A624E35EC511A22EA96BE3E7265ABF72
Opinion on the Ethics of Research in the Sciences of Human Behaviour
https://www.ccne-ethique.fr/sites/default/files/publications/avis038en.pdf
http://leaux.net/URLS/ConvertAPI Text Files/3F53EB6A5403FF925CBE7244937C2CFB.en.txt
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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
Political / Captive/Exiled Population
Searching for indicator captive:
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p.(None):
p.(None): In France, the protection of persons who consent to biomedical research depends on law N° 88-1138 of December 20th 1988
p.(None): (amended as N° 90-86). The protection of persons who consent to behavioural research depends, for the time
p.(None): being, on the deontology of the researchers (for example, the psychologists' code of ethics(3)).
p.(None):
p.(None): The recommendations that the CCNE is going to formulate on the ethics of behavioural research must, in
p.(None): the interests of consistency, be in line with the law N° 88-1138 of December 20th 1988. The main
p.(None): principles of directives concerning research with human subjects, as formulated in the United States by the
p.(None): National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-78), or in Canada
p.(None): by the Medical Research Council (1986), and then by the National Council on Bioethics in Human Research (NCBHR), are
p.(None): the same for all such research, whether in the biomedical sciences or the human sciences, even if specific problems are
p.(None): then identified, as a function of the discipline (cancerology, psychiatry, ethnology, etc.), or for different
p.(None): categories of subjects (children, captive or exiled populations, old people with reduced autonomy, etc.).
p.(None):
p.(None): Thus, it can be accepted that the main ethical principles governing research with human subjects (which the American
p.(None): National Commission refers to as the principles of justice, of beneficence, and of respect for the autonomy of
p.(None): individuals), as well as the rules flowing therefrom (rule of equal treatment or non-discrimination, rule of
p.(None): minimization of risk and optimization of benefit, rule of consent), are the same, whether the research is biomedical or
p.(None): behavioural. It can also be accepted, that the procedure, consisting in submission of human subject
p.(None): research protocols, before their execution, for review by an " independent committee" , an " ethics committee" or a "
p.(None): committee for the protection of persons" , is applicable to behavioural research. In the sequel, we refer to
p.(None): " CCPPRCs" (Consultative Committees for the Protection of Persons consenting to Behavioural Research),
p.(None): without prejudging their relationship with the CCPPRBs instituted by the law N° 88-1138 of December 20th
p.(None): 1988 (which will be discussed below).
p.(None):
p.(None): Main principles
p.(None): The freedom of persons
p.(None):
...
p.(None): for in fact, as
p.(None):
p.(None): D. Widl\'9acher has quite rightly pointed out, there are " quite innocent experiments" and potentially traumatizing
p.(None): observations.
p.(None):
p.(None): Problems specific to behavioural research, as identified from the protocols submitted by the CNRS
p.(None): Consent
p.(None):
p.(None): - Under what conditions is behavioural research admissible, when the subjects have a problematic ability to
p.(None): give consent (limited competence, dependence)?
p.(None):
p.(None): The general rule is that persons, whose consent is dubious, should be protected against the possibility of serving as
p.(None): research " subjects" , in a manner proportionate to their incapacity and their dependence.
p.(None):
p.(None): Some of the vulnerable categories, requiring special protection in behavioural research, are: children, the mentally
p.(None): infirm, persons easily manipulable because of their own weakness or dependence (for example, drug addicts),
p.(None): captive institutionalized populations (prison inmates, pupils, adolescents in reform schools, young people
p.(None): in residential institutions, soldiers).
p.(None):
p.(None): - For minors and adults under guardianship , the rule accepted in biomedical research (L.209-10) can be
p.(None): generalized: consent of the parents or legal guardians, information given to the child or disabled person to the
p.(None): greatest extent possible, respect for the child's or disabled person's possible refusal.
p.(None):
p.(None): - For institutionalised captive populations (prison inmates, pupils, adolescents in reform schools, young
p.(None): people in residential institutions), the usual rule is to assess the project as admissible, only when it is (1) "
p.(None): minimal risk" and (2) non-discriminatory. Consent must be obtained both from the responsible officials of the
p.(None): institution, and from each subject individually (if the subjects are minors, from the person who exercises parental
p.(None): authority).
p.(None):
p.(None): - The use of " rewards" must be looked at very closely at the time of ethical review (for example, recruitment of
p.(None): homeless or native people as research subjects by offering them alcohol).
p.(None):
p.(None): - In so far as inmates are concerned, the law of December 20th 1988 prohibits research without direct individual
p.(None): benefit, when the persons concerned are deprived of their freedom. In the behavioural sciences, such research can be
p.(None): harmless for the persons concerned, and socially useful, or even necessary; therefore they cannot be prohibited
p.(None): without individual review.
p.(None):
p.(None): - How can one reconcile the obligation of consent, that is to be informed , with the methodological
p.(None): necessity (which can arise in the case of certain experimental protocols ) of not saying everything ?
p.(None):
p.(None): This is a question that has arisen with regard to biomedical research, but it is particularly relevant in psychology,
...
Searching for indicator exiled:
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p.(None):
p.(None): In France, the protection of persons who consent to biomedical research depends on law N° 88-1138 of December 20th 1988
p.(None): (amended as N° 90-86). The protection of persons who consent to behavioural research depends, for the time
p.(None): being, on the deontology of the researchers (for example, the psychologists' code of ethics(3)).
p.(None):
p.(None): The recommendations that the CCNE is going to formulate on the ethics of behavioural research must, in
p.(None): the interests of consistency, be in line with the law N° 88-1138 of December 20th 1988. The main
p.(None): principles of directives concerning research with human subjects, as formulated in the United States by the
p.(None): National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-78), or in Canada
p.(None): by the Medical Research Council (1986), and then by the National Council on Bioethics in Human Research (NCBHR), are
p.(None): the same for all such research, whether in the biomedical sciences or the human sciences, even if specific problems are
p.(None): then identified, as a function of the discipline (cancerology, psychiatry, ethnology, etc.), or for different
p.(None): categories of subjects (children, captive or exiled populations, old people with reduced autonomy, etc.).
p.(None):
p.(None): Thus, it can be accepted that the main ethical principles governing research with human subjects (which the American
p.(None): National Commission refers to as the principles of justice, of beneficence, and of respect for the autonomy of
p.(None): individuals), as well as the rules flowing therefrom (rule of equal treatment or non-discrimination, rule of
p.(None): minimization of risk and optimization of benefit, rule of consent), are the same, whether the research is biomedical or
p.(None): behavioural. It can also be accepted, that the procedure, consisting in submission of human subject
p.(None): research protocols, before their execution, for review by an " independent committee" , an " ethics committee" or a "
p.(None): committee for the protection of persons" , is applicable to behavioural research. In the sequel, we refer to
p.(None): " CCPPRCs" (Consultative Committees for the Protection of Persons consenting to Behavioural Research),
p.(None): without prejudging their relationship with the CCPPRBs instituted by the law N° 88-1138 of December 20th
p.(None): 1988 (which will be discussed below).
p.(None):
p.(None): Main principles
p.(None): The freedom of persons
p.(None):
p.(None): Freedom has a negative dimension (independence): not being forced to do something one does not want to do, and a
...
Political / Criminal Convictions
Searching for indicator prisoners:
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p.(None): Subject, Professions
p.(None):
p.(None): and State in the Human Experimentation Process, New York: Russell Sage Foundation.
p.(None):
p.(None): Levine Carol (1982), Former soldier denied compensation for damage in army LSD tests, IRB, 4(3):7.
p.(None):
p.(None): Levine Robert J. (1986), Ethics and Regulation of Clinical Research, Baltimore-Munich: Urban & Schwarzenberg,
p.(None):
p.(None): 2nd edition.
p.(None):
p.(None): Macklin Ruth (1989), The paradoxical case of payment as benefit to research subjects, IRB, 11(6):1-3.
p.(None):
p.(None): Marini James L. (1980), Methodology and ethics: research on human agression, IRB, 2(5):1-4.
p.(None):
p.(None): Mead Margaret (1969), Research with human beings: a model derived from anthropological field practice,
p.(None):
p.(None): Daedalus, 98: 361-386.
p.(None):
p.(None): Meyer Roger E. (1977), Subjects' rights, freedom of inquiry, and the future of research in the addictions,
p.(None):
p.(None): Am J Psychiatry, 134(8):899-903.
p.(None):
p.(None): Menard Joël (1990), Rapport du groupe de réflexion INSERM sur certains aspects de la protection des sujets
p.(None): volontaires sains et des personnes qui se prêtent à des recherches bio- médicales, Paris: INSERM.
p.(None):
p.(None): National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research
p.(None): Involving Prisoners: Report and Recommendations, and Appendix (1976). Research Involving Children: Report
p.(None):
p.(None): and Recommendations, and Appendix (1977). Research Involving Those Institutionalized as Mentally Infirm: Report and
p.(None): Recommendations, and Appendix (1978). The Belmont Report: Ethical Principles and Guidelines for Research
p.(None): Involving Human Subjects (1978),
p.(None):
p.(None): Washington D.C.: US Govt Printing Office (DHEW) French translation in: Médecine et expérimentation (1982),
p.(None): Cahiers de bioéthique, 4, Québec: Presses de l'Université Laval, 233-250.
p.(None):
p.(None): Newton Lisa H. (1982), Dentists and pseudo-patients: further meditations on deception in research, IRB, 4(8):6-8.
p.(None):
p.(None): Park L.C., Covi L., Uhlenhuth E.H. (1967), Effects of informed consent on research patients and study results,
p.(None):
p.(None): J Nerv Ment Dis, 145: 349-357.
p.(None):
p.(None): Pattulo E.L. (1980), Who risks what in social research?, IRB, 2(3):1-3,12.
p.(None):
p.(None): Queheillard Jean-Louis (1989), Secret professionnel, le grand oublié ?, Psychologues et psychologies, N° 89.
p.(None):
p.(None): Redlich Fritz (1973), The anthropologist as observer; ethical aspects of clinical observations of behavior,
p.(None):
p.(None): J Nerv Ment Dis, 157: 313-319.
p.(None):
p.(None): Robertson John A. (1981), Ethical review of social experiments, IRB, 3(7):10-11.
p.(None):
...
Political / Illegal Activity
Searching for indicator crime:
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p.(None): to the psychological risks of experiments, and to their possible consequences (no humiliating, degrading or
p.(None): traumatizing experiments).
p.(None):
p.(None): Justice. Human dignity
p.(None):
p.(None): In biomedical research, the principle of justice serves primarily to recall, that scientific research must
p.(None): never involve exploitation (for example, exploitation by researchers in developed countries of poor
p.(None): populations in developing countries, which serve as " guinea pigs" for the acquisition of knowledge, whose therapeutic
p.(None): spin-offs are of benefit mainly to populations in rich countries: see WHO-CIOMS, 1982). It then serves to recall, as
p.(None): the CCNE has done in its 1990 Report (p. 72), that participation in a research protocol calls for " fair indemnity "
p.(None): or " compensation" for the subjects, but to the exclusion of any remuneration.
p.(None):
p.(None): In behavioural research, cases of (North-South) exploitation have been brought (in ethnology, in
p.(None): anthropology), but in the background there was usually a problem of ethnic or cultural discrimination (attitude of
p.(None): the " developed" to the " savage" ). Clear risks of discrimination have been raised in the case of
p.(None): investigation of distinctive characteristics, that are a source of social worth or the opposite ("
p.(None): intelligence quotient" , " crime chromosome" , etc.). On the other hand, the practice in
p.(None): behavioural research of remunerating subjects (for example, on a fee basis) has not given rise to many objections
p.(None): as yet. There are salaried professionals (test pilots, underwater divers) who accept being guinea pigs in the
p.(None): exercise of their profession. Conversely, many volunteers are not indemnified (when their contribution is
p.(None): minimal, or when, as in the case of students, they receive an intellectual or didactic benefit). Therefore, it
p.(None): cannot be said either that all volunteers should be indemnified, or that any remuneration is contrary to ethical
p.(None): principles.
p.(None):
p.(None): From the point of view of equity, the central problem in behavioural research seems to be the problem of possible
p.(None): discrimination, whether connected with the research protocol itself, or with the research results and the way they are
p.(None): understood and utilised (socio-cultural " spin-offs" ).
p.(None):
p.(None): Ethical review by "independent" bodies
p.(None):
p.(None): In the case of biomedical research, French law submits to review by CCPPRBs any " trials or experiments" . It exempts "
p.(None): studies" (research work done only on paper, or with samples collected independently of the study, for example, taken
p.(None): from a blood bank).
p.(None):
p.(None): The American federal directives (DHHS, 1981) set out three categories of research with human subjects:
p.(None): exempted from ethical review, submitted to a simplified procedure of ethical review (" expedited review" by
...
Political / Indigenous
Searching for indicator native:
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p.(None): in residential institutions, soldiers).
p.(None):
p.(None): - For minors and adults under guardianship , the rule accepted in biomedical research (L.209-10) can be
p.(None): generalized: consent of the parents or legal guardians, information given to the child or disabled person to the
p.(None): greatest extent possible, respect for the child's or disabled person's possible refusal.
p.(None):
p.(None): - For institutionalised captive populations (prison inmates, pupils, adolescents in reform schools, young
p.(None): people in residential institutions), the usual rule is to assess the project as admissible, only when it is (1) "
p.(None): minimal risk" and (2) non-discriminatory. Consent must be obtained both from the responsible officials of the
p.(None): institution, and from each subject individually (if the subjects are minors, from the person who exercises parental
p.(None): authority).
p.(None):
p.(None): - The use of " rewards" must be looked at very closely at the time of ethical review (for example, recruitment of
p.(None): homeless or native people as research subjects by offering them alcohol).
p.(None):
p.(None): - In so far as inmates are concerned, the law of December 20th 1988 prohibits research without direct individual
p.(None): benefit, when the persons concerned are deprived of their freedom. In the behavioural sciences, such research can be
p.(None): harmless for the persons concerned, and socially useful, or even necessary; therefore they cannot be prohibited
p.(None): without individual review.
p.(None):
p.(None): - How can one reconcile the obligation of consent, that is to be informed , with the methodological
p.(None): necessity (which can arise in the case of certain experimental protocols ) of not saying everything ?
p.(None):
p.(None): This is a question that has arisen with regard to biomedical research, but it is particularly relevant in psychology,
p.(None): social psychology(5), and research of sports performances.
p.(None):
p.(None): The Canadian Medical Research Council has dealt with this issue as follows:
p.(None):
p.(None): Deception (6)
p.(None):
p.(None): " ... Given the critical importance of free and informed consent, it seems incongruous to take up the issue of
p.(None): deception.
p.(None):
p.(None): " Deception means deliberately providing potential subjects with erroneous information, or
p.(None):
p.(None): concealing information from them, with a view to having them believe that the research objectives, or
p.(None): the procedure to be followed, are different from what they are in reality. Deception can also consist
p.(None): in deliberately providing them with false information, in dissimulating important information, or in revealing
...
Political / Political
Searching for indicator party:
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p.(None): behavioural. It can also be accepted, that the procedure, consisting in submission of human subject
p.(None): research protocols, before their execution, for review by an " independent committee" , an " ethics committee" or a "
p.(None): committee for the protection of persons" , is applicable to behavioural research. In the sequel, we refer to
p.(None): " CCPPRCs" (Consultative Committees for the Protection of Persons consenting to Behavioural Research),
p.(None): without prejudging their relationship with the CCPPRBs instituted by the law N° 88-1138 of December 20th
p.(None): 1988 (which will be discussed below).
p.(None):
p.(None): Main principles
p.(None): The freedom of persons
p.(None):
p.(None): Freedom has a negative dimension (independence): not being forced to do something one does not want to do, and a
p.(None): positive dimension (autonomy): acting in accordance with what one really wants for oneself. It is generally accepted,
p.(None): that respecting the freedom of persons implies that one accepts the rule: no investigation shall be conducted with
p.(None): human subjects, unless these persons give their " free, informed and expressed" (L.209-9) consent(4) to the
p.(None): investigation.
p.(None):
p.(None): Interpreting the law N° 88-1138 of December 20th 1988 (Article L.209-9):
p.(None):
p.(None): - The consent is expressed , if it is " given in writing, or, should that be impossible, attested by a third party
p.(None): (...) independent of the investigators" .
p.(None):
p.(None): - The consent is informed , if the subject has been sufficiently informed, has understood the information, and has
p.(None): had time to reflect before making his choice known. For the information to be sufficient, the law of December
p.(None): 20th 1988 specifies that the investigator must make known to the subject:
p.(None):
p.(None): - the research objectives, methodology and duration,
p.(None):
p.(None): - the expected benefits, and the foreseeable constraints and risks, even when the research is halted before its planned
p.(None): ending date,
p.(None):
p.(None): - the opinion of a CCPPRC.
p.(None): - The consent is free if the investigator abstains from all forms pressure, coercion and strong incentive (money,
p.(None): passing an examination, career advantage, affective blackmail, etc.).
p.(None):
p.(None): Moreover, consent for the research is revocable. Subjects must be informed that they may cease to participate, at any
p.(None): time, without incurring any penalty or reproach.
p.(None):
p.(None): Safety. The human cost
p.(None):
p.(None): In biomedical research, it is accepted that certain research protocols may involve a " direct individual benefit "
p.(None): (Article L.209-1) for consenting persons. This concept of (potential) benefit for the subject serves, in
p.(None): medicine, to authorize the inclusion in research protocols, but under certain conditions (Article L.209-6), persons
...
p.(None): A project may also involve a risk of discrimination against an entire population, because of the way its
p.(None): results will be interpreted (for example, determination of statistically poorer results on several intelligence tests
p.(None): among blacks than among whites).
p.(None):
p.(None): In the United States at the end of the sixties, the interest in a " science for the people" caused some investigations
p.(None): to be stopped, on the grounds that their theoretical implications were slanderous for certain categories of
p.(None): individuals. There is even reference to attempts to force researchers to " revise" their conclusions, and/or to publish
p.(None): only expurgated results.
p.(None):
p.(None): The discrimination risk is a function of the social level of tolerance of a given " difference" . One could propose
p.(None): the following rule: the discrimination risks must be identified, and weighed in the balance against the
p.(None): collective interest, and the theoretical interest of obtaining the expected result.
p.(None):
p.(None): - Should promoters of behavioural research take out insurance to cover the risks, to which research subjects are
p.(None): exposed because of the investigation?
p.(None):
p.(None): In biomedical research, French law obligates the promoter to take out insurance (Article L.209-7),
p.(None): guaranteeing his third-party liability, in the event of damaging consequences of the research for the consenting
p.(None): person. It is known that this provision of the law cause no problems, when the promoter is the pharmaceutical industry,
p.(None): but that it causes problems for research carried out by university teams and/or in hospitals of modest size, which have
p.(None): trouble finding a promoter with sufficient financial depth to take out insurance. In behavioural research,
p.(None): are the large research bodies (CNRS, university laboratories) in a position to stand as research promoters?
p.(None): Without identification of the promoter, one cannot, in fact, tackle the problem of insurance in a satisfactory manner.
p.(None):
p.(None): It could be argued that, in the case of minimal risk behavioural research, the insurance is not indispensable, even
p.(None): though consideation must be given to physical risks, which, without being a direct consequence of the research
p.(None): as such, occur in the course of the research (falls, accidents during transit). One could also argue that, for
p.(None): research with more risk, such as that proposed only to adult, responsible and fully consenting volunteers, it is up to
p.(None): them to take out insurance, as for other risky activities (for example, certain sports). But in the event of
p.(None): litigation, it can always be argued that the researchers responsible for the project should not have offered volunteers
p.(None): such a risky situation. To our knowledge, there has been at least one example in France of a suicide following risky
p.(None): behavioural research (prolonged isolation with no temporal references).
p.(None):
...
Health / Cognitive Impairment
Searching for indicator cognitive:
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p.(None): description of psychology research at the CNRS. Among the five files in question, which had been approved by the
p.(None): competent scientific commission of the CNRS, two (the Duyme and Carlier files(2)) relate to the laboratory headed by
p.(None): Professor Roubertoux, and correspond to research that was interrupted, following the appearance on December
p.(None): 17th 1992 of an article in the weekly L'Express .
p.(None):
p.(None): The CCNE set up a working group.
p.(None):
p.(None): This group familiarized itself with the great variety of research done at the CNRS in the human
p.(None): sciences. For psychology alone, about fifteen research units (mostly Applied Research Units), representing
p.(None): 150 researchers and about 200 teaching researchers, are grouped together in Section 29, called " Mental
p.(None): functions, integrative neurosciences and behaviours" , and co-managed by the Life Sciences Department and the Human
p.(None): and Social Sciences Department. The objective of this research is " to understand the skills and the performances of
p.(None): the human being in the course of different periods of his life, in habitual situations as well as in exceptional
p.(None): circumstances" . The methods range from simple observation in a natural or standardised situation, to
p.(None): tests of reactions in " extreme situations" . The subjects are recruited on a volunteer basis. The identified
p.(None): subdisciplines are: psychology of the child and of development, social psychology, cognitive psychology, psychology of
p.(None): work, ergonomics, psycholinguistics, psychopathology, clinical psychology, neuropsychology, psychopharmacology.
p.(None): There is frequent interface with neighbouring disciplines: anthropology, neurosciences, psychiatry,
p.(None): linguistics, sociology, education sciences, artificial intelligence, etc.
p.(None):
p.(None): The working group met approximately once per month between January and June 1993. It met with the Operational
p.(None): committee for ethics in the life sciences of the CNRS (COPÉ, January 22th 1993). It heard from several
p.(None): researchers. It gathered information on problems specific to research in human sciences, on professional codes of
p.(None): ethics, and on the way in which experimental human sciences investigations with human subjects are organized
p.(None): in other countries.
p.(None):
p.(None): The CCNE notes that in France, since the " Law on the protection of subjects in biomedical research" of December 20th
p.(None): 1988, " trials or experiments organised with and practised on human subjects, with a view to increasing
p.(None): biological or medical knowledge" take place within a precise and constraining legal framework. On the other hand,
p.(None): the legislator has not brought his attention to bear on the protection of persons who consent to
p.(None): behavioural research, and investigations with human subjects, that aim to develop knowledge in the
...
p.(None): - the opinion of a CCPPRC.
p.(None): - The consent is free if the investigator abstains from all forms pressure, coercion and strong incentive (money,
p.(None): passing an examination, career advantage, affective blackmail, etc.).
p.(None):
p.(None): Moreover, consent for the research is revocable. Subjects must be informed that they may cease to participate, at any
p.(None): time, without incurring any penalty or reproach.
p.(None):
p.(None): Safety. The human cost
p.(None):
p.(None): In biomedical research, it is accepted that certain research protocols may involve a " direct individual benefit "
p.(None): (Article L.209-1) for consenting persons. This concept of (potential) benefit for the subject serves, in
p.(None): medicine, to authorize the inclusion in research protocols, but under certain conditions (Article L.209-6), persons
p.(None): whose consent is dubious or even impossible (minors, adults under guardianship, persons residing in a public health or
p.(None): social institution, patients in an emergency situation).
p.(None):
p.(None): In behavioural research, there may also be cases of investigations " with direct individual benefit" , for example,
p.(None): in clinical psychology, in the case of a comparative study of two psychotherapeutic methods (if the
p.(None): benefit for consenting subjects of at least one of the methods is established), or in cognitive psychology (if
p.(None): the fact that children consent to a study gives them an educational advantage, as was stated in the CNRS file regarding
p.(None): the Lautrey protocol). But given the absence of vital emergencies that obligate the practitioner to intervene, and
p.(None): given how difficult it is to argue that research is done " for the good" of included subjects, or " in the interest of
p.(None): their health" , the " with/without direct individual benefit" distinction is not sufficiently applicable to behavioural
p.(None): research, to justify relaxing the consent conditions, even in the case of applied research. This distinction is
p.(None): applicable only within the framework of the risk-advantage balance.
p.(None):
p.(None): In its report of 1990, the CCNE noted that, as a general rule, persons who consent to an investigation, whose objective
p.(None): is gaining knowledge about human beings, do not see this as to their personal advantage. The CCNE considered this to be
p.(None): admisible, " provided there is
p.(None):
p.(None): an acceptable risk-advantage balance, that is, a definite advantage for the community, and a zero or minimal risk for
p.(None): the individual" (p. 70).
p.(None):
p.(None): To assess the risk-advantage balance means to ask whether the risks, constraints or discomfort imposed on
...
p.(None): physician or psychologist from confidentiality is that, in order to allow someone to share a secret, one has to know
p.(None): what the secret is. But a clinical psychologist is not obligated to communicate his files to his client. And the French
p.(None): patient has only indirect access to his medical file, and he usually does not know what it contains.
p.(None):
p.(None): If French legislation is moving in the direction of a new form of waiver to medical confidentiality, for
p.(None): the purposes of scientific research, this would then also imply a change in the Medical Code of ethics, a change in the
p.(None): Psychologists' Code of ethics, and no doubt, in the longer term and for all patients, a right of direct access to their
p.(None): medical files, and hence a change in the " Computerisation and Liberties" law, and in the Law on access
p.(None): to administrative documents.
p.(None):
p.(None): Problems of equity
p.(None):
p.(None): - How can one reconcile research on discriminating characteristics with the imperative of
p.(None): non-discrimination ?
p.(None):
p.(None): This is a delicate issue, precisely because the identification of significant differences and of
p.(None):
p.(None): discriminating characteristics is a plausible research objective. For instance, it is of interest, and of importance
p.(None): for the evaluation of assisted maternity techniques, to ask whether there is a significance difference between the
p.(None): cognitive development of children born of artificial insemination and other children (CNRS file, Duyme project). But if
p.(None): one finds that artificial insemination children develop less well than the others, and if such research
p.(None): results are made public, then children already born through artificial insemination (or their parents) are put in a
p.(None): difficult situation, even if confidentiality of origins is well protected (the danger of guilt feelings).
p.(None):
p.(None): In the case of the Duyme protocol, all precautions were taken to ensure that the research would not be a source of
p.(None): discrimination through its methodology.
p.(None):
p.(None): Apart from the methodology, a research project may involve explicit or implicit risk of discrimination
p.(None): against individuals, because of the hypotheses on which it is based (for example, experimentation with "
p.(None): aversion therapies" to treat homosexuals, or psychosocial follow-up of a cohort of children born to alcoholic mothers).
p.(None): A project may also involve a risk of discrimination against an entire population, because of the way its
p.(None): results will be interpreted (for example, determination of statistically poorer results on several intelligence tests
p.(None): among blacks than among whites).
p.(None):
...
Health / Drug Dependence
Searching for indicator dependence:
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p.(None): understood and utilised (socio-cultural " spin-offs" ).
p.(None):
p.(None): Ethical review by "independent" bodies
p.(None):
p.(None): In the case of biomedical research, French law submits to review by CCPPRBs any " trials or experiments" . It exempts "
p.(None): studies" (research work done only on paper, or with samples collected independently of the study, for example, taken
p.(None): from a blood bank).
p.(None):
p.(None): The American federal directives (DHHS, 1981) set out three categories of research with human subjects:
p.(None): exempted from ethical review, submitted to a simplified procedure of ethical review (" expedited review" by
p.(None): the bureau of an IRB), and submitted to in-depth ethical discussion (discussion in session by an IRB).
p.(None):
p.(None): For the human sciences, one could propose a distinction between simple observation and construction of an experimental
p.(None): situation, in order to provide for a rapid procedure (simple review of the protocol), and a normal ethical review
p.(None): procedure (possibly requiring the actual presence of the investigators). However, this distinction is tricky to make,
p.(None): for in fact, as
p.(None):
p.(None): D. Widl\'9acher has quite rightly pointed out, there are " quite innocent experiments" and potentially traumatizing
p.(None): observations.
p.(None):
p.(None): Problems specific to behavioural research, as identified from the protocols submitted by the CNRS
p.(None): Consent
p.(None):
p.(None): - Under what conditions is behavioural research admissible, when the subjects have a problematic ability to
p.(None): give consent (limited competence, dependence)?
p.(None):
p.(None): The general rule is that persons, whose consent is dubious, should be protected against the possibility of serving as
p.(None): research " subjects" , in a manner proportionate to their incapacity and their dependence.
p.(None):
p.(None): Some of the vulnerable categories, requiring special protection in behavioural research, are: children, the mentally
p.(None): infirm, persons easily manipulable because of their own weakness or dependence (for example, drug addicts),
p.(None): captive institutionalized populations (prison inmates, pupils, adolescents in reform schools, young people
p.(None): in residential institutions, soldiers).
p.(None):
p.(None): - For minors and adults under guardianship , the rule accepted in biomedical research (L.209-10) can be
p.(None): generalized: consent of the parents or legal guardians, information given to the child or disabled person to the
p.(None): greatest extent possible, respect for the child's or disabled person's possible refusal.
p.(None):
p.(None): - For institutionalised captive populations (prison inmates, pupils, adolescents in reform schools, young
p.(None): people in residential institutions), the usual rule is to assess the project as admissible, only when it is (1) "
p.(None): minimal risk" and (2) non-discriminatory. Consent must be obtained both from the responsible officials of the
p.(None): institution, and from each subject individually (if the subjects are minors, from the person who exercises parental
...
Health / Drug Usage
Searching for indicator influence:
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p.(None): arguments,
p.(None):
p.(None): Res Adv Alcohol Drug Probl, 6: 471-511.
p.(None):
p.(None): Schiff Michel (1991), Les impasses de la recherche en psychologie, Psychologues et psychologies, N° 104.
p.(None):
p.(None): Schmutte Gregory T. (1980), Using students as subjects without their knowledge, IRB, 2(10):5-6.
p.(None):
p.(None): Schuler Heinz (1980), Ethische Probleme psychologischer Forschung, G\'9attingen.
p.(None):
p.(None): Sieber Joan E. (1982), How humanism and determinism differ: understanding risk in psychological research,
p.(None): IRB, 4(3):1-3,12.
p.(None):
p.(None): Sieber Joan E. (1982), Deception in social research I: Kinds of deception and the wrong they may involve,
p.(None): IRB, 4(9):1-5.
p.(None):
p.(None): Sieber Joan E. (1983), Deception in social research II: Evaluating the potential for harm or wrong, IRB, 5(1):1-6.
p.(None):
p.(None): Sieber Joan E. (1983), Deception in social research III: The nature and limits of debriefing, IRB, 5(3):1-4.
p.(None):
p.(None): Sieber Joan E. (1989), On studying the powerful (or fearing to do so): a vital role for IRBs, IRB, 11(5):1-6.
p.(None):
p.(None): St James-Robert Ian (1976), Are researchers trustworthy?, New Scientist, 171: 481-483. Thouvenin Dominique (1992),
p.(None): L'influence de la loi N° 88-1138 du 20 décembre 1988
p.(None):
p.(None): (modifié N° 90-86) sur l'organisation de la recherche, Gestions hospitalières - La recherche
p.(None): - L'hôpital, N° 320.
p.(None):
p.(None): Thouvenin Dominique (1992), Consentement et assujetissement, in: Gros & Huber, eds., Vers un anti-destin?
p.(None): Patrimoine génétique et droits de l'humanité, Paris: Editions Odile Jacob, pp. 471-478.
p.(None):
p.(None): US Dept of Health and Human Services (1981), Final regulations amending basic HHS policy for the protection of human
p.(None): research subjects, Federal Register, 26 01 81, 46(16):8366-
p.(None): 8392.
p.(None):
p.(None): Villey Raymond (1986), Histoire du secret médical, Paris: Seghers.
p.(None):
p.(None): Warwick Donald P. (1975), Deceptive research: social scientists ought to stop lying, Psychology Today, Feb:
p.(None): 38-.
p.(None):
p.(None): Académies scientifiques suisses, 22-26 March 1993, Symposium " Freedom and responsibility: Moral
p.(None): issues facing
p.(None):
p.(None): the humanities and social sciences" (Proceedings to appear). American Anthropological Association, Code of Ethics.
p.(None): Anthropologie et sociétés, Département d'anthropologie de l'Université Laval, Québec, special issue "
p.(None): Comprendre et modifié" , 1984, Vol. 8, N° 3, including a professional code of ethics.
p.(None):
...
Searching for indicator drug:
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p.(None): procedure (possibly requiring the actual presence of the investigators). However, this distinction is tricky to make,
p.(None): for in fact, as
p.(None):
p.(None): D. Widl\'9acher has quite rightly pointed out, there are " quite innocent experiments" and potentially traumatizing
p.(None): observations.
p.(None):
p.(None): Problems specific to behavioural research, as identified from the protocols submitted by the CNRS
p.(None): Consent
p.(None):
p.(None): - Under what conditions is behavioural research admissible, when the subjects have a problematic ability to
p.(None): give consent (limited competence, dependence)?
p.(None):
p.(None): The general rule is that persons, whose consent is dubious, should be protected against the possibility of serving as
p.(None): research " subjects" , in a manner proportionate to their incapacity and their dependence.
p.(None):
p.(None): Some of the vulnerable categories, requiring special protection in behavioural research, are: children, the mentally
p.(None): infirm, persons easily manipulable because of their own weakness or dependence (for example, drug addicts),
p.(None): captive institutionalized populations (prison inmates, pupils, adolescents in reform schools, young people
p.(None): in residential institutions, soldiers).
p.(None):
p.(None): - For minors and adults under guardianship , the rule accepted in biomedical research (L.209-10) can be
p.(None): generalized: consent of the parents or legal guardians, information given to the child or disabled person to the
p.(None): greatest extent possible, respect for the child's or disabled person's possible refusal.
p.(None):
p.(None): - For institutionalised captive populations (prison inmates, pupils, adolescents in reform schools, young
p.(None): people in residential institutions), the usual rule is to assess the project as admissible, only when it is (1) "
p.(None): minimal risk" and (2) non-discriminatory. Consent must be obtained both from the responsible officials of the
p.(None): institution, and from each subject individually (if the subjects are minors, from the person who exercises parental
p.(None): authority).
p.(None):
...
p.(None): Recommendations, and Appendix (1978). The Belmont Report: Ethical Principles and Guidelines for Research
p.(None): Involving Human Subjects (1978),
p.(None):
p.(None): Washington D.C.: US Govt Printing Office (DHEW) French translation in: Médecine et expérimentation (1982),
p.(None): Cahiers de bioéthique, 4, Québec: Presses de l'Université Laval, 233-250.
p.(None):
p.(None): Newton Lisa H. (1982), Dentists and pseudo-patients: further meditations on deception in research, IRB, 4(8):6-8.
p.(None):
p.(None): Park L.C., Covi L., Uhlenhuth E.H. (1967), Effects of informed consent on research patients and study results,
p.(None):
p.(None): J Nerv Ment Dis, 145: 349-357.
p.(None):
p.(None): Pattulo E.L. (1980), Who risks what in social research?, IRB, 2(3):1-3,12.
p.(None):
p.(None): Queheillard Jean-Louis (1989), Secret professionnel, le grand oublié ?, Psychologues et psychologies, N° 89.
p.(None):
p.(None): Redlich Fritz (1973), The anthropologist as observer; ethical aspects of clinical observations of behavior,
p.(None):
p.(None): J Nerv Ment Dis, 157: 313-319.
p.(None):
p.(None): Robertson John A. (1981), Ethical review of social experiments, IRB, 3(7):10-11.
p.(None):
p.(None): Royal College of Physicians (1986), 'Research on healthy volunteers', J Roy Coll Physicians, London, 20: 243-257.
p.(None):
p.(None): Schafer Arthur (1981), The ethics of research on human beings; a critical review of the issues and
p.(None): arguments,
p.(None):
p.(None): Res Adv Alcohol Drug Probl, 6: 471-511.
p.(None):
p.(None): Schiff Michel (1991), Les impasses de la recherche en psychologie, Psychologues et psychologies, N° 104.
p.(None):
p.(None): Schmutte Gregory T. (1980), Using students as subjects without their knowledge, IRB, 2(10):5-6.
p.(None):
p.(None): Schuler Heinz (1980), Ethische Probleme psychologischer Forschung, G\'9attingen.
p.(None):
p.(None): Sieber Joan E. (1982), How humanism and determinism differ: understanding risk in psychological research,
p.(None): IRB, 4(3):1-3,12.
p.(None):
p.(None): Sieber Joan E. (1982), Deception in social research I: Kinds of deception and the wrong they may involve,
p.(None): IRB, 4(9):1-5.
p.(None):
p.(None): Sieber Joan E. (1983), Deception in social research II: Evaluating the potential for harm or wrong, IRB, 5(1):1-6.
p.(None):
p.(None): Sieber Joan E. (1983), Deception in social research III: The nature and limits of debriefing, IRB, 5(3):1-4.
p.(None):
p.(None): Sieber Joan E. (1989), On studying the powerful (or fearing to do so): a vital role for IRBs, IRB, 11(5):1-6.
p.(None):
p.(None): St James-Robert Ian (1976), Are researchers trustworthy?, New Scientist, 171: 481-483. Thouvenin Dominique (1992),
p.(None): L'influence de la loi N° 88-1138 du 20 décembre 1988
p.(None):
p.(None): (modifié N° 90-86) sur l'organisation de la recherche, Gestions hospitalières - La recherche
p.(None): - L'hôpital, N° 320.
p.(None):
...
Health / Health
Searching for indicator health:
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p.(None): Opinion on the ethics of research in the sciences of human behaviour. Report.
p.(None):
p.(None): N°38 - October 14, 1993
p.(None):
p.(None):
p.(None): Contents
p.(None):
p.(None): Opinion Report
p.(None): Main principles
p.(None): The freedom of persons Safety. The human cost Justice. Human dignity
p.(None): Ethical review by "independent" bodies
p.(None): Problems specific to behavioural research, as identified from the protocols submitted by the CNRS
p.(None): Consent Safety
p.(None): Problems of equity
p.(None): Review of protocols. How would CCPPRCs (Consultative Committees for the Protection of Persons consenting to Behavioural
p.(None): research) operate ?
p.(None):
p.(None): Opinion (1)
p.(None): The Director of the Life Sciences Department of the Centre national de la recherche scientifique (CNRS -
p.(None): National Scientific Research Centre) has consulted the National Consultative Ethics Committee for Health and
p.(None): Life Sciences (CCNE) on the subject of the ethics of research on human beings in the behavioural sciences,
p.(None): and especially in psychology.
p.(None):
p.(None): The CCNE observes that in France, since the " Opinion on the testing of new treatments on humans" , pronounced by
p.(None): the CCNE on October 9th 1984, and then the " law on the protection of persons who consent to biomedical
p.(None): research" of December 20th 1988, all " trials or experiments organised and practised on the human being,
p.(None): with a view to developing biological or medical knowledge" are taking place within a precise ethical and legal
p.(None): framework. On the other hand, the legislator does not seem to have brought his attention to bear on the
p.(None): protection of persons who consent to behavioural research, and investigations with human subjects, that aim to develop
p.(None): our knowledge in the behavioural sciences, have less explicit ethical references.
p.(None):
p.(None): The CCNE recalls that any experimental investigation with human subjects, whether for the purpose of developing
p.(None): biomedical knowledge, or in order to gain behavioural understanding, must be carried out in accordance with an
p.(None): irreproachable scientific method, and with full respect for the freedom of action of persons, of their safety and of
...
p.(None): of the observations made of themselves, and of the use to be made of the data, allowing them, once fully
p.(None): informed, to confirm or to withdraw their consent. Whenever researchers collect data that (directly or
p.(None): indirectly) identifies a subject, his explicit consent is absolutely necessary for any use to be made of such data.
p.(None):
p.(None): The sharing, for research purposes, of medical and/or psychological information about individual subjects
p.(None): is presently prohibited in France both by the law, and by deontology. However, the CCNE feels that some
p.(None): research work, whose value is recognized, could be done under the umbrella of shared professional
p.(None): confidentiality. If, as part of a research project, psychologists were to process certain personal medical
p.(None): data, under their own responsibility, it would be necessary that these psychologists be formally entitled to do so,
p.(None): and the physician be explicitly authorized in advance by the persons concerned to communicate these data.
p.(None): Analogously, if medical researchers, were, as part of a research project, to use identifying data collected by
p.(None): practising psychologists in the course of their work, it would be necessary that these medical researchers be formally
p.(None): entitled to do so, and that the psychologist be explicitly authorised by the persons concerned to communicate these
p.(None): data. The entitlement could be given by a multidisciplinary body, under the aegis of the ministries responsible for
p.(None): research and health. If ever the law does come around to permitting such sharing of professional secrets for
p.(None): research purposes, the conditions, under which a person may release his physician or his psychologist from
p.(None): the confidentiality obligation, would have to be spelled out very carefully.
p.(None):
p.(None): The CCNE believes that research protocols in the human behaviour sciences should be submitted, for opinion
p.(None): and before execution, to Consultative Committees for the Protection of Persons consenting to Behavioural Research
p.(None): (CCPPRC), whose composition would guarantee enough diversity of competence, to examine research protocols in
p.(None): various human sciences other than medicine.
p.(None):
p.(None): These committees would be entrusted, in particular:
p.(None):
p.(None): (1) with evaluating the scientific relevance of research projects,
p.(None):
p.(None): (2) with ensuring that the freedom and safety of subjects are protected:
p.(None):
p.(None): - by making sure that proposed experiments do not threaten either the safety or the dignity of persons who consent to
p.(None): them,
p.(None):
p.(None): - by assessing the procedures in the protocol for information of and consent by persons participating in
p.(None): the study, especially when this information is to be incomplete, in the initial phase of the project,
p.(None):
p.(None): (3) to hear out researchers or subjects, at their request, should a particular ethical problem arise in the course of a
p.(None): study.
p.(None):
p.(None): On a provisional basis, and until the legislator is inspired by the example of the corresponding
p.(None): biomedical committees (CCPPRB) to create such committees, and to set out the main guidelines for their action, the
p.(None): French experience previous to the 1988 law would point in the direction of creating " Research Ethics
p.(None): Committees for Human Behavioural Sciences" , at institutions where such research is done: CNRS, INSERM,
p.(None): universities, etc. These committees would be the consciences of these institutions, and an expression of their
p.(None):
p.(None): will to ensure that their research is of high quality, and that subjects are adequately protected.
p.(None):
p.(None): This opinion is a first stage in the CCNE's thinking, which will have to develop together with that of human
p.(None): sciences researchers, scientific institutions harbouring human sciences research (whether the research is
p.(None): basic or applied), the competent administrative authorities, and the legislator, with a view to setting out
p.(None): the ethical and legal framework, in which it seems desirable that experimental investigations into human
p.(None): behaviour be conducted in the future.
p.(None):
p.(None): Report
p.(None): By a letter dated January 15th 1993 to the Chairman of the National Consultative Ethics Committee for Health and
p.(None): Life Sciences (CCNE), the Director of the Life Sciences Department of the Centre national de la recherche
p.(None): scientifique (CNRS) submitted five files, for the CCNE's opinion, describing psychology research carried out in
p.(None): university laboratories supported by the CNRS, or carried out in part by CNRS researchers, together with an overall
p.(None): description of psychology research at the CNRS. Among the five files in question, which had been approved by the
p.(None): competent scientific commission of the CNRS, two (the Duyme and Carlier files(2)) relate to the laboratory headed by
p.(None): Professor Roubertoux, and correspond to research that was interrupted, following the appearance on December
p.(None): 17th 1992 of an article in the weekly L'Express .
p.(None):
p.(None): The CCNE set up a working group.
p.(None):
p.(None): This group familiarized itself with the great variety of research done at the CNRS in the human
p.(None): sciences. For psychology alone, about fifteen research units (mostly Applied Research Units), representing
p.(None): 150 researchers and about 200 teaching researchers, are grouped together in Section 29, called " Mental
p.(None): functions, integrative neurosciences and behaviours" , and co-managed by the Life Sciences Department and the Human
p.(None): and Social Sciences Department. The objective of this research is " to understand the skills and the performances of
p.(None): the human being in the course of different periods of his life, in habitual situations as well as in exceptional
p.(None): circumstances" . The methods range from simple observation in a natural or standardised situation, to
...
p.(None): had time to reflect before making his choice known. For the information to be sufficient, the law of December
p.(None): 20th 1988 specifies that the investigator must make known to the subject:
p.(None):
p.(None): - the research objectives, methodology and duration,
p.(None):
p.(None): - the expected benefits, and the foreseeable constraints and risks, even when the research is halted before its planned
p.(None): ending date,
p.(None):
p.(None): - the opinion of a CCPPRC.
p.(None): - The consent is free if the investigator abstains from all forms pressure, coercion and strong incentive (money,
p.(None): passing an examination, career advantage, affective blackmail, etc.).
p.(None):
p.(None): Moreover, consent for the research is revocable. Subjects must be informed that they may cease to participate, at any
p.(None): time, without incurring any penalty or reproach.
p.(None):
p.(None): Safety. The human cost
p.(None):
p.(None): In biomedical research, it is accepted that certain research protocols may involve a " direct individual benefit "
p.(None): (Article L.209-1) for consenting persons. This concept of (potential) benefit for the subject serves, in
p.(None): medicine, to authorize the inclusion in research protocols, but under certain conditions (Article L.209-6), persons
p.(None): whose consent is dubious or even impossible (minors, adults under guardianship, persons residing in a public health or
p.(None): social institution, patients in an emergency situation).
p.(None):
p.(None): In behavioural research, there may also be cases of investigations " with direct individual benefit" , for example,
p.(None): in clinical psychology, in the case of a comparative study of two psychotherapeutic methods (if the
p.(None): benefit for consenting subjects of at least one of the methods is established), or in cognitive psychology (if
p.(None): the fact that children consent to a study gives them an educational advantage, as was stated in the CNRS file regarding
p.(None): the Lautrey protocol). But given the absence of vital emergencies that obligate the practitioner to intervene, and
p.(None): given how difficult it is to argue that research is done " for the good" of included subjects, or " in the interest of
p.(None): their health" , the " with/without direct individual benefit" distinction is not sufficiently applicable to behavioural
p.(None): research, to justify relaxing the consent conditions, even in the case of applied research. This distinction is
p.(None): applicable only within the framework of the risk-advantage balance.
p.(None):
p.(None): In its report of 1990, the CCNE noted that, as a general rule, persons who consent to an investigation, whose objective
p.(None): is gaining knowledge about human beings, do not see this as to their personal advantage. The CCNE considered this to be
p.(None): admisible, " provided there is
p.(None):
p.(None): an acceptable risk-advantage balance, that is, a definite advantage for the community, and a zero or minimal risk for
p.(None): the individual" (p. 70).
p.(None):
p.(None): To assess the risk-advantage balance means to ask whether the risks, constraints or discomfort imposed on
p.(None): the subjects (" human cost" ) are sufficiently justified by the scientific significance of the question
p.(None): posed, and by the assurance that the suggested protocol will serve to resolve this question.
p.(None):
p.(None): In behavioural research, apart from the need explicitly to evaluate physical risk, one must pay particular attention
p.(None): to the psychological risks of experiments, and to their possible consequences (no humiliating, degrading or
p.(None): traumatizing experiments).
p.(None):
...
p.(None): hypotheses, which are themselves based on previously acquired knowledge, and that this background knowledge allows
p.(None): for at least an approximate assessment of the risk to subjects involved in the experiment. The same
p.(None): reasoning applies to psychology.
p.(None):
p.(None): We recall that, technically speaking, risk is the product of an event's severity and its probability.
p.(None): Hence the evaluation of risk involves estimation of both the severity of disorders that might be provoked in the
p.(None): experiment's subjects, and of the probability of occurrence of these disorders.
p.(None):
p.(None): The distinction between " minimal risk " (or negligible) and " non-minimal risk " (or non- negligible, serious(8)) was
p.(None): introduced in 1978 by the American National Commission. " Zero risk" does not exist in human endeavours. " Minimal"
p.(None): risks are risks of the same order of magnitude as risks commonly accepted without thinking in everyday life. For
p.(None): children, for instance, minimal risk is defined as risk whose " probability and severity are of the order as those of
p.(None): physical or psychological damage, to which children in good health are normally exposed in their lives, or in
p.(None): routine medical or psychological examinations" (National Commission..., 1978-12, Appendix 1)(9).
p.(None):
p.(None): Examples of serious risk: isolation with no temporal references, sensory deprivation experiments, endurance
p.(None): under " extreme" conditions, etc.
p.(None):
p.(None): For categories of vulnerable subjects, only experiments whose risk is at a minimal level can be proposed, or, to use
p.(None): the terminology of the French Law of 1988, experiments that do not involve " any foreseeable serious risk" .
p.(None):
p.(None): It is only to adult subjects in good health, in full possession of their mental faculties, and fully informed, that
p.(None): one may offer, for the purposes of human sciences research, involvement in experiments with risk at a higher
p.(None): level than the minimal level (no matter how small the difference).
p.(None):
p.(None): - How can one reconcile the imperative of data confidentiality with the communication to non-physician researchers
p.(None): of confidential medical files, when the purpose is to advance research?
p.(None):
p.(None): The ethical problem is one of respect for the personal domain, and of non-divulgation of confidential data, of which
p.(None): the treating physician is the depository. One can rely on Articles 7 to 13 of the Psychologist's Code of Ethics
p.(None): (footnote 3), which are almost literal copies of the rules governing medical confidentiality.
p.(None):
p.(None): Beyond the ethical problem, there is also a legal and regulatory problem in France. Some of the reference texts
p.(None): include: Articles 226.13 and 226.14 (previously 378) of the Penal Code(10), law N° 78-17 of January 6th
p.(None): 1978 on Computerisation, Records and Liberties, decree N° 79-506 of June 28th 1979 proclaiming the Medical Code of
p.(None): Ethics. These texts prohibit the communication by the physician of identifying data to anyone, save to another
p.(None): physician and solely in the interests of the patient's health (for example, consultation of a specialist for a
p.(None): therapeutic opinion).
p.(None):
p.(None): The problem of data communication for research purposes was studied extensively in the
p.(None):
p.(None): eighties, in connection with cancer registers and epidemiological research, by the CNIL, the CCNE and the Ordre des
p.(None): Médecins (French Medical Association). The proposed solution was that of shared confidentiality . This solution is not
p.(None): yet legal (11) .
p.(None):
p.(None): In the present state of the legislation, the only admissible kind of study (for example, within a hospital) is one that
p.(None): uses personal medical data within the department where the patients were treated, and under the responsibility of a
p.(None): chief physician. The procedure followed by Professeur M. Carlier (CNRS file, Carlier project) is not correct.
p.(None):
p.(None): It is the physician responsible for the ward (and not the psychology researcher) who should have contacted the
p.(None): families, and sollicited their consent to the research. The families could legitimately complain that a psychologist
p.(None): contacted them (by telephone, then directly) for a research project about their twins, which implied that this
p.(None): psychologist had knowledge of their medical files before any consent had been given, and hence that the
p.(None): head of the department did not observe medical confidentiality.
p.(None):
p.(None): It is obligatory that the use of identifying medical data for research purposes remain under medical responsibility,
p.(None): the persons concerned having the right to be informed in advance of the use that is to be made of their data, and the
p.(None): right to oppose that use.
p.(None):
...
p.(None):
p.(None): Schuler Heinz (1980), Ethische Probleme psychologischer Forschung, G\'9attingen.
p.(None):
p.(None): Sieber Joan E. (1982), How humanism and determinism differ: understanding risk in psychological research,
p.(None): IRB, 4(3):1-3,12.
p.(None):
p.(None): Sieber Joan E. (1982), Deception in social research I: Kinds of deception and the wrong they may involve,
p.(None): IRB, 4(9):1-5.
p.(None):
p.(None): Sieber Joan E. (1983), Deception in social research II: Evaluating the potential for harm or wrong, IRB, 5(1):1-6.
p.(None):
p.(None): Sieber Joan E. (1983), Deception in social research III: The nature and limits of debriefing, IRB, 5(3):1-4.
p.(None):
p.(None): Sieber Joan E. (1989), On studying the powerful (or fearing to do so): a vital role for IRBs, IRB, 11(5):1-6.
p.(None):
p.(None): St James-Robert Ian (1976), Are researchers trustworthy?, New Scientist, 171: 481-483. Thouvenin Dominique (1992),
p.(None): L'influence de la loi N° 88-1138 du 20 décembre 1988
p.(None):
p.(None): (modifié N° 90-86) sur l'organisation de la recherche, Gestions hospitalières - La recherche
p.(None): - L'hôpital, N° 320.
p.(None):
p.(None): Thouvenin Dominique (1992), Consentement et assujetissement, in: Gros & Huber, eds., Vers un anti-destin?
p.(None): Patrimoine génétique et droits de l'humanité, Paris: Editions Odile Jacob, pp. 471-478.
p.(None):
p.(None): US Dept of Health and Human Services (1981), Final regulations amending basic HHS policy for the protection of human
p.(None): research subjects, Federal Register, 26 01 81, 46(16):8366-
p.(None): 8392.
p.(None):
p.(None): Villey Raymond (1986), Histoire du secret médical, Paris: Seghers.
p.(None):
p.(None): Warwick Donald P. (1975), Deceptive research: social scientists ought to stop lying, Psychology Today, Feb:
p.(None): 38-.
p.(None):
p.(None): Académies scientifiques suisses, 22-26 March 1993, Symposium " Freedom and responsibility: Moral
p.(None): issues facing
p.(None):
p.(None): the humanities and social sciences" (Proceedings to appear). American Anthropological Association, Code of Ethics.
p.(None): Anthropologie et sociétés, Département d'anthropologie de l'Université Laval, Québec, special issue "
p.(None): Comprendre et modifié" , 1984, Vol. 8, N° 3, including a professional code of ethics.
p.(None):
p.(None): Code of Ethics of the Brazilian Association of Anthropology, adopted at its 16th meeting, Campinas (Sao Paulo),
p.(None): March 30th 1988 (" Codico de Etica" ).
p.(None):
p.(None): Current Anthropology, Chicago, Vol. IX, 5, 1968, then Vol. XI, 1, 1970, and finally Vol. XII, 1, 1971 (on the
p.(None): basis of a Symposium " On the social responsibilities in social anthropology").
p.(None):
...
p.(None): either by dint of his state or by profession, either by dint of a permanent function or a temporary
p.(None): mission, is punishable by one year imprisonment and a fine of 100,000 F."
p.(None):
p.(None): Article 226.14 - " Article 226.13 is not applicable, when the law imposes or authorizes the revelation of the
p.(None): confidential information. Moreover, it is not applicable: 1) To any person who informs the judicial, medical
p.(None): or administrative authorities of maltreatment or deprivation of which he has knowledge, and which has been
p.(None): inflicted on a minor of fifteen years or less, or a person unable to protect himself, because of his age
p.(None): or physical or mental state; 2) To a physician who, with the agreement of the victim, brings to the
p.(None): attention of the Prosecutor of the Republic maltreatment he has observed in the exercise of his profession, and which
p.(None): gives him grounds for supposing that sexual violence of some kind has been committed."
p.(None):
p.(None): Law N° 92.684 of July 22th 1992, Official Gazette of July 23th 1992, making amendments to the Penal Code. This Law
p.(None): enters into force on March 1st 1994.
p.(None):
p.(None): 11. A change to the 1978 Law in favour of epidemiological research is foreseen in the Draft Law on the treatment of
p.(None): research oriented nominal data with a view to protecting or improving health, adopted in first reading
p.(None): at the National Assembly on November 25th
p.(None):
p.(None): 1992.
p.(None):
p.(None): This draft law does not take up the concept of research oriented shared confidentiality between
p.(None): physicians and non-physicians. It authorizes the sharing of a secret among physicians for the purposes of
p.(None): research. The case of psychology research is not taken into consideration by the draft law, which essentially
p.(None): covers statistical processing of nominal data for the purpose of public health research.
p.(None):
p.(None): The transmission of data from a hospital department to a research institute for the purposes of investigation (for
p.(None): example, statistical processing) is authorized by the draft law, on condition that the future " National
p.(None): Consultative Committee for Information Processing in Health Research" has given its approval to the study, that the
p.(None): persons concerned have been informed individually and have been able to exercise their right of opposition (unless that
p.(None): is impossible), and that the data are received by a physician, designated by the research body, and
p.(None): entrusted with the safety of these data, and with ensuring respect for the research goals.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
Health / Mentally Disabled
Searching for indicator mentally:
(return to top)
p.(None):
p.(None): For the human sciences, one could propose a distinction between simple observation and construction of an experimental
p.(None): situation, in order to provide for a rapid procedure (simple review of the protocol), and a normal ethical review
p.(None): procedure (possibly requiring the actual presence of the investigators). However, this distinction is tricky to make,
p.(None): for in fact, as
p.(None):
p.(None): D. Widl\'9acher has quite rightly pointed out, there are " quite innocent experiments" and potentially traumatizing
p.(None): observations.
p.(None):
p.(None): Problems specific to behavioural research, as identified from the protocols submitted by the CNRS
p.(None): Consent
p.(None):
p.(None): - Under what conditions is behavioural research admissible, when the subjects have a problematic ability to
p.(None): give consent (limited competence, dependence)?
p.(None):
p.(None): The general rule is that persons, whose consent is dubious, should be protected against the possibility of serving as
p.(None): research " subjects" , in a manner proportionate to their incapacity and their dependence.
p.(None):
p.(None): Some of the vulnerable categories, requiring special protection in behavioural research, are: children, the mentally
p.(None): infirm, persons easily manipulable because of their own weakness or dependence (for example, drug addicts),
p.(None): captive institutionalized populations (prison inmates, pupils, adolescents in reform schools, young people
p.(None): in residential institutions, soldiers).
p.(None):
p.(None): - For minors and adults under guardianship , the rule accepted in biomedical research (L.209-10) can be
p.(None): generalized: consent of the parents or legal guardians, information given to the child or disabled person to the
p.(None): greatest extent possible, respect for the child's or disabled person's possible refusal.
p.(None):
p.(None): - For institutionalised captive populations (prison inmates, pupils, adolescents in reform schools, young
p.(None): people in residential institutions), the usual rule is to assess the project as admissible, only when it is (1) "
...
p.(None):
p.(None): Levine Robert J. (1986), Ethics and Regulation of Clinical Research, Baltimore-Munich: Urban & Schwarzenberg,
p.(None):
p.(None): 2nd edition.
p.(None):
p.(None): Macklin Ruth (1989), The paradoxical case of payment as benefit to research subjects, IRB, 11(6):1-3.
p.(None):
p.(None): Marini James L. (1980), Methodology and ethics: research on human agression, IRB, 2(5):1-4.
p.(None):
p.(None): Mead Margaret (1969), Research with human beings: a model derived from anthropological field practice,
p.(None):
p.(None): Daedalus, 98: 361-386.
p.(None):
p.(None): Meyer Roger E. (1977), Subjects' rights, freedom of inquiry, and the future of research in the addictions,
p.(None):
p.(None): Am J Psychiatry, 134(8):899-903.
p.(None):
p.(None): Menard Joël (1990), Rapport du groupe de réflexion INSERM sur certains aspects de la protection des sujets
p.(None): volontaires sains et des personnes qui se prêtent à des recherches bio- médicales, Paris: INSERM.
p.(None):
p.(None): National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research
p.(None): Involving Prisoners: Report and Recommendations, and Appendix (1976). Research Involving Children: Report
p.(None):
p.(None): and Recommendations, and Appendix (1977). Research Involving Those Institutionalized as Mentally Infirm: Report and
p.(None): Recommendations, and Appendix (1978). The Belmont Report: Ethical Principles and Guidelines for Research
p.(None): Involving Human Subjects (1978),
p.(None):
p.(None): Washington D.C.: US Govt Printing Office (DHEW) French translation in: Médecine et expérimentation (1982),
p.(None): Cahiers de bioéthique, 4, Québec: Presses de l'Université Laval, 233-250.
p.(None):
p.(None): Newton Lisa H. (1982), Dentists and pseudo-patients: further meditations on deception in research, IRB, 4(8):6-8.
p.(None):
p.(None): Park L.C., Covi L., Uhlenhuth E.H. (1967), Effects of informed consent on research patients and study results,
p.(None):
p.(None): J Nerv Ment Dis, 145: 349-357.
p.(None):
p.(None): Pattulo E.L. (1980), Who risks what in social research?, IRB, 2(3):1-3,12.
p.(None):
p.(None): Queheillard Jean-Louis (1989), Secret professionnel, le grand oublié ?, Psychologues et psychologies, N° 89.
p.(None):
p.(None): Redlich Fritz (1973), The anthropologist as observer; ethical aspects of clinical observations of behavior,
p.(None):
p.(None): J Nerv Ment Dis, 157: 313-319.
p.(None):
p.(None): Robertson John A. (1981), Ethical review of social experiments, IRB, 3(7):10-11.
p.(None):
p.(None): Royal College of Physicians (1986), 'Research on healthy volunteers', J Roy Coll Physicians, London, 20: 243-257.
p.(None):
p.(None): Schafer Arthur (1981), The ethics of research on human beings; a critical review of the issues and
p.(None): arguments,
p.(None):
...
Searching for indicator disabled:
(return to top)
p.(None):
p.(None): The general rule is that persons, whose consent is dubious, should be protected against the possibility of serving as
p.(None): research " subjects" , in a manner proportionate to their incapacity and their dependence.
p.(None):
p.(None): Some of the vulnerable categories, requiring special protection in behavioural research, are: children, the mentally
p.(None): infirm, persons easily manipulable because of their own weakness or dependence (for example, drug addicts),
p.(None): captive institutionalized populations (prison inmates, pupils, adolescents in reform schools, young people
p.(None): in residential institutions, soldiers).
p.(None):
p.(None): - For minors and adults under guardianship , the rule accepted in biomedical research (L.209-10) can be
p.(None): generalized: consent of the parents or legal guardians, information given to the child or disabled person to the
p.(None): greatest extent possible, respect for the child's or disabled person's possible refusal.
p.(None):
p.(None): - For institutionalised captive populations (prison inmates, pupils, adolescents in reform schools, young
p.(None): people in residential institutions), the usual rule is to assess the project as admissible, only when it is (1) "
p.(None): minimal risk" and (2) non-discriminatory. Consent must be obtained both from the responsible officials of the
p.(None): institution, and from each subject individually (if the subjects are minors, from the person who exercises parental
p.(None): authority).
p.(None):
p.(None): - The use of " rewards" must be looked at very closely at the time of ethical review (for example, recruitment of
p.(None): homeless or native people as research subjects by offering them alcohol).
p.(None):
p.(None): - In so far as inmates are concerned, the law of December 20th 1988 prohibits research without direct individual
p.(None): benefit, when the persons concerned are deprived of their freedom. In the behavioural sciences, such research can be
p.(None): harmless for the persons concerned, and socially useful, or even necessary; therefore they cannot be prohibited
p.(None): without individual review.
p.(None):
p.(None): - How can one reconcile the obligation of consent, that is to be informed , with the methodological
p.(None): necessity (which can arise in the case of certain experimental protocols ) of not saying everything ?
p.(None):
...
Health / alcoholism
Searching for indicator alcoholic:
(return to top)
p.(None):
p.(None): This is a delicate issue, precisely because the identification of significant differences and of
p.(None):
p.(None): discriminating characteristics is a plausible research objective. For instance, it is of interest, and of importance
p.(None): for the evaluation of assisted maternity techniques, to ask whether there is a significance difference between the
p.(None): cognitive development of children born of artificial insemination and other children (CNRS file, Duyme project). But if
p.(None): one finds that artificial insemination children develop less well than the others, and if such research
p.(None): results are made public, then children already born through artificial insemination (or their parents) are put in a
p.(None): difficult situation, even if confidentiality of origins is well protected (the danger of guilt feelings).
p.(None):
p.(None): In the case of the Duyme protocol, all precautions were taken to ensure that the research would not be a source of
p.(None): discrimination through its methodology.
p.(None):
p.(None): Apart from the methodology, a research project may involve explicit or implicit risk of discrimination
p.(None): against individuals, because of the hypotheses on which it is based (for example, experimentation with "
p.(None): aversion therapies" to treat homosexuals, or psychosocial follow-up of a cohort of children born to alcoholic mothers).
p.(None): A project may also involve a risk of discrimination against an entire population, because of the way its
p.(None): results will be interpreted (for example, determination of statistically poorer results on several intelligence tests
p.(None): among blacks than among whites).
p.(None):
p.(None): In the United States at the end of the sixties, the interest in a " science for the people" caused some investigations
p.(None): to be stopped, on the grounds that their theoretical implications were slanderous for certain categories of
p.(None): individuals. There is even reference to attempts to force researchers to " revise" their conclusions, and/or to publish
p.(None): only expurgated results.
p.(None):
p.(None): The discrimination risk is a function of the social level of tolerance of a given " difference" . One could propose
p.(None): the following rule: the discrimination risks must be identified, and weighed in the balance against the
p.(None): collective interest, and the theoretical interest of obtaining the expected result.
p.(None):
p.(None): - Should promoters of behavioural research take out insurance to cover the risks, to which research subjects are
p.(None): exposed because of the investigation?
p.(None):
p.(None): In biomedical research, French law obligates the promoter to take out insurance (Article L.209-7),
p.(None): guaranteeing his third-party liability, in the event of damaging consequences of the research for the consenting
p.(None): person. It is known that this provision of the law cause no problems, when the promoter is the pharmaceutical industry,
...
Health / healthy volunteers
Searching for indicator healthy volunteers:
(return to top)
p.(None):
p.(None): and Recommendations, and Appendix (1977). Research Involving Those Institutionalized as Mentally Infirm: Report and
p.(None): Recommendations, and Appendix (1978). The Belmont Report: Ethical Principles and Guidelines for Research
p.(None): Involving Human Subjects (1978),
p.(None):
p.(None): Washington D.C.: US Govt Printing Office (DHEW) French translation in: Médecine et expérimentation (1982),
p.(None): Cahiers de bioéthique, 4, Québec: Presses de l'Université Laval, 233-250.
p.(None):
p.(None): Newton Lisa H. (1982), Dentists and pseudo-patients: further meditations on deception in research, IRB, 4(8):6-8.
p.(None):
p.(None): Park L.C., Covi L., Uhlenhuth E.H. (1967), Effects of informed consent on research patients and study results,
p.(None):
p.(None): J Nerv Ment Dis, 145: 349-357.
p.(None):
p.(None): Pattulo E.L. (1980), Who risks what in social research?, IRB, 2(3):1-3,12.
p.(None):
p.(None): Queheillard Jean-Louis (1989), Secret professionnel, le grand oublié ?, Psychologues et psychologies, N° 89.
p.(None):
p.(None): Redlich Fritz (1973), The anthropologist as observer; ethical aspects of clinical observations of behavior,
p.(None):
p.(None): J Nerv Ment Dis, 157: 313-319.
p.(None):
p.(None): Robertson John A. (1981), Ethical review of social experiments, IRB, 3(7):10-11.
p.(None):
p.(None): Royal College of Physicians (1986), 'Research on healthy volunteers', J Roy Coll Physicians, London, 20: 243-257.
p.(None):
p.(None): Schafer Arthur (1981), The ethics of research on human beings; a critical review of the issues and
p.(None): arguments,
p.(None):
p.(None): Res Adv Alcohol Drug Probl, 6: 471-511.
p.(None):
p.(None): Schiff Michel (1991), Les impasses de la recherche en psychologie, Psychologues et psychologies, N° 104.
p.(None):
p.(None): Schmutte Gregory T. (1980), Using students as subjects without their knowledge, IRB, 2(10):5-6.
p.(None):
p.(None): Schuler Heinz (1980), Ethische Probleme psychologischer Forschung, G\'9attingen.
p.(None):
p.(None): Sieber Joan E. (1982), How humanism and determinism differ: understanding risk in psychological research,
p.(None): IRB, 4(3):1-3,12.
p.(None):
p.(None): Sieber Joan E. (1982), Deception in social research I: Kinds of deception and the wrong they may involve,
p.(None): IRB, 4(9):1-5.
p.(None):
p.(None): Sieber Joan E. (1983), Deception in social research II: Evaluating the potential for harm or wrong, IRB, 5(1):1-6.
p.(None):
p.(None): Sieber Joan E. (1983), Deception in social research III: The nature and limits of debriefing, IRB, 5(3):1-4.
p.(None):
p.(None): Sieber Joan E. (1989), On studying the powerful (or fearing to do so): a vital role for IRBs, IRB, 11(5):1-6.
p.(None):
p.(None): St James-Robert Ian (1976), Are researchers trustworthy?, New Scientist, 171: 481-483. Thouvenin Dominique (1992),
...
Health / volunteers
Searching for indicator volunteers:
(return to top)
p.(None): never involve exploitation (for example, exploitation by researchers in developed countries of poor
p.(None): populations in developing countries, which serve as " guinea pigs" for the acquisition of knowledge, whose therapeutic
p.(None): spin-offs are of benefit mainly to populations in rich countries: see WHO-CIOMS, 1982). It then serves to recall, as
p.(None): the CCNE has done in its 1990 Report (p. 72), that participation in a research protocol calls for " fair indemnity "
p.(None): or " compensation" for the subjects, but to the exclusion of any remuneration.
p.(None):
p.(None): In behavioural research, cases of (North-South) exploitation have been brought (in ethnology, in
p.(None): anthropology), but in the background there was usually a problem of ethnic or cultural discrimination (attitude of
p.(None): the " developed" to the " savage" ). Clear risks of discrimination have been raised in the case of
p.(None): investigation of distinctive characteristics, that are a source of social worth or the opposite ("
p.(None): intelligence quotient" , " crime chromosome" , etc.). On the other hand, the practice in
p.(None): behavioural research of remunerating subjects (for example, on a fee basis) has not given rise to many objections
p.(None): as yet. There are salaried professionals (test pilots, underwater divers) who accept being guinea pigs in the
p.(None): exercise of their profession. Conversely, many volunteers are not indemnified (when their contribution is
p.(None): minimal, or when, as in the case of students, they receive an intellectual or didactic benefit). Therefore, it
p.(None): cannot be said either that all volunteers should be indemnified, or that any remuneration is contrary to ethical
p.(None): principles.
p.(None):
p.(None): From the point of view of equity, the central problem in behavioural research seems to be the problem of possible
p.(None): discrimination, whether connected with the research protocol itself, or with the research results and the way they are
p.(None): understood and utilised (socio-cultural " spin-offs" ).
p.(None):
p.(None): Ethical review by "independent" bodies
p.(None):
p.(None): In the case of biomedical research, French law submits to review by CCPPRBs any " trials or experiments" . It exempts "
p.(None): studies" (research work done only on paper, or with samples collected independently of the study, for example, taken
p.(None): from a blood bank).
p.(None):
p.(None): The American federal directives (DHHS, 1981) set out three categories of research with human subjects:
p.(None): exempted from ethical review, submitted to a simplified procedure of ethical review (" expedited review" by
p.(None): the bureau of an IRB), and submitted to in-depth ethical discussion (discussion in session by an IRB).
p.(None):
p.(None): For the human sciences, one could propose a distinction between simple observation and construction of an experimental
p.(None): situation, in order to provide for a rapid procedure (simple review of the protocol), and a normal ethical review
p.(None): procedure (possibly requiring the actual presence of the investigators). However, this distinction is tricky to make,
p.(None): for in fact, as
p.(None):
p.(None): D. Widl\'9acher has quite rightly pointed out, there are " quite innocent experiments" and potentially traumatizing
p.(None): observations.
p.(None):
p.(None): Problems specific to behavioural research, as identified from the protocols submitted by the CNRS
...
p.(None): collective interest, and the theoretical interest of obtaining the expected result.
p.(None):
p.(None): - Should promoters of behavioural research take out insurance to cover the risks, to which research subjects are
p.(None): exposed because of the investigation?
p.(None):
p.(None): In biomedical research, French law obligates the promoter to take out insurance (Article L.209-7),
p.(None): guaranteeing his third-party liability, in the event of damaging consequences of the research for the consenting
p.(None): person. It is known that this provision of the law cause no problems, when the promoter is the pharmaceutical industry,
p.(None): but that it causes problems for research carried out by university teams and/or in hospitals of modest size, which have
p.(None): trouble finding a promoter with sufficient financial depth to take out insurance. In behavioural research,
p.(None): are the large research bodies (CNRS, university laboratories) in a position to stand as research promoters?
p.(None): Without identification of the promoter, one cannot, in fact, tackle the problem of insurance in a satisfactory manner.
p.(None):
p.(None): It could be argued that, in the case of minimal risk behavioural research, the insurance is not indispensable, even
p.(None): though consideation must be given to physical risks, which, without being a direct consequence of the research
p.(None): as such, occur in the course of the research (falls, accidents during transit). One could also argue that, for
p.(None): research with more risk, such as that proposed only to adult, responsible and fully consenting volunteers, it is up to
p.(None): them to take out insurance, as for other risky activities (for example, certain sports). But in the event of
p.(None): litigation, it can always be argued that the researchers responsible for the project should not have offered volunteers
p.(None): such a risky situation. To our knowledge, there has been at least one example in France of a suicide following risky
p.(None): behavioural research (prolonged isolation with no temporal references).
p.(None):
p.(None): The problem of insurance for behavioural research with human subjects must at least be put clearly. Solving it in the
p.(None): general case is the business of the legislator.
p.(None):
p.(None): Review of protocols. How would CCPPRCs (Consultative Committees for the Protection of Persons consenting to
p.(None): Behavioural Research) operate?
p.(None):
p.(None): It would seem to be out of the question that the biomedical CCPPRBs be able, in their present
p.(None): composition, to review research protocols in the human sciences. They were not designed for it.
p.(None):
p.(None): It is not included in the mission statement of the CCNE's technical section, that it should undertake systematic review
p.(None): of research protocols in the human sciences.
p.(None):
p.(None): French experience prior to law N° 88-1138 of December 20th 1988 (for example, the Assistance
p.(None): Publique-Hôpitaux de Paris), as well as the North American model, would point in the direction of creating " Ethics
p.(None): Committees for Human Sciences Research" at institutions that actually engage in behavioural research with human
p.(None): subjects: CNRS, universities. According to R.J. Levine (1986), these Committees are " the conscience of the
p.(None): institution" , and an expression of its interest in ensuring that its research is of high quality, and that the persons
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.(None): medical data for research purposes, and to process them under their own responsibility. For the sake of
p.(None): equity, this would imply, inversely, that physicians could be entitled to gain knowledge for
p.(None): research purposes of nominal psychological data.
p.(None):
p.(None): This would suppose (1) an entitlement procedure, (2) a change in the legislation, in order to render admissible the
p.(None): concept of shared confidentiality between physicians and non- physicians.
p.(None):
p.(None): We note that the " Computerisation and Liberties" law of January 6th 1978 does not authorise any
p.(None): exception to medical confidentiality for the purpose of research, unless the persons concerned have agreed. Now the
p.(None): French Medical Code of ethics does not provide for the patient being able to release the physician from
p.(None): confidentiality (the only cases of confidentiality waivers are those prescribed by the law) (see Villey,
p.(None): 1986, p. 135). The Psychologists' Code of ethics goes further: " With the exception of cases of legal obligation,
p.(None): the psychologist cannot be released from confidentiality by anyone, not even by those whom the confidential
p.(None): information concerns" (Article 13). The justification for the rule, that even the person concerned cannot release the
p.(None): physician or psychologist from confidentiality is that, in order to allow someone to share a secret, one has to know
p.(None): what the secret is. But a clinical psychologist is not obligated to communicate his files to his client. And the French
p.(None): patient has only indirect access to his medical file, and he usually does not know what it contains.
p.(None):
p.(None): If French legislation is moving in the direction of a new form of waiver to medical confidentiality, for
p.(None): the purposes of scientific research, this would then also imply a change in the Medical Code of ethics, a change in the
p.(None): Psychologists' Code of ethics, and no doubt, in the longer term and for all patients, a right of direct access to their
p.(None): medical files, and hence a change in the " Computerisation and Liberties" law, and in the Law on access
p.(None): to administrative documents.
p.(None):
p.(None): Problems of equity
p.(None):
p.(None): - How can one reconcile research on discriminating characteristics with the imperative of
p.(None): non-discrimination ?
p.(None):
p.(None): This is a delicate issue, precisely because the identification of significant differences and of
p.(None):
p.(None): discriminating characteristics is a plausible research objective. For instance, it is of interest, and of importance
p.(None): for the evaluation of assisted maternity techniques, to ask whether there is a significance difference between the
p.(None): cognitive development of children born of artificial insemination and other children (CNRS file, Duyme project). But if
p.(None): one finds that artificial insemination children develop less well than the others, and if such research
p.(None): results are made public, then children already born through artificial insemination (or their parents) are put in a
p.(None): difficult situation, even if confidentiality of origins is well protected (the danger of guilt feelings).
p.(None):
p.(None): In the case of the Duyme protocol, all precautions were taken to ensure that the research would not be a source of
p.(None): discrimination through its methodology.
p.(None):
p.(None): Apart from the methodology, a research project may involve explicit or implicit risk of discrimination
...
p.(None): institution" , and an expression of its interest in ensuring that its research is of high quality, and that the persons
p.(None): who consent to it are adequately protected. Rules concerning the composition of these committees (which should include
p.(None): a certain proportion of members from outside the institution, and/or outside human sciences, for example, lawyers,
p.(None): philosophers, physicians) could be drawn up by a joint commission (CNRS, universities, CCNE, ministries and
p.(None): professional organizations). A procedure for entitling these committees could be determined by a text of the Minister
p.(None): of Research. This would probably be a provisional solution, but one that could be implemented rather quickly.
p.(None):
p.(None): In the French context, it seems difficult to imagine a longer term solution other than that of legislative constitution
p.(None): of several regional CCPPRCs on the model of the CCPPRBs , but with a composition giving them the expertise required to
p.(None): review research protocols with human subjects in the human sciences other than the biomedical: anthropology, ethnology,
p.(None): various branches of psychology, sociology, linguistics, history, education sciences, etc. This is the business of the
p.(None): legislator.
p.(None):
p.(None): Any file submitted to a CCPPRC should provide the following information, as a minimum: 1) the research objectives and
p.(None): the working hypotheses; 2) the study's target population and the ways in which subjects are to be recruited (including
p.(None): the text of any advertisements) 3) the detailed methodology; 4) steps taken to ensure anonymity of collected
p.(None): data, their storage and access to them for consultation; 5) evaluation of the risks, costs, constraints and potential
p.(None): benefits; 6) presentation of information to persons participating in the study, and the modalities of their consent,
p.(None): including the study presentation document distributed to such people, and the consent form (consent to the study, and,
p.(None): as appropriate, to the use of results).
p.(None):
p.(None): References
p.(None):
p.(None): American Psychological Association (1986), Ethical issues in psychological research in AIDS,
p.(None): Committee
p.(None):
p.(None): for the protection of human participants in research, IRB, 8(4):8-10.
p.(None):
p.(None): Barber B. (1976), The ethics of experimentation with human subjects, Scientific American, 234(2):25-31.
p.(None):
p.(None): Baumrind Diana (1979), IRBs and social science research: the costs of deception, IRB, 1(6):1-4.
p.(None):
p.(None): Bourdieu Pierre, ed. (1993), La misère du monde, Paris: Seuil.
p.(None):
p.(None): Medical Research Council of Canada (1986),Lignes directrices concernant la recherche sur des sujets humains, Ottawa.
p.(None):
p.(None): Cupples Brian & Gochnauer Myron (1985), The investigator's duty not to deceive, IRB,
p.(None):
p.(None): 7(5):1-6.
p.(None):
p.(None): De Sola Pool Ithiel (1983), Do social scientists have unlimited research rights?, IRB, 5(6):10.
p.(None):
p.(None): Desportes Jean-Pierre (1974), Les manipulations du comportement, La Recherche, 47: 654- 661.
p.(None):
...
p.(None): shares with them only such information as is strictly necessary for a team to be able to take care of the " client" ."
p.(None):
p.(None): " 12
p.(None): - He makes sure to protect the identity of individuals, when making up data files, in accordance with
p.(None): the Law of April 6th 1978 on information and personal liberties."
p.(None): " 13
p.(None): - With the exception of a legal obligation, the psychologist cannot be released from the confidentiality
p.(None): rule by anyone, not even those directly concerned by the confidential information."
p.(None): Two rules pertain to scientific work through the responsability to be well trained: " 17
p.(None): - Every psychologist, whatever his speciality, must constantly keep abreast of scientific
p.(None): progress in his discipline, and consequently keep up his training. He takes such progress into account in his work,
p.(None): and strives to contribute to it. He accepts all the rules, requirements and constraints imposed by
p.(None): scientific work."
p.(None):
p.(None): " 19
p.(None): - Every psychologist seeks to determine and to apply scientifically validated and communicative
p.(None): criteria and methods, thereby rejecting the principle of authority."
p.(None):
p.(None): One rule can be applied to the informed consent request:
p.(None):
p.(None): " 18
p.(None): - The psychologist refrains from restricting any other person's autonomy, and, in particular, his access to
p.(None): information, and his freedom of judgement and decision-making."
p.(None): A special rule covers the treatment of experimental animals:
p.(None):
p.(None): " 26
p.(None): - When his activities relate to animal behaviour, with a view to understanding human behaviour, he strives
p.(None): to ensure the welfare and the survival of the animals being studied."
p.(None):
p.(None): The absence of an equivalent rule, covering the treatment of persons consenting to behavioural research,
p.(None): implies that research subjects are not treated differently from other sujects, with whom the psychologist is in
p.(None): contact on a professional basis (hence, for example, that different treatment in the " therapeutic" and "
p.(None): non-therapeutic" situations is not envisaged).
p.(None):
p.(None): 4. On the concept of consent and its ambiguities, see: Thouvenin (1992).
p.(None):
p.(None): 5. See Stanley Milgram's experiments, evoked in the film " 'I' as in Icarus" . Reference publication:
p.(None): Milgram S. (1963), " Behavioral study of obedience" , J Abnorm Psychol, 67: 371-378.
p.(None):
p.(None): 6. Also known as " deceptive research" (" tromperie" in French).
p.(None):
p.(None): 7. This is refered to as " debriefing" .
p.(None):
p.(None): 8. The French Law of December 20th 1988 uses the term " serious risk" , and stipulates that, for persons belonging
p.(None): to vulnerable categories, research " without direct individual benefit" is admissible, only if it involves " no
p.(None): serious foreseeable risk" (Article L.209-6).
p.(None):
...
Social / Age
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p.(None): to vulnerable categories, research " without direct individual benefit" is admissible, only if it involves " no
p.(None): serious foreseeable risk" (Article L.209-6).
p.(None):
p.(None): 9. The Report of the Royal College of Physicians (1986) shows that risk is deemed minimal, either because the potential
p.(None): disorder is not very serious at all, or because the probability of the event is very low. In the latter case, the risk
p.(None): " is comparable to that run by an airplane passenger taking a regular flight" (see the Menard Report, 1990).
p.(None):
p.(None): 10. Article 226.13 - " The revelation of confidential information, by a person who is its depository,
p.(None): either by dint of his state or by profession, either by dint of a permanent function or a temporary
p.(None): mission, is punishable by one year imprisonment and a fine of 100,000 F."
p.(None):
p.(None): Article 226.14 - " Article 226.13 is not applicable, when the law imposes or authorizes the revelation of the
p.(None): confidential information. Moreover, it is not applicable: 1) To any person who informs the judicial, medical
p.(None): or administrative authorities of maltreatment or deprivation of which he has knowledge, and which has been
p.(None): inflicted on a minor of fifteen years or less, or a person unable to protect himself, because of his age
p.(None): or physical or mental state; 2) To a physician who, with the agreement of the victim, brings to the
p.(None): attention of the Prosecutor of the Republic maltreatment he has observed in the exercise of his profession, and which
p.(None): gives him grounds for supposing that sexual violence of some kind has been committed."
p.(None):
p.(None): Law N° 92.684 of July 22th 1992, Official Gazette of July 23th 1992, making amendments to the Penal Code. This Law
p.(None): enters into force on March 1st 1994.
p.(None):
p.(None): 11. A change to the 1978 Law in favour of epidemiological research is foreseen in the Draft Law on the treatment of
p.(None): research oriented nominal data with a view to protecting or improving health, adopted in first reading
p.(None): at the National Assembly on November 25th
p.(None):
p.(None): 1992.
p.(None):
p.(None): This draft law does not take up the concept of research oriented shared confidentiality between
p.(None): physicians and non-physicians. It authorizes the sharing of a secret among physicians for the purposes of
p.(None): research. The case of psychology research is not taken into consideration by the draft law, which essentially
p.(None): covers statistical processing of nominal data for the purpose of public health research.
p.(None):
p.(None): The transmission of data from a hospital department to a research institute for the purposes of investigation (for
p.(None): example, statistical processing) is authorized by the draft law, on condition that the future " National
...
Social / Child
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p.(None): university laboratories supported by the CNRS, or carried out in part by CNRS researchers, together with an overall
p.(None): description of psychology research at the CNRS. Among the five files in question, which had been approved by the
p.(None): competent scientific commission of the CNRS, two (the Duyme and Carlier files(2)) relate to the laboratory headed by
p.(None): Professor Roubertoux, and correspond to research that was interrupted, following the appearance on December
p.(None): 17th 1992 of an article in the weekly L'Express .
p.(None):
p.(None): The CCNE set up a working group.
p.(None):
p.(None): This group familiarized itself with the great variety of research done at the CNRS in the human
p.(None): sciences. For psychology alone, about fifteen research units (mostly Applied Research Units), representing
p.(None): 150 researchers and about 200 teaching researchers, are grouped together in Section 29, called " Mental
p.(None): functions, integrative neurosciences and behaviours" , and co-managed by the Life Sciences Department and the Human
p.(None): and Social Sciences Department. The objective of this research is " to understand the skills and the performances of
p.(None): the human being in the course of different periods of his life, in habitual situations as well as in exceptional
p.(None): circumstances" . The methods range from simple observation in a natural or standardised situation, to
p.(None): tests of reactions in " extreme situations" . The subjects are recruited on a volunteer basis. The identified
p.(None): subdisciplines are: psychology of the child and of development, social psychology, cognitive psychology, psychology of
p.(None): work, ergonomics, psycholinguistics, psychopathology, clinical psychology, neuropsychology, psychopharmacology.
p.(None): There is frequent interface with neighbouring disciplines: anthropology, neurosciences, psychiatry,
p.(None): linguistics, sociology, education sciences, artificial intelligence, etc.
p.(None):
p.(None): The working group met approximately once per month between January and June 1993. It met with the Operational
p.(None): committee for ethics in the life sciences of the CNRS (COPÉ, January 22th 1993). It heard from several
p.(None): researchers. It gathered information on problems specific to research in human sciences, on professional codes of
p.(None): ethics, and on the way in which experimental human sciences investigations with human subjects are organized
p.(None): in other countries.
p.(None):
p.(None): The CCNE notes that in France, since the " Law on the protection of subjects in biomedical research" of December 20th
p.(None): 1988, " trials or experiments organised with and practised on human subjects, with a view to increasing
p.(None): biological or medical knowledge" take place within a precise and constraining legal framework. On the other hand,
p.(None): the legislator has not brought his attention to bear on the protection of persons who consent to
...
p.(None):
p.(None): The general rule is that persons, whose consent is dubious, should be protected against the possibility of serving as
p.(None): research " subjects" , in a manner proportionate to their incapacity and their dependence.
p.(None):
p.(None): Some of the vulnerable categories, requiring special protection in behavioural research, are: children, the mentally
p.(None): infirm, persons easily manipulable because of their own weakness or dependence (for example, drug addicts),
p.(None): captive institutionalized populations (prison inmates, pupils, adolescents in reform schools, young people
p.(None): in residential institutions, soldiers).
p.(None):
p.(None): - For minors and adults under guardianship , the rule accepted in biomedical research (L.209-10) can be
p.(None): generalized: consent of the parents or legal guardians, information given to the child or disabled person to the
p.(None): greatest extent possible, respect for the child's or disabled person's possible refusal.
p.(None):
p.(None): - For institutionalised captive populations (prison inmates, pupils, adolescents in reform schools, young
p.(None): people in residential institutions), the usual rule is to assess the project as admissible, only when it is (1) "
p.(None): minimal risk" and (2) non-discriminatory. Consent must be obtained both from the responsible officials of the
p.(None): institution, and from each subject individually (if the subjects are minors, from the person who exercises parental
p.(None): authority).
p.(None):
p.(None): - The use of " rewards" must be looked at very closely at the time of ethical review (for example, recruitment of
p.(None): homeless or native people as research subjects by offering them alcohol).
p.(None):
p.(None): - In so far as inmates are concerned, the law of December 20th 1988 prohibits research without direct individual
p.(None): benefit, when the persons concerned are deprived of their freedom. In the behavioural sciences, such research can be
p.(None): harmless for the persons concerned, and socially useful, or even necessary; therefore they cannot be prohibited
p.(None): without individual review.
p.(None):
p.(None): - How can one reconcile the obligation of consent, that is to be informed , with the methodological
...
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p.(None): or endurance sporting, civilian or military exploits), on the quality of life and harmful environmental effects.
p.(None):
p.(None): In France, the protection of persons who consent to biomedical research depends on law N° 88-1138 of December 20th 1988
p.(None): (amended as N° 90-86). The protection of persons who consent to behavioural research depends, for the time
p.(None): being, on the deontology of the researchers (for example, the psychologists' code of ethics(3)).
p.(None):
p.(None): The recommendations that the CCNE is going to formulate on the ethics of behavioural research must, in
p.(None): the interests of consistency, be in line with the law N° 88-1138 of December 20th 1988. The main
p.(None): principles of directives concerning research with human subjects, as formulated in the United States by the
p.(None): National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-78), or in Canada
p.(None): by the Medical Research Council (1986), and then by the National Council on Bioethics in Human Research (NCBHR), are
p.(None): the same for all such research, whether in the biomedical sciences or the human sciences, even if specific problems are
p.(None): then identified, as a function of the discipline (cancerology, psychiatry, ethnology, etc.), or for different
p.(None): categories of subjects (children, captive or exiled populations, old people with reduced autonomy, etc.).
p.(None):
p.(None): Thus, it can be accepted that the main ethical principles governing research with human subjects (which the American
p.(None): National Commission refers to as the principles of justice, of beneficence, and of respect for the autonomy of
p.(None): individuals), as well as the rules flowing therefrom (rule of equal treatment or non-discrimination, rule of
p.(None): minimization of risk and optimization of benefit, rule of consent), are the same, whether the research is biomedical or
p.(None): behavioural. It can also be accepted, that the procedure, consisting in submission of human subject
p.(None): research protocols, before their execution, for review by an " independent committee" , an " ethics committee" or a "
p.(None): committee for the protection of persons" , is applicable to behavioural research. In the sequel, we refer to
p.(None): " CCPPRCs" (Consultative Committees for the Protection of Persons consenting to Behavioural Research),
p.(None): without prejudging their relationship with the CCPPRBs instituted by the law N° 88-1138 of December 20th
p.(None): 1988 (which will be discussed below).
p.(None):
p.(None): Main principles
p.(None): The freedom of persons
p.(None):
...
p.(None): passing an examination, career advantage, affective blackmail, etc.).
p.(None):
p.(None): Moreover, consent for the research is revocable. Subjects must be informed that they may cease to participate, at any
p.(None): time, without incurring any penalty or reproach.
p.(None):
p.(None): Safety. The human cost
p.(None):
p.(None): In biomedical research, it is accepted that certain research protocols may involve a " direct individual benefit "
p.(None): (Article L.209-1) for consenting persons. This concept of (potential) benefit for the subject serves, in
p.(None): medicine, to authorize the inclusion in research protocols, but under certain conditions (Article L.209-6), persons
p.(None): whose consent is dubious or even impossible (minors, adults under guardianship, persons residing in a public health or
p.(None): social institution, patients in an emergency situation).
p.(None):
p.(None): In behavioural research, there may also be cases of investigations " with direct individual benefit" , for example,
p.(None): in clinical psychology, in the case of a comparative study of two psychotherapeutic methods (if the
p.(None): benefit for consenting subjects of at least one of the methods is established), or in cognitive psychology (if
p.(None): the fact that children consent to a study gives them an educational advantage, as was stated in the CNRS file regarding
p.(None): the Lautrey protocol). But given the absence of vital emergencies that obligate the practitioner to intervene, and
p.(None): given how difficult it is to argue that research is done " for the good" of included subjects, or " in the interest of
p.(None): their health" , the " with/without direct individual benefit" distinction is not sufficiently applicable to behavioural
p.(None): research, to justify relaxing the consent conditions, even in the case of applied research. This distinction is
p.(None): applicable only within the framework of the risk-advantage balance.
p.(None):
p.(None): In its report of 1990, the CCNE noted that, as a general rule, persons who consent to an investigation, whose objective
p.(None): is gaining knowledge about human beings, do not see this as to their personal advantage. The CCNE considered this to be
p.(None): admisible, " provided there is
p.(None):
p.(None): an acceptable risk-advantage balance, that is, a definite advantage for the community, and a zero or minimal risk for
p.(None): the individual" (p. 70).
p.(None):
p.(None): To assess the risk-advantage balance means to ask whether the risks, constraints or discomfort imposed on
p.(None): the subjects (" human cost" ) are sufficiently justified by the scientific significance of the question
...
p.(None): the bureau of an IRB), and submitted to in-depth ethical discussion (discussion in session by an IRB).
p.(None):
p.(None): For the human sciences, one could propose a distinction between simple observation and construction of an experimental
p.(None): situation, in order to provide for a rapid procedure (simple review of the protocol), and a normal ethical review
p.(None): procedure (possibly requiring the actual presence of the investigators). However, this distinction is tricky to make,
p.(None): for in fact, as
p.(None):
p.(None): D. Widl\'9acher has quite rightly pointed out, there are " quite innocent experiments" and potentially traumatizing
p.(None): observations.
p.(None):
p.(None): Problems specific to behavioural research, as identified from the protocols submitted by the CNRS
p.(None): Consent
p.(None):
p.(None): - Under what conditions is behavioural research admissible, when the subjects have a problematic ability to
p.(None): give consent (limited competence, dependence)?
p.(None):
p.(None): The general rule is that persons, whose consent is dubious, should be protected against the possibility of serving as
p.(None): research " subjects" , in a manner proportionate to their incapacity and their dependence.
p.(None):
p.(None): Some of the vulnerable categories, requiring special protection in behavioural research, are: children, the mentally
p.(None): infirm, persons easily manipulable because of their own weakness or dependence (for example, drug addicts),
p.(None): captive institutionalized populations (prison inmates, pupils, adolescents in reform schools, young people
p.(None): in residential institutions, soldiers).
p.(None):
p.(None): - For minors and adults under guardianship , the rule accepted in biomedical research (L.209-10) can be
p.(None): generalized: consent of the parents or legal guardians, information given to the child or disabled person to the
p.(None): greatest extent possible, respect for the child's or disabled person's possible refusal.
p.(None):
p.(None): - For institutionalised captive populations (prison inmates, pupils, adolescents in reform schools, young
p.(None): people in residential institutions), the usual rule is to assess the project as admissible, only when it is (1) "
...
p.(None):
p.(None): Safety
p.(None):
p.(None): - How can one evaluate the psychological risk , and the possible consequences for subjects of a behavioural research
p.(None): project?
p.(None):
p.(None): In the case of biomedical research, it has been argued that, by definition, when one searches the risks
p.(None): are not known, and therefore cannot be evaluated. The usual counter- argument is that all research relies on
p.(None): hypotheses, which are themselves based on previously acquired knowledge, and that this background knowledge allows
p.(None): for at least an approximate assessment of the risk to subjects involved in the experiment. The same
p.(None): reasoning applies to psychology.
p.(None):
p.(None): We recall that, technically speaking, risk is the product of an event's severity and its probability.
p.(None): Hence the evaluation of risk involves estimation of both the severity of disorders that might be provoked in the
p.(None): experiment's subjects, and of the probability of occurrence of these disorders.
p.(None):
p.(None): The distinction between " minimal risk " (or negligible) and " non-minimal risk " (or non- negligible, serious(8)) was
p.(None): introduced in 1978 by the American National Commission. " Zero risk" does not exist in human endeavours. " Minimal"
p.(None): risks are risks of the same order of magnitude as risks commonly accepted without thinking in everyday life. For
p.(None): children, for instance, minimal risk is defined as risk whose " probability and severity are of the order as those of
p.(None): physical or psychological damage, to which children in good health are normally exposed in their lives, or in
p.(None): routine medical or psychological examinations" (National Commission..., 1978-12, Appendix 1)(9).
p.(None):
p.(None): Examples of serious risk: isolation with no temporal references, sensory deprivation experiments, endurance
p.(None): under " extreme" conditions, etc.
p.(None):
p.(None): For categories of vulnerable subjects, only experiments whose risk is at a minimal level can be proposed, or, to use
p.(None): the terminology of the French Law of 1988, experiments that do not involve " any foreseeable serious risk" .
p.(None):
p.(None): It is only to adult subjects in good health, in full possession of their mental faculties, and fully informed, that
p.(None): one may offer, for the purposes of human sciences research, involvement in experiments with risk at a higher
p.(None): level than the minimal level (no matter how small the difference).
p.(None):
p.(None): - How can one reconcile the imperative of data confidentiality with the communication to non-physician researchers
p.(None): of confidential medical files, when the purpose is to advance research?
p.(None):
p.(None): The ethical problem is one of respect for the personal domain, and of non-divulgation of confidential data, of which
p.(None): the treating physician is the depository. One can rely on Articles 7 to 13 of the Psychologist's Code of Ethics
...
p.(None): physician or psychologist from confidentiality is that, in order to allow someone to share a secret, one has to know
p.(None): what the secret is. But a clinical psychologist is not obligated to communicate his files to his client. And the French
p.(None): patient has only indirect access to his medical file, and he usually does not know what it contains.
p.(None):
p.(None): If French legislation is moving in the direction of a new form of waiver to medical confidentiality, for
p.(None): the purposes of scientific research, this would then also imply a change in the Medical Code of ethics, a change in the
p.(None): Psychologists' Code of ethics, and no doubt, in the longer term and for all patients, a right of direct access to their
p.(None): medical files, and hence a change in the " Computerisation and Liberties" law, and in the Law on access
p.(None): to administrative documents.
p.(None):
p.(None): Problems of equity
p.(None):
p.(None): - How can one reconcile research on discriminating characteristics with the imperative of
p.(None): non-discrimination ?
p.(None):
p.(None): This is a delicate issue, precisely because the identification of significant differences and of
p.(None):
p.(None): discriminating characteristics is a plausible research objective. For instance, it is of interest, and of importance
p.(None): for the evaluation of assisted maternity techniques, to ask whether there is a significance difference between the
p.(None): cognitive development of children born of artificial insemination and other children (CNRS file, Duyme project). But if
p.(None): one finds that artificial insemination children develop less well than the others, and if such research
p.(None): results are made public, then children already born through artificial insemination (or their parents) are put in a
p.(None): difficult situation, even if confidentiality of origins is well protected (the danger of guilt feelings).
p.(None):
p.(None): In the case of the Duyme protocol, all precautions were taken to ensure that the research would not be a source of
p.(None): discrimination through its methodology.
p.(None):
p.(None): Apart from the methodology, a research project may involve explicit or implicit risk of discrimination
p.(None): against individuals, because of the hypotheses on which it is based (for example, experimentation with "
p.(None): aversion therapies" to treat homosexuals, or psychosocial follow-up of a cohort of children born to alcoholic mothers).
p.(None): A project may also involve a risk of discrimination against an entire population, because of the way its
p.(None): results will be interpreted (for example, determination of statistically poorer results on several intelligence tests
p.(None): among blacks than among whites).
p.(None):
p.(None): In the United States at the end of the sixties, the interest in a " science for the people" caused some investigations
p.(None): to be stopped, on the grounds that their theoretical implications were slanderous for certain categories of
p.(None): individuals. There is even reference to attempts to force researchers to " revise" their conclusions, and/or to publish
p.(None): only expurgated results.
p.(None):
p.(None): The discrimination risk is a function of the social level of tolerance of a given " difference" . One could propose
p.(None): the following rule: the discrimination risks must be identified, and weighed in the balance against the
p.(None): collective interest, and the theoretical interest of obtaining the expected result.
p.(None):
p.(None): - Should promoters of behavioural research take out insurance to cover the risks, to which research subjects are
p.(None): exposed because of the investigation?
p.(None):
p.(None): In biomedical research, French law obligates the promoter to take out insurance (Article L.209-7),
p.(None): guaranteeing his third-party liability, in the event of damaging consequences of the research for the consenting
...
p.(None):
p.(None): and State in the Human Experimentation Process, New York: Russell Sage Foundation.
p.(None):
p.(None): Levine Carol (1982), Former soldier denied compensation for damage in army LSD tests, IRB, 4(3):7.
p.(None):
p.(None): Levine Robert J. (1986), Ethics and Regulation of Clinical Research, Baltimore-Munich: Urban & Schwarzenberg,
p.(None):
p.(None): 2nd edition.
p.(None):
p.(None): Macklin Ruth (1989), The paradoxical case of payment as benefit to research subjects, IRB, 11(6):1-3.
p.(None):
p.(None): Marini James L. (1980), Methodology and ethics: research on human agression, IRB, 2(5):1-4.
p.(None):
p.(None): Mead Margaret (1969), Research with human beings: a model derived from anthropological field practice,
p.(None):
p.(None): Daedalus, 98: 361-386.
p.(None):
p.(None): Meyer Roger E. (1977), Subjects' rights, freedom of inquiry, and the future of research in the addictions,
p.(None):
p.(None): Am J Psychiatry, 134(8):899-903.
p.(None):
p.(None): Menard Joël (1990), Rapport du groupe de réflexion INSERM sur certains aspects de la protection des sujets
p.(None): volontaires sains et des personnes qui se prêtent à des recherches bio- médicales, Paris: INSERM.
p.(None):
p.(None): National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research
p.(None): Involving Prisoners: Report and Recommendations, and Appendix (1976). Research Involving Children: Report
p.(None):
p.(None): and Recommendations, and Appendix (1977). Research Involving Those Institutionalized as Mentally Infirm: Report and
p.(None): Recommendations, and Appendix (1978). The Belmont Report: Ethical Principles and Guidelines for Research
p.(None): Involving Human Subjects (1978),
p.(None):
p.(None): Washington D.C.: US Govt Printing Office (DHEW) French translation in: Médecine et expérimentation (1982),
p.(None): Cahiers de bioéthique, 4, Québec: Presses de l'Université Laval, 233-250.
p.(None):
p.(None): Newton Lisa H. (1982), Dentists and pseudo-patients: further meditations on deception in research, IRB, 4(8):6-8.
p.(None):
p.(None): Park L.C., Covi L., Uhlenhuth E.H. (1967), Effects of informed consent on research patients and study results,
p.(None):
p.(None): J Nerv Ment Dis, 145: 349-357.
p.(None):
p.(None): Pattulo E.L. (1980), Who risks what in social research?, IRB, 2(3):1-3,12.
p.(None):
p.(None): Queheillard Jean-Louis (1989), Secret professionnel, le grand oublié ?, Psychologues et psychologies, N° 89.
p.(None):
p.(None): Redlich Fritz (1973), The anthropologist as observer; ethical aspects of clinical observations of behavior,
p.(None):
p.(None): J Nerv Ment Dis, 157: 313-319.
p.(None):
p.(None): Robertson John A. (1981), Ethical review of social experiments, IRB, 3(7):10-11.
p.(None):
p.(None): Royal College of Physicians (1986), 'Research on healthy volunteers', J Roy Coll Physicians, London, 20: 243-257.
p.(None):
...
Social / Educational
Searching for indicator education:
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p.(None): 17th 1992 of an article in the weekly L'Express .
p.(None):
p.(None): The CCNE set up a working group.
p.(None):
p.(None): This group familiarized itself with the great variety of research done at the CNRS in the human
p.(None): sciences. For psychology alone, about fifteen research units (mostly Applied Research Units), representing
p.(None): 150 researchers and about 200 teaching researchers, are grouped together in Section 29, called " Mental
p.(None): functions, integrative neurosciences and behaviours" , and co-managed by the Life Sciences Department and the Human
p.(None): and Social Sciences Department. The objective of this research is " to understand the skills and the performances of
p.(None): the human being in the course of different periods of his life, in habitual situations as well as in exceptional
p.(None): circumstances" . The methods range from simple observation in a natural or standardised situation, to
p.(None): tests of reactions in " extreme situations" . The subjects are recruited on a volunteer basis. The identified
p.(None): subdisciplines are: psychology of the child and of development, social psychology, cognitive psychology, psychology of
p.(None): work, ergonomics, psycholinguistics, psychopathology, clinical psychology, neuropsychology, psychopharmacology.
p.(None): There is frequent interface with neighbouring disciplines: anthropology, neurosciences, psychiatry,
p.(None): linguistics, sociology, education sciences, artificial intelligence, etc.
p.(None):
p.(None): The working group met approximately once per month between January and June 1993. It met with the Operational
p.(None): committee for ethics in the life sciences of the CNRS (COPÉ, January 22th 1993). It heard from several
p.(None): researchers. It gathered information on problems specific to research in human sciences, on professional codes of
p.(None): ethics, and on the way in which experimental human sciences investigations with human subjects are organized
p.(None): in other countries.
p.(None):
p.(None): The CCNE notes that in France, since the " Law on the protection of subjects in biomedical research" of December 20th
p.(None): 1988, " trials or experiments organised with and practised on human subjects, with a view to increasing
p.(None): biological or medical knowledge" take place within a precise and constraining legal framework. On the other hand,
p.(None): the legislator has not brought his attention to bear on the protection of persons who consent to
p.(None): behavioural research, and investigations with human subjects, that aim to develop knowledge in the
p.(None): disciplines collectively known as the " human sciences" , have been left in a fuzzy legal situation.
p.(None):
p.(None): The CCNE hereinafter recapitulates:
p.(None):
p.(None): - the ethical principles that must guide any investigation with human subjects,
p.(None):
p.(None): - the particular problems it has identified in the case of behavioural research, and the approaches or
p.(None): solutions it proposes.
...
p.(None):
p.(None): French experience prior to law N° 88-1138 of December 20th 1988 (for example, the Assistance
p.(None): Publique-Hôpitaux de Paris), as well as the North American model, would point in the direction of creating " Ethics
p.(None): Committees for Human Sciences Research" at institutions that actually engage in behavioural research with human
p.(None): subjects: CNRS, universities. According to R.J. Levine (1986), these Committees are " the conscience of the
p.(None): institution" , and an expression of its interest in ensuring that its research is of high quality, and that the persons
p.(None): who consent to it are adequately protected. Rules concerning the composition of these committees (which should include
p.(None): a certain proportion of members from outside the institution, and/or outside human sciences, for example, lawyers,
p.(None): philosophers, physicians) could be drawn up by a joint commission (CNRS, universities, CCNE, ministries and
p.(None): professional organizations). A procedure for entitling these committees could be determined by a text of the Minister
p.(None): of Research. This would probably be a provisional solution, but one that could be implemented rather quickly.
p.(None):
p.(None): In the French context, it seems difficult to imagine a longer term solution other than that of legislative constitution
p.(None): of several regional CCPPRCs on the model of the CCPPRBs , but with a composition giving them the expertise required to
p.(None): review research protocols with human subjects in the human sciences other than the biomedical: anthropology, ethnology,
p.(None): various branches of psychology, sociology, linguistics, history, education sciences, etc. This is the business of the
p.(None): legislator.
p.(None):
p.(None): Any file submitted to a CCPPRC should provide the following information, as a minimum: 1) the research objectives and
p.(None): the working hypotheses; 2) the study's target population and the ways in which subjects are to be recruited (including
p.(None): the text of any advertisements) 3) the detailed methodology; 4) steps taken to ensure anonymity of collected
p.(None): data, their storage and access to them for consultation; 5) evaluation of the risks, costs, constraints and potential
p.(None): benefits; 6) presentation of information to persons participating in the study, and the modalities of their consent,
p.(None): including the study presentation document distributed to such people, and the consent form (consent to the study, and,
p.(None): as appropriate, to the use of results).
p.(None):
p.(None): References
p.(None):
p.(None): American Psychological Association (1986), Ethical issues in psychological research in AIDS,
p.(None): Committee
p.(None):
p.(None): for the protection of human participants in research, IRB, 8(4):8-10.
p.(None):
p.(None): Barber B. (1976), The ethics of experimentation with human subjects, Scientific American, 234(2):25-31.
p.(None):
p.(None): Baumrind Diana (1979), IRBs and social science research: the costs of deception, IRB, 1(6):1-4.
p.(None):
p.(None): Bourdieu Pierre, ed. (1993), La misère du monde, Paris: Seuil.
p.(None):
...
Searching for indicator educational:
(return to top)
p.(None): passing an examination, career advantage, affective blackmail, etc.).
p.(None):
p.(None): Moreover, consent for the research is revocable. Subjects must be informed that they may cease to participate, at any
p.(None): time, without incurring any penalty or reproach.
p.(None):
p.(None): Safety. The human cost
p.(None):
p.(None): In biomedical research, it is accepted that certain research protocols may involve a " direct individual benefit "
p.(None): (Article L.209-1) for consenting persons. This concept of (potential) benefit for the subject serves, in
p.(None): medicine, to authorize the inclusion in research protocols, but under certain conditions (Article L.209-6), persons
p.(None): whose consent is dubious or even impossible (minors, adults under guardianship, persons residing in a public health or
p.(None): social institution, patients in an emergency situation).
p.(None):
p.(None): In behavioural research, there may also be cases of investigations " with direct individual benefit" , for example,
p.(None): in clinical psychology, in the case of a comparative study of two psychotherapeutic methods (if the
p.(None): benefit for consenting subjects of at least one of the methods is established), or in cognitive psychology (if
p.(None): the fact that children consent to a study gives them an educational advantage, as was stated in the CNRS file regarding
p.(None): the Lautrey protocol). But given the absence of vital emergencies that obligate the practitioner to intervene, and
p.(None): given how difficult it is to argue that research is done " for the good" of included subjects, or " in the interest of
p.(None): their health" , the " with/without direct individual benefit" distinction is not sufficiently applicable to behavioural
p.(None): research, to justify relaxing the consent conditions, even in the case of applied research. This distinction is
p.(None): applicable only within the framework of the risk-advantage balance.
p.(None):
p.(None): In its report of 1990, the CCNE noted that, as a general rule, persons who consent to an investigation, whose objective
p.(None): is gaining knowledge about human beings, do not see this as to their personal advantage. The CCNE considered this to be
p.(None): admisible, " provided there is
p.(None):
p.(None): an acceptable risk-advantage balance, that is, a definite advantage for the community, and a zero or minimal risk for
p.(None): the individual" (p. 70).
p.(None):
p.(None): To assess the risk-advantage balance means to ask whether the risks, constraints or discomfort imposed on
p.(None): the subjects (" human cost" ) are sufficiently justified by the scientific significance of the question
p.(None): posed, and by the assurance that the suggested protocol will serve to resolve this question.
p.(None):
...
Social / Elderly
Searching for indicator elderly:
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p.(None):
p.(None): References
p.(None):
p.(None): American Psychological Association (1986), Ethical issues in psychological research in AIDS,
p.(None): Committee
p.(None):
p.(None): for the protection of human participants in research, IRB, 8(4):8-10.
p.(None):
p.(None): Barber B. (1976), The ethics of experimentation with human subjects, Scientific American, 234(2):25-31.
p.(None):
p.(None): Baumrind Diana (1979), IRBs and social science research: the costs of deception, IRB, 1(6):1-4.
p.(None):
p.(None): Bourdieu Pierre, ed. (1993), La misère du monde, Paris: Seuil.
p.(None):
p.(None): Medical Research Council of Canada (1986),Lignes directrices concernant la recherche sur des sujets humains, Ottawa.
p.(None):
p.(None): Cupples Brian & Gochnauer Myron (1985), The investigator's duty not to deceive, IRB,
p.(None):
p.(None): 7(5):1-6.
p.(None):
p.(None): De Sola Pool Ithiel (1983), Do social scientists have unlimited research rights?, IRB, 5(6):10.
p.(None):
p.(None): Desportes Jean-Pierre (1974), Les manipulations du comportement, La Recherche, 47: 654- 661.
p.(None):
p.(None): Fagot-Largeault A. (1985),L'homme bio-éthique. Pour une déontologie de la recherche sur le vivant, Paris: Maloine.
p.(None):
p.(None): Gordis Leon & Gold Ellen (1980), Privacy, confidentiality, and the use of medical records in research, Science, 207:
p.(None): 153-156.
p.(None):
p.(None): Gosselin Gabriel (1992), Une éthique des sciences sociales, Paris: L'Harmattan.
p.(None):
p.(None): Harris S.L. et al. (1977), Behavior modification therapy with elderly demented patients: implementation and
p.(None): ethical considerations, J Chron Dis, 30: 129-134.
p.(None):
p.(None): Katz Jay (1972), Experimentation with Human Beings? The Authority of the Investigator,
p.(None): Subject, Professions
p.(None):
p.(None): and State in the Human Experimentation Process, New York: Russell Sage Foundation.
p.(None):
p.(None): Levine Carol (1982), Former soldier denied compensation for damage in army LSD tests, IRB, 4(3):7.
p.(None):
p.(None): Levine Robert J. (1986), Ethics and Regulation of Clinical Research, Baltimore-Munich: Urban & Schwarzenberg,
p.(None):
p.(None): 2nd edition.
p.(None):
p.(None): Macklin Ruth (1989), The paradoxical case of payment as benefit to research subjects, IRB, 11(6):1-3.
p.(None):
p.(None): Marini James L. (1980), Methodology and ethics: research on human agression, IRB, 2(5):1-4.
p.(None):
p.(None): Mead Margaret (1969), Research with human beings: a model derived from anthropological field practice,
p.(None):
p.(None): Daedalus, 98: 361-386.
p.(None):
p.(None): Meyer Roger E. (1977), Subjects' rights, freedom of inquiry, and the future of research in the addictions,
p.(None):
p.(None): Am J Psychiatry, 134(8):899-903.
p.(None):
p.(None): Menard Joël (1990), Rapport du groupe de réflexion INSERM sur certains aspects de la protection des sujets
p.(None): volontaires sains et des personnes qui se prêtent à des recherches bio- médicales, Paris: INSERM.
p.(None):
...
Social / Ethnicity
Searching for indicator ethnic:
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p.(None): the subjects (" human cost" ) are sufficiently justified by the scientific significance of the question
p.(None): posed, and by the assurance that the suggested protocol will serve to resolve this question.
p.(None):
p.(None): In behavioural research, apart from the need explicitly to evaluate physical risk, one must pay particular attention
p.(None): to the psychological risks of experiments, and to their possible consequences (no humiliating, degrading or
p.(None): traumatizing experiments).
p.(None):
p.(None): Justice. Human dignity
p.(None):
p.(None): In biomedical research, the principle of justice serves primarily to recall, that scientific research must
p.(None): never involve exploitation (for example, exploitation by researchers in developed countries of poor
p.(None): populations in developing countries, which serve as " guinea pigs" for the acquisition of knowledge, whose therapeutic
p.(None): spin-offs are of benefit mainly to populations in rich countries: see WHO-CIOMS, 1982). It then serves to recall, as
p.(None): the CCNE has done in its 1990 Report (p. 72), that participation in a research protocol calls for " fair indemnity "
p.(None): or " compensation" for the subjects, but to the exclusion of any remuneration.
p.(None):
p.(None): In behavioural research, cases of (North-South) exploitation have been brought (in ethnology, in
p.(None): anthropology), but in the background there was usually a problem of ethnic or cultural discrimination (attitude of
p.(None): the " developed" to the " savage" ). Clear risks of discrimination have been raised in the case of
p.(None): investigation of distinctive characteristics, that are a source of social worth or the opposite ("
p.(None): intelligence quotient" , " crime chromosome" , etc.). On the other hand, the practice in
p.(None): behavioural research of remunerating subjects (for example, on a fee basis) has not given rise to many objections
p.(None): as yet. There are salaried professionals (test pilots, underwater divers) who accept being guinea pigs in the
p.(None): exercise of their profession. Conversely, many volunteers are not indemnified (when their contribution is
p.(None): minimal, or when, as in the case of students, they receive an intellectual or didactic benefit). Therefore, it
p.(None): cannot be said either that all volunteers should be indemnified, or that any remuneration is contrary to ethical
p.(None): principles.
p.(None):
p.(None): From the point of view of equity, the central problem in behavioural research seems to be the problem of possible
p.(None): discrimination, whether connected with the research protocol itself, or with the research results and the way they are
p.(None): understood and utilised (socio-cultural " spin-offs" ).
p.(None):
p.(None): Ethical review by "independent" bodies
p.(None):
p.(None): In the case of biomedical research, French law submits to review by CCPPRBs any " trials or experiments" . It exempts "
...
Social / Homeless Persons
Searching for indicator homeless:
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p.(None): in residential institutions, soldiers).
p.(None):
p.(None): - For minors and adults under guardianship , the rule accepted in biomedical research (L.209-10) can be
p.(None): generalized: consent of the parents or legal guardians, information given to the child or disabled person to the
p.(None): greatest extent possible, respect for the child's or disabled person's possible refusal.
p.(None):
p.(None): - For institutionalised captive populations (prison inmates, pupils, adolescents in reform schools, young
p.(None): people in residential institutions), the usual rule is to assess the project as admissible, only when it is (1) "
p.(None): minimal risk" and (2) non-discriminatory. Consent must be obtained both from the responsible officials of the
p.(None): institution, and from each subject individually (if the subjects are minors, from the person who exercises parental
p.(None): authority).
p.(None):
p.(None): - The use of " rewards" must be looked at very closely at the time of ethical review (for example, recruitment of
p.(None): homeless or native people as research subjects by offering them alcohol).
p.(None):
p.(None): - In so far as inmates are concerned, the law of December 20th 1988 prohibits research without direct individual
p.(None): benefit, when the persons concerned are deprived of their freedom. In the behavioural sciences, such research can be
p.(None): harmless for the persons concerned, and socially useful, or even necessary; therefore they cannot be prohibited
p.(None): without individual review.
p.(None):
p.(None): - How can one reconcile the obligation of consent, that is to be informed , with the methodological
p.(None): necessity (which can arise in the case of certain experimental protocols ) of not saying everything ?
p.(None):
p.(None): This is a question that has arisen with regard to biomedical research, but it is particularly relevant in psychology,
p.(None): social psychology(5), and research of sports performances.
p.(None):
p.(None): The Canadian Medical Research Council has dealt with this issue as follows:
p.(None):
p.(None): Deception (6)
p.(None):
p.(None): " ... Given the critical importance of free and informed consent, it seems incongruous to take up the issue of
p.(None): deception.
p.(None):
p.(None): " Deception means deliberately providing potential subjects with erroneous information, or
p.(None):
p.(None): concealing information from them, with a view to having them believe that the research objectives, or
p.(None): the procedure to be followed, are different from what they are in reality. Deception can also consist
...
Social / Incarcerated
Searching for indicator prison:
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p.(None): D. Widl\'9acher has quite rightly pointed out, there are " quite innocent experiments" and potentially traumatizing
p.(None): observations.
p.(None):
p.(None): Problems specific to behavioural research, as identified from the protocols submitted by the CNRS
p.(None): Consent
p.(None):
p.(None): - Under what conditions is behavioural research admissible, when the subjects have a problematic ability to
p.(None): give consent (limited competence, dependence)?
p.(None):
p.(None): The general rule is that persons, whose consent is dubious, should be protected against the possibility of serving as
p.(None): research " subjects" , in a manner proportionate to their incapacity and their dependence.
p.(None):
p.(None): Some of the vulnerable categories, requiring special protection in behavioural research, are: children, the mentally
p.(None): infirm, persons easily manipulable because of their own weakness or dependence (for example, drug addicts),
p.(None): captive institutionalized populations (prison inmates, pupils, adolescents in reform schools, young people
p.(None): in residential institutions, soldiers).
p.(None):
p.(None): - For minors and adults under guardianship , the rule accepted in biomedical research (L.209-10) can be
p.(None): generalized: consent of the parents or legal guardians, information given to the child or disabled person to the
p.(None): greatest extent possible, respect for the child's or disabled person's possible refusal.
p.(None):
p.(None): - For institutionalised captive populations (prison inmates, pupils, adolescents in reform schools, young
p.(None): people in residential institutions), the usual rule is to assess the project as admissible, only when it is (1) "
p.(None): minimal risk" and (2) non-discriminatory. Consent must be obtained both from the responsible officials of the
p.(None): institution, and from each subject individually (if the subjects are minors, from the person who exercises parental
p.(None): authority).
p.(None):
p.(None): - The use of " rewards" must be looked at very closely at the time of ethical review (for example, recruitment of
p.(None): homeless or native people as research subjects by offering them alcohol).
p.(None):
p.(None): - In so far as inmates are concerned, the law of December 20th 1988 prohibits research without direct individual
p.(None): benefit, when the persons concerned are deprived of their freedom. In the behavioural sciences, such research can be
p.(None): harmless for the persons concerned, and socially useful, or even necessary; therefore they cannot be prohibited
p.(None): without individual review.
p.(None):
p.(None): - How can one reconcile the obligation of consent, that is to be informed , with the methodological
p.(None): necessity (which can arise in the case of certain experimental protocols ) of not saying everything ?
p.(None):
p.(None): This is a question that has arisen with regard to biomedical research, but it is particularly relevant in psychology,
...
Social / Institutionalized
Searching for indicator institutionalized:
(return to top)
p.(None): for in fact, as
p.(None):
p.(None): D. Widl\'9acher has quite rightly pointed out, there are " quite innocent experiments" and potentially traumatizing
p.(None): observations.
p.(None):
p.(None): Problems specific to behavioural research, as identified from the protocols submitted by the CNRS
p.(None): Consent
p.(None):
p.(None): - Under what conditions is behavioural research admissible, when the subjects have a problematic ability to
p.(None): give consent (limited competence, dependence)?
p.(None):
p.(None): The general rule is that persons, whose consent is dubious, should be protected against the possibility of serving as
p.(None): research " subjects" , in a manner proportionate to their incapacity and their dependence.
p.(None):
p.(None): Some of the vulnerable categories, requiring special protection in behavioural research, are: children, the mentally
p.(None): infirm, persons easily manipulable because of their own weakness or dependence (for example, drug addicts),
p.(None): captive institutionalized populations (prison inmates, pupils, adolescents in reform schools, young people
p.(None): in residential institutions, soldiers).
p.(None):
p.(None): - For minors and adults under guardianship , the rule accepted in biomedical research (L.209-10) can be
p.(None): generalized: consent of the parents or legal guardians, information given to the child or disabled person to the
p.(None): greatest extent possible, respect for the child's or disabled person's possible refusal.
p.(None):
p.(None): - For institutionalised captive populations (prison inmates, pupils, adolescents in reform schools, young
p.(None): people in residential institutions), the usual rule is to assess the project as admissible, only when it is (1) "
p.(None): minimal risk" and (2) non-discriminatory. Consent must be obtained both from the responsible officials of the
p.(None): institution, and from each subject individually (if the subjects are minors, from the person who exercises parental
p.(None): authority).
p.(None):
p.(None): - The use of " rewards" must be looked at very closely at the time of ethical review (for example, recruitment of
...
p.(None):
p.(None): Levine Robert J. (1986), Ethics and Regulation of Clinical Research, Baltimore-Munich: Urban & Schwarzenberg,
p.(None):
p.(None): 2nd edition.
p.(None):
p.(None): Macklin Ruth (1989), The paradoxical case of payment as benefit to research subjects, IRB, 11(6):1-3.
p.(None):
p.(None): Marini James L. (1980), Methodology and ethics: research on human agression, IRB, 2(5):1-4.
p.(None):
p.(None): Mead Margaret (1969), Research with human beings: a model derived from anthropological field practice,
p.(None):
p.(None): Daedalus, 98: 361-386.
p.(None):
p.(None): Meyer Roger E. (1977), Subjects' rights, freedom of inquiry, and the future of research in the addictions,
p.(None):
p.(None): Am J Psychiatry, 134(8):899-903.
p.(None):
p.(None): Menard Joël (1990), Rapport du groupe de réflexion INSERM sur certains aspects de la protection des sujets
p.(None): volontaires sains et des personnes qui se prêtent à des recherches bio- médicales, Paris: INSERM.
p.(None):
p.(None): National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research
p.(None): Involving Prisoners: Report and Recommendations, and Appendix (1976). Research Involving Children: Report
p.(None):
p.(None): and Recommendations, and Appendix (1977). Research Involving Those Institutionalized as Mentally Infirm: Report and
p.(None): Recommendations, and Appendix (1978). The Belmont Report: Ethical Principles and Guidelines for Research
p.(None): Involving Human Subjects (1978),
p.(None):
p.(None): Washington D.C.: US Govt Printing Office (DHEW) French translation in: Médecine et expérimentation (1982),
p.(None): Cahiers de bioéthique, 4, Québec: Presses de l'Université Laval, 233-250.
p.(None):
p.(None): Newton Lisa H. (1982), Dentists and pseudo-patients: further meditations on deception in research, IRB, 4(8):6-8.
p.(None):
p.(None): Park L.C., Covi L., Uhlenhuth E.H. (1967), Effects of informed consent on research patients and study results,
p.(None):
p.(None): J Nerv Ment Dis, 145: 349-357.
p.(None):
p.(None): Pattulo E.L. (1980), Who risks what in social research?, IRB, 2(3):1-3,12.
p.(None):
p.(None): Queheillard Jean-Louis (1989), Secret professionnel, le grand oublié ?, Psychologues et psychologies, N° 89.
p.(None):
p.(None): Redlich Fritz (1973), The anthropologist as observer; ethical aspects of clinical observations of behavior,
p.(None):
p.(None): J Nerv Ment Dis, 157: 313-319.
p.(None):
p.(None): Robertson John A. (1981), Ethical review of social experiments, IRB, 3(7):10-11.
p.(None):
p.(None): Royal College of Physicians (1986), 'Research on healthy volunteers', J Roy Coll Physicians, London, 20: 243-257.
p.(None):
p.(None): Schafer Arthur (1981), The ethics of research on human beings; a critical review of the issues and
p.(None): arguments,
p.(None):
...
Social / Mothers
Searching for indicator mothers:
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p.(None):
p.(None): discriminating characteristics is a plausible research objective. For instance, it is of interest, and of importance
p.(None): for the evaluation of assisted maternity techniques, to ask whether there is a significance difference between the
p.(None): cognitive development of children born of artificial insemination and other children (CNRS file, Duyme project). But if
p.(None): one finds that artificial insemination children develop less well than the others, and if such research
p.(None): results are made public, then children already born through artificial insemination (or their parents) are put in a
p.(None): difficult situation, even if confidentiality of origins is well protected (the danger of guilt feelings).
p.(None):
p.(None): In the case of the Duyme protocol, all precautions were taken to ensure that the research would not be a source of
p.(None): discrimination through its methodology.
p.(None):
p.(None): Apart from the methodology, a research project may involve explicit or implicit risk of discrimination
p.(None): against individuals, because of the hypotheses on which it is based (for example, experimentation with "
p.(None): aversion therapies" to treat homosexuals, or psychosocial follow-up of a cohort of children born to alcoholic mothers).
p.(None): A project may also involve a risk of discrimination against an entire population, because of the way its
p.(None): results will be interpreted (for example, determination of statistically poorer results on several intelligence tests
p.(None): among blacks than among whites).
p.(None):
p.(None): In the United States at the end of the sixties, the interest in a " science for the people" caused some investigations
p.(None): to be stopped, on the grounds that their theoretical implications were slanderous for certain categories of
p.(None): individuals. There is even reference to attempts to force researchers to " revise" their conclusions, and/or to publish
p.(None): only expurgated results.
p.(None):
p.(None): The discrimination risk is a function of the social level of tolerance of a given " difference" . One could propose
p.(None): the following rule: the discrimination risks must be identified, and weighed in the balance against the
p.(None): collective interest, and the theoretical interest of obtaining the expected result.
p.(None):
p.(None): - Should promoters of behavioural research take out insurance to cover the risks, to which research subjects are
p.(None): exposed because of the investigation?
p.(None):
p.(None): In biomedical research, French law obligates the promoter to take out insurance (Article L.209-7),
p.(None): guaranteeing his third-party liability, in the event of damaging consequences of the research for the consenting
p.(None): person. It is known that this provision of the law cause no problems, when the promoter is the pharmaceutical industry,
...
Social / Social
Searching for indicator social:
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p.(None): the ethical and legal framework, in which it seems desirable that experimental investigations into human
p.(None): behaviour be conducted in the future.
p.(None):
p.(None): Report
p.(None): By a letter dated January 15th 1993 to the Chairman of the National Consultative Ethics Committee for Health and
p.(None): Life Sciences (CCNE), the Director of the Life Sciences Department of the Centre national de la recherche
p.(None): scientifique (CNRS) submitted five files, for the CCNE's opinion, describing psychology research carried out in
p.(None): university laboratories supported by the CNRS, or carried out in part by CNRS researchers, together with an overall
p.(None): description of psychology research at the CNRS. Among the five files in question, which had been approved by the
p.(None): competent scientific commission of the CNRS, two (the Duyme and Carlier files(2)) relate to the laboratory headed by
p.(None): Professor Roubertoux, and correspond to research that was interrupted, following the appearance on December
p.(None): 17th 1992 of an article in the weekly L'Express .
p.(None):
p.(None): The CCNE set up a working group.
p.(None):
p.(None): This group familiarized itself with the great variety of research done at the CNRS in the human
p.(None): sciences. For psychology alone, about fifteen research units (mostly Applied Research Units), representing
p.(None): 150 researchers and about 200 teaching researchers, are grouped together in Section 29, called " Mental
p.(None): functions, integrative neurosciences and behaviours" , and co-managed by the Life Sciences Department and the Human
p.(None): and Social Sciences Department. The objective of this research is " to understand the skills and the performances of
p.(None): the human being in the course of different periods of his life, in habitual situations as well as in exceptional
p.(None): circumstances" . The methods range from simple observation in a natural or standardised situation, to
p.(None): tests of reactions in " extreme situations" . The subjects are recruited on a volunteer basis. The identified
p.(None): subdisciplines are: psychology of the child and of development, social psychology, cognitive psychology, psychology of
p.(None): work, ergonomics, psycholinguistics, psychopathology, clinical psychology, neuropsychology, psychopharmacology.
p.(None): There is frequent interface with neighbouring disciplines: anthropology, neurosciences, psychiatry,
p.(None): linguistics, sociology, education sciences, artificial intelligence, etc.
p.(None):
p.(None): The working group met approximately once per month between January and June 1993. It met with the Operational
p.(None): committee for ethics in the life sciences of the CNRS (COPÉ, January 22th 1993). It heard from several
p.(None): researchers. It gathered information on problems specific to research in human sciences, on professional codes of
p.(None): ethics, and on the way in which experimental human sciences investigations with human subjects are organized
p.(None): in other countries.
p.(None):
p.(None): The CCNE notes that in France, since the " Law on the protection of subjects in biomedical research" of December 20th
p.(None): 1988, " trials or experiments organised with and practised on human subjects, with a view to increasing
p.(None): biological or medical knowledge" take place within a precise and constraining legal framework. On the other hand,
p.(None): the legislator has not brought his attention to bear on the protection of persons who consent to
p.(None): behavioural research, and investigations with human subjects, that aim to develop knowledge in the
...
p.(None): had time to reflect before making his choice known. For the information to be sufficient, the law of December
p.(None): 20th 1988 specifies that the investigator must make known to the subject:
p.(None):
p.(None): - the research objectives, methodology and duration,
p.(None):
p.(None): - the expected benefits, and the foreseeable constraints and risks, even when the research is halted before its planned
p.(None): ending date,
p.(None):
p.(None): - the opinion of a CCPPRC.
p.(None): - The consent is free if the investigator abstains from all forms pressure, coercion and strong incentive (money,
p.(None): passing an examination, career advantage, affective blackmail, etc.).
p.(None):
p.(None): Moreover, consent for the research is revocable. Subjects must be informed that they may cease to participate, at any
p.(None): time, without incurring any penalty or reproach.
p.(None):
p.(None): Safety. The human cost
p.(None):
p.(None): In biomedical research, it is accepted that certain research protocols may involve a " direct individual benefit "
p.(None): (Article L.209-1) for consenting persons. This concept of (potential) benefit for the subject serves, in
p.(None): medicine, to authorize the inclusion in research protocols, but under certain conditions (Article L.209-6), persons
p.(None): whose consent is dubious or even impossible (minors, adults under guardianship, persons residing in a public health or
p.(None): social institution, patients in an emergency situation).
p.(None):
p.(None): In behavioural research, there may also be cases of investigations " with direct individual benefit" , for example,
p.(None): in clinical psychology, in the case of a comparative study of two psychotherapeutic methods (if the
p.(None): benefit for consenting subjects of at least one of the methods is established), or in cognitive psychology (if
p.(None): the fact that children consent to a study gives them an educational advantage, as was stated in the CNRS file regarding
p.(None): the Lautrey protocol). But given the absence of vital emergencies that obligate the practitioner to intervene, and
p.(None): given how difficult it is to argue that research is done " for the good" of included subjects, or " in the interest of
p.(None): their health" , the " with/without direct individual benefit" distinction is not sufficiently applicable to behavioural
p.(None): research, to justify relaxing the consent conditions, even in the case of applied research. This distinction is
p.(None): applicable only within the framework of the risk-advantage balance.
p.(None):
p.(None): In its report of 1990, the CCNE noted that, as a general rule, persons who consent to an investigation, whose objective
p.(None): is gaining knowledge about human beings, do not see this as to their personal advantage. The CCNE considered this to be
...
p.(None): to the psychological risks of experiments, and to their possible consequences (no humiliating, degrading or
p.(None): traumatizing experiments).
p.(None):
p.(None): Justice. Human dignity
p.(None):
p.(None): In biomedical research, the principle of justice serves primarily to recall, that scientific research must
p.(None): never involve exploitation (for example, exploitation by researchers in developed countries of poor
p.(None): populations in developing countries, which serve as " guinea pigs" for the acquisition of knowledge, whose therapeutic
p.(None): spin-offs are of benefit mainly to populations in rich countries: see WHO-CIOMS, 1982). It then serves to recall, as
p.(None): the CCNE has done in its 1990 Report (p. 72), that participation in a research protocol calls for " fair indemnity "
p.(None): or " compensation" for the subjects, but to the exclusion of any remuneration.
p.(None):
p.(None): In behavioural research, cases of (North-South) exploitation have been brought (in ethnology, in
p.(None): anthropology), but in the background there was usually a problem of ethnic or cultural discrimination (attitude of
p.(None): the " developed" to the " savage" ). Clear risks of discrimination have been raised in the case of
p.(None): investigation of distinctive characteristics, that are a source of social worth or the opposite ("
p.(None): intelligence quotient" , " crime chromosome" , etc.). On the other hand, the practice in
p.(None): behavioural research of remunerating subjects (for example, on a fee basis) has not given rise to many objections
p.(None): as yet. There are salaried professionals (test pilots, underwater divers) who accept being guinea pigs in the
p.(None): exercise of their profession. Conversely, many volunteers are not indemnified (when their contribution is
p.(None): minimal, or when, as in the case of students, they receive an intellectual or didactic benefit). Therefore, it
p.(None): cannot be said either that all volunteers should be indemnified, or that any remuneration is contrary to ethical
p.(None): principles.
p.(None):
p.(None): From the point of view of equity, the central problem in behavioural research seems to be the problem of possible
p.(None): discrimination, whether connected with the research protocol itself, or with the research results and the way they are
p.(None): understood and utilised (socio-cultural " spin-offs" ).
p.(None):
p.(None): Ethical review by "independent" bodies
p.(None):
p.(None): In the case of biomedical research, French law submits to review by CCPPRBs any " trials or experiments" . It exempts "
p.(None): studies" (research work done only on paper, or with samples collected independently of the study, for example, taken
p.(None): from a blood bank).
p.(None):
p.(None): The American federal directives (DHHS, 1981) set out three categories of research with human subjects:
...
p.(None): people in residential institutions), the usual rule is to assess the project as admissible, only when it is (1) "
p.(None): minimal risk" and (2) non-discriminatory. Consent must be obtained both from the responsible officials of the
p.(None): institution, and from each subject individually (if the subjects are minors, from the person who exercises parental
p.(None): authority).
p.(None):
p.(None): - The use of " rewards" must be looked at very closely at the time of ethical review (for example, recruitment of
p.(None): homeless or native people as research subjects by offering them alcohol).
p.(None):
p.(None): - In so far as inmates are concerned, the law of December 20th 1988 prohibits research without direct individual
p.(None): benefit, when the persons concerned are deprived of their freedom. In the behavioural sciences, such research can be
p.(None): harmless for the persons concerned, and socially useful, or even necessary; therefore they cannot be prohibited
p.(None): without individual review.
p.(None):
p.(None): - How can one reconcile the obligation of consent, that is to be informed , with the methodological
p.(None): necessity (which can arise in the case of certain experimental protocols ) of not saying everything ?
p.(None):
p.(None): This is a question that has arisen with regard to biomedical research, but it is particularly relevant in psychology,
p.(None): social psychology(5), and research of sports performances.
p.(None):
p.(None): The Canadian Medical Research Council has dealt with this issue as follows:
p.(None):
p.(None): Deception (6)
p.(None):
p.(None): " ... Given the critical importance of free and informed consent, it seems incongruous to take up the issue of
p.(None): deception.
p.(None):
p.(None): " Deception means deliberately providing potential subjects with erroneous information, or
p.(None):
p.(None): concealing information from them, with a view to having them believe that the research objectives, or
p.(None): the procedure to be followed, are different from what they are in reality. Deception can also consist
p.(None): in deliberately providing them with false information, in dissimulating important information, or in revealing
p.(None): only bits of information, so as to give the persons concerned an erroneous picture of the research.
p.(None):
p.(None): " As deception is diametrically contrary to the principle of respect for the individual, the Committee
p.(None): had enormous difficulty in accepting the idea, that it could sometimes be justifiable from an ethical
p.(None): point of view. But if, for one reason or another, it really is indispensable that the subjects not be made
p.(None): aware of the nature of the research, and this for reasons of scientific integrity, then one must make sure
p.(None): that the following rules are strictly adhered to:
p.(None):
p.(None): - One must never have recourse to deception, when there is another way of achieving the research objectives. The
p.(None): researcher must demonstrate, in the protocol, that there is no other way of proceeding.
p.(None):
...
p.(None): difficult situation, even if confidentiality of origins is well protected (the danger of guilt feelings).
p.(None):
p.(None): In the case of the Duyme protocol, all precautions were taken to ensure that the research would not be a source of
p.(None): discrimination through its methodology.
p.(None):
p.(None): Apart from the methodology, a research project may involve explicit or implicit risk of discrimination
p.(None): against individuals, because of the hypotheses on which it is based (for example, experimentation with "
p.(None): aversion therapies" to treat homosexuals, or psychosocial follow-up of a cohort of children born to alcoholic mothers).
p.(None): A project may also involve a risk of discrimination against an entire population, because of the way its
p.(None): results will be interpreted (for example, determination of statistically poorer results on several intelligence tests
p.(None): among blacks than among whites).
p.(None):
p.(None): In the United States at the end of the sixties, the interest in a " science for the people" caused some investigations
p.(None): to be stopped, on the grounds that their theoretical implications were slanderous for certain categories of
p.(None): individuals. There is even reference to attempts to force researchers to " revise" their conclusions, and/or to publish
p.(None): only expurgated results.
p.(None):
p.(None): The discrimination risk is a function of the social level of tolerance of a given " difference" . One could propose
p.(None): the following rule: the discrimination risks must be identified, and weighed in the balance against the
p.(None): collective interest, and the theoretical interest of obtaining the expected result.
p.(None):
p.(None): - Should promoters of behavioural research take out insurance to cover the risks, to which research subjects are
p.(None): exposed because of the investigation?
p.(None):
p.(None): In biomedical research, French law obligates the promoter to take out insurance (Article L.209-7),
p.(None): guaranteeing his third-party liability, in the event of damaging consequences of the research for the consenting
p.(None): person. It is known that this provision of the law cause no problems, when the promoter is the pharmaceutical industry,
p.(None): but that it causes problems for research carried out by university teams and/or in hospitals of modest size, which have
p.(None): trouble finding a promoter with sufficient financial depth to take out insurance. In behavioural research,
p.(None): are the large research bodies (CNRS, university laboratories) in a position to stand as research promoters?
p.(None): Without identification of the promoter, one cannot, in fact, tackle the problem of insurance in a satisfactory manner.
p.(None):
p.(None): It could be argued that, in the case of minimal risk behavioural research, the insurance is not indispensable, even
p.(None): though consideation must be given to physical risks, which, without being a direct consequence of the research
p.(None): as such, occur in the course of the research (falls, accidents during transit). One could also argue that, for
...
p.(None): various branches of psychology, sociology, linguistics, history, education sciences, etc. This is the business of the
p.(None): legislator.
p.(None):
p.(None): Any file submitted to a CCPPRC should provide the following information, as a minimum: 1) the research objectives and
p.(None): the working hypotheses; 2) the study's target population and the ways in which subjects are to be recruited (including
p.(None): the text of any advertisements) 3) the detailed methodology; 4) steps taken to ensure anonymity of collected
p.(None): data, their storage and access to them for consultation; 5) evaluation of the risks, costs, constraints and potential
p.(None): benefits; 6) presentation of information to persons participating in the study, and the modalities of their consent,
p.(None): including the study presentation document distributed to such people, and the consent form (consent to the study, and,
p.(None): as appropriate, to the use of results).
p.(None):
p.(None): References
p.(None):
p.(None): American Psychological Association (1986), Ethical issues in psychological research in AIDS,
p.(None): Committee
p.(None):
p.(None): for the protection of human participants in research, IRB, 8(4):8-10.
p.(None):
p.(None): Barber B. (1976), The ethics of experimentation with human subjects, Scientific American, 234(2):25-31.
p.(None):
p.(None): Baumrind Diana (1979), IRBs and social science research: the costs of deception, IRB, 1(6):1-4.
p.(None):
p.(None): Bourdieu Pierre, ed. (1993), La misère du monde, Paris: Seuil.
p.(None):
p.(None): Medical Research Council of Canada (1986),Lignes directrices concernant la recherche sur des sujets humains, Ottawa.
p.(None):
p.(None): Cupples Brian & Gochnauer Myron (1985), The investigator's duty not to deceive, IRB,
p.(None):
p.(None): 7(5):1-6.
p.(None):
p.(None): De Sola Pool Ithiel (1983), Do social scientists have unlimited research rights?, IRB, 5(6):10.
p.(None):
p.(None): Desportes Jean-Pierre (1974), Les manipulations du comportement, La Recherche, 47: 654- 661.
p.(None):
p.(None): Fagot-Largeault A. (1985),L'homme bio-éthique. Pour une déontologie de la recherche sur le vivant, Paris: Maloine.
p.(None):
p.(None): Gordis Leon & Gold Ellen (1980), Privacy, confidentiality, and the use of medical records in research, Science, 207:
p.(None): 153-156.
p.(None):
p.(None): Gosselin Gabriel (1992), Une éthique des sciences sociales, Paris: L'Harmattan.
p.(None):
p.(None): Harris S.L. et al. (1977), Behavior modification therapy with elderly demented patients: implementation and
p.(None): ethical considerations, J Chron Dis, 30: 129-134.
p.(None):
p.(None): Katz Jay (1972), Experimentation with Human Beings? The Authority of the Investigator,
p.(None): Subject, Professions
p.(None):
p.(None): and State in the Human Experimentation Process, New York: Russell Sage Foundation.
p.(None):
p.(None): Levine Carol (1982), Former soldier denied compensation for damage in army LSD tests, IRB, 4(3):7.
p.(None):
p.(None): Levine Robert J. (1986), Ethics and Regulation of Clinical Research, Baltimore-Munich: Urban & Schwarzenberg,
p.(None):
p.(None): 2nd edition.
p.(None):
p.(None): Macklin Ruth (1989), The paradoxical case of payment as benefit to research subjects, IRB, 11(6):1-3.
p.(None):
p.(None): Marini James L. (1980), Methodology and ethics: research on human agression, IRB, 2(5):1-4.
p.(None):
...
p.(None):
p.(None): Am J Psychiatry, 134(8):899-903.
p.(None):
p.(None): Menard Joël (1990), Rapport du groupe de réflexion INSERM sur certains aspects de la protection des sujets
p.(None): volontaires sains et des personnes qui se prêtent à des recherches bio- médicales, Paris: INSERM.
p.(None):
p.(None): National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research
p.(None): Involving Prisoners: Report and Recommendations, and Appendix (1976). Research Involving Children: Report
p.(None):
p.(None): and Recommendations, and Appendix (1977). Research Involving Those Institutionalized as Mentally Infirm: Report and
p.(None): Recommendations, and Appendix (1978). The Belmont Report: Ethical Principles and Guidelines for Research
p.(None): Involving Human Subjects (1978),
p.(None):
p.(None): Washington D.C.: US Govt Printing Office (DHEW) French translation in: Médecine et expérimentation (1982),
p.(None): Cahiers de bioéthique, 4, Québec: Presses de l'Université Laval, 233-250.
p.(None):
p.(None): Newton Lisa H. (1982), Dentists and pseudo-patients: further meditations on deception in research, IRB, 4(8):6-8.
p.(None):
p.(None): Park L.C., Covi L., Uhlenhuth E.H. (1967), Effects of informed consent on research patients and study results,
p.(None):
p.(None): J Nerv Ment Dis, 145: 349-357.
p.(None):
p.(None): Pattulo E.L. (1980), Who risks what in social research?, IRB, 2(3):1-3,12.
p.(None):
p.(None): Queheillard Jean-Louis (1989), Secret professionnel, le grand oublié ?, Psychologues et psychologies, N° 89.
p.(None):
p.(None): Redlich Fritz (1973), The anthropologist as observer; ethical aspects of clinical observations of behavior,
p.(None):
p.(None): J Nerv Ment Dis, 157: 313-319.
p.(None):
p.(None): Robertson John A. (1981), Ethical review of social experiments, IRB, 3(7):10-11.
p.(None):
p.(None): Royal College of Physicians (1986), 'Research on healthy volunteers', J Roy Coll Physicians, London, 20: 243-257.
p.(None):
p.(None): Schafer Arthur (1981), The ethics of research on human beings; a critical review of the issues and
p.(None): arguments,
p.(None):
p.(None): Res Adv Alcohol Drug Probl, 6: 471-511.
p.(None):
p.(None): Schiff Michel (1991), Les impasses de la recherche en psychologie, Psychologues et psychologies, N° 104.
p.(None):
p.(None): Schmutte Gregory T. (1980), Using students as subjects without their knowledge, IRB, 2(10):5-6.
p.(None):
p.(None): Schuler Heinz (1980), Ethische Probleme psychologischer Forschung, G\'9attingen.
p.(None):
p.(None): Sieber Joan E. (1982), How humanism and determinism differ: understanding risk in psychological research,
p.(None): IRB, 4(3):1-3,12.
p.(None):
p.(None): Sieber Joan E. (1982), Deception in social research I: Kinds of deception and the wrong they may involve,
p.(None): IRB, 4(9):1-5.
p.(None):
p.(None): Sieber Joan E. (1983), Deception in social research II: Evaluating the potential for harm or wrong, IRB, 5(1):1-6.
p.(None):
p.(None): Sieber Joan E. (1983), Deception in social research III: The nature and limits of debriefing, IRB, 5(3):1-4.
p.(None):
p.(None): Sieber Joan E. (1989), On studying the powerful (or fearing to do so): a vital role for IRBs, IRB, 11(5):1-6.
p.(None):
p.(None): St James-Robert Ian (1976), Are researchers trustworthy?, New Scientist, 171: 481-483. Thouvenin Dominique (1992),
p.(None): L'influence de la loi N° 88-1138 du 20 décembre 1988
p.(None):
p.(None): (modifié N° 90-86) sur l'organisation de la recherche, Gestions hospitalières - La recherche
p.(None): - L'hôpital, N° 320.
p.(None):
p.(None): Thouvenin Dominique (1992), Consentement et assujetissement, in: Gros & Huber, eds., Vers un anti-destin?
p.(None): Patrimoine génétique et droits de l'humanité, Paris: Editions Odile Jacob, pp. 471-478.
p.(None):
p.(None): US Dept of Health and Human Services (1981), Final regulations amending basic HHS policy for the protection of human
p.(None): research subjects, Federal Register, 26 01 81, 46(16):8366-
p.(None): 8392.
p.(None):
p.(None): Villey Raymond (1986), Histoire du secret médical, Paris: Seghers.
p.(None):
p.(None): Warwick Donald P. (1975), Deceptive research: social scientists ought to stop lying, Psychology Today, Feb:
p.(None): 38-.
p.(None):
p.(None): Académies scientifiques suisses, 22-26 March 1993, Symposium " Freedom and responsibility: Moral
p.(None): issues facing
p.(None):
p.(None): the humanities and social sciences" (Proceedings to appear). American Anthropological Association, Code of Ethics.
p.(None): Anthropologie et sociétés, Département d'anthropologie de l'Université Laval, Québec, special issue "
p.(None): Comprendre et modifié" , 1984, Vol. 8, N° 3, including a professional code of ethics.
p.(None):
p.(None): Code of Ethics of the Brazilian Association of Anthropology, adopted at its 16th meeting, Campinas (Sao Paulo),
p.(None): March 30th 1988 (" Codico de Etica" ).
p.(None):
p.(None): Current Anthropology, Chicago, Vol. IX, 5, 1968, then Vol. XI, 1, 1970, and finally Vol. XII, 1, 1971 (on the
p.(None): basis of a Symposium " On the social responsibilities in social anthropology").
p.(None):
p.(None): Journal des anthropologues, winter 1992 to spring 1993, N° 50-511, devoted to " professional ethics"
p.(None):
p.(None): and to " field experiments" (EHESS, 1 rue du 11 novembre, 92120 Montrouge).
p.(None):
p.(None): Sociétés contemporaines (IRESCO, CNRS), special issue " Ethique professionnelle" ,
p.(None): September 1991, N° 7
p.(None):
p.(None): (ethics of statisticians, geneticists, in anthropology, etc.). Sociology, November 1992, " BSA Statement of Ethical
p.(None): Practice" .
p.(None):
p.(None):
p.(None):
p.(None): Notes
p.(None):
p.(None): 1. In the following, it is accepted that speaking is a behaviour, and that the term " sciences of human behaviour"
p.(None): does not exclude clinical disciplines, such as analytically inspired psychology. This term has the advantage of
p.(None): stressing that we are dealing with research on the human being, other than biomedical research.
p.(None):
p.(None): 2. See the report drafted by Y. Laporte.
p.(None):
p.(None): 3. A Code of Ethics was adopted in 1961 (and revised in 1976) by the French Society of
p.(None):
p.(None): Psychology. It applied to members of the Society. This Code was taken over and brought up to date by the National
p.(None): Association of Organizations of Psychologists (ANOP), following " the evolution of the profession and its legislation"
p.(None): (Law of July 25th 1985). The Code of Ethics of Psychologists (1987) now applies to all French psychologists, as well as
p.(None): to students of psychology.
p.(None):
...
Social / Soldier
Searching for indicator military:
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p.(None):
p.(None): - the particular problems it has identified in the case of behavioural research, and the approaches or
p.(None): solutions it proposes.
p.(None):
p.(None): With this work having been done, the CCNE invites all human sciences researchers, scientific institutions
p.(None): that harbour human sciences research (whether the research is basic or applied), the competent administrative
p.(None): authorities, and the legislator to engage in joint reflection and broad consultation, with a view to setting out the
p.(None): ethical and legal framework, within which our society would like to see experimental investigations into human
p.(None): behaviour conducted in the future.
p.(None):
p.(None): In its report Ethique et Connaissance (Ethics and Knowledge), the CCNE writes: " seeking to gain scientific knowledge
p.(None): of the human being is a good, but this cannot be done at the expense of justice, or of the safety and
p.(None): autonomy of individuals " (p. 74, 1990).
p.(None):
p.(None): This applies to any research on human beings, just as much in the behavioural sciences as in the biomedical
p.(None): sciences. In fact, in this 1990 Report (Chapter 2), the CCNE took into consideration a whole range of
p.(None): research work at the intersection of the biomedical and behavioural domains: studies on learning, on adaptation
p.(None): to the environment and to work tasks (ergonomics), on reactions of the human organism to extreme conditions
p.(None): (hyperbaric, hypobaric, microgravitational, extreme climates, perturbation of nyctohemeral cycles, competitive
p.(None): or endurance sporting, civilian or military exploits), on the quality of life and harmful environmental effects.
p.(None):
p.(None): In France, the protection of persons who consent to biomedical research depends on law N° 88-1138 of December 20th 1988
p.(None): (amended as N° 90-86). The protection of persons who consent to behavioural research depends, for the time
p.(None): being, on the deontology of the researchers (for example, the psychologists' code of ethics(3)).
p.(None):
p.(None): The recommendations that the CCNE is going to formulate on the ethics of behavioural research must, in
p.(None): the interests of consistency, be in line with the law N° 88-1138 of December 20th 1988. The main
p.(None): principles of directives concerning research with human subjects, as formulated in the United States by the
p.(None): National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-78), or in Canada
p.(None): by the Medical Research Council (1986), and then by the National Council on Bioethics in Human Research (NCBHR), are
p.(None): the same for all such research, whether in the biomedical sciences or the human sciences, even if specific problems are
p.(None): then identified, as a function of the discipline (cancerology, psychiatry, ethnology, etc.), or for different
...
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p.(None):
p.(None): Baumrind Diana (1979), IRBs and social science research: the costs of deception, IRB, 1(6):1-4.
p.(None):
p.(None): Bourdieu Pierre, ed. (1993), La misère du monde, Paris: Seuil.
p.(None):
p.(None): Medical Research Council of Canada (1986),Lignes directrices concernant la recherche sur des sujets humains, Ottawa.
p.(None):
p.(None): Cupples Brian & Gochnauer Myron (1985), The investigator's duty not to deceive, IRB,
p.(None):
p.(None): 7(5):1-6.
p.(None):
p.(None): De Sola Pool Ithiel (1983), Do social scientists have unlimited research rights?, IRB, 5(6):10.
p.(None):
p.(None): Desportes Jean-Pierre (1974), Les manipulations du comportement, La Recherche, 47: 654- 661.
p.(None):
p.(None): Fagot-Largeault A. (1985),L'homme bio-éthique. Pour une déontologie de la recherche sur le vivant, Paris: Maloine.
p.(None):
p.(None): Gordis Leon & Gold Ellen (1980), Privacy, confidentiality, and the use of medical records in research, Science, 207:
p.(None): 153-156.
p.(None):
p.(None): Gosselin Gabriel (1992), Une éthique des sciences sociales, Paris: L'Harmattan.
p.(None):
p.(None): Harris S.L. et al. (1977), Behavior modification therapy with elderly demented patients: implementation and
p.(None): ethical considerations, J Chron Dis, 30: 129-134.
p.(None):
p.(None): Katz Jay (1972), Experimentation with Human Beings? The Authority of the Investigator,
p.(None): Subject, Professions
p.(None):
p.(None): and State in the Human Experimentation Process, New York: Russell Sage Foundation.
p.(None):
p.(None): Levine Carol (1982), Former soldier denied compensation for damage in army LSD tests, IRB, 4(3):7.
p.(None):
p.(None): Levine Robert J. (1986), Ethics and Regulation of Clinical Research, Baltimore-Munich: Urban & Schwarzenberg,
p.(None):
p.(None): 2nd edition.
p.(None):
p.(None): Macklin Ruth (1989), The paradoxical case of payment as benefit to research subjects, IRB, 11(6):1-3.
p.(None):
p.(None): Marini James L. (1980), Methodology and ethics: research on human agression, IRB, 2(5):1-4.
p.(None):
p.(None): Mead Margaret (1969), Research with human beings: a model derived from anthropological field practice,
p.(None):
p.(None): Daedalus, 98: 361-386.
p.(None):
p.(None): Meyer Roger E. (1977), Subjects' rights, freedom of inquiry, and the future of research in the addictions,
p.(None):
p.(None): Am J Psychiatry, 134(8):899-903.
p.(None):
p.(None): Menard Joël (1990), Rapport du groupe de réflexion INSERM sur certains aspects de la protection des sujets
p.(None): volontaires sains et des personnes qui se prêtent à des recherches bio- médicales, Paris: INSERM.
p.(None):
p.(None): National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research
p.(None): Involving Prisoners: Report and Recommendations, and Appendix (1976). Research Involving Children: Report
p.(None):
...
Searching for indicator army:
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p.(None):
p.(None): Bourdieu Pierre, ed. (1993), La misère du monde, Paris: Seuil.
p.(None):
p.(None): Medical Research Council of Canada (1986),Lignes directrices concernant la recherche sur des sujets humains, Ottawa.
p.(None):
p.(None): Cupples Brian & Gochnauer Myron (1985), The investigator's duty not to deceive, IRB,
p.(None):
p.(None): 7(5):1-6.
p.(None):
p.(None): De Sola Pool Ithiel (1983), Do social scientists have unlimited research rights?, IRB, 5(6):10.
p.(None):
p.(None): Desportes Jean-Pierre (1974), Les manipulations du comportement, La Recherche, 47: 654- 661.
p.(None):
p.(None): Fagot-Largeault A. (1985),L'homme bio-éthique. Pour une déontologie de la recherche sur le vivant, Paris: Maloine.
p.(None):
p.(None): Gordis Leon & Gold Ellen (1980), Privacy, confidentiality, and the use of medical records in research, Science, 207:
p.(None): 153-156.
p.(None):
p.(None): Gosselin Gabriel (1992), Une éthique des sciences sociales, Paris: L'Harmattan.
p.(None):
p.(None): Harris S.L. et al. (1977), Behavior modification therapy with elderly demented patients: implementation and
p.(None): ethical considerations, J Chron Dis, 30: 129-134.
p.(None):
p.(None): Katz Jay (1972), Experimentation with Human Beings? The Authority of the Investigator,
p.(None): Subject, Professions
p.(None):
p.(None): and State in the Human Experimentation Process, New York: Russell Sage Foundation.
p.(None):
p.(None): Levine Carol (1982), Former soldier denied compensation for damage in army LSD tests, IRB, 4(3):7.
p.(None):
p.(None): Levine Robert J. (1986), Ethics and Regulation of Clinical Research, Baltimore-Munich: Urban & Schwarzenberg,
p.(None):
p.(None): 2nd edition.
p.(None):
p.(None): Macklin Ruth (1989), The paradoxical case of payment as benefit to research subjects, IRB, 11(6):1-3.
p.(None):
p.(None): Marini James L. (1980), Methodology and ethics: research on human agression, IRB, 2(5):1-4.
p.(None):
p.(None): Mead Margaret (1969), Research with human beings: a model derived from anthropological field practice,
p.(None):
p.(None): Daedalus, 98: 361-386.
p.(None):
p.(None): Meyer Roger E. (1977), Subjects' rights, freedom of inquiry, and the future of research in the addictions,
p.(None):
p.(None): Am J Psychiatry, 134(8):899-903.
p.(None):
p.(None): Menard Joël (1990), Rapport du groupe de réflexion INSERM sur certains aspects de la protection des sujets
p.(None): volontaires sains et des personnes qui se prêtent à des recherches bio- médicales, Paris: INSERM.
p.(None):
p.(None): National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research
p.(None): Involving Prisoners: Report and Recommendations, and Appendix (1976). Research Involving Children: Report
p.(None):
p.(None): and Recommendations, and Appendix (1977). Research Involving Those Institutionalized as Mentally Infirm: Report and
...
Social / Threat of Stigma
Searching for indicator threat:
(return to top)
p.(None): participation in the research, when the data still allow for identification of subjects. However, one should not lose
p.(None): sight of the fact that such reporting does not fully cancel out the deception. Data concerning subjects,
p.(None): who refuse to give their consent to the study, must be destroyed or returned to the persons concerned. In our view,
p.(None): this condition will serve to dissuade researchers from using deception." (MRC, 1986, A, Chapter 5, Paragraph F).
p.(None):
p.(None): The following rules may be proposed:
p.(None):
p.(None): - The protocol must include arguments, demonstrating that the acquisition of the knowledge being sought is of
p.(None): scientific value, that the dissimulation of certain aspects of the protocol is indispensable for achieving the
p.(None): objective aimed at, and that none of the aspects concealed from the subjects is likely to threaten their safety or
p.(None): their dignity, or to dissuade them from consenting if it had been revealed to them.
p.(None):
p.(None): - The CCPPRC has to have accepted these arguments, judged that the situation in which the study's subjects will be
p.(None): placed is an acceptable one, and given an opinion in favour of the study.
p.(None):
p.(None): - The subjects are informed, at the time of initial consent, that certain aspects of the methodology are
p.(None): being withheld from them deliberately, that this is necessary for the study, that such are " the rules of the
p.(None): game" , that the CCPPRC has judged that nothing dissimulated from them represents a threat to their
p.(None): safety or to their dignity, and that everything will be explained, and all their questions answered at the end of
p.(None): the study.
p.(None): - At the end of the study, the subjects who so desire are made completely aware of the purpose of the research, and of
p.(None): observations made of themselves(7), and all their questions are answered. They are informed of the use to
p.(None): which the resulting data will be put. If identifying data (for example, photographs or films) were collected,
p.(None): the persons concerned
p.(None):
p.(None): must give explicit consent for their use. Identifying data concerning persons, who refuse to consent to the desired
p.(None): use, will be destroyed or returned to the interested persons.
p.(None):
p.(None): Safety
p.(None):
p.(None): - How can one evaluate the psychological risk , and the possible consequences for subjects of a behavioural research
p.(None): project?
p.(None):
p.(None): In the case of biomedical research, it has been argued that, by definition, when one searches the risks
p.(None): are not known, and therefore cannot be evaluated. The usual counter- argument is that all research relies on
p.(None): hypotheses, which are themselves based on previously acquired knowledge, and that this background knowledge allows
p.(None): for at least an approximate assessment of the risk to subjects involved in the experiment. The same
p.(None): reasoning applies to psychology.
p.(None):
...
Social / Threat of Violence
Searching for indicator violence:
(return to top)
p.(None): disorder is not very serious at all, or because the probability of the event is very low. In the latter case, the risk
p.(None): " is comparable to that run by an airplane passenger taking a regular flight" (see the Menard Report, 1990).
p.(None):
p.(None): 10. Article 226.13 - " The revelation of confidential information, by a person who is its depository,
p.(None): either by dint of his state or by profession, either by dint of a permanent function or a temporary
p.(None): mission, is punishable by one year imprisonment and a fine of 100,000 F."
p.(None):
p.(None): Article 226.14 - " Article 226.13 is not applicable, when the law imposes or authorizes the revelation of the
p.(None): confidential information. Moreover, it is not applicable: 1) To any person who informs the judicial, medical
p.(None): or administrative authorities of maltreatment or deprivation of which he has knowledge, and which has been
p.(None): inflicted on a minor of fifteen years or less, or a person unable to protect himself, because of his age
p.(None): or physical or mental state; 2) To a physician who, with the agreement of the victim, brings to the
p.(None): attention of the Prosecutor of the Republic maltreatment he has observed in the exercise of his profession, and which
p.(None): gives him grounds for supposing that sexual violence of some kind has been committed."
p.(None):
p.(None): Law N° 92.684 of July 22th 1992, Official Gazette of July 23th 1992, making amendments to the Penal Code. This Law
p.(None): enters into force on March 1st 1994.
p.(None):
p.(None): 11. A change to the 1978 Law in favour of epidemiological research is foreseen in the Draft Law on the treatment of
p.(None): research oriented nominal data with a view to protecting or improving health, adopted in first reading
p.(None): at the National Assembly on November 25th
p.(None):
p.(None): 1992.
p.(None):
p.(None): This draft law does not take up the concept of research oriented shared confidentiality between
p.(None): physicians and non-physicians. It authorizes the sharing of a secret among physicians for the purposes of
p.(None): research. The case of psychology research is not taken into consideration by the draft law, which essentially
p.(None): covers statistical processing of nominal data for the purpose of public health research.
p.(None):
p.(None): The transmission of data from a hospital department to a research institute for the purposes of investigation (for
p.(None): example, statistical processing) is authorized by the draft law, on condition that the future " National
p.(None): Consultative Committee for Information Processing in Health Research" has given its approval to the study, that the
p.(None): persons concerned have been informed individually and have been able to exercise their right of opposition (unless that
p.(None): is impossible), and that the data are received by a physician, designated by the research body, and
...
Social / Victim of Abuse
Searching for indicator victim:
(return to top)
p.(None): serious foreseeable risk" (Article L.209-6).
p.(None):
p.(None): 9. The Report of the Royal College of Physicians (1986) shows that risk is deemed minimal, either because the potential
p.(None): disorder is not very serious at all, or because the probability of the event is very low. In the latter case, the risk
p.(None): " is comparable to that run by an airplane passenger taking a regular flight" (see the Menard Report, 1990).
p.(None):
p.(None): 10. Article 226.13 - " The revelation of confidential information, by a person who is its depository,
p.(None): either by dint of his state or by profession, either by dint of a permanent function or a temporary
p.(None): mission, is punishable by one year imprisonment and a fine of 100,000 F."
p.(None):
p.(None): Article 226.14 - " Article 226.13 is not applicable, when the law imposes or authorizes the revelation of the
p.(None): confidential information. Moreover, it is not applicable: 1) To any person who informs the judicial, medical
p.(None): or administrative authorities of maltreatment or deprivation of which he has knowledge, and which has been
p.(None): inflicted on a minor of fifteen years or less, or a person unable to protect himself, because of his age
p.(None): or physical or mental state; 2) To a physician who, with the agreement of the victim, brings to the
p.(None): attention of the Prosecutor of the Republic maltreatment he has observed in the exercise of his profession, and which
p.(None): gives him grounds for supposing that sexual violence of some kind has been committed."
p.(None):
p.(None): Law N° 92.684 of July 22th 1992, Official Gazette of July 23th 1992, making amendments to the Penal Code. This Law
p.(None): enters into force on March 1st 1994.
p.(None):
p.(None): 11. A change to the 1978 Law in favour of epidemiological research is foreseen in the Draft Law on the treatment of
p.(None): research oriented nominal data with a view to protecting or improving health, adopted in first reading
p.(None): at the National Assembly on November 25th
p.(None):
p.(None): 1992.
p.(None):
p.(None): This draft law does not take up the concept of research oriented shared confidentiality between
p.(None): physicians and non-physicians. It authorizes the sharing of a secret among physicians for the purposes of
p.(None): research. The case of psychology research is not taken into consideration by the draft law, which essentially
p.(None): covers statistical processing of nominal data for the purpose of public health research.
p.(None):
p.(None): The transmission of data from a hospital department to a research institute for the purposes of investigation (for
p.(None): example, statistical processing) is authorized by the draft law, on condition that the future " National
p.(None): Consultative Committee for Information Processing in Health Research" has given its approval to the study, that the
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.(None):
p.(None): 7. This is refered to as " debriefing" .
p.(None):
p.(None): 8. The French Law of December 20th 1988 uses the term " serious risk" , and stipulates that, for persons belonging
p.(None): to vulnerable categories, research " without direct individual benefit" is admissible, only if it involves " no
p.(None): serious foreseeable risk" (Article L.209-6).
p.(None):
p.(None): 9. The Report of the Royal College of Physicians (1986) shows that risk is deemed minimal, either because the potential
p.(None): disorder is not very serious at all, or because the probability of the event is very low. In the latter case, the risk
p.(None): " is comparable to that run by an airplane passenger taking a regular flight" (see the Menard Report, 1990).
p.(None):
p.(None): 10. Article 226.13 - " The revelation of confidential information, by a person who is its depository,
p.(None): either by dint of his state or by profession, either by dint of a permanent function or a temporary
p.(None): mission, is punishable by one year imprisonment and a fine of 100,000 F."
p.(None):
p.(None): Article 226.14 - " Article 226.13 is not applicable, when the law imposes or authorizes the revelation of the
p.(None): confidential information. Moreover, it is not applicable: 1) To any person who informs the judicial, medical
p.(None): or administrative authorities of maltreatment or deprivation of which he has knowledge, and which has been
p.(None): inflicted on a minor of fifteen years or less, or a person unable to protect himself, because of his age
p.(None): or physical or mental state; 2) To a physician who, with the agreement of the victim, brings to the
p.(None): attention of the Prosecutor of the Republic maltreatment he has observed in the exercise of his profession, and which
p.(None): gives him grounds for supposing that sexual violence of some kind has been committed."
p.(None):
p.(None): Law N° 92.684 of July 22th 1992, Official Gazette of July 23th 1992, making amendments to the Penal Code. This Law
p.(None): enters into force on March 1st 1994.
p.(None):
p.(None): 11. A change to the 1978 Law in favour of epidemiological research is foreseen in the Draft Law on the treatment of
p.(None): research oriented nominal data with a view to protecting or improving health, adopted in first reading
p.(None): at the National Assembly on November 25th
p.(None):
p.(None): 1992.
p.(None):
p.(None): This draft law does not take up the concept of research oriented shared confidentiality between
p.(None): physicians and non-physicians. It authorizes the sharing of a secret among physicians for the purposes of
p.(None): research. The case of psychology research is not taken into consideration by the draft law, which essentially
p.(None): covers statistical processing of nominal data for the purpose of public health research.
p.(None):
p.(None): The transmission of data from a hospital department to a research institute for the purposes of investigation (for
...
Social / parents
Searching for indicator parents:
(return to top)
p.(None): give consent (limited competence, dependence)?
p.(None):
p.(None): The general rule is that persons, whose consent is dubious, should be protected against the possibility of serving as
p.(None): research " subjects" , in a manner proportionate to their incapacity and their dependence.
p.(None):
p.(None): Some of the vulnerable categories, requiring special protection in behavioural research, are: children, the mentally
p.(None): infirm, persons easily manipulable because of their own weakness or dependence (for example, drug addicts),
p.(None): captive institutionalized populations (prison inmates, pupils, adolescents in reform schools, young people
p.(None): in residential institutions, soldiers).
p.(None):
p.(None): - For minors and adults under guardianship , the rule accepted in biomedical research (L.209-10) can be
p.(None): generalized: consent of the parents or legal guardians, information given to the child or disabled person to the
p.(None): greatest extent possible, respect for the child's or disabled person's possible refusal.
p.(None):
p.(None): - For institutionalised captive populations (prison inmates, pupils, adolescents in reform schools, young
p.(None): people in residential institutions), the usual rule is to assess the project as admissible, only when it is (1) "
p.(None): minimal risk" and (2) non-discriminatory. Consent must be obtained both from the responsible officials of the
p.(None): institution, and from each subject individually (if the subjects are minors, from the person who exercises parental
p.(None): authority).
p.(None):
p.(None): - The use of " rewards" must be looked at very closely at the time of ethical review (for example, recruitment of
p.(None): homeless or native people as research subjects by offering them alcohol).
p.(None):
p.(None): - In so far as inmates are concerned, the law of December 20th 1988 prohibits research without direct individual
p.(None): benefit, when the persons concerned are deprived of their freedom. In the behavioural sciences, such research can be
...
p.(None): the purposes of scientific research, this would then also imply a change in the Medical Code of ethics, a change in the
p.(None): Psychologists' Code of ethics, and no doubt, in the longer term and for all patients, a right of direct access to their
p.(None): medical files, and hence a change in the " Computerisation and Liberties" law, and in the Law on access
p.(None): to administrative documents.
p.(None):
p.(None): Problems of equity
p.(None):
p.(None): - How can one reconcile research on discriminating characteristics with the imperative of
p.(None): non-discrimination ?
p.(None):
p.(None): This is a delicate issue, precisely because the identification of significant differences and of
p.(None):
p.(None): discriminating characteristics is a plausible research objective. For instance, it is of interest, and of importance
p.(None): for the evaluation of assisted maternity techniques, to ask whether there is a significance difference between the
p.(None): cognitive development of children born of artificial insemination and other children (CNRS file, Duyme project). But if
p.(None): one finds that artificial insemination children develop less well than the others, and if such research
p.(None): results are made public, then children already born through artificial insemination (or their parents) are put in a
p.(None): difficult situation, even if confidentiality of origins is well protected (the danger of guilt feelings).
p.(None):
p.(None): In the case of the Duyme protocol, all precautions were taken to ensure that the research would not be a source of
p.(None): discrimination through its methodology.
p.(None):
p.(None): Apart from the methodology, a research project may involve explicit or implicit risk of discrimination
p.(None): against individuals, because of the hypotheses on which it is based (for example, experimentation with "
p.(None): aversion therapies" to treat homosexuals, or psychosocial follow-up of a cohort of children born to alcoholic mothers).
p.(None): A project may also involve a risk of discrimination against an entire population, because of the way its
p.(None): results will be interpreted (for example, determination of statistically poorer results on several intelligence tests
p.(None): among blacks than among whites).
p.(None):
p.(None): In the United States at the end of the sixties, the interest in a " science for the people" caused some investigations
p.(None): to be stopped, on the grounds that their theoretical implications were slanderous for certain categories of
p.(None): individuals. There is even reference to attempts to force researchers to " revise" their conclusions, and/or to publish
p.(None): only expurgated results.
p.(None):
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.(None): Opinion on the ethics of research in the sciences of human behaviour. Report.
p.(None):
p.(None): N°38 - October 14, 1993
p.(None):
p.(None):
p.(None): Contents
p.(None):
p.(None): Opinion Report
p.(None): Main principles
p.(None): The freedom of persons Safety. The human cost Justice. Human dignity
p.(None): Ethical review by "independent" bodies
p.(None): Problems specific to behavioural research, as identified from the protocols submitted by the CNRS
p.(None): Consent Safety
p.(None): Problems of equity
p.(None): Review of protocols. How would CCPPRCs (Consultative Committees for the Protection of Persons consenting to Behavioural
p.(None): research) operate ?
p.(None):
p.(None): Opinion (1)
p.(None): The Director of the Life Sciences Department of the Centre national de la recherche scientifique (CNRS -
p.(None): National Scientific Research Centre) has consulted the National Consultative Ethics Committee for Health and
p.(None): Life Sciences (CCNE) on the subject of the ethics of research on human beings in the behavioural sciences,
p.(None): and especially in psychology.
p.(None):
p.(None): The CCNE observes that in France, since the " Opinion on the testing of new treatments on humans" , pronounced by
p.(None): the CCNE on October 9th 1984, and then the " law on the protection of persons who consent to biomedical
p.(None): research" of December 20th 1988, all " trials or experiments organised and practised on the human being,
p.(None): with a view to developing biological or medical knowledge" are taking place within a precise ethical and legal
p.(None): framework. On the other hand, the legislator does not seem to have brought his attention to bear on the
p.(None): protection of persons who consent to behavioural research, and investigations with human subjects, that aim to develop
p.(None): our knowledge in the behavioural sciences, have less explicit ethical references.
p.(None):
p.(None): The CCNE recalls that any experimental investigation with human subjects, whether for the purpose of developing
p.(None): biomedical knowledge, or in order to gain behavioural understanding, must be carried out in accordance with an
p.(None): irreproachable scientific method, and with full respect for the freedom of action of persons, of their safety and of
p.(None): the principle of justice; and that free, informed and expressed consent of the persons, who consent to the research,
p.(None): does not discharge researchers of their moral and scientific responsibility.
p.(None):
...
p.(None):
p.(None): The sharing, for research purposes, of medical and/or psychological information about individual subjects
p.(None): is presently prohibited in France both by the law, and by deontology. However, the CCNE feels that some
p.(None): research work, whose value is recognized, could be done under the umbrella of shared professional
p.(None): confidentiality. If, as part of a research project, psychologists were to process certain personal medical
p.(None): data, under their own responsibility, it would be necessary that these psychologists be formally entitled to do so,
p.(None): and the physician be explicitly authorized in advance by the persons concerned to communicate these data.
p.(None): Analogously, if medical researchers, were, as part of a research project, to use identifying data collected by
p.(None): practising psychologists in the course of their work, it would be necessary that these medical researchers be formally
p.(None): entitled to do so, and that the psychologist be explicitly authorised by the persons concerned to communicate these
p.(None): data. The entitlement could be given by a multidisciplinary body, under the aegis of the ministries responsible for
p.(None): research and health. If ever the law does come around to permitting such sharing of professional secrets for
p.(None): research purposes, the conditions, under which a person may release his physician or his psychologist from
p.(None): the confidentiality obligation, would have to be spelled out very carefully.
p.(None):
p.(None): The CCNE believes that research protocols in the human behaviour sciences should be submitted, for opinion
p.(None): and before execution, to Consultative Committees for the Protection of Persons consenting to Behavioural Research
p.(None): (CCPPRC), whose composition would guarantee enough diversity of competence, to examine research protocols in
p.(None): various human sciences other than medicine.
p.(None):
p.(None): These committees would be entrusted, in particular:
p.(None):
p.(None): (1) with evaluating the scientific relevance of research projects,
p.(None):
p.(None): (2) with ensuring that the freedom and safety of subjects are protected:
p.(None):
p.(None): - by making sure that proposed experiments do not threaten either the safety or the dignity of persons who consent to
p.(None): them,
p.(None):
p.(None): - by assessing the procedures in the protocol for information of and consent by persons participating in
p.(None): the study, especially when this information is to be incomplete, in the initial phase of the project,
p.(None):
p.(None): (3) to hear out researchers or subjects, at their request, should a particular ethical problem arise in the course of a
p.(None): study.
p.(None):
p.(None): On a provisional basis, and until the legislator is inspired by the example of the corresponding
p.(None): biomedical committees (CCPPRB) to create such committees, and to set out the main guidelines for their action, the
p.(None): French experience previous to the 1988 law would point in the direction of creating " Research Ethics
p.(None): Committees for Human Behavioural Sciences" , at institutions where such research is done: CNRS, INSERM,
p.(None): universities, etc. These committees would be the consciences of these institutions, and an expression of their
p.(None):
p.(None): will to ensure that their research is of high quality, and that subjects are adequately protected.
p.(None):
p.(None): This opinion is a first stage in the CCNE's thinking, which will have to develop together with that of human
p.(None): sciences researchers, scientific institutions harbouring human sciences research (whether the research is
p.(None): basic or applied), the competent administrative authorities, and the legislator, with a view to setting out
p.(None): the ethical and legal framework, in which it seems desirable that experimental investigations into human
p.(None): behaviour be conducted in the future.
p.(None):
p.(None): Report
p.(None): By a letter dated January 15th 1993 to the Chairman of the National Consultative Ethics Committee for Health and
p.(None): Life Sciences (CCNE), the Director of the Life Sciences Department of the Centre national de la recherche
p.(None): scientifique (CNRS) submitted five files, for the CCNE's opinion, describing psychology research carried out in
p.(None): university laboratories supported by the CNRS, or carried out in part by CNRS researchers, together with an overall
p.(None): description of psychology research at the CNRS. Among the five files in question, which had been approved by the
p.(None): competent scientific commission of the CNRS, two (the Duyme and Carlier files(2)) relate to the laboratory headed by
p.(None): Professor Roubertoux, and correspond to research that was interrupted, following the appearance on December
p.(None): 17th 1992 of an article in the weekly L'Express .
p.(None):
p.(None): The CCNE set up a working group.
p.(None):
p.(None): This group familiarized itself with the great variety of research done at the CNRS in the human
p.(None): sciences. For psychology alone, about fifteen research units (mostly Applied Research Units), representing
p.(None): 150 researchers and about 200 teaching researchers, are grouped together in Section 29, called " Mental
p.(None): functions, integrative neurosciences and behaviours" , and co-managed by the Life Sciences Department and the Human
p.(None): and Social Sciences Department. The objective of this research is " to understand the skills and the performances of
p.(None): the human being in the course of different periods of his life, in habitual situations as well as in exceptional
p.(None): circumstances" . The methods range from simple observation in a natural or standardised situation, to
p.(None): tests of reactions in " extreme situations" . The subjects are recruited on a volunteer basis. The identified
...
p.(None): 1988 (which will be discussed below).
p.(None):
p.(None): Main principles
p.(None): The freedom of persons
p.(None):
p.(None): Freedom has a negative dimension (independence): not being forced to do something one does not want to do, and a
p.(None): positive dimension (autonomy): acting in accordance with what one really wants for oneself. It is generally accepted,
p.(None): that respecting the freedom of persons implies that one accepts the rule: no investigation shall be conducted with
p.(None): human subjects, unless these persons give their " free, informed and expressed" (L.209-9) consent(4) to the
p.(None): investigation.
p.(None):
p.(None): Interpreting the law N° 88-1138 of December 20th 1988 (Article L.209-9):
p.(None):
p.(None): - The consent is expressed , if it is " given in writing, or, should that be impossible, attested by a third party
p.(None): (...) independent of the investigators" .
p.(None):
p.(None): - The consent is informed , if the subject has been sufficiently informed, has understood the information, and has
p.(None): had time to reflect before making his choice known. For the information to be sufficient, the law of December
p.(None): 20th 1988 specifies that the investigator must make known to the subject:
p.(None):
p.(None): - the research objectives, methodology and duration,
p.(None):
p.(None): - the expected benefits, and the foreseeable constraints and risks, even when the research is halted before its planned
p.(None): ending date,
p.(None):
p.(None): - the opinion of a CCPPRC.
p.(None): - The consent is free if the investigator abstains from all forms pressure, coercion and strong incentive (money,
p.(None): passing an examination, career advantage, affective blackmail, etc.).
p.(None):
p.(None): Moreover, consent for the research is revocable. Subjects must be informed that they may cease to participate, at any
p.(None): time, without incurring any penalty or reproach.
p.(None):
p.(None): Safety. The human cost
p.(None):
p.(None): In biomedical research, it is accepted that certain research protocols may involve a " direct individual benefit "
p.(None): (Article L.209-1) for consenting persons. This concept of (potential) benefit for the subject serves, in
p.(None): medicine, to authorize the inclusion in research protocols, but under certain conditions (Article L.209-6), persons
p.(None): whose consent is dubious or even impossible (minors, adults under guardianship, persons residing in a public health or
p.(None): social institution, patients in an emergency situation).
p.(None):
p.(None): In behavioural research, there may also be cases of investigations " with direct individual benefit" , for example,
p.(None): in clinical psychology, in the case of a comparative study of two psychotherapeutic methods (if the
p.(None): benefit for consenting subjects of at least one of the methods is established), or in cognitive psychology (if
...
p.(None): - The CDR must be assured that the research could result in considerable scientific progress, to justify the use of
p.(None): even the slightest deception.
p.(None):
p.(None): - Deception can only be accepted, when it is possible fully to inform the subjects, and to report to them as to the
p.(None): experimental procedure, once the research is over, and to obtain their consent for the use of the data. The
p.(None): reporting method must be indicated in the research protocol, and this step must occur immediately after
p.(None): participation in the research, when the data still allow for identification of subjects. However, one should not lose
p.(None): sight of the fact that such reporting does not fully cancel out the deception. Data concerning subjects,
p.(None): who refuse to give their consent to the study, must be destroyed or returned to the persons concerned. In our view,
p.(None): this condition will serve to dissuade researchers from using deception." (MRC, 1986, A, Chapter 5, Paragraph F).
p.(None):
p.(None): The following rules may be proposed:
p.(None):
p.(None): - The protocol must include arguments, demonstrating that the acquisition of the knowledge being sought is of
p.(None): scientific value, that the dissimulation of certain aspects of the protocol is indispensable for achieving the
p.(None): objective aimed at, and that none of the aspects concealed from the subjects is likely to threaten their safety or
p.(None): their dignity, or to dissuade them from consenting if it had been revealed to them.
p.(None):
p.(None): - The CCPPRC has to have accepted these arguments, judged that the situation in which the study's subjects will be
p.(None): placed is an acceptable one, and given an opinion in favour of the study.
p.(None):
p.(None): - The subjects are informed, at the time of initial consent, that certain aspects of the methodology are
p.(None): being withheld from them deliberately, that this is necessary for the study, that such are " the rules of the
p.(None): game" , that the CCPPRC has judged that nothing dissimulated from them represents a threat to their
p.(None): safety or to their dignity, and that everything will be explained, and all their questions answered at the end of
p.(None): the study.
p.(None): - At the end of the study, the subjects who so desire are made completely aware of the purpose of the research, and of
p.(None): observations made of themselves(7), and all their questions are answered. They are informed of the use to
p.(None): which the resulting data will be put. If identifying data (for example, photographs or films) were collected,
p.(None): the persons concerned
p.(None):
p.(None): must give explicit consent for their use. Identifying data concerning persons, who refuse to consent to the desired
p.(None): use, will be destroyed or returned to the interested persons.
p.(None):
p.(None): Safety
p.(None):
p.(None): - How can one evaluate the psychological risk , and the possible consequences for subjects of a behavioural research
p.(None): project?
p.(None):
p.(None): In the case of biomedical research, it has been argued that, by definition, when one searches the risks
p.(None): are not known, and therefore cannot be evaluated. The usual counter- argument is that all research relies on
...
p.(None):
p.(None): It is only to adult subjects in good health, in full possession of their mental faculties, and fully informed, that
p.(None): one may offer, for the purposes of human sciences research, involvement in experiments with risk at a higher
p.(None): level than the minimal level (no matter how small the difference).
p.(None):
p.(None): - How can one reconcile the imperative of data confidentiality with the communication to non-physician researchers
p.(None): of confidential medical files, when the purpose is to advance research?
p.(None):
p.(None): The ethical problem is one of respect for the personal domain, and of non-divulgation of confidential data, of which
p.(None): the treating physician is the depository. One can rely on Articles 7 to 13 of the Psychologist's Code of Ethics
p.(None): (footnote 3), which are almost literal copies of the rules governing medical confidentiality.
p.(None):
p.(None): Beyond the ethical problem, there is also a legal and regulatory problem in France. Some of the reference texts
p.(None): include: Articles 226.13 and 226.14 (previously 378) of the Penal Code(10), law N° 78-17 of January 6th
p.(None): 1978 on Computerisation, Records and Liberties, decree N° 79-506 of June 28th 1979 proclaiming the Medical Code of
p.(None): Ethics. These texts prohibit the communication by the physician of identifying data to anyone, save to another
p.(None): physician and solely in the interests of the patient's health (for example, consultation of a specialist for a
p.(None): therapeutic opinion).
p.(None):
p.(None): The problem of data communication for research purposes was studied extensively in the
p.(None):
p.(None): eighties, in connection with cancer registers and epidemiological research, by the CNIL, the CCNE and the Ordre des
p.(None): Médecins (French Medical Association). The proposed solution was that of shared confidentiality . This solution is not
p.(None): yet legal (11) .
p.(None):
p.(None): In the present state of the legislation, the only admissible kind of study (for example, within a hospital) is one that
p.(None): uses personal medical data within the department where the patients were treated, and under the responsibility of a
p.(None): chief physician. The procedure followed by Professeur M. Carlier (CNRS file, Carlier project) is not correct.
p.(None):
p.(None): It is the physician responsible for the ward (and not the psychology researcher) who should have contacted the
p.(None): families, and sollicited their consent to the research. The families could legitimately complain that a psychologist
p.(None): contacted them (by telephone, then directly) for a research project about their twins, which implied that this
p.(None): psychologist had knowledge of their medical files before any consent had been given, and hence that the
p.(None): head of the department did not observe medical confidentiality.
p.(None):
p.(None): It is obligatory that the use of identifying medical data for research purposes remain under medical responsibility,
p.(None): the persons concerned having the right to be informed in advance of the use that is to be made of their data, and the
p.(None): right to oppose that use.
p.(None):
p.(None): One could imagine that psychology researchers (or statisticians, or biologists, or anthropologists,
...
Economic / Economic/Poverty
Searching for indicator poor:
(return to top)
p.(None):
p.(None): In its report of 1990, the CCNE noted that, as a general rule, persons who consent to an investigation, whose objective
p.(None): is gaining knowledge about human beings, do not see this as to their personal advantage. The CCNE considered this to be
p.(None): admisible, " provided there is
p.(None):
p.(None): an acceptable risk-advantage balance, that is, a definite advantage for the community, and a zero or minimal risk for
p.(None): the individual" (p. 70).
p.(None):
p.(None): To assess the risk-advantage balance means to ask whether the risks, constraints or discomfort imposed on
p.(None): the subjects (" human cost" ) are sufficiently justified by the scientific significance of the question
p.(None): posed, and by the assurance that the suggested protocol will serve to resolve this question.
p.(None):
p.(None): In behavioural research, apart from the need explicitly to evaluate physical risk, one must pay particular attention
p.(None): to the psychological risks of experiments, and to their possible consequences (no humiliating, degrading or
p.(None): traumatizing experiments).
p.(None):
p.(None): Justice. Human dignity
p.(None):
p.(None): In biomedical research, the principle of justice serves primarily to recall, that scientific research must
p.(None): never involve exploitation (for example, exploitation by researchers in developed countries of poor
p.(None): populations in developing countries, which serve as " guinea pigs" for the acquisition of knowledge, whose therapeutic
p.(None): spin-offs are of benefit mainly to populations in rich countries: see WHO-CIOMS, 1982). It then serves to recall, as
p.(None): the CCNE has done in its 1990 Report (p. 72), that participation in a research protocol calls for " fair indemnity "
p.(None): or " compensation" for the subjects, but to the exclusion of any remuneration.
p.(None):
p.(None): In behavioural research, cases of (North-South) exploitation have been brought (in ethnology, in
p.(None): anthropology), but in the background there was usually a problem of ethnic or cultural discrimination (attitude of
p.(None): the " developed" to the " savage" ). Clear risks of discrimination have been raised in the case of
p.(None): investigation of distinctive characteristics, that are a source of social worth or the opposite ("
p.(None): intelligence quotient" , " crime chromosome" , etc.). On the other hand, the practice in
p.(None): behavioural research of remunerating subjects (for example, on a fee basis) has not given rise to many objections
p.(None): as yet. There are salaried professionals (test pilots, underwater divers) who accept being guinea pigs in the
p.(None): exercise of their profession. Conversely, many volunteers are not indemnified (when their contribution is
p.(None): minimal, or when, as in the case of students, they receive an intellectual or didactic benefit). Therefore, it
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
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p.(None): biological or medical knowledge" take place within a precise and constraining legal framework. On the other hand,
p.(None): the legislator has not brought his attention to bear on the protection of persons who consent to
p.(None): behavioural research, and investigations with human subjects, that aim to develop knowledge in the
p.(None): disciplines collectively known as the " human sciences" , have been left in a fuzzy legal situation.
p.(None):
p.(None): The CCNE hereinafter recapitulates:
p.(None):
p.(None): - the ethical principles that must guide any investigation with human subjects,
p.(None):
p.(None): - the particular problems it has identified in the case of behavioural research, and the approaches or
p.(None): solutions it proposes.
p.(None):
p.(None): With this work having been done, the CCNE invites all human sciences researchers, scientific institutions
p.(None): that harbour human sciences research (whether the research is basic or applied), the competent administrative
p.(None): authorities, and the legislator to engage in joint reflection and broad consultation, with a view to setting out the
p.(None): ethical and legal framework, within which our society would like to see experimental investigations into human
p.(None): behaviour conducted in the future.
p.(None):
p.(None): In its report Ethique et Connaissance (Ethics and Knowledge), the CCNE writes: " seeking to gain scientific knowledge
p.(None): of the human being is a good, but this cannot be done at the expense of justice, or of the safety and
p.(None): autonomy of individuals " (p. 74, 1990).
p.(None):
p.(None): This applies to any research on human beings, just as much in the behavioural sciences as in the biomedical
p.(None): sciences. In fact, in this 1990 Report (Chapter 2), the CCNE took into consideration a whole range of
p.(None): research work at the intersection of the biomedical and behavioural domains: studies on learning, on adaptation
p.(None): to the environment and to work tasks (ergonomics), on reactions of the human organism to extreme conditions
p.(None): (hyperbaric, hypobaric, microgravitational, extreme climates, perturbation of nyctohemeral cycles, competitive
p.(None): or endurance sporting, civilian or military exploits), on the quality of life and harmful environmental effects.
p.(None):
p.(None): In France, the protection of persons who consent to biomedical research depends on law N° 88-1138 of December 20th 1988
p.(None): (amended as N° 90-86). The protection of persons who consent to behavioural research depends, for the time
p.(None): being, on the deontology of the researchers (for example, the psychologists' code of ethics(3)).
p.(None):
p.(None): The recommendations that the CCNE is going to formulate on the ethics of behavioural research must, in
p.(None): the interests of consistency, be in line with the law N° 88-1138 of December 20th 1988. The main
p.(None): principles of directives concerning research with human subjects, as formulated in the United States by the
p.(None): National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-78), or in Canada
p.(None): by the Medical Research Council (1986), and then by the National Council on Bioethics in Human Research (NCBHR), are
p.(None): the same for all such research, whether in the biomedical sciences or the human sciences, even if specific problems are
p.(None): then identified, as a function of the discipline (cancerology, psychiatry, ethnology, etc.), or for different
p.(None): categories of subjects (children, captive or exiled populations, old people with reduced autonomy, etc.).
p.(None):
p.(None): Thus, it can be accepted that the main ethical principles governing research with human subjects (which the American
p.(None): National Commission refers to as the principles of justice, of beneficence, and of respect for the autonomy of
p.(None): individuals), as well as the rules flowing therefrom (rule of equal treatment or non-discrimination, rule of
p.(None): minimization of risk and optimization of benefit, rule of consent), are the same, whether the research is biomedical or
p.(None): behavioural. It can also be accepted, that the procedure, consisting in submission of human subject
p.(None): research protocols, before their execution, for review by an " independent committee" , an " ethics committee" or a "
p.(None): committee for the protection of persons" , is applicable to behavioural research. In the sequel, we refer to
p.(None): " CCPPRCs" (Consultative Committees for the Protection of Persons consenting to Behavioural Research),
p.(None): without prejudging their relationship with the CCPPRBs instituted by the law N° 88-1138 of December 20th
p.(None): 1988 (which will be discussed below).
p.(None):
p.(None): Main principles
p.(None): The freedom of persons
p.(None):
p.(None): Freedom has a negative dimension (independence): not being forced to do something one does not want to do, and a
p.(None): positive dimension (autonomy): acting in accordance with what one really wants for oneself. It is generally accepted,
p.(None): that respecting the freedom of persons implies that one accepts the rule: no investigation shall be conducted with
p.(None): human subjects, unless these persons give their " free, informed and expressed" (L.209-9) consent(4) to the
p.(None): investigation.
p.(None):
p.(None): Interpreting the law N° 88-1138 of December 20th 1988 (Article L.209-9):
p.(None):
p.(None): - The consent is expressed , if it is " given in writing, or, should that be impossible, attested by a third party
p.(None): (...) independent of the investigators" .
p.(None):
p.(None): - The consent is informed , if the subject has been sufficiently informed, has understood the information, and has
p.(None): had time to reflect before making his choice known. For the information to be sufficient, the law of December
p.(None): 20th 1988 specifies that the investigator must make known to the subject:
p.(None):
p.(None): - the research objectives, methodology and duration,
p.(None):
p.(None): - the expected benefits, and the foreseeable constraints and risks, even when the research is halted before its planned
p.(None): ending date,
p.(None):
p.(None): - the opinion of a CCPPRC.
p.(None): - The consent is free if the investigator abstains from all forms pressure, coercion and strong incentive (money,
p.(None): passing an examination, career advantage, affective blackmail, etc.).
p.(None):
...
p.(None):
p.(None): " 11
p.(None): - In his cooperation with other specialists, who are also subject to the rule of confidentiality, the psychologist
p.(None): shares with them only such information as is strictly necessary for a team to be able to take care of the " client" ."
p.(None):
p.(None): " 12
p.(None): - He makes sure to protect the identity of individuals, when making up data files, in accordance with
p.(None): the Law of April 6th 1978 on information and personal liberties."
p.(None): " 13
p.(None): - With the exception of a legal obligation, the psychologist cannot be released from the confidentiality
p.(None): rule by anyone, not even those directly concerned by the confidential information."
p.(None): Two rules pertain to scientific work through the responsability to be well trained: " 17
p.(None): - Every psychologist, whatever his speciality, must constantly keep abreast of scientific
p.(None): progress in his discipline, and consequently keep up his training. He takes such progress into account in his work,
p.(None): and strives to contribute to it. He accepts all the rules, requirements and constraints imposed by
p.(None): scientific work."
p.(None):
p.(None): " 19
p.(None): - Every psychologist seeks to determine and to apply scientifically validated and communicative
p.(None): criteria and methods, thereby rejecting the principle of authority."
p.(None):
p.(None): One rule can be applied to the informed consent request:
p.(None):
p.(None): " 18
p.(None): - The psychologist refrains from restricting any other person's autonomy, and, in particular, his access to
p.(None): information, and his freedom of judgement and decision-making."
p.(None): A special rule covers the treatment of experimental animals:
p.(None):
p.(None): " 26
p.(None): - When his activities relate to animal behaviour, with a view to understanding human behaviour, he strives
p.(None): to ensure the welfare and the survival of the animals being studied."
p.(None):
p.(None): The absence of an equivalent rule, covering the treatment of persons consenting to behavioural research,
p.(None): implies that research subjects are not treated differently from other sujects, with whom the psychologist is in
p.(None): contact on a professional basis (hence, for example, that different treatment in the " therapeutic" and "
p.(None): non-therapeutic" situations is not envisaged).
p.(None):
p.(None): 4. On the concept of consent and its ambiguities, see: Thouvenin (1992).
p.(None):
p.(None): 5. See Stanley Milgram's experiments, evoked in the film " 'I' as in Icarus" . Reference publication:
p.(None): Milgram S. (1963), " Behavioral study of obedience" , J Abnorm Psychol, 67: 371-378.
p.(None):
p.(None): 6. Also known as " deceptive research" (" tromperie" in French).
p.(None):
p.(None): 7. This is refered to as " debriefing" .
p.(None):
p.(None): 8. The French Law of December 20th 1988 uses the term " serious risk" , and stipulates that, for persons belonging
p.(None): to vulnerable categories, research " without direct individual benefit" is admissible, only if it involves " no
...
General/Other / Incapacitated
Searching for indicator incapacity:
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p.(None): studies" (research work done only on paper, or with samples collected independently of the study, for example, taken
p.(None): from a blood bank).
p.(None):
p.(None): The American federal directives (DHHS, 1981) set out three categories of research with human subjects:
p.(None): exempted from ethical review, submitted to a simplified procedure of ethical review (" expedited review" by
p.(None): the bureau of an IRB), and submitted to in-depth ethical discussion (discussion in session by an IRB).
p.(None):
p.(None): For the human sciences, one could propose a distinction between simple observation and construction of an experimental
p.(None): situation, in order to provide for a rapid procedure (simple review of the protocol), and a normal ethical review
p.(None): procedure (possibly requiring the actual presence of the investigators). However, this distinction is tricky to make,
p.(None): for in fact, as
p.(None):
p.(None): D. Widl\'9acher has quite rightly pointed out, there are " quite innocent experiments" and potentially traumatizing
p.(None): observations.
p.(None):
p.(None): Problems specific to behavioural research, as identified from the protocols submitted by the CNRS
p.(None): Consent
p.(None):
p.(None): - Under what conditions is behavioural research admissible, when the subjects have a problematic ability to
p.(None): give consent (limited competence, dependence)?
p.(None):
p.(None): The general rule is that persons, whose consent is dubious, should be protected against the possibility of serving as
p.(None): research " subjects" , in a manner proportionate to their incapacity and their dependence.
p.(None):
p.(None): Some of the vulnerable categories, requiring special protection in behavioural research, are: children, the mentally
p.(None): infirm, persons easily manipulable because of their own weakness or dependence (for example, drug addicts),
p.(None): captive institutionalized populations (prison inmates, pupils, adolescents in reform schools, young people
p.(None): in residential institutions, soldiers).
p.(None):
p.(None): - For minors and adults under guardianship , the rule accepted in biomedical research (L.209-10) can be
p.(None): generalized: consent of the parents or legal guardians, information given to the child or disabled person to the
p.(None): greatest extent possible, respect for the child's or disabled person's possible refusal.
p.(None):
...
General/Other / Manipulable
Searching for indicator manipulable:
(return to top)
p.(None): For the human sciences, one could propose a distinction between simple observation and construction of an experimental
p.(None): situation, in order to provide for a rapid procedure (simple review of the protocol), and a normal ethical review
p.(None): procedure (possibly requiring the actual presence of the investigators). However, this distinction is tricky to make,
p.(None): for in fact, as
p.(None):
p.(None): D. Widl\'9acher has quite rightly pointed out, there are " quite innocent experiments" and potentially traumatizing
p.(None): observations.
p.(None):
p.(None): Problems specific to behavioural research, as identified from the protocols submitted by the CNRS
p.(None): Consent
p.(None):
p.(None): - Under what conditions is behavioural research admissible, when the subjects have a problematic ability to
p.(None): give consent (limited competence, dependence)?
p.(None):
p.(None): The general rule is that persons, whose consent is dubious, should be protected against the possibility of serving as
p.(None): research " subjects" , in a manner proportionate to their incapacity and their dependence.
p.(None):
p.(None): Some of the vulnerable categories, requiring special protection in behavioural research, are: children, the mentally
p.(None): infirm, persons easily manipulable because of their own weakness or dependence (for example, drug addicts),
p.(None): captive institutionalized populations (prison inmates, pupils, adolescents in reform schools, young people
p.(None): in residential institutions, soldiers).
p.(None):
p.(None): - For minors and adults under guardianship , the rule accepted in biomedical research (L.209-10) can be
p.(None): generalized: consent of the parents or legal guardians, information given to the child or disabled person to the
p.(None): greatest extent possible, respect for the child's or disabled person's possible refusal.
p.(None):
p.(None): - For institutionalised captive populations (prison inmates, pupils, adolescents in reform schools, young
p.(None): people in residential institutions), the usual rule is to assess the project as admissible, only when it is (1) "
p.(None): minimal risk" and (2) non-discriminatory. Consent must be obtained both from the responsible officials of the
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.(None): 20th 1988 specifies that the investigator must make known to the subject:
p.(None):
p.(None): - the research objectives, methodology and duration,
p.(None):
p.(None): - the expected benefits, and the foreseeable constraints and risks, even when the research is halted before its planned
p.(None): ending date,
p.(None):
p.(None): - the opinion of a CCPPRC.
p.(None): - The consent is free if the investigator abstains from all forms pressure, coercion and strong incentive (money,
p.(None): passing an examination, career advantage, affective blackmail, etc.).
p.(None):
p.(None): Moreover, consent for the research is revocable. Subjects must be informed that they may cease to participate, at any
p.(None): time, without incurring any penalty or reproach.
p.(None):
p.(None): Safety. The human cost
p.(None):
p.(None): In biomedical research, it is accepted that certain research protocols may involve a " direct individual benefit "
p.(None): (Article L.209-1) for consenting persons. This concept of (potential) benefit for the subject serves, in
p.(None): medicine, to authorize the inclusion in research protocols, but under certain conditions (Article L.209-6), persons
p.(None): whose consent is dubious or even impossible (minors, adults under guardianship, persons residing in a public health or
p.(None): social institution, patients in an emergency situation).
p.(None):
p.(None): In behavioural research, there may also be cases of investigations " with direct individual benefit" , for example,
p.(None): in clinical psychology, in the case of a comparative study of two psychotherapeutic methods (if the
p.(None): benefit for consenting subjects of at least one of the methods is established), or in cognitive psychology (if
p.(None): the fact that children consent to a study gives them an educational advantage, as was stated in the CNRS file regarding
p.(None): the Lautrey protocol). But given the absence of vital emergencies that obligate the practitioner to intervene, and
p.(None): given how difficult it is to argue that research is done " for the good" of included subjects, or " in the interest of
p.(None): their health" , the " with/without direct individual benefit" distinction is not sufficiently applicable to behavioural
p.(None): research, to justify relaxing the consent conditions, even in the case of applied research. This distinction is
p.(None): applicable only within the framework of the risk-advantage balance.
p.(None):
p.(None): In its report of 1990, the CCNE noted that, as a general rule, persons who consent to an investigation, whose objective
p.(None): is gaining knowledge about human beings, do not see this as to their personal advantage. The CCNE considered this to be
p.(None): admisible, " provided there is
p.(None):
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): captive institutionalized populations (prison inmates, pupils, adolescents in reform schools, young people
p.(None): in residential institutions, soldiers).
p.(None):
p.(None): - For minors and adults under guardianship , the rule accepted in biomedical research (L.209-10) can be
p.(None): generalized: consent of the parents or legal guardians, information given to the child or disabled person to the
p.(None): greatest extent possible, respect for the child's or disabled person's possible refusal.
p.(None):
p.(None): - For institutionalised captive populations (prison inmates, pupils, adolescents in reform schools, young
p.(None): people in residential institutions), the usual rule is to assess the project as admissible, only when it is (1) "
p.(None): minimal risk" and (2) non-discriminatory. Consent must be obtained both from the responsible officials of the
p.(None): institution, and from each subject individually (if the subjects are minors, from the person who exercises parental
p.(None): authority).
p.(None):
p.(None): - The use of " rewards" must be looked at very closely at the time of ethical review (for example, recruitment of
p.(None): homeless or native people as research subjects by offering them alcohol).
p.(None):
p.(None): - In so far as inmates are concerned, the law of December 20th 1988 prohibits research without direct individual
p.(None): benefit, when the persons concerned are deprived of their freedom. In the behavioural sciences, such research can be
p.(None): harmless for the persons concerned, and socially useful, or even necessary; therefore they cannot be prohibited
p.(None): without individual review.
p.(None):
p.(None): - How can one reconcile the obligation of consent, that is to be informed , with the methodological
p.(None): necessity (which can arise in the case of certain experimental protocols ) of not saying everything ?
p.(None):
p.(None): This is a question that has arisen with regard to biomedical research, but it is particularly relevant in psychology,
p.(None): social psychology(5), and research of sports performances.
p.(None):
p.(None): The Canadian Medical Research Council has dealt with this issue as follows:
p.(None):
p.(None): Deception (6)
p.(None):
p.(None): " ... Given the critical importance of free and informed consent, it seems incongruous to take up the issue of
p.(None): deception.
p.(None):
p.(None): " Deception means deliberately providing potential subjects with erroneous information, or
p.(None):
p.(None): concealing information from them, with a view to having them believe that the research objectives, or
...
p.(None):
p.(None): Barber B. (1976), The ethics of experimentation with human subjects, Scientific American, 234(2):25-31.
p.(None):
p.(None): Baumrind Diana (1979), IRBs and social science research: the costs of deception, IRB, 1(6):1-4.
p.(None):
p.(None): Bourdieu Pierre, ed. (1993), La misère du monde, Paris: Seuil.
p.(None):
p.(None): Medical Research Council of Canada (1986),Lignes directrices concernant la recherche sur des sujets humains, Ottawa.
p.(None):
p.(None): Cupples Brian & Gochnauer Myron (1985), The investigator's duty not to deceive, IRB,
p.(None):
p.(None): 7(5):1-6.
p.(None):
p.(None): De Sola Pool Ithiel (1983), Do social scientists have unlimited research rights?, IRB, 5(6):10.
p.(None):
p.(None): Desportes Jean-Pierre (1974), Les manipulations du comportement, La Recherche, 47: 654- 661.
p.(None):
p.(None): Fagot-Largeault A. (1985),L'homme bio-éthique. Pour une déontologie de la recherche sur le vivant, Paris: Maloine.
p.(None):
p.(None): Gordis Leon & Gold Ellen (1980), Privacy, confidentiality, and the use of medical records in research, Science, 207:
p.(None): 153-156.
p.(None):
p.(None): Gosselin Gabriel (1992), Une éthique des sciences sociales, Paris: L'Harmattan.
p.(None):
p.(None): Harris S.L. et al. (1977), Behavior modification therapy with elderly demented patients: implementation and
p.(None): ethical considerations, J Chron Dis, 30: 129-134.
p.(None):
p.(None): Katz Jay (1972), Experimentation with Human Beings? The Authority of the Investigator,
p.(None): Subject, Professions
p.(None):
p.(None): and State in the Human Experimentation Process, New York: Russell Sage Foundation.
p.(None):
p.(None): Levine Carol (1982), Former soldier denied compensation for damage in army LSD tests, IRB, 4(3):7.
p.(None):
p.(None): Levine Robert J. (1986), Ethics and Regulation of Clinical Research, Baltimore-Munich: Urban & Schwarzenberg,
p.(None):
p.(None): 2nd edition.
p.(None):
p.(None): Macklin Ruth (1989), The paradoxical case of payment as benefit to research subjects, IRB, 11(6):1-3.
p.(None):
p.(None): Marini James L. (1980), Methodology and ethics: research on human agression, IRB, 2(5):1-4.
p.(None):
p.(None): Mead Margaret (1969), Research with human beings: a model derived from anthropological field practice,
p.(None):
p.(None): Daedalus, 98: 361-386.
p.(None):
p.(None): Meyer Roger E. (1977), Subjects' rights, freedom of inquiry, and the future of research in the addictions,
p.(None):
p.(None): Am J Psychiatry, 134(8):899-903.
p.(None):
p.(None): Menard Joël (1990), Rapport du groupe de réflexion INSERM sur certains aspects de la protection des sujets
p.(None): volontaires sains et des personnes qui se prêtent à des recherches bio- médicales, Paris: INSERM.
p.(None):
p.(None): National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research
...
p.(None): dissemination of documents. The psychologist must make sure that all the products of his work (minutes,
p.(None): conclusions, reports, exposés, etc.) are always drafted, presented and filed in such a way, as to
p.(None): preserve and safeguard confidentiality."
p.(None):
p.(None): " 11
p.(None): - In his cooperation with other specialists, who are also subject to the rule of confidentiality, the psychologist
p.(None): shares with them only such information as is strictly necessary for a team to be able to take care of the " client" ."
p.(None):
p.(None): " 12
p.(None): - He makes sure to protect the identity of individuals, when making up data files, in accordance with
p.(None): the Law of April 6th 1978 on information and personal liberties."
p.(None): " 13
p.(None): - With the exception of a legal obligation, the psychologist cannot be released from the confidentiality
p.(None): rule by anyone, not even those directly concerned by the confidential information."
p.(None): Two rules pertain to scientific work through the responsability to be well trained: " 17
p.(None): - Every psychologist, whatever his speciality, must constantly keep abreast of scientific
p.(None): progress in his discipline, and consequently keep up his training. He takes such progress into account in his work,
p.(None): and strives to contribute to it. He accepts all the rules, requirements and constraints imposed by
p.(None): scientific work."
p.(None):
p.(None): " 19
p.(None): - Every psychologist seeks to determine and to apply scientifically validated and communicative
p.(None): criteria and methods, thereby rejecting the principle of authority."
p.(None):
p.(None): One rule can be applied to the informed consent request:
p.(None):
p.(None): " 18
p.(None): - The psychologist refrains from restricting any other person's autonomy, and, in particular, his access to
p.(None): information, and his freedom of judgement and decision-making."
p.(None): A special rule covers the treatment of experimental animals:
p.(None):
p.(None): " 26
p.(None): - When his activities relate to animal behaviour, with a view to understanding human behaviour, he strives
p.(None): to ensure the welfare and the survival of the animals being studied."
p.(None):
p.(None): The absence of an equivalent rule, covering the treatment of persons consenting to behavioural research,
p.(None): implies that research subjects are not treated differently from other sujects, with whom the psychologist is in
p.(None): contact on a professional basis (hence, for example, that different treatment in the " therapeutic" and "
p.(None): non-therapeutic" situations is not envisaged).
p.(None):
p.(None): 4. On the concept of consent and its ambiguities, see: Thouvenin (1992).
p.(None):
p.(None): 5. See Stanley Milgram's experiments, evoked in the film " 'I' as in Icarus" . Reference publication:
p.(None): Milgram S. (1963), " Behavioral study of obedience" , J Abnorm Psychol, 67: 371-378.
p.(None):
p.(None): 6. Also known as " deceptive research" (" tromperie" in French).
p.(None):
p.(None): 7. This is refered to as " debriefing" .
p.(None):
...
Orphaned Trigger Words
p.(None): framework. On the other hand, the legislator does not seem to have brought his attention to bear on the
p.(None): protection of persons who consent to behavioural research, and investigations with human subjects, that aim to develop
p.(None): our knowledge in the behavioural sciences, have less explicit ethical references.
p.(None):
p.(None): The CCNE recalls that any experimental investigation with human subjects, whether for the purpose of developing
p.(None): biomedical knowledge, or in order to gain behavioural understanding, must be carried out in accordance with an
p.(None): irreproachable scientific method, and with full respect for the freedom of action of persons, of their safety and of
p.(None): the principle of justice; and that free, informed and expressed consent of the persons, who consent to the research,
p.(None): does not discharge researchers of their moral and scientific responsibility.
p.(None):
p.(None): The CCNE has been attentive to methodological and ethical difficulties specific to scientific investigation of human
p.(None): behaviour. After having heard out a number of researchers, it recalls that a study with human subjects must
p.(None): not be an occasion for manipulation or discrimination, and that the chain of professional
p.(None): confidentiality must remain strong throughout.
p.(None):
p.(None): In the event, that subjects who consent to the study cannot be completely informed before
p.(None):
p.(None): the experiment, because providing them with complete information could modify the behaviour one wishes to
p.(None): study, the CCNE recommends:
p.(None):
p.(None): (1) that, when they give their initial consent, the subjects be warned that certain aspects of the research objectives
p.(None): or methodology are being deliberately held back, in the interests of the study, that they may interrupt their
p.(None): participation at any time, and that all their questions will be answered when the study is over;
p.(None):
p.(None): (2) that the subjects be given, at the end of the experiment, an exhaustive explanation of the objective of the work,
p.(None): of the observations made of themselves, and of the use to be made of the data, allowing them, once fully
p.(None): informed, to confirm or to withdraw their consent. Whenever researchers collect data that (directly or
p.(None): indirectly) identifies a subject, his explicit consent is absolutely necessary for any use to be made of such data.
p.(None):
p.(None): The sharing, for research purposes, of medical and/or psychological information about individual subjects
p.(None): is presently prohibited in France both by the law, and by deontology. However, the CCNE feels that some
p.(None): research work, whose value is recognized, could be done under the umbrella of shared professional
p.(None): confidentiality. If, as part of a research project, psychologists were to process certain personal medical
p.(None): data, under their own responsibility, it would be necessary that these psychologists be formally entitled to do so,
p.(None): and the physician be explicitly authorized in advance by the persons concerned to communicate these data.
p.(None): Analogously, if medical researchers, were, as part of a research project, to use identifying data collected by
...
p.(None):
p.(None): Deception (6)
p.(None):
p.(None): " ... Given the critical importance of free and informed consent, it seems incongruous to take up the issue of
p.(None): deception.
p.(None):
p.(None): " Deception means deliberately providing potential subjects with erroneous information, or
p.(None):
p.(None): concealing information from them, with a view to having them believe that the research objectives, or
p.(None): the procedure to be followed, are different from what they are in reality. Deception can also consist
p.(None): in deliberately providing them with false information, in dissimulating important information, or in revealing
p.(None): only bits of information, so as to give the persons concerned an erroneous picture of the research.
p.(None):
p.(None): " As deception is diametrically contrary to the principle of respect for the individual, the Committee
p.(None): had enormous difficulty in accepting the idea, that it could sometimes be justifiable from an ethical
p.(None): point of view. But if, for one reason or another, it really is indispensable that the subjects not be made
p.(None): aware of the nature of the research, and this for reasons of scientific integrity, then one must make sure
p.(None): that the following rules are strictly adhered to:
p.(None):
p.(None): - One must never have recourse to deception, when there is another way of achieving the research objectives. The
p.(None): researcher must demonstrate, in the protocol, that there is no other way of proceeding.
p.(None):
p.(None): - One must abstain from conducting deceptive research, when there could be risks for the subjects: it is impossible to
p.(None): justify exposing a subject to risk when he has not given his consent.
p.(None):
p.(None): - The CDR must be assured that there will no dissimulation of any item of information, whose revelation
p.(None): would result in refusal to participate.
p.(None): - The CDR must be assured that the research could result in considerable scientific progress, to justify the use of
p.(None): even the slightest deception.
p.(None):
p.(None): - Deception can only be accepted, when it is possible fully to inform the subjects, and to report to them as to the
p.(None): experimental procedure, once the research is over, and to obtain their consent for the use of the data. The
p.(None): reporting method must be indicated in the research protocol, and this step must occur immediately after
p.(None): participation in the research, when the data still allow for identification of subjects. However, one should not lose
p.(None): sight of the fact that such reporting does not fully cancel out the deception. Data concerning subjects,
p.(None): who refuse to give their consent to the study, must be destroyed or returned to the persons concerned. In our view,
p.(None): this condition will serve to dissuade researchers from using deception." (MRC, 1986, A, Chapter 5, Paragraph F).
p.(None):
p.(None): The following rules may be proposed:
p.(None):
p.(None): - The protocol must include arguments, demonstrating that the acquisition of the knowledge being sought is of
p.(None): scientific value, that the dissimulation of certain aspects of the protocol is indispensable for achieving the
p.(None): objective aimed at, and that none of the aspects concealed from the subjects is likely to threaten their safety or
p.(None): their dignity, or to dissuade them from consenting if it had been revealed to them.
p.(None):
...
p.(None):
p.(None): Journal des anthropologues, winter 1992 to spring 1993, N° 50-511, devoted to " professional ethics"
p.(None):
p.(None): and to " field experiments" (EHESS, 1 rue du 11 novembre, 92120 Montrouge).
p.(None):
p.(None): Sociétés contemporaines (IRESCO, CNRS), special issue " Ethique professionnelle" ,
p.(None): September 1991, N° 7
p.(None):
p.(None): (ethics of statisticians, geneticists, in anthropology, etc.). Sociology, November 1992, " BSA Statement of Ethical
p.(None): Practice" .
p.(None):
p.(None):
p.(None):
p.(None): Notes
p.(None):
p.(None): 1. In the following, it is accepted that speaking is a behaviour, and that the term " sciences of human behaviour"
p.(None): does not exclude clinical disciplines, such as analytically inspired psychology. This term has the advantage of
p.(None): stressing that we are dealing with research on the human being, other than biomedical research.
p.(None):
p.(None): 2. See the report drafted by Y. Laporte.
p.(None):
p.(None): 3. A Code of Ethics was adopted in 1961 (and revised in 1976) by the French Society of
p.(None):
p.(None): Psychology. It applied to members of the Society. This Code was taken over and brought up to date by the National
p.(None): Association of Organizations of Psychologists (ANOP), following " the evolution of the profession and its legislation"
p.(None): (Law of July 25th 1985). The Code of Ethics of Psychologists (1987) now applies to all French psychologists, as well as
p.(None): to students of psychology.
p.(None):
p.(None): This is a professional code of ethics, analogous to the code of ethics of French physicians. It is not a code of
p.(None): research ethics (as in the case of the World Medical Association's Helsinki- Tokyo Declaration for physicians).
p.(None):
p.(None): This Code includes rules that also apply to research activities, in as much as they apply to all activities of
p.(None): psychologists. There are general rules: " implement only such measures as respect human dignity" (Article 2), " avoid
p.(None): doing harm" (Article 15), and there are specific rules concerning confidentiality (Articles 7 through 12):
p.(None):
p.(None): " 7
p.(None): - The psychologist is subject to the rule of confidentiality, defined herein as psychological confidentiality."
p.(None): " 8
p.(None): - This rule must be applied under conditions analogous to those defined by Article 378 of the Penal."
p.(None): " 9
p.(None): - In particular, it is recalled that this confidentiality must be extended, in the private domain of persons concerned,
p.(None): to anything that the psychologist " sees, hears or understands" in the course of his practice or research."
p.(None):
p.(None): " 10
p.(None): - Confidentiality must be ensured as much with respect to oral transmission, as in the storage and
p.(None): dissemination of documents. The psychologist must make sure that all the products of his work (minutes,
p.(None): conclusions, reports, exposés, etc.) are always drafted, presented and filed in such a way, as to
p.(None): preserve and safeguard confidentiality."
p.(None):
p.(None): " 11
p.(None): - In his cooperation with other specialists, who are also subject to the rule of confidentiality, the psychologist
p.(None): shares with them only such information as is strictly necessary for a team to be able to take care of the " client" ."
p.(None):
p.(None): " 12
p.(None): - He makes sure to protect the identity of individuals, when making up data files, in accordance with
p.(None): the Law of April 6th 1978 on information and personal liberties."
p.(None): " 13
p.(None): - With the exception of a legal obligation, the psychologist cannot be released from the confidentiality
p.(None): rule by anyone, not even those directly concerned by the confidential information."
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| alcoholic | alcoholism |
| army | Soldier |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| captive | Captive/Exiled Population |
| child | Child |
| children | Child |
| cognitive | Cognitive Impairment |
| crime | Illegal Activity |
| dependence | Drug Dependence |
| disabled | Mentally Disabled |
| drug | Drug Usage |
| education | Educational |
| educational | Educational |
| elderly | Elderly |
| emergency | Public Emergency |
| ethnic | Ethnicity |
| exiled | Captive/Exiled Population |
| health | Health |
| healthy volunteers | healthy volunteers |
| homeless | Homeless Persons |
| incapacity | Incapacitated |
| influence | Drug Usage |
| institutionalized | Institutionalized |
| manipulable | Manipulable |
| mentally | Mentally Disabled |
| military | Soldier |
| minor | Youth/Minors |
| mothers | Mothers |
| native | Indigenous |
| opinion | philosophical differences/differences of opinion |
| parents | parents |
| party | Political |
| poor | Economic/Poverty |
| prison | Incarcerated |
| prisoners | Criminal Convictions |
| social | Social |
| soldier | Soldier |
| threat | Threat of Stigma |
| victim | Victim of Abuse |
| violence | Threat of Violence |
| volunteers | volunteers |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| army | ['military', 'soldier'] |
| captive | ['exiled'] |
| child | ['children'] |
| children | ['child'] |
| disabled | ['mentally'] |
| drug | ['influence'] |
| education | ['educational'] |
| educational | ['education'] |
| exiled | ['captive'] |
| influence | ['drug'] |
| mentally | ['disabled'] |
| military | ['soldier', 'army'] |
| soldier | ['military', 'army'] |
Trigger Words
coercion
consent
cultural
developing
ethics
harm
justice
protect
protection
risk
volunteer
vulnerable
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input