding women (in view of the possible consequences for their unborn children), as well as studies where
p.000004: obtaining individual consent interferes with the research itself2.
p.000004: Similarly, the issue of healthy volunteers will not be covered here.
p.000004: The questions of research on embryos in vitro, material obtained during abortions and devitalised tissue
p.000004: and organs (products of operating theatres and cadavers) will not be dealt with in this opinion, either.
p.000004: The same applies for the questions raised by research into dossiers.
p.000004: Finally, the situation with regard to the issue of therapeutic innovation should be clarified. In many respects, this
p.000004: process differs from experimentation. It consist of treating a patient using a new method or a new medicinal
p.000004: product and its objectives do not differ from those of ordinary therapy: there is no need to draw up an experimental
p.000004: protocol, the patient is not a trial subject and ultimate aim of the treatment remains solely the patient himself and
p.000004: his personal well-being. In fact, what is involved here is the legitimacy of the innovative medical intervention. It
p.000004: has been decided that questions relating to therapeutic innovation as such will not be covered in this opinion.
p.000004:
p.000004: To sum up: the opinion concerns only adult and capable trial subjects.
p.000004:
...
p.000028: committee that examined the protocol. This information must also be updated as the experiment progresses
p.000028: when relevant new information becomes available.
p.000028:
p.000028:
p.000028: 5. CONCLUSION
p.000028:
p.000028: In addition to these general rules, there are also special rules that are not part of this opinion for
p.000028: vulnerable groups and special situations such as:
p.000028: - healthy volunteers;
p.000028: Opinion no. 13 of 9 July 2001 – Final version
p.000029: 29
p.000029:
p.000029: - individuals who are legally or de facto incapable (psychiatric patients, unconscious patients,
p.000029: underage patients);
p.000029: - the protocols of behavioural studies where obtaining consent prevents the experiment from being carried
p.000029: out at all;
p.000029:
p.000029: - socially vulnerable groups: separate cultural communities, prisoners, persons who are be likely to be
p.000029: forced (such as medical students), persons in need;
p.000029: - pregnant or breastfeeding women;
p.000029: - in vitro human embryos;
p.000029: - experiments on cadavers;
p.000029: - experiments on organs, tissue or tumours removed from patients;
p.000029: - experiments on the products of spontaneous or induced abortions.
p.000029:
p.000029: It appears that a growing number of firms are asking to keep samples with a view to carrying out subsequent genetic
p.000029: analyses. A procedure like this which may involve research carried out unbeknown to the patient poses particular
p.000029: problems and will be the subject of a separate opinion.
p.000029:
p.000029: The aspects of data confidentiality are in principle governed by the legislation on the protection of
p.000029: privacy (act of 8 December 1992 on the protection of privacy with regard to the processing of personal data
p.000029: (Moniteur belge of 18 March 1993)) and the directives of the National Council of the Order of Doctors
p.000029: concerning access to human experimentation dossiers (opinions of 22 August 1992, 17 February 1996, 13 December
p.000029: 1997, 19 September
p.000029: 1998, 24 April 1999, 15 January 2000 and 19 February 2000).
p.000029:
p.000029: Finally, for some members, ethics committees should follow up the protocol (information on progress with the
p.000029: experiment, interim results, unwanted side effects), which for them constitutes an activity that is as yet
p.000029: unfamiliar. Other members, however, believe that this mission should not be entrusted to them.
...
Health / ill
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p.000004: reflections, aware that even limited to biomedical experimentation, this is vast and brings up a great many questions
p.000004: which would be worth considering specifically. This is why some members believed that it would be advisable to specify
p.000004: straight away that the opinion will relate to biomedical human experimentation, which does not prejudge a subsequent
p.000004: extension to other experimentation involving human subjects, on the basis of considerations which may be relevant for
p.000004: both. Irrespective of the choices made, there will inevitably still be borderline situations. The object of the
p.000004: experimentation, the parties carrying out the research and the place where it is undertaken can help clarify difficult
p.000004: situations.
p.000004: 2 The examples that illustrate this type of obstacle to obtaining consent are the famous experiment
p.000004: on submission to authority (Milgram experiment) popularised by the film “Mon Oncle d’Amerique” and the
p.000004: Semmelweiss experiment on the comparison of the incidence of puerperal fever in two delivery rooms in
p.000004: Budapest which led to the discover of the rules of asepsis.
p.000004: Opinion no. 13 of 9 July 2001 – Final version
p.000005: 5
p.000005:
p.000005: Without underestimating the philosophical difficulties posed by biomedical research, the Advisory Committee stresses
p.000005: the ethical legitimacy of experimentation and considers that those who take part in it render a major service to
p.000005: the community as a whole – and to those who are ill in particular – by enabling medical progress. Society
p.000005: owes them recognition.
p.000005:
p.000005: The legitimacy of human experimentation is closely linked to the acknowledged legitimacy of
p.000005: scientific medicine: it may even be said to depend on it. Today, the importance granted to
p.000005: evidence-based medicine or EBM, illustrates the success of this approach. In fact, experimentation
p.000005: understood to mean systematically testing assumptions by carrying out rigorously monitored and
p.000005: interpreted experiments constitutes the specific method of acquiring knowledge used for scientific medicine
p.000005: which, since the 19th century, has planned to establish its therapeutic basis as widely as possible on knowledge
p.000005: (theoretical or practical) that is validated by experiment.
p.000005:
p.000005: 2. Conflict of values linked to human experimentation
p.000005:
p.000005: Human experimentation is the scene of a conflict between the freedom to research, respect for human
p.000005: beings and the principles of beneficence and justice. This conflict comprises several aspects.
p.000005: Some members consider that by having recourse to human experimentation in order to provide a scientific basis for its
p.000005: therapeutic practices, scientific medicine moves away, in its principles, from the secular but always current
p.000005: rule laid down ever since the Hippocratic Oath: “I will consider the health of my patient to be my first concern”
p.000005: (the Geneva Oath)3. The priority given to the cognitive objective and the collective interest dimension inherent
...
p.000020: 20
p.000020:
p.000020: b. EXAMINING ETHICAL REQUIREMENTS - METHODOLOGY
p.000020:
p.000020: Most texts on medical ethics and deontology put forward a series of principles which are based on different ethical
p.000020: outlooks, without suggesting a link between them. This situation may lead to excesses when one of these
p.000020: principles is considered to be the sole determinant, or when the ethical interpretation of the basis for this principle
p.000020: leads to a distorted interpretation of others. To overcome this difficulty, it would be advisable to suggest a
p.000020: methodology like that now put forward by certain texts7, and accompany it with this rule: any condition
p.000020: not met releases the ethics committee from having to examine the following conditions; only protocols for which
p.000020: all the conditions examined, in order, have been given a positive assessment can be granted a favourable opinion.
p.000020:
p.000020: c. THE LINK BETWEEN AUTONOMY AND VULNERABILITY
p.000020:
p.000020: In addition to the principle of autonomy, it is also important to take account of a principle of
p.000020: vulnerability which not only expresses the condition of all individuals, but also requires particular attention
p.000020: when the experimentation concerns those who are weaker, such as those who are ill, children, the mentally
p.000020: disabled, the elderly, people in institutions or suffering from neuralgic disorders. So when an experiment involves
p.000020: those who are ill, the basic question becomes that of the link to be established between the risk accepted by the
p.000020: patient (autonomy) and the benefits the latter expects. The link between autonomy and vulnerability is
p.000020: particularly acute when experimentation is suggested as the last chance of a cure for a patient who is often
p.000020: distressed.
p.000020:
p.000020: d. PARTNERSHIP
p.000020:
p.000020: Rather than seeing consent as authorisation given by a patient or a subject to carry out an experiment on him as a
p.000020: procedure that aims to find out whether this patient or this subject illustrates the relevance of an assumption, would
p.000020: it not be better to see consent and experimentation rather as a partnership? In fact, the relationship between the
p.000020: doctor and the patient must be seen in terms of evolutive agreement that is constantly renegotiated.
p.000020: Actually obtaining informed consent implies abandoning medical paternalism. The doctor cannot decide alone
p.000020: what is good for the patient. He must take the time to correctly inform his partner-patient. The individual
p.000020: taking part freely in research is not an object being manipulated to achieve ends that have nothing to do with him.
p.000020: Ideally, he is an individual who is cooperating, to a limited but effective extent, on improving medical therapeutics
...
Health / visual impairment
Searching for indicator blind:
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p.000017: carried out by a team of people, an investigator is the head or leader of this team, in charge of the team as a whole.
p.000017: He is referred to as the principal investigator.
p.000017:
p.000017: The sponsor or body subsidising the study is the person, the company, the institution or the body that takes
p.000017: responsibility for devising, managing and funding the clinical study.
p.000017:
p.000017: The experimental protocol is a document that describes, in particular, the objectives, the procedure, the
p.000017: methodology, the statistical elements and the organisation of the study. The experimental protocol also usually
p.000017: explains the foundations of and justifications for the study, even though this information may also appear in
p.000017: other documents to which reference is made in the experimental protocol.
p.000017:
p.000017: A placebo is a tablet, an injection or a treatment which the trial subject believes will have an effect (positive or
p.000017: negative) on his state of health and which, owing to this conviction on the part of the person concerned, can actually
p.000017: have such an effect, but which the investigator is convinced is inert vis-à-vis the state of the trial subject.
p.000017:
p.000017: When, in the context of any experiment during which a treatment is compared to an acknowledged existing
p.000017: treatment or a placebo, one or several of the parties concerned are kept in ignorance of the allocation of
p.000017: treatments to the trial subjects (e.g. the active treatment or the placebo), this is known as a blind
p.000017: study. The experiment is single blind when only the trial subjects are not informed; it is double blind) when the
p.000017: investigator, his team, the supervisor and, in some cases, the data analyst or analysts are also unaware which subject
p.000017: is given which treatment.
p.000017:
p.000017: Basic research is research during which phenomena are studied with a view to improving scientific knowledge,
p.000017: but without any direct intention of applying this knowledge in practice.
p.000017:
p.000017: Applied research, on the other hand, involves experimentation where the objective is to apply the
p.000017: scientific knowledge acquired to practical situations such as illnesses.
p.000017:
p.000017: Randomisation is the use of chance to determine the allocation of trial subjects to treatment or control groups; the
p.000017: aim here is to reduce bias which may distort the conclusions.
p.000017:
p.000017: The control treatment is the better medical treatment or the usual medical treatment for a patient or, for instance if
p.000017: there is no such treatment, the placebo treatment with which the experimental treatment is being compared.
p.000017:
p.000017: Bias is the term used if a systematic error is observed in the experimental protocol that is likely to have led to
p.000017: distorted conclusions.
p.000017:
p.000017: An experimentation protocol must be submitted to a local ethics committee for an opinion. A local ethics committee is
p.000017: understood here to refer to the local ethics committees instituted by Article 70 ter of the act of 7 August 1987 on
p.000017: hospitals (inserted by Article 194 of the act of 25 January 1999, Moniteur belge (Belgian official journal) of
p.000017: 6 February 1999). The Advisory Committee points out that, as regards its advisory mission, the local
p.000017: ethics committee has a twofold task of ‘assessment and supervision of the research’.
p.000017: In the context of this report, the term used will be ‘ethics committee’.
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
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p.000017:
p.000017:
p.000017: Opinion no. 13 of 9 July 2001 – Final version
p.000018: 18
p.000018:
p.000018: C. MEDICAL-SCIENTIFIC RESEARCH ON HUMANS – ETHICAL AND LEGAL PROBLEMS
p.000018:
p.000018: 1. 1. LEGITIMACY BASED ON EFFICACY
p.000018:
p.000018: The history of experimentation in medicine coincides with the gradual learning of how to experiment on
p.000018: human subjects appropriately, both in terms of methodology and from an ethical point of view. The use of human
p.000018: experimentation is only justified in cases of clinical uncertainty.
p.000018: Little by little, experimental methods have become more refined: comparative experiment, experimental plan,
p.000018: randomisation of patients assigned to the ‘treated’ group and the ‘control’ group, use of placebos,
p.000018: double-blind method, statistical calculations, etc. These experiments, properly conducted scientifically, are
p.000018: far more fruitful in terms of advancing knowledge than the simple empirical trial and error approaches of
p.000018: previous centuries. We therefore have a duty to experiment in order to provide patients with better knowledge and
p.000018: better treatments.
p.000018:
p.000018: 2. CARE AND RESEARCH
p.000018:
p.000018: Experimentation radically transforms medicine. Medicine itself is no longer seen exclusively as the art of curing. The
p.000018: aim is for this art, which remains its main objective and nature, to be able to rely on scientific knowledge,
p.000018: acquired through experimentation, of the human body, its illnesses, and diagnostic and therapeutic means. By doing
p.000018: so, it is divided into two fields of activity: care and research.
p.000018: These differ from one another in the immediate objectives pursued: care on the one hand, contribution to scientific
p.000018: knowledge on the other. Fulfilling these objectives requires the implementation of separate procedures. In
p.000018: fact, the abundance of features common to therapeutic acts, in particular those considered ‘experimental’, and to
p.000018: experiments (whether therapeutic or not) undertaken for the purpose of research cannot hide the fact that they are part
p.000018: of separate processes. An act undertaken mainly for therapeutic purposes is controlled by the characteristics of the
p.000018: patient, which may lead the doctor to diverge from standard practice in the hope of achieving greater
p.000018: efficacy. This is therefore essential a practical procedure: it involves seeking to obtain the best
p.000018: effect for a given patient. Two features should be noted: this type of act is intended for a given person; it
...
Social / Access to Social Goods
Searching for indicator access:
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p.000005:
p.000005: Opinion no. 13 of 9 July 2001 – Final version
p.000006: 6
p.000006:
p.000006: expressed as well as possible on a case-by-case basis. Ethics and the law both have a role to play in this respect,
p.000006: according to their own specific features. Through the rules they set out, in particular they have to watch over
p.000006: professional conscience in the face of the extension of activities involving medical experimentation.
p.000006:
p.000006: Finally, human experimentation raises the following question: how can we experiment while respecting the
p.000006: autonomy of the individuals involved and protecting them in their vulnerability? This general question in fact
p.000006: summarises several aspects which are worthy of attention and vigilance, in both ethical and in legal terms.
p.000006: The conflict relating to human experimentation cannot be reduced to an opposition between the freedom to
p.000006: research and the autonomy of the individual. It is also important to take into consideration
p.000006: beneficence and collective utility. The latter aspect can only be researched by taking into account a principle of
p.000006: justice that ensures both the fair distribution of the advantages and disadvantages of experiments conducted
p.000006: within populations and the setting up of structures that enable all citizens to have fair access to quality care.
p.000006: For more information, see Introductory Report, C., 1, 2 and 3.
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p.000006: Opinion no. 13 of 9 July 2001 – Final version
p.000007: 7
p.000007:
p.000007: 3. The reference framework of ethics committees is based on four fundamental principles
p.000007:
p.000007: a. THE PRINCIPLE OF RELEVANCE: does the response to the question behind the experiment hold out the
p.000007: possibility of progress in knowledge?
p.000007: b. THE PRINCIPLE OF SCIENTIFIC RIGOUR: the research must be carried out in an adequate scientific context
p.000007: using a rigorous methodology.
p.000007: c. THE PRINCIPLE OF ‘NO HARM’ OR ‘PRIMUM NON NOCERE’: the experiment must respect the condition of the subject and
p.000007: limit the risks incurred so as that they remain proportionate to the anticipated benefit.
p.000007: d. THE PRINCIPLE OF AUTONOMY: corresponds to the need to obtain the free and informed consent of the subject. It
p.000007: therefore supposes that the subject has the capacities of free thought and that the doctor has the capacities
...
p.000007: science, this collective utility cannot be considered purely and simply an effect of the progress made in
p.000007: scientific knowledge. When they do deal with this question, which is unfortunately only too rare, texts stress
p.000007: that collective utility can only be sought by taking into account a principle of justice, that is a
p.000007: fair distribution between the advantages and the disadvantages of experimentation4.
p.000007: This principle of justice draws attention to the selection of the individuals taking part in research, both those
p.000007: who, owing to their vulnerability, may be exploited by their inclusion (for instance, those who are
p.000007: incapable of consenting, such as nurslings, children, mentally disabled people, prisoners or elderly people living
p.000007: in institutions), and those who are usually excluded, possibly to their disadvantage. In fact, it may be
p.000007: observed that drug treatment in children, for example, is based on observations made in adults, which is not
p.000007: necessarily optimal. The principle of justice also leads to the concern to offer and guarantee fair access to quality
p.000007: health care.
p.000007: For additional information, see Introductory Report, C., 4.
p.000007:
p.000007:
p.000007: C. WHAT IS THE NORMATIVE FRAMEWORK FOR HUMAN EXPERIMENTATION?
p.000007:
p.000007:
p.000007: Belgian law is incomplete as regards human experimentation.
p.000007: In addition to Belgian legislation, there are also European and international normative texts and deontological rules
p.000007: (see Introductory Report, D.).
p.000007:
p.000007: The Advisory Committee suggests:
p.000007: 1) setting up legally established local ethics committees as bodies for the assessment of human experimentation
p.000007: protocols, with clearly defined areas of competence;
p.000007: 2) harmonisation of national, European and international standards in the field of human experimentation and
p.000007: complementarity between the deontological rules and the legal rules;
p.000007: 3) a framework law containing legal rules on ethics committees, the rights and duties of
p.000007:
p.000007: 4 Among others: The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research,
p.000007: The Belmont Report, 1978; Council for International Organizations of Medical Sciences (CIOMS), in collab. with World
p.000007: Health Association (WHO), International Ethical Guidelines for Biomedical Research Involving Human Subjects, 1993, as
p.000007: well as: Conseil de recherches médicales du Canada, Conseil de recherché en sciences naturelles du Canada and Conseil
p.000007: de recherches en sciences sur l’homme du Canada, Code d’éthique de la recherché sur l’homme, 1997.
...
p.000027: withdrawing from the experiment and those that apply in circumstances requiring a halt to the experiment.
p.000027:
p.000027: The concept of risk, too, is complex: the risk for the individual is expressed in terms of physical and
p.000027: psychological risks, but also in social and economic terms. But other aspects of the risk also have to be taken into
p.000027: account, such as its seriousness, the probability that it will arise, its reversibility and the possibility that the
p.000027: investigator can overcome it. Overall, this is a difficult assessment, even if serious accidents appear to be
p.000027: exceptional, in any case in the field of trials of new medicinal products.
p.000027:
p.000027:
p.000027: 3. QUALIFICATION OF THE INVESTIGATORS AND EXPERIMENTATION ENVIRONMENT
p.000027:
p.000027: The need for an adequate protocol and the assessment of the risk make it necessary to consider the
p.000027: quality of the investigator (is he the most competent person to carry out the planned experiment?) and the resources
p.000027: available, not only to carry out the experiment with optimal efficacy but also to respond to any unwanted effect.
p.000027: The experiment must be undertaken by qualified and competent people in a suitable environment. This
p.000027: requirement involves clearly identifying the investigators and justifies the need for the dossier to be submitted to
p.000027: the ethics committee by the principal investigator (and not the promoter). It also involves having access to
p.000027: the curriculum vitae of the investigators, and the need for the ethics committee to be familiar with the
p.000027: environment in which the experiment is to take place.
p.000027:
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p.000027:
p.000027: Opinion no. 13 of 9 July 2001 – Final version
p.000028: 28
p.000028:
p.000028: 4. FREE AND INFORMED CONSENT
p.000028:
p.000028: The process of obtaining free and informed consent is a crucial stage in the ethical legitimacy of a
p.000028: research protocol, placed at the head of the ethical requirements of biomedical research even by the
p.000028: Nuremberg Code of 19 July 1947.
p.000028:
p.000028: a. PRIOR INFORMATION ESSENTIAL FOR INFORMED CONSENT
p.000028:
p.000028: The consent must be informed, that is prior to giving consent, the individual must have been informed of the study
p.000028: and the methodology used, the length of study, the anticipated benefits, the constraints, the foreseeable
p.000028: risks, the undertaking to ensure the confidentiality of the data, compensation, the right to withdraw from the study
p.000028: at any time and the possible communication of the results. It is crucial to clearly separate acts and examinations
...
p.000029: out at all;
p.000029:
p.000029: - socially vulnerable groups: separate cultural communities, prisoners, persons who are be likely to be
p.000029: forced (such as medical students), persons in need;
p.000029: - pregnant or breastfeeding women;
p.000029: - in vitro human embryos;
p.000029: - experiments on cadavers;
p.000029: - experiments on organs, tissue or tumours removed from patients;
p.000029: - experiments on the products of spontaneous or induced abortions.
p.000029:
p.000029: It appears that a growing number of firms are asking to keep samples with a view to carrying out subsequent genetic
p.000029: analyses. A procedure like this which may involve research carried out unbeknown to the patient poses particular
p.000029: problems and will be the subject of a separate opinion.
p.000029:
p.000029: The aspects of data confidentiality are in principle governed by the legislation on the protection of
p.000029: privacy (act of 8 December 1992 on the protection of privacy with regard to the processing of personal data
p.000029: (Moniteur belge of 18 March 1993)) and the directives of the National Council of the Order of Doctors
p.000029: concerning access to human experimentation dossiers (opinions of 22 August 1992, 17 February 1996, 13 December
p.000029: 1997, 19 September
p.000029: 1998, 24 April 1999, 15 January 2000 and 19 February 2000).
p.000029:
p.000029: Finally, for some members, ethics committees should follow up the protocol (information on progress with the
p.000029: experiment, interim results, unwanted side effects), which for them constitutes an activity that is as yet
p.000029: unfamiliar. Other members, however, believe that this mission should not be entrusted to them.
p.000029:
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p.000029:
p.000029: Opinion no. 13 of 9 July 2001 – Final version
p.000030: 30
p.000030:
p.000030: This introductory report for the opinion was prepared in select committee 97/8 consisting of*:
p.000030:
p.000030:
p.000030: Joint chairpersons
p.000030:
p.000030: M. Bogaert
p.000030:
p.000030: Y. Galloy
p.000030:
p.000030: Joint reporters
p.000030:
p.000030: M.L. Delfosse (2000)
p.000030:
p.000030: E. Guldix
p.000030:
p.000030: Members
p.000030:
p.000030: M. Abramowicz ('96- '99)
p.000030: M. Baum
p.000030: P. Devroey
p.000030: X. Dijon (resigned '98)
p.000030: I. Liebaers ('96-'99)
p.000030: J.N. Missa (2000)
p.000030: H. Nijs
p.000030: G. Sokal ('96-'99)
p.000030: M. Somville ('96-'99)
p.000030: J. Stiennon (resigned '99)
p.000030: F. Van Neste
p.000030:
p.000030: Member of the Bureau
...
Social / Child
Searching for indicator children:
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p.000003:
p.000003:
p.000003: In the absence of the existence of a joint compensation fund, it seems to us that a delicate situation arises where
p.000003: patients who are the subjects of clinical trials may be inadequately protected and insurance in the event of
p.000003: harm would be more suitable in the case of protocols for clinical studies.
p.000003: We think that this is a problem that concerns all local ethics committees and we are asking for the opinion of the
p.000003: Advisory Committee on Bioethics regarding the attitude to be adopted to safeguard our patients as well as possible.
p.000003: […]”.
p.000003:
p.000003: Opinion no. 13 of 9 July 2001 – Final version
p.000004: 4
p.000004:
p.000004: At its first meetings in the spring of 1998, the select committee held preliminary discussions on the basis of a
p.000004: certain number of discussion notes. At that time, its members decided to see their mission, initially, as a
p.000004: reflection on the ethical problem raised by human experimentation1 and the advisability and content of a
p.000004: normative framework in this area.
p.000004: It was in fact immediately decided to defer to another opinion the practical situations that require special
p.000004: precautions owing either to the vulnerability of the individual or to the impossibility of obtaining
p.000004: informed consent. This concerns, among other things but not exclusively, experiments on children, psychiatric
p.000004: patients and other incapable individuals, prisoners, elderly people living in homes, individuals more likely to be
p.000004: constrained (military personnel, police officers, students, laboratory staff, etc.), vulnerable groups
p.000004: (separate cultural communities, those in need, citizens of developing countries, etc.), pregnant or
p.000004: breastfeeding women (in view of the possible consequences for their unborn children), as well as studies where
p.000004: obtaining individual consent interferes with the research itself2.
p.000004: Similarly, the issue of healthy volunteers will not be covered here.
p.000004: The questions of research on embryos in vitro, material obtained during abortions and devitalised tissue
p.000004: and organs (products of operating theatres and cadavers) will not be dealt with in this opinion, either.
p.000004: The same applies for the questions raised by research into dossiers.
p.000004: Finally, the situation with regard to the issue of therapeutic innovation should be clarified. In many respects, this
p.000004: process differs from experimentation. It consist of treating a patient using a new method or a new medicinal
p.000004: product and its objectives do not differ from those of ordinary therapy: there is no need to draw up an experimental
p.000004: protocol, the patient is not a trial subject and ultimate aim of the treatment remains solely the patient himself and
p.000004: his personal well-being. In fact, what is involved here is the legitimacy of the innovative medical intervention. It
p.000004: has been decided that questions relating to therapeutic innovation as such will not be covered in this opinion.
p.000004:
p.000004: To sum up: the opinion concerns only adult and capable trial subjects.
p.000004:
p.000004: A more in-depth analysis of the issue is provided in the introductory report relating to the opinion.
p.000004:
p.000004:
...
p.000007: needed to provide clear information.
p.000007:
p.000007: 4. Reflections and expansion: focus on the principle of justice
p.000007:
p.000007: In the light of these principles – as is stipulated in point 2 above – at first glance the conflict of values
p.000007: inherent in human experimentation appears to be a dilemma between scientificity (principles a and b) and the
p.000007: protection of the autonomy and integrity of individuals (principles c and d). However, experimentation also aims
p.000007: to achieve collective utility. Now, even if we are inclined to believe it owing to the credit currently accorded to
p.000007: science, this collective utility cannot be considered purely and simply an effect of the progress made in
p.000007: scientific knowledge. When they do deal with this question, which is unfortunately only too rare, texts stress
p.000007: that collective utility can only be sought by taking into account a principle of justice, that is a
p.000007: fair distribution between the advantages and the disadvantages of experimentation4.
p.000007: This principle of justice draws attention to the selection of the individuals taking part in research, both those
p.000007: who, owing to their vulnerability, may be exploited by their inclusion (for instance, those who are
p.000007: incapable of consenting, such as nurslings, children, mentally disabled people, prisoners or elderly people living
p.000007: in institutions), and those who are usually excluded, possibly to their disadvantage. In fact, it may be
p.000007: observed that drug treatment in children, for example, is based on observations made in adults, which is not
p.000007: necessarily optimal. The principle of justice also leads to the concern to offer and guarantee fair access to quality
p.000007: health care.
p.000007: For additional information, see Introductory Report, C., 4.
p.000007:
p.000007:
p.000007: C. WHAT IS THE NORMATIVE FRAMEWORK FOR HUMAN EXPERIMENTATION?
p.000007:
p.000007:
p.000007: Belgian law is incomplete as regards human experimentation.
p.000007: In addition to Belgian legislation, there are also European and international normative texts and deontological rules
p.000007: (see Introductory Report, D.).
p.000007:
p.000007: The Advisory Committee suggests:
p.000007: 1) setting up legally established local ethics committees as bodies for the assessment of human experimentation
p.000007: protocols, with clearly defined areas of competence;
p.000007: 2) harmonisation of national, European and international standards in the field of human experimentation and
p.000007: complementarity between the deontological rules and the legal rules;
p.000007: 3) a framework law containing legal rules on ethics committees, the rights and duties of
p.000007:
p.000007: 4 Among others: The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research,
p.000007: The Belmont Report, 1978; Council for International Organizations of Medical Sciences (CIOMS), in collab. with World
...
p.000020: 20
p.000020:
p.000020: b. EXAMINING ETHICAL REQUIREMENTS - METHODOLOGY
p.000020:
p.000020: Most texts on medical ethics and deontology put forward a series of principles which are based on different ethical
p.000020: outlooks, without suggesting a link between them. This situation may lead to excesses when one of these
p.000020: principles is considered to be the sole determinant, or when the ethical interpretation of the basis for this principle
p.000020: leads to a distorted interpretation of others. To overcome this difficulty, it would be advisable to suggest a
p.000020: methodology like that now put forward by certain texts7, and accompany it with this rule: any condition
p.000020: not met releases the ethics committee from having to examine the following conditions; only protocols for which
p.000020: all the conditions examined, in order, have been given a positive assessment can be granted a favourable opinion.
p.000020:
p.000020: c. THE LINK BETWEEN AUTONOMY AND VULNERABILITY
p.000020:
p.000020: In addition to the principle of autonomy, it is also important to take account of a principle of
p.000020: vulnerability which not only expresses the condition of all individuals, but also requires particular attention
p.000020: when the experimentation concerns those who are weaker, such as those who are ill, children, the mentally
p.000020: disabled, the elderly, people in institutions or suffering from neuralgic disorders. So when an experiment involves
p.000020: those who are ill, the basic question becomes that of the link to be established between the risk accepted by the
p.000020: patient (autonomy) and the benefits the latter expects. The link between autonomy and vulnerability is
p.000020: particularly acute when experimentation is suggested as the last chance of a cure for a patient who is often
p.000020: distressed.
p.000020:
p.000020: d. PARTNERSHIP
p.000020:
p.000020: Rather than seeing consent as authorisation given by a patient or a subject to carry out an experiment on him as a
p.000020: procedure that aims to find out whether this patient or this subject illustrates the relevance of an assumption, would
p.000020: it not be better to see consent and experimentation rather as a partnership? In fact, the relationship between the
p.000020: doctor and the patient must be seen in terms of evolutive agreement that is constantly renegotiated.
p.000020: Actually obtaining informed consent implies abandoning medical paternalism. The doctor cannot decide alone
...
Social / Elderly
Searching for indicator elderly:
(return to top)
p.000003: harm would be more suitable in the case of protocols for clinical studies.
p.000003: We think that this is a problem that concerns all local ethics committees and we are asking for the opinion of the
p.000003: Advisory Committee on Bioethics regarding the attitude to be adopted to safeguard our patients as well as possible.
p.000003: […]”.
p.000003:
p.000003: Opinion no. 13 of 9 July 2001 – Final version
p.000004: 4
p.000004:
p.000004: At its first meetings in the spring of 1998, the select committee held preliminary discussions on the basis of a
p.000004: certain number of discussion notes. At that time, its members decided to see their mission, initially, as a
p.000004: reflection on the ethical problem raised by human experimentation1 and the advisability and content of a
p.000004: normative framework in this area.
p.000004: It was in fact immediately decided to defer to another opinion the practical situations that require special
p.000004: precautions owing either to the vulnerability of the individual or to the impossibility of obtaining
p.000004: informed consent. This concerns, among other things but not exclusively, experiments on children, psychiatric
p.000004: patients and other incapable individuals, prisoners, elderly people living in homes, individuals more likely to be
p.000004: constrained (military personnel, police officers, students, laboratory staff, etc.), vulnerable groups
p.000004: (separate cultural communities, those in need, citizens of developing countries, etc.), pregnant or
p.000004: breastfeeding women (in view of the possible consequences for their unborn children), as well as studies where
p.000004: obtaining individual consent interferes with the research itself2.
p.000004: Similarly, the issue of healthy volunteers will not be covered here.
p.000004: The questions of research on embryos in vitro, material obtained during abortions and devitalised tissue
p.000004: and organs (products of operating theatres and cadavers) will not be dealt with in this opinion, either.
p.000004: The same applies for the questions raised by research into dossiers.
p.000004: Finally, the situation with regard to the issue of therapeutic innovation should be clarified. In many respects, this
p.000004: process differs from experimentation. It consist of treating a patient using a new method or a new medicinal
...
p.000007: inherent in human experimentation appears to be a dilemma between scientificity (principles a and b) and the
p.000007: protection of the autonomy and integrity of individuals (principles c and d). However, experimentation also aims
p.000007: to achieve collective utility. Now, even if we are inclined to believe it owing to the credit currently accorded to
p.000007: science, this collective utility cannot be considered purely and simply an effect of the progress made in
p.000007: scientific knowledge. When they do deal with this question, which is unfortunately only too rare, texts stress
p.000007: that collective utility can only be sought by taking into account a principle of justice, that is a
p.000007: fair distribution between the advantages and the disadvantages of experimentation4.
p.000007: This principle of justice draws attention to the selection of the individuals taking part in research, both those
p.000007: who, owing to their vulnerability, may be exploited by their inclusion (for instance, those who are
p.000007: incapable of consenting, such as nurslings, children, mentally disabled people, prisoners or elderly people living
p.000007: in institutions), and those who are usually excluded, possibly to their disadvantage. In fact, it may be
p.000007: observed that drug treatment in children, for example, is based on observations made in adults, which is not
p.000007: necessarily optimal. The principle of justice also leads to the concern to offer and guarantee fair access to quality
p.000007: health care.
p.000007: For additional information, see Introductory Report, C., 4.
p.000007:
p.000007:
p.000007: C. WHAT IS THE NORMATIVE FRAMEWORK FOR HUMAN EXPERIMENTATION?
p.000007:
p.000007:
p.000007: Belgian law is incomplete as regards human experimentation.
p.000007: In addition to Belgian legislation, there are also European and international normative texts and deontological rules
p.000007: (see Introductory Report, D.).
p.000007:
p.000007: The Advisory Committee suggests:
p.000007: 1) setting up legally established local ethics committees as bodies for the assessment of human experimentation
p.000007: protocols, with clearly defined areas of competence;
p.000007: 2) harmonisation of national, European and international standards in the field of human experimentation and
p.000007: complementarity between the deontological rules and the legal rules;
p.000007: 3) a framework law containing legal rules on ethics committees, the rights and duties of
p.000007:
p.000007: 4 Among others: The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research,
...
p.000020: outlooks, without suggesting a link between them. This situation may lead to excesses when one of these
p.000020: principles is considered to be the sole determinant, or when the ethical interpretation of the basis for this principle
p.000020: leads to a distorted interpretation of others. To overcome this difficulty, it would be advisable to suggest a
p.000020: methodology like that now put forward by certain texts7, and accompany it with this rule: any condition
p.000020: not met releases the ethics committee from having to examine the following conditions; only protocols for which
p.000020: all the conditions examined, in order, have been given a positive assessment can be granted a favourable opinion.
p.000020:
p.000020: c. THE LINK BETWEEN AUTONOMY AND VULNERABILITY
p.000020:
p.000020: In addition to the principle of autonomy, it is also important to take account of a principle of
p.000020: vulnerability which not only expresses the condition of all individuals, but also requires particular attention
p.000020: when the experimentation concerns those who are weaker, such as those who are ill, children, the mentally
p.000020: disabled, the elderly, people in institutions or suffering from neuralgic disorders. So when an experiment involves
p.000020: those who are ill, the basic question becomes that of the link to be established between the risk accepted by the
p.000020: patient (autonomy) and the benefits the latter expects. The link between autonomy and vulnerability is
p.000020: particularly acute when experimentation is suggested as the last chance of a cure for a patient who is often
p.000020: distressed.
p.000020:
p.000020: d. PARTNERSHIP
p.000020:
p.000020: Rather than seeing consent as authorisation given by a patient or a subject to carry out an experiment on him as a
p.000020: procedure that aims to find out whether this patient or this subject illustrates the relevance of an assumption, would
p.000020: it not be better to see consent and experimentation rather as a partnership? In fact, the relationship between the
p.000020: doctor and the patient must be seen in terms of evolutive agreement that is constantly renegotiated.
p.000020: Actually obtaining informed consent implies abandoning medical paternalism. The doctor cannot decide alone
p.000020: what is good for the patient. He must take the time to correctly inform his partner-patient. The individual
p.000020: taking part freely in research is not an object being manipulated to achieve ends that have nothing to do with him.
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027:
p.000027: Opinion no. 13 of 9 July 2001 – Final version
p.000028: 28
p.000028:
p.000028: 4. FREE AND INFORMED CONSENT
p.000028:
p.000028: The process of obtaining free and informed consent is a crucial stage in the ethical legitimacy of a
p.000028: research protocol, placed at the head of the ethical requirements of biomedical research even by the
p.000028: Nuremberg Code of 19 July 1947.
p.000028:
p.000028: a. PRIOR INFORMATION ESSENTIAL FOR INFORMED CONSENT
p.000028:
p.000028: The consent must be informed, that is prior to giving consent, the individual must have been informed of the study
p.000028: and the methodology used, the length of study, the anticipated benefits, the constraints, the foreseeable
p.000028: risks, the undertaking to ensure the confidentiality of the data, compensation, the right to withdraw from the study
p.000028: at any time and the possible communication of the results. It is crucial to clearly separate acts and examinations
p.000028: linked to the experiment from those that are part of the usual treatment of the patient, both on the
p.000028: information form and on the consent form. The main points of this information must be included on an
p.000028: information form drafted in comprehensible terms and as far as possible in the language of the patient and attached
p.000028: to the consent document so that there can be no challenge regarding the information which the patient (or the
p.000028: healthy volunteer) has received. A further oral explanation from the investigator is necessary in order to be
p.000028: adapted to the understanding of each individual and so that questions can be asked. The information document must
p.000028: expressly indicate which ethics committee or committees has (have) given an opinion, and the content of
p.000028: this opinion.
p.000028:
p.000028: b. OBTAINING CONSENT
p.000028:
p.000028: The French act of 20 December 1988 on the protection of individual who take part in biomedical research (the Huriet
p.000028: act) stresses the fact that, thanks to their consent, the individuals included in a research project become partners
p.000028: who can collaborate actively with the investigator, emphasising the importance of this informed consent. This must be
p.000028: personal, prior and preferably laid down in writing. It must be free (that is exempt of any pressure, including
p.000028: moral or financial pressure). The aspect of compensation to cover the costs incurred by the patient or
p.000028: any other indirect advantage (free medical products for some trial subjects, for example) is particularly tricky.
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000013:
p.000013: M.L. Delfosse (2000)
p.000013:
p.000013: E. Guldix
p.000013:
p.000013: Members
p.000013:
p.000013: M. Abramowicz ('96- '99)
p.000013: M. Baum
p.000013: P. Devroey
p.000013: X. Dijon (resigned '98)
p.000013: I. Liebaers ('96-'99)
p.000013: J.N. Missa (2000)
p.000013: H. Nijs
p.000013: G. Sokal ('96-'99)
p.000013: M. Somville ('96-'99)
p.000013: J. Stiennon (resigned '99)
p.000013: F. Van Neste
p.000013:
p.000013: Member of the Bureau
p.000013: Y. Englert
p.000013:
p.000013:
p.000013:
p.000013: Member of the secretariaat
p.000013:
p.000013: E. Morbé
p.000013:
p.000013:
p.000013: Permanent experts
p.000013:
p.000013: • Ms M.L. Delfosse (1996-1999), philosopher, Facultes universitaires Notre-Dame de la Paix-Faculte de
p.000013: droit, and CIDES, Namur.
p.000013: • Ms I. Liebaers (2000), lecturer, Centrum Medische Genetica, AZ-VUB, Brussels.
p.000013: • Mr J.N. Missa (1996-1999), philosopher, CRIB, director of the Institut de Philosophie at the ULB, Brussels.
p.000013:
p.000013: The working documents of select committee 97/8 – request for opinion, personal contributions from members,
p.000013: minutes of the meetings, documents consulted – are stored as Annexes 97/8 at the Committee’s documentation centre,
p.000013: where they may be consulted and copies.
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: * Some members took part in the work of the select committee during the Committee’s two terms of
p.000013: office (1996-1999 and 2000). The length of the term is indicated next to the name of members who took part in the work
p.000013: of the committee during a single term.
p.000013:
p.000013: Opinion no. 13 of 9 July 2001 – Final version
p.000014: 14
p.000014:
p.000014: INTRODUCTORY REPORT FOR OPINION No 13 of 9 July 2001 on human experimentation
p.000014:
p.000014:
p.000014: CONTENTS
p.000014:
p.000014: A. Objectives and method
p.000014: B. Definitions
p.000014: C. Medical-scientific research on humans – Ethical and legal problems
p.000014: 1. Legitimacy based on efficacy
p.000014: 2. Care and research
p.000014: 3. The cultural context
p.000014: 4. Problems
p.000014: a. A question of methodology
p.000014: b. Examining ethical requirements – methodology
p.000014: c. The link between autonomy and vulnerability
p.000014: d. Partnership
p.000014: e. Consent
p.000014: f. Insurance
p.000014: g. Should all experimentation protocols be submitted for assessment of by an ethics committee?
p.000014: D. The current normative framework
p.000014: E. Ethics committees
p.000014: 1. Composition
p.000014: 2. Independence
p.000014: 3. Liability and insurance
p.000014: 4. Options to be taken
p.000014: a. Need for an advisory or a binding opinion?
p.000014: b. Professionalisation of ethics committees?
...
p.000017: He is referred to as the principal investigator.
p.000017:
p.000017: The sponsor or body subsidising the study is the person, the company, the institution or the body that takes
p.000017: responsibility for devising, managing and funding the clinical study.
p.000017:
p.000017: The experimental protocol is a document that describes, in particular, the objectives, the procedure, the
p.000017: methodology, the statistical elements and the organisation of the study. The experimental protocol also usually
p.000017: explains the foundations of and justifications for the study, even though this information may also appear in
p.000017: other documents to which reference is made in the experimental protocol.
p.000017:
p.000017: A placebo is a tablet, an injection or a treatment which the trial subject believes will have an effect (positive or
p.000017: negative) on his state of health and which, owing to this conviction on the part of the person concerned, can actually
p.000017: have such an effect, but which the investigator is convinced is inert vis-à-vis the state of the trial subject.
p.000017:
p.000017: When, in the context of any experiment during which a treatment is compared to an acknowledged existing
p.000017: treatment or a placebo, one or several of the parties concerned are kept in ignorance of the allocation of
p.000017: treatments to the trial subjects (e.g. the active treatment or the placebo), this is known as a blind
p.000017: study. The experiment is single blind when only the trial subjects are not informed; it is double blind) when the
p.000017: investigator, his team, the supervisor and, in some cases, the data analyst or analysts are also unaware which subject
p.000017: is given which treatment.
p.000017:
p.000017: Basic research is research during which phenomena are studied with a view to improving scientific knowledge,
p.000017: but without any direct intention of applying this knowledge in practice.
p.000017:
p.000017: Applied research, on the other hand, involves experimentation where the objective is to apply the
p.000017: scientific knowledge acquired to practical situations such as illnesses.
p.000017:
p.000017: Randomisation is the use of chance to determine the allocation of trial subjects to treatment or control groups; the
p.000017: aim here is to reduce bias which may distort the conclusions.
p.000017:
p.000017: The control treatment is the better medical treatment or the usual medical treatment for a patient or, for instance if
p.000017: there is no such treatment, the placebo treatment with which the experimental treatment is being compared.
p.000017:
p.000017: Bias is the term used if a systematic error is observed in the experimental protocol that is likely to have led to
p.000017: distorted conclusions.
p.000017:
p.000017: An experimentation protocol must be submitted to a local ethics committee for an opinion. A local ethics committee is
...
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: 8 See opinion, C.1.
p.000023: Opinion no. 13 of 9 July 2001 – Final version
p.000024: 24
p.000024:
p.000024: c. RESTRUCTURING ETHICS COMMITTEES TO FORM LOCAL COMMITTEES AND ‘REGIONAL’ COMMITTEES?
p.000024:
p.000024: Some members of the Advisory Committee recommend introducing ‘regional’ committees alongside local ethics committees.
p.000024: These ‘regional’ committees would have the exclusive task of assessing research protocols, in order to
p.000024: enable a certain level of professionalisation by combining the available resources and skills. With this
p.000024: system, the local committees’ mission would simply be to check the feasibility of the planned research in the
p.000024: local context, and the ‘regional’ committees would be set up either by the local authority or on a
p.000024: voluntary basis in line with geographic or ideological criteria.
p.000024:
p.000024: For other members of the Advisory Committee, creating a new structure like this is not only superfluous, but also
p.000024: inadvisable.
p.000024: Superfluous, because Article 7 of Directive 2001/20/EC stipulates, in the event of multi- centre studies, that there
p.000024: shall be a procedure for the adoption of a single opinion per country. The other committees can limit the
p.000024: examination to ensuring that local conditions fulfil the requirements of the research. The ethics committee of a
p.000024: university hospital, for instance, could therefore give this sole opinion (moreover, this would virtually
p.000024: always be where the national coordinator of a study like this would be), without the need to create another structure.
p.000024: Moreover, the creation of a second structure would present two risks. First of all, distancing the ethical
p.000024: assessment structure from the situation on the ground will inevitably weaken the ethical debate in terms of
p.000024: proximity and favour the role of the bureaucratic control of ethics committees (assessment ‘on paper’) to
p.000024: the detriment of their educational and interactive role with the investigators within institutions; in addition,
p.000024: their role as regards the ethical aspects of hospital procedures will be weakened as their legal missions cover
p.000024: the same procedure, based on the same principles and often involve the same people. Finally, the creation of a second
p.000024: structure would lead to a haemorrhaging of competent people and financial resources to the new structures whereas these
p.000024: human and material resources are already limited and are better concentrated on existing ethics committees. These
p.000024: fulfil a substantial role that must be developed and supported financially, which is not always the case
...
p.000030:
p.000030: Joint reporters
p.000030:
p.000030: M.L. Delfosse (2000)
p.000030:
p.000030: E. Guldix
p.000030:
p.000030: Members
p.000030:
p.000030: M. Abramowicz ('96- '99)
p.000030: M. Baum
p.000030: P. Devroey
p.000030: X. Dijon (resigned '98)
p.000030: I. Liebaers ('96-'99)
p.000030: J.N. Missa (2000)
p.000030: H. Nijs
p.000030: G. Sokal ('96-'99)
p.000030: M. Somville ('96-'99)
p.000030: J. Stiennon (resigned '99)
p.000030: F. Van Neste
p.000030:
p.000030: Member of the Bureau
p.000030: Y. Englert
p.000030:
p.000030:
p.000030:
p.000030: Member of the secretariaat
p.000030:
p.000030: E. Morbé
p.000030:
p.000030:
p.000030: Permanent experts
p.000030:
p.000030: • Ms M.L. Delfosse (1996-1999), philosopher, Facultes universitaires Notre-Dame de la Paix-Faculte de
p.000030: droit, and CIDES, Namur.
p.000030: • Ms I. Liebaers (2000), lecturer, Centrum Medische Genetica, AZ-VUB, Brussels.
p.000030: • Mr J.N. Missa (1996-1999), philosopher, CRIB, director of the Institut de Philosophie at the ULB, Brussels.
p.000030:
p.000030:
p.000030:
p.000030: The working documents of select committee 97/8 – request for opinion, personal contributions from members,
p.000030: minutes of the reunions, documents consulted – are stored as Annexes 97/8 at the Committee’s documentation centre,
p.000030: where they may be consulted and copied.
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: * Some members took part in the work of the select committee during the Committee’s two terms of office (1996-1999 and
p.000030: 2000). The length of the term is indicated next to the names of the members who took part in the work of the committee
p.000030: during a single term of office.
p.000030:
p.000030: Opinion no. 13 of 9 July 2001 – Final version
...
Social / Police Officer
Searching for indicator police:
(return to top)
p.000003: Advisory Committee on Bioethics regarding the attitude to be adopted to safeguard our patients as well as possible.
p.000003: […]”.
p.000003:
p.000003: Opinion no. 13 of 9 July 2001 – Final version
p.000004: 4
p.000004:
p.000004: At its first meetings in the spring of 1998, the select committee held preliminary discussions on the basis of a
p.000004: certain number of discussion notes. At that time, its members decided to see their mission, initially, as a
p.000004: reflection on the ethical problem raised by human experimentation1 and the advisability and content of a
p.000004: normative framework in this area.
p.000004: It was in fact immediately decided to defer to another opinion the practical situations that require special
p.000004: precautions owing either to the vulnerability of the individual or to the impossibility of obtaining
p.000004: informed consent. This concerns, among other things but not exclusively, experiments on children, psychiatric
p.000004: patients and other incapable individuals, prisoners, elderly people living in homes, individuals more likely to be
p.000004: constrained (military personnel, police officers, students, laboratory staff, etc.), vulnerable groups
p.000004: (separate cultural communities, those in need, citizens of developing countries, etc.), pregnant or
p.000004: breastfeeding women (in view of the possible consequences for their unborn children), as well as studies where
p.000004: obtaining individual consent interferes with the research itself2.
p.000004: Similarly, the issue of healthy volunteers will not be covered here.
p.000004: The questions of research on embryos in vitro, material obtained during abortions and devitalised tissue
p.000004: and organs (products of operating theatres and cadavers) will not be dealt with in this opinion, either.
p.000004: The same applies for the questions raised by research into dossiers.
p.000004: Finally, the situation with regard to the issue of therapeutic innovation should be clarified. In many respects, this
p.000004: process differs from experimentation. It consist of treating a patient using a new method or a new medicinal
p.000004: product and its objectives do not differ from those of ordinary therapy: there is no need to draw up an experimental
p.000004: protocol, the patient is not a trial subject and ultimate aim of the treatment remains solely the patient himself and
...
Social / Religion
Searching for indicator conviction:
(return to top)
p.000016: which is added to the cognitive objective of an experiment can only ever be considered a secondary objective; under no
p.000016: circumstances does it annul or attenuate the experimental (and therefore primarily cognitive) nature of
p.000016: the procedure undertaken.
p.000016: Opinion no. 13 of 9 July 2001 – Final version
p.000017: 17
p.000017:
p.000017: and whose organism or mind is the subject of the research.
p.000017:
p.000017: The experimenter or investigator is the person in charge of conducting the clinical study. When the study is
p.000017: carried out by a team of people, an investigator is the head or leader of this team, in charge of the team as a whole.
p.000017: He is referred to as the principal investigator.
p.000017:
p.000017: The sponsor or body subsidising the study is the person, the company, the institution or the body that takes
p.000017: responsibility for devising, managing and funding the clinical study.
p.000017:
p.000017: The experimental protocol is a document that describes, in particular, the objectives, the procedure, the
p.000017: methodology, the statistical elements and the organisation of the study. The experimental protocol also usually
p.000017: explains the foundations of and justifications for the study, even though this information may also appear in
p.000017: other documents to which reference is made in the experimental protocol.
p.000017:
p.000017: A placebo is a tablet, an injection or a treatment which the trial subject believes will have an effect (positive or
p.000017: negative) on his state of health and which, owing to this conviction on the part of the person concerned, can actually
p.000017: have such an effect, but which the investigator is convinced is inert vis-à-vis the state of the trial subject.
p.000017:
p.000017: When, in the context of any experiment during which a treatment is compared to an acknowledged existing
p.000017: treatment or a placebo, one or several of the parties concerned are kept in ignorance of the allocation of
p.000017: treatments to the trial subjects (e.g. the active treatment or the placebo), this is known as a blind
p.000017: study. The experiment is single blind when only the trial subjects are not informed; it is double blind) when the
p.000017: investigator, his team, the supervisor and, in some cases, the data analyst or analysts are also unaware which subject
p.000017: is given which treatment.
p.000017:
p.000017: Basic research is research during which phenomena are studied with a view to improving scientific knowledge,
p.000017: but without any direct intention of applying this knowledge in practice.
p.000017:
p.000017: Applied research, on the other hand, involves experimentation where the objective is to apply the
p.000017: scientific knowledge acquired to practical situations such as illnesses.
p.000017:
p.000017: Randomisation is the use of chance to determine the allocation of trial subjects to treatment or control groups; the
p.000017: aim here is to reduce bias which may distort the conclusions.
p.000017:
...
Social / Soldier
Searching for indicator military:
(return to top)
p.000003: We think that this is a problem that concerns all local ethics committees and we are asking for the opinion of the
p.000003: Advisory Committee on Bioethics regarding the attitude to be adopted to safeguard our patients as well as possible.
p.000003: […]”.
p.000003:
p.000003: Opinion no. 13 of 9 July 2001 – Final version
p.000004: 4
p.000004:
p.000004: At its first meetings in the spring of 1998, the select committee held preliminary discussions on the basis of a
p.000004: certain number of discussion notes. At that time, its members decided to see their mission, initially, as a
p.000004: reflection on the ethical problem raised by human experimentation1 and the advisability and content of a
p.000004: normative framework in this area.
p.000004: It was in fact immediately decided to defer to another opinion the practical situations that require special
p.000004: precautions owing either to the vulnerability of the individual or to the impossibility of obtaining
p.000004: informed consent. This concerns, among other things but not exclusively, experiments on children, psychiatric
p.000004: patients and other incapable individuals, prisoners, elderly people living in homes, individuals more likely to be
p.000004: constrained (military personnel, police officers, students, laboratory staff, etc.), vulnerable groups
p.000004: (separate cultural communities, those in need, citizens of developing countries, etc.), pregnant or
p.000004: breastfeeding women (in view of the possible consequences for their unborn children), as well as studies where
p.000004: obtaining individual consent interferes with the research itself2.
p.000004: Similarly, the issue of healthy volunteers will not be covered here.
p.000004: The questions of research on embryos in vitro, material obtained during abortions and devitalised tissue
p.000004: and organs (products of operating theatres and cadavers) will not be dealt with in this opinion, either.
p.000004: The same applies for the questions raised by research into dossiers.
p.000004: Finally, the situation with regard to the issue of therapeutic innovation should be clarified. In many respects, this
p.000004: process differs from experimentation. It consist of treating a patient using a new method or a new medicinal
p.000004: product and its objectives do not differ from those of ordinary therapy: there is no need to draw up an experimental
...
Social / Victim of Abuse
Searching for indicator victim:
(return to top)
p.000003:
p.000003: The request from Prof. Dr. W. Betz was deemed admissible by the Advisory Committee on bioethics (hereinafter: the
p.000003: Advisory Committee). Select committee 97/8 was set up with a view to drawing up a draft opinion
p.000003: concerning the general question of human experimentation. In fact, the Advisory Committee believed that the
p.000003: question posed should be expanded.
p.000003:
p.000003: The request for an opinion of 8 June 1998 from Dr. S. SCHREIBER, chairman of the local ethics committee
p.000003: of the CHU Tivoli in La Louvière, concerning ‘civil liability’ insurance in the event of harm caused during
p.000003: clinical trials on human subjects is also taken into consideration. This request is worded as follows:
p.000003:
p.000003: “Among the many ethical questions raised by the examination of clinical trials protocols, we are frequently
p.000003: confronted with the problem of insurance covering harm caused to patients who undergo these trials.
p.000003: This insurance, for which incidentally we require the certificate, usually covers civil liability. This implies that
p.000003: in order for compensation to be paid, not only must harm have been caused, but in addition an error must have been
p.000003: committed, and that there is a causal link to the harm. In addition, in our legislation, the burden of proof lies with
p.000003: the victim.
p.000003:
p.000003:
p.000003: In the absence of the existence of a joint compensation fund, it seems to us that a delicate situation arises where
p.000003: patients who are the subjects of clinical trials may be inadequately protected and insurance in the event of
p.000003: harm would be more suitable in the case of protocols for clinical studies.
p.000003: We think that this is a problem that concerns all local ethics committees and we are asking for the opinion of the
p.000003: Advisory Committee on Bioethics regarding the attitude to be adopted to safeguard our patients as well as possible.
p.000003: […]”.
p.000003:
p.000003: Opinion no. 13 of 9 July 2001 – Final version
p.000004: 4
p.000004:
p.000004: At its first meetings in the spring of 1998, the select committee held preliminary discussions on the basis of a
p.000004: certain number of discussion notes. At that time, its members decided to see their mission, initially, as a
p.000004: reflection on the ethical problem raised by human experimentation1 and the advisability and content of a
p.000004: normative framework in this area.
p.000004: It was in fact immediately decided to defer to another opinion the practical situations that require special
p.000004: precautions owing either to the vulnerability of the individual or to the impossibility of obtaining
...
p.000011: questioning of its efficacy. In response to the question of formalism, they stress that for them, right and morals are
p.000011: not separate normative disciplines. They believe that the rules of law are often replicas of moral rules and that it is
p.000011: therefore not correct to say that observing a legal rule is merely a formal factor that can never be morally
p.000011: experienced or accepted. By making compliance with legal rules mandatory, citizens can also be educated to
p.000011: adopt responsible social behaviour. An initial stage when it is mainly the constraint of the legal rule that is felt
p.000011: and perhaps criticised, is often succeeded by a period of habituation and finally moral integration of the rule
p.000011: (such as the obligation to wear seat belt, mandatory health inspections at school, etc.). These members
p.000011: consider it obvious that the law formulates what was previously seen to be advisable by everyone: the
p.000011: regulation of relationships between human beings.
p.000011:
p.000011: Radicalising their outlooks, they think it is utopian to believe that specific bioethical questions could
p.000011: be definitively resolved outside any legal context. In fact, the trial subject is the weak participant and
p.000011: therefore the one above all who must be protected. Once this subject suffers harm owing to any dysfunction of the
p.000011: experiment whatsoever, he will seek reparation. Practice shows that the party liable usually does not wish to be called
p.000011: into question on the basis of his liability and rarely offers reparation spontaneously. The
p.000011: only option is therefore for the victim to turn to the courts in the hope of finding reparation there. However,
p.000011: appealing to the courts is only possible if this is allowed by law, that is if the experimentation is regulated by law
p.000011: and not by medical ethics. It is therefore in the very best interest of the trial subject that there are rules of law,
p.000011: as a judge can only rule on the basis of these rules.
p.000011:
p.000011: Finally, the advocates of this point of view state that for them, legislation like this does not have to be
p.000011: exhaustive, or deal with the issue in full. The law can be confined to establishing the minimum rules of
p.000011: behaviour and procedures that nevertheless guarantee the protection of trial subjects. It should also be stated that a
p.000011: law does not, by its very nature, address individual cases but is enacted for a group of individual who are
p.000011: in a similar situation. Its formulation and its content are adapted to this ‘common denominator’
p.000011: approach. So even if the preferred option is regulations that are fairly complete and binding, this
p.000011: permits complementary standards, notably in the case in point decisions taken by ethics committees.
p.000011:
p.000011: 3. A framework law
p.000011:
p.000011: The Advisory Committee is of the opinion that a framework law concerning biomedical human experimentation is needed.
p.000011: This is a matter of converting the ethical legitimacy of this experimentation into a legality that puts an end to the
p.000011: current ambiguity of Belgian law in this area. The framework law must, of course, leave the necessary scope for an
...
Social / Women
Searching for indicator women:
(return to top)
p.000004: certain number of discussion notes. At that time, its members decided to see their mission, initially, as a
p.000004: reflection on the ethical problem raised by human experimentation1 and the advisability and content of a
p.000004: normative framework in this area.
p.000004: It was in fact immediately decided to defer to another opinion the practical situations that require special
p.000004: precautions owing either to the vulnerability of the individual or to the impossibility of obtaining
p.000004: informed consent. This concerns, among other things but not exclusively, experiments on children, psychiatric
p.000004: patients and other incapable individuals, prisoners, elderly people living in homes, individuals more likely to be
p.000004: constrained (military personnel, police officers, students, laboratory staff, etc.), vulnerable groups
p.000004: (separate cultural communities, those in need, citizens of developing countries, etc.), pregnant or
p.000004: breastfeeding women (in view of the possible consequences for their unborn children), as well as studies where
p.000004: obtaining individual consent interferes with the research itself2.
p.000004: Similarly, the issue of healthy volunteers will not be covered here.
p.000004: The questions of research on embryos in vitro, material obtained during abortions and devitalised tissue
p.000004: and organs (products of operating theatres and cadavers) will not be dealt with in this opinion, either.
p.000004: The same applies for the questions raised by research into dossiers.
p.000004: Finally, the situation with regard to the issue of therapeutic innovation should be clarified. In many respects, this
p.000004: process differs from experimentation. It consist of treating a patient using a new method or a new medicinal
p.000004: product and its objectives do not differ from those of ordinary therapy: there is no need to draw up an experimental
p.000004: protocol, the patient is not a trial subject and ultimate aim of the treatment remains solely the patient himself and
p.000004: his personal well-being. In fact, what is involved here is the legitimacy of the innovative medical intervention. It
p.000004: has been decided that questions relating to therapeutic innovation as such will not be covered in this opinion.
p.000004:
p.000004: To sum up: the opinion concerns only adult and capable trial subjects.
p.000004:
...
p.000028: committee that examined the protocol. This information must also be updated as the experiment progresses
p.000028: when relevant new information becomes available.
p.000028:
p.000028:
p.000028: 5. CONCLUSION
p.000028:
p.000028: In addition to these general rules, there are also special rules that are not part of this opinion for
p.000028: vulnerable groups and special situations such as:
p.000028: - healthy volunteers;
p.000028: Opinion no. 13 of 9 July 2001 – Final version
p.000029: 29
p.000029:
p.000029: - individuals who are legally or de facto incapable (psychiatric patients, unconscious patients,
p.000029: underage patients);
p.000029: - the protocols of behavioural studies where obtaining consent prevents the experiment from being carried
p.000029: out at all;
p.000029:
p.000029: - socially vulnerable groups: separate cultural communities, prisoners, persons who are be likely to be
p.000029: forced (such as medical students), persons in need;
p.000029: - pregnant or breastfeeding women;
p.000029: - in vitro human embryos;
p.000029: - experiments on cadavers;
p.000029: - experiments on organs, tissue or tumours removed from patients;
p.000029: - experiments on the products of spontaneous or induced abortions.
p.000029:
p.000029: It appears that a growing number of firms are asking to keep samples with a view to carrying out subsequent genetic
p.000029: analyses. A procedure like this which may involve research carried out unbeknown to the patient poses particular
p.000029: problems and will be the subject of a separate opinion.
p.000029:
p.000029: The aspects of data confidentiality are in principle governed by the legislation on the protection of
p.000029: privacy (act of 8 December 1992 on the protection of privacy with regard to the processing of personal data
p.000029: (Moniteur belge of 18 March 1993)) and the directives of the National Council of the Order of Doctors
p.000029: concerning access to human experimentation dossiers (opinions of 22 August 1992, 17 February 1996, 13 December
p.000029: 1997, 19 September
p.000029: 1998, 24 April 1999, 15 January 2000 and 19 February 2000).
p.000029:
p.000029: Finally, for some members, ethics committees should follow up the protocol (information on progress with the
p.000029: experiment, interim results, unwanted side effects), which for them constitutes an activity that is as yet
p.000029: unfamiliar. Other members, however, believe that this mission should not be entrusted to them.
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
...
Social / education
Searching for indicator educational:
(return to top)
p.000024: system, the local committees’ mission would simply be to check the feasibility of the planned research in the
p.000024: local context, and the ‘regional’ committees would be set up either by the local authority or on a
p.000024: voluntary basis in line with geographic or ideological criteria.
p.000024:
p.000024: For other members of the Advisory Committee, creating a new structure like this is not only superfluous, but also
p.000024: inadvisable.
p.000024: Superfluous, because Article 7 of Directive 2001/20/EC stipulates, in the event of multi- centre studies, that there
p.000024: shall be a procedure for the adoption of a single opinion per country. The other committees can limit the
p.000024: examination to ensuring that local conditions fulfil the requirements of the research. The ethics committee of a
p.000024: university hospital, for instance, could therefore give this sole opinion (moreover, this would virtually
p.000024: always be where the national coordinator of a study like this would be), without the need to create another structure.
p.000024: Moreover, the creation of a second structure would present two risks. First of all, distancing the ethical
p.000024: assessment structure from the situation on the ground will inevitably weaken the ethical debate in terms of
p.000024: proximity and favour the role of the bureaucratic control of ethics committees (assessment ‘on paper’) to
p.000024: the detriment of their educational and interactive role with the investigators within institutions; in addition,
p.000024: their role as regards the ethical aspects of hospital procedures will be weakened as their legal missions cover
p.000024: the same procedure, based on the same principles and often involve the same people. Finally, the creation of a second
p.000024: structure would lead to a haemorrhaging of competent people and financial resources to the new structures whereas these
p.000024: human and material resources are already limited and are better concentrated on existing ethics committees. These
p.000024: fulfil a substantial role that must be developed and supported financially, which is not always the case
p.000024: today. For these reasons of rationality and priority as regards objectives, it is essential to maintain the current
p.000024: structure while defining certain aspects more precisely: real means (secretariat, staff) must be
p.000024: allocated to existing ethics committees and a training programme must be gradually developed.
p.000024:
p.000024: As regards research that is not carried out in a hospital (for example research carried out by general practitioners)
p.000024: or research that is undertaken in an institution which does not have its own ethics committee (retirement homes, rest
p.000024: homes and care centres, etc.), the question is which ethics committee the researcher should submit his protocol to.
p.000024: Four possibilities can be considered:
p.000024: • firstly, the researcher can consult the ethics committee of his choice. Some members consider that this
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000002:
p.000002:
p.000002:
p.000002:
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p.000002:
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p.000002:
p.000002:
p.000002: Opinion no. 13 of 9 July 2001 on human experimentation
p.000002:
p.000002: Request for opinion of 12 November 1997
p.000002: from Pr. W. Betz, Chairman of the Medical Ethics Commission at the ‘Vlaams Huisartsen Instituut’ (Flemish institute of
p.000002: general practitioners)
p.000002:
p.000002: and
p.000002:
p.000002:
p.000002: Request for opinion of 8 June 1998
p.000002: from Dr. S. Schreiber, President of the Local Ethics Committee of the CHU Tivoli in La Louvière
p.000002:
p.000002:
p.000002:
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p.000002:
p.000002:
p.000002: Opinion no. 13 of 9 July 2001 – Final version
p.000002: 2
p.000002:
p.000002: CONTENTS
p.000002:
p.000002: A. Introduction
p.000002:
p.000002: B. The legitimacy of human experimentation
p.000002:
p.000002: 1. The Advisory Committee has noted the importance acquired since experimental medicine was defined in the late 19th
p.000002: century by biomedical experimentation on humans and its major impact on progress in medicine in the 20th century
p.000002: 2. Conflict of values linked to experimentation
p.000002: 3. The reference framework of ethics committees is based on four fundamental principles
p.000007: 7
p.000007: a. The principle of relevance
p.000007: b. The principle of scientific rigour
p.000007: c. The principle of ‘no harm’ or ‘primum non nocere’
p.000007: d. The principle of autonomy
p.000007: 4. Reflections and expansion: focus on the principle of justice
p.000007:
p.000007: C. What is the normative framework for human experimentation?
p.000007:
p.000007: 1. Ethics committees as assessment bodies
p.000007: 2. Harmonisation of legal standards and complementarity of deontological and legal rules – Advocates and opponents
p.000007: a. Arguing in favour of a normative polyphony
p.000007: b. Rejection of all legal formalism
p.000007: c. Requirements beyond the law
p.000007: d. Nevertheless, legal regulations are desirable, if not essential
p.000007: 3. A framework law
p.000007:
p.000007:
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p.000007:
p.000007: Opinion no. 13 of 9 July 2001 – Final version
p.000003: 3
p.000003:
p.000003: A. INTRODUCTION
p.000003:
p.000003:
p.000003: This opinion is issued further to a request dated 12 November 1997 from Professor Dr. W. BETZ, Chairman of the
p.000003: Medical Ethics Commission of the Vlaams Huisartsen Instituut – Flemish institute of general practitioners.
p.000003: This institute studies the research protocols carried out by family doctors. Professor Betz was concerned
p.000003: about certain investigators ‘shopping’ if a local ethics committee issued a negative opinion. He suggested a number
p.000003: of avenues for a solution, including the creation of a central register of projects regarding which
p.000003: requests have been submitted, or the establishment of a mandatory procedure for the exchange of information
p.000003: between ethics committees consulted successively by the researcher.
p.000003: The text of the request for an opinion was worded as follows:
p.000003:
p.000003: “I am contacting you in my capacity as Chairman of the Medical Ethics Committee of the V.H.I. (OM 071) regarding the
p.000003: following matter.
p.000003:
p.000003: Our committee regularly issues negative opinions on research projects considering, for example, that they do not
p.000003: contribute much scientific added value or have not been sufficiently well prepared. The authors of such
p.000003: projects therefore turn to ‘easy committees’ which do not take as much account of the ‘ethical reflection’ and
p.000003: therefore give the go-ahead after a fast procedure.
p.000003: In some cases, this second committee is nevertheless informed of the negative opinion of the first; consequently, I
p.000003: believe that it is necessary to establish a procedure for the mandatory exchange of data between committees. A central
p.000003: register of all projects for which a request has been submitted seems to me to be necessary.
p.000003: In this respect, two years ago I sent a letter to the National Council of the Order of Doctors which was supposed to
p.000003: monitor recognition and supervision. However, to date I have received no reply.
p.000003: Moreover, our Committee is of the opinion that a law on ‘human experimentation’ should regulate this matter
p.000003: exhaustively. The current system does not sufficiently guarantee patient protection [….]
p.000003:
p.000003: The request from Prof. Dr. W. Betz was deemed admissible by the Advisory Committee on bioethics (hereinafter: the
p.000003: Advisory Committee). Select committee 97/8 was set up with a view to drawing up a draft opinion
p.000003: concerning the general question of human experimentation. In fact, the Advisory Committee believed that the
p.000003: question posed should be expanded.
p.000003:
p.000003: The request for an opinion of 8 June 1998 from Dr. S. SCHREIBER, chairman of the local ethics committee
p.000003: of the CHU Tivoli in La Louvière, concerning ‘civil liability’ insurance in the event of harm caused during
p.000003: clinical trials on human subjects is also taken into consideration. This request is worded as follows:
p.000003:
p.000003: “Among the many ethical questions raised by the examination of clinical trials protocols, we are frequently
p.000003: confronted with the problem of insurance covering harm caused to patients who undergo these trials.
p.000003: This insurance, for which incidentally we require the certificate, usually covers civil liability. This implies that
p.000003: in order for compensation to be paid, not only must harm have been caused, but in addition an error must have been
p.000003: committed, and that there is a causal link to the harm. In addition, in our legislation, the burden of proof lies with
p.000003: the victim.
p.000003:
p.000003:
p.000003: In the absence of the existence of a joint compensation fund, it seems to us that a delicate situation arises where
p.000003: patients who are the subjects of clinical trials may be inadequately protected and insurance in the event of
p.000003: harm would be more suitable in the case of protocols for clinical studies.
p.000003: We think that this is a problem that concerns all local ethics committees and we are asking for the opinion of the
p.000003: Advisory Committee on Bioethics regarding the attitude to be adopted to safeguard our patients as well as possible.
p.000003: […]”.
p.000003:
p.000003: Opinion no. 13 of 9 July 2001 – Final version
p.000004: 4
p.000004:
p.000004: At its first meetings in the spring of 1998, the select committee held preliminary discussions on the basis of a
p.000004: certain number of discussion notes. At that time, its members decided to see their mission, initially, as a
p.000004: reflection on the ethical problem raised by human experimentation1 and the advisability and content of a
p.000004: normative framework in this area.
p.000004: It was in fact immediately decided to defer to another opinion the practical situations that require special
p.000004: precautions owing either to the vulnerability of the individual or to the impossibility of obtaining
p.000004: informed consent. This concerns, among other things but not exclusively, experiments on children, psychiatric
p.000004: patients and other incapable individuals, prisoners, elderly people living in homes, individuals more likely to be
p.000004: constrained (military personnel, police officers, students, laboratory staff, etc.), vulnerable groups
p.000004: (separate cultural communities, those in need, citizens of developing countries, etc.), pregnant or
p.000004: breastfeeding women (in view of the possible consequences for their unborn children), as well as studies where
p.000004: obtaining individual consent interferes with the research itself2.
p.000004: Similarly, the issue of healthy volunteers will not be covered here.
p.000004: The questions of research on embryos in vitro, material obtained during abortions and devitalised tissue
p.000004: and organs (products of operating theatres and cadavers) will not be dealt with in this opinion, either.
p.000004: The same applies for the questions raised by research into dossiers.
p.000004: Finally, the situation with regard to the issue of therapeutic innovation should be clarified. In many respects, this
p.000004: process differs from experimentation. It consist of treating a patient using a new method or a new medicinal
p.000004: product and its objectives do not differ from those of ordinary therapy: there is no need to draw up an experimental
p.000004: protocol, the patient is not a trial subject and ultimate aim of the treatment remains solely the patient himself and
p.000004: his personal well-being. In fact, what is involved here is the legitimacy of the innovative medical intervention. It
p.000004: has been decided that questions relating to therapeutic innovation as such will not be covered in this opinion.
p.000004:
p.000004: To sum up: the opinion concerns only adult and capable trial subjects.
p.000004:
p.000004: A more in-depth analysis of the issue is provided in the introductory report relating to the opinion.
p.000004:
p.000004:
p.000004: B. THE LEGITIMACY OF HUMAN EXPERIMENTATION
p.000004:
p.000004:
p.000004: 1. The Advisory Committee has noted the importance acquired since experimental medicine was defined in
p.000004: the late 19th century by biomedical experimentation on humans and its major impact on progress in medicine in the
p.000004: 20th century.
p.000004:
p.000004:
p.000004:
p.000004: 1 One question was repeatedly asked during the work of the select committee: how should this opinion be extended, in
p.000004: other words, what does it relate to precisely? Is it a matter of considering all forms of experimentation that involve
p.000004: human subjects, or only those which are medical or biomedical? While the initial requests of course relate to
p.000004: biomedical experimentation, the select committee nevertheless noted, immediately as of its introductory work on
p.000004: definitions (Chapter B of the introductory report) that it was led to consider wider aspects (psychological or social
p.000004: experiments in particular). At the same time, it showed a constant concern to precisely delimit the object of its
p.000004: reflections, aware that even limited to biomedical experimentation, this is vast and brings up a great many questions
p.000004: which would be worth considering specifically. This is why some members believed that it would be advisable to specify
p.000004: straight away that the opinion will relate to biomedical human experimentation, which does not prejudge a subsequent
p.000004: extension to other experimentation involving human subjects, on the basis of considerations which may be relevant for
p.000004: both. Irrespective of the choices made, there will inevitably still be borderline situations. The object of the
p.000004: experimentation, the parties carrying out the research and the place where it is undertaken can help clarify difficult
p.000004: situations.
p.000004: 2 The examples that illustrate this type of obstacle to obtaining consent are the famous experiment
p.000004: on submission to authority (Milgram experiment) popularised by the film “Mon Oncle d’Amerique” and the
p.000004: Semmelweiss experiment on the comparison of the incidence of puerperal fever in two delivery rooms in
p.000004: Budapest which led to the discover of the rules of asepsis.
p.000004: Opinion no. 13 of 9 July 2001 – Final version
p.000005: 5
p.000005:
p.000005: Without underestimating the philosophical difficulties posed by biomedical research, the Advisory Committee stresses
p.000005: the ethical legitimacy of experimentation and considers that those who take part in it render a major service to
p.000005: the community as a whole – and to those who are ill in particular – by enabling medical progress. Society
p.000005: owes them recognition.
p.000005:
p.000005: The legitimacy of human experimentation is closely linked to the acknowledged legitimacy of
p.000005: scientific medicine: it may even be said to depend on it. Today, the importance granted to
p.000005: evidence-based medicine or EBM, illustrates the success of this approach. In fact, experimentation
p.000005: understood to mean systematically testing assumptions by carrying out rigorously monitored and
p.000005: interpreted experiments constitutes the specific method of acquiring knowledge used for scientific medicine
p.000005: which, since the 19th century, has planned to establish its therapeutic basis as widely as possible on knowledge
p.000005: (theoretical or practical) that is validated by experiment.
p.000005:
p.000005: 2. Conflict of values linked to human experimentation
p.000005:
p.000005: Human experimentation is the scene of a conflict between the freedom to research, respect for human
p.000005: beings and the principles of beneficence and justice. This conflict comprises several aspects.
p.000005: Some members consider that by having recourse to human experimentation in order to provide a scientific basis for its
...
p.000005: individual taking part freely in research is not an object being manipulated to achieve ends that have nothing to
p.000005: do with him. Ideally, he is an individual who is cooperating, to a limited but effective extent, in improving medical
p.000005: therapeutics and refining scientific knowledge of the human being.
p.000005:
p.000005: Notwithstanding these two views, experimentation is the scene of tension between on the one hand the freedom to
p.000005: research and the therapeutic progress this gives rise to for the benefit of the community and, on the other
p.000005: hand, the respect and protection of individuals. We cannot accept the advantages brought by scientific medicine
p.000005: without at the same time admitting the methods and activities that make it possible to attain these advantages and
p.000005: which are far more fruitful in terms of progress in knowledge than the simple empirical trial and error
p.000005: approaches of previous centuries. Affirming the legitimacy of experimentation means accepting
p.000005: the tension inherent in all experimentation between values that are difficult to harmonise which
p.000005: will have to b
p.000005:
p.000005: 3 In Belgium, Royal Decree No 78 of 10 November 1967 on the exercising of the art of curing, the
p.000005: art of nursing, the paramedical professions and medical commissions (Moniteur belge, 14 November 1967), Article 1,
p.000005: gives legal form to this concern by assigning to the medical act a preventive, diagnostic or curative purpose.
p.000005:
p.000005: Opinion no. 13 of 9 July 2001 – Final version
p.000006: 6
p.000006:
p.000006: expressed as well as possible on a case-by-case basis. Ethics and the law both have a role to play in this respect,
p.000006: according to their own specific features. Through the rules they set out, in particular they have to watch over
p.000006: professional conscience in the face of the extension of activities involving medical experimentation.
p.000006:
p.000006: Finally, human experimentation raises the following question: how can we experiment while respecting the
p.000006: autonomy of the individuals involved and protecting them in their vulnerability? This general question in fact
p.000006: summarises several aspects which are worthy of attention and vigilance, in both ethical and in legal terms.
p.000006: The conflict relating to human experimentation cannot be reduced to an opposition between the freedom to
p.000006: research and the autonomy of the individual. It is also important to take into consideration
p.000006: beneficence and collective utility. The latter aspect can only be researched by taking into account a principle of
p.000006: justice that ensures both the fair distribution of the advantages and disadvantages of experiments conducted
p.000006: within populations and the setting up of structures that enable all citizens to have fair access to quality care.
p.000006: For more information, see Introductory Report, C., 1, 2 and 3.
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p.000006: Opinion no. 13 of 9 July 2001 – Final version
p.000007: 7
p.000007:
p.000007: 3. The reference framework of ethics committees is based on four fundamental principles
p.000007:
p.000007: a. THE PRINCIPLE OF RELEVANCE: does the response to the question behind the experiment hold out the
p.000007: possibility of progress in knowledge?
p.000007: b. THE PRINCIPLE OF SCIENTIFIC RIGOUR: the research must be carried out in an adequate scientific context
p.000007: using a rigorous methodology.
p.000007: c. THE PRINCIPLE OF ‘NO HARM’ OR ‘PRIMUM NON NOCERE’: the experiment must respect the condition of the subject and
p.000007: limit the risks incurred so as that they remain proportionate to the anticipated benefit.
p.000007: d. THE PRINCIPLE OF AUTONOMY: corresponds to the need to obtain the free and informed consent of the subject. It
p.000007: therefore supposes that the subject has the capacities of free thought and that the doctor has the capacities
p.000007: needed to provide clear information.
p.000007:
p.000007: 4. Reflections and expansion: focus on the principle of justice
p.000007:
p.000007: In the light of these principles – as is stipulated in point 2 above – at first glance the conflict of values
p.000007: inherent in human experimentation appears to be a dilemma between scientificity (principles a and b) and the
p.000007: protection of the autonomy and integrity of individuals (principles c and d). However, experimentation also aims
...
p.000007:
p.000007:
p.000007: C. WHAT IS THE NORMATIVE FRAMEWORK FOR HUMAN EXPERIMENTATION?
p.000007:
p.000007:
p.000007: Belgian law is incomplete as regards human experimentation.
p.000007: In addition to Belgian legislation, there are also European and international normative texts and deontological rules
p.000007: (see Introductory Report, D.).
p.000007:
p.000007: The Advisory Committee suggests:
p.000007: 1) setting up legally established local ethics committees as bodies for the assessment of human experimentation
p.000007: protocols, with clearly defined areas of competence;
p.000007: 2) harmonisation of national, European and international standards in the field of human experimentation and
p.000007: complementarity between the deontological rules and the legal rules;
p.000007: 3) a framework law containing legal rules on ethics committees, the rights and duties of
p.000007:
p.000007: 4 Among others: The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research,
p.000007: The Belmont Report, 1978; Council for International Organizations of Medical Sciences (CIOMS), in collab. with World
p.000007: Health Association (WHO), International Ethical Guidelines for Biomedical Research Involving Human Subjects, 1993, as
p.000007: well as: Conseil de recherches médicales du Canada, Conseil de recherché en sciences naturelles du Canada and Conseil
p.000007: de recherches en sciences sur l’homme du Canada, Code d’éthique de la recherché sur l’homme, 1997.
p.000007: Opinion no. 13 of 9 July 2001 – Final version
p.000008: 8
p.000008:
p.000008: everyone concerned, their liability and insurance.
p.000008:
p.000008: 1. Ethics committees as assessment bodies
p.000008:
p.000008: Ethics committees basically fulfil two roles: the application of principles that set standards in human
p.000008: experimentation and discussion of the problems raised by each individual case. From this point of view, ethics
p.000008: committees become the main forums for the regulation of clinical research. They thus offer the advantage of forming a
p.000008: flexible system that can be used to manage the ethical problems raised by human experimentation
p.000008: pragmatically but vigilantly while staying close to clinical reality.
p.000008:
p.000008: Analysing a research protocol involves examining and assessing the following elements:
p.000008: 1) legitimacy of the aim
p.000008: 2) proportionality of the means
p.000008: 3) qualification of investigators and the experimentation environment
p.000008: 4) free and informed consent.
p.000008: For additional information, see Introductory Report, F.
p.000008:
p.000008: When assessing the protocol, the role of the ethics committee is to keep a particular eye on the safety, autonomy,
p.000008: physical integrity, well-being and rights of the people who are taking part in a medical experiment, above and beyond
p.000008: the context of the general rules on civil liability. It also has to make sure that the agreements on
p.000008: funding reached between the sponsor and the investigator do not interfere with the independence of the investigator.
p.000008: For additional information, see Introductory Report, E.
p.000008:
p.000008: The ethics committee may not, under any circumstances, issue a positive opinion on the research protocol if it is not
p.000008: convinced that this actually meets each of these assessment criteria.
p.000008: According to Article 9 of European Directive 2001/20/EC of 4 April 2001 on the approximation of the
p.000008: laws, regulations and administrative provisions of the Member States relating to the implementation of good
p.000008: clinical practice in the conduct of clinical trials on medicinal products for human use (O.J. 1 May 2001), a
p.000008: clinical trial may not start until the ethics committee has issued a favourable opinion.
p.000008:
p.000008: Some members of the Advisory Committee believe that when the opinion of the ethics committee is negative, this must be
p.000008: binding for the investigator because they think that this is the only way to guarantee the safety of the trial subject.
p.000008:
p.000008: Other members believe that it is, of course, legitimate to require that all human experimentation
p.000008: protocols be submitted for assessment to local ethics committee, but on condition that this opinion is advisory and
p.000008: not binding (as is stipulated, moreover, by Article 70 ter of the act of 7 August 1987 on hospitals, inserted by
p.000008: Article 194 of the act of 25 January 1999 (Moniteur belge of 6 February 1999)). In fact, even if the
p.000008: reasons relating to protection of the trial subject are understandable, making a negative option binding5 has major
p.000008: disadvantages:
p.000008: 1) it could lead to the introduction of a power of censorship of the freedom to research: many major
p.000008: experiments in the history of medicine would not have been possible if a binding opinion from a ethics committee had
p.000008: been required;
p.000008: 2) it shifts the centre of liability for experimentation from the researcher to the ethics committee, the effect
p.000008: (paradoxically) being to weaken the civil and criminal liability of the researcher and correlatively to increase that
p.000008: of ethics committee members who thus risk being encouraged to issue ‘defensive’ opinions for fear of incurring
p.000008: liability, to the detriment of any hypothetical progress which the research project may permit.
p.000008: Again according to these members, protection of the trial subject could be guaranteed
p.000008:
p.000008:
p.000008: 5Because a positive opinion will never be binding, so it will never oblige an investigator to proceed with the
p.000008: experimentation.
p.000008: Opinion no. 13 of 9 July 2001 – Final version
p.000009: 9
p.000009:
p.000009: by the threefold obligation for the researcher:
p.000009: 1. to submit the research project to an ethics committee for assessment,
p.000009: 2. to note on the information document that the opinion given was, if appropriate, negative and
p.000009: 3. only to undertake the experimentation once insurance has been taken out.
p.000009:
p.000009: If the opinion is negative, however, the researcher is unlikely to find a hospital and scientific
p.000009: structure that will support his research project. Nevertheless, if only for reasons of principle he must be able to
p.000009: retain the possibility of ignoring the negative opinion of the ethics committee, while remaining aware that he is
p.000009: incurring serious personal legal liability.
p.000009: Incidentally, some of these same members point out that as a matter of principle, an opinion only has
p.000009: ethical value if it is not legally binding. The ethical process is based on dialogue; it is open and does not
p.000009: always lead to univocal conclusions. It specifically differs from the legal process which is imperative and
p.000009: univocal. If the two processes are confused, this risks not only reducing free scientific research, but also
p.000009: compromising the actual ethical nature of the assessment carried out by the committees of the research
p.000009: protocols submitted to them. And yet such ethical assessment is now more necessary than ever in a changing
p.000009: society.
p.000009: For these same reasons, it seems essential to these members to require ethics committee to hear the view of the
p.000009: investigator in a debate between both sides before issuing a negative opinion on the research project.
p.000009:
p.000009: By virtue of Good Clinical Practice (G.C.P.), the ethics committee is given responsibility for ongoing re-assessment:
p.000009: an ethics committee must stay regularly informed of the progress made in the practical application of a
p.000009: research protocol, at a frequency in proportion to the risk incurred by the subjects. Unlike the period
p.000009: of six months recommended by the G.C.P. directive, the Advisory Committee suggests at least annual follow-up. This
p.000009: obligation means that the ethics committee may take the initiative to question the researcher. The latter
p.000009: must, however, make sure that this re-assessment by the ethics committee is possible. He must also take the
p.000009: initiative to inform the ethics committee of any serious complication or new relevant data (positive or negative).
p.000009: The ethics committee has to re-assess a research protocol in the light of these new elements. It must also react to
p.000009: these new elements when the study is over.
p.000009: Nevertheless, some members of the Advisory Committee believe it is highly desirable that this follow-up
p.000009: mission should not be entrusted to ethics committees.
p.000009:
p.000009: 2. Harmonisation of legal standards and complementarity of deontological and legal rules – Advocates and opponents
p.000009:
...
p.000009:
p.000009: a. ARGUING IN FAVOUR OF A NORMATIVE POLYPHONY
p.000009:
p.000009: Here in Belgium, human experimentation is now underpinned by various standards, international medical ethics,
p.000009: deontology and Belgian law. Some people believe that this situation is characterised by a normative polyphony.
p.000009: The idea of normative polyphony refers to the collaboration of separate normative sets in that they are each
p.000009: prompted by a specific logic that corresponds to their own function. Medical ethics, as expressed in the international
p.000009: recommendations, and deontology aim to define the obligations of doctors so as to guarantee the quality of professional
p.000009: behaviour; the protection of the subjects is therefore only considered through this particular prism as a duty of the
p.000009: doctor. The law pursues a different objective: to organise relations between the parties concerned, taking into account
p.000009: their respective interests; the protection of the subjects is therefore not only a duty of the doctor, but is also
p.000009: linked to the recognition of rights that are specific to the subjects.
p.000009: Despite the apparent but deceptive similarity of the concepts invoked by these three normative sets, each
p.000009: of them tackles the questions from a specific angle which supplements the approach of the others. This is why
p.000009: the advocates of this option believe that it is important for the law to watch over the situation, since ultimately,
p.000009: its role is to
p.000009: Opinion no. 13 of 9 July 2001 – Final version
p.000010: 10
p.000010:
p.000010: ensure a harmonious normative polyphony, in other words it should not seek to protect people alone, but should
p.000010: rather promote the fact that other normative sets also contribute to this. This gives rise to the possibility
p.000010: of protecting people more effectively, precisely because this protection is considered from multiple points of view.
p.000010: In fact, the gaps in Belgian law as regards human experimentation are clear and need to be filled. From this point
p.000010: of view of a normative polyphony, the feeling is on the one hand that the law cannot provide for everything or
p.000010: cover everything and on the other that situations involving human experimentation harbour issues that only appear
p.000010: clearly to a professional conscience aware of the ethical aspects. This is why collaboration between normative sets,
p.000010: organised by law, is ultimately seen as the most satisfactory way of dealing with the complex problem of
p.000010: human experimentation.
p.000010:
p.000010: b. REJECTION OF ALL LEGAL FORMALISM
p.000010:
p.000010: However, unlike this ‘polyphony’, the current trend is leading to the introduction into law of rules of another kind
p.000010: (G.C.P. rules, rules of medical ethics or deontology). In the eyes of the advocates of the normative polyphony,
p.000010: this situation should be assessed in qualified terms. If fact, while the law has the advantage of being able to
p.000010: penalise failure to comply with the rules it sets out, it nevertheless only requires formal compliance with these
...
p.000010: activities require not only formal compliance but also a state of mind marked by attention to individuals, in
p.000010: particular when obtaining consent, and the ability to enter into and maintain a non-binding dialogue.
p.000010: Considering the relationship between the investigator and the trial subject as a partnership in
p.000010: fact presupposes qualities on a human level that go beyond the requirements that can be imposed by legal
p.000010: rules: having the willingness, on the part of the investigator, to discuss the research project in the context of
p.000010: personal contact with each trial subject, having the required communication skills, identifying the clinical
p.000010: picture of each participant in the trial and closely following their development as the experiment
p.000010: proceeds, continuing to openly and frankly inform the trial subject and, if need be, consulting and
p.000010: deliberating with him.
p.000010: The trial subject cannot, therefore, be an anonymous number in a series of participants. As in the doctor-patient
p.000010: relationship, he must have a face for the investigator: the latter’s concern for the well-being of the trial
p.000010: subject must equal his wish to expand his knowledge.
p.000010: Monitoring the quality of this state of mind means not only establishing a normative framework, but also
p.000010: – and urgently – mandatory training in human relations for investigators. The legal provision would therefore
p.000010: also have to cover this requirement.
p.000010:
p.000010: d. NEVERTHELESS, LEGAL REGULATIONS ARE DESIRABLE, IF NOT ESSENTIAL
p.000010:
p.000010: Opinion no. 13 of 9 July 2001 – Final version
p.000011: 11
p.000011:
p.000011: These observations and comments provoke a reaction among some certain members of the Advisory Committee who see
p.000011: here not only a radical criticism of the law – by highlighting its formalist dimension – but also a
p.000011: questioning of its efficacy. In response to the question of formalism, they stress that for them, right and morals are
p.000011: not separate normative disciplines. They believe that the rules of law are often replicas of moral rules and that it is
p.000011: therefore not correct to say that observing a legal rule is merely a formal factor that can never be morally
p.000011: experienced or accepted. By making compliance with legal rules mandatory, citizens can also be educated to
p.000011: adopt responsible social behaviour. An initial stage when it is mainly the constraint of the legal rule that is felt
p.000011: and perhaps criticised, is often succeeded by a period of habituation and finally moral integration of the rule
p.000011: (such as the obligation to wear seat belt, mandatory health inspections at school, etc.). These members
p.000011: consider it obvious that the law formulates what was previously seen to be advisable by everyone: the
p.000011: regulation of relationships between human beings.
p.000011:
p.000011: Radicalising their outlooks, they think it is utopian to believe that specific bioethical questions could
p.000011: be definitively resolved outside any legal context. In fact, the trial subject is the weak participant and
p.000011: therefore the one above all who must be protected. Once this subject suffers harm owing to any dysfunction of the
p.000011: experiment whatsoever, he will seek reparation. Practice shows that the party liable usually does not wish to be called
p.000011: into question on the basis of his liability and rarely offers reparation spontaneously. The
p.000011: only option is therefore for the victim to turn to the courts in the hope of finding reparation there. However,
p.000011: appealing to the courts is only possible if this is allowed by law, that is if the experimentation is regulated by law
p.000011: and not by medical ethics. It is therefore in the very best interest of the trial subject that there are rules of law,
p.000011: as a judge can only rule on the basis of these rules.
p.000011:
p.000011: Finally, the advocates of this point of view state that for them, legislation like this does not have to be
p.000011: exhaustive, or deal with the issue in full. The law can be confined to establishing the minimum rules of
p.000011: behaviour and procedures that nevertheless guarantee the protection of trial subjects. It should also be stated that a
p.000011: law does not, by its very nature, address individual cases but is enacted for a group of individual who are
p.000011: in a similar situation. Its formulation and its content are adapted to this ‘common denominator’
p.000011: approach. So even if the preferred option is regulations that are fairly complete and binding, this
p.000011: permits complementary standards, notably in the case in point decisions taken by ethics committees.
p.000011:
p.000011: 3. A framework law
p.000011:
p.000011: The Advisory Committee is of the opinion that a framework law concerning biomedical human experimentation is needed.
p.000011: This is a matter of converting the ethical legitimacy of this experimentation into a legality that puts an end to the
p.000011: current ambiguity of Belgian law in this area. The framework law must, of course, leave the necessary scope for an
p.000011: ethical debate.
p.000011:
p.000011: It is also a matter of specifying the rights and stating the responsibilities of each of the parties involved in order
p.000011: to give them appropriate protection. More specifically, the law must acknowledge the freedom of an individual to
p.000011: participate, under defined conditions, in biomedical experimentation and recall the right to respect
p.000011: for physical and psychological integrity. The individual must be informed of his rights and the guarantees provided
p.000011: for his protection and must be able to express free and informed consent, laid down in writing, prior to the
p.000011: experimentation. Throughout the process, the protection of confidential personal data must be guaranteed. Finally
p.000011: the law has to provide for and specify the rights of the individual to medical care and to compensation for harm
p.000011: in the event of prejudice resulting from his participation in the experiment.
p.000011:
p.000011: To conclude, the Advisory Committee believes that the ethics committee is the appropriate forum
p.000011: in which to study and carry out a prior assessment of the experimentation protocol, the central
p.000011: concern being the protection of the individual who is the subject of the experiment. The law must define the rules on
p.000011: the composition and functioning of the ethics committee, its funding and the training of its members. The
p.000011: Opinion no. 13 of 9 July 2001 – Final version
p.000012: 12
p.000012:
p.000012: ethics committee must be recognised by the authority following principles that guarantee its independence, particularly
p.000012: as regards any sponsors of the research.
p.000012:
p.000012: Some members of the Advisory Committee consider that biomedical human experimentation cannot be
p.000012: undertaken without a positive opinion from the ethics committee. Other members consider that it is
p.000012: essential for the opinion to remain advisory and not binding for the investigator, and that the trial
p.000012: subject should be informed of the conclusion reached further to the request for an opinion.
p.000012:
p.000012: Some members are in favour of a structure of local ethics committees as they exist in hospitals. In their view, this
p.000012: structure has the advantage of proximity to the work carried out in the field and close contact with the other mission
p.000012: of the ethics committee (advice on the ethical aspects of hospital practices), as well as protecting the ethical
p.000012: pluralism of our society.
p.000012: Other members come out in favour of a more centralised structure which would be devoted solely to
p.000012: assessment of research protocols. In their view, this structure has the advantage of greater independence in terms
p.000012: of the situation on the ground and the concentration of the multiple skills required to fulfil its
p.000012: assessment mission; finally, it would be easier for the authority to monitor such a structure. The local structures
p.000012: would take on the other task of ethics committees and remain responsible for the assessment of the local conditions for
p.000012: the fulfilment of the experiment (see Introductory Report, E., 4., c).
p.000012:
p.000012: The Advisory Committee is pleased to note, on the basis of the available data, that human experimentation
p.000012: rarely causes harm. It nevertheless believes that it is necessary to protect the trial subject and therefore recommends
p.000012: that the investigator be obliged to compensate in full anyone who may suffer harm due to the investigator,
p.000012: even in the absence of error, unless the harm is due to a cause that is not related to the experiment. Insurance must
p.000012: be taken out to cover those who take part in experiments. The law must ensure that this insurance provides sufficient
p.000012: and appropriate cover for those who lend themselves to such experiments. All these measures are intended to prevent
p.000012: individuals who suffer any harm from having to bear the weight of the procedure whereas they are undertaking an act of
p.000012: solidarity for the benefit of the community.
p.000012:
p.000012: The Advisory Committee stresses that the scope of this opinion is general and that it will be supplemented by
p.000012: specific opinions on situations that call for adjustments and additional precautions, such as
p.000012: experiments involving those who are incapable, individuals belonging to vulnerable groups or healthy
p.000012: volunteers.
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p.000012: Opinion no. 13 of 9 July 2001 – Final version
p.000013: 13
p.000013:
p.000013: The opinion was prepared in select committee 97/8, consisting of*:
p.000013:
p.000013:
p.000013: Joint chairpersons
p.000013:
p.000013: M. Bogaert
p.000013:
p.000013: Y. Galloy
p.000013:
p.000013: Joint reporters
p.000013:
p.000013: M.L. Delfosse (2000)
p.000013:
p.000013: E. Guldix
p.000013:
p.000013: Members
p.000013:
p.000013: M. Abramowicz ('96- '99)
p.000013: M. Baum
p.000013: P. Devroey
p.000013: X. Dijon (resigned '98)
p.000013: I. Liebaers ('96-'99)
p.000013: J.N. Missa (2000)
p.000013: H. Nijs
p.000013: G. Sokal ('96-'99)
p.000013: M. Somville ('96-'99)
p.000013: J. Stiennon (resigned '99)
p.000013: F. Van Neste
p.000013:
p.000013: Member of the Bureau
p.000013: Y. Englert
p.000013:
p.000013:
p.000013:
p.000013: Member of the secretariaat
p.000013:
p.000013: E. Morbé
p.000013:
p.000013:
p.000013: Permanent experts
p.000013:
p.000013: • Ms M.L. Delfosse (1996-1999), philosopher, Facultes universitaires Notre-Dame de la Paix-Faculte de
p.000013: droit, and CIDES, Namur.
p.000013: • Ms I. Liebaers (2000), lecturer, Centrum Medische Genetica, AZ-VUB, Brussels.
p.000013: • Mr J.N. Missa (1996-1999), philosopher, CRIB, director of the Institut de Philosophie at the ULB, Brussels.
p.000013:
p.000013: The working documents of select committee 97/8 – request for opinion, personal contributions from members,
p.000013: minutes of the meetings, documents consulted – are stored as Annexes 97/8 at the Committee’s documentation centre,
p.000013: where they may be consulted and copies.
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: * Some members took part in the work of the select committee during the Committee’s two terms of
p.000013: office (1996-1999 and 2000). The length of the term is indicated next to the name of members who took part in the work
p.000013: of the committee during a single term.
p.000013:
p.000013: Opinion no. 13 of 9 July 2001 – Final version
p.000014: 14
p.000014:
p.000014: INTRODUCTORY REPORT FOR OPINION No 13 of 9 July 2001 on human experimentation
p.000014:
p.000014:
p.000014: CONTENTS
p.000014:
p.000014: A. Objectives and method
p.000014: B. Definitions
p.000014: C. Medical-scientific research on humans – Ethical and legal problems
p.000014: 1. Legitimacy based on efficacy
p.000014: 2. Care and research
p.000014: 3. The cultural context
p.000014: 4. Problems
p.000014: a. A question of methodology
p.000014: b. Examining ethical requirements – methodology
p.000014: c. The link between autonomy and vulnerability
p.000014: d. Partnership
p.000014: e. Consent
p.000014: f. Insurance
p.000014: g. Should all experimentation protocols be submitted for assessment of by an ethics committee?
p.000014: D. The current normative framework
p.000014: E. Ethics committees
p.000014: 1. Composition
p.000014: 2. Independence
p.000014: 3. Liability and insurance
p.000014: 4. Options to be taken
p.000014: a. Need for an advisory or a binding opinion?
p.000014: b. Professionalisation of ethics committees?
p.000014: c. Restructuring ethics committees to form local committees and ‘regional’ committees?
p.000014: d. An appeal structure
p.000014: e. Forum shopping
p.000014: F. Ethical assessment of an experimental protocol – Procedures
p.000014: 1. The ethical legitimacy of the aim
p.000014: a. The scientific interest of the project
p.000014: b. Drawing up an adequate protocol
p.000014: c. The existence of prerequisites
p.000014: 2. Proportionality of means
p.000014: 3. Qualification of the investigators and the experimentation environment
p.000014: 4. Free and informed consent
p.000014: a. Prior information, essential for informed consent
p.000014: b. Obtaining consent
p.000014: 5. Conclusion
p.000014:
p.000014: A. OBJECTIVES AND METHOD
p.000014:
p.000014: Ethical reflection on a given activity (in this case, human experimentation) involves thinking about the objectives of
p.000014: this activity and studying the extent to which these objectives benefit human beings or not: what advantages and hopes
p.000014: do the experiments bring, but what are the risks? (Part C, below). In this way, we can form an idea of the values we
p.000014: want to achieve.
p.000014:
p.000014: By analysing objectives and values, it is possible to determine our expectations as regards those involved in the
p.000014: experimentation, the attitudes needed and ethical requirements that this type of activity should fulfil.
p.000014:
p.000014: Examining attitudes and requirements will result in a debate on the issue of whether a normative
p.000014: framework relating to human experimentation is desirable and even necessary (Part E). This normative
p.000014: framework, made up of ethical, deontological and legal rules, may provide indications on how to proceed when carrying
p.000014: out human experimentation so as to
p.000014: Opinion no. 13 of 9 July 2001 – Final version
p.000015: 15
p.000015:
p.000015: guarantee its ethical quality.
p.000015:
p.000015: The debate on a normative framework seeks to fulfil a twofold objective: on the one hand, to make clear what are the
p.000015: ethical standards relating to the experimentation regarding which a consensus can be reached within the Advisory
p.000015: Committee; on the other hand, to indicate the extent to which the ethical requirements and standards to be
p.000015: met by the various players have to be established by legal rules.
p.000015:
p.000015:
p.000015: B. DEFINITIONS
p.000015:
p.000015: Ethical reflections, the analysis of objectives and values and the formulation of standards for a specific activity
p.000015: assume the use of clear and correct concepts.
p.000015: When establishing its own key concepts, the Advisory Committee took inspiration from the following:
p.000015:
p.000015: 1. the Declaration of Helsinki adopted by the World Medical Association in June 1964 (amended in
p.000015: Tokyo in October 1983, then in Hong Kong in September 1989, in Somerset West (Republic of South Africa) in
p.000015: October 1996 and finally in Edinburgh in October 2000),
p.000015: 2. the Dictionnaire Permanent de Bioethique, Ed. Legislatives, Montrouge, France,
p.000015: 3. the Encyclopedia of Applied Ethics, Editor CHADWICK, R., 4 volumes, Academic Press, USA, 1998
p.000015: 4. the Guidelines for Good Clinical Practice (G.C.P.) of the International Conference on
p.000015: Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH),
p.000015: 5. European Directive 2001/20/EC of 4 April 2001 on the approximation of the laws, regulations and
p.000015: administrative provisions of the Member States relating to the implementation of good clinical practice in the
p.000015: conduct of clinical trials on medicinal products for human use (O.J. 1 May 2001), and
p.000015: 6. Article ATLAN, H., “Distinctions necessaires: l’innovation therapeutique, l’expérimentation sur
p.000015: l’adulte, l’expérimentation sur l’embryon”, in the collective work “Expérimentation biomédicale et Droits de
p.000015: l’Homme”, PUF, Paris, 1988.
p.000015:
p.000015: The central concept is that of experimentation.
p.000015:
p.000015: Experimenting means submitting to a scientific test. The researcher starts from an assumption and
p.000015: wants to see whether, when confronted with the facts, this assumption is confirmed or invalidated.
p.000015: The objective of experimentation is the acquisition of general knowledge that is beneficial to the community and to
p.000015: humanity. The means used to achieve this objective is the experimental strategy.
p.000015: This report is confined to human experimentation: this is referred to by the terms:
p.000015: experimentation subject, trial subject or subject.
p.000015: It was decided to defer until a subsequent examination the practical situations that require special precautions
p.000015: owing either to the vulnerability of individual or the impossibility of obtaining informed consent, as
p.000015: expressed in the opinion.
p.000015:
p.000015: All experimentation in the medical field pursues a cognitive objective, as it always aims to acquire new knowledge.
p.000015: Consequently, there is always a cognitive objective alongside any benefit for the trial subject.
p.000015: However, some members of the Advisory Committee deem it useful to recall the distinction often made between
p.000015: cognitive experimentation, non-therapeutic experimentation and therapeutic experimentation.
p.000015: The sole aim of cognitive experimentation is to improve the state of knowledge and it is not, in principle, of any
p.000015: immediate interest for the trial subjects.
p.000015: Non-therapeutic experimentation has no therapeutic objective as regards the trial subjects and is therefore
p.000015: ultimately synonymous with cognitive experimentation. In this case, the trial subjects are often (but not
p.000015: always) volunteers in good health.
p.000015: Opinion no. 13 of 9 July 2001 – Final version
p.000016: 16
p.000016:
p.000016: Therapeutic experimentation aims to advance scientific knowledge by testing a treatment, diagnostic or prevention
p.000016: process on individuals who are likely, at the same time, to benefit directly in terms of their state of health.
p.000016: Other members reject these distinctions: they stress that as the objective of experimentation is always advance
p.000016: knowledge, all experiments are for cognitive purposes5. The "therapeutic- cognitive" distinction will not be discussed
p.000016: any further here.
p.000016:
p.000016: Therapeutic innovation (also known as new therapy or experimental therapy) is not experimentation. It
p.000016: involves treating an individual patient using a new method or a new medicinal product and its objectives are
p.000016: no different from those of ordinary therapy: it is not necessary to draw up an experimental protocol, the
p.000016: patient is not a trial subject and the ultimate aim of the treatment remains exclusively the patient himself and
p.000016: his personal well- being. In fact, the question here concerns the legitimacy of the medical intervention.
p.000016:
p.000016: The Advisory Committee feels it is important to keep in mind the successive phases of biomedical
p.000016: experimentation concerning potential medicinal substances as they show in exemplary fashion the complexity
p.000016: of an experimentation procedure. They thus make it possible to be aware of the ethical and legal problems that
p.000016: arise.
p.000016:
p.000016: This type of experimentation begins with laboratory studies, for example in the form of trials on animals, which in
...
p.000016: enable better knowledge of the product: the possible association with other therapies, the discovery of new actions,
p.000016: the rare or belated side effects, etc.
p.000016:
p.000016: It should be remembered that the concept of human experimentation is far broader than that of
p.000016: pharmaco-therapeutic experimentation. Without claiming to be exhaustive, it includes the fields of physiology and
p.000016: physiopathology; it may also concern screening and diagnosis techniques, or involve the assessment of new
p.000016: devices or non-medicinal treatments: new techniques, medical appliances, psychotherapy, for instance.
p.000016:
p.000016: In addition to the principle concept of experimentation, the following key concepts also require
p.000016: explanation.
p.000016:
p.000016: The trial subject is the person who, alone or as part of a group, takes part in the experiment
p.000016:
p.000016: 5 These members consider that the distinction between therapeutic experimentation and non-therapeutic
p.000016: experimentation is ultimately not decisive because in both cases, since it is a matter of
p.000016: experimentation, the cognitive objective takes precedence. From this point of view, a therapeutic objective
p.000016: which is added to the cognitive objective of an experiment can only ever be considered a secondary objective; under no
p.000016: circumstances does it annul or attenuate the experimental (and therefore primarily cognitive) nature of
p.000016: the procedure undertaken.
p.000016: Opinion no. 13 of 9 July 2001 – Final version
p.000017: 17
p.000017:
p.000017: and whose organism or mind is the subject of the research.
p.000017:
p.000017: The experimenter or investigator is the person in charge of conducting the clinical study. When the study is
p.000017: carried out by a team of people, an investigator is the head or leader of this team, in charge of the team as a whole.
p.000017: He is referred to as the principal investigator.
p.000017:
p.000017: The sponsor or body subsidising the study is the person, the company, the institution or the body that takes
p.000017: responsibility for devising, managing and funding the clinical study.
p.000017:
p.000017: The experimental protocol is a document that describes, in particular, the objectives, the procedure, the
p.000017: methodology, the statistical elements and the organisation of the study. The experimental protocol also usually
p.000017: explains the foundations of and justifications for the study, even though this information may also appear in
p.000017: other documents to which reference is made in the experimental protocol.
p.000017:
p.000017: A placebo is a tablet, an injection or a treatment which the trial subject believes will have an effect (positive or
p.000017: negative) on his state of health and which, owing to this conviction on the part of the person concerned, can actually
p.000017: have such an effect, but which the investigator is convinced is inert vis-à-vis the state of the trial subject.
p.000017:
p.000017: When, in the context of any experiment during which a treatment is compared to an acknowledged existing
...
p.000017: study. The experiment is single blind when only the trial subjects are not informed; it is double blind) when the
p.000017: investigator, his team, the supervisor and, in some cases, the data analyst or analysts are also unaware which subject
p.000017: is given which treatment.
p.000017:
p.000017: Basic research is research during which phenomena are studied with a view to improving scientific knowledge,
p.000017: but without any direct intention of applying this knowledge in practice.
p.000017:
p.000017: Applied research, on the other hand, involves experimentation where the objective is to apply the
p.000017: scientific knowledge acquired to practical situations such as illnesses.
p.000017:
p.000017: Randomisation is the use of chance to determine the allocation of trial subjects to treatment or control groups; the
p.000017: aim here is to reduce bias which may distort the conclusions.
p.000017:
p.000017: The control treatment is the better medical treatment or the usual medical treatment for a patient or, for instance if
p.000017: there is no such treatment, the placebo treatment with which the experimental treatment is being compared.
p.000017:
p.000017: Bias is the term used if a systematic error is observed in the experimental protocol that is likely to have led to
p.000017: distorted conclusions.
p.000017:
p.000017: An experimentation protocol must be submitted to a local ethics committee for an opinion. A local ethics committee is
p.000017: understood here to refer to the local ethics committees instituted by Article 70 ter of the act of 7 August 1987 on
p.000017: hospitals (inserted by Article 194 of the act of 25 January 1999, Moniteur belge (Belgian official journal) of
p.000017: 6 February 1999). The Advisory Committee points out that, as regards its advisory mission, the local
p.000017: ethics committee has a twofold task of ‘assessment and supervision of the research’.
p.000017: In the context of this report, the term used will be ‘ethics committee’.
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Opinion no. 13 of 9 July 2001 – Final version
p.000018: 18
p.000018:
p.000018: C. MEDICAL-SCIENTIFIC RESEARCH ON HUMANS – ETHICAL AND LEGAL PROBLEMS
p.000018:
p.000018: 1. 1. LEGITIMACY BASED ON EFFICACY
p.000018:
p.000018: The history of experimentation in medicine coincides with the gradual learning of how to experiment on
p.000018: human subjects appropriately, both in terms of methodology and from an ethical point of view. The use of human
p.000018: experimentation is only justified in cases of clinical uncertainty.
p.000018: Little by little, experimental methods have become more refined: comparative experiment, experimental plan,
p.000018: randomisation of patients assigned to the ‘treated’ group and the ‘control’ group, use of placebos,
p.000018: double-blind method, statistical calculations, etc. These experiments, properly conducted scientifically, are
p.000018: far more fruitful in terms of advancing knowledge than the simple empirical trial and error approaches of
p.000018: previous centuries. We therefore have a duty to experiment in order to provide patients with better knowledge and
p.000018: better treatments.
p.000018:
p.000018: 2. CARE AND RESEARCH
p.000018:
p.000018: Experimentation radically transforms medicine. Medicine itself is no longer seen exclusively as the art of curing. The
p.000018: aim is for this art, which remains its main objective and nature, to be able to rely on scientific knowledge,
p.000018: acquired through experimentation, of the human body, its illnesses, and diagnostic and therapeutic means. By doing
p.000018: so, it is divided into two fields of activity: care and research.
p.000018: These differ from one another in the immediate objectives pursued: care on the one hand, contribution to scientific
...
p.000018: induced by the pursuit of different objectives. The important thing to remember is that ‘good’ scientific
p.000018: experimentation presupposes strict compliance with experimentation plan drawn up beforehand, whereas the act of
p.000018: experimental care requires constant adjustment to the needs of the patient.
p.000018: Separate procedures have to be planned with regard to ethics, deontology and the law, as they involve specific
p.000018: modalities in the relationship with patients, as with individuals in good health.
p.000018:
p.000018: The distinction between care and research is difficult to establish for a number of reasons. The procedures relating
p.000018: to the one or the other are indiscernible in material terms: same players, same places, often the same acts
p.000018: and sometimes the search for an effect in both cases. They are all marked by uncertainty; moreover in both cases, the
p.000018: term used is trial. They are very closely intertwined: practice stimulates and extends research. Finally,
p.000018: they share an ultimate objective: to improve knowledge, relieve suffering and restore health.
p.000018:
p.000018: The difficulty of establishing this distinction leads to the risk of concealing it behind the ultimate
p.000018: therapeutic objective, which is common to all medical activities. This risk is all the greater as the doctor is
p.000018: obliged to provide care "in line with current scientific data". Consequently, from his point of view,
p.000018: there is a constant exchange between care and
p.000018: Opinion no. 13 of 9 July 2001 – Final version
p.000019: 19
p.000019:
p.000019: research, or even a continuum: experimentation appears as the most rigorous means of acquiring experience,
p.000019: of becoming an experienced doctor, that is a doctor who has practised a great deal and has learnt lessons from his
p.000019: practising6.
p.000019:
p.000019: If doctors sense a close connection between care and research, this results from the collaboration
p.000019: between activities with separate epistemological statuses which, for this reason, involve specific modalities
p.000019: as regards the relationship with patients, when they are also trial subjects.
p.000019: Maintaining the distinction between care and research is therefore vitally important and makes it possible
p.000019: to avoid unsound compromises in both epistemological and moral terms. This does not mean, however, that the
p.000019: qualities required when exercising either of these activities are mutually exclusive. For instance, the
p.000019: attention paid to people – which is expected to be of paramount importance in the context of care – must
p.000019: also underlie and motivate experimental activities even if, in this context, it has to be combined with and often be
p.000019: overshadowed by the requirements of clinical research. However, being overshadowed does not mean disappearing.
p.000019: It means being removed from view, while remaining present. Conversely, care given without scientific competence is
p.000019: unacceptable in every respect.
p.000019:
p.000019:
p.000019: 3. THE CULTURAL CONTEXT
p.000019:
p.000019: Current consideration of human experimentation is taking place in a cultural context marked by the tension between the
p.000019: affirmation of principles expressing the acknowledged value of individuals as such (human rights) on the on one hand
p.000019: and principles that link the morality of an action to a rational calculation of utility and emphasise the
p.000019: collective good on the other. Excessive preference for the common good could lead to neglect of the rights of the
p.000019: individual; an absolutist view of the rights of the individual could result in hindering scientific
p.000019: progress and subsequently, the common good.
p.000019:
p.000019: As regards human experimentation, this situation fosters confusion between the interest of the patient, social
p.000019: utility and well-being through science. It also supports two types of simplistic approaches to questions:
p.000019: scientism and the rational calculation of usefulness. In response, there is a need for vigilance, ethically and
p.000019: legally, so as to avoid inconsistency between the idealistic invocation of principles and pragmatism
p.000019: which, when it becomes cynical, can lead to mercantilism. This is why it is important to question the
p.000019: normative framework of experimentation which gradually came into being during the 20th century, taking care
p.000019: to ensure that the prevailing cultural context does not affect the interpretation of the principles it sets out.
p.000019:
p.000019:
p.000019: 4. PROBLEMS
p.000019:
p.000019: The basic principles on which all human experimentation is based – as set out in the attached opinion,
p.000019: that is the principles of relevance, scientific rigour, ‘no harm’, autonomy and justice – raise a certain number of
p.000019: questions.
p.000019:
p.000019: a. A QUESTION OF METHODOLOGY
p.000019:
p.000019: Some members of the Advisory Committee believe it is essential not to look at questions raised by human experimentation
p.000019: from a normative point of view (solely in the light of the principles mentioned above), but again to take as a
p.000019: basis the description of situations that could lead everyone to question again the limits of the principles on
p.000019: which their ethical judgements are based. What should we so, for example when faced with patients, such as
p.000019: certain AIDS sufferers, who want to take part in an experiment despite the risks of which they have been informed? This
p.000019: situation leads to reconsideration of the link to be established between autonomy, vulnerability and acceptable
p.000019: risk-benefit ratio.
p.000019:
p.000019:
p.000019: 6 Cf. in this respect: KENIS, Y., "Expérimentation, recherche, soins. L'expérience d'un cancerologue", in
p.000019: Le devoir d'experimenter, texts compiled by J.-N. Missa, coll. Sciences, éthiques, sociétés, Brussels, De
p.000019: Boeck University, 1996. p. 80-84.
p.000019: Opinion no. 13 of 9 July 2001 – Final version
p.000020: 20
p.000020:
p.000020: b. EXAMINING ETHICAL REQUIREMENTS - METHODOLOGY
p.000020:
p.000020: Most texts on medical ethics and deontology put forward a series of principles which are based on different ethical
p.000020: outlooks, without suggesting a link between them. This situation may lead to excesses when one of these
p.000020: principles is considered to be the sole determinant, or when the ethical interpretation of the basis for this principle
p.000020: leads to a distorted interpretation of others. To overcome this difficulty, it would be advisable to suggest a
p.000020: methodology like that now put forward by certain texts7, and accompany it with this rule: any condition
p.000020: not met releases the ethics committee from having to examine the following conditions; only protocols for which
p.000020: all the conditions examined, in order, have been given a positive assessment can be granted a favourable opinion.
p.000020:
p.000020: c. THE LINK BETWEEN AUTONOMY AND VULNERABILITY
p.000020:
p.000020: In addition to the principle of autonomy, it is also important to take account of a principle of
p.000020: vulnerability which not only expresses the condition of all individuals, but also requires particular attention
p.000020: when the experimentation concerns those who are weaker, such as those who are ill, children, the mentally
p.000020: disabled, the elderly, people in institutions or suffering from neuralgic disorders. So when an experiment involves
p.000020: those who are ill, the basic question becomes that of the link to be established between the risk accepted by the
p.000020: patient (autonomy) and the benefits the latter expects. The link between autonomy and vulnerability is
p.000020: particularly acute when experimentation is suggested as the last chance of a cure for a patient who is often
p.000020: distressed.
p.000020:
p.000020: d. PARTNERSHIP
p.000020:
...
p.000020: these normative sets all contain provisions that indicate a tendency to protect individuals, irrespective of
p.000020: any wish they may express. While consent must not be regarded as sacred, considered to be the sole expression of an
p.000020: individual’s autonomy – which itself is wrongly identified with the dignity of human beings – it nevertheless plays
p.000020: a central role in a view that enhances the value of partnership. It is, however, important to stress
p.000020: that irrespective of the situation as regards standards, ethics committees remain vigilant regarding related
p.000020: questions.
p.000020:
p.000020: f. INSURANCE
p.000020:
p.000020: Whatever the causes and provided it relates to the experiment, any harm suffered by trial subjects, patients or healthy
p.000020: volunteers must be covered by insurance.
p.000020: According to Article 6.3 i) of European Directive 2001/20 EC of 4 April 2001 (O.J. 1 May 2001), ethics committees must
p.000020: ensure that the experimentation is covered by insurance
p.000020:
p.000020: 7 Cf. in particular: CIOMS, International Ethical Guidelines for Biomedical Research Involving Human
p.000020: Subjects, 1993, Guideline 14, Commentary, p. 38-39.
p.000020: Opinion no. 13 of 9 July 2001 – Final version
p.000021: 21
p.000021:
p.000021: and check the clauses of this insurance.
p.000021:
p.000021: g. SHOULD ALL EXPERIMENTATION PROTOCOLS BE SUBMITTED FOR ASSESSMENT BY AN ETHICS COMMITTEE?
p.000021:
p.000021: The main aim of the rule underlying this question is to provide protection for those involved. However,
p.000021: this objective cannot be achieved. In fact, the cumbersome nature of the administrative procedure can lead to the
p.000021: planned medical activity being considered a therapeutic innovation rather than an experiment. Moreover, while the
p.000021: problem that the submission of experimentation protocols to the ethics committee is intended to resolve is that of
p.000021: the risks involved, there are many risk situations which are not collectively assessed if the doctors
p.000021: confine themselves to formal compliance with the requirements. This demonstrates the benefit of increasing
p.000021: awareness of ethics: it enables a more qualified assessment of the stakes for the various parties involved. It
p.000021: should also make it possible to avoid the situation in which always striving to protect people better, the
p.000021: regulations become ever more extensive, so that they weigh increasingly heavily and consequently give rise
p.000021: to strategies designed to avoid them.
p.000021: Some people respond that everything that does not strictly benefit the patient must be assessed. But the concept of
...
p.000021: whereas until now they have escaped because they are assimilated to care. From this point of view, it would however
p.000021: be advisable to monitor compliance with the information and consent requirements.
p.000021:
p.000021:
p.000021: 2. D. THE CURRENT NORMATIVE FRAMEWORK
p.000021:
p.000021: The legitimacy of experimentation activities is not provided for in Royal Decree No 78 of 10 November 1967 on the
p.000021: exercising of the art of curing, nursing, paramedical professions and medical commissions (Moniteur belge of 14
p.000021: November 1967), but these activities are expressly required elsewhere (act of 25 March 1964 on medicinal products
p.000021: (Moniteur belge of 17 April 1964), Royal Decree of 3 July 1969 on the registration of medicinal products (Moniteur
p.000021: belge of 10 July 1969)).
p.000021:
p.000021: Furthermore, it should be noted that the European Directive on the registration of medicinal products (Commission
p.000021: Directive 91/507/EEC of 19 July 1991) led to the integration into Belgian law of the concept of ‘good clinical
p.000021: practice’ (G.C.P.), including reference to the World Medical Association Declaration of Helsinki (Royal
p.000021: Decree of 22 September 1992 amending the Royal Decree of 16 September 1985 on the standards and protocols
p.000021: applicable to trials on medicinal products for human use (Moniteur belge of 5 December 1992)). Finally, the Medical
p.000021: Deontology Code of the National Council of the Order of Doctors of 1 March 1993, imposes on doctors deontological
p.000021: principles and recourse to the opinion of an independent ethics committee.
p.000021:
p.000021: Article 70 ter of the act on les hospitals, included in this act by Article 194 of the act of 25 January 1999 (Moniteur
p.000021: belge of 6 February 1999) now established a legal basis for local committees by stating that “all hospitals
p.000021: must have a local ethics committee” and determining their missions; according to an annulment decree from
p.000021: the Court of Arbitration of 31 October 2000, these are as follows:
p.000021: Opinion no. 13 of 9 July 2001 – Final version
p.000022: 22
p.000022:
p.000022: “1° a mission to provide support and advice concerning the ethical aspects of practical hospital care;
p.000022: 2° …;
p.000022: 3° an advisory function relating to all human experimentation protocols and human reproductive material”.
p.000022:
p.000022: These standards may, admittedly be considered inadequate. In practice, they are supplemented by the
p.000022: provisions of ‘good clinical practice’, the Declaration of Helsinki and the deontological rules.
p.000022: Moreover, human experimentation is dealt with by the Council of Europe Convention on Human Rights and Biomedicine,
p.000022: Oviedo, 4 April 1997.
p.000022: It is also worth noting in this context the European Directive 2001/20/EC of 4 April 2001 on the approximation of the
p.000022: laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical
p.000022: practice in the conduct of clinical trials on medicinal products for human use (O.J. 1 May 2001).
p.000022:
p.000022:
p.000022: 3. E. ETHICS COMMITTEES
p.000022:
p.000022: The ethics committee procedure has one characteristic whose importance must be stressed. In fact, they are based on a
p.000022: collegial and pluri-disciplinary approach and they lie between the investigator and the trial subject, unlike the
p.000022: singular colloquium between the doctor and his patient, as their mission is to assess research protocol with regard to
p.000022: bioethical standards. They have the task of monitoring the application of the five principles set out in C.4 above and
...
p.000022:
p.000022:
p.000022: 1. COMPOSITION
p.000022:
p.000022: The ethics committee must be composed of a reasonable number of members who together have the qualifications and
p.000022: the experience required to be able to judge and assess the scientific, medical, ethical and legal
p.000022: aspects of a research protocol involving human experimentation.
p.000022:
p.000022:
p.000022: 2. INDEPENDENCE
p.000022:
p.000022: The ethics committee and each of its members must be able to carry out their mission successfully in
p.000022: total independence, whether this be in respect of the sponsor of the research, the researcher or the research
p.000022: institute, for example.
p.000022: The procedure for appointment members must guarantee this independence.
p.000022: In order that this ethics committee can fulfil its missions successfully as it should, its functioning
p.000022: must be funded in a manner that guarantees its independence in respect of the sponsor, the research institute and the
p.000022: researcher. The ethics committee must, moreover, render account of the use made of these financial resources.
p.000022: The Advisory Committee believes that ethics committees set up within the pharmaceutical industry would not fulfil the
p.000022: independence criteria set by both medical deontology and legal requirements.
p.000022:
p.000022:
p.000022: 3. LIABILITY AND INSURANCE
p.000022:
p.000022: The Advisory Committee believes that by giving its opinion on the ethical nature of an experimentation
p.000022: protocol, as on the other mission entrusted to it by Article 70 ter of the act of 7 August 1987 on hospitals, an ethics
p.000022: committee does not incur liability either on its own account or as regards its members because its opinion is
p.000022: neither a directive nor an
p.000022: Opinion no. 13 of 9 July 2001 – Final version
p.000023: 23
p.000023:
p.000023: authorisation and moreover, it is not carrying out the experimentation itself. Nevertheless, the Advisory Committee
p.000023: recommends that the hospital should take out adequate insurance to cover the members of the ethics committee for the
p.000023: consequences of any lawsuits.
p.000023:
p.000023:
p.000023: 4. OPTIONS TO BE TAKEN
p.000023:
p.000023: a. NEED FOR AN ADVISORY OR A BINDING OPINION?
p.000023:
p.000023: The principle whereby a research protocol should be given a positive opinion from an ethics committee, the monitoring
p.000023: framework (assessment criteria) and the assessment structure (missions and composition) are taken from various
p.000023: international documents:
p.000023: - ICH guidelines,
p.000023: - Directive 2001/20/EC of 4 April 2001 on the
p.000023: approximation of the laws, regulations and administrative provisions of the Member States relating to the
p.000023: implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
p.000023: (O.J. 1 May 2001),
p.000023: - the Council of Europe Convention on Human Rights and Biomedicine,
p.000023: Oviedo, 4 April 1997.
p.000023:
p.000023: Nevertheless, some members criticise this requirement for a mandatory positive opinion and put forward arguments in
p.000023: favour of a non-binding opinion, as currently required by Belgian legislation8.
p.000023:
p.000023: b. PROFESSIONALISATION OF ETHICS COMMITTEES?
p.000023:
p.000023: Some members are concerned about the professionalisation of local ethics committees, which would entail the risk of a
p.000023: loss of perception of the reality on the ground. On the other hand, promoting the competence of the committee members
p.000023: is desirable.
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p.000023:
p.000023:
p.000023: 8 See opinion, C.1.
p.000023: Opinion no. 13 of 9 July 2001 – Final version
p.000024: 24
p.000024:
p.000024: c. RESTRUCTURING ETHICS COMMITTEES TO FORM LOCAL COMMITTEES AND ‘REGIONAL’ COMMITTEES?
p.000024:
p.000024: Some members of the Advisory Committee recommend introducing ‘regional’ committees alongside local ethics committees.
p.000024: These ‘regional’ committees would have the exclusive task of assessing research protocols, in order to
p.000024: enable a certain level of professionalisation by combining the available resources and skills. With this
p.000024: system, the local committees’ mission would simply be to check the feasibility of the planned research in the
p.000024: local context, and the ‘regional’ committees would be set up either by the local authority or on a
p.000024: voluntary basis in line with geographic or ideological criteria.
p.000024:
p.000024: For other members of the Advisory Committee, creating a new structure like this is not only superfluous, but also
p.000024: inadvisable.
p.000024: Superfluous, because Article 7 of Directive 2001/20/EC stipulates, in the event of multi- centre studies, that there
p.000024: shall be a procedure for the adoption of a single opinion per country. The other committees can limit the
p.000024: examination to ensuring that local conditions fulfil the requirements of the research. The ethics committee of a
p.000024: university hospital, for instance, could therefore give this sole opinion (moreover, this would virtually
p.000024: always be where the national coordinator of a study like this would be), without the need to create another structure.
p.000024: Moreover, the creation of a second structure would present two risks. First of all, distancing the ethical
p.000024: assessment structure from the situation on the ground will inevitably weaken the ethical debate in terms of
p.000024: proximity and favour the role of the bureaucratic control of ethics committees (assessment ‘on paper’) to
p.000024: the detriment of their educational and interactive role with the investigators within institutions; in addition,
p.000024: their role as regards the ethical aspects of hospital procedures will be weakened as their legal missions cover
p.000024: the same procedure, based on the same principles and often involve the same people. Finally, the creation of a second
p.000024: structure would lead to a haemorrhaging of competent people and financial resources to the new structures whereas these
p.000024: human and material resources are already limited and are better concentrated on existing ethics committees. These
p.000024: fulfil a substantial role that must be developed and supported financially, which is not always the case
p.000024: today. For these reasons of rationality and priority as regards objectives, it is essential to maintain the current
p.000024: structure while defining certain aspects more precisely: real means (secretariat, staff) must be
p.000024: allocated to existing ethics committees and a training programme must be gradually developed.
p.000024:
...
p.000024: Four possibilities can be considered:
p.000024: • firstly, the researcher can consult the ethics committee of his choice. Some members consider that this
p.000024: solution discriminates with respect to researchers linked to an institution that has an ethics committee, who
p.000024: obviously do not have this choice.
p.000024: • a second possibility is to ask the researcher to contact a ‘regional’ committee set up for this purpose, with
p.000024: the risk that such committees only assess a small number of protocols and cannot therefore acquire a great
p.000024: deal of experience.
p.000024: • a third possibility is to invite the researcher to submit his protocol to the ethics committee of
p.000024: one of the faculties of medicine or a university hospital, or if appropriate an inter-university ethics committee.
p.000024: • a fourth possibility consists of asking the researcher to submit his protocol to an ethics
p.000024: committee set up, following the example of the Vlaams Huisartsen Instituut, within a professional group.
p.000024:
p.000024: Local ethics committees would continue to exercise their function of support and advice concerning the ethical aspects
p.000024: of practical hospital care.
p.000024:
p.000024: d. AN APPEAL STRUCTURE
p.000024:
p.000024: Opinion no. 13 of 9 July 2001 – Final version
p.000025: 25
p.000025:
p.000025: Some members of the Advisory Committee feel that when an ethics committee issues a negative opinion on a research
p.000025: protocol, provision must be made for the possibility of appealing. Nevertheless, it is important not to lose sight
p.000025: of the fact that if the appeal decision were to overturn the negative opinion, the researcher would in practice come
p.000025: up against resistance from the institution concerned, which could not be forced to permit this research to take place
p.000025: on its premises.
p.000025: Other members think it is pointless to make provision for an appeal if, irrespective of the opinion and even if it
p.000025: is negative, it is not binding; in this case, indeed, either the hospital will not agree to implement a
p.000025: project that has been rejected by its own ethics committee or the investigators and the hospital will take
p.000025: their responsibilities in fully knowledge of the facts, the researcher having to appear before the committee if,
p.000025: despite the negative opinion, he would still like to carry out the research project. In any case, it seems essential
p.000025: to all members of the Advisory Committee for the investigator to be heard in a debate between both parties
p.000025: before the ethics committee issues a negative opinion.
p.000025:
p.000025: e. FORUM SHOPPING
p.000025:
p.000025: In order to avoid forum shopping, some members propose that a given research protocol can only be submitted to one
p.000025: ethics committee, the choice of which may or may not be left to the discretion of a the researcher; moreover, he should
p.000025: only be able to consult an approved ethics committee, which raises the question of the legitimacy of non-hospital
p.000025: ethics committees: a certain number of them should be recognised owing to their experience and their
p.000025: independence, particularly as regards sponsors. The solution of ethics committees linked to medicine faculties
p.000025: or a university hospital is an interesting avenue in this respect.
p.000025:
p.000025: Other members do not object to investigators requesting multiple opinions, provided that they are obliged to
p.000025: include the opinion or opinions already obtained.
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p.000025:
p.000025:
p.000025: Opinion no. 13 of 9 July 2001 – Final version
p.000026: 26
p.000026:
p.000026: F. ETHICAL ASSESSMENT OF AN EXPERIMENTAL PROTOCOL – PROCEDURES
p.000026:
p.000026:
p.000026: 1. THE ETHICAL LEGITIMACY OF THE AIM
p.000026:
p.000026: This first principle which is essential for the legitimacy of any act of human
p.000026: experimentation in actual fact combines three parameters:
p.000026: a. the scientific interest of the project
p.000026: b. drawing up an adequate protocol
p.000026: c. the existence of prerequisites.
p.000026:
p.000026: a. THE SCIENTIFIC INTEREST OF THE PROJECT
p.000026:
p.000026: Submitting a human being to an experiment of any kind whatsoever can only be rendered legitimate by the
p.000026: importance of the information which this may be expected to yield in the field of health in the broad sense of the
p.000026: term, including the understanding of physiology and physiopathology. It is therefore essential to be able to justify
p.000026: the way in which the planned experiment will contribute to an improved knowledge of humans by means of a new
p.000026: contribution at one level or another that is worth achieving. There is indisputably a link between the
p.000026: importance of this interest and the risks examined later on, but the scientific interest criterion exists
p.000026: absolutely in spite of everything: no scientific interest, no ethical legitimacy. This applies, for instance, for
p.000026: repetitive studies without any scientific interest and raises the question of the legitimacy of multiplying
p.000026: essentially similar medicinal products, which implies bioequivalent studies of doubtful interest.
p.000026:
p.000026: b. DRAWING UP AN ADEQUATE PROTOCOL
p.000026:
p.000026: If the project is of scientific interest, does the protocol put forward (that is the document describing the
...
p.000026: could the protocol be implemented less expensively (principle of economy) or even on an animal model or an ‘in
p.000026: vitro’ model? The requirement for an adequate protocol comprises multiple facets: drawing up the
p.000026: experiment, validity of the measuring instruments and statistical methods, size of the sample tested. But
p.000026: this requirement also relates to the practical aspects of implementing the protocol examined in point 3.
p.000026:
p.000026: c. THE EXISTENCE OF PREREQUISITES
p.000026:
p.000026: This requirement recalls that, as a matter of principle itself, rigorous scientific procedure is based on prior
p.000026: knowledge. While this is true for all scientific experimentation, it is particularly important in human
p.000026: experimentation: have all the existing data relevant for the protocol in question been examined? Do these prior
p.000026: data give legitimacy to the project? Are the prior data (especially the data gathered during animal experiments
p.000026: and previous experiments on human subjects) sufficient to move on to the planned stage in the study?
p.000026:
p.000026:
p.000026: 2. PROPORTIONALITY OF RESOURCES
p.000026:
p.000026: The concept of the proportionality of resources is a conventional if complex concept in medicine: it
p.000026: refers to the fact that all acts (a fortiori all acts of experimentation, however harmless they may appear)
p.000026: entail a risk. Does the anticipated benefit justify this risk? But also: is there an alternative, less risky
p.000026: method of answering the question asked? (We are
p.000026: Opinion no. 13 of 9 July 2001 – Final version
p.000027: 27
p.000027:
p.000027: thinking here, for instance, of the new possibilities of experimentation on isolated cells, even though at some point
p.000027: human experimentation becomes essential).
p.000027:
p.000027: With experimentation carried out for therapeutic purposes, the anticipated direct benefit for the patient may make
p.000027: a high risk acceptable, whereas in the case of purely cognitive experimentation, risk for the person taking
p.000027: part in the experimentation must be slight. On the other hand, the risk assessment must cover the entire
p.000027: experimental procedure (and therefore include, for example, the examinations necessary to assess a new
p.000027: medicinal product), the procedures for the inclusion and exclusion of trial subjects, and the procedures for
p.000027: withdrawing from the experiment and those that apply in circumstances requiring a halt to the experiment.
p.000027:
p.000027: The concept of risk, too, is complex: the risk for the individual is expressed in terms of physical and
p.000027: psychological risks, but also in social and economic terms. But other aspects of the risk also have to be taken into
p.000027: account, such as its seriousness, the probability that it will arise, its reversibility and the possibility that the
p.000027: investigator can overcome it. Overall, this is a difficult assessment, even if serious accidents appear to be
p.000027: exceptional, in any case in the field of trials of new medicinal products.
p.000027:
p.000027:
p.000027: 3. QUALIFICATION OF THE INVESTIGATORS AND EXPERIMENTATION ENVIRONMENT
p.000027:
p.000027: The need for an adequate protocol and the assessment of the risk make it necessary to consider the
p.000027: quality of the investigator (is he the most competent person to carry out the planned experiment?) and the resources
p.000027: available, not only to carry out the experiment with optimal efficacy but also to respond to any unwanted effect.
p.000027: The experiment must be undertaken by qualified and competent people in a suitable environment. This
p.000027: requirement involves clearly identifying the investigators and justifies the need for the dossier to be submitted to
p.000027: the ethics committee by the principal investigator (and not the promoter). It also involves having access to
p.000027: the curriculum vitae of the investigators, and the need for the ethics committee to be familiar with the
p.000027: environment in which the experiment is to take place.
p.000027:
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p.000027: Opinion no. 13 of 9 July 2001 – Final version
p.000028: 28
p.000028:
p.000028: 4. FREE AND INFORMED CONSENT
p.000028:
p.000028: The process of obtaining free and informed consent is a crucial stage in the ethical legitimacy of a
p.000028: research protocol, placed at the head of the ethical requirements of biomedical research even by the
p.000028: Nuremberg Code of 19 July 1947.
p.000028:
p.000028: a. PRIOR INFORMATION ESSENTIAL FOR INFORMED CONSENT
p.000028:
p.000028: The consent must be informed, that is prior to giving consent, the individual must have been informed of the study
p.000028: and the methodology used, the length of study, the anticipated benefits, the constraints, the foreseeable
p.000028: risks, the undertaking to ensure the confidentiality of the data, compensation, the right to withdraw from the study
p.000028: at any time and the possible communication of the results. It is crucial to clearly separate acts and examinations
p.000028: linked to the experiment from those that are part of the usual treatment of the patient, both on the
p.000028: information form and on the consent form. The main points of this information must be included on an
p.000028: information form drafted in comprehensible terms and as far as possible in the language of the patient and attached
p.000028: to the consent document so that there can be no challenge regarding the information which the patient (or the
p.000028: healthy volunteer) has received. A further oral explanation from the investigator is necessary in order to be
p.000028: adapted to the understanding of each individual and so that questions can be asked. The information document must
p.000028: expressly indicate which ethics committee or committees has (have) given an opinion, and the content of
p.000028: this opinion.
p.000028:
p.000028: b. OBTAINING CONSENT
p.000028:
p.000028: The French act of 20 December 1988 on the protection of individual who take part in biomedical research (the Huriet
p.000028: act) stresses the fact that, thanks to their consent, the individuals included in a research project become partners
p.000028: who can collaborate actively with the investigator, emphasising the importance of this informed consent. This must be
p.000028: personal, prior and preferably laid down in writing. It must be free (that is exempt of any pressure, including
p.000028: moral or financial pressure). The aspect of compensation to cover the costs incurred by the patient or
p.000028: any other indirect advantage (free medical products for some trial subjects, for example) is particularly tricky.
p.000028: The principle of compensation is that it can only offset any inconvenience suffered (costs incurred, lack of work,
p.000028: etc.) and cannot become remuneration which may constitute an incentive. The direct advantage may become an
p.000028: incentive, for example, for patients without social security.
p.000028: It must be possible to withdraw consent at any time without giving a reason and without any consequences, which
p.000028: involves taking very specific precautions when the consent is obtained by the general practitioner, which
p.000028: is usually the case with human experimentation involving a patient.
p.000028:
p.000028: The validity of this information and this consent is subject to the same type of discussion as information and consent
p.000028: in the context of medical acts. As for such acts, it must be fair and complete without presenting all the eventualities
p.000028: that are theoretically possible in full, which would become a source of anxiety. Finally, as regards the condition of
p.000028: the patient, it must respect his wish to know the seriousness of his condition or not. It is generally considered
p.000028: necessary to pass on "all information that a reasonable person would deem important to take the decision to
p.000028: consent". This information must include the details relating to liability and insurance in the event of an accident,
p.000028: the limits of the confidentiality of the data obtained and the opinion and comments from the ethics
p.000028: committee that examined the protocol. This information must also be updated as the experiment progresses
p.000028: when relevant new information becomes available.
p.000028:
p.000028:
p.000028: 5. CONCLUSION
p.000028:
p.000028: In addition to these general rules, there are also special rules that are not part of this opinion for
p.000028: vulnerable groups and special situations such as:
p.000028: - healthy volunteers;
p.000028: Opinion no. 13 of 9 July 2001 – Final version
p.000029: 29
p.000029:
p.000029: - individuals who are legally or de facto incapable (psychiatric patients, unconscious patients,
p.000029: underage patients);
p.000029: - the protocols of behavioural studies where obtaining consent prevents the experiment from being carried
p.000029: out at all;
p.000029:
p.000029: - socially vulnerable groups: separate cultural communities, prisoners, persons who are be likely to be
p.000029: forced (such as medical students), persons in need;
p.000029: - pregnant or breastfeeding women;
p.000029: - in vitro human embryos;
p.000029: - experiments on cadavers;
p.000029: - experiments on organs, tissue or tumours removed from patients;
p.000029: - experiments on the products of spontaneous or induced abortions.
p.000029:
p.000029: It appears that a growing number of firms are asking to keep samples with a view to carrying out subsequent genetic
p.000029: analyses. A procedure like this which may involve research carried out unbeknown to the patient poses particular
p.000029: problems and will be the subject of a separate opinion.
p.000029:
p.000029: The aspects of data confidentiality are in principle governed by the legislation on the protection of
p.000029: privacy (act of 8 December 1992 on the protection of privacy with regard to the processing of personal data
p.000029: (Moniteur belge of 18 March 1993)) and the directives of the National Council of the Order of Doctors
p.000029: concerning access to human experimentation dossiers (opinions of 22 August 1992, 17 February 1996, 13 December
p.000029: 1997, 19 September
p.000029: 1998, 24 April 1999, 15 January 2000 and 19 February 2000).
p.000029:
p.000029: Finally, for some members, ethics committees should follow up the protocol (information on progress with the
p.000029: experiment, interim results, unwanted side effects), which for them constitutes an activity that is as yet
p.000029: unfamiliar. Other members, however, believe that this mission should not be entrusted to them.
p.000029:
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p.000029:
p.000029: Opinion no. 13 of 9 July 2001 – Final version
p.000030: 30
p.000030:
p.000030: This introductory report for the opinion was prepared in select committee 97/8 consisting of*:
p.000030:
p.000030:
p.000030: Joint chairpersons
p.000030:
p.000030: M. Bogaert
p.000030:
p.000030: Y. Galloy
p.000030:
p.000030: Joint reporters
p.000030:
p.000030: M.L. Delfosse (2000)
p.000030:
p.000030: E. Guldix
p.000030:
p.000030: Members
p.000030:
p.000030: M. Abramowicz ('96- '99)
p.000030: M. Baum
p.000030: P. Devroey
p.000030: X. Dijon (resigned '98)
p.000030: I. Liebaers ('96-'99)
p.000030: J.N. Missa (2000)
p.000030: H. Nijs
p.000030: G. Sokal ('96-'99)
p.000030: M. Somville ('96-'99)
p.000030: J. Stiennon (resigned '99)
p.000030: F. Van Neste
p.000030:
p.000030: Member of the Bureau
p.000030: Y. Englert
p.000030:
p.000030:
p.000030:
p.000030: Member of the secretariaat
p.000030:
p.000030: E. Morbé
p.000030:
p.000030:
p.000030: Permanent experts
p.000030:
p.000030: • Ms M.L. Delfosse (1996-1999), philosopher, Facultes universitaires Notre-Dame de la Paix-Faculte de
p.000030: droit, and CIDES, Namur.
p.000030: • Ms I. Liebaers (2000), lecturer, Centrum Medische Genetica, AZ-VUB, Brussels.
p.000030: • Mr J.N. Missa (1996-1999), philosopher, CRIB, director of the Institut de Philosophie at the ULB, Brussels.
p.000030:
p.000030:
p.000030:
p.000030: The working documents of select committee 97/8 – request for opinion, personal contributions from members,
p.000030: minutes of the reunions, documents consulted – are stored as Annexes 97/8 at the Committee’s documentation centre,
p.000030: where they may be consulted and copied.
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: * Some members took part in the work of the select committee during the Committee’s two terms of office (1996-1999 and
p.000030: 2000). The length of the term is indicated next to the names of the members who took part in the work of the committee
p.000030: during a single term of office.
p.000030:
p.000030: Opinion no. 13 of 9 July 2001 – Final version
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General/Other / Impaired Autonomy
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p.000002: Request for opinion of 8 June 1998
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p.000002:
p.000002:
p.000002: Opinion no. 13 of 9 July 2001 – Final version
p.000002: 2
p.000002:
p.000002: CONTENTS
p.000002:
p.000002: A. Introduction
p.000002:
p.000002: B. The legitimacy of human experimentation
p.000002:
p.000002: 1. The Advisory Committee has noted the importance acquired since experimental medicine was defined in the late 19th
p.000002: century by biomedical experimentation on humans and its major impact on progress in medicine in the 20th century
p.000002: 2. Conflict of values linked to experimentation
p.000002: 3. The reference framework of ethics committees is based on four fundamental principles
p.000007: 7
p.000007: a. The principle of relevance
p.000007: b. The principle of scientific rigour
p.000007: c. The principle of ‘no harm’ or ‘primum non nocere’
p.000007: d. The principle of autonomy
p.000007: 4. Reflections and expansion: focus on the principle of justice
p.000007:
p.000007: C. What is the normative framework for human experimentation?
p.000007:
p.000007: 1. Ethics committees as assessment bodies
p.000007: 2. Harmonisation of legal standards and complementarity of deontological and legal rules – Advocates and opponents
p.000007: a. Arguing in favour of a normative polyphony
p.000007: b. Rejection of all legal formalism
p.000007: c. Requirements beyond the law
p.000007: d. Nevertheless, legal regulations are desirable, if not essential
p.000007: 3. A framework law
p.000007:
p.000007:
p.000007:
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p.000007:
p.000007: Opinion no. 13 of 9 July 2001 – Final version
p.000003: 3
p.000003:
p.000003: A. INTRODUCTION
p.000003:
p.000003:
p.000003: This opinion is issued further to a request dated 12 November 1997 from Professor Dr. W. BETZ, Chairman of the
p.000003: Medical Ethics Commission of the Vlaams Huisartsen Instituut – Flemish institute of general practitioners.
p.000003: This institute studies the research protocols carried out by family doctors. Professor Betz was concerned
...
p.000005: hand, the respect and protection of individuals. We cannot accept the advantages brought by scientific medicine
p.000005: without at the same time admitting the methods and activities that make it possible to attain these advantages and
p.000005: which are far more fruitful in terms of progress in knowledge than the simple empirical trial and error
p.000005: approaches of previous centuries. Affirming the legitimacy of experimentation means accepting
p.000005: the tension inherent in all experimentation between values that are difficult to harmonise which
p.000005: will have to b
p.000005:
p.000005: 3 In Belgium, Royal Decree No 78 of 10 November 1967 on the exercising of the art of curing, the
p.000005: art of nursing, the paramedical professions and medical commissions (Moniteur belge, 14 November 1967), Article 1,
p.000005: gives legal form to this concern by assigning to the medical act a preventive, diagnostic or curative purpose.
p.000005:
p.000005: Opinion no. 13 of 9 July 2001 – Final version
p.000006: 6
p.000006:
p.000006: expressed as well as possible on a case-by-case basis. Ethics and the law both have a role to play in this respect,
p.000006: according to their own specific features. Through the rules they set out, in particular they have to watch over
p.000006: professional conscience in the face of the extension of activities involving medical experimentation.
p.000006:
p.000006: Finally, human experimentation raises the following question: how can we experiment while respecting the
p.000006: autonomy of the individuals involved and protecting them in their vulnerability? This general question in fact
p.000006: summarises several aspects which are worthy of attention and vigilance, in both ethical and in legal terms.
p.000006: The conflict relating to human experimentation cannot be reduced to an opposition between the freedom to
p.000006: research and the autonomy of the individual. It is also important to take into consideration
p.000006: beneficence and collective utility. The latter aspect can only be researched by taking into account a principle of
p.000006: justice that ensures both the fair distribution of the advantages and disadvantages of experiments conducted
p.000006: within populations and the setting up of structures that enable all citizens to have fair access to quality care.
p.000006: For more information, see Introductory Report, C., 1, 2 and 3.
p.000006:
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p.000006:
p.000006:
p.000006: Opinion no. 13 of 9 July 2001 – Final version
p.000007: 7
p.000007:
p.000007: 3. The reference framework of ethics committees is based on four fundamental principles
p.000007:
p.000007: a. THE PRINCIPLE OF RELEVANCE: does the response to the question behind the experiment hold out the
p.000007: possibility of progress in knowledge?
p.000007: b. THE PRINCIPLE OF SCIENTIFIC RIGOUR: the research must be carried out in an adequate scientific context
p.000007: using a rigorous methodology.
p.000007: c. THE PRINCIPLE OF ‘NO HARM’ OR ‘PRIMUM NON NOCERE’: the experiment must respect the condition of the subject and
p.000007: limit the risks incurred so as that they remain proportionate to the anticipated benefit.
p.000007: d. THE PRINCIPLE OF AUTONOMY: corresponds to the need to obtain the free and informed consent of the subject. It
p.000007: therefore supposes that the subject has the capacities of free thought and that the doctor has the capacities
p.000007: needed to provide clear information.
p.000007:
p.000007: 4. Reflections and expansion: focus on the principle of justice
p.000007:
p.000007: In the light of these principles – as is stipulated in point 2 above – at first glance the conflict of values
p.000007: inherent in human experimentation appears to be a dilemma between scientificity (principles a and b) and the
p.000007: protection of the autonomy and integrity of individuals (principles c and d). However, experimentation also aims
p.000007: to achieve collective utility. Now, even if we are inclined to believe it owing to the credit currently accorded to
p.000007: science, this collective utility cannot be considered purely and simply an effect of the progress made in
p.000007: scientific knowledge. When they do deal with this question, which is unfortunately only too rare, texts stress
p.000007: that collective utility can only be sought by taking into account a principle of justice, that is a
p.000007: fair distribution between the advantages and the disadvantages of experimentation4.
p.000007: This principle of justice draws attention to the selection of the individuals taking part in research, both those
p.000007: who, owing to their vulnerability, may be exploited by their inclusion (for instance, those who are
p.000007: incapable of consenting, such as nurslings, children, mentally disabled people, prisoners or elderly people living
p.000007: in institutions), and those who are usually excluded, possibly to their disadvantage. In fact, it may be
p.000007: observed that drug treatment in children, for example, is based on observations made in adults, which is not
...
p.000007: de recherches en sciences sur l’homme du Canada, Code d’éthique de la recherché sur l’homme, 1997.
p.000007: Opinion no. 13 of 9 July 2001 – Final version
p.000008: 8
p.000008:
p.000008: everyone concerned, their liability and insurance.
p.000008:
p.000008: 1. Ethics committees as assessment bodies
p.000008:
p.000008: Ethics committees basically fulfil two roles: the application of principles that set standards in human
p.000008: experimentation and discussion of the problems raised by each individual case. From this point of view, ethics
p.000008: committees become the main forums for the regulation of clinical research. They thus offer the advantage of forming a
p.000008: flexible system that can be used to manage the ethical problems raised by human experimentation
p.000008: pragmatically but vigilantly while staying close to clinical reality.
p.000008:
p.000008: Analysing a research protocol involves examining and assessing the following elements:
p.000008: 1) legitimacy of the aim
p.000008: 2) proportionality of the means
p.000008: 3) qualification of investigators and the experimentation environment
p.000008: 4) free and informed consent.
p.000008: For additional information, see Introductory Report, F.
p.000008:
p.000008: When assessing the protocol, the role of the ethics committee is to keep a particular eye on the safety, autonomy,
p.000008: physical integrity, well-being and rights of the people who are taking part in a medical experiment, above and beyond
p.000008: the context of the general rules on civil liability. It also has to make sure that the agreements on
p.000008: funding reached between the sponsor and the investigator do not interfere with the independence of the investigator.
p.000008: For additional information, see Introductory Report, E.
p.000008:
p.000008: The ethics committee may not, under any circumstances, issue a positive opinion on the research protocol if it is not
p.000008: convinced that this actually meets each of these assessment criteria.
p.000008: According to Article 9 of European Directive 2001/20/EC of 4 April 2001 on the approximation of the
p.000008: laws, regulations and administrative provisions of the Member States relating to the implementation of good
p.000008: clinical practice in the conduct of clinical trials on medicinal products for human use (O.J. 1 May 2001), a
p.000008: clinical trial may not start until the ethics committee has issued a favourable opinion.
p.000008:
p.000008: Some members of the Advisory Committee believe that when the opinion of the ethics committee is negative, this must be
p.000008: binding for the investigator because they think that this is the only way to guarantee the safety of the trial subject.
p.000008:
p.000008: Other members believe that it is, of course, legitimate to require that all human experimentation
...
p.000013:
p.000013: The working documents of select committee 97/8 – request for opinion, personal contributions from members,
p.000013: minutes of the meetings, documents consulted – are stored as Annexes 97/8 at the Committee’s documentation centre,
p.000013: where they may be consulted and copies.
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013:
p.000013: * Some members took part in the work of the select committee during the Committee’s two terms of
p.000013: office (1996-1999 and 2000). The length of the term is indicated next to the name of members who took part in the work
p.000013: of the committee during a single term.
p.000013:
p.000013: Opinion no. 13 of 9 July 2001 – Final version
p.000014: 14
p.000014:
p.000014: INTRODUCTORY REPORT FOR OPINION No 13 of 9 July 2001 on human experimentation
p.000014:
p.000014:
p.000014: CONTENTS
p.000014:
p.000014: A. Objectives and method
p.000014: B. Definitions
p.000014: C. Medical-scientific research on humans – Ethical and legal problems
p.000014: 1. Legitimacy based on efficacy
p.000014: 2. Care and research
p.000014: 3. The cultural context
p.000014: 4. Problems
p.000014: a. A question of methodology
p.000014: b. Examining ethical requirements – methodology
p.000014: c. The link between autonomy and vulnerability
p.000014: d. Partnership
p.000014: e. Consent
p.000014: f. Insurance
p.000014: g. Should all experimentation protocols be submitted for assessment of by an ethics committee?
p.000014: D. The current normative framework
p.000014: E. Ethics committees
p.000014: 1. Composition
p.000014: 2. Independence
p.000014: 3. Liability and insurance
p.000014: 4. Options to be taken
p.000014: a. Need for an advisory or a binding opinion?
p.000014: b. Professionalisation of ethics committees?
p.000014: c. Restructuring ethics committees to form local committees and ‘regional’ committees?
p.000014: d. An appeal structure
p.000014: e. Forum shopping
p.000014: F. Ethical assessment of an experimental protocol – Procedures
p.000014: 1. The ethical legitimacy of the aim
p.000014: a. The scientific interest of the project
p.000014: b. Drawing up an adequate protocol
p.000014: c. The existence of prerequisites
p.000014: 2. Proportionality of means
p.000014: 3. Qualification of the investigators and the experimentation environment
p.000014: 4. Free and informed consent
p.000014: a. Prior information, essential for informed consent
p.000014: b. Obtaining consent
p.000014: 5. Conclusion
p.000014:
...
p.000019: affirmation of principles expressing the acknowledged value of individuals as such (human rights) on the on one hand
p.000019: and principles that link the morality of an action to a rational calculation of utility and emphasise the
p.000019: collective good on the other. Excessive preference for the common good could lead to neglect of the rights of the
p.000019: individual; an absolutist view of the rights of the individual could result in hindering scientific
p.000019: progress and subsequently, the common good.
p.000019:
p.000019: As regards human experimentation, this situation fosters confusion between the interest of the patient, social
p.000019: utility and well-being through science. It also supports two types of simplistic approaches to questions:
p.000019: scientism and the rational calculation of usefulness. In response, there is a need for vigilance, ethically and
p.000019: legally, so as to avoid inconsistency between the idealistic invocation of principles and pragmatism
p.000019: which, when it becomes cynical, can lead to mercantilism. This is why it is important to question the
p.000019: normative framework of experimentation which gradually came into being during the 20th century, taking care
p.000019: to ensure that the prevailing cultural context does not affect the interpretation of the principles it sets out.
p.000019:
p.000019:
p.000019: 4. PROBLEMS
p.000019:
p.000019: The basic principles on which all human experimentation is based – as set out in the attached opinion,
p.000019: that is the principles of relevance, scientific rigour, ‘no harm’, autonomy and justice – raise a certain number of
p.000019: questions.
p.000019:
p.000019: a. A QUESTION OF METHODOLOGY
p.000019:
p.000019: Some members of the Advisory Committee believe it is essential not to look at questions raised by human experimentation
p.000019: from a normative point of view (solely in the light of the principles mentioned above), but again to take as a
p.000019: basis the description of situations that could lead everyone to question again the limits of the principles on
p.000019: which their ethical judgements are based. What should we so, for example when faced with patients, such as
p.000019: certain AIDS sufferers, who want to take part in an experiment despite the risks of which they have been informed? This
p.000019: situation leads to reconsideration of the link to be established between autonomy, vulnerability and acceptable
p.000019: risk-benefit ratio.
p.000019:
p.000019:
p.000019: 6 Cf. in this respect: KENIS, Y., "Expérimentation, recherche, soins. L'expérience d'un cancerologue", in
p.000019: Le devoir d'experimenter, texts compiled by J.-N. Missa, coll. Sciences, éthiques, sociétés, Brussels, De
p.000019: Boeck University, 1996. p. 80-84.
p.000019: Opinion no. 13 of 9 July 2001 – Final version
p.000020: 20
p.000020:
p.000020: b. EXAMINING ETHICAL REQUIREMENTS - METHODOLOGY
p.000020:
p.000020: Most texts on medical ethics and deontology put forward a series of principles which are based on different ethical
p.000020: outlooks, without suggesting a link between them. This situation may lead to excesses when one of these
p.000020: principles is considered to be the sole determinant, or when the ethical interpretation of the basis for this principle
p.000020: leads to a distorted interpretation of others. To overcome this difficulty, it would be advisable to suggest a
p.000020: methodology like that now put forward by certain texts7, and accompany it with this rule: any condition
p.000020: not met releases the ethics committee from having to examine the following conditions; only protocols for which
p.000020: all the conditions examined, in order, have been given a positive assessment can be granted a favourable opinion.
p.000020:
p.000020: c. THE LINK BETWEEN AUTONOMY AND VULNERABILITY
p.000020:
p.000020: In addition to the principle of autonomy, it is also important to take account of a principle of
p.000020: vulnerability which not only expresses the condition of all individuals, but also requires particular attention
p.000020: when the experimentation concerns those who are weaker, such as those who are ill, children, the mentally
p.000020: disabled, the elderly, people in institutions or suffering from neuralgic disorders. So when an experiment involves
p.000020: those who are ill, the basic question becomes that of the link to be established between the risk accepted by the
p.000020: patient (autonomy) and the benefits the latter expects. The link between autonomy and vulnerability is
p.000020: particularly acute when experimentation is suggested as the last chance of a cure for a patient who is often
p.000020: distressed.
p.000020:
p.000020: d. PARTNERSHIP
p.000020:
p.000020: Rather than seeing consent as authorisation given by a patient or a subject to carry out an experiment on him as a
p.000020: procedure that aims to find out whether this patient or this subject illustrates the relevance of an assumption, would
p.000020: it not be better to see consent and experimentation rather as a partnership? In fact, the relationship between the
p.000020: doctor and the patient must be seen in terms of evolutive agreement that is constantly renegotiated.
p.000020: Actually obtaining informed consent implies abandoning medical paternalism. The doctor cannot decide alone
p.000020: what is good for the patient. He must take the time to correctly inform his partner-patient. The individual
p.000020: taking part freely in research is not an object being manipulated to achieve ends that have nothing to do with him.
p.000020: Ideally, he is an individual who is cooperating, to a limited but effective extent, on improving medical therapeutics
p.000020: and refining scientific knowledge of the human being. Would it not, therefore, be advisable to start from a
p.000020: position of uncertainty common to the patient and the observer?
p.000020:
p.000020: e. CONSENT
p.000020:
p.000020: Without calling into question the compulsory nature of free and informed consent, it should be pointed
p.000020: out that a careful analysis of international medical ethics and of Belgian deontology and law indicates that
p.000020: these normative sets all contain provisions that indicate a tendency to protect individuals, irrespective of
p.000020: any wish they may express. While consent must not be regarded as sacred, considered to be the sole expression of an
p.000020: individual’s autonomy – which itself is wrongly identified with the dignity of human beings – it nevertheless plays
p.000020: a central role in a view that enhances the value of partnership. It is, however, important to stress
p.000020: that irrespective of the situation as regards standards, ethics committees remain vigilant regarding related
p.000020: questions.
p.000020:
p.000020: f. INSURANCE
p.000020:
p.000020: Whatever the causes and provided it relates to the experiment, any harm suffered by trial subjects, patients or healthy
p.000020: volunteers must be covered by insurance.
p.000020: According to Article 6.3 i) of European Directive 2001/20 EC of 4 April 2001 (O.J. 1 May 2001), ethics committees must
p.000020: ensure that the experimentation is covered by insurance
p.000020:
p.000020: 7 Cf. in particular: CIOMS, International Ethical Guidelines for Biomedical Research Involving Human
p.000020: Subjects, 1993, Guideline 14, Commentary, p. 38-39.
p.000020: Opinion no. 13 of 9 July 2001 – Final version
p.000021: 21
p.000021:
p.000021: and check the clauses of this insurance.
p.000021:
p.000021: g. SHOULD ALL EXPERIMENTATION PROTOCOLS BE SUBMITTED FOR ASSESSMENT BY AN ETHICS COMMITTEE?
p.000021:
p.000021: The main aim of the rule underlying this question is to provide protection for those involved. However,
...
General/Other / Manipulable
Searching for indicator manipulated:
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p.000005: experimentation involves instrumentalising the latter as well as healthy volunteers. In fact, in
p.000005: experimentation, obtaining therapeutic benefit, when this exists, is doubly mediatised: it is linked to the pursuit
p.000005: of a cognitive objective which always takes priority; through the person involved in the experiment, a category or set
p.000005: of people are targeted. The emphasis here is placed on all the conditions that have to be fulfilled during experiments:
p.000005: the relevance of the research, the appropriateness of the methodology and the context, the attention paid to the
p.000005: risks-benefits ratio, and finally – an essential but not sufficient condition – the free and informed
p.000005: consent of the trial subjects.
p.000005:
p.000005: Other members put the emphasis more on the principle of respect for individuals understood as respect for
p.000005: their self-determination. They consider that experimentation should ideally be conceived as a form of partnership
p.000005: between doctors and the subjects involved in the research. From this point of view, the rule of informed consent plays
p.000005: a fundamental role. The genuine implementation of this rule implies abandoning medical paternalism. The doctor cannot
p.000005: decide alone what is good for the patient. He must take the time to correctly inform his partner-patient. The
p.000005: individual taking part freely in research is not an object being manipulated to achieve ends that have nothing to
p.000005: do with him. Ideally, he is an individual who is cooperating, to a limited but effective extent, in improving medical
p.000005: therapeutics and refining scientific knowledge of the human being.
p.000005:
p.000005: Notwithstanding these two views, experimentation is the scene of tension between on the one hand the freedom to
p.000005: research and the therapeutic progress this gives rise to for the benefit of the community and, on the other
p.000005: hand, the respect and protection of individuals. We cannot accept the advantages brought by scientific medicine
p.000005: without at the same time admitting the methods and activities that make it possible to attain these advantages and
p.000005: which are far more fruitful in terms of progress in knowledge than the simple empirical trial and error
p.000005: approaches of previous centuries. Affirming the legitimacy of experimentation means accepting
p.000005: the tension inherent in all experimentation between values that are difficult to harmonise which
p.000005: will have to b
p.000005:
p.000005: 3 In Belgium, Royal Decree No 78 of 10 November 1967 on the exercising of the art of curing, the
p.000005: art of nursing, the paramedical professions and medical commissions (Moniteur belge, 14 November 1967), Article 1,
p.000005: gives legal form to this concern by assigning to the medical act a preventive, diagnostic or curative purpose.
p.000005:
p.000005: Opinion no. 13 of 9 July 2001 – Final version
p.000006: 6
p.000006:
p.000006: expressed as well as possible on a case-by-case basis. Ethics and the law both have a role to play in this respect,
...
p.000020: those who are ill, the basic question becomes that of the link to be established between the risk accepted by the
p.000020: patient (autonomy) and the benefits the latter expects. The link between autonomy and vulnerability is
p.000020: particularly acute when experimentation is suggested as the last chance of a cure for a patient who is often
p.000020: distressed.
p.000020:
p.000020: d. PARTNERSHIP
p.000020:
p.000020: Rather than seeing consent as authorisation given by a patient or a subject to carry out an experiment on him as a
p.000020: procedure that aims to find out whether this patient or this subject illustrates the relevance of an assumption, would
p.000020: it not be better to see consent and experimentation rather as a partnership? In fact, the relationship between the
p.000020: doctor and the patient must be seen in terms of evolutive agreement that is constantly renegotiated.
p.000020: Actually obtaining informed consent implies abandoning medical paternalism. The doctor cannot decide alone
p.000020: what is good for the patient. He must take the time to correctly inform his partner-patient. The individual
p.000020: taking part freely in research is not an object being manipulated to achieve ends that have nothing to do with him.
p.000020: Ideally, he is an individual who is cooperating, to a limited but effective extent, on improving medical therapeutics
p.000020: and refining scientific knowledge of the human being. Would it not, therefore, be advisable to start from a
p.000020: position of uncertainty common to the patient and the observer?
p.000020:
p.000020: e. CONSENT
p.000020:
p.000020: Without calling into question the compulsory nature of free and informed consent, it should be pointed
p.000020: out that a careful analysis of international medical ethics and of Belgian deontology and law indicates that
p.000020: these normative sets all contain provisions that indicate a tendency to protect individuals, irrespective of
p.000020: any wish they may express. While consent must not be regarded as sacred, considered to be the sole expression of an
p.000020: individual’s autonomy – which itself is wrongly identified with the dignity of human beings – it nevertheless plays
p.000020: a central role in a view that enhances the value of partnership. It is, however, important to stress
p.000020: that irrespective of the situation as regards standards, ethics committees remain vigilant regarding related
p.000020: questions.
p.000020:
p.000020: f. INSURANCE
p.000020:
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.000004:
p.000004:
p.000004: 1 One question was repeatedly asked during the work of the select committee: how should this opinion be extended, in
p.000004: other words, what does it relate to precisely? Is it a matter of considering all forms of experimentation that involve
p.000004: human subjects, or only those which are medical or biomedical? While the initial requests of course relate to
p.000004: biomedical experimentation, the select committee nevertheless noted, immediately as of its introductory work on
p.000004: definitions (Chapter B of the introductory report) that it was led to consider wider aspects (psychological or social
p.000004: experiments in particular). At the same time, it showed a constant concern to precisely delimit the object of its
p.000004: reflections, aware that even limited to biomedical experimentation, this is vast and brings up a great many questions
p.000004: which would be worth considering specifically. This is why some members believed that it would be advisable to specify
p.000004: straight away that the opinion will relate to biomedical human experimentation, which does not prejudge a subsequent
p.000004: extension to other experimentation involving human subjects, on the basis of considerations which may be relevant for
p.000004: both. Irrespective of the choices made, there will inevitably still be borderline situations. The object of the
p.000004: experimentation, the parties carrying out the research and the place where it is undertaken can help clarify difficult
p.000004: situations.
p.000004: 2 The examples that illustrate this type of obstacle to obtaining consent are the famous experiment
p.000004: on submission to authority (Milgram experiment) popularised by the film “Mon Oncle d’Amerique” and the
p.000004: Semmelweiss experiment on the comparison of the incidence of puerperal fever in two delivery rooms in
p.000004: Budapest which led to the discover of the rules of asepsis.
p.000004: Opinion no. 13 of 9 July 2001 – Final version
p.000005: 5
p.000005:
p.000005: Without underestimating the philosophical difficulties posed by biomedical research, the Advisory Committee stresses
p.000005: the ethical legitimacy of experimentation and considers that those who take part in it render a major service to
p.000005: the community as a whole – and to those who are ill in particular – by enabling medical progress. Society
p.000005: owes them recognition.
p.000005:
p.000005: The legitimacy of human experimentation is closely linked to the acknowledged legitimacy of
p.000005: scientific medicine: it may even be said to depend on it. Today, the importance granted to
p.000005: evidence-based medicine or EBM, illustrates the success of this approach. In fact, experimentation
p.000005: understood to mean systematically testing assumptions by carrying out rigorously monitored and
p.000005: interpreted experiments constitutes the specific method of acquiring knowledge used for scientific medicine
p.000005: which, since the 19th century, has planned to establish its therapeutic basis as widely as possible on knowledge
p.000005: (theoretical or practical) that is validated by experiment.
p.000005:
p.000005: 2. Conflict of values linked to human experimentation
p.000005:
p.000005: Human experimentation is the scene of a conflict between the freedom to research, respect for human
...
p.000011: participate, under defined conditions, in biomedical experimentation and recall the right to respect
p.000011: for physical and psychological integrity. The individual must be informed of his rights and the guarantees provided
p.000011: for his protection and must be able to express free and informed consent, laid down in writing, prior to the
p.000011: experimentation. Throughout the process, the protection of confidential personal data must be guaranteed. Finally
p.000011: the law has to provide for and specify the rights of the individual to medical care and to compensation for harm
p.000011: in the event of prejudice resulting from his participation in the experiment.
p.000011:
p.000011: To conclude, the Advisory Committee believes that the ethics committee is the appropriate forum
p.000011: in which to study and carry out a prior assessment of the experimentation protocol, the central
p.000011: concern being the protection of the individual who is the subject of the experiment. The law must define the rules on
p.000011: the composition and functioning of the ethics committee, its funding and the training of its members. The
p.000011: Opinion no. 13 of 9 July 2001 – Final version
p.000012: 12
p.000012:
p.000012: ethics committee must be recognised by the authority following principles that guarantee its independence, particularly
p.000012: as regards any sponsors of the research.
p.000012:
p.000012: Some members of the Advisory Committee consider that biomedical human experimentation cannot be
p.000012: undertaken without a positive opinion from the ethics committee. Other members consider that it is
p.000012: essential for the opinion to remain advisory and not binding for the investigator, and that the trial
p.000012: subject should be informed of the conclusion reached further to the request for an opinion.
p.000012:
p.000012: Some members are in favour of a structure of local ethics committees as they exist in hospitals. In their view, this
p.000012: structure has the advantage of proximity to the work carried out in the field and close contact with the other mission
p.000012: of the ethics committee (advice on the ethical aspects of hospital practices), as well as protecting the ethical
p.000012: pluralism of our society.
p.000012: Other members come out in favour of a more centralised structure which would be devoted solely to
p.000012: assessment of research protocols. In their view, this structure has the advantage of greater independence in terms
p.000012: of the situation on the ground and the concentration of the multiple skills required to fulfil its
p.000012: assessment mission; finally, it would be easier for the authority to monitor such a structure. The local structures
p.000012: would take on the other task of ethics committees and remain responsible for the assessment of the local conditions for
p.000012: the fulfilment of the experiment (see Introductory Report, E., 4., c).
p.000012:
p.000012: The Advisory Committee is pleased to note, on the basis of the available data, that human experimentation
p.000012: rarely causes harm. It nevertheless believes that it is necessary to protect the trial subject and therefore recommends
p.000012: that the investigator be obliged to compensate in full anyone who may suffer harm due to the investigator,
p.000012: even in the absence of error, unless the harm is due to a cause that is not related to the experiment. Insurance must
p.000012: be taken out to cover those who take part in experiments. The law must ensure that this insurance provides sufficient
p.000012: and appropriate cover for those who lend themselves to such experiments. All these measures are intended to prevent
p.000012: individuals who suffer any harm from having to bear the weight of the procedure whereas they are undertaking an act of
p.000012: solidarity for the benefit of the community.
p.000012:
p.000012: The Advisory Committee stresses that the scope of this opinion is general and that it will be supplemented by
p.000012: specific opinions on situations that call for adjustments and additional precautions, such as
...
p.000023:
p.000023: Some members are concerned about the professionalisation of local ethics committees, which would entail the risk of a
p.000023: loss of perception of the reality on the ground. On the other hand, promoting the competence of the committee members
p.000023: is desirable.
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: 8 See opinion, C.1.
p.000023: Opinion no. 13 of 9 July 2001 – Final version
p.000024: 24
p.000024:
p.000024: c. RESTRUCTURING ETHICS COMMITTEES TO FORM LOCAL COMMITTEES AND ‘REGIONAL’ COMMITTEES?
p.000024:
p.000024: Some members of the Advisory Committee recommend introducing ‘regional’ committees alongside local ethics committees.
p.000024: These ‘regional’ committees would have the exclusive task of assessing research protocols, in order to
p.000024: enable a certain level of professionalisation by combining the available resources and skills. With this
p.000024: system, the local committees’ mission would simply be to check the feasibility of the planned research in the
p.000024: local context, and the ‘regional’ committees would be set up either by the local authority or on a
p.000024: voluntary basis in line with geographic or ideological criteria.
p.000024:
p.000024: For other members of the Advisory Committee, creating a new structure like this is not only superfluous, but also
p.000024: inadvisable.
p.000024: Superfluous, because Article 7 of Directive 2001/20/EC stipulates, in the event of multi- centre studies, that there
p.000024: shall be a procedure for the adoption of a single opinion per country. The other committees can limit the
p.000024: examination to ensuring that local conditions fulfil the requirements of the research. The ethics committee of a
p.000024: university hospital, for instance, could therefore give this sole opinion (moreover, this would virtually
p.000024: always be where the national coordinator of a study like this would be), without the need to create another structure.
p.000024: Moreover, the creation of a second structure would present two risks. First of all, distancing the ethical
p.000024: assessment structure from the situation on the ground will inevitably weaken the ethical debate in terms of
p.000024: proximity and favour the role of the bureaucratic control of ethics committees (assessment ‘on paper’) to
p.000024: the detriment of their educational and interactive role with the investigators within institutions; in addition,
p.000024: their role as regards the ethical aspects of hospital procedures will be weakened as their legal missions cover
...
General/Other / belmont
Searching for indicator belmont:
(return to top)
p.000007: observed that drug treatment in children, for example, is based on observations made in adults, which is not
p.000007: necessarily optimal. The principle of justice also leads to the concern to offer and guarantee fair access to quality
p.000007: health care.
p.000007: For additional information, see Introductory Report, C., 4.
p.000007:
p.000007:
p.000007: C. WHAT IS THE NORMATIVE FRAMEWORK FOR HUMAN EXPERIMENTATION?
p.000007:
p.000007:
p.000007: Belgian law is incomplete as regards human experimentation.
p.000007: In addition to Belgian legislation, there are also European and international normative texts and deontological rules
p.000007: (see Introductory Report, D.).
p.000007:
p.000007: The Advisory Committee suggests:
p.000007: 1) setting up legally established local ethics committees as bodies for the assessment of human experimentation
p.000007: protocols, with clearly defined areas of competence;
p.000007: 2) harmonisation of national, European and international standards in the field of human experimentation and
p.000007: complementarity between the deontological rules and the legal rules;
p.000007: 3) a framework law containing legal rules on ethics committees, the rights and duties of
p.000007:
p.000007: 4 Among others: The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research,
p.000007: The Belmont Report, 1978; Council for International Organizations of Medical Sciences (CIOMS), in collab. with World
p.000007: Health Association (WHO), International Ethical Guidelines for Biomedical Research Involving Human Subjects, 1993, as
p.000007: well as: Conseil de recherches médicales du Canada, Conseil de recherché en sciences naturelles du Canada and Conseil
p.000007: de recherches en sciences sur l’homme du Canada, Code d’éthique de la recherché sur l’homme, 1997.
p.000007: Opinion no. 13 of 9 July 2001 – Final version
p.000008: 8
p.000008:
p.000008: everyone concerned, their liability and insurance.
p.000008:
p.000008: 1. Ethics committees as assessment bodies
p.000008:
p.000008: Ethics committees basically fulfil two roles: the application of principles that set standards in human
p.000008: experimentation and discussion of the problems raised by each individual case. From this point of view, ethics
p.000008: committees become the main forums for the regulation of clinical research. They thus offer the advantage of forming a
p.000008: flexible system that can be used to manage the ethical problems raised by human experimentation
p.000008: pragmatically but vigilantly while staying close to clinical reality.
p.000008:
p.000008: Analysing a research protocol involves examining and assessing the following elements:
p.000008: 1) legitimacy of the aim
p.000008: 2) proportionality of the means
p.000008: 3) qualification of investigators and the experimentation environment
p.000008: 4) free and informed consent.
...
General/Other / cioms guidelines
Searching for indicator cioms:
(return to top)
p.000007: necessarily optimal. The principle of justice also leads to the concern to offer and guarantee fair access to quality
p.000007: health care.
p.000007: For additional information, see Introductory Report, C., 4.
p.000007:
p.000007:
p.000007: C. WHAT IS THE NORMATIVE FRAMEWORK FOR HUMAN EXPERIMENTATION?
p.000007:
p.000007:
p.000007: Belgian law is incomplete as regards human experimentation.
p.000007: In addition to Belgian legislation, there are also European and international normative texts and deontological rules
p.000007: (see Introductory Report, D.).
p.000007:
p.000007: The Advisory Committee suggests:
p.000007: 1) setting up legally established local ethics committees as bodies for the assessment of human experimentation
p.000007: protocols, with clearly defined areas of competence;
p.000007: 2) harmonisation of national, European and international standards in the field of human experimentation and
p.000007: complementarity between the deontological rules and the legal rules;
p.000007: 3) a framework law containing legal rules on ethics committees, the rights and duties of
p.000007:
p.000007: 4 Among others: The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research,
p.000007: The Belmont Report, 1978; Council for International Organizations of Medical Sciences (CIOMS), in collab. with World
p.000007: Health Association (WHO), International Ethical Guidelines for Biomedical Research Involving Human Subjects, 1993, as
p.000007: well as: Conseil de recherches médicales du Canada, Conseil de recherché en sciences naturelles du Canada and Conseil
p.000007: de recherches en sciences sur l’homme du Canada, Code d’éthique de la recherché sur l’homme, 1997.
p.000007: Opinion no. 13 of 9 July 2001 – Final version
p.000008: 8
p.000008:
p.000008: everyone concerned, their liability and insurance.
p.000008:
p.000008: 1. Ethics committees as assessment bodies
p.000008:
p.000008: Ethics committees basically fulfil two roles: the application of principles that set standards in human
p.000008: experimentation and discussion of the problems raised by each individual case. From this point of view, ethics
p.000008: committees become the main forums for the regulation of clinical research. They thus offer the advantage of forming a
p.000008: flexible system that can be used to manage the ethical problems raised by human experimentation
p.000008: pragmatically but vigilantly while staying close to clinical reality.
p.000008:
p.000008: Analysing a research protocol involves examining and assessing the following elements:
p.000008: 1) legitimacy of the aim
p.000008: 2) proportionality of the means
p.000008: 3) qualification of investigators and the experimentation environment
p.000008: 4) free and informed consent.
p.000008: For additional information, see Introductory Report, F.
p.000008:
...
p.000020: Without calling into question the compulsory nature of free and informed consent, it should be pointed
p.000020: out that a careful analysis of international medical ethics and of Belgian deontology and law indicates that
p.000020: these normative sets all contain provisions that indicate a tendency to protect individuals, irrespective of
p.000020: any wish they may express. While consent must not be regarded as sacred, considered to be the sole expression of an
p.000020: individual’s autonomy – which itself is wrongly identified with the dignity of human beings – it nevertheless plays
p.000020: a central role in a view that enhances the value of partnership. It is, however, important to stress
p.000020: that irrespective of the situation as regards standards, ethics committees remain vigilant regarding related
p.000020: questions.
p.000020:
p.000020: f. INSURANCE
p.000020:
p.000020: Whatever the causes and provided it relates to the experiment, any harm suffered by trial subjects, patients or healthy
p.000020: volunteers must be covered by insurance.
p.000020: According to Article 6.3 i) of European Directive 2001/20 EC of 4 April 2001 (O.J. 1 May 2001), ethics committees must
p.000020: ensure that the experimentation is covered by insurance
p.000020:
p.000020: 7 Cf. in particular: CIOMS, International Ethical Guidelines for Biomedical Research Involving Human
p.000020: Subjects, 1993, Guideline 14, Commentary, p. 38-39.
p.000020: Opinion no. 13 of 9 July 2001 – Final version
p.000021: 21
p.000021:
p.000021: and check the clauses of this insurance.
p.000021:
p.000021: g. SHOULD ALL EXPERIMENTATION PROTOCOLS BE SUBMITTED FOR ASSESSMENT BY AN ETHICS COMMITTEE?
p.000021:
p.000021: The main aim of the rule underlying this question is to provide protection for those involved. However,
p.000021: this objective cannot be achieved. In fact, the cumbersome nature of the administrative procedure can lead to the
p.000021: planned medical activity being considered a therapeutic innovation rather than an experiment. Moreover, while the
p.000021: problem that the submission of experimentation protocols to the ethics committee is intended to resolve is that of
p.000021: the risks involved, there are many risk situations which are not collectively assessed if the doctors
p.000021: confine themselves to formal compliance with the requirements. This demonstrates the benefit of increasing
p.000021: awareness of ethics: it enables a more qualified assessment of the stakes for the various parties involved. It
p.000021: should also make it possible to avoid the situation in which always striving to protect people better, the
p.000021: regulations become ever more extensive, so that they weigh increasingly heavily and consequently give rise
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.000014: want to achieve.
p.000014:
p.000014: By analysing objectives and values, it is possible to determine our expectations as regards those involved in the
p.000014: experimentation, the attitudes needed and ethical requirements that this type of activity should fulfil.
p.000014:
p.000014: Examining attitudes and requirements will result in a debate on the issue of whether a normative
p.000014: framework relating to human experimentation is desirable and even necessary (Part E). This normative
p.000014: framework, made up of ethical, deontological and legal rules, may provide indications on how to proceed when carrying
p.000014: out human experimentation so as to
p.000014: Opinion no. 13 of 9 July 2001 – Final version
p.000015: 15
p.000015:
p.000015: guarantee its ethical quality.
p.000015:
p.000015: The debate on a normative framework seeks to fulfil a twofold objective: on the one hand, to make clear what are the
p.000015: ethical standards relating to the experimentation regarding which a consensus can be reached within the Advisory
p.000015: Committee; on the other hand, to indicate the extent to which the ethical requirements and standards to be
p.000015: met by the various players have to be established by legal rules.
p.000015:
p.000015:
p.000015: B. DEFINITIONS
p.000015:
p.000015: Ethical reflections, the analysis of objectives and values and the formulation of standards for a specific activity
p.000015: assume the use of clear and correct concepts.
p.000015: When establishing its own key concepts, the Advisory Committee took inspiration from the following:
p.000015:
p.000015: 1. the Declaration of Helsinki adopted by the World Medical Association in June 1964 (amended in
p.000015: Tokyo in October 1983, then in Hong Kong in September 1989, in Somerset West (Republic of South Africa) in
p.000015: October 1996 and finally in Edinburgh in October 2000),
p.000015: 2. the Dictionnaire Permanent de Bioethique, Ed. Legislatives, Montrouge, France,
p.000015: 3. the Encyclopedia of Applied Ethics, Editor CHADWICK, R., 4 volumes, Academic Press, USA, 1998
p.000015: 4. the Guidelines for Good Clinical Practice (G.C.P.) of the International Conference on
p.000015: Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH),
p.000015: 5. European Directive 2001/20/EC of 4 April 2001 on the approximation of the laws, regulations and
p.000015: administrative provisions of the Member States relating to the implementation of good clinical practice in the
p.000015: conduct of clinical trials on medicinal products for human use (O.J. 1 May 2001), and
p.000015: 6. Article ATLAN, H., “Distinctions necessaires: l’innovation therapeutique, l’expérimentation sur
p.000015: l’adulte, l’expérimentation sur l’embryon”, in the collective work “Expérimentation biomédicale et Droits de
p.000015: l’Homme”, PUF, Paris, 1988.
p.000015:
p.000015: The central concept is that of experimentation.
p.000015:
p.000015: Experimenting means submitting to a scientific test. The researcher starts from an assumption and
p.000015: wants to see whether, when confronted with the facts, this assumption is confirmed or invalidated.
p.000015: The objective of experimentation is the acquisition of general knowledge that is beneficial to the community and to
...
p.000021: the assessment of another yields a positive response as the local experimentation conditions are not
p.000021: necessarily identical in each institution.
p.000021:
p.000021: Another approach would be to rethink the demarcation between research through experimentation and
p.000021: experimental care, first taking into consideration the risks. This would mean it would not be necessary to
p.000021: submit certain experiments to assessment by committees, while henceforth some innovations should be so submitted,
p.000021: whereas until now they have escaped because they are assimilated to care. From this point of view, it would however
p.000021: be advisable to monitor compliance with the information and consent requirements.
p.000021:
p.000021:
p.000021: 2. D. THE CURRENT NORMATIVE FRAMEWORK
p.000021:
p.000021: The legitimacy of experimentation activities is not provided for in Royal Decree No 78 of 10 November 1967 on the
p.000021: exercising of the art of curing, nursing, paramedical professions and medical commissions (Moniteur belge of 14
p.000021: November 1967), but these activities are expressly required elsewhere (act of 25 March 1964 on medicinal products
p.000021: (Moniteur belge of 17 April 1964), Royal Decree of 3 July 1969 on the registration of medicinal products (Moniteur
p.000021: belge of 10 July 1969)).
p.000021:
p.000021: Furthermore, it should be noted that the European Directive on the registration of medicinal products (Commission
p.000021: Directive 91/507/EEC of 19 July 1991) led to the integration into Belgian law of the concept of ‘good clinical
p.000021: practice’ (G.C.P.), including reference to the World Medical Association Declaration of Helsinki (Royal
p.000021: Decree of 22 September 1992 amending the Royal Decree of 16 September 1985 on the standards and protocols
p.000021: applicable to trials on medicinal products for human use (Moniteur belge of 5 December 1992)). Finally, the Medical
p.000021: Deontology Code of the National Council of the Order of Doctors of 1 March 1993, imposes on doctors deontological
p.000021: principles and recourse to the opinion of an independent ethics committee.
p.000021:
p.000021: Article 70 ter of the act on les hospitals, included in this act by Article 194 of the act of 25 January 1999 (Moniteur
p.000021: belge of 6 February 1999) now established a legal basis for local committees by stating that “all hospitals
p.000021: must have a local ethics committee” and determining their missions; according to an annulment decree from
p.000021: the Court of Arbitration of 31 October 2000, these are as follows:
p.000021: Opinion no. 13 of 9 July 2001 – Final version
p.000022: 22
p.000022:
p.000022: “1° a mission to provide support and advice concerning the ethical aspects of practical hospital care;
p.000022: 2° …;
p.000022: 3° an advisory function relating to all human experimentation protocols and human reproductive material”.
p.000022:
p.000022: These standards may, admittedly be considered inadequate. In practice, they are supplemented by the
p.000022: provisions of ‘good clinical practice’, the Declaration of Helsinki and the deontological rules.
p.000022: Moreover, human experimentation is dealt with by the Council of Europe Convention on Human Rights and Biomedicine,
p.000022: Oviedo, 4 April 1997.
p.000022: It is also worth noting in this context the European Directive 2001/20/EC of 4 April 2001 on the approximation of the
p.000022: laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical
p.000022: practice in the conduct of clinical trials on medicinal products for human use (O.J. 1 May 2001).
p.000022:
p.000022:
p.000022: 3. E. ETHICS COMMITTEES
p.000022:
p.000022: The ethics committee procedure has one characteristic whose importance must be stressed. In fact, they are based on a
p.000022: collegial and pluri-disciplinary approach and they lie between the investigator and the trial subject, unlike the
p.000022: singular colloquium between the doctor and his patient, as their mission is to assess research protocol with regard to
p.000022: bioethical standards. They have the task of monitoring the application of the five principles set out in C.4 above and
p.000022: of discussing the problems that arise in each particular case. Fulfilling this task presupposes, in any
p.000022: case, that all ethics committees refer to the same assessment criteria for protocols and that the ethics committee
p.000022: members are informed of the methodology of clinical trials. Some members believe, moreover, that familiarisation with
p.000022: the rudiments of the various disciplines underlying bioethics is desirable. As well as medical and biological
...
General/Other / oviedo
Searching for indicator oviedo:
(return to top)
p.000021: applicable to trials on medicinal products for human use (Moniteur belge of 5 December 1992)). Finally, the Medical
p.000021: Deontology Code of the National Council of the Order of Doctors of 1 March 1993, imposes on doctors deontological
p.000021: principles and recourse to the opinion of an independent ethics committee.
p.000021:
p.000021: Article 70 ter of the act on les hospitals, included in this act by Article 194 of the act of 25 January 1999 (Moniteur
p.000021: belge of 6 February 1999) now established a legal basis for local committees by stating that “all hospitals
p.000021: must have a local ethics committee” and determining their missions; according to an annulment decree from
p.000021: the Court of Arbitration of 31 October 2000, these are as follows:
p.000021: Opinion no. 13 of 9 July 2001 – Final version
p.000022: 22
p.000022:
p.000022: “1° a mission to provide support and advice concerning the ethical aspects of practical hospital care;
p.000022: 2° …;
p.000022: 3° an advisory function relating to all human experimentation protocols and human reproductive material”.
p.000022:
p.000022: These standards may, admittedly be considered inadequate. In practice, they are supplemented by the
p.000022: provisions of ‘good clinical practice’, the Declaration of Helsinki and the deontological rules.
p.000022: Moreover, human experimentation is dealt with by the Council of Europe Convention on Human Rights and Biomedicine,
p.000022: Oviedo, 4 April 1997.
p.000022: It is also worth noting in this context the European Directive 2001/20/EC of 4 April 2001 on the approximation of the
p.000022: laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical
p.000022: practice in the conduct of clinical trials on medicinal products for human use (O.J. 1 May 2001).
p.000022:
p.000022:
p.000022: 3. E. ETHICS COMMITTEES
p.000022:
p.000022: The ethics committee procedure has one characteristic whose importance must be stressed. In fact, they are based on a
p.000022: collegial and pluri-disciplinary approach and they lie between the investigator and the trial subject, unlike the
p.000022: singular colloquium between the doctor and his patient, as their mission is to assess research protocol with regard to
p.000022: bioethical standards. They have the task of monitoring the application of the five principles set out in C.4 above and
p.000022: of discussing the problems that arise in each particular case. Fulfilling this task presupposes, in any
p.000022: case, that all ethics committees refer to the same assessment criteria for protocols and that the ethics committee
p.000022: members are informed of the methodology of clinical trials. Some members believe, moreover, that familiarisation with
p.000022: the rudiments of the various disciplines underlying bioethics is desirable. As well as medical and biological
p.000022: information, provision should also be made for an initiation into law and medical ethics.
p.000022:
p.000022:
p.000022: 1. COMPOSITION
p.000022:
...
p.000022: neither a directive nor an
p.000022: Opinion no. 13 of 9 July 2001 – Final version
p.000023: 23
p.000023:
p.000023: authorisation and moreover, it is not carrying out the experimentation itself. Nevertheless, the Advisory Committee
p.000023: recommends that the hospital should take out adequate insurance to cover the members of the ethics committee for the
p.000023: consequences of any lawsuits.
p.000023:
p.000023:
p.000023: 4. OPTIONS TO BE TAKEN
p.000023:
p.000023: a. NEED FOR AN ADVISORY OR A BINDING OPINION?
p.000023:
p.000023: The principle whereby a research protocol should be given a positive opinion from an ethics committee, the monitoring
p.000023: framework (assessment criteria) and the assessment structure (missions and composition) are taken from various
p.000023: international documents:
p.000023: - ICH guidelines,
p.000023: - Directive 2001/20/EC of 4 April 2001 on the
p.000023: approximation of the laws, regulations and administrative provisions of the Member States relating to the
p.000023: implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
p.000023: (O.J. 1 May 2001),
p.000023: - the Council of Europe Convention on Human Rights and Biomedicine,
p.000023: Oviedo, 4 April 1997.
p.000023:
p.000023: Nevertheless, some members criticise this requirement for a mandatory positive opinion and put forward arguments in
p.000023: favour of a non-binding opinion, as currently required by Belgian legislation8.
p.000023:
p.000023: b. PROFESSIONALISATION OF ETHICS COMMITTEES?
p.000023:
p.000023: Some members are concerned about the professionalisation of local ethics committees, which would entail the risk of a
p.000023: loss of perception of the reality on the ground. On the other hand, promoting the competence of the committee members
p.000023: is desirable.
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023:
p.000023: 8 See opinion, C.1.
p.000023: Opinion no. 13 of 9 July 2001 – Final version
p.000024: 24
p.000024:
p.000024: c. RESTRUCTURING ETHICS COMMITTEES TO FORM LOCAL COMMITTEES AND ‘REGIONAL’ COMMITTEES?
p.000024:
p.000024: Some members of the Advisory Committee recommend introducing ‘regional’ committees alongside local ethics committees.
...
General/Other / participants in a control group
Searching for indicator placebo:
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p.000016: experimentation, the cognitive objective takes precedence. From this point of view, a therapeutic objective
p.000016: which is added to the cognitive objective of an experiment can only ever be considered a secondary objective; under no
p.000016: circumstances does it annul or attenuate the experimental (and therefore primarily cognitive) nature of
p.000016: the procedure undertaken.
p.000016: Opinion no. 13 of 9 July 2001 – Final version
p.000017: 17
p.000017:
p.000017: and whose organism or mind is the subject of the research.
p.000017:
p.000017: The experimenter or investigator is the person in charge of conducting the clinical study. When the study is
p.000017: carried out by a team of people, an investigator is the head or leader of this team, in charge of the team as a whole.
p.000017: He is referred to as the principal investigator.
p.000017:
p.000017: The sponsor or body subsidising the study is the person, the company, the institution or the body that takes
p.000017: responsibility for devising, managing and funding the clinical study.
p.000017:
p.000017: The experimental protocol is a document that describes, in particular, the objectives, the procedure, the
p.000017: methodology, the statistical elements and the organisation of the study. The experimental protocol also usually
p.000017: explains the foundations of and justifications for the study, even though this information may also appear in
p.000017: other documents to which reference is made in the experimental protocol.
p.000017:
p.000017: A placebo is a tablet, an injection or a treatment which the trial subject believes will have an effect (positive or
p.000017: negative) on his state of health and which, owing to this conviction on the part of the person concerned, can actually
p.000017: have such an effect, but which the investigator is convinced is inert vis-à-vis the state of the trial subject.
p.000017:
p.000017: When, in the context of any experiment during which a treatment is compared to an acknowledged existing
p.000017: treatment or a placebo, one or several of the parties concerned are kept in ignorance of the allocation of
p.000017: treatments to the trial subjects (e.g. the active treatment or the placebo), this is known as a blind
p.000017: study. The experiment is single blind when only the trial subjects are not informed; it is double blind) when the
p.000017: investigator, his team, the supervisor and, in some cases, the data analyst or analysts are also unaware which subject
p.000017: is given which treatment.
p.000017:
p.000017: Basic research is research during which phenomena are studied with a view to improving scientific knowledge,
p.000017: but without any direct intention of applying this knowledge in practice.
p.000017:
p.000017: Applied research, on the other hand, involves experimentation where the objective is to apply the
p.000017: scientific knowledge acquired to practical situations such as illnesses.
p.000017:
p.000017: Randomisation is the use of chance to determine the allocation of trial subjects to treatment or control groups; the
p.000017: aim here is to reduce bias which may distort the conclusions.
p.000017:
p.000017: The control treatment is the better medical treatment or the usual medical treatment for a patient or, for instance if
p.000017: there is no such treatment, the placebo treatment with which the experimental treatment is being compared.
p.000017:
p.000017: Bias is the term used if a systematic error is observed in the experimental protocol that is likely to have led to
p.000017: distorted conclusions.
p.000017:
p.000017: An experimentation protocol must be submitted to a local ethics committee for an opinion. A local ethics committee is
p.000017: understood here to refer to the local ethics committees instituted by Article 70 ter of the act of 7 August 1987 on
p.000017: hospitals (inserted by Article 194 of the act of 25 January 1999, Moniteur belge (Belgian official journal) of
p.000017: 6 February 1999). The Advisory Committee points out that, as regards its advisory mission, the local
p.000017: ethics committee has a twofold task of ‘assessment and supervision of the research’.
p.000017: In the context of this report, the term used will be ‘ethics committee’.
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017:
p.000017: Opinion no. 13 of 9 July 2001 – Final version
p.000018: 18
p.000018:
p.000018: C. MEDICAL-SCIENTIFIC RESEARCH ON HUMANS – ETHICAL AND LEGAL PROBLEMS
p.000018:
p.000018: 1. 1. LEGITIMACY BASED ON EFFICACY
p.000018:
p.000018: The history of experimentation in medicine coincides with the gradual learning of how to experiment on
p.000018: human subjects appropriately, both in terms of methodology and from an ethical point of view. The use of human
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Orphaned Trigger Words
p.000009:
p.000009: By virtue of Good Clinical Practice (G.C.P.), the ethics committee is given responsibility for ongoing re-assessment:
p.000009: an ethics committee must stay regularly informed of the progress made in the practical application of a
p.000009: research protocol, at a frequency in proportion to the risk incurred by the subjects. Unlike the period
p.000009: of six months recommended by the G.C.P. directive, the Advisory Committee suggests at least annual follow-up. This
p.000009: obligation means that the ethics committee may take the initiative to question the researcher. The latter
p.000009: must, however, make sure that this re-assessment by the ethics committee is possible. He must also take the
p.000009: initiative to inform the ethics committee of any serious complication or new relevant data (positive or negative).
p.000009: The ethics committee has to re-assess a research protocol in the light of these new elements. It must also react to
p.000009: these new elements when the study is over.
p.000009: Nevertheless, some members of the Advisory Committee believe it is highly desirable that this follow-up
p.000009: mission should not be entrusted to ethics committees.
p.000009:
p.000009: 2. Harmonisation of legal standards and complementarity of deontological and legal rules – Advocates and opponents
p.000009:
p.000009: The question of the respective roles of ethics and the law is complex and controversial because it involves various
p.000009: philosophical views of the role of the law in a pluralist society.
p.000009:
p.000009: a. ARGUING IN FAVOUR OF A NORMATIVE POLYPHONY
p.000009:
p.000009: Here in Belgium, human experimentation is now underpinned by various standards, international medical ethics,
p.000009: deontology and Belgian law. Some people believe that this situation is characterised by a normative polyphony.
p.000009: The idea of normative polyphony refers to the collaboration of separate normative sets in that they are each
p.000009: prompted by a specific logic that corresponds to their own function. Medical ethics, as expressed in the international
p.000009: recommendations, and deontology aim to define the obligations of doctors so as to guarantee the quality of professional
p.000009: behaviour; the protection of the subjects is therefore only considered through this particular prism as a duty of the
p.000009: doctor. The law pursues a different objective: to organise relations between the parties concerned, taking into account
p.000009: their respective interests; the protection of the subjects is therefore not only a duty of the doctor, but is also
p.000009: linked to the recognition of rights that are specific to the subjects.
p.000009: Despite the apparent but deceptive similarity of the concepts invoked by these three normative sets, each
p.000009: of them tackles the questions from a specific angle which supplements the approach of the others. This is why
p.000009: the advocates of this option believe that it is important for the law to watch over the situation, since ultimately,
...
p.000010: of protecting people more effectively, precisely because this protection is considered from multiple points of view.
p.000010: In fact, the gaps in Belgian law as regards human experimentation are clear and need to be filled. From this point
p.000010: of view of a normative polyphony, the feeling is on the one hand that the law cannot provide for everything or
p.000010: cover everything and on the other that situations involving human experimentation harbour issues that only appear
p.000010: clearly to a professional conscience aware of the ethical aspects. This is why collaboration between normative sets,
p.000010: organised by law, is ultimately seen as the most satisfactory way of dealing with the complex problem of
p.000010: human experimentation.
p.000010:
p.000010: b. REJECTION OF ALL LEGAL FORMALISM
p.000010:
p.000010: However, unlike this ‘polyphony’, the current trend is leading to the introduction into law of rules of another kind
p.000010: (G.C.P. rules, rules of medical ethics or deontology). In the eyes of the advocates of the normative polyphony,
p.000010: this situation should be assessed in qualified terms. If fact, while the law has the advantage of being able to
p.000010: penalise failure to comply with the rules it sets out, it nevertheless only requires formal compliance with these
p.000010: rules. The ‘leave it all to the law’ trend therefore risks leading to the ‘de- moralisation’ – in the
p.000010: literal sense of the term – of the scientific community which could be content simply to abide formally by the rules
p.000010: imposed.
p.000010: One question is illustrative in this respect: should all experimentation protocols be submitted for the
p.000010: assessment of an ethics committee? The main objective of this rule is to provide protection for the people involved.
p.000010: However, this objective cannot be attained. While the problem that the submission of experimentation protocols
p.000010: to the ethics committee is intended to resolve is that of risks, there are many risky situations that do not undergo
p.000010: collective assessment, if the doctors are satisfied with formal compliance with the requirements. This shows
p.000010: the contribution made by ethical awareness in this area: it permits a more qualified assessment of the
p.000010: issues for the different parties involved. It should also make it possible to avoid a situation in which, always
p.000010: wanting to improve the protection of individuals, the regulations become increasingly extensive, and therefore weigh
p.000010: increasingly heavily, thus giving rise to strategies aimed at avoiding them. The cumbersomeness of the
p.000010: administrative process could therefore lead to the medical activity that is to be undertaken being qualified as
p.000010: therapeutic innovation rather than experimentation.
p.000010:
p.000010: c. REQUIREMENTS BEYOND THE LAW
p.000010:
p.000010: To be truly fulfilled, the medical ethics requirements that currently underpin human experimentation
p.000010: activities require not only formal compliance but also a state of mind marked by attention to individuals, in
p.000010: particular when obtaining consent, and the ability to enter into and maintain a non-binding dialogue.
p.000010: Considering the relationship between the investigator and the trial subject as a partnership in
p.000010: fact presupposes qualities on a human level that go beyond the requirements that can be imposed by legal
p.000010: rules: having the willingness, on the part of the investigator, to discuss the research project in the context of
p.000010: personal contact with each trial subject, having the required communication skills, identifying the clinical
p.000010: picture of each participant in the trial and closely following their development as the experiment
p.000010: proceeds, continuing to openly and frankly inform the trial subject and, if need be, consulting and
p.000010: deliberating with him.
p.000010: The trial subject cannot, therefore, be an anonymous number in a series of participants. As in the doctor-patient
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| belmont | belmont |
| blind | visual impairment |
| breastfeeding | breastfeeding |
| cadavers | Cadavers |
| children | Child |
| cioms | cioms guidelines |
| cognitive | Cognitive Impairment |
| conviction | Religion |
| criminal | criminal |
| disabled | Mentally Disabled |
| drug | Drug Usage |
| educational | education |
| elderly | Elderly |
| family | Motherhood/Family |
| healthy volunteers | Healthy People |
| helsinki | declaration of helsinki |
| ill | ill |
| incapable | Mentally Incapacitated |
| language | Linguistic Proficiency |
| manipulated | Manipulable |
| mentally | Mentally Disabled |
| military | Soldier |
| opinion | philosophical differences/differences of opinion |
| oviedo | oviedo |
| party | political affiliation |
| placebo | participants in a control group |
| police | Police Officer |
| pregnant | Pregnant |
| prisoners | Criminal Convictions |
| single | Marital Status |
| unconscious | Unconscious People |
| victim | Victim of Abuse |
| volunteers | Healthy People |
| vulnerability | vulnerable |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| disabled | ['mentally'] |
| healthy volunteers | ['volunteers'] |
| mentally | ['disabled'] |
| volunteers | ['healthyXvolunteers'] |
| vulnerability | ['vulnerable'] |
| vulnerable | ['vulnerability'] |
Trigger Words
capacity
consent
cultural
developing
ethics
harm
justice
protect
protection
risk
self-determination
volunteer
Applicable Type / Vulnerability / Indicator Overlay for this Input