79C3C34C52B45572883A05D425EB0F82

Opinion no. 36 of 11 September 2006 on the ethical testing of research in certain branches of the life sciences

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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)


Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability TypeVulnerabilityIndicator# Matches
Politicalpolitical affiliationparty2
Politicalpolitical affiliationpolitical3
Politicalvulnerablevulnerable2
HealthDrug Usagedrug2
HealthDrug Usageinfluence4
HealthHealthy Peoplehealthy volunteers1
HealthHealthy Peoplevolunteers1
HealthPhysically Illsick1
SocialAccess to Social Goodsaccess1
SocialAgeage1
SocialChildchild1
SocialChildchildren3
SocialElderlyelderly1
SocialFetus/Neonatefoetus1
SocialIncarceratedprison2
SocialLinguistic Proficiencylanguage1
SocialOccupationjob2
SocialProperty Ownershiphome1
SocialRacial Minorityracist1
SocialStudentstudent1
SocialUnemploymentunemployment1
Socialeducationeducational15
Socialemployeesemployees1
Socialparentsparent1
Socialparentsparents2
Socialphilosophical differences/differences of opinionopinion32
General/OtherImpaired Autonomyautonomy2
General/OtherManipulablemanipulated1
General/OtherRelationship to Authorityauthority3
General/Otherparticipants in a control groupplacebo3

Political / political affiliation

Searching for indicator party:

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p.000008: who are not members of the scientific community. These aforementioned bodies resemble local medical ethics committees
p.000008: or ethics committees in life sciences faculties.
p.000008: According to the Caverni code researchers should guarantee respect for and protection of the people taking part in the
p.000008: study and should moreover vouch for respect for human beings and for life in general. They are obliged to respect
p.000008: confidentiality vis-à-vis everything they may have learnt about the participants in the study. The researcher is
p.000008: responsible for protection and confidentiality of the data.
p.000008: Before participation in any study, the people approached must explicitly give their informed and free consent. They
p.000008: must be informed, in a manner comprehensible to them, of all aspects that could influence their consent (risks,
p.000008: inconvenience, immediate or deferred negative effects, limitation of confidentiality, etc.), as well as the
p.000008: study’s objectives and the procedure to be used. The position of authority that the researcher generally has may not be
p.000008: used to induce the potential participant to give his consent.
p.000008: The party concerned may withdraw from the study after he has obtained information, or even when the experiment is under
p.000008: way.
p.000008: Before their possible participation, people must know that they are free to take part or not to take part, without a
p.000008: refusal on their part having any negative consequences of any kind for them (here we are thinking of students or
p.000008: members of staff). That is precisely what is applied in the case of medical experiments.
p.000008: Now, there may be cases of certain people not being in a position to give their free and informed consent (children and
p.000008: vulnerable people, for example). In such cases the researcher has to obtain “autorisation appropriée” (suitable
p.000008: authorisation) from a legally authorised person. However, he must give the person wishing to take part in the study
p.000008: “des explications appropriées” (suitable explanations) at all times, and obtain his “assentiment” (consent) in
p.000008: circumstances that are as close as possible to the circumstances in which ordinary people find themselves.
p.000008: The researcher does not have to secure the consent of the test subjects if non-identifiable data are collected which
p.000008: only relate to observations in a natural setting or relate to isolated data from archives.
p.000008: The freedom to consult certain elements of an archive does not yet give entitlement to consultation of
p.000008: the entire archive or file.
p.000008:
p.000009: 9
p.000009: Opinion no. 36 of 11 September 2006 – Final version
p.000009:
...

p.000012:
p.000012: As regards sociology and criminology, the experts who were heard by the select committee display a certain reservation
p.000012: about the setting up of an ethics committee that would assess the ethical value of their research projects. Of the view
p.000012: that they are the preferential witnesses of society’s growing interference in people’s private lives and the increased
p.000012: social pressure (at economic, political and other levels) that this exerts on individuals on a day-to-day basis, they
p.000012: fear that ethics committees could curb their studies and thereby prevent them from bringing certain dysfunctions or
p.000012: pressures to light.
p.000012: On the other hand, they advocate the setting up of a code of professional practice specific to their profession and
p.000012: containing ethical guidelines for researchers. These guidelines of course relate to the informed consent of the persons
p.000012: studied and respect for their privacy.
p.000012: One expert is of the view that an ethics committee at inter-university level could be useful. This committee would only
p.000012: be allowed to have an advisory role.
p.000012: Two experts who were interviewed also complained of the existence of collusion between life sciences research and the
p.000012: political establishment, which is often the party subsidising the studies and tends to orientate the research according
p.000012: to its objectives.
p.000012:
p.000012: Some members of the Committee and the experts interviewed stress that university research budgets have been
p.000012: severely scaled down in the last few decades. The possibility of the various centres taking on researchers, carrying
p.000012: out research and producing publications, depends more on research budgets from outside the university, which are often
p.000012: granted by the government. For example, a minister is looking for an answer to a particular problem and commissions a
p.000012: study, in the pursuit of political efficiency. Unfortunately, research seldom delivers unambiguous solutions for
p.000012: contemporary social problems. If the result of the study does not answer the question posed by the commissioning
p.000012: authority, or does not meet the latter’s wishes, there is a good chance that the centre will not receive any further
p.000012: subsidies for a subsequent study. When the study attempts to reach a solution that tallies with the commissioning
p.000012: authority’s expectations, the researchers may feel manipulated. If the centre refuses to comply, this leads in any
p.000012: case to a drop in its productivity.
p.000012:
p.000012:
p.000012: 5. Conclusions
p.000012:
p.000012: a. Ethics committees in the faculties of psychology
p.000012:
p.000012: Expediency
p.000012:
...

Searching for indicator political:

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p.000011: sociological, criminological or psychological studies, various different – and sometimes conflicting –
p.000011: theoretical bases can be used within one and the same discipline. If the job of an ethics committee is to assess the
p.000011: scientific basis of a study, it should do so without prejudice to the theoretical basis from which the study draws its
p.000011: inspiration. There may indeed be contradictions at theoretical level which do not, however, challenge the
p.000011: relevance of the research.
p.000011:
p.000011: The French-speaking experts, and the Dutch-speaking expert, who were interviewed by the select committee are in
p.000011: favour of ethics committees being set up. The faculties of psychology and educational sciences are also
p.000011: reportedly advocates of ethics committees being set up in the faculties.
p.000011:
p.000012: 12
p.000012: Opinion no. 36 of 11 September 2006 – Final version
p.000012:
p.000012: As regards sociology and criminology, the experts who were heard by the select committee display a certain reservation
p.000012: about the setting up of an ethics committee that would assess the ethical value of their research projects. Of the view
p.000012: that they are the preferential witnesses of society’s growing interference in people’s private lives and the increased
p.000012: social pressure (at economic, political and other levels) that this exerts on individuals on a day-to-day basis, they
p.000012: fear that ethics committees could curb their studies and thereby prevent them from bringing certain dysfunctions or
p.000012: pressures to light.
p.000012: On the other hand, they advocate the setting up of a code of professional practice specific to their profession and
p.000012: containing ethical guidelines for researchers. These guidelines of course relate to the informed consent of the persons
p.000012: studied and respect for their privacy.
p.000012: One expert is of the view that an ethics committee at inter-university level could be useful. This committee would only
p.000012: be allowed to have an advisory role.
p.000012: Two experts who were interviewed also complained of the existence of collusion between life sciences research and the
p.000012: political establishment, which is often the party subsidising the studies and tends to orientate the research according
p.000012: to its objectives.
p.000012:
p.000012: Some members of the Committee and the experts interviewed stress that university research budgets have been
p.000012: severely scaled down in the last few decades. The possibility of the various centres taking on researchers, carrying
p.000012: out research and producing publications, depends more on research budgets from outside the university, which are often
p.000012: granted by the government. For example, a minister is looking for an answer to a particular problem and commissions a
p.000012: study, in the pursuit of political efficiency. Unfortunately, research seldom delivers unambiguous solutions for
p.000012: contemporary social problems. If the result of the study does not answer the question posed by the commissioning
p.000012: authority, or does not meet the latter’s wishes, there is a good chance that the centre will not receive any further
p.000012: subsidies for a subsequent study. When the study attempts to reach a solution that tallies with the commissioning
p.000012: authority’s expectations, the researchers may feel manipulated. If the centre refuses to comply, this leads in any
p.000012: case to a drop in its productivity.
p.000012:
p.000012:
p.000012: 5. Conclusions
p.000012:
p.000012: a. Ethics committees in the faculties of psychology
p.000012:
p.000012: Expediency
p.000012:
p.000012: The experts whose opinions were heard and the members of the Advisory Committee for Bio- ethics are in favour of ethics
p.000012: committees being set up in faculties of psychology. Some faculties already have their ethics committee and there are
p.000012: many arguments advocating the establishment of such committees. Even though the risk for the participants in such
p.000012: studies is seldom one of physical and mental harm, it is nonetheless important that that risk be examined. The examples
...

Political / vulnerable

Searching for indicator vulnerable:

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p.000008: responsible for protection and confidentiality of the data.
p.000008: Before participation in any study, the people approached must explicitly give their informed and free consent. They
p.000008: must be informed, in a manner comprehensible to them, of all aspects that could influence their consent (risks,
p.000008: inconvenience, immediate or deferred negative effects, limitation of confidentiality, etc.), as well as the
p.000008: study’s objectives and the procedure to be used. The position of authority that the researcher generally has may not be
p.000008: used to induce the potential participant to give his consent.
p.000008: The party concerned may withdraw from the study after he has obtained information, or even when the experiment is under
p.000008: way.
p.000008: Before their possible participation, people must know that they are free to take part or not to take part, without a
p.000008: refusal on their part having any negative consequences of any kind for them (here we are thinking of students or
p.000008: members of staff). That is precisely what is applied in the case of medical experiments.
p.000008: Now, there may be cases of certain people not being in a position to give their free and informed consent (children and
p.000008: vulnerable people, for example). In such cases the researcher has to obtain “autorisation appropriée” (suitable
p.000008: authorisation) from a legally authorised person. However, he must give the person wishing to take part in the study
p.000008: “des explications appropriées” (suitable explanations) at all times, and obtain his “assentiment” (consent) in
p.000008: circumstances that are as close as possible to the circumstances in which ordinary people find themselves.
p.000008: The researcher does not have to secure the consent of the test subjects if non-identifiable data are collected which
p.000008: only relate to observations in a natural setting or relate to isolated data from archives.
p.000008: The freedom to consult certain elements of an archive does not yet give entitlement to consultation of
p.000008: the entire archive or file.
p.000008:
p.000009: 9
p.000009: Opinion no. 36 of 11 September 2006 – Final version
p.000009:
p.000009: Whenever possible and relevant, the researcher must inform the public of the knowledge collected, the
p.000009: method followed to obtain that knowledge, and the reliability thereof. He may not fail to mention the fact that the
p.000009: bulk of this knowledge is of a provisional and incomplete nature. He must see to it that the scientific knowledge is
p.000009: put to good use. In particular, he must oppose any distorted reproduction of it and the use of it for
p.000009: purposes that run counter to ethical principles.
p.000009: One heading in this code also relates to confidentiality of the data and the conditions for
p.000009: dissemination of the results.
p.000009:
p.000009: “Deception” in research
p.000009:
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p.000010:
p.000010: In the same Bioethica Forum, Ron Berghmans3 of the University of Maastricht states that “deceiving or misinforming
p.000010: subjects should be considered prima facie wrong and thus unjustified from an ethical point of view”. Nonetheless, he
p.000010: adds that people can validly agree to be given only some of the information, or not to be informed at all.
p.000010:
p.000010: d. The situation in Belgium
p.000010:
p.000010: With the exception of ethics committees in certain faculties of psychology, the Committee concludes that
p.000010: there are no ethics committees in the life sciences in Belgium. Experiments in the field of behavioural science,
p.000010: and more generally experiments in the life sciences, are not necessarily presented to medical ethics
p.000010: committees and are not assessed by ethics committees in the corresponding faculties.
p.000010:
p.000010: Studies in psychology, criminology, educational science or sociology are often conducted on people but are
p.000010: not necessarily carried out in a medical framework, and still less in a hospital. Some studies belong to the field of
p.000010: labour psychology, others relate to language use or other subjects for which there is no reason for submission to
p.000010: medical ethics committees, which in any case are not well grounded in these matters. Just like every biomedical study,
p.000010: behavioural research can also relate to vulnerable populations, such as children, prison inmates, the
p.000010: elderly, and students, and in those cases the ethical issue is all the more pertinent.
p.000010: The circumstances in which people take part in experiments in the field of behavioural science are very wide-ranging.
p.000010: All kinds of behaviour are studied: during diverse development phases, during learning processes, in normal situations,
p.000010: or in pathological circumstances. The stimuli used can also vary considerably: physical (images, noise, etc.),
p.000010: symbolic, psychological, foreign to the body or body-specific. The observed tasks or reactions can vary considerably,
p.000010: as can the characteristics of the environment concerned.
p.000010:
p.000010: As regards studies into human behaviour, these can relate to studies on premature births, babies, children, twins,
p.000010: teenagers, normal adults, or adults who are representative of a specific social group (teachers, sports freaks, etc.).
p.000010:
p.000010: Although the test subjects are usually informed and freely agree to take part, in some studies in the field of the life
p.000010: sciences special terms and stipulations may be required which violate the principle of freely informed consent
p.000010: applicable in biomedical science. We recall the generally applicable principle in medical experiments that the
p.000010: test subject must always retain his freedom to take part or not to take part, that a person’s refusal may not have any
p.000010: negative consequences whatsoever, and that no refusal may entail a change in the quality of the care
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Health / Drug Usage

Searching for indicator drug:

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p.000009: nature of the information originally supplied must always have an indisputable scientific justification. A check should
p.000009: also be made to see whether any other procedures are possible, whether the participants will be adequately informed as
p.000009: soon as possible, and whether advice will be obtained as to the way in which the complete information will be
p.000009: assimilated by the test subjects when it is passed on to them (for example consulting of people who come from
p.000009: the same cultural and social environment as the study participants). The incompleteness and inaccuracy of the
p.000009: information may never concern aspects that could influence the prospective participant’s willingness to take part
p.000009: (physical risks, inconvenience, negative emotions, etc.). The fact that comprehensive information is provided
p.000009: at the end of the study cannot in itself justify the fact that the original information was incomplete.”
p.000009: In biomedical sciences, situations where it is necessary to deceive the participant for the purposes of the result of
p.000009: the experiment hardly ever arise. In the very frequent situation in biomedical sciences in which a new medicine is
p.000009: tested by means of comparison with a placebo, the participant is always told beforehand that he might be given a
p.000009: placebo, but as soon as the patient has given his agreement and the experiment has started, he is of course not told
p.000009: whether he was given the experimental drug or the placebo.
p.000009: In behavioural sciences the “deception” of the test subject would occur very often. In the March 2005 issue of the
p.000009: journal Bioethica Forum, B. Baertschi2 estimates that deception is used in 58% of research protocols in psychology.
p.000009: The concept of “deception”, as the American Psychology Association sees it (“deception in research”), tends to mean
p.000009: a lie on account of omission or the concealing of a part of the truth. Baertschi takes account of the
p.000009: possibility of a “permitted deception” if the test subject is specifically informed beforehand that he will not be
p.000009: told everything before the experiment starts. He is of the opinion that deception in experiments can be justified on
p.000009: the grounds of the foreseeable advantages that the results of the experiment will entail. Other authors feel that
p.000009: test subjects should have it pointed out to them beforehand that some information will not be given to them
p.000009: before the experiment, but that they will be given this information after the experiment and only then have to give
p.000009: their consent for use of the data concerned (such as in the case of programmes of the “Candid Camera” variety, where
p.000009: recordings, made without the knowledge of the person concerned, are broadcast on TV). Recommendations for this have
p.000009: been drawn up by the American Psychology Society (“Ethical principles of psychologists and code of conduct”,
p.000009: June 2003).
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: 2 L’éthique de la recherche en psychologie, Bernard Baertschi, University of Geneva, in Bioethica Forum (a publication
...

p.000010: that a person who is aware that he is being observed will adjust his behaviour, which is what the study aims to
p.000010: describe. In that case it should be ensured that the test subjects or their representatives are informed, after
p.000010: the study, of the results of the experiment and the justification for it, and are given the possibility of
p.000010: agreeing to these being used. As a rule these situations are regulated by codes of good practice.
p.000010:
p.000010: Moreover, the rules for the testing of research projects are very diverse. In many cases no thought is given to the
p.000010: ethical aspects of the study, other than by those responsible for the study and the people actually carrying out the
p.000010: experiments. These studies can thus be conducted under the leadership of lecturers, recognised researchers or
p.000010: individuals holding a doctorate, but these studies can also include studies carried out in the context of a thesis
p.000010: for a master’s degree.
p.000010:
p.000010: 3 Moral aspects of deception in psychological research, Ron L.P. Berghmans, University of Maastricht, in Bioethica
p.000010: Forum (a publication of the “Société Suisse d’Éthique Biomédicale”), no. 44, March 2005, pp. 2-4.
p.000010:
p.000011: 11
p.000011: Opinion no. 36 of 11 September 2006 – Final version
p.000011:
p.000011: People who take part in behavioural analysis studies, in particular in the field of psychology, thus do not necessarily
p.000011: receive the same attention, and therefore perhaps not the same degree of protection, as participants in a clinical
p.000011: experiment in the medical field or in the study of a new drug, for example as regards insurance cover in the event of
p.000011: damage or accident.
p.000011:
p.000011: Finally, some aspects of research conducted in the field of the life sciences differ from the aspects of medical
p.000011: research, whilst other aspects show many similarities.
p.000011: Some projects in the field of the life sciences are clearly distinguishable from medical experiments when it comes to
p.000011: the objective: biomedical research always strives for advancement in medical knowledge and has a therapeutic goal in
p.000011: the shorter or longer term. Like fundamental research, research in the life sciences can aim for a better knowledge of
p.000011: our surroundings and of people’s response and adjustment mechanisms.
p.000011:
p.000011: e. Conclusions regarding general ethical requirements in experiments involving human subjects
p.000011:
p.000011: From the foregoing it emerges that experiments involving human subjects, irrespective of the framework in which they
p.000011: are conducted, must meet a number of common conditions:
p.000011: ▪ The study must be scientifically justified and should be carried out in a scientifically flawless
p.000011: manner.
p.000011: ▪ Respect for people’s freedom should be guaranteed and their free and informed consent must be obtained before
p.000011: participation in the study. Here it ought to be recalled that some experiments, especially in the field of psychology,
p.000011: are very specific in nature, and imply that the participants cannot be comprehensively informed beforehand because this
p.000011: could impact on the results. The test subjects should have it clearly explained to them that they will not be
p.000011: comprehensively and accurately informed before the experiment begins, but that they will receive all the information
...

Searching for indicator influence:

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p.000004: are administered or the interventions carried out. It is also in function of the hypotheses that
p.000004: comparable groups are put together.
p.000004:
p.000004: In some branches of the life sciences, more especially in experimental psychology and neuropsychology, the
p.000004: approach closely resembles that of experimental sciences. In other branches it can differ considerably. The
p.000004: approach in social psychology (and no doubt even more so in sociology) is more “open”, in the sense that more
p.000004: correlations and causal links are sought which do not catch the eye at first sight but which the researchers attempt to
p.000004: bring to light.
p.000004: Whereas we can certainly talk of experimental psychology, we cannot talk of experimental sociology in the
p.000004: sense of the above-mentioned definition, not even in the trends of sociology that use quantitative methods based on
p.000004: statistics.
p.000004:
p.000004: What links in most closely to traditional experiments in the quantitative trends is termed “causal” or “multivariable”
p.000004: analysis. “Suicide” by Emile Durkheim (1897) is a good example of this approach. In this study the author
p.000004: shows that the increase in the number of suicides, where other data are identical, is directly proportional to the
p.000004: number of Protestants. According to the statistical material Durkheim had at his disposal, the suicide figures in the
p.000004: Swiss cantons increased as the number of Protestants increased. Here the first two experiment conditions are met (or
p.000004: met to a greater or lesser degree): the reduction to variables and the demonstration of causality or at least a
p.000004: correlation. However, the third condition is missing: the sociologist has no influence on the protestant ethos or on
p.000004: suicidal tendencies.
p.000004: It would therefore be a major error to reduce sociology to trends that are based on statistical methods. Qualitative
p.000004: sociology is chiefly founded on hermeneutics. Without wishing to engage in a far-reaching epistemological debate –
p.000004: although this is where the difference and the controversy lie –, the distinction needs to be made between “explaining”
p.000004: and “understanding”. The explicit intention of a large number of sociologists is the understanding and explanation
p.000004: of complex processes and mechanisms through painstaking - ethnographic and quasi “entomological” -
p.000004: observation of human behaviour, methods that are not reconcilable with the statistical approach. We can refer to these
p.000004: studies as involving experiments. Harold Garfinkel, an American sociologist, asked his students to approach their
p.000004: parents as friends when they got home. The aim here was, via transgression, to reveal the precise rules that govern the
p.000004: parent-child relationship. The moral rules are often very clearly demarcated, yet may of course differ considerably
p.000004: from the agreements existing between friends. In this example, the “manipulation factor” is very much present: the
p.000004: student interferes in the type of relationship with his parents. The other two conditions, however, are not present.
p.000004: The epistemological preconception does not permit reduction to a few simple variables, and demonstrating the causality
...

p.000006: sustained to the person’s physical integrity, goods or psychological balance. This scarcely differs from what we know
p.000006: in the biomedical field.
p.000006: In the opinion paper the objectives of biomedical research are clearly distinguished from those of behavioural
p.000006: research. The CCNE is of the view that the main ethical principles governing research involving human subjects
p.000006: (justice, well-doing, respect for autonomy) and the rules stemming from them (fairness, non-discrimination, consent,
p.000006: limitation of the risks), are the same whether they be in respect of biomedical research or behavioural research. In
p.000006: the case of behavioural research, too, the research protocols would also have to be submitted to an independent and
p.000006: professional ethics committee before the research is carried out.
p.000006:
p.000006: There is also an Ethics in Science Committee (Comité d’éthique pour les Sciences - COMETS), which was set up in 1994 by
p.000006: the National Centre for Scientific Research (Centre national de la Recherche scientifique - CNRS), to deal with the
p.000006: ethical aspects of scientific research which is not handled by
p.000006:
p.000007: 7
p.000007: Opinion no. 36 of 11 September 2006 – Final version
p.000007:
p.000007: the CCNE. The subjects dealt with include studies into the influence of audio-visual techniques and into
p.000007: environmentally related problems, but also behavioural research.
p.000007:
p.000007: There is also an Operational Committee for Ethics in the Life Sciences (Comité opérationnel pour l’éthique dans les
p.000007: sciences de la vie - COPE), which is linked to the CNRS and has a threefold task: to inform researchers of the existing
p.000007: legislation, to trace any ethical problems so as to present these to the competent bodies (for example CCNE), and to
p.000007: take stock of the obstacles encountered by researchers, in order then to forward these to the CCNE or the COMETS.
p.000007:
p.000007: The CNRS’s life sciences department (Département des sciences de la vie) has a document entitled “Ethique en sciences
p.000007: de la vie” (Ethics in the Life Sciences), which was published to help researchers assess the stress and risk level
p.000007: to which study participants are exposed and the degree of invasiveness of the research techniques. Some
p.000007: studies are considered as stress-free, in particular when they relate to everyday activities carried out by the
p.000007: participants where it is known that these do not entail any special risk whatsoever (for example a study of a
p.000007: physiological movement which is not of any unusual scope or duration, an observation of test subjects in a driving
p.000007: simulator, and so on). In the case of research “with stress”, on the other hand, the study participant runs a
p.000007: heightened, variable risk (for example a study of a movement carried out in unusual circumstances,
...

p.000008: to the improvement of human welfare, both individually and socially.
p.000008: The researcher must be a professional person who is responsible at scientific and ethical level for the studies he
p.000008: plans and conducts. Assessment by an ethics committee is not specifically laid down in the code, but it is stated that
p.000008: whenever there is the possibility of a study exceeding the generally recognised rules, the researcher should obtain the
p.000008: positive opinion of his peers and if necessary, also of recognised bodies in which there are representatives of society
p.000008: who are not members of the scientific community. These aforementioned bodies resemble local medical ethics committees
p.000008: or ethics committees in life sciences faculties.
p.000008: According to the Caverni code researchers should guarantee respect for and protection of the people taking part in the
p.000008: study and should moreover vouch for respect for human beings and for life in general. They are obliged to respect
p.000008: confidentiality vis-à-vis everything they may have learnt about the participants in the study. The researcher is
p.000008: responsible for protection and confidentiality of the data.
p.000008: Before participation in any study, the people approached must explicitly give their informed and free consent. They
p.000008: must be informed, in a manner comprehensible to them, of all aspects that could influence their consent (risks,
p.000008: inconvenience, immediate or deferred negative effects, limitation of confidentiality, etc.), as well as the
p.000008: study’s objectives and the procedure to be used. The position of authority that the researcher generally has may not be
p.000008: used to induce the potential participant to give his consent.
p.000008: The party concerned may withdraw from the study after he has obtained information, or even when the experiment is under
p.000008: way.
p.000008: Before their possible participation, people must know that they are free to take part or not to take part, without a
p.000008: refusal on their part having any negative consequences of any kind for them (here we are thinking of students or
p.000008: members of staff). That is precisely what is applied in the case of medical experiments.
p.000008: Now, there may be cases of certain people not being in a position to give their free and informed consent (children and
p.000008: vulnerable people, for example). In such cases the researcher has to obtain “autorisation appropriée” (suitable
p.000008: authorisation) from a legally authorised person. However, he must give the person wishing to take part in the study
p.000008: “des explications appropriées” (suitable explanations) at all times, and obtain his “assentiment” (consent) in
p.000008: circumstances that are as close as possible to the circumstances in which ordinary people find themselves.
...

p.000009: put to good use. In particular, he must oppose any distorted reproduction of it and the use of it for
p.000009: purposes that run counter to ethical principles.
p.000009: One heading in this code also relates to confidentiality of the data and the conditions for
p.000009: dissemination of the results.
p.000009:
p.000009: “Deception” in research
p.000009:
p.000009: One special point in the Caverni code concerns the possibility of the information supplied by the researcher being
p.000009: incomplete or even inaccurate. The aforesaid code states that: “(our translation) when, for scientifically valid
p.000009: reasons, the test subject cannot be fully informed of the objectives pursued before the study gets under way, it is
p.000009: agreed that he is informed only in an incomplete fashion beforehand and that the information knowingly contains
p.000009: incorrect elements. However, he must be fully informed at the end of his participation. The incomplete and incorrect
p.000009: nature of the information originally supplied must always have an indisputable scientific justification. A check should
p.000009: also be made to see whether any other procedures are possible, whether the participants will be adequately informed as
p.000009: soon as possible, and whether advice will be obtained as to the way in which the complete information will be
p.000009: assimilated by the test subjects when it is passed on to them (for example consulting of people who come from
p.000009: the same cultural and social environment as the study participants). The incompleteness and inaccuracy of the
p.000009: information may never concern aspects that could influence the prospective participant’s willingness to take part
p.000009: (physical risks, inconvenience, negative emotions, etc.). The fact that comprehensive information is provided
p.000009: at the end of the study cannot in itself justify the fact that the original information was incomplete.”
p.000009: In biomedical sciences, situations where it is necessary to deceive the participant for the purposes of the result of
p.000009: the experiment hardly ever arise. In the very frequent situation in biomedical sciences in which a new medicine is
p.000009: tested by means of comparison with a placebo, the participant is always told beforehand that he might be given a
p.000009: placebo, but as soon as the patient has given his agreement and the experiment has started, he is of course not told
p.000009: whether he was given the experimental drug or the placebo.
p.000009: In behavioural sciences the “deception” of the test subject would occur very often. In the March 2005 issue of the
p.000009: journal Bioethica Forum, B. Baertschi2 estimates that deception is used in 58% of research protocols in psychology.
p.000009: The concept of “deception”, as the American Psychology Association sees it (“deception in research”), tends to mean
p.000009: a lie on account of omission or the concealing of a part of the truth. Baertschi takes account of the
p.000009: possibility of a “permitted deception” if the test subject is specifically informed beforehand that he will not be
...

Health / Healthy People

Searching for indicator healthy volunteers:

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p.000004: from the agreements existing between friends. In this example, the “manipulation factor” is very much present: the
p.000004: student interferes in the type of relationship with his parents. The other two conditions, however, are not present.
p.000004: The epistemological preconception does not permit reduction to a few simple variables, and demonstrating the causality
p.000004: is not the end objective. Therefore here we can only refer to a perception or observation, but not an “experiment” in
p.000004: the meaning used in experimental social psychology and in medicine when clinical trials are involved.
p.000004:
p.000004:
p.000005: 5
p.000005: Opinion no. 36 of 11 September 2006 – Final version
p.000005:
p.000005: 2. Risks for test subjects taking part in research in the life sciences
p.000005:
p.000005: Whilst experiments on patients or on healthy test subjects involving certain health risks for the test subjects have
p.000005: to be subject to an assessment by a medical ethics committee, this is not necessarily the case for surveys which in
p.000005: principle do not have any medical purpose. However, these are not always without risk for the parties involved.
p.000005:
p.000005: Possible risks are lack of confidentiality, invasion of privacy, stigmatisation, discrimination,
p.000005: psychological effects and even health risks. It must be possible for these risks to be assessed. By way of
p.000005: illustration, a few examples of the possible risks are presented below.
p.000005:
p.000005: We may be talking about experiments on patients or healthy volunteers, but also surveys of a varyingly exhaustive
p.000005: nature depending on the subject.
p.000005: For example, some surveys are used to study changes and developments in the holiday destinations chosen by
p.000005: a particular population group. Other surveys are intended to study the incidence of smoking and non-smokers’ tolerance
p.000005: of other people smoking. These apparently simple and neutral surveys may require an analysis of the correlation with
p.000005: the respondents’ age, sex, income and even educational level. These are examples for which provision is made in the law
p.000005: for anonymisation of the data. What is more, the development of these lists is subject to the regulations of the
p.000005: privacy committee. The significance in 2005 of the fact that someone smokes may not have any immediate effects for the
p.000005: interviewee, but that might not always be the case. The World Health Organisation has already decided henceforth not to
p.000005: hire staff who are smokers, and there is no reason to suppose that other employers will not follow this example. So
p.000005: saying that you smoke is not such a harmless declaration if you are identifiable and do not know what will happen to
p.000005: the survey data.
p.000005: In other studies, for example in anthropogeography, an attempt is made to demarcate neglected areas. This can be done
p.000005: on the basis of data from the National Institute for Statistics, without the residents of the districts in question
p.000005: having to be bothered. Then in-depth surveys can be used to gauge the subjective and objective health situation of the
p.000005: residents of those districts. Their informed consent has to be obtained in order for them to be interviewed. It
...

Searching for indicator volunteers:

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p.000003: of an inter-university harmonisation of the criteria and procedures for ethical consultation in research in these
p.000003: disciplines in Belgian faculties.
p.000003:
p.000003: Another question raised by Professor B. Mouvet concerns the scope of the law of 7 May 2004 on experiments involving
p.000003: human subjects, in particular in the field of the life sciences. This question will form the subject of a separate
p.000003: opinion paper.
p.000003:
p.000003:
p.000003: Introduction
p.000003: In this opinion paper we deal with Professor B. Mouvet’s original question concerning the degree to which it is
p.000003: expedient for ethics committees to be set up in faculties of psychology and the degree to which it is expedient for
p.000003: inter-university harmonisation to be achieved.
p.000003: These ethics committees would have the task of assessing research projects submitted to the faculty of psychology, just
p.000003: as the medical ethics committees have to assess medical protocols. The Committee deemed it expedient from the
p.000003: outset to extend our reflection to include all faculties in the life sciences.
p.000003:
p.000003: The ethical testing of research projects involving human subjects is carried out by medical ethics committees when
p.000003: the experiment involves patients or healthy volunteers making themselves available for experiments of a medical
p.000003: nature, such as clinical studies with new medicines, for example.
p.000003: As regards medical ethics committees, a distinction needs to be made between medical ethics committees as defined in
p.000003: the law on experiments involving human subjects of 7 May 2004 (committees authorised to assess research
p.000003: projects, either as a committee authorised to publish a final opinion, or as a committee of one of the cooperating
p.000003: centres, provided the centre meets the official competence criteria), and local ethics committees which should exist in
p.000003: all hospitals and health establishments but which are not legally “recognised” when it comes to experiments involving
p.000003: human subjects.
p.000003:
p.000003: There is the possibility of medical ethics committees that are authorised to assess protocols also having to assess
p.000003: certain protocols for experiments in the life sciences. Indeed, the Belgian legislator has given a wider
p.000003: interpretation to European Directive 2001/20/EC on the conduct of clinical trials on medicinal products for human use.
p.000003: However, many studies in the field of the life sciences do not fall within the legal or scientific competence of
p.000003: medical ethics committees. The question that then arises is whether the research protocols in life sciences that have a
...

Health / Physically Ill

Searching for indicator sick:

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p.000007: inevitably be taken of local cultural values. The
p.000007:
p.000007: 1 The British Psychological Society, in Sue Eckstein (editor) “Manual for Research Ethics Committees: Centre of Medical
p.000007: Law and Ethics, King’s College London”, Cambridge University Press, 2003, pp. 269-273.
p.000008: 8
p.000008: Opinion no. 36 of 11 September 2006 – Final version
p.000008:
p.000008: observation, even in public places, of people who could reasonably assume that they are not being watched, is
p.000008: absolutely forbidden.
p.000008:
p.000008: c. Existing codes
p.000008:
p.000008: The Caverni code
p.000008:
p.000008: The aspects of psychological research are also specifically covered in “Un code de conduite des chercheurs dans les
p.000008: sciences du comportement humain” (a code of conduct for researchers in behavioural sciences), drafted by J.-P. Caverni
p.000008: (Research Department of the French Psychological Society, Un code de conduite des chercheurs dans les sciences du
p.000008: comportement humain, 2003). A few of the key ideas contained in this are discussed below.
p.000008:
p.000008: According to this code, the purpose of behavioural research is to develop a body of fundamental knowledge that is
p.000008: scientifically validated according to an objectivised, entirely communicable and reproducible methodology. Behavioural
p.000008: research concerns all aspects of human behaviour, at all ages, equally in the case of the foetus as in the case of
p.000008: healthy or sick individuals, insofar as that is ethically acceptable. The study must, if possible, aim at contributing
p.000008: to the improvement of human welfare, both individually and socially.
p.000008: The researcher must be a professional person who is responsible at scientific and ethical level for the studies he
p.000008: plans and conducts. Assessment by an ethics committee is not specifically laid down in the code, but it is stated that
p.000008: whenever there is the possibility of a study exceeding the generally recognised rules, the researcher should obtain the
p.000008: positive opinion of his peers and if necessary, also of recognised bodies in which there are representatives of society
p.000008: who are not members of the scientific community. These aforementioned bodies resemble local medical ethics committees
p.000008: or ethics committees in life sciences faculties.
p.000008: According to the Caverni code researchers should guarantee respect for and protection of the people taking part in the
p.000008: study and should moreover vouch for respect for human beings and for life in general. They are obliged to respect
p.000008: confidentiality vis-à-vis everything they may have learnt about the participants in the study. The researcher is
p.000008: responsible for protection and confidentiality of the data.
p.000008: Before participation in any study, the people approached must explicitly give their informed and free consent. They
...

Social / Access to Social Goods

Searching for indicator access:

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p.000011: the objective: biomedical research always strives for advancement in medical knowledge and has a therapeutic goal in
p.000011: the shorter or longer term. Like fundamental research, research in the life sciences can aim for a better knowledge of
p.000011: our surroundings and of people’s response and adjustment mechanisms.
p.000011:
p.000011: e. Conclusions regarding general ethical requirements in experiments involving human subjects
p.000011:
p.000011: From the foregoing it emerges that experiments involving human subjects, irrespective of the framework in which they
p.000011: are conducted, must meet a number of common conditions:
p.000011: ▪ The study must be scientifically justified and should be carried out in a scientifically flawless
p.000011: manner.
p.000011: ▪ Respect for people’s freedom should be guaranteed and their free and informed consent must be obtained before
p.000011: participation in the study. Here it ought to be recalled that some experiments, especially in the field of psychology,
p.000011: are very specific in nature, and imply that the participants cannot be comprehensively informed beforehand because this
p.000011: could impact on the results. The test subjects should have it clearly explained to them that they will not be
p.000011: comprehensively and accurately informed before the experiment begins, but that they will receive all the information
p.000011: after they have taken part.
p.000011: ▪ The safety of the participants must be guaranteed; here it should be stressed that this concerns physical and
p.000011: mental safety, especially that of minors, prison inmates, etc.
p.000011: ▪ Confidentiality must be guaranteed and access to the data and results should be controlled. The
p.000011: experiments should be carried out with respect for privacy. In some cases the data should be anonymised so that it is
p.000011: impossible to identify the participants in an experiment either directly or indirectly. The protection of
p.000011: personal data implies an irreversible anonymisation of sensitive data obtained during certain studies.
p.000011:
p.000011:
p.000011: 4. Thoughts on the role and place of ethics committees in the life sciences
p.000011:
p.000011: Ethics committees in the life sciences should have the responsibility of monitoring the various points discussed
p.000011: above: scientific pertinence, assessment of the possible risks for the participants, conditions for
p.000011: inclusion of the participants, information supplied, observance of confidentiality, and so forth.
p.000011: Following on from interviews with colleagues and experts, we would like to emphasise the following. In
p.000011: sociological, criminological or psychological studies, various different – and sometimes conflicting –
p.000011: theoretical bases can be used within one and the same discipline. If the job of an ethics committee is to assess the
p.000011: scientific basis of a study, it should do so without prejudice to the theoretical basis from which the study draws its
p.000011: inspiration. There may indeed be contradictions at theoretical level which do not, however, challenge the
p.000011: relevance of the research.
p.000011:
...

Social / Age

Searching for indicator age:

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p.000004: the meaning used in experimental social psychology and in medicine when clinical trials are involved.
p.000004:
p.000004:
p.000005: 5
p.000005: Opinion no. 36 of 11 September 2006 – Final version
p.000005:
p.000005: 2. Risks for test subjects taking part in research in the life sciences
p.000005:
p.000005: Whilst experiments on patients or on healthy test subjects involving certain health risks for the test subjects have
p.000005: to be subject to an assessment by a medical ethics committee, this is not necessarily the case for surveys which in
p.000005: principle do not have any medical purpose. However, these are not always without risk for the parties involved.
p.000005:
p.000005: Possible risks are lack of confidentiality, invasion of privacy, stigmatisation, discrimination,
p.000005: psychological effects and even health risks. It must be possible for these risks to be assessed. By way of
p.000005: illustration, a few examples of the possible risks are presented below.
p.000005:
p.000005: We may be talking about experiments on patients or healthy volunteers, but also surveys of a varyingly exhaustive
p.000005: nature depending on the subject.
p.000005: For example, some surveys are used to study changes and developments in the holiday destinations chosen by
p.000005: a particular population group. Other surveys are intended to study the incidence of smoking and non-smokers’ tolerance
p.000005: of other people smoking. These apparently simple and neutral surveys may require an analysis of the correlation with
p.000005: the respondents’ age, sex, income and even educational level. These are examples for which provision is made in the law
p.000005: for anonymisation of the data. What is more, the development of these lists is subject to the regulations of the
p.000005: privacy committee. The significance in 2005 of the fact that someone smokes may not have any immediate effects for the
p.000005: interviewee, but that might not always be the case. The World Health Organisation has already decided henceforth not to
p.000005: hire staff who are smokers, and there is no reason to suppose that other employers will not follow this example. So
p.000005: saying that you smoke is not such a harmless declaration if you are identifiable and do not know what will happen to
p.000005: the survey data.
p.000005: In other studies, for example in anthropogeography, an attempt is made to demarcate neglected areas. This can be done
p.000005: on the basis of data from the National Institute for Statistics, without the residents of the districts in question
p.000005: having to be bothered. Then in-depth surveys can be used to gauge the subjective and objective health situation of the
p.000005: residents of those districts. Their informed consent has to be obtained in order for them to be interviewed. It
p.000005: therefore seems necessary to explain the purpose of the study to them, a purpose consisting in
p.000005: ascertaining whether or not their living conditions have an adverse effect on their state of health. Discovering that
p.000005: there is a link between the location of their house and their health can bewilder some residents.
p.000005:
p.000005: When researchers in sociology, educational science or criminology try to find lines of reasoning to explain why some
...

Social / Child

Searching for indicator child:

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p.000004: number of Protestants. According to the statistical material Durkheim had at his disposal, the suicide figures in the
p.000004: Swiss cantons increased as the number of Protestants increased. Here the first two experiment conditions are met (or
p.000004: met to a greater or lesser degree): the reduction to variables and the demonstration of causality or at least a
p.000004: correlation. However, the third condition is missing: the sociologist has no influence on the protestant ethos or on
p.000004: suicidal tendencies.
p.000004: It would therefore be a major error to reduce sociology to trends that are based on statistical methods. Qualitative
p.000004: sociology is chiefly founded on hermeneutics. Without wishing to engage in a far-reaching epistemological debate –
p.000004: although this is where the difference and the controversy lie –, the distinction needs to be made between “explaining”
p.000004: and “understanding”. The explicit intention of a large number of sociologists is the understanding and explanation
p.000004: of complex processes and mechanisms through painstaking - ethnographic and quasi “entomological” -
p.000004: observation of human behaviour, methods that are not reconcilable with the statistical approach. We can refer to these
p.000004: studies as involving experiments. Harold Garfinkel, an American sociologist, asked his students to approach their
p.000004: parents as friends when they got home. The aim here was, via transgression, to reveal the precise rules that govern the
p.000004: parent-child relationship. The moral rules are often very clearly demarcated, yet may of course differ considerably
p.000004: from the agreements existing between friends. In this example, the “manipulation factor” is very much present: the
p.000004: student interferes in the type of relationship with his parents. The other two conditions, however, are not present.
p.000004: The epistemological preconception does not permit reduction to a few simple variables, and demonstrating the causality
p.000004: is not the end objective. Therefore here we can only refer to a perception or observation, but not an “experiment” in
p.000004: the meaning used in experimental social psychology and in medicine when clinical trials are involved.
p.000004:
p.000004:
p.000005: 5
p.000005: Opinion no. 36 of 11 September 2006 – Final version
p.000005:
p.000005: 2. Risks for test subjects taking part in research in the life sciences
p.000005:
p.000005: Whilst experiments on patients or on healthy test subjects involving certain health risks for the test subjects have
p.000005: to be subject to an assessment by a medical ethics committee, this is not necessarily the case for surveys which in
p.000005: principle do not have any medical purpose. However, these are not always without risk for the parties involved.
p.000005:
p.000005: Possible risks are lack of confidentiality, invasion of privacy, stigmatisation, discrimination,
p.000005: psychological effects and even health risks. It must be possible for these risks to be assessed. By way of
p.000005: illustration, a few examples of the possible risks are presented below.
p.000005:
...

Searching for indicator children:

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p.000008: confidentiality vis-à-vis everything they may have learnt about the participants in the study. The researcher is
p.000008: responsible for protection and confidentiality of the data.
p.000008: Before participation in any study, the people approached must explicitly give their informed and free consent. They
p.000008: must be informed, in a manner comprehensible to them, of all aspects that could influence their consent (risks,
p.000008: inconvenience, immediate or deferred negative effects, limitation of confidentiality, etc.), as well as the
p.000008: study’s objectives and the procedure to be used. The position of authority that the researcher generally has may not be
p.000008: used to induce the potential participant to give his consent.
p.000008: The party concerned may withdraw from the study after he has obtained information, or even when the experiment is under
p.000008: way.
p.000008: Before their possible participation, people must know that they are free to take part or not to take part, without a
p.000008: refusal on their part having any negative consequences of any kind for them (here we are thinking of students or
p.000008: members of staff). That is precisely what is applied in the case of medical experiments.
p.000008: Now, there may be cases of certain people not being in a position to give their free and informed consent (children and
p.000008: vulnerable people, for example). In such cases the researcher has to obtain “autorisation appropriée” (suitable
p.000008: authorisation) from a legally authorised person. However, he must give the person wishing to take part in the study
p.000008: “des explications appropriées” (suitable explanations) at all times, and obtain his “assentiment” (consent) in
p.000008: circumstances that are as close as possible to the circumstances in which ordinary people find themselves.
p.000008: The researcher does not have to secure the consent of the test subjects if non-identifiable data are collected which
p.000008: only relate to observations in a natural setting or relate to isolated data from archives.
p.000008: The freedom to consult certain elements of an archive does not yet give entitlement to consultation of
p.000008: the entire archive or file.
p.000008:
p.000009: 9
p.000009: Opinion no. 36 of 11 September 2006 – Final version
p.000009:
p.000009: Whenever possible and relevant, the researcher must inform the public of the knowledge collected, the
p.000009: method followed to obtain that knowledge, and the reliability thereof. He may not fail to mention the fact that the
p.000009: bulk of this knowledge is of a provisional and incomplete nature. He must see to it that the scientific knowledge is
p.000009: put to good use. In particular, he must oppose any distorted reproduction of it and the use of it for
p.000009: purposes that run counter to ethical principles.
p.000009: One heading in this code also relates to confidentiality of the data and the conditions for
p.000009: dissemination of the results.
p.000009:
...

p.000010: subjects should be considered prima facie wrong and thus unjustified from an ethical point of view”. Nonetheless, he
p.000010: adds that people can validly agree to be given only some of the information, or not to be informed at all.
p.000010:
p.000010: d. The situation in Belgium
p.000010:
p.000010: With the exception of ethics committees in certain faculties of psychology, the Committee concludes that
p.000010: there are no ethics committees in the life sciences in Belgium. Experiments in the field of behavioural science,
p.000010: and more generally experiments in the life sciences, are not necessarily presented to medical ethics
p.000010: committees and are not assessed by ethics committees in the corresponding faculties.
p.000010:
p.000010: Studies in psychology, criminology, educational science or sociology are often conducted on people but are
p.000010: not necessarily carried out in a medical framework, and still less in a hospital. Some studies belong to the field of
p.000010: labour psychology, others relate to language use or other subjects for which there is no reason for submission to
p.000010: medical ethics committees, which in any case are not well grounded in these matters. Just like every biomedical study,
p.000010: behavioural research can also relate to vulnerable populations, such as children, prison inmates, the
p.000010: elderly, and students, and in those cases the ethical issue is all the more pertinent.
p.000010: The circumstances in which people take part in experiments in the field of behavioural science are very wide-ranging.
p.000010: All kinds of behaviour are studied: during diverse development phases, during learning processes, in normal situations,
p.000010: or in pathological circumstances. The stimuli used can also vary considerably: physical (images, noise, etc.),
p.000010: symbolic, psychological, foreign to the body or body-specific. The observed tasks or reactions can vary considerably,
p.000010: as can the characteristics of the environment concerned.
p.000010:
p.000010: As regards studies into human behaviour, these can relate to studies on premature births, babies, children, twins,
p.000010: teenagers, normal adults, or adults who are representative of a specific social group (teachers, sports freaks, etc.).
p.000010:
p.000010: Although the test subjects are usually informed and freely agree to take part, in some studies in the field of the life
p.000010: sciences special terms and stipulations may be required which violate the principle of freely informed consent
p.000010: applicable in biomedical science. We recall the generally applicable principle in medical experiments that the
p.000010: test subject must always retain his freedom to take part or not to take part, that a person’s refusal may not have any
p.000010: negative consequences whatsoever, and that no refusal may entail a change in the quality of the care
p.000010: administered. However, in psychology the researcher may deem that giving comprehensive information on the purpose of
p.000010: the study and the study methods to be used makes it impossible to obtain valid data. Indeed, it is accepted knowledge
p.000010: that a person who is aware that he is being observed will adjust his behaviour, which is what the study aims to
p.000010: describe. In that case it should be ensured that the test subjects or their representatives are informed, after
p.000010: the study, of the results of the experiment and the justification for it, and are given the possibility of
p.000010: agreeing to these being used. As a rule these situations are regulated by codes of good practice.
p.000010:
p.000010: Moreover, the rules for the testing of research projects are very diverse. In many cases no thought is given to the
p.000010: ethical aspects of the study, other than by those responsible for the study and the people actually carrying out the
...

Social / Elderly

Searching for indicator elderly:

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p.000010: adds that people can validly agree to be given only some of the information, or not to be informed at all.
p.000010:
p.000010: d. The situation in Belgium
p.000010:
p.000010: With the exception of ethics committees in certain faculties of psychology, the Committee concludes that
p.000010: there are no ethics committees in the life sciences in Belgium. Experiments in the field of behavioural science,
p.000010: and more generally experiments in the life sciences, are not necessarily presented to medical ethics
p.000010: committees and are not assessed by ethics committees in the corresponding faculties.
p.000010:
p.000010: Studies in psychology, criminology, educational science or sociology are often conducted on people but are
p.000010: not necessarily carried out in a medical framework, and still less in a hospital. Some studies belong to the field of
p.000010: labour psychology, others relate to language use or other subjects for which there is no reason for submission to
p.000010: medical ethics committees, which in any case are not well grounded in these matters. Just like every biomedical study,
p.000010: behavioural research can also relate to vulnerable populations, such as children, prison inmates, the
p.000010: elderly, and students, and in those cases the ethical issue is all the more pertinent.
p.000010: The circumstances in which people take part in experiments in the field of behavioural science are very wide-ranging.
p.000010: All kinds of behaviour are studied: during diverse development phases, during learning processes, in normal situations,
p.000010: or in pathological circumstances. The stimuli used can also vary considerably: physical (images, noise, etc.),
p.000010: symbolic, psychological, foreign to the body or body-specific. The observed tasks or reactions can vary considerably,
p.000010: as can the characteristics of the environment concerned.
p.000010:
p.000010: As regards studies into human behaviour, these can relate to studies on premature births, babies, children, twins,
p.000010: teenagers, normal adults, or adults who are representative of a specific social group (teachers, sports freaks, etc.).
p.000010:
p.000010: Although the test subjects are usually informed and freely agree to take part, in some studies in the field of the life
p.000010: sciences special terms and stipulations may be required which violate the principle of freely informed consent
p.000010: applicable in biomedical science. We recall the generally applicable principle in medical experiments that the
p.000010: test subject must always retain his freedom to take part or not to take part, that a person’s refusal may not have any
p.000010: negative consequences whatsoever, and that no refusal may entail a change in the quality of the care
p.000010: administered. However, in psychology the researcher may deem that giving comprehensive information on the purpose of
p.000010: the study and the study methods to be used makes it impossible to obtain valid data. Indeed, it is accepted knowledge
...

Social / Fetus/Neonate

Searching for indicator foetus:

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p.000007: situations in which the observed person is aware that he or she can be seen by strangers. Account must
p.000007: inevitably be taken of local cultural values. The
p.000007:
p.000007: 1 The British Psychological Society, in Sue Eckstein (editor) “Manual for Research Ethics Committees: Centre of Medical
p.000007: Law and Ethics, King’s College London”, Cambridge University Press, 2003, pp. 269-273.
p.000008: 8
p.000008: Opinion no. 36 of 11 September 2006 – Final version
p.000008:
p.000008: observation, even in public places, of people who could reasonably assume that they are not being watched, is
p.000008: absolutely forbidden.
p.000008:
p.000008: c. Existing codes
p.000008:
p.000008: The Caverni code
p.000008:
p.000008: The aspects of psychological research are also specifically covered in “Un code de conduite des chercheurs dans les
p.000008: sciences du comportement humain” (a code of conduct for researchers in behavioural sciences), drafted by J.-P. Caverni
p.000008: (Research Department of the French Psychological Society, Un code de conduite des chercheurs dans les sciences du
p.000008: comportement humain, 2003). A few of the key ideas contained in this are discussed below.
p.000008:
p.000008: According to this code, the purpose of behavioural research is to develop a body of fundamental knowledge that is
p.000008: scientifically validated according to an objectivised, entirely communicable and reproducible methodology. Behavioural
p.000008: research concerns all aspects of human behaviour, at all ages, equally in the case of the foetus as in the case of
p.000008: healthy or sick individuals, insofar as that is ethically acceptable. The study must, if possible, aim at contributing
p.000008: to the improvement of human welfare, both individually and socially.
p.000008: The researcher must be a professional person who is responsible at scientific and ethical level for the studies he
p.000008: plans and conducts. Assessment by an ethics committee is not specifically laid down in the code, but it is stated that
p.000008: whenever there is the possibility of a study exceeding the generally recognised rules, the researcher should obtain the
p.000008: positive opinion of his peers and if necessary, also of recognised bodies in which there are representatives of society
p.000008: who are not members of the scientific community. These aforementioned bodies resemble local medical ethics committees
p.000008: or ethics committees in life sciences faculties.
p.000008: According to the Caverni code researchers should guarantee respect for and protection of the people taking part in the
p.000008: study and should moreover vouch for respect for human beings and for life in general. They are obliged to respect
p.000008: confidentiality vis-à-vis everything they may have learnt about the participants in the study. The researcher is
p.000008: responsible for protection and confidentiality of the data.
...

Social / Incarcerated

Searching for indicator prison:

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p.000010: adds that people can validly agree to be given only some of the information, or not to be informed at all.
p.000010:
p.000010: d. The situation in Belgium
p.000010:
p.000010: With the exception of ethics committees in certain faculties of psychology, the Committee concludes that
p.000010: there are no ethics committees in the life sciences in Belgium. Experiments in the field of behavioural science,
p.000010: and more generally experiments in the life sciences, are not necessarily presented to medical ethics
p.000010: committees and are not assessed by ethics committees in the corresponding faculties.
p.000010:
p.000010: Studies in psychology, criminology, educational science or sociology are often conducted on people but are
p.000010: not necessarily carried out in a medical framework, and still less in a hospital. Some studies belong to the field of
p.000010: labour psychology, others relate to language use or other subjects for which there is no reason for submission to
p.000010: medical ethics committees, which in any case are not well grounded in these matters. Just like every biomedical study,
p.000010: behavioural research can also relate to vulnerable populations, such as children, prison inmates, the
p.000010: elderly, and students, and in those cases the ethical issue is all the more pertinent.
p.000010: The circumstances in which people take part in experiments in the field of behavioural science are very wide-ranging.
p.000010: All kinds of behaviour are studied: during diverse development phases, during learning processes, in normal situations,
p.000010: or in pathological circumstances. The stimuli used can also vary considerably: physical (images, noise, etc.),
p.000010: symbolic, psychological, foreign to the body or body-specific. The observed tasks or reactions can vary considerably,
p.000010: as can the characteristics of the environment concerned.
p.000010:
p.000010: As regards studies into human behaviour, these can relate to studies on premature births, babies, children, twins,
p.000010: teenagers, normal adults, or adults who are representative of a specific social group (teachers, sports freaks, etc.).
p.000010:
p.000010: Although the test subjects are usually informed and freely agree to take part, in some studies in the field of the life
p.000010: sciences special terms and stipulations may be required which violate the principle of freely informed consent
p.000010: applicable in biomedical science. We recall the generally applicable principle in medical experiments that the
p.000010: test subject must always retain his freedom to take part or not to take part, that a person’s refusal may not have any
p.000010: negative consequences whatsoever, and that no refusal may entail a change in the quality of the care
p.000010: administered. However, in psychology the researcher may deem that giving comprehensive information on the purpose of
...

p.000011: Some projects in the field of the life sciences are clearly distinguishable from medical experiments when it comes to
p.000011: the objective: biomedical research always strives for advancement in medical knowledge and has a therapeutic goal in
p.000011: the shorter or longer term. Like fundamental research, research in the life sciences can aim for a better knowledge of
p.000011: our surroundings and of people’s response and adjustment mechanisms.
p.000011:
p.000011: e. Conclusions regarding general ethical requirements in experiments involving human subjects
p.000011:
p.000011: From the foregoing it emerges that experiments involving human subjects, irrespective of the framework in which they
p.000011: are conducted, must meet a number of common conditions:
p.000011: ▪ The study must be scientifically justified and should be carried out in a scientifically flawless
p.000011: manner.
p.000011: ▪ Respect for people’s freedom should be guaranteed and their free and informed consent must be obtained before
p.000011: participation in the study. Here it ought to be recalled that some experiments, especially in the field of psychology,
p.000011: are very specific in nature, and imply that the participants cannot be comprehensively informed beforehand because this
p.000011: could impact on the results. The test subjects should have it clearly explained to them that they will not be
p.000011: comprehensively and accurately informed before the experiment begins, but that they will receive all the information
p.000011: after they have taken part.
p.000011: ▪ The safety of the participants must be guaranteed; here it should be stressed that this concerns physical and
p.000011: mental safety, especially that of minors, prison inmates, etc.
p.000011: ▪ Confidentiality must be guaranteed and access to the data and results should be controlled. The
p.000011: experiments should be carried out with respect for privacy. In some cases the data should be anonymised so that it is
p.000011: impossible to identify the participants in an experiment either directly or indirectly. The protection of
p.000011: personal data implies an irreversible anonymisation of sensitive data obtained during certain studies.
p.000011:
p.000011:
p.000011: 4. Thoughts on the role and place of ethics committees in the life sciences
p.000011:
p.000011: Ethics committees in the life sciences should have the responsibility of monitoring the various points discussed
p.000011: above: scientific pertinence, assessment of the possible risks for the participants, conditions for
p.000011: inclusion of the participants, information supplied, observance of confidentiality, and so forth.
p.000011: Following on from interviews with colleagues and experts, we would like to emphasise the following. In
p.000011: sociological, criminological or psychological studies, various different – and sometimes conflicting –
p.000011: theoretical bases can be used within one and the same discipline. If the job of an ethics committee is to assess the
p.000011: scientific basis of a study, it should do so without prejudice to the theoretical basis from which the study draws its
...

Social / Linguistic Proficiency

Searching for indicator language:

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p.000009:
p.000009:
p.000009:
p.000009: 2 L’éthique de la recherche en psychologie, Bernard Baertschi, University of Geneva, in Bioethica Forum (a publication
p.000009: of the “Société Suisse d’Éthique Biomédicale”), no. 44, March 2005, pp. 9-11.
p.000010: 10
p.000010: Opinion no. 36 of 11 September 2006 – Final version
p.000010:
p.000010: In the same Bioethica Forum, Ron Berghmans3 of the University of Maastricht states that “deceiving or misinforming
p.000010: subjects should be considered prima facie wrong and thus unjustified from an ethical point of view”. Nonetheless, he
p.000010: adds that people can validly agree to be given only some of the information, or not to be informed at all.
p.000010:
p.000010: d. The situation in Belgium
p.000010:
p.000010: With the exception of ethics committees in certain faculties of psychology, the Committee concludes that
p.000010: there are no ethics committees in the life sciences in Belgium. Experiments in the field of behavioural science,
p.000010: and more generally experiments in the life sciences, are not necessarily presented to medical ethics
p.000010: committees and are not assessed by ethics committees in the corresponding faculties.
p.000010:
p.000010: Studies in psychology, criminology, educational science or sociology are often conducted on people but are
p.000010: not necessarily carried out in a medical framework, and still less in a hospital. Some studies belong to the field of
p.000010: labour psychology, others relate to language use or other subjects for which there is no reason for submission to
p.000010: medical ethics committees, which in any case are not well grounded in these matters. Just like every biomedical study,
p.000010: behavioural research can also relate to vulnerable populations, such as children, prison inmates, the
p.000010: elderly, and students, and in those cases the ethical issue is all the more pertinent.
p.000010: The circumstances in which people take part in experiments in the field of behavioural science are very wide-ranging.
p.000010: All kinds of behaviour are studied: during diverse development phases, during learning processes, in normal situations,
p.000010: or in pathological circumstances. The stimuli used can also vary considerably: physical (images, noise, etc.),
p.000010: symbolic, psychological, foreign to the body or body-specific. The observed tasks or reactions can vary considerably,
p.000010: as can the characteristics of the environment concerned.
p.000010:
p.000010: As regards studies into human behaviour, these can relate to studies on premature births, babies, children, twins,
p.000010: teenagers, normal adults, or adults who are representative of a specific social group (teachers, sports freaks, etc.).
p.000010:
p.000010: Although the test subjects are usually informed and freely agree to take part, in some studies in the field of the life
p.000010: sciences special terms and stipulations may be required which violate the principle of freely informed consent
...

Social / Occupation

Searching for indicator job:

(return to top)
p.000005: on the basis of data from the National Institute for Statistics, without the residents of the districts in question
p.000005: having to be bothered. Then in-depth surveys can be used to gauge the subjective and objective health situation of the
p.000005: residents of those districts. Their informed consent has to be obtained in order for them to be interviewed. It
p.000005: therefore seems necessary to explain the purpose of the study to them, a purpose consisting in
p.000005: ascertaining whether or not their living conditions have an adverse effect on their state of health. Discovering that
p.000005: there is a link between the location of their house and their health can bewilder some residents.
p.000005:
p.000005: When researchers in sociology, educational science or criminology try to find lines of reasoning to explain why some
p.000005: young people drop out of school by interviewing young people who are ambling around in the street at times of the day
p.000005: when they should normally be in the classroom, this is a situation that provokes a whole host of questions. Is the
p.000005: young person old enough to give his informed consent? Does he remain identifiable thereafter, and how are
p.000005: the data subsequently anonymised? Does the mere fact of a pollster showing an interest in him have an effect on him,
p.000005: and if so, what is that effect?
p.000005:
p.000005: Neither is it harmless to ask a random passer-by who knows he is suffering from cancer, about the fear of dying, even
p.000005: if he has agreed to answer a questionnaire on this.
p.000005:
p.000005: Research into grieving processes when someone loses their job can also trigger unpredictable reactions among the
p.000005: persons affected, which not only hamper but even harm their adaptation to unemployment.
p.000005:
p.000005: Even some surveys that look into the quality of a company’s management by asking employees a number of questions, are
p.000005: not per se inoffensive and can destabilise some of the respondents, all the more since their freedom to choose whether
p.000005: or not to take part in the interview is de facto often limited.
p.000005:
p.000006: 6
p.000006: Opinion no. 36 of 11 September 2006 – Final version
p.000006:
p.000006: The same goes for studies carried out by university lecturers among their students and for all studies involving
p.000006: persons who fall under some form of judicial measure, irrespective of whether they are detainees or not.
p.000006:
p.000006: In anthropology and the life sciences in general there are certain studies that take the form of interaction or
p.000006: participatory role models, which, by describing or depicting types of persons, aim to formulate a number of
p.000006: hypotheses on the cultural determinants of their behaviour and attitudes. It is often laid down in the study
p.000006: protocol that the researcher must obtain the prior agreement of the person in order to publish his
p.000006: observations of this person’s behaviour or attitude. From an ethical standpoint that is certainly a good thing,
p.000006: and even an essential condition for a person’s inclusion in a study. Nevertheless, merely confronting a person with
p.000006: what for him is a stigmatising description can be harmful.
...

p.000011: after they have taken part.
p.000011: ▪ The safety of the participants must be guaranteed; here it should be stressed that this concerns physical and
p.000011: mental safety, especially that of minors, prison inmates, etc.
p.000011: ▪ Confidentiality must be guaranteed and access to the data and results should be controlled. The
p.000011: experiments should be carried out with respect for privacy. In some cases the data should be anonymised so that it is
p.000011: impossible to identify the participants in an experiment either directly or indirectly. The protection of
p.000011: personal data implies an irreversible anonymisation of sensitive data obtained during certain studies.
p.000011:
p.000011:
p.000011: 4. Thoughts on the role and place of ethics committees in the life sciences
p.000011:
p.000011: Ethics committees in the life sciences should have the responsibility of monitoring the various points discussed
p.000011: above: scientific pertinence, assessment of the possible risks for the participants, conditions for
p.000011: inclusion of the participants, information supplied, observance of confidentiality, and so forth.
p.000011: Following on from interviews with colleagues and experts, we would like to emphasise the following. In
p.000011: sociological, criminological or psychological studies, various different – and sometimes conflicting –
p.000011: theoretical bases can be used within one and the same discipline. If the job of an ethics committee is to assess the
p.000011: scientific basis of a study, it should do so without prejudice to the theoretical basis from which the study draws its
p.000011: inspiration. There may indeed be contradictions at theoretical level which do not, however, challenge the
p.000011: relevance of the research.
p.000011:
p.000011: The French-speaking experts, and the Dutch-speaking expert, who were interviewed by the select committee are in
p.000011: favour of ethics committees being set up. The faculties of psychology and educational sciences are also
p.000011: reportedly advocates of ethics committees being set up in the faculties.
p.000011:
p.000012: 12
p.000012: Opinion no. 36 of 11 September 2006 – Final version
p.000012:
p.000012: As regards sociology and criminology, the experts who were heard by the select committee display a certain reservation
p.000012: about the setting up of an ethics committee that would assess the ethical value of their research projects. Of the view
p.000012: that they are the preferential witnesses of society’s growing interference in people’s private lives and the increased
p.000012: social pressure (at economic, political and other levels) that this exerts on individuals on a day-to-day basis, they
p.000012: fear that ethics committees could curb their studies and thereby prevent them from bringing certain dysfunctions or
p.000012: pressures to light.
...

Social / Property Ownership

Searching for indicator home:

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p.000004: analysis. “Suicide” by Emile Durkheim (1897) is a good example of this approach. In this study the author
p.000004: shows that the increase in the number of suicides, where other data are identical, is directly proportional to the
p.000004: number of Protestants. According to the statistical material Durkheim had at his disposal, the suicide figures in the
p.000004: Swiss cantons increased as the number of Protestants increased. Here the first two experiment conditions are met (or
p.000004: met to a greater or lesser degree): the reduction to variables and the demonstration of causality or at least a
p.000004: correlation. However, the third condition is missing: the sociologist has no influence on the protestant ethos or on
p.000004: suicidal tendencies.
p.000004: It would therefore be a major error to reduce sociology to trends that are based on statistical methods. Qualitative
p.000004: sociology is chiefly founded on hermeneutics. Without wishing to engage in a far-reaching epistemological debate –
p.000004: although this is where the difference and the controversy lie –, the distinction needs to be made between “explaining”
p.000004: and “understanding”. The explicit intention of a large number of sociologists is the understanding and explanation
p.000004: of complex processes and mechanisms through painstaking - ethnographic and quasi “entomological” -
p.000004: observation of human behaviour, methods that are not reconcilable with the statistical approach. We can refer to these
p.000004: studies as involving experiments. Harold Garfinkel, an American sociologist, asked his students to approach their
p.000004: parents as friends when they got home. The aim here was, via transgression, to reveal the precise rules that govern the
p.000004: parent-child relationship. The moral rules are often very clearly demarcated, yet may of course differ considerably
p.000004: from the agreements existing between friends. In this example, the “manipulation factor” is very much present: the
p.000004: student interferes in the type of relationship with his parents. The other two conditions, however, are not present.
p.000004: The epistemological preconception does not permit reduction to a few simple variables, and demonstrating the causality
p.000004: is not the end objective. Therefore here we can only refer to a perception or observation, but not an “experiment” in
p.000004: the meaning used in experimental social psychology and in medicine when clinical trials are involved.
p.000004:
p.000004:
p.000005: 5
p.000005: Opinion no. 36 of 11 September 2006 – Final version
p.000005:
p.000005: 2. Risks for test subjects taking part in research in the life sciences
p.000005:
p.000005: Whilst experiments on patients or on healthy test subjects involving certain health risks for the test subjects have
p.000005: to be subject to an assessment by a medical ethics committee, this is not necessarily the case for surveys which in
p.000005: principle do not have any medical purpose. However, these are not always without risk for the parties involved.
p.000005:
p.000005: Possible risks are lack of confidentiality, invasion of privacy, stigmatisation, discrimination,
...

Social / Racial Minority

Searching for indicator racist:

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p.000005:
p.000005: Even some surveys that look into the quality of a company’s management by asking employees a number of questions, are
p.000005: not per se inoffensive and can destabilise some of the respondents, all the more since their freedom to choose whether
p.000005: or not to take part in the interview is de facto often limited.
p.000005:
p.000006: 6
p.000006: Opinion no. 36 of 11 September 2006 – Final version
p.000006:
p.000006: The same goes for studies carried out by university lecturers among their students and for all studies involving
p.000006: persons who fall under some form of judicial measure, irrespective of whether they are detainees or not.
p.000006:
p.000006: In anthropology and the life sciences in general there are certain studies that take the form of interaction or
p.000006: participatory role models, which, by describing or depicting types of persons, aim to formulate a number of
p.000006: hypotheses on the cultural determinants of their behaviour and attitudes. It is often laid down in the study
p.000006: protocol that the researcher must obtain the prior agreement of the person in order to publish his
p.000006: observations of this person’s behaviour or attitude. From an ethical standpoint that is certainly a good thing,
p.000006: and even an essential condition for a person’s inclusion in a study. Nevertheless, merely confronting a person with
p.000006: what for him is a stigmatising description can be harmful.
p.000006: The examination of intentional or unintentional racist reactions, which are present in all of us, or of potential
p.000006: aggression in some people in certain situations, does not mean that it is acceptable to place people, who have
p.000006: been pre-selected to provoke hostile reactions in other study participants, into physical or psychological
p.000006: danger.
p.000006:
p.000006: It is undeniable that acceptable risks sometimes have to be taken in order to make progress in the life sciences. These
p.000006: risks should be carefully studied and described, even if the survey in question is for all other intents and purposes
p.000006: quite inoffensive. There is therefore reason to be concerned about the procedures followed in the life sciences to
p.000006: weigh up the potential risks of a study against the result one is hoping to achieve. At the same time it is useful to
p.000006: pose questions in advance about the potential risks of research procedures and the methodology used to limit the risks
p.000006: as far as possible.
p.000006:
p.000006:
p.000006: 3. The current ethical reflection in the life sciences
p.000006:
p.000006: a. The situation in France
p.000006:
p.000006: The laws on research in the health sector have in recent years often been applied to experiments in behavioural science
p.000006: further to a 1994 amendment to the law of 1988 (Huriet-Serusclat law, France, 20 December 1988).
p.000006:
p.000006: In October 1993 the French National Advisory Committee for Ethics (Comité consultatif national d’éthique - CCNE)
p.000006: published an opinion paper on research in behavioural science (la recherche dans les sciences du comportement humain –
p.000006: opinion no. 98).
...

Social / Student

Searching for indicator student:

(return to top)
p.000004: met to a greater or lesser degree): the reduction to variables and the demonstration of causality or at least a
p.000004: correlation. However, the third condition is missing: the sociologist has no influence on the protestant ethos or on
p.000004: suicidal tendencies.
p.000004: It would therefore be a major error to reduce sociology to trends that are based on statistical methods. Qualitative
p.000004: sociology is chiefly founded on hermeneutics. Without wishing to engage in a far-reaching epistemological debate –
p.000004: although this is where the difference and the controversy lie –, the distinction needs to be made between “explaining”
p.000004: and “understanding”. The explicit intention of a large number of sociologists is the understanding and explanation
p.000004: of complex processes and mechanisms through painstaking - ethnographic and quasi “entomological” -
p.000004: observation of human behaviour, methods that are not reconcilable with the statistical approach. We can refer to these
p.000004: studies as involving experiments. Harold Garfinkel, an American sociologist, asked his students to approach their
p.000004: parents as friends when they got home. The aim here was, via transgression, to reveal the precise rules that govern the
p.000004: parent-child relationship. The moral rules are often very clearly demarcated, yet may of course differ considerably
p.000004: from the agreements existing between friends. In this example, the “manipulation factor” is very much present: the
p.000004: student interferes in the type of relationship with his parents. The other two conditions, however, are not present.
p.000004: The epistemological preconception does not permit reduction to a few simple variables, and demonstrating the causality
p.000004: is not the end objective. Therefore here we can only refer to a perception or observation, but not an “experiment” in
p.000004: the meaning used in experimental social psychology and in medicine when clinical trials are involved.
p.000004:
p.000004:
p.000005: 5
p.000005: Opinion no. 36 of 11 September 2006 – Final version
p.000005:
p.000005: 2. Risks for test subjects taking part in research in the life sciences
p.000005:
p.000005: Whilst experiments on patients or on healthy test subjects involving certain health risks for the test subjects have
p.000005: to be subject to an assessment by a medical ethics committee, this is not necessarily the case for surveys which in
p.000005: principle do not have any medical purpose. However, these are not always without risk for the parties involved.
p.000005:
p.000005: Possible risks are lack of confidentiality, invasion of privacy, stigmatisation, discrimination,
p.000005: psychological effects and even health risks. It must be possible for these risks to be assessed. By way of
p.000005: illustration, a few examples of the possible risks are presented below.
p.000005:
p.000005: We may be talking about experiments on patients or healthy volunteers, but also surveys of a varyingly exhaustive
p.000005: nature depending on the subject.
...

Social / Unemployment

Searching for indicator unemployment:

(return to top)
p.000005: residents of those districts. Their informed consent has to be obtained in order for them to be interviewed. It
p.000005: therefore seems necessary to explain the purpose of the study to them, a purpose consisting in
p.000005: ascertaining whether or not their living conditions have an adverse effect on their state of health. Discovering that
p.000005: there is a link between the location of their house and their health can bewilder some residents.
p.000005:
p.000005: When researchers in sociology, educational science or criminology try to find lines of reasoning to explain why some
p.000005: young people drop out of school by interviewing young people who are ambling around in the street at times of the day
p.000005: when they should normally be in the classroom, this is a situation that provokes a whole host of questions. Is the
p.000005: young person old enough to give his informed consent? Does he remain identifiable thereafter, and how are
p.000005: the data subsequently anonymised? Does the mere fact of a pollster showing an interest in him have an effect on him,
p.000005: and if so, what is that effect?
p.000005:
p.000005: Neither is it harmless to ask a random passer-by who knows he is suffering from cancer, about the fear of dying, even
p.000005: if he has agreed to answer a questionnaire on this.
p.000005:
p.000005: Research into grieving processes when someone loses their job can also trigger unpredictable reactions among the
p.000005: persons affected, which not only hamper but even harm their adaptation to unemployment.
p.000005:
p.000005: Even some surveys that look into the quality of a company’s management by asking employees a number of questions, are
p.000005: not per se inoffensive and can destabilise some of the respondents, all the more since their freedom to choose whether
p.000005: or not to take part in the interview is de facto often limited.
p.000005:
p.000006: 6
p.000006: Opinion no. 36 of 11 September 2006 – Final version
p.000006:
p.000006: The same goes for studies carried out by university lecturers among their students and for all studies involving
p.000006: persons who fall under some form of judicial measure, irrespective of whether they are detainees or not.
p.000006:
p.000006: In anthropology and the life sciences in general there are certain studies that take the form of interaction or
p.000006: participatory role models, which, by describing or depicting types of persons, aim to formulate a number of
p.000006: hypotheses on the cultural determinants of their behaviour and attitudes. It is often laid down in the study
p.000006: protocol that the researcher must obtain the prior agreement of the person in order to publish his
p.000006: observations of this person’s behaviour or attitude. From an ethical standpoint that is certainly a good thing,
p.000006: and even an essential condition for a person’s inclusion in a study. Nevertheless, merely confronting a person with
p.000006: what for him is a stigmatising description can be harmful.
p.000006: The examination of intentional or unintentional racist reactions, which are present in all of us, or of potential
...

Social / education

Searching for indicator educational:

(return to top)
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: Opinion no. 36 of 11 September 2006 on the ethical testing of research in certain branches of the life sciences
p.000002:
p.000002: Request for an opinion submitted on 6 February 2004
p.000002:
p.000002: by Professor B. Mouvet, Chairperson of the Ethics Committee of the Faculty of Psychology and Educational Sciences of
p.000002: the University of Liège, concerning:
p.000002: (1) the expediency of setting up ethics committees in faculties of psychology and educational sciences, and
p.000002: (2) the expediency of arriving at inter-university harmonisation of criteria and procedures for ethical consultation
p.000002: on research in Belgian faculties of psychology and educational sciences.
p.000002:
p.000002:
p.000002:
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p.000002:
p.000002: 2
p.000002: Opinion no. 36 of 11 September 2006 – Final version
p.000002:
p.000002: CONTENT OF THE OPINION
p.000002:
p.000002:
p.000002:
p.000002: Question put to the Committee
p.000002:
p.000002:
p.000002: Introduction
p.000002:
p.000002:
p.000002: 1. The specific character of research in the life sciences
p.000002:
p.000002: 2. Risks for test subjects taking part in research in the life sciences
p.000002:
p.000002: 3. The current ethical reflection in the life sciences
p.000002: a. The situation in France
p.000002: b. The situation in the United Kingdom
p.000002: c. Existing codes
p.000002: The Caverni code
p.000002: “Deception” in research
p.000002: d. The situation in Belgium
p.000002: e. Conclusions regarding general ethical requirements in experiments involving human subjects
p.000002:
p.000002: 4. Thoughts on the role and place of ethics committees in the life sciences
p.000002:
p.000002: 5. Conclusions
p.000002: a. Ethics committees in faculties of psychology
p.000002: Expediency
p.000002: Inter-university harmonisation
p.000002: b. Ethics committees in other branches of the life sciences (sociology, criminology, etc.)
p.000002:
p.000002:
p.000002:
p.000002:
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p.000002:
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003: Opinion no. 36 of 11 September 2006 – Final version
p.000003:
p.000003: Question put to the Committee
p.000003: Professor B. Mouvet, chairperson of the Ethics Committee of the Faculty of Psychology and Educational
p.000003: Sciences of the University of Liège, sent the Advisory Committee for Bio-Ethics a letter, on 6/2/2004, which was
p.000003: followed by another letter dated 4/5/2005.
p.000003: The Advisory Committee for Bio-Ethics declared this request for an opinion admissible during its session of 8/3/2004.
p.000003: Since the Committee’s term of office came to an end in June 2004, the Committee entrusted the subsequent Committee,
p.000003: which took office on 21/4/2005, with the drafting of the opinion paper.
p.000003:
p.000003: The Advisory Committee for Bio-Ethics has decided in this opinion paper to answer the questions concerning the
p.000003: expediency of setting up ethics committees in the faculties of psychology and educational sciences, and the expediency
p.000003: of an inter-university harmonisation of the criteria and procedures for ethical consultation in research in these
p.000003: disciplines in Belgian faculties.
p.000003:
p.000003: Another question raised by Professor B. Mouvet concerns the scope of the law of 7 May 2004 on experiments involving
p.000003: human subjects, in particular in the field of the life sciences. This question will form the subject of a separate
p.000003: opinion paper.
p.000003:
p.000003:
p.000003: Introduction
p.000003: In this opinion paper we deal with Professor B. Mouvet’s original question concerning the degree to which it is
p.000003: expedient for ethics committees to be set up in faculties of psychology and the degree to which it is expedient for
p.000003: inter-university harmonisation to be achieved.
p.000003: These ethics committees would have the task of assessing research projects submitted to the faculty of psychology, just
p.000003: as the medical ethics committees have to assess medical protocols. The Committee deemed it expedient from the
p.000003: outset to extend our reflection to include all faculties in the life sciences.
p.000003:
p.000003: The ethical testing of research projects involving human subjects is carried out by medical ethics committees when
p.000003: the experiment involves patients or healthy volunteers making themselves available for experiments of a medical
p.000003: nature, such as clinical studies with new medicines, for example.
...

p.000004:
p.000004:
p.000005: 5
p.000005: Opinion no. 36 of 11 September 2006 – Final version
p.000005:
p.000005: 2. Risks for test subjects taking part in research in the life sciences
p.000005:
p.000005: Whilst experiments on patients or on healthy test subjects involving certain health risks for the test subjects have
p.000005: to be subject to an assessment by a medical ethics committee, this is not necessarily the case for surveys which in
p.000005: principle do not have any medical purpose. However, these are not always without risk for the parties involved.
p.000005:
p.000005: Possible risks are lack of confidentiality, invasion of privacy, stigmatisation, discrimination,
p.000005: psychological effects and even health risks. It must be possible for these risks to be assessed. By way of
p.000005: illustration, a few examples of the possible risks are presented below.
p.000005:
p.000005: We may be talking about experiments on patients or healthy volunteers, but also surveys of a varyingly exhaustive
p.000005: nature depending on the subject.
p.000005: For example, some surveys are used to study changes and developments in the holiday destinations chosen by
p.000005: a particular population group. Other surveys are intended to study the incidence of smoking and non-smokers’ tolerance
p.000005: of other people smoking. These apparently simple and neutral surveys may require an analysis of the correlation with
p.000005: the respondents’ age, sex, income and even educational level. These are examples for which provision is made in the law
p.000005: for anonymisation of the data. What is more, the development of these lists is subject to the regulations of the
p.000005: privacy committee. The significance in 2005 of the fact that someone smokes may not have any immediate effects for the
p.000005: interviewee, but that might not always be the case. The World Health Organisation has already decided henceforth not to
p.000005: hire staff who are smokers, and there is no reason to suppose that other employers will not follow this example. So
p.000005: saying that you smoke is not such a harmless declaration if you are identifiable and do not know what will happen to
p.000005: the survey data.
p.000005: In other studies, for example in anthropogeography, an attempt is made to demarcate neglected areas. This can be done
p.000005: on the basis of data from the National Institute for Statistics, without the residents of the districts in question
p.000005: having to be bothered. Then in-depth surveys can be used to gauge the subjective and objective health situation of the
p.000005: residents of those districts. Their informed consent has to be obtained in order for them to be interviewed. It
p.000005: therefore seems necessary to explain the purpose of the study to them, a purpose consisting in
p.000005: ascertaining whether or not their living conditions have an adverse effect on their state of health. Discovering that
p.000005: there is a link between the location of their house and their health can bewilder some residents.
p.000005:
p.000005: When researchers in sociology, educational science or criminology try to find lines of reasoning to explain why some
p.000005: young people drop out of school by interviewing young people who are ambling around in the street at times of the day
p.000005: when they should normally be in the classroom, this is a situation that provokes a whole host of questions. Is the
p.000005: young person old enough to give his informed consent? Does he remain identifiable thereafter, and how are
p.000005: the data subsequently anonymised? Does the mere fact of a pollster showing an interest in him have an effect on him,
p.000005: and if so, what is that effect?
p.000005:
p.000005: Neither is it harmless to ask a random passer-by who knows he is suffering from cancer, about the fear of dying, even
p.000005: if he has agreed to answer a questionnaire on this.
p.000005:
p.000005: Research into grieving processes when someone loses their job can also trigger unpredictable reactions among the
p.000005: persons affected, which not only hamper but even harm their adaptation to unemployment.
p.000005:
p.000005: Even some surveys that look into the quality of a company’s management by asking employees a number of questions, are
p.000005: not per se inoffensive and can destabilise some of the respondents, all the more since their freedom to choose whether
p.000005: or not to take part in the interview is de facto often limited.
p.000005:
p.000006: 6
p.000006: Opinion no. 36 of 11 September 2006 – Final version
p.000006:
...

p.000009: recordings, made without the knowledge of the person concerned, are broadcast on TV). Recommendations for this have
p.000009: been drawn up by the American Psychology Society (“Ethical principles of psychologists and code of conduct”,
p.000009: June 2003).
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: 2 L’éthique de la recherche en psychologie, Bernard Baertschi, University of Geneva, in Bioethica Forum (a publication
p.000009: of the “Société Suisse d’Éthique Biomédicale”), no. 44, March 2005, pp. 9-11.
p.000010: 10
p.000010: Opinion no. 36 of 11 September 2006 – Final version
p.000010:
p.000010: In the same Bioethica Forum, Ron Berghmans3 of the University of Maastricht states that “deceiving or misinforming
p.000010: subjects should be considered prima facie wrong and thus unjustified from an ethical point of view”. Nonetheless, he
p.000010: adds that people can validly agree to be given only some of the information, or not to be informed at all.
p.000010:
p.000010: d. The situation in Belgium
p.000010:
p.000010: With the exception of ethics committees in certain faculties of psychology, the Committee concludes that
p.000010: there are no ethics committees in the life sciences in Belgium. Experiments in the field of behavioural science,
p.000010: and more generally experiments in the life sciences, are not necessarily presented to medical ethics
p.000010: committees and are not assessed by ethics committees in the corresponding faculties.
p.000010:
p.000010: Studies in psychology, criminology, educational science or sociology are often conducted on people but are
p.000010: not necessarily carried out in a medical framework, and still less in a hospital. Some studies belong to the field of
p.000010: labour psychology, others relate to language use or other subjects for which there is no reason for submission to
p.000010: medical ethics committees, which in any case are not well grounded in these matters. Just like every biomedical study,
p.000010: behavioural research can also relate to vulnerable populations, such as children, prison inmates, the
p.000010: elderly, and students, and in those cases the ethical issue is all the more pertinent.
p.000010: The circumstances in which people take part in experiments in the field of behavioural science are very wide-ranging.
p.000010: All kinds of behaviour are studied: during diverse development phases, during learning processes, in normal situations,
p.000010: or in pathological circumstances. The stimuli used can also vary considerably: physical (images, noise, etc.),
p.000010: symbolic, psychological, foreign to the body or body-specific. The observed tasks or reactions can vary considerably,
p.000010: as can the characteristics of the environment concerned.
p.000010:
p.000010: As regards studies into human behaviour, these can relate to studies on premature births, babies, children, twins,
p.000010: teenagers, normal adults, or adults who are representative of a specific social group (teachers, sports freaks, etc.).
p.000010:
...

p.000011: personal data implies an irreversible anonymisation of sensitive data obtained during certain studies.
p.000011:
p.000011:
p.000011: 4. Thoughts on the role and place of ethics committees in the life sciences
p.000011:
p.000011: Ethics committees in the life sciences should have the responsibility of monitoring the various points discussed
p.000011: above: scientific pertinence, assessment of the possible risks for the participants, conditions for
p.000011: inclusion of the participants, information supplied, observance of confidentiality, and so forth.
p.000011: Following on from interviews with colleagues and experts, we would like to emphasise the following. In
p.000011: sociological, criminological or psychological studies, various different – and sometimes conflicting –
p.000011: theoretical bases can be used within one and the same discipline. If the job of an ethics committee is to assess the
p.000011: scientific basis of a study, it should do so without prejudice to the theoretical basis from which the study draws its
p.000011: inspiration. There may indeed be contradictions at theoretical level which do not, however, challenge the
p.000011: relevance of the research.
p.000011:
p.000011: The French-speaking experts, and the Dutch-speaking expert, who were interviewed by the select committee are in
p.000011: favour of ethics committees being set up. The faculties of psychology and educational sciences are also
p.000011: reportedly advocates of ethics committees being set up in the faculties.
p.000011:
p.000012: 12
p.000012: Opinion no. 36 of 11 September 2006 – Final version
p.000012:
p.000012: As regards sociology and criminology, the experts who were heard by the select committee display a certain reservation
p.000012: about the setting up of an ethics committee that would assess the ethical value of their research projects. Of the view
p.000012: that they are the preferential witnesses of society’s growing interference in people’s private lives and the increased
p.000012: social pressure (at economic, political and other levels) that this exerts on individuals on a day-to-day basis, they
p.000012: fear that ethics committees could curb their studies and thereby prevent them from bringing certain dysfunctions or
p.000012: pressures to light.
p.000012: On the other hand, they advocate the setting up of a code of professional practice specific to their profession and
p.000012: containing ethical guidelines for researchers. These guidelines of course relate to the informed consent of the persons
p.000012: studied and respect for their privacy.
p.000012: One expert is of the view that an ethics committee at inter-university level could be useful. This committee would only
p.000012: be allowed to have an advisory role.
p.000012: Two experts who were interviewed also complained of the existence of collusion between life sciences research and the
...

p.000012: case to a drop in its productivity.
p.000012:
p.000012:
p.000012: 5. Conclusions
p.000012:
p.000012: a. Ethics committees in the faculties of psychology
p.000012:
p.000012: Expediency
p.000012:
p.000012: The experts whose opinions were heard and the members of the Advisory Committee for Bio- ethics are in favour of ethics
p.000012: committees being set up in faculties of psychology. Some faculties already have their ethics committee and there are
p.000012: many arguments advocating the establishment of such committees. Even though the risk for the participants in such
p.000012: studies is seldom one of physical and mental harm, it is nonetheless important that that risk be examined. The examples
p.000012: in point 2 illustrate certain risks of stigmatisation or undesired consequences that are associated with some
p.000012: experiments. The people’s protection is therefore at issue.
p.000012: Ethics committees in the faculties of psychology could play an advisory role and could have preferential
p.000012: contact with the medical ethics committees when the protocol falls under the scope of the law on experiments involving
p.000012: human subjects and therefore has to be submitted to these latter committees.
p.000012: It is up to the faculties of psychology and educational sciences to work out in greater detail the composition and
p.000012: operation of their committees.
p.000012:
p.000012: In a letter to us dated 27/10/2005, in answer to a request made by the co-chairmen of the 2005/5 select committee for
p.000012: information on research in the faculties of psychology and educational sciences and on whether or not an
p.000012: ad-hoc ethics committee existed, Professor B. Harmegnies told
p.000013: 13
p.000013: Opinion no. 36 of 11 September 2006 – Final version
p.000013:
p.000013: us that the faculties of psychology and educational sciences of the universities of the French Community of Belgium
p.000013: “(translation) recently decided, each individually, to set up and/or restructure their own ethics committee
p.000013: per faculty, out of a concern that opinions on the ethical validity of research studies in psychology and educational
p.000013: sciences be published by specific bodies in psychology and educational sciences”.
p.000013:
p.000013: Inter-university harmonisation
p.000013:
p.000013: Professor B. Mouvet also asked us for an opinion on the expediency of harmonising the activities of ethics committees
p.000013: in psychology. The Committee is of the view that a harmonisation of the working procedures and methods used by ethics
p.000013: committees in psychology should certainly be encouraged.
p.000013: In the same letter of 27/10/2005, Professor B. Harmegnies tells us that the Conférence des Doyens (Conference of Deans)
p.000013: of the universities of the French Community of Belgium “(our translation) has set up a consultative structure which it
p.000013: has asked to prepare the convergence measures that have to be implemented so that the four faculty ethics committees
p.000013: can organise their operation swiftly on a harmonised basis”.
p.000013:
p.000013: b. Ethics committees in other branches of the life sciences (sociology, criminology, etc.)
p.000013:
p.000013: The Advisory Committee for Bio-ethics is of the opinion that ethics committees could have a supporting
p.000013: function in areas of the life sciences other than psychology, for the ethical reflection on research protocols.
p.000013: These ethics committees do not have to be a copy of the medical ethics committees, but would have to focus on the
...

p.000013: conflicts between the government, the financing bodies and the researchers, the Committee advocates a refinancing of
p.000013: research at universities so that they are able to work in a totally independent fashion.
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:
p.000013:
p.000013:
p.000013:
p.000014: 14
p.000014: Opinion no. 36 of 11 September 2006 – Final version
p.000014:
p.000014: The opinion was prepared by the select commission 2005-5, consisting of:
p.000014:
p.000014:
p.000014: Joint chairpersons
p.000014: M. Roelandt
p.000014:
p.000014: J.-M. Maloteaux
p.000014: Joint reporters
p.000014:
p.000014:
p.000014: M. Roelandt
p.000014:
p.000014: J.-M. Maloteaux
p.000014: Members
p.000014:
p.000014:
p.000014: M. Bogaert
p.000014:
p.000014: F. Caeymaex
p.000014:
p.000014: M. Dumont
p.000014:
p.000014: E. Eggermont
p.000014:
p.000014: M. Eisenhuth
p.000014:
p.000014: R. Rubens
p.000014:
p.000014: G. Verdonk
p.000014: From 13-03-2006:
p.000014: M.-L. Delfosse
p.000014: G. Lebeer
p.000014: Member of the Bureau
p.000014: J.-A. Stiennon
p.000014:
p.000014:
p.000014: Member of the secretariat
p.000014:
p.000014: Veerle Weltens
p.000014:
p.000014:
p.000014: Experts consulted in 2005 / beginning of 2006
p.000014:
p.000014: - Prof. B. Mouvet, Chairperson of the Ethics Committee of the Faculty of Psychology and Educational
p.000014: Sciences of the University of Liège
p.000014: - Prof. I. Kristoffersen-Ponjaert, Psychologist attached to the Free University of Brussels and member of the
p.000014: Committee
p.000014: - Prof. M. Jacquemain, Sociologist attached to the University of Liège and member of the Committee
p.000014: - Prof. G. Lebeer, Sociologist attached to the Free University of Brussels and member of the Committee
p.000014: - Prof. Y. Cartuyvels, Dean of the Faculty of Law of the Facultés Universitaires Saint-Louis
p.000014:
p.000014:
p.000014: The working documents of the select commission 2005-5 – the question, personal contributions of
p.000014: the members, minutes of the meetings, documents consulted – are kept at the Committee’s documentation centre, where
p.000014: they are available to be consulted and copied.
p.000014:
p.000014: This opinion is available on the website www.health.belgium.be/bioeth under the “List of Opinions”
p.000014: section.
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000015: 15
...

Social / employees

Searching for indicator employees:

(return to top)
p.000005: therefore seems necessary to explain the purpose of the study to them, a purpose consisting in
p.000005: ascertaining whether or not their living conditions have an adverse effect on their state of health. Discovering that
p.000005: there is a link between the location of their house and their health can bewilder some residents.
p.000005:
p.000005: When researchers in sociology, educational science or criminology try to find lines of reasoning to explain why some
p.000005: young people drop out of school by interviewing young people who are ambling around in the street at times of the day
p.000005: when they should normally be in the classroom, this is a situation that provokes a whole host of questions. Is the
p.000005: young person old enough to give his informed consent? Does he remain identifiable thereafter, and how are
p.000005: the data subsequently anonymised? Does the mere fact of a pollster showing an interest in him have an effect on him,
p.000005: and if so, what is that effect?
p.000005:
p.000005: Neither is it harmless to ask a random passer-by who knows he is suffering from cancer, about the fear of dying, even
p.000005: if he has agreed to answer a questionnaire on this.
p.000005:
p.000005: Research into grieving processes when someone loses their job can also trigger unpredictable reactions among the
p.000005: persons affected, which not only hamper but even harm their adaptation to unemployment.
p.000005:
p.000005: Even some surveys that look into the quality of a company’s management by asking employees a number of questions, are
p.000005: not per se inoffensive and can destabilise some of the respondents, all the more since their freedom to choose whether
p.000005: or not to take part in the interview is de facto often limited.
p.000005:
p.000006: 6
p.000006: Opinion no. 36 of 11 September 2006 – Final version
p.000006:
p.000006: The same goes for studies carried out by university lecturers among their students and for all studies involving
p.000006: persons who fall under some form of judicial measure, irrespective of whether they are detainees or not.
p.000006:
p.000006: In anthropology and the life sciences in general there are certain studies that take the form of interaction or
p.000006: participatory role models, which, by describing or depicting types of persons, aim to formulate a number of
p.000006: hypotheses on the cultural determinants of their behaviour and attitudes. It is often laid down in the study
p.000006: protocol that the researcher must obtain the prior agreement of the person in order to publish his
p.000006: observations of this person’s behaviour or attitude. From an ethical standpoint that is certainly a good thing,
p.000006: and even an essential condition for a person’s inclusion in a study. Nevertheless, merely confronting a person with
p.000006: what for him is a stigmatising description can be harmful.
p.000006: The examination of intentional or unintentional racist reactions, which are present in all of us, or of potential
p.000006: aggression in some people in certain situations, does not mean that it is acceptable to place people, who have
p.000006: been pre-selected to provoke hostile reactions in other study participants, into physical or psychological
p.000006: danger.
...

Social / parents

Searching for indicator parent:

(return to top)
p.000004: number of Protestants. According to the statistical material Durkheim had at his disposal, the suicide figures in the
p.000004: Swiss cantons increased as the number of Protestants increased. Here the first two experiment conditions are met (or
p.000004: met to a greater or lesser degree): the reduction to variables and the demonstration of causality or at least a
p.000004: correlation. However, the third condition is missing: the sociologist has no influence on the protestant ethos or on
p.000004: suicidal tendencies.
p.000004: It would therefore be a major error to reduce sociology to trends that are based on statistical methods. Qualitative
p.000004: sociology is chiefly founded on hermeneutics. Without wishing to engage in a far-reaching epistemological debate –
p.000004: although this is where the difference and the controversy lie –, the distinction needs to be made between “explaining”
p.000004: and “understanding”. The explicit intention of a large number of sociologists is the understanding and explanation
p.000004: of complex processes and mechanisms through painstaking - ethnographic and quasi “entomological” -
p.000004: observation of human behaviour, methods that are not reconcilable with the statistical approach. We can refer to these
p.000004: studies as involving experiments. Harold Garfinkel, an American sociologist, asked his students to approach their
p.000004: parents as friends when they got home. The aim here was, via transgression, to reveal the precise rules that govern the
p.000004: parent-child relationship. The moral rules are often very clearly demarcated, yet may of course differ considerably
p.000004: from the agreements existing between friends. In this example, the “manipulation factor” is very much present: the
p.000004: student interferes in the type of relationship with his parents. The other two conditions, however, are not present.
p.000004: The epistemological preconception does not permit reduction to a few simple variables, and demonstrating the causality
p.000004: is not the end objective. Therefore here we can only refer to a perception or observation, but not an “experiment” in
p.000004: the meaning used in experimental social psychology and in medicine when clinical trials are involved.
p.000004:
p.000004:
p.000005: 5
p.000005: Opinion no. 36 of 11 September 2006 – Final version
p.000005:
p.000005: 2. Risks for test subjects taking part in research in the life sciences
p.000005:
p.000005: Whilst experiments on patients or on healthy test subjects involving certain health risks for the test subjects have
p.000005: to be subject to an assessment by a medical ethics committee, this is not necessarily the case for surveys which in
p.000005: principle do not have any medical purpose. However, these are not always without risk for the parties involved.
p.000005:
p.000005: Possible risks are lack of confidentiality, invasion of privacy, stigmatisation, discrimination,
p.000005: psychological effects and even health risks. It must be possible for these risks to be assessed. By way of
...

Searching for indicator parents:

(return to top)
p.000004:
p.000004: What links in most closely to traditional experiments in the quantitative trends is termed “causal” or “multivariable”
p.000004: analysis. “Suicide” by Emile Durkheim (1897) is a good example of this approach. In this study the author
p.000004: shows that the increase in the number of suicides, where other data are identical, is directly proportional to the
p.000004: number of Protestants. According to the statistical material Durkheim had at his disposal, the suicide figures in the
p.000004: Swiss cantons increased as the number of Protestants increased. Here the first two experiment conditions are met (or
p.000004: met to a greater or lesser degree): the reduction to variables and the demonstration of causality or at least a
p.000004: correlation. However, the third condition is missing: the sociologist has no influence on the protestant ethos or on
p.000004: suicidal tendencies.
p.000004: It would therefore be a major error to reduce sociology to trends that are based on statistical methods. Qualitative
p.000004: sociology is chiefly founded on hermeneutics. Without wishing to engage in a far-reaching epistemological debate –
p.000004: although this is where the difference and the controversy lie –, the distinction needs to be made between “explaining”
p.000004: and “understanding”. The explicit intention of a large number of sociologists is the understanding and explanation
p.000004: of complex processes and mechanisms through painstaking - ethnographic and quasi “entomological” -
p.000004: observation of human behaviour, methods that are not reconcilable with the statistical approach. We can refer to these
p.000004: studies as involving experiments. Harold Garfinkel, an American sociologist, asked his students to approach their
p.000004: parents as friends when they got home. The aim here was, via transgression, to reveal the precise rules that govern the
p.000004: parent-child relationship. The moral rules are often very clearly demarcated, yet may of course differ considerably
p.000004: from the agreements existing between friends. In this example, the “manipulation factor” is very much present: the
p.000004: student interferes in the type of relationship with his parents. The other two conditions, however, are not present.
p.000004: The epistemological preconception does not permit reduction to a few simple variables, and demonstrating the causality
p.000004: is not the end objective. Therefore here we can only refer to a perception or observation, but not an “experiment” in
p.000004: the meaning used in experimental social psychology and in medicine when clinical trials are involved.
p.000004:
p.000004:
p.000005: 5
p.000005: Opinion no. 36 of 11 September 2006 – Final version
p.000005:
p.000005: 2. Risks for test subjects taking part in research in the life sciences
p.000005:
p.000005: Whilst experiments on patients or on healthy test subjects involving certain health risks for the test subjects have
p.000005: to be subject to an assessment by a medical ethics committee, this is not necessarily the case for surveys which in
p.000005: principle do not have any medical purpose. However, these are not always without risk for the parties involved.
p.000005:
p.000005: Possible risks are lack of confidentiality, invasion of privacy, stigmatisation, discrimination,
p.000005: psychological effects and even health risks. It must be possible for these risks to be assessed. By way of
p.000005: illustration, a few examples of the possible risks are presented below.
p.000005:
p.000005: We may be talking about experiments on patients or healthy volunteers, but also surveys of a varyingly exhaustive
p.000005: nature depending on the subject.
p.000005: For example, some surveys are used to study changes and developments in the holiday destinations chosen by
...

Social / philosophical differences/differences of opinion

Searching for indicator opinion:

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p.000002: Opinion no. 36 of 11 September 2006 on the ethical testing of research in certain branches of the life sciences
p.000002:
p.000002: Request for an opinion submitted on 6 February 2004
p.000002:
p.000002: by Professor B. Mouvet, Chairperson of the Ethics Committee of the Faculty of Psychology and Educational Sciences of
p.000002: the University of Liège, concerning:
p.000002: (1) the expediency of setting up ethics committees in faculties of psychology and educational sciences, and
p.000002: (2) the expediency of arriving at inter-university harmonisation of criteria and procedures for ethical consultation
p.000002: on research in Belgian faculties of psychology and educational sciences.
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p.000002: 2
p.000002: Opinion no. 36 of 11 September 2006 – Final version
p.000002:
p.000002: CONTENT OF THE OPINION
p.000002:
p.000002:
p.000002:
p.000002: Question put to the Committee
p.000002:
p.000002:
p.000002: Introduction
p.000002:
p.000002:
p.000002: 1. The specific character of research in the life sciences
p.000002:
p.000002: 2. Risks for test subjects taking part in research in the life sciences
p.000002:
p.000002: 3. The current ethical reflection in the life sciences
p.000002: a. The situation in France
p.000002: b. The situation in the United Kingdom
p.000002: c. Existing codes
p.000002: The Caverni code
p.000002: “Deception” in research
p.000002: d. The situation in Belgium
p.000002: e. Conclusions regarding general ethical requirements in experiments involving human subjects
p.000002:
p.000002: 4. Thoughts on the role and place of ethics committees in the life sciences
p.000002:
p.000002: 5. Conclusions
p.000002: a. Ethics committees in faculties of psychology
p.000002: Expediency
p.000002: Inter-university harmonisation
p.000002: b. Ethics committees in other branches of the life sciences (sociology, criminology, etc.)
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p.000003: 3
p.000003: Opinion no. 36 of 11 September 2006 – Final version
p.000003:
p.000003: Question put to the Committee
p.000003: Professor B. Mouvet, chairperson of the Ethics Committee of the Faculty of Psychology and Educational
p.000003: Sciences of the University of Liège, sent the Advisory Committee for Bio-Ethics a letter, on 6/2/2004, which was
p.000003: followed by another letter dated 4/5/2005.
p.000003: The Advisory Committee for Bio-Ethics declared this request for an opinion admissible during its session of 8/3/2004.
p.000003: Since the Committee’s term of office came to an end in June 2004, the Committee entrusted the subsequent Committee,
p.000003: which took office on 21/4/2005, with the drafting of the opinion paper.
p.000003:
p.000003: The Advisory Committee for Bio-Ethics has decided in this opinion paper to answer the questions concerning the
p.000003: expediency of setting up ethics committees in the faculties of psychology and educational sciences, and the expediency
p.000003: of an inter-university harmonisation of the criteria and procedures for ethical consultation in research in these
p.000003: disciplines in Belgian faculties.
p.000003:
p.000003: Another question raised by Professor B. Mouvet concerns the scope of the law of 7 May 2004 on experiments involving
p.000003: human subjects, in particular in the field of the life sciences. This question will form the subject of a separate
p.000003: opinion paper.
p.000003:
p.000003:
p.000003: Introduction
p.000003: In this opinion paper we deal with Professor B. Mouvet’s original question concerning the degree to which it is
p.000003: expedient for ethics committees to be set up in faculties of psychology and the degree to which it is expedient for
p.000003: inter-university harmonisation to be achieved.
p.000003: These ethics committees would have the task of assessing research projects submitted to the faculty of psychology, just
p.000003: as the medical ethics committees have to assess medical protocols. The Committee deemed it expedient from the
p.000003: outset to extend our reflection to include all faculties in the life sciences.
p.000003:
p.000003: The ethical testing of research projects involving human subjects is carried out by medical ethics committees when
p.000003: the experiment involves patients or healthy volunteers making themselves available for experiments of a medical
p.000003: nature, such as clinical studies with new medicines, for example.
p.000003: As regards medical ethics committees, a distinction needs to be made between medical ethics committees as defined in
p.000003: the law on experiments involving human subjects of 7 May 2004 (committees authorised to assess research
p.000003: projects, either as a committee authorised to publish a final opinion, or as a committee of one of the cooperating
p.000003: centres, provided the centre meets the official competence criteria), and local ethics committees which should exist in
p.000003: all hospitals and health establishments but which are not legally “recognised” when it comes to experiments involving
p.000003: human subjects.
p.000003:
p.000003: There is the possibility of medical ethics committees that are authorised to assess protocols also having to assess
p.000003: certain protocols for experiments in the life sciences. Indeed, the Belgian legislator has given a wider
p.000003: interpretation to European Directive 2001/20/EC on the conduct of clinical trials on medicinal products for human use.
p.000003: However, many studies in the field of the life sciences do not fall within the legal or scientific competence of
p.000003: medical ethics committees. The question that then arises is whether the research protocols in life sciences that have a
p.000003: specific character (more especially as regards methodology) should not be subject to review by an ethics committee
p.000003: specific to each field within the life sciences.
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004: Opinion no. 36 of 11 September 2006 – Final version
p.000004:
p.000004: 1. The specific character of research in the life sciences
p.000004:
p.000004: Every research assignment and every study is constructed according to a hypothetical-deductive working method. Whilst
p.000004: the term “research” can refer to very wide-ranging approaches such as “surveys”, “experience” and “experiments”, an
p.000004: experiment is an empirical research strategy aimed at demonstrating the causal links between a series of
p.000004: selected variables. Experiments play a fundamental role in sciences such as chemistry, physics, biology and
p.000004: biomedical sciences. Three conditions have to be met in order to be able to talk of an experiment: 1) the reduction of
p.000004: the problem to a small number of variables; 2) the search for a causality between the variables through use of the
p.000004: probability theory; 3) the researcher’s direct contribution to the observed situation. At this stage there is no
p.000004: significant difference between the meaning of experiment adopted here and the meaning used in medical studies and
p.000004: clinical trials. In clinical trials with medicines the basic hypothesis plays an important role. The aim is precisely
p.000004: to confirm (or negate) this. It is on the grounds of this basic hypothesis that the trial set-up is conceived, and
p.000004: therefore the formulation of the relevant variables, and the conditions and methods according to which the treatments
p.000004: are administered or the interventions carried out. It is also in function of the hypotheses that
p.000004: comparable groups are put together.
p.000004:
p.000004: In some branches of the life sciences, more especially in experimental psychology and neuropsychology, the
...

p.000004: although this is where the difference and the controversy lie –, the distinction needs to be made between “explaining”
p.000004: and “understanding”. The explicit intention of a large number of sociologists is the understanding and explanation
p.000004: of complex processes and mechanisms through painstaking - ethnographic and quasi “entomological” -
p.000004: observation of human behaviour, methods that are not reconcilable with the statistical approach. We can refer to these
p.000004: studies as involving experiments. Harold Garfinkel, an American sociologist, asked his students to approach their
p.000004: parents as friends when they got home. The aim here was, via transgression, to reveal the precise rules that govern the
p.000004: parent-child relationship. The moral rules are often very clearly demarcated, yet may of course differ considerably
p.000004: from the agreements existing between friends. In this example, the “manipulation factor” is very much present: the
p.000004: student interferes in the type of relationship with his parents. The other two conditions, however, are not present.
p.000004: The epistemological preconception does not permit reduction to a few simple variables, and demonstrating the causality
p.000004: is not the end objective. Therefore here we can only refer to a perception or observation, but not an “experiment” in
p.000004: the meaning used in experimental social psychology and in medicine when clinical trials are involved.
p.000004:
p.000004:
p.000005: 5
p.000005: Opinion no. 36 of 11 September 2006 – Final version
p.000005:
p.000005: 2. Risks for test subjects taking part in research in the life sciences
p.000005:
p.000005: Whilst experiments on patients or on healthy test subjects involving certain health risks for the test subjects have
p.000005: to be subject to an assessment by a medical ethics committee, this is not necessarily the case for surveys which in
p.000005: principle do not have any medical purpose. However, these are not always without risk for the parties involved.
p.000005:
p.000005: Possible risks are lack of confidentiality, invasion of privacy, stigmatisation, discrimination,
p.000005: psychological effects and even health risks. It must be possible for these risks to be assessed. By way of
p.000005: illustration, a few examples of the possible risks are presented below.
p.000005:
p.000005: We may be talking about experiments on patients or healthy volunteers, but also surveys of a varyingly exhaustive
p.000005: nature depending on the subject.
p.000005: For example, some surveys are used to study changes and developments in the holiday destinations chosen by
p.000005: a particular population group. Other surveys are intended to study the incidence of smoking and non-smokers’ tolerance
p.000005: of other people smoking. These apparently simple and neutral surveys may require an analysis of the correlation with
p.000005: the respondents’ age, sex, income and even educational level. These are examples for which provision is made in the law
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p.000005:
p.000005: When researchers in sociology, educational science or criminology try to find lines of reasoning to explain why some
p.000005: young people drop out of school by interviewing young people who are ambling around in the street at times of the day
p.000005: when they should normally be in the classroom, this is a situation that provokes a whole host of questions. Is the
p.000005: young person old enough to give his informed consent? Does he remain identifiable thereafter, and how are
p.000005: the data subsequently anonymised? Does the mere fact of a pollster showing an interest in him have an effect on him,
p.000005: and if so, what is that effect?
p.000005:
p.000005: Neither is it harmless to ask a random passer-by who knows he is suffering from cancer, about the fear of dying, even
p.000005: if he has agreed to answer a questionnaire on this.
p.000005:
p.000005: Research into grieving processes when someone loses their job can also trigger unpredictable reactions among the
p.000005: persons affected, which not only hamper but even harm their adaptation to unemployment.
p.000005:
p.000005: Even some surveys that look into the quality of a company’s management by asking employees a number of questions, are
p.000005: not per se inoffensive and can destabilise some of the respondents, all the more since their freedom to choose whether
p.000005: or not to take part in the interview is de facto often limited.
p.000005:
p.000006: 6
p.000006: Opinion no. 36 of 11 September 2006 – Final version
p.000006:
p.000006: The same goes for studies carried out by university lecturers among their students and for all studies involving
p.000006: persons who fall under some form of judicial measure, irrespective of whether they are detainees or not.
p.000006:
p.000006: In anthropology and the life sciences in general there are certain studies that take the form of interaction or
p.000006: participatory role models, which, by describing or depicting types of persons, aim to formulate a number of
p.000006: hypotheses on the cultural determinants of their behaviour and attitudes. It is often laid down in the study
p.000006: protocol that the researcher must obtain the prior agreement of the person in order to publish his
p.000006: observations of this person’s behaviour or attitude. From an ethical standpoint that is certainly a good thing,
p.000006: and even an essential condition for a person’s inclusion in a study. Nevertheless, merely confronting a person with
p.000006: what for him is a stigmatising description can be harmful.
p.000006: The examination of intentional or unintentional racist reactions, which are present in all of us, or of potential
p.000006: aggression in some people in certain situations, does not mean that it is acceptable to place people, who have
p.000006: been pre-selected to provoke hostile reactions in other study participants, into physical or psychological
p.000006: danger.
p.000006:
p.000006: It is undeniable that acceptable risks sometimes have to be taken in order to make progress in the life sciences. These
p.000006: risks should be carefully studied and described, even if the survey in question is for all other intents and purposes
p.000006: quite inoffensive. There is therefore reason to be concerned about the procedures followed in the life sciences to
p.000006: weigh up the potential risks of a study against the result one is hoping to achieve. At the same time it is useful to
p.000006: pose questions in advance about the potential risks of research procedures and the methodology used to limit the risks
p.000006: as far as possible.
p.000006:
p.000006:
p.000006: 3. The current ethical reflection in the life sciences
p.000006:
p.000006: a. The situation in France
p.000006:
p.000006: The laws on research in the health sector have in recent years often been applied to experiments in behavioural science
p.000006: further to a 1994 amendment to the law of 1988 (Huriet-Serusclat law, France, 20 December 1988).
p.000006:
p.000006: In October 1993 the French National Advisory Committee for Ethics (Comité consultatif national d’éthique - CCNE)
p.000006: published an opinion paper on research in behavioural science (la recherche dans les sciences du comportement humain –
p.000006: opinion no. 98).
p.000006: The ethical aspects concern the protection of persons, the respective responsibility of the commissioning
p.000006: authorities, researchers and participants, and the collective interest or individual interest of the participants in
p.000006: the study.
p.000006: The researcher has the duty to avoid any foreseeable harm and to redress any harm. The concept of harm concerns damage
p.000006: sustained to the person’s physical integrity, goods or psychological balance. This scarcely differs from what we know
p.000006: in the biomedical field.
p.000006: In the opinion paper the objectives of biomedical research are clearly distinguished from those of behavioural
p.000006: research. The CCNE is of the view that the main ethical principles governing research involving human subjects
p.000006: (justice, well-doing, respect for autonomy) and the rules stemming from them (fairness, non-discrimination, consent,
p.000006: limitation of the risks), are the same whether they be in respect of biomedical research or behavioural research. In
p.000006: the case of behavioural research, too, the research protocols would also have to be submitted to an independent and
p.000006: professional ethics committee before the research is carried out.
p.000006:
p.000006: There is also an Ethics in Science Committee (Comité d’éthique pour les Sciences - COMETS), which was set up in 1994 by
p.000006: the National Centre for Scientific Research (Centre national de la Recherche scientifique - CNRS), to deal with the
p.000006: ethical aspects of scientific research which is not handled by
p.000006:
p.000007: 7
p.000007: Opinion no. 36 of 11 September 2006 – Final version
p.000007:
p.000007: the CCNE. The subjects dealt with include studies into the influence of audio-visual techniques and into
p.000007: environmentally related problems, but also behavioural research.
p.000007:
p.000007: There is also an Operational Committee for Ethics in the Life Sciences (Comité opérationnel pour l’éthique dans les
p.000007: sciences de la vie - COPE), which is linked to the CNRS and has a threefold task: to inform researchers of the existing
p.000007: legislation, to trace any ethical problems so as to present these to the competent bodies (for example CCNE), and to
p.000007: take stock of the obstacles encountered by researchers, in order then to forward these to the CCNE or the COMETS.
p.000007:
p.000007: The CNRS’s life sciences department (Département des sciences de la vie) has a document entitled “Ethique en sciences
p.000007: de la vie” (Ethics in the Life Sciences), which was published to help researchers assess the stress and risk level
p.000007: to which study participants are exposed and the degree of invasiveness of the research techniques. Some
p.000007: studies are considered as stress-free, in particular when they relate to everyday activities carried out by the
p.000007: participants where it is known that these do not entail any special risk whatsoever (for example a study of a
p.000007: physiological movement which is not of any unusual scope or duration, an observation of test subjects in a driving
p.000007: simulator, and so on). In the case of research “with stress”, on the other hand, the study participant runs a
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p.000007: reverse.
p.000007:
p.000007: The Society stresses the importance of avoiding test subjects being subjected to experimental situations or test
p.000007: situations implying a greater risk than that which people are prepared to take in normal life.
p.000007:
p.000007: At any event the implications and psychological consequences of the study for the participants should be taken into
p.000007: consideration. If the study targets people of different generations, of a different sex, or from different
p.000007: backgrounds, then, in our multicultural and multiethnic society, the research protocols should also be submitted to
p.000007: persons from the same background as the participants, so as to ascertain in advance that the test subjects concerned do
p.000007: not feel as though the study constitutes an affront to their dignity.
p.000007:
p.000007: In the case of studies based on observation, the British Psychological Society stipulates that, with the exception of
p.000007: studies in which the observed test subjects have agreed to the observation, observation is only acceptable in
p.000007: situations in which the observed person is aware that he or she can be seen by strangers. Account must
p.000007: inevitably be taken of local cultural values. The
p.000007:
p.000007: 1 The British Psychological Society, in Sue Eckstein (editor) “Manual for Research Ethics Committees: Centre of Medical
p.000007: Law and Ethics, King’s College London”, Cambridge University Press, 2003, pp. 269-273.
p.000008: 8
p.000008: Opinion no. 36 of 11 September 2006 – Final version
p.000008:
p.000008: observation, even in public places, of people who could reasonably assume that they are not being watched, is
p.000008: absolutely forbidden.
p.000008:
p.000008: c. Existing codes
p.000008:
p.000008: The Caverni code
p.000008:
p.000008: The aspects of psychological research are also specifically covered in “Un code de conduite des chercheurs dans les
p.000008: sciences du comportement humain” (a code of conduct for researchers in behavioural sciences), drafted by J.-P. Caverni
p.000008: (Research Department of the French Psychological Society, Un code de conduite des chercheurs dans les sciences du
p.000008: comportement humain, 2003). A few of the key ideas contained in this are discussed below.
p.000008:
p.000008: According to this code, the purpose of behavioural research is to develop a body of fundamental knowledge that is
p.000008: scientifically validated according to an objectivised, entirely communicable and reproducible methodology. Behavioural
p.000008: research concerns all aspects of human behaviour, at all ages, equally in the case of the foetus as in the case of
p.000008: healthy or sick individuals, insofar as that is ethically acceptable. The study must, if possible, aim at contributing
p.000008: to the improvement of human welfare, both individually and socially.
p.000008: The researcher must be a professional person who is responsible at scientific and ethical level for the studies he
p.000008: plans and conducts. Assessment by an ethics committee is not specifically laid down in the code, but it is stated that
p.000008: whenever there is the possibility of a study exceeding the generally recognised rules, the researcher should obtain the
p.000008: positive opinion of his peers and if necessary, also of recognised bodies in which there are representatives of society
p.000008: who are not members of the scientific community. These aforementioned bodies resemble local medical ethics committees
p.000008: or ethics committees in life sciences faculties.
p.000008: According to the Caverni code researchers should guarantee respect for and protection of the people taking part in the
p.000008: study and should moreover vouch for respect for human beings and for life in general. They are obliged to respect
p.000008: confidentiality vis-à-vis everything they may have learnt about the participants in the study. The researcher is
p.000008: responsible for protection and confidentiality of the data.
p.000008: Before participation in any study, the people approached must explicitly give their informed and free consent. They
p.000008: must be informed, in a manner comprehensible to them, of all aspects that could influence their consent (risks,
p.000008: inconvenience, immediate or deferred negative effects, limitation of confidentiality, etc.), as well as the
p.000008: study’s objectives and the procedure to be used. The position of authority that the researcher generally has may not be
p.000008: used to induce the potential participant to give his consent.
p.000008: The party concerned may withdraw from the study after he has obtained information, or even when the experiment is under
p.000008: way.
p.000008: Before their possible participation, people must know that they are free to take part or not to take part, without a
p.000008: refusal on their part having any negative consequences of any kind for them (here we are thinking of students or
p.000008: members of staff). That is precisely what is applied in the case of medical experiments.
p.000008: Now, there may be cases of certain people not being in a position to give their free and informed consent (children and
p.000008: vulnerable people, for example). In such cases the researcher has to obtain “autorisation appropriée” (suitable
p.000008: authorisation) from a legally authorised person. However, he must give the person wishing to take part in the study
p.000008: “des explications appropriées” (suitable explanations) at all times, and obtain his “assentiment” (consent) in
p.000008: circumstances that are as close as possible to the circumstances in which ordinary people find themselves.
p.000008: The researcher does not have to secure the consent of the test subjects if non-identifiable data are collected which
p.000008: only relate to observations in a natural setting or relate to isolated data from archives.
p.000008: The freedom to consult certain elements of an archive does not yet give entitlement to consultation of
p.000008: the entire archive or file.
p.000008:
p.000009: 9
p.000009: Opinion no. 36 of 11 September 2006 – Final version
p.000009:
p.000009: Whenever possible and relevant, the researcher must inform the public of the knowledge collected, the
p.000009: method followed to obtain that knowledge, and the reliability thereof. He may not fail to mention the fact that the
p.000009: bulk of this knowledge is of a provisional and incomplete nature. He must see to it that the scientific knowledge is
p.000009: put to good use. In particular, he must oppose any distorted reproduction of it and the use of it for
p.000009: purposes that run counter to ethical principles.
p.000009: One heading in this code also relates to confidentiality of the data and the conditions for
p.000009: dissemination of the results.
p.000009:
p.000009: “Deception” in research
p.000009:
p.000009: One special point in the Caverni code concerns the possibility of the information supplied by the researcher being
p.000009: incomplete or even inaccurate. The aforesaid code states that: “(our translation) when, for scientifically valid
p.000009: reasons, the test subject cannot be fully informed of the objectives pursued before the study gets under way, it is
p.000009: agreed that he is informed only in an incomplete fashion beforehand and that the information knowingly contains
p.000009: incorrect elements. However, he must be fully informed at the end of his participation. The incomplete and incorrect
p.000009: nature of the information originally supplied must always have an indisputable scientific justification. A check should
p.000009: also be made to see whether any other procedures are possible, whether the participants will be adequately informed as
p.000009: soon as possible, and whether advice will be obtained as to the way in which the complete information will be
...

p.000009: (physical risks, inconvenience, negative emotions, etc.). The fact that comprehensive information is provided
p.000009: at the end of the study cannot in itself justify the fact that the original information was incomplete.”
p.000009: In biomedical sciences, situations where it is necessary to deceive the participant for the purposes of the result of
p.000009: the experiment hardly ever arise. In the very frequent situation in biomedical sciences in which a new medicine is
p.000009: tested by means of comparison with a placebo, the participant is always told beforehand that he might be given a
p.000009: placebo, but as soon as the patient has given his agreement and the experiment has started, he is of course not told
p.000009: whether he was given the experimental drug or the placebo.
p.000009: In behavioural sciences the “deception” of the test subject would occur very often. In the March 2005 issue of the
p.000009: journal Bioethica Forum, B. Baertschi2 estimates that deception is used in 58% of research protocols in psychology.
p.000009: The concept of “deception”, as the American Psychology Association sees it (“deception in research”), tends to mean
p.000009: a lie on account of omission or the concealing of a part of the truth. Baertschi takes account of the
p.000009: possibility of a “permitted deception” if the test subject is specifically informed beforehand that he will not be
p.000009: told everything before the experiment starts. He is of the opinion that deception in experiments can be justified on
p.000009: the grounds of the foreseeable advantages that the results of the experiment will entail. Other authors feel that
p.000009: test subjects should have it pointed out to them beforehand that some information will not be given to them
p.000009: before the experiment, but that they will be given this information after the experiment and only then have to give
p.000009: their consent for use of the data concerned (such as in the case of programmes of the “Candid Camera” variety, where
p.000009: recordings, made without the knowledge of the person concerned, are broadcast on TV). Recommendations for this have
p.000009: been drawn up by the American Psychology Society (“Ethical principles of psychologists and code of conduct”,
p.000009: June 2003).
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: 2 L’éthique de la recherche en psychologie, Bernard Baertschi, University of Geneva, in Bioethica Forum (a publication
p.000009: of the “Société Suisse d’Éthique Biomédicale”), no. 44, March 2005, pp. 9-11.
p.000010: 10
p.000010: Opinion no. 36 of 11 September 2006 – Final version
p.000010:
p.000010: In the same Bioethica Forum, Ron Berghmans3 of the University of Maastricht states that “deceiving or misinforming
p.000010: subjects should be considered prima facie wrong and thus unjustified from an ethical point of view”. Nonetheless, he
p.000010: adds that people can validly agree to be given only some of the information, or not to be informed at all.
p.000010:
p.000010: d. The situation in Belgium
p.000010:
p.000010: With the exception of ethics committees in certain faculties of psychology, the Committee concludes that
p.000010: there are no ethics committees in the life sciences in Belgium. Experiments in the field of behavioural science,
p.000010: and more generally experiments in the life sciences, are not necessarily presented to medical ethics
p.000010: committees and are not assessed by ethics committees in the corresponding faculties.
p.000010:
p.000010: Studies in psychology, criminology, educational science or sociology are often conducted on people but are
p.000010: not necessarily carried out in a medical framework, and still less in a hospital. Some studies belong to the field of
p.000010: labour psychology, others relate to language use or other subjects for which there is no reason for submission to
p.000010: medical ethics committees, which in any case are not well grounded in these matters. Just like every biomedical study,
...

p.000010: test subject must always retain his freedom to take part or not to take part, that a person’s refusal may not have any
p.000010: negative consequences whatsoever, and that no refusal may entail a change in the quality of the care
p.000010: administered. However, in psychology the researcher may deem that giving comprehensive information on the purpose of
p.000010: the study and the study methods to be used makes it impossible to obtain valid data. Indeed, it is accepted knowledge
p.000010: that a person who is aware that he is being observed will adjust his behaviour, which is what the study aims to
p.000010: describe. In that case it should be ensured that the test subjects or their representatives are informed, after
p.000010: the study, of the results of the experiment and the justification for it, and are given the possibility of
p.000010: agreeing to these being used. As a rule these situations are regulated by codes of good practice.
p.000010:
p.000010: Moreover, the rules for the testing of research projects are very diverse. In many cases no thought is given to the
p.000010: ethical aspects of the study, other than by those responsible for the study and the people actually carrying out the
p.000010: experiments. These studies can thus be conducted under the leadership of lecturers, recognised researchers or
p.000010: individuals holding a doctorate, but these studies can also include studies carried out in the context of a thesis
p.000010: for a master’s degree.
p.000010:
p.000010: 3 Moral aspects of deception in psychological research, Ron L.P. Berghmans, University of Maastricht, in Bioethica
p.000010: Forum (a publication of the “Société Suisse d’Éthique Biomédicale”), no. 44, March 2005, pp. 2-4.
p.000010:
p.000011: 11
p.000011: Opinion no. 36 of 11 September 2006 – Final version
p.000011:
p.000011: People who take part in behavioural analysis studies, in particular in the field of psychology, thus do not necessarily
p.000011: receive the same attention, and therefore perhaps not the same degree of protection, as participants in a clinical
p.000011: experiment in the medical field or in the study of a new drug, for example as regards insurance cover in the event of
p.000011: damage or accident.
p.000011:
p.000011: Finally, some aspects of research conducted in the field of the life sciences differ from the aspects of medical
p.000011: research, whilst other aspects show many similarities.
p.000011: Some projects in the field of the life sciences are clearly distinguishable from medical experiments when it comes to
p.000011: the objective: biomedical research always strives for advancement in medical knowledge and has a therapeutic goal in
p.000011: the shorter or longer term. Like fundamental research, research in the life sciences can aim for a better knowledge of
p.000011: our surroundings and of people’s response and adjustment mechanisms.
p.000011:
p.000011: e. Conclusions regarding general ethical requirements in experiments involving human subjects
p.000011:
p.000011: From the foregoing it emerges that experiments involving human subjects, irrespective of the framework in which they
p.000011: are conducted, must meet a number of common conditions:
p.000011: ▪ The study must be scientifically justified and should be carried out in a scientifically flawless
p.000011: manner.
p.000011: ▪ Respect for people’s freedom should be guaranteed and their free and informed consent must be obtained before
...

p.000011:
p.000011: Ethics committees in the life sciences should have the responsibility of monitoring the various points discussed
p.000011: above: scientific pertinence, assessment of the possible risks for the participants, conditions for
p.000011: inclusion of the participants, information supplied, observance of confidentiality, and so forth.
p.000011: Following on from interviews with colleagues and experts, we would like to emphasise the following. In
p.000011: sociological, criminological or psychological studies, various different – and sometimes conflicting –
p.000011: theoretical bases can be used within one and the same discipline. If the job of an ethics committee is to assess the
p.000011: scientific basis of a study, it should do so without prejudice to the theoretical basis from which the study draws its
p.000011: inspiration. There may indeed be contradictions at theoretical level which do not, however, challenge the
p.000011: relevance of the research.
p.000011:
p.000011: The French-speaking experts, and the Dutch-speaking expert, who were interviewed by the select committee are in
p.000011: favour of ethics committees being set up. The faculties of psychology and educational sciences are also
p.000011: reportedly advocates of ethics committees being set up in the faculties.
p.000011:
p.000012: 12
p.000012: Opinion no. 36 of 11 September 2006 – Final version
p.000012:
p.000012: As regards sociology and criminology, the experts who were heard by the select committee display a certain reservation
p.000012: about the setting up of an ethics committee that would assess the ethical value of their research projects. Of the view
p.000012: that they are the preferential witnesses of society’s growing interference in people’s private lives and the increased
p.000012: social pressure (at economic, political and other levels) that this exerts on individuals on a day-to-day basis, they
p.000012: fear that ethics committees could curb their studies and thereby prevent them from bringing certain dysfunctions or
p.000012: pressures to light.
p.000012: On the other hand, they advocate the setting up of a code of professional practice specific to their profession and
p.000012: containing ethical guidelines for researchers. These guidelines of course relate to the informed consent of the persons
p.000012: studied and respect for their privacy.
p.000012: One expert is of the view that an ethics committee at inter-university level could be useful. This committee would only
p.000012: be allowed to have an advisory role.
p.000012: Two experts who were interviewed also complained of the existence of collusion between life sciences research and the
p.000012: political establishment, which is often the party subsidising the studies and tends to orientate the research according
p.000012: to its objectives.
p.000012:
...

p.000012: many arguments advocating the establishment of such committees. Even though the risk for the participants in such
p.000012: studies is seldom one of physical and mental harm, it is nonetheless important that that risk be examined. The examples
p.000012: in point 2 illustrate certain risks of stigmatisation or undesired consequences that are associated with some
p.000012: experiments. The people’s protection is therefore at issue.
p.000012: Ethics committees in the faculties of psychology could play an advisory role and could have preferential
p.000012: contact with the medical ethics committees when the protocol falls under the scope of the law on experiments involving
p.000012: human subjects and therefore has to be submitted to these latter committees.
p.000012: It is up to the faculties of psychology and educational sciences to work out in greater detail the composition and
p.000012: operation of their committees.
p.000012:
p.000012: In a letter to us dated 27/10/2005, in answer to a request made by the co-chairmen of the 2005/5 select committee for
p.000012: information on research in the faculties of psychology and educational sciences and on whether or not an
p.000012: ad-hoc ethics committee existed, Professor B. Harmegnies told
p.000013: 13
p.000013: Opinion no. 36 of 11 September 2006 – Final version
p.000013:
p.000013: us that the faculties of psychology and educational sciences of the universities of the French Community of Belgium
p.000013: “(translation) recently decided, each individually, to set up and/or restructure their own ethics committee
p.000013: per faculty, out of a concern that opinions on the ethical validity of research studies in psychology and educational
p.000013: sciences be published by specific bodies in psychology and educational sciences”.
p.000013:
p.000013: Inter-university harmonisation
p.000013:
p.000013: Professor B. Mouvet also asked us for an opinion on the expediency of harmonising the activities of ethics committees
p.000013: in psychology. The Committee is of the view that a harmonisation of the working procedures and methods used by ethics
p.000013: committees in psychology should certainly be encouraged.
p.000013: In the same letter of 27/10/2005, Professor B. Harmegnies tells us that the Conférence des Doyens (Conference of Deans)
p.000013: of the universities of the French Community of Belgium “(our translation) has set up a consultative structure which it
p.000013: has asked to prepare the convergence measures that have to be implemented so that the four faculty ethics committees
p.000013: can organise their operation swiftly on a harmonised basis”.
p.000013:
p.000013: b. Ethics committees in other branches of the life sciences (sociology, criminology, etc.)
p.000013:
p.000013: The Advisory Committee for Bio-ethics is of the opinion that ethics committees could have a supporting
p.000013: function in areas of the life sciences other than psychology, for the ethical reflection on research protocols.
p.000013: These ethics committees do not have to be a copy of the medical ethics committees, but would have to focus on the
p.000013: protection of the people taking part in research and be organised in cooperation with the researchers in
p.000013: those fields. Those working in the life sciences would have to work out how we could arrive at an optimal operation of
p.000013: such ethics committees and the fair representation in them of the various members of the life sciences fraternity.
p.000013: Thought should also be given to the idea of including “outsiders” on these committees, i.e. people who are not involved
p.000013: in the research or in the field being studied. Such committees could also form a buffer against the incidence of
p.000013: certain bodies that commission research interfering in the objective, progress or financing of the research study
p.000013: itself. These committees could thus help guarantee the autonomy and freedom of the research.
p.000013: Apart from the reflection on the usefulness of ethics committees being set up in the life sciences in order to avoid
p.000013: conflicts between the government, the financing bodies and the researchers, the Committee advocates a refinancing of
p.000013: research at universities so that they are able to work in a totally independent fashion.
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:
p.000013:
p.000013:
p.000013:
p.000014: 14
p.000014: Opinion no. 36 of 11 September 2006 – Final version
p.000014:
p.000014: The opinion was prepared by the select commission 2005-5, consisting of:
p.000014:
p.000014:
p.000014: Joint chairpersons
p.000014: M. Roelandt
p.000014:
p.000014: J.-M. Maloteaux
p.000014: Joint reporters
p.000014:
p.000014:
p.000014: M. Roelandt
p.000014:
p.000014: J.-M. Maloteaux
p.000014: Members
p.000014:
p.000014:
p.000014: M. Bogaert
p.000014:
p.000014: F. Caeymaex
p.000014:
p.000014: M. Dumont
p.000014:
p.000014: E. Eggermont
p.000014:
p.000014: M. Eisenhuth
p.000014:
p.000014: R. Rubens
p.000014:
p.000014: G. Verdonk
p.000014: From 13-03-2006:
p.000014: M.-L. Delfosse
p.000014: G. Lebeer
p.000014: Member of the Bureau
p.000014: J.-A. Stiennon
p.000014:
p.000014:
p.000014: Member of the secretariat
p.000014:
p.000014: Veerle Weltens
p.000014:
p.000014:
p.000014: Experts consulted in 2005 / beginning of 2006
p.000014:
p.000014: - Prof. B. Mouvet, Chairperson of the Ethics Committee of the Faculty of Psychology and Educational
p.000014: Sciences of the University of Liège
p.000014: - Prof. I. Kristoffersen-Ponjaert, Psychologist attached to the Free University of Brussels and member of the
p.000014: Committee
p.000014: - Prof. M. Jacquemain, Sociologist attached to the University of Liège and member of the Committee
p.000014: - Prof. G. Lebeer, Sociologist attached to the Free University of Brussels and member of the Committee
p.000014: - Prof. Y. Cartuyvels, Dean of the Faculty of Law of the Facultés Universitaires Saint-Louis
p.000014:
p.000014:
p.000014: The working documents of the select commission 2005-5 – the question, personal contributions of
p.000014: the members, minutes of the meetings, documents consulted – are kept at the Committee’s documentation centre, where
p.000014: they are available to be consulted and copied.
p.000014:
p.000014: This opinion is available on the website www.health.belgium.be/bioeth under the “List of Opinions”
p.000014: section.
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000014:
p.000015: 15
...

General/Other / Impaired Autonomy

Searching for indicator autonomy:

(return to top)
p.000006: The laws on research in the health sector have in recent years often been applied to experiments in behavioural science
p.000006: further to a 1994 amendment to the law of 1988 (Huriet-Serusclat law, France, 20 December 1988).
p.000006:
p.000006: In October 1993 the French National Advisory Committee for Ethics (Comité consultatif national d’éthique - CCNE)
p.000006: published an opinion paper on research in behavioural science (la recherche dans les sciences du comportement humain –
p.000006: opinion no. 98).
p.000006: The ethical aspects concern the protection of persons, the respective responsibility of the commissioning
p.000006: authorities, researchers and participants, and the collective interest or individual interest of the participants in
p.000006: the study.
p.000006: The researcher has the duty to avoid any foreseeable harm and to redress any harm. The concept of harm concerns damage
p.000006: sustained to the person’s physical integrity, goods or psychological balance. This scarcely differs from what we know
p.000006: in the biomedical field.
p.000006: In the opinion paper the objectives of biomedical research are clearly distinguished from those of behavioural
p.000006: research. The CCNE is of the view that the main ethical principles governing research involving human subjects
p.000006: (justice, well-doing, respect for autonomy) and the rules stemming from them (fairness, non-discrimination, consent,
p.000006: limitation of the risks), are the same whether they be in respect of biomedical research or behavioural research. In
p.000006: the case of behavioural research, too, the research protocols would also have to be submitted to an independent and
p.000006: professional ethics committee before the research is carried out.
p.000006:
p.000006: There is also an Ethics in Science Committee (Comité d’éthique pour les Sciences - COMETS), which was set up in 1994 by
p.000006: the National Centre for Scientific Research (Centre national de la Recherche scientifique - CNRS), to deal with the
p.000006: ethical aspects of scientific research which is not handled by
p.000006:
p.000007: 7
p.000007: Opinion no. 36 of 11 September 2006 – Final version
p.000007:
p.000007: the CCNE. The subjects dealt with include studies into the influence of audio-visual techniques and into
p.000007: environmentally related problems, but also behavioural research.
p.000007:
p.000007: There is also an Operational Committee for Ethics in the Life Sciences (Comité opérationnel pour l’éthique dans les
p.000007: sciences de la vie - COPE), which is linked to the CNRS and has a threefold task: to inform researchers of the existing
p.000007: legislation, to trace any ethical problems so as to present these to the competent bodies (for example CCNE), and to
p.000007: take stock of the obstacles encountered by researchers, in order then to forward these to the CCNE or the COMETS.
p.000007:
...

p.000013: can organise their operation swiftly on a harmonised basis”.
p.000013:
p.000013: b. Ethics committees in other branches of the life sciences (sociology, criminology, etc.)
p.000013:
p.000013: The Advisory Committee for Bio-ethics is of the opinion that ethics committees could have a supporting
p.000013: function in areas of the life sciences other than psychology, for the ethical reflection on research protocols.
p.000013: These ethics committees do not have to be a copy of the medical ethics committees, but would have to focus on the
p.000013: protection of the people taking part in research and be organised in cooperation with the researchers in
p.000013: those fields. Those working in the life sciences would have to work out how we could arrive at an optimal operation of
p.000013: such ethics committees and the fair representation in them of the various members of the life sciences fraternity.
p.000013: Thought should also be given to the idea of including “outsiders” on these committees, i.e. people who are not involved
p.000013: in the research or in the field being studied. Such committees could also form a buffer against the incidence of
p.000013: certain bodies that commission research interfering in the objective, progress or financing of the research study
p.000013: itself. These committees could thus help guarantee the autonomy and freedom of the research.
p.000013: Apart from the reflection on the usefulness of ethics committees being set up in the life sciences in order to avoid
p.000013: conflicts between the government, the financing bodies and the researchers, the Committee advocates a refinancing of
p.000013: research at universities so that they are able to work in a totally independent fashion.
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:
p.000013:
p.000013:
p.000013:
p.000014: 14
p.000014: Opinion no. 36 of 11 September 2006 – Final version
p.000014:
p.000014: The opinion was prepared by the select commission 2005-5, consisting of:
p.000014:
p.000014:
p.000014: Joint chairpersons
p.000014: M. Roelandt
p.000014:
p.000014: J.-M. Maloteaux
p.000014: Joint reporters
p.000014:
p.000014:
p.000014: M. Roelandt
p.000014:
p.000014: J.-M. Maloteaux
p.000014: Members
p.000014:
p.000014:
p.000014: M. Bogaert
p.000014:
p.000014: F. Caeymaex
p.000014:
p.000014: M. Dumont
p.000014:
p.000014: E. Eggermont
p.000014:
p.000014: M. Eisenhuth
p.000014:
p.000014: R. Rubens
p.000014:
p.000014: G. Verdonk
p.000014: From 13-03-2006:
p.000014: M.-L. Delfosse
p.000014: G. Lebeer
p.000014: Member of the Bureau
p.000014: J.-A. Stiennon
p.000014:
p.000014:
p.000014: Member of the secretariat
p.000014:
p.000014: Veerle Weltens
p.000014:
p.000014:
p.000014: Experts consulted in 2005 / beginning of 2006
p.000014:
...

General/Other / Manipulable

Searching for indicator manipulated:

(return to top)
p.000012: One expert is of the view that an ethics committee at inter-university level could be useful. This committee would only
p.000012: be allowed to have an advisory role.
p.000012: Two experts who were interviewed also complained of the existence of collusion between life sciences research and the
p.000012: political establishment, which is often the party subsidising the studies and tends to orientate the research according
p.000012: to its objectives.
p.000012:
p.000012: Some members of the Committee and the experts interviewed stress that university research budgets have been
p.000012: severely scaled down in the last few decades. The possibility of the various centres taking on researchers, carrying
p.000012: out research and producing publications, depends more on research budgets from outside the university, which are often
p.000012: granted by the government. For example, a minister is looking for an answer to a particular problem and commissions a
p.000012: study, in the pursuit of political efficiency. Unfortunately, research seldom delivers unambiguous solutions for
p.000012: contemporary social problems. If the result of the study does not answer the question posed by the commissioning
p.000012: authority, or does not meet the latter’s wishes, there is a good chance that the centre will not receive any further
p.000012: subsidies for a subsequent study. When the study attempts to reach a solution that tallies with the commissioning
p.000012: authority’s expectations, the researchers may feel manipulated. If the centre refuses to comply, this leads in any
p.000012: case to a drop in its productivity.
p.000012:
p.000012:
p.000012: 5. Conclusions
p.000012:
p.000012: a. Ethics committees in the faculties of psychology
p.000012:
p.000012: Expediency
p.000012:
p.000012: The experts whose opinions were heard and the members of the Advisory Committee for Bio- ethics are in favour of ethics
p.000012: committees being set up in faculties of psychology. Some faculties already have their ethics committee and there are
p.000012: many arguments advocating the establishment of such committees. Even though the risk for the participants in such
p.000012: studies is seldom one of physical and mental harm, it is nonetheless important that that risk be examined. The examples
p.000012: in point 2 illustrate certain risks of stigmatisation or undesired consequences that are associated with some
p.000012: experiments. The people’s protection is therefore at issue.
p.000012: Ethics committees in the faculties of psychology could play an advisory role and could have preferential
p.000012: contact with the medical ethics committees when the protocol falls under the scope of the law on experiments involving
p.000012: human subjects and therefore has to be submitted to these latter committees.
...

General/Other / Relationship to Authority

Searching for indicator authority:

(return to top)
p.000008: whenever there is the possibility of a study exceeding the generally recognised rules, the researcher should obtain the
p.000008: positive opinion of his peers and if necessary, also of recognised bodies in which there are representatives of society
p.000008: who are not members of the scientific community. These aforementioned bodies resemble local medical ethics committees
p.000008: or ethics committees in life sciences faculties.
p.000008: According to the Caverni code researchers should guarantee respect for and protection of the people taking part in the
p.000008: study and should moreover vouch for respect for human beings and for life in general. They are obliged to respect
p.000008: confidentiality vis-à-vis everything they may have learnt about the participants in the study. The researcher is
p.000008: responsible for protection and confidentiality of the data.
p.000008: Before participation in any study, the people approached must explicitly give their informed and free consent. They
p.000008: must be informed, in a manner comprehensible to them, of all aspects that could influence their consent (risks,
p.000008: inconvenience, immediate or deferred negative effects, limitation of confidentiality, etc.), as well as the
p.000008: study’s objectives and the procedure to be used. The position of authority that the researcher generally has may not be
p.000008: used to induce the potential participant to give his consent.
p.000008: The party concerned may withdraw from the study after he has obtained information, or even when the experiment is under
p.000008: way.
p.000008: Before their possible participation, people must know that they are free to take part or not to take part, without a
p.000008: refusal on their part having any negative consequences of any kind for them (here we are thinking of students or
p.000008: members of staff). That is precisely what is applied in the case of medical experiments.
p.000008: Now, there may be cases of certain people not being in a position to give their free and informed consent (children and
p.000008: vulnerable people, for example). In such cases the researcher has to obtain “autorisation appropriée” (suitable
p.000008: authorisation) from a legally authorised person. However, he must give the person wishing to take part in the study
p.000008: “des explications appropriées” (suitable explanations) at all times, and obtain his “assentiment” (consent) in
p.000008: circumstances that are as close as possible to the circumstances in which ordinary people find themselves.
p.000008: The researcher does not have to secure the consent of the test subjects if non-identifiable data are collected which
p.000008: only relate to observations in a natural setting or relate to isolated data from archives.
...

p.000012: pressures to light.
p.000012: On the other hand, they advocate the setting up of a code of professional practice specific to their profession and
p.000012: containing ethical guidelines for researchers. These guidelines of course relate to the informed consent of the persons
p.000012: studied and respect for their privacy.
p.000012: One expert is of the view that an ethics committee at inter-university level could be useful. This committee would only
p.000012: be allowed to have an advisory role.
p.000012: Two experts who were interviewed also complained of the existence of collusion between life sciences research and the
p.000012: political establishment, which is often the party subsidising the studies and tends to orientate the research according
p.000012: to its objectives.
p.000012:
p.000012: Some members of the Committee and the experts interviewed stress that university research budgets have been
p.000012: severely scaled down in the last few decades. The possibility of the various centres taking on researchers, carrying
p.000012: out research and producing publications, depends more on research budgets from outside the university, which are often
p.000012: granted by the government. For example, a minister is looking for an answer to a particular problem and commissions a
p.000012: study, in the pursuit of political efficiency. Unfortunately, research seldom delivers unambiguous solutions for
p.000012: contemporary social problems. If the result of the study does not answer the question posed by the commissioning
p.000012: authority, or does not meet the latter’s wishes, there is a good chance that the centre will not receive any further
p.000012: subsidies for a subsequent study. When the study attempts to reach a solution that tallies with the commissioning
p.000012: authority’s expectations, the researchers may feel manipulated. If the centre refuses to comply, this leads in any
p.000012: case to a drop in its productivity.
p.000012:
p.000012:
p.000012: 5. Conclusions
p.000012:
p.000012: a. Ethics committees in the faculties of psychology
p.000012:
p.000012: Expediency
p.000012:
p.000012: The experts whose opinions were heard and the members of the Advisory Committee for Bio- ethics are in favour of ethics
p.000012: committees being set up in faculties of psychology. Some faculties already have their ethics committee and there are
p.000012: many arguments advocating the establishment of such committees. Even though the risk for the participants in such
p.000012: studies is seldom one of physical and mental harm, it is nonetheless important that that risk be examined. The examples
p.000012: in point 2 illustrate certain risks of stigmatisation or undesired consequences that are associated with some
p.000012: experiments. The people’s protection is therefore at issue.
p.000012: Ethics committees in the faculties of psychology could play an advisory role and could have preferential
p.000012: contact with the medical ethics committees when the protocol falls under the scope of the law on experiments involving
...

General/Other / participants in a control group

Searching for indicator placebo:

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p.000009: reasons, the test subject cannot be fully informed of the objectives pursued before the study gets under way, it is
p.000009: agreed that he is informed only in an incomplete fashion beforehand and that the information knowingly contains
p.000009: incorrect elements. However, he must be fully informed at the end of his participation. The incomplete and incorrect
p.000009: nature of the information originally supplied must always have an indisputable scientific justification. A check should
p.000009: also be made to see whether any other procedures are possible, whether the participants will be adequately informed as
p.000009: soon as possible, and whether advice will be obtained as to the way in which the complete information will be
p.000009: assimilated by the test subjects when it is passed on to them (for example consulting of people who come from
p.000009: the same cultural and social environment as the study participants). The incompleteness and inaccuracy of the
p.000009: information may never concern aspects that could influence the prospective participant’s willingness to take part
p.000009: (physical risks, inconvenience, negative emotions, etc.). The fact that comprehensive information is provided
p.000009: at the end of the study cannot in itself justify the fact that the original information was incomplete.”
p.000009: In biomedical sciences, situations where it is necessary to deceive the participant for the purposes of the result of
p.000009: the experiment hardly ever arise. In the very frequent situation in biomedical sciences in which a new medicine is
p.000009: tested by means of comparison with a placebo, the participant is always told beforehand that he might be given a
p.000009: placebo, but as soon as the patient has given his agreement and the experiment has started, he is of course not told
p.000009: whether he was given the experimental drug or the placebo.
p.000009: In behavioural sciences the “deception” of the test subject would occur very often. In the March 2005 issue of the
p.000009: journal Bioethica Forum, B. Baertschi2 estimates that deception is used in 58% of research protocols in psychology.
p.000009: The concept of “deception”, as the American Psychology Association sees it (“deception in research”), tends to mean
p.000009: a lie on account of omission or the concealing of a part of the truth. Baertschi takes account of the
p.000009: possibility of a “permitted deception” if the test subject is specifically informed beforehand that he will not be
p.000009: told everything before the experiment starts. He is of the opinion that deception in experiments can be justified on
p.000009: the grounds of the foreseeable advantages that the results of the experiment will entail. Other authors feel that
p.000009: test subjects should have it pointed out to them beforehand that some information will not be given to them
p.000009: before the experiment, but that they will be given this information after the experiment and only then have to give
p.000009: their consent for use of the data concerned (such as in the case of programmes of the “Candid Camera” variety, where
p.000009: recordings, made without the knowledge of the person concerned, are broadcast on TV). Recommendations for this have
p.000009: been drawn up by the American Psychology Society (“Ethical principles of psychologists and code of conduct”,
p.000009: June 2003).
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: 2 L’éthique de la recherche en psychologie, Bernard Baertschi, University of Geneva, in Bioethica Forum (a publication
p.000009: of the “Société Suisse d’Éthique Biomédicale”), no. 44, March 2005, pp. 9-11.
p.000010: 10
...


Orphaned Trigger Words



p.000007: to which study participants are exposed and the degree of invasiveness of the research techniques. Some
p.000007: studies are considered as stress-free, in particular when they relate to everyday activities carried out by the
p.000007: participants where it is known that these do not entail any special risk whatsoever (for example a study of a
p.000007: physiological movement which is not of any unusual scope or duration, an observation of test subjects in a driving
p.000007: simulator, and so on). In the case of research “with stress”, on the other hand, the study participant runs a
p.000007: heightened, variable risk (for example a study of a movement carried out in unusual circumstances,
p.000007: an experiment conducted after sleep deprivation, and so on). A distinction is made between the techniques, according to
p.000007: their “invasive” or “non-invasive” character. Examples of these are the recording of the electrocardiogram and
p.000007: electroencephalogram which are considered as non-invasive, unlike invasive techniques such as injecting and implanting
p.000007: of electrodes, the administration of contrast mediums or tracer materials, and X-ray imaging.
p.000007:
p.000007: b. The situation in the United Kingdom
p.000007:
p.000007: In 2003 the British Psychological Society published1 new “Ethical Principles for Conducting Research with
p.000007: Human Participants”, which replaced the ethical principles that the same society had issued in 1978.
p.000007: This publication contains the general ethical principles surrounding consent, the right to withdraw from the study at
p.000007: any time, respect for privacy, etc.
p.000007:
p.000007: The Society also stresses the need for a debriefing after every study, which in particular should see to it that when
p.000007: the study is over the participants can resume their normal course of action, should the study have provoked the
p.000007: reverse.
p.000007:
p.000007: The Society stresses the importance of avoiding test subjects being subjected to experimental situations or test
p.000007: situations implying a greater risk than that which people are prepared to take in normal life.
p.000007:
p.000007: At any event the implications and psychological consequences of the study for the participants should be taken into
p.000007: consideration. If the study targets people of different generations, of a different sex, or from different
p.000007: backgrounds, then, in our multicultural and multiethnic society, the research protocols should also be submitted to
p.000007: persons from the same background as the participants, so as to ascertain in advance that the test subjects concerned do
p.000007: not feel as though the study constitutes an affront to their dignity.
p.000007:
p.000007: In the case of studies based on observation, the British Psychological Society stipulates that, with the exception of
p.000007: studies in which the observed test subjects have agreed to the observation, observation is only acceptable in
p.000007: situations in which the observed person is aware that he or she can be seen by strangers. Account must
p.000007: inevitably be taken of local cultural values. The
p.000007: ...

Appendix

Indicator List

IndicatorVulnerability
accessAccess to Social Goods
ageAge
authorityRelationship to Authority
autonomyImpaired Autonomy
childChild
childrenChild
drugDrug Usage
educationaleducation
elderlyElderly
employeesemployees
foetusFetus/Neonate
healthy volunteersHealthy People
homeProperty Ownership
influenceDrug Usage
jobOccupation
languageLinguistic Proficiency
manipulatedManipulable
opinionphilosophical differences/differences of opinion
parentparents
parentsparents
partypolitical affiliation
placeboparticipants in a control group
politicalpolitical affiliation
prisonIncarcerated
racistRacial Minority
sickPhysically Ill
studentStudent
unemploymentUnemployment
volunteersHealthy People
vulnerablevulnerable

Indicator Peers (Indicators in Same Vulnerability)

IndicatorPeers
child['children']
children['child']
drug['influence']
healthy volunteers['volunteers']
influence['drug']
parent['parents']
parents['parent']
party['political']
political['party']
volunteers['healthyXvolunteers']

Trigger Words

consent

cultural

ethics

harm

justice

protection

risk

sensitive

welfare


Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability TypeVulnerabilityIndicator# Matches
Politicalpolitical affiliationparty2
Politicalpolitical affiliationpolitical3
Politicalvulnerablevulnerable2
HealthDrug Usagedrug2
HealthDrug Usageinfluence4
HealthHealthy Peoplehealthy volunteers1
HealthHealthy Peoplevolunteers1
HealthPhysically Illsick1
SocialAccess to Social Goodsaccess1
SocialAgeage1
SocialChildchild1
SocialChildchildren3
SocialElderlyelderly1
SocialFetus/Neonatefoetus1
SocialIncarceratedprison2
SocialLinguistic Proficiencylanguage1
SocialOccupationjob2
SocialProperty Ownershiphome1
SocialRacial Minorityracist1
SocialStudentstudent1
SocialUnemploymentunemployment1
Socialeducationeducational15
Socialemployeesemployees1
Socialparentsparent1
Socialparentsparents2
Socialphilosophical differences/differences of opinionopinion32
General/OtherImpaired Autonomyautonomy2
General/OtherManipulablemanipulated1
General/OtherRelationship to Authorityauthority3
General/Otherparticipants in a control groupplacebo3