79C3C34C52B45572883A05D425EB0F82

Opinion on the Ethics of Research in the Science of Human Behavior No. 38

https://www.ccne-ethique.fr/sites/default/files/publications/avis038.pdf

http://leaux.net/URLS/ConvertAPI Text Files/B5051119901EEF06FDB35A08B544DB60.en.txt

Examining the file media/Synopses/B5051119901EEF06FDB35A08B544DB60.html:

This file was generated: 2020-12-01 07:27:48

Indicators in focus are typically shown highlighted in yellow;

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

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

Trigger Words/Phrases are shown highlighted in gray.

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

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	Captive/Exiled Population	captive	3
Political	Criminal Convictions	prisoners	3
Political	Illegal Activity	crime	1
Political	Refugee Status	asylum	1
Political	criminal	criminal	2
Political	political affiliation	party	1
Political	vulnerable	vulnerable	3
Health	Cognitive Impairment	cognitive	3
Health	Drug Dependence	dependence	3
Health	Drug Usage	drug	2
Health	Drug Usage	influence	1
Health	Healthy People	healthy volunteers	2
Health	Healthy People	volunteers	5
Health	Mentally Disabled	mentally	1
Health	Mentally Incapacitated	incapable	2
Health	Physically Ill	sick	1
Health	addiction	addicts	1
Health	alcoholism	alcoholic	1
Health	ill	ill	2
Health	patients in emergency situations	emergencies	1
Health	sensory impairment	sensory	1
Social	Access to Social Goods	access	3
Social	Age	age	1
Social	Child	child	3
Social	Child	children	10
Social	Elderly	elderly	2
Social	Ethnicity	ethnic	1
Social	Incarcerated	liberty	2
Social	Institutionalized	institutionalized	3
Social	Mothers	mothers	1
Social	Presence of Coercion	coerce	1
Social	Soldier	army	1
Social	Soldier	military	1
Social	Soldier	soldier	1
Social	Threat of Violence	violence	1
Social	Victim of Abuse	victim	1
Social	Youth/Minors	minor	2
Social	education	education	2
Social	education	educational	2
Social	parents	parents	2
Social	philosophical differences/differences of opinion	opinion	8
Economic	Economic/Poverty	poor	1
General/Other	Impaired Autonomy	autonomy	5
General/Other	Incapacitated	incapacity	1
General/Other	Manipulable	manipulated	1
General/Other	Public Emergency	emergency	1
General/Other	Relationship to Authority	authority	3
General/Other	belmont	belmont	1
General/Other	cioms guidelines	cioms	1

Political / Captive/Exiled Population

Searching for indicator captive:

Political / Criminal Convictions

Searching for indicator prisoners:

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p.(None): ethical review (may require the effective presence of investigators). However, this distinction is
p.(None): delicate handling: there are indeed, as D. Widlöcher pointed out to us, "very harmless experiments",
p.(None): and possibly traumatic observations.
p.(None): Problems specific to behavioral research, identified using protocols submitted by the CNRS
p.(None): Consent
p.(None): - Under what conditions is behavioral research admissible on subjects including the ability to consent
p.(None): is problematic (limited competence, dependence)?
p.(None): The general rule is that people whose consent is precarious must be protected against
p.(None): the possibility of serving as "subjects" of research, in proportion to their incapacity and their dependence.
p.(None): Some vulnerable categories to be protected especially in behavioral research are: children, infirm
p.(None): mental, people easily manipulated by their own weakness or dependence
p.(None): (e.g. drug addicts), institutionalized captive populations (prisoners, pupils, adolescents under
p.(None): supervised education, young people in shelters, soldiers).
p.(None): - For minors and adults under guardianship, the accepted rule for biomedical research (L. 209-10) can be
p.(None): generalized: consent of parents or legal guardians, information of the child or the incapable person throughout the
p.(None): as far as possible, respect for a possible refusal by the child or the incapable person.
p.(None): - For institutionalized captive populations (prisoners, pupils, adolescents from
p.(None): recovery ', young people in homes), the usual rule is to consider admissible only research (1)
p.(None): "minimal risk", and (2) non-discriminatory. Consent must be obtained from those responsible for
p.(None): the institution, on the other hand of each subject individually (if the subjects are minor, of the person who
p.(None): has parental authority).
p.(None): - The use of "rewards" must be subject to special attention at the time of the ethical review
p.(None): (eg recruiting tramps or Indians as research subjects through an offer of alcohol).
p.(None): - With regard to detainees, the law of 20 December 1988 excludes research without direct individual benefit
p.(None): in persons deprived of their liberty. In behavioral sciences, this research can be without
p.(None): harmful to the people concerned, and socially useful, even necessary; therefore they cannot be
p.(None): prohibited without further examination.
p.(None): - How to reconcile the obligation of consent which should be informed with the methodological necessity (which can
p.(None): appear in certain experimental protocols) not to say everything?
p.(None): This is a question raised about biomedical research, but mostly known about
p.(None): psychology, social psychology (5), and research on sports performance.
p.(None): The Canadian MRC treated this issue as follows:
p.(None): Deception (6)
p.(None): "... Given the critical importance of free and informed consent, it seems incongruous to consider the
...

p.(None): Ethical considerations, J Chron Dis, 30: 129-134.
p.(None): Katz Jay (1972), Experimentation with Human Beings? The Authority of the Investigator, Subject, Professions and State
p.(None): in the Human Experimentation Process, New York: Russell Sage Foundation.
p.(None): Levine Carol (1982), Former soldier denied compensation for damage in army LSD tests, IRB, 4 (3): 7.
p.(None): Levine Robert J. (1986), Ethics and Regulation of Clinical Research, Baltimore-Munich: Urban & Schwarzenberg,
p.(None): 2nd edition.
p.(None): Macklin Ruth (1989), The paradoxical case of payment as benefit to research subjects, IRB, 11 (6): 1-3.
p.(None): Marini James L. (1980), Methodology and ethics: research on human aggression, IRB, 2 (5): 1-4.
p.(None): Mead Margaret (1969), Research with human beings: a model derived from anthropological field practice, Daedalus, 98:
p.(None): 361-386.
p.(None): Meyer Roger E. (1977), Subjects' rights, freedom of inquiry, and the future of research in the addictions, Am J
p.(None): Psychiatry, 134 (8): 899-903.
p.(None): Menard Joël (1990), Report from the INSERM think tank on certain aspects of protecting subjects
p.(None): healthy volunteers and people who lend themselves to biomedical research, Paris: INSERM.
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 and
p.(None): Recommendations, and Appendix (1977). Research Involving Those Institutionalized as Mentally Infirm:
p.(None): Report and Recommendations, and Appendix (1978). The Belmont Report: Ethical Principles and Guidelines
p.(None): for Research Involving Human Subjects (1978), Washington D.C .: US Govt Printing Office (DHEW); tr. Fr.
p.(None): in: Medicine and experimentation (1982), Cahiers de bioéthique, 4, Québec: Presses de l'Université Laval, 233-250.
p.(None): Newton Lisa H. (1982), Dentists and pseudo-patients: further meditations on deception in research, IRB, 4 (8): 6-8.
p.(None): Park L.C., Covi L., Uhlenhuth E.H. (1967), Effects of informed consent on research patients and study results, J Nerv
p.(None): Ment Dis, 145: 349-357.
p.(None): Pattulo E.L. (1980), Who risks what in social research ?, IRB, 2 (3): 1-3, 12.
p.(None): Queheillard Jean-Louis (1989), Professional secret: the great forgotten?, Psychologists and psychologies, n ° 89.
p.(None): Redlich Fritz (1973), The anthropologist as observer; ethical aspects of clinical observations of behavior, J Nerv Ment
p.(None): Say, 157: 313-319.
p.(None): Robertson John A. (1981), Ethical review of social experiments, IRB, 3 (7): 10-11.
p.(None): Royal College of Physicians (1986), 'Research on healthy volunteers', J Roy Coll Physicians, London, 20: 243-257.
p.(None): Schafer Arthur (1981), The ethics of research on human beings; a critical review of the issues and
...

Political / Illegal Activity

Searching for indicator crime:

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p.(None): In behavioral research, in addition to making an explicit assessment of physical risks,
p.(None): one must be particularly attentive to the psychological risks of the experiences and their consequences
p.(None): possible (no humiliating, degrading or traumatic experiences).
p.(None): Justice. Human dignity
p.(None): In biomedical research, the principle of justice serves first to remind us that scientific research must not
p.(None): be an opportunity for exploitation (for example, exploitation by researchers from developed countries,
p.(None): poor people in developing countries, who serve as "guinea pigs" for the acquisition of knowledge including
p.(None): the therapeutic benefits mainly benefit the populations of rich countries: cf. WHO-CIOMS, 1982). It serves
p.(None): then recall, as CCNE did in its 1990 report (p. 72), that participation in a protocol
p.(None): research calls for "fair compensation" or "compensation" for subjects, but excludes any compensation.
p.(None): In behavioral research, cases of exploitation (north-south) have been mentioned (in ethnology, in
p.(None): anthropology), but there was, in general, in the background a problem of ethnic or cultural discrimination
p.(None): (relation of "developed" to "wild"). Frank risks of discrimination have been raised in connection with
p.(None): the investigation of distinctive features which are a source of social valuation or devaluation ("intelligence quotient",
p.(None): "crime chromosome", etc.). On the other hand, in behavioral research, the practice of paying subjects
p.(None): (on vacations, for example) has so far raised few objections. There are salaried professionals
p.(None): (test pilots, scuba divers) who agree to be guinea pigs in the exercise of their profession.
p.(None): Conversely, many volunteers are not compensated (when their contribution is minimal, or when, as
p.(None): in the case of students, they derive an intellectual or didactic benefit). It is therefore not possible to say,
p.(None): neither that all volunteers should be compensated, nor that any remuneration is unethical.
p.(None): From the equity point of view, the central problem in behavioral research therefore seems to be that of a possible
p.(None): discrimination, whether related to the research protocol itself, or to research results and
p.(None): how they will be understood and used (socio-cultural "spin-offs").
p.(None): Ethical review by "independent" bodies
p.(None): For bio-medical research, French law subjects the CCPPRB to "tests or experiments". She
p.(None): exempt "studies" (research work carried out on file, or on samples taken independently of
p.(None): the study (e.g. serum library).
p.(None): The federal American directives (DHHS, 1981) provided for three categories of research on
p.(None): humans: exempt from ethical review ("exempted research"), subject to an ethical review procedure
p.(None): simplified ("expedited review", by the office of an IRB), subject to in-depth ethical discussion (discussion in session
p.(None): by an IRB).
p.(None): We could propose for the human sciences a distinction between simple observation and situation
...

Political / Refugee Status

Searching for indicator asylum:

Political / criminal

Searching for indicator criminal:

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p.(None): or routine psychological "(National Commission ..., 1978-12, App. 1) (9).
p.(None): Examples of serious risks: experiences of isolation "out of time", sensory deprivation, endurance at
p.(None): "extreme" conditions, etc.
p.(None): For categories of vulnerable subjects, only experiences whose risks are of a level can be proposed
p.(None): minimal, or to use the terms of the French law of 1988, experiences which present "no risk
p.(None): seriously predictable. "
p.(None): Only healthy, adult subjects in full possession of their mental faculties, and
p.(None): fully informed, that we can offer to lend ourselves for the needs of research in the humanities to
p.(None): experiences involving risks from a level higher (as little as it is) to the minimum level.
p.(None): - How to reconcile the imperative of confidentiality of data with communication to non-medical researchers, in
p.(None): view of research, confidential medical records?
p.(None): The problem of ethics is a problem of respect for the personal sphere, and of non-disclosure of
p.(None): confidential data of which the attending physician is the custodian. We can trust sections 7 to 13 of the Code
p.(None): of ethics of psychologists (3), modeled on the rules of medical confidentiality.
p.(None): Beyond the ethical problem, there is a legal and regulatory problem in France. Some texts by
p.(None): reference are: Art. 226.13 and 226.14 (former Art. 378) of the Criminal Code (10), Law No. 78-17 of January 6
p.(None): 1978 relating to data processing, files and freedoms, Decree n ° 79-506 of June 28, 1979 relating
p.(None): Code of medical ethics. These texts exclude the communication by the doctor of personal data to
p.(None): anyone, except to another doctor and in the strict interest of the health of a patient (e.g. specialist consultation
p.(None): for a therapeutic opinion).
p.(None): The problem of communication of data for research has been studied extensively in
p.(None): 1980s on cancer registers and epidemiological research, between the CNIL, the CCNE, the Order of
p.(None): doctors. The solution proposed had been that of shared professional secrecy. This solution is not yet
p.(None): legal (11).
p.(None): In the current state of the law, only is admissible (in the hospital setting, for example) a
p.(None): study using nominative medical data within the department where the patients were treated, and under the
p.(None): responsibility of a doctor of the service. The procedure followed by Pr. M. Carlier (CNRS file, Carlier project) is not
p.(None): not right. It is the doctor in charge of the service (and not the research psychologist) who should have
p.(None): contact the families and seek their consent to the research. Families could
p.(None): legitimately complain that a psychologist contacted them (by phone, then directly) for a
p.(None): research on their twins, which implied that this psychologist had read their medical records
p.(None): before any consent from them, and therefore that the head of department concerned has not respected medical confidentiality.
p.(None): The use of nominative medical data for research is therefore necessarily under
...

p.(None): of human behavior "does not exclude clinical disciplines, such as inspirational psychology
p.(None): This denomination has the advantage of emphasizing that this is research on human beings other than
p.(None): biomedical.
p.(None): 2. See report written by Y. Laporte.
p.(None): 3. A Code of ethics was adopted in 1961 (rev.1976) by the French Psychological Society. It applied
p.(None): to the members of the Society. This code has been taken up and updated, following "the evolution of the profession and its legislation"
p.(None): (law of July 25, 85) by the National Association of Organizations of Psychologists (ANOP). The Code of Ethics
p.(None): des psychologues (1987) applies to all French psychologists, and to psychology students.
p.(None): This is a professional code of ethics, analogous to the doctors' code of ethics
p.(None): French. It is not a research ethics code (as the declaration is for doctors
p.(None): Helsinki-Tokyo of the World Medical Association).
p.(None): This code contains rules which, applying to all activities of psychologists, also apply
p.(None): research activities. General rules: "use only means which respect dignity
p.(None): human "(Art.2)," avoid harm "(Art.15). Special rules relating to professional secrecy (Arts 7 to 12):
p.(None): "7 The psychologist is subject to the rule of professional secrecy defined here as psychological secrecy."
p.(None): "8 This rule must apply under conditions analogous to those defined by article 378 of the Code
p.(None): criminal. "
p.(None): "9 In particular, it is recalled that this secrecy must extend, in the private domain of persons, to
p.(None): everything that the psychologist "saw, heard or understood" during his practice or research. "
p.(None): "10 Secrecy must be safeguarded both in words and in the conservation and
p.(None): dissemination of documents.The psychologist must ensure that the elements resulting from his work (reports,
p.(None): conclusions, reports, presentations, etc ...) are always written, presented and classified in a way to prevent and
p.(None): keep that secret. "
p.(None): "11 In its cooperation with other specialists, also subject to professional secrecy, the
p.(None): psychologist shares with them the information strictly necessary for the team management of a "client". "
p.(None): "12 He shall safeguard the secrecy of the identity of persons during the creation of data files, in
p.(None): compliance with the law of April 6, 1978, relating to information and freedoms. "
p.(None): "13 Apart from cases of legal obligation, the psychologist cannot be released from its secrecy by anyone, even by those
p.(None): that this secret concerns. "
p.(None): Two rules concern scientific work, through the duty of training:
p.(None): "17 All psychologists, whatever their specialty, must be constantly informed of scientific progress
p.(None): discipline and train accordingly. He takes these advances into account in his work and strives to
p.(None): to compete. He will accept all the rules, requirements and constraints imposed by scientific work. "
p.(None): "19 All psychologists endeavor to research and apply scientifically controlled criteria and methods and
p.(None): communicative, thereby excluding the principle of authority. "
p.(None): A rule may apply to the request for informed consent:
...

Political / political affiliation

Searching for indicator party:

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p.(None): risk minimization and profit optimization, consent rule), are the same, that
p.(None): be biomedical research, or behavioral research. It will also be recognized that the procedure consisting
p.(None): to submit research protocols on humans, before their execution, to the examination of a committee
p.(None): independent ', or' ethics committee ', or' personal protection committee, is applicable to research
p.(None): behavioral. In what follows we will speak of "CCPPRC" (Consultative committees for the protection of persons in the
p.(None): behavioral research), without prejudging their relationship with the CCPPRB instituted by law n ° 88-1138 of 20 December
p.(None): 1988 (which will be considered later).
p.(None): Broad outlines
p.(None): Freedom of the people
p.(None): Freedom has a negative aspect (independence): not being led to do what you don't want, and a positive aspect
p.(None): (autonomy): act in accordance with what you really want for yourself. It is usually accepted that respecting the
p.(None): freedom of people implies that we accept the rule: no investigation will be conducted on people
p.(None): without these people having given their "free, informed and
p.(None): express "(L. 209-9).
p.(None): By adapting the law n ° 88-1138 of December 20, 1988 (Art. L. 209-9):
p.(None): - Consent is express if it is "given in writing or, if impossible, attested by an independent third party ...
p.(None): investigators. "
p.(None): - Consent is informed if the subject has been sufficiently informed, if he has understood
p.(None): the information, if it has had a period of reflection before making its choice known. So that the information is
p.(None): sufficient, the law of 20 December 1988 specifies that the investigator must make known to the subject:
p.(None): - the objective of the research, its methodology and its duration,
p.(None): - the expected benefits, the constraints and the foreseeable risks, including in the event of stopping the research before
p.(None): his term,
p.(None): - the opinion of the CCPPRC.
p.(None): - Consent is free if the investigator abstains from any pressure, coercion, or incitement
p.(None): strong (money, passing an exam, career advantage, emotional blackmail, etc.).
p.(None): Furthermore, consent to research is revocable. Subjects should be informed that they can at any
p.(None): moment stop participating, without incurring any sanction or reproach.
p.(None): Security. The human cost
p.(None): In biomedical research it is admitted that certain research protocols imply for the people who are there
p.(None): lend a "direct individual benefit" (Art. L. 209-1). This notion of (potential) benefit for the subject
p.(None): is used in medicine to authorize inclusion in research protocols, under certain conditions (Art. L.
p.(None): 209-6) of persons whose consent is precarious or even impossible (minors, adults under guardianship,
...

Political / vulnerable

Searching for indicator vulnerable:

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p.(None): exempt "studies" (research work carried out on file, or on samples taken independently of
p.(None): the study (e.g. serum library).
p.(None): The federal American directives (DHHS, 1981) provided for three categories of research on
p.(None): humans: exempt from ethical review ("exempted research"), subject to an ethical review procedure
p.(None): simplified ("expedited review", by the office of an IRB), subject to in-depth ethical discussion (discussion in session
p.(None): by an IRB).
p.(None): We could propose for the human sciences a distinction between simple observation and situation
p.(None): experimental to provide for a rapid procedure (simple examination of the protocol), and a normal procedure
p.(None): ethical review (may require the effective presence of investigators). However, this distinction is
p.(None): delicate handling: there are indeed, as D. Widlöcher pointed out to us, "very harmless experiments",
p.(None): and possibly traumatic observations.
p.(None): Problems specific to behavioral research, identified using protocols submitted by the CNRS
p.(None): Consent
p.(None): - Under what conditions is behavioral research admissible on subjects including the ability to consent
p.(None): is problematic (limited competence, dependence)?
p.(None): The general rule is that people whose consent is precarious must be protected against
p.(None): the possibility of serving as "subjects" of research, in proportion to their incapacity and their dependence.
p.(None): Some vulnerable categories to be protected especially in behavioral research are: children, infirm
p.(None): mental, people easily manipulated by their own weakness or dependence
p.(None): (e.g. drug addicts), institutionalized captive populations (prisoners, pupils, adolescents under
p.(None): supervised education, young people in shelters, soldiers).
p.(None): - For minors and adults under guardianship, the accepted rule for biomedical research (L. 209-10) can be
p.(None): generalized: consent of parents or legal guardians, information of the child or the incapable person throughout the
p.(None): as far as possible, respect for a possible refusal by the child or the incapable person.
p.(None): - For institutionalized captive populations (prisoners, pupils, adolescents from
p.(None): recovery ', young people in homes), the usual rule is to consider admissible only research (1)
...

p.(None): risks incurred by subjects subjected to the experiment. The same reasoning applies to psychology.
p.(None): Reminder: technically a risk is the product of gravity by a probability. Risk assessment
p.(None): therefore involves a double assessment: of the seriousness of the disorders likely to be provoked in the subject
p.(None): experience, the probability of occurrence of these disorders.
p.(None): The distinction between "minimal risk" (negligible) and "non minimal risk" (significant, serious (8)) has been
p.(None): introduced in 1978 by the American National Commission. "No risk" does not exist in companies
p.(None): human. The "minimal" risks are risks of the same order of magnitude as the risks taken
p.(None): fluently without thinking about it in everyday life. So, for children, the minimum risk is defined
p.(None): like the one whose "probability and severity are of the same order as those of physical damage or
p.(None): psychological problems to which healthy children are normally exposed in their lives, or in medical examinations
p.(None): or routine psychological "(National Commission ..., 1978-12, App. 1) (9).
p.(None): Examples of serious risks: experiences of isolation "out of time", sensory deprivation, endurance at
p.(None): "extreme" conditions, etc.
p.(None): For categories of vulnerable subjects, only experiences whose risks are of a level can be proposed
p.(None): minimal, or to use the terms of the French law of 1988, experiences which present "no risk
p.(None): seriously predictable. "
p.(None): Only healthy, adult subjects in full possession of their mental faculties, and
p.(None): fully informed, that we can offer to lend ourselves for the needs of research in the humanities to
p.(None): experiences involving risks from a level higher (as little as it is) to the minimum level.
p.(None): - How to reconcile the imperative of confidentiality of data with communication to non-medical researchers, in
p.(None): view of research, confidential medical records?
p.(None): The problem of ethics is a problem of respect for the personal sphere, and of non-disclosure of
p.(None): confidential data of which the attending physician is the custodian. We can trust sections 7 to 13 of the Code
p.(None): of ethics of psychologists (3), modeled on the rules of medical confidentiality.
p.(None): Beyond the ethical problem, there is a legal and regulatory problem in France. Some texts by
p.(None): reference are: Art. 226.13 and 226.14 (former Art. 378) of the Criminal Code (10), Law No. 78-17 of January 6
p.(None): 1978 relating to data processing, files and freedoms, Decree n ° 79-506 of June 28, 1979 relating
p.(None): Code of medical ethics. These texts exclude the communication by the doctor of personal data to
p.(None): anyone, except to another doctor and in the strict interest of the health of a patient (e.g. specialist consultation
p.(None): for a therapeutic opinion).
...

p.(None): "19 All psychologists endeavor to research and apply scientifically controlled criteria and methods and
p.(None): communicative, thereby excluding the principle of authority. "
p.(None): A rule may apply to the request for informed consent:
p.(None): "18 The psychologist is careful not to limit the autonomy of others and, in particular, their possibilities
p.(None): of information, freedom of judgment and decision. "
p.(None): A special rule applies to the treatment of experimental animals:
p.(None): "26 When its activities relate to animal behavior with a view to understanding human behavior,
p.(None): it strives to ensure the well-being and survival of the animals studied. "
p.(None): The absence of an equivalent rule for the treatment of persons suitable for research
p.(None): behavioral implies that research subjects are not treated differently from other subjects
p.(None): that the psychologist is dealing with in his professional activity (therefore, for example, that a treatment
p.(None): different in "therapeutic" and "non-therapeutic" situation is not envisaged).
p.(None): 4. On the concept of consent and its ambiguities, see: Thouvenin (1992).
p.(None): 5. cf. experiences of Stanley Milgram, evoked in the film "I" like Icarus. Reference publication: Milgram S.
p.(None): (1963), 'Behavioral study of obedience ", J Abnorm Psychol, 67: 371-378.
p.(None): 6. Engl. "Deception", "deceptive research".
p.(None): 7. In English: "debriefing"
p.(None): 8. The French law of 20 Dec. 1988 says "serious risk" and states that for people belonging to categories
p.(None): vulnerable research "without direct individual benefit" is admissible only if it presents "no risk
p.(None): foreseeable seriousness "(Art. L.209-6).
p.(None): 9. The Royal College of Physicians of London Report (1986) shows that the risk is considered minimal, either because the
p.(None): disorder is of very low severity, either because the
p.(None): accident probability is very low. In the latter case, the risk "is comparable to the risk incurred by a passenger
p.(None): plane using a regular flight "(cf. Ménard Report, 1990).
p.(None): 10. Art. 226.13 - "The revelation of secret information by a person who is its custodian either
p.(None): by state or by profession, either because of a temporary function or mission, is punished by one year
p.(None): imprisonment and a fine of 100,000 francs. "
p.(None): Art.226.14 - "Article 226.13 is not applicable in cases where the law requires or authorizes the disclosure of the secret.
p.(None): In addition, it does not apply: 1) To one who informs the judicial, medical or administrative authorities of
p.(None): ill-treatment or hardship of which he has knowledge and which has been inflicted on a minor of fifteen years or on a person who
p.(None): is unable to protect himself because of his age or his physical or mental state; 2) To the doctor who, with
...

Health / Cognitive Impairment

Searching for indicator cognitive:

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p.(None): of ethics for the life sciences and health (CCNE) five files describing research in
p.(None): psychology carried out in university laboratories supported by the CNRS or carried out in part by
p.(None): CNRS researchers, as well as a description of the research carried out in psychology at the CNRS. Among the five files
p.(None): submitted, which had the approval of the competent scientific commission of the CNRS, two (Duyme and
p.(None): Carlier2) come from the laboratory directed by Pr. Roubertoux and correspond to research that has been
p.(None): interrupted, following an article published in the newspaper L'Express on December 17, 1992.
p.(None): CCNE has set up a working group.
p.(None): The working group took note of the wide variety of research carried out at the CNRS in the humanities.
p.(None): For psychology: fifteen research units (URA in general), i.e. 150 researchers and around 200
p.(None): teacher-researchers, are grouped in Section 29 "Mental functions, integrative neuroscience and
p.(None): behaviors ", co-managed by the Department of Life Sciences, and the Department of Life Sciences
p.(None): man and society. The objective of research is to "understand the skills and performance of being
p.(None): human during different periods of his life, in usual situations as well as in
p.(None): exceptional situations ". The methods range from simple observation in a natural situation or
p.(None): standardized, to test reactions in "borderline situations". Subjects are recruited on the basis of
p.(None): volunteering. The sub-disciplines identified are: child and developmental psychology,
p.(None): social psychology, cognitive psychology, work psychology, ergonomics, psycholinguistics,
p.(None): psychopathology, clinical psychology, neuropsychology, psychopharmacology. Interfaces with
p.(None): neighboring disciplines are frequent: anthropology, neuroscience, psychiatry, linguistics, sociology,
p.(None): educational sciences, artificial intelligence, etc.
p.(None): The working group met approximately once a month between January and June 1993. It met with the Committee
p.(None): operational on ethics in the life sciences of the CNRS (COPE,
p.(None): January 22, 1993). He heard from several researchers. He inquired about the specific problems of
p.(None): humanities research, professional codes of ethics, how investigations
p.(None): experimental studies in the humanities are supervised in other countries.
p.(None): CCNE notes that in France, since the "law on the protection of persons who lend themselves to research
p.(None): biomedical "of December 20, 1988, the" tests or experiments organized and practiced on the being
p.(None): human for the development of biological or medical knowledge "takes place in a legal framework
p.(None): precise and binding. In contrast, the legislator did not pay attention to the protection of persons who
p.(None): lend themselves to behavioral research, and investigations carried out on human beings with a view to
p.(None): development of knowledge in the disciplines called "human sciences" remained in a situation
p.(None): fuzzy legal.
p.(None): CCNE summarizes below:
p.(None): - the ethical principles which must guide any investigation into human subjects,
...

p.(None): - the expected benefits, the constraints and the foreseeable risks, including in the event of stopping the research before
p.(None): his term,
p.(None): - the opinion of the CCPPRC.
p.(None): - Consent is free if the investigator abstains from any pressure, coercion, or incitement
p.(None): strong (money, passing an exam, career advantage, emotional blackmail, etc.).
p.(None): Furthermore, consent to research is revocable. Subjects should be informed that they can at any
p.(None): moment stop participating, without incurring any sanction or reproach.
p.(None): Security. The human cost
p.(None): In biomedical research it is admitted that certain research protocols imply for the people who are there
p.(None): lend a "direct individual benefit" (Art. L. 209-1). This notion of (potential) benefit for the subject
p.(None): is used in medicine to authorize inclusion in research protocols, under certain conditions (Art. L.
p.(None): 209-6) of persons whose consent is precarious or even impossible (minors, adults under guardianship,
p.(None): people staying in a health or social establishment, sick in an emergency).
p.(None): In behavioral research, there may exist cases of investigation "with direct individual benefit", for example
p.(None): example in clinical psychology during a comparative study of two psychotherapeutic methods (if for subjects
p.(None): which lend themselves to the benefit of at least one of the methods is established), or in cognitive psychology (if doing so for
p.(None): children to participate in a study gives them an educational advantage, as was discussed in the
p.(None): CNRS file on the Lautrey protocol). But the absence of vital emergencies forcing the practitioner to intervene, and
p.(None): the difficulty of arguing that research is conducted "for the good" of the subjects included, or "in the interest of their
p.(None): health ", fact that the distinction" with / without direct individual benefit "is not relevant in research
p.(None): behavior to relax the conditions of consent, even when it comes to applied research. The
p.(None): distinction is only relevant in the context of the risk / benefit balance.
p.(None): CCNE noted in its 1990 report that, in general, people who lend themselves to a
p.(None): investigation whose objective is the acquisition of knowledge about the human being do not find there
p.(None): personal benefit. CCNE considered that this is admissible, "on condition of a balance sheet
p.(None): acceptable risk-benefit, that is, definite benefit to the community, little or no risk to the individual "
p.(None): (p. 70).
p.(None): Taking a risk-benefit assessment is asking yourself whether the risks, constraints or
p.(None): inconvenience imposed on subjects ("human cost") are sufficiently justified by the importance
p.(None): scientist of the question asked, and by the assurance that the protocol gives to resolve this question.
...

p.(None): far: "Apart from cases of legal obligation, the psychologist cannot be released from his secret by anyone, even by
p.(None): those to whom this secrecy concerns "(Art. 13). The justification of the rule that even the person concerned cannot untie
p.(None): doctor or psychologist of the secret is that, to untie someone from the secret, you have to know what it is. Now the
p.(None): clinical psychologist is not required to communicate his cards to his client. And the French patient has only one access
p.(None): indirect to his medical file, of which he generally ignores what it contains.
p.(None): If French law is moving towards a new derogation from medical confidentiality, with a view to scientific research,
p.(None): this therefore also implies a modification of the Code of medical ethics, a modification of the Code of ethics of
p.(None): psychologists, and undoubtedly in the long term for all patients a right of direct access to their medical file, therefore a
p.(None): modification of the law "IT and liberties", and of the law on access to administrative documents.
p.(None): Equity issues
p.(None): - How to reconcile research on discriminating traits with the imperative of non-discrimination?
p.(None): This is a delicate problem, because the identification of significant differences and discriminating traits
p.(None): is precisely a plausible research objective. So it is interesting, and important for
p.(None): assessing LDC techniques, to ask whether
p.(None): there is a significant difference between the cognitive development of children born with an IAD and the others (dossier
p.(None): CNRS, Duyme project). But if we find that IAD children develop less well than others, and
p.(None): that the result of the research is made public, children already born of IAD (or their parents) are put in position
p.(None): difficult, even if the secret of the origins is well kept (danger of guilt).
p.(None): In the case of the Duyme protocol, every precaution was taken so that research was not a source of
p.(None): discrimination by its methodology.
p.(None): In addition to the methodology, research may involve a risk of explicit or implicit discrimination against
p.(None): individuals by the assumptions on which it is based (eg experimentation with "aversion therapies" to
p.(None): caring for homosexuals; psychosocial monitoring of a cohort of children born to alcoholic mothers). A search can also
p.(None): entail a risk of discrimination against an entire population by the interpretation which will be made of its results
p.(None): (e.g. highlighting statistically worse results in some intelligence tests)
p.(None): among blacks than among whites).
p.(None): In the United States at the end of the 1960s, the concern for a "science for the people" caused investigations to be halted,
p.(None): reason that their theoretical implications were infamous for certain categories of individuals. We
...

Health / Drug Dependence

Searching for indicator dependence:

(return to top)
p.(None): From the equity point of view, the central problem in behavioral research therefore seems to be that of a possible
p.(None): discrimination, whether related to the research protocol itself, or to research results and
p.(None): how they will be understood and used (socio-cultural "spin-offs").
p.(None): Ethical review by "independent" bodies
p.(None): For bio-medical research, French law subjects the CCPPRB to "tests or experiments". She
p.(None): exempt "studies" (research work carried out on file, or on samples taken independently of
p.(None): the study (e.g. serum library).
p.(None): The federal American directives (DHHS, 1981) provided for three categories of research on
p.(None): humans: exempt from ethical review ("exempted research"), subject to an ethical review procedure
p.(None): simplified ("expedited review", by the office of an IRB), subject to in-depth ethical discussion (discussion in session
p.(None): by an IRB).
p.(None): We could propose for the human sciences a distinction between simple observation and situation
p.(None): experimental to provide for a rapid procedure (simple examination of the protocol), and a normal procedure
p.(None): ethical review (may require the effective presence of investigators). However, this distinction is
p.(None): delicate handling: there are indeed, as D. Widlöcher pointed out to us, "very harmless experiments",
p.(None): and possibly traumatic observations.
p.(None): Problems specific to behavioral research, identified using protocols submitted by the CNRS
p.(None): Consent
p.(None): - Under what conditions is behavioral research admissible on subjects including the ability to consent
p.(None): is problematic (limited competence, dependence)?
p.(None): The general rule is that people whose consent is precarious must be protected against
p.(None): the possibility of serving as "subjects" of research, in proportion to their incapacity and their dependence.
p.(None): Some vulnerable categories to be protected especially in behavioral research are: children, infirm
p.(None): mental, people easily manipulated by their own weakness or dependence
p.(None): (e.g. drug addicts), institutionalized captive populations (prisoners, pupils, adolescents under
p.(None): supervised education, young people in shelters, soldiers).
p.(None): - For minors and adults under guardianship, the accepted rule for biomedical research (L. 209-10) can be
p.(None): generalized: consent of parents or legal guardians, information of the child or the incapable person throughout the
p.(None): as far as possible, respect for a possible refusal by the child or the incapable person.
p.(None): - For institutionalized captive populations (prisoners, pupils, adolescents from
p.(None): recovery ', young people in homes), the usual rule is to consider admissible only research (1)
p.(None): "minimal risk", and (2) non-discriminatory. Consent must be obtained from those responsible for
...

Health / Drug Usage

Searching for indicator drug:

(return to top)
p.(None): by an IRB).
p.(None): We could propose for the human sciences a distinction between simple observation and situation
p.(None): experimental to provide for a rapid procedure (simple examination of the protocol), and a normal procedure
p.(None): ethical review (may require the effective presence of investigators). However, this distinction is
p.(None): delicate handling: there are indeed, as D. Widlöcher pointed out to us, "very harmless experiments",
p.(None): and possibly traumatic observations.
p.(None): Problems specific to behavioral research, identified using protocols submitted by the CNRS
p.(None): Consent
p.(None): - Under what conditions is behavioral research admissible on subjects including the ability to consent
p.(None): is problematic (limited competence, dependence)?
p.(None): The general rule is that people whose consent is precarious must be protected against
p.(None): the possibility of serving as "subjects" of research, in proportion to their incapacity and their dependence.
p.(None): Some vulnerable categories to be protected especially in behavioral research are: children, infirm
p.(None): mental, people easily manipulated by their own weakness or dependence
p.(None): (e.g. drug addicts), institutionalized captive populations (prisoners, pupils, adolescents under
p.(None): supervised education, young people in shelters, soldiers).
p.(None): - For minors and adults under guardianship, the accepted rule for biomedical research (L. 209-10) can be
p.(None): generalized: consent of parents or legal guardians, information of the child or the incapable person throughout the
p.(None): as far as possible, respect for a possible refusal by the child or the incapable person.
p.(None): - For institutionalized captive populations (prisoners, pupils, adolescents from
p.(None): recovery ', young people in homes), the usual rule is to consider admissible only research (1)
p.(None): "minimal risk", and (2) non-discriminatory. Consent must be obtained from those responsible for
p.(None): the institution, on the other hand of each subject individually (if the subjects are minor, of the person who
...

p.(None): Recommendations, and Appendix (1977). Research Involving Those Institutionalized as Mentally Infirm:
p.(None): Report and Recommendations, and Appendix (1978). The Belmont Report: Ethical Principles and Guidelines
p.(None): for Research Involving Human Subjects (1978), Washington D.C .: US Govt Printing Office (DHEW); tr. Fr.
p.(None): in: Medicine and experimentation (1982), Cahiers de bioéthique, 4, Québec: Presses de l'Université Laval, 233-250.
p.(None): Newton Lisa H. (1982), Dentists and pseudo-patients: further meditations on deception in research, IRB, 4 (8): 6-8.
p.(None): Park L.C., Covi L., Uhlenhuth E.H. (1967), Effects of informed consent on research patients and study results, J Nerv
p.(None): Ment Dis, 145: 349-357.
p.(None): Pattulo E.L. (1980), Who risks what in social research ?, IRB, 2 (3): 1-3, 12.
p.(None): Queheillard Jean-Louis (1989), Professional secret: the great forgotten?, Psychologists and psychologies, n ° 89.
p.(None): Redlich Fritz (1973), The anthropologist as observer; ethical aspects of clinical observations of behavior, J Nerv Ment
p.(None): Say, 157: 313-319.
p.(None): Robertson John A. (1981), Ethical review of social experiments, IRB, 3 (7): 10-11.
p.(None): Royal College of Physicians (1986), 'Research on healthy volunteers', J Roy Coll Physicians, London, 20: 243-257.
p.(None): Schafer Arthur (1981), The ethics of research on human beings; a critical review of the issues and
p.(None): arguments, Res Adv Alcohol Drug Probl, 6: 471-511.
p.(None): Schiff Michel (1991), The dead ends of research in psychology, Psychologists and psychologies, n ° 104.
p.(None): Schmutte Gregory T. (1980), Using students as subjects without their knowledge, IRB, 2 (10): 5-6.
p.(None): Schuler Heinz (1980), Ethische Probleme psychologischer Forschung, Göttingen.
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): 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): Sieber Joan E. (1983), Deception in social research II: Evaluating the potential for harm or wrong, IRB, 5 (1): 1-6.
p.(None): Sieber Joan E. (1983), Deception in social research III: The nature and limits of debriefing, IRB, 5 (3): 1-4.
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): St James-Roberts Ian (1976), Are researchers trustworthy ?, New Scientist, 171: 481-483.
p.(None): Thouvenin Dominique (1992), The influence of law n ° 88-1138 of 20 Dec 1988 (modified n ° 90-86) on the organization of
p.(None): research, Hospital management - Research - The hospital, n ° 320.
p.(None): Thouvenin D. (1992), Consent and subjugation, in: Gros & Huber, eds., Vers un anti-destin? Heritage
p.(None): genetics and human rights, Paris: Editions Odile Jacob, pp. 471-478.
p.(None): US Dept of Health and Human Services (1981), Final regulations amending basic HHS policy for the protection of human
...

Searching for indicator influence:

(return to top)
p.(None): Say, 157: 313-319.
p.(None): Robertson John A. (1981), Ethical review of social experiments, IRB, 3 (7): 10-11.
p.(None): Royal College of Physicians (1986), 'Research on healthy volunteers', J Roy Coll Physicians, London, 20: 243-257.
p.(None): Schafer Arthur (1981), The ethics of research on human beings; a critical review of the issues and
p.(None): arguments, Res Adv Alcohol Drug Probl, 6: 471-511.
p.(None): Schiff Michel (1991), The dead ends of research in psychology, Psychologists and psychologies, n ° 104.
p.(None): Schmutte Gregory T. (1980), Using students as subjects without their knowledge, IRB, 2 (10): 5-6.
p.(None): Schuler Heinz (1980), Ethische Probleme psychologischer Forschung, Göttingen.
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): 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): Sieber Joan E. (1983), Deception in social research II: Evaluating the potential for harm or wrong, IRB, 5 (1): 1-6.
p.(None): Sieber Joan E. (1983), Deception in social research III: The nature and limits of debriefing, IRB, 5 (3): 1-4.
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): St James-Roberts Ian (1976), Are researchers trustworthy ?, New Scientist, 171: 481-483.
p.(None): Thouvenin Dominique (1992), The influence of law n ° 88-1138 of 20 Dec 1988 (modified n ° 90-86) on the organization of
p.(None): research, Hospital management - Research - The hospital, n ° 320.
p.(None): Thouvenin D. (1992), Consent and subjugation, in: Gros & Huber, eds., Vers un anti-destin? Heritage
p.(None): genetics and human rights, Paris: Editions Odile Jacob, pp. 471-478.
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): Villey Raymond (1986), History of medical secrecy, Paris: Seghers.
p.(None): Warwick Donald P. (1975), Deceptive research: social scientists ought to stop lying, Psychology Today, Feb:
p.(None): 38-.
p.(None): Swiss scientific academies, 22-26 March 93, Symposium "Freedom and responsibility: Moral issues facing the
p.(None): humanities and social sciences "(Acts to appear).
p.(None): American Anthropological Association, Code of Ethics.
p.(None): Anthropology and societies, Department of anthropology of Laval University, Quebec, special issue
p.(None): "Understanding and Modifying", 1984, vol. 8, n ° 3, including a code of professional ethics.
p.(None): Code of ethics of the Brazilian Association of Anthropology, adopted at its 16th meeting, in Campinas (Sâo
p.(None): Paulo), March 30, 1988 ("Codico de Etica").
p.(None): Current Anthropology, Chicago, vol. IX, 5, 1968, then vol. XI, 1, 1970, finally vol. XII, 1, 1971 (to
p.(None): from a symposium "On the social responsabilities in social anthropology".
...

Health / Healthy People

Searching for indicator healthy volunteers:

(return to top)
p.(None): 153-156.
p.(None): Gosselin Gabriel (1992), An ethics of the social sciences, Paris: L'Harmattan.
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): Katz Jay (1972), Experimentation with Human Beings? The Authority of the Investigator, Subject, Professions and State
p.(None): in the Human Experimentation Process, New York: Russell Sage Foundation.
p.(None): Levine Carol (1982), Former soldier denied compensation for damage in army LSD tests, IRB, 4 (3): 7.
p.(None): Levine Robert J. (1986), Ethics and Regulation of Clinical Research, Baltimore-Munich: Urban & Schwarzenberg,
p.(None): 2nd edition.
p.(None): Macklin Ruth (1989), The paradoxical case of payment as benefit to research subjects, IRB, 11 (6): 1-3.
p.(None): Marini James L. (1980), Methodology and ethics: research on human aggression, IRB, 2 (5): 1-4.
p.(None): Mead Margaret (1969), Research with human beings: a model derived from anthropological field practice, Daedalus, 98:
p.(None): 361-386.
p.(None): Meyer Roger E. (1977), Subjects' rights, freedom of inquiry, and the future of research in the addictions, Am J
p.(None): Psychiatry, 134 (8): 899-903.
p.(None): Menard Joël (1990), Report from the INSERM think tank on certain aspects of protecting subjects
p.(None): healthy volunteers and people who lend themselves to biomedical research, Paris: INSERM.
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 and
p.(None): Recommendations, and Appendix (1977). Research Involving Those Institutionalized as Mentally Infirm:
p.(None): Report and Recommendations, and Appendix (1978). The Belmont Report: Ethical Principles and Guidelines
p.(None): for Research Involving Human Subjects (1978), Washington D.C .: US Govt Printing Office (DHEW); tr. Fr.
p.(None): in: Medicine and experimentation (1982), Cahiers de bioéthique, 4, Québec: Presses de l'Université Laval, 233-250.
p.(None): Newton Lisa H. (1982), Dentists and pseudo-patients: further meditations on deception in research, IRB, 4 (8): 6-8.
p.(None): Park L.C., Covi L., Uhlenhuth E.H. (1967), Effects of informed consent on research patients and study results, J Nerv
p.(None): Ment Dis, 145: 349-357.
p.(None): Pattulo E.L. (1980), Who risks what in social research ?, IRB, 2 (3): 1-3, 12.
p.(None): Queheillard Jean-Louis (1989), Professional secret: the great forgotten?, Psychologists and psychologies, n ° 89.
p.(None): Redlich Fritz (1973), The anthropologist as observer; ethical aspects of clinical observations of behavior, J Nerv Ment
p.(None): Say, 157: 313-319.
p.(None): Robertson John A. (1981), Ethical review of social experiments, IRB, 3 (7): 10-11.
p.(None): Royal College of Physicians (1986), 'Research on healthy volunteers', J Roy Coll Physicians, London, 20: 243-257.
p.(None): Schafer Arthur (1981), The ethics of research on human beings; a critical review of the issues and
p.(None): arguments, Res Adv Alcohol Drug Probl, 6: 471-511.
p.(None): Schiff Michel (1991), The dead ends of research in psychology, Psychologists and psychologies, n ° 104.
p.(None): Schmutte Gregory T. (1980), Using students as subjects without their knowledge, IRB, 2 (10): 5-6.
p.(None): Schuler Heinz (1980), Ethische Probleme psychologischer Forschung, Göttingen.
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): 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): Sieber Joan E. (1983), Deception in social research II: Evaluating the potential for harm or wrong, IRB, 5 (1): 1-6.
p.(None): Sieber Joan E. (1983), Deception in social research III: The nature and limits of debriefing, IRB, 5 (3): 1-4.
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): St James-Roberts Ian (1976), Are researchers trustworthy ?, New Scientist, 171: 481-483.
p.(None): Thouvenin Dominique (1992), The influence of law n ° 88-1138 of 20 Dec 1988 (modified n ° 90-86) on the organization of
p.(None): research, Hospital management - Research - The hospital, n ° 320.
p.(None): Thouvenin D. (1992), Consent and subjugation, in: Gros & Huber, eds., Vers un anti-destin? Heritage
...

Searching for indicator volunteers:

(return to top)
p.(None): In biomedical research, the principle of justice serves first to remind us that scientific research must not
p.(None): be an opportunity for exploitation (for example, exploitation by researchers from developed countries,
p.(None): poor people in developing countries, who serve as "guinea pigs" for the acquisition of knowledge including
p.(None): the therapeutic benefits mainly benefit the populations of rich countries: cf. WHO-CIOMS, 1982). It serves
p.(None): then recall, as CCNE did in its 1990 report (p. 72), that participation in a protocol
p.(None): research calls for "fair compensation" or "compensation" for subjects, but excludes any compensation.
p.(None): In behavioral research, cases of exploitation (north-south) have been mentioned (in ethnology, in
p.(None): anthropology), but there was, in general, in the background a problem of ethnic or cultural discrimination
p.(None): (relation of "developed" to "wild"). Frank risks of discrimination have been raised in connection with
p.(None): the investigation of distinctive features which are a source of social valuation or devaluation ("intelligence quotient",
p.(None): "crime chromosome", etc.). On the other hand, in behavioral research, the practice of paying subjects
p.(None): (on vacations, for example) has so far raised few objections. There are salaried professionals
p.(None): (test pilots, scuba divers) who agree to be guinea pigs in the exercise of their profession.
p.(None): Conversely, many volunteers are not compensated (when their contribution is minimal, or when, as
p.(None): in the case of students, they derive an intellectual or didactic benefit). It is therefore not possible to say,
p.(None): neither that all volunteers should be compensated, nor that any remuneration is unethical.
p.(None): From the equity point of view, the central problem in behavioral research therefore seems to be that of a possible
p.(None): discrimination, whether related to the research protocol itself, or to research results and
p.(None): how they will be understood and used (socio-cultural "spin-offs").
p.(None): Ethical review by "independent" bodies
p.(None): For bio-medical research, French law subjects the CCPPRB to "tests or experiments". She
p.(None): exempt "studies" (research work carried out on file, or on samples taken independently of
p.(None): the study (e.g. serum library).
p.(None): The federal American directives (DHHS, 1981) provided for three categories of research on
p.(None): humans: exempt from ethical review ("exempted research"), subject to an ethical review procedure
p.(None): simplified ("expedited review", by the office of an IRB), subject to in-depth ethical discussion (discussion in session
p.(None): by an IRB).
p.(None): We could propose for the human sciences a distinction between simple observation and situation
p.(None): experimental to provide for a rapid procedure (simple examination of the protocol), and a normal procedure
p.(None): ethical review (may require the effective presence of investigators). However, this distinction is
p.(None): delicate handling: there are indeed, as D. Widlöcher pointed out to us, "very harmless experiments",
p.(None): and possibly traumatic observations.
p.(None): Problems specific to behavioral research, identified using protocols submitted by the CNRS
p.(None): Consent
p.(None): - Under what conditions is behavioral research admissible on subjects including the ability to consent
...

p.(None): redacted results.
p.(None): The risks of discrimination depend on the level of social tolerance for this or that "difference". We can
p.(None): propose the rule: the risks of discrimination must be identified, and weighed against the collective interest and
p.(None): theoretical interest in obtaining the desired result.
p.(None): - Should the promoters of behavioral research take out insurance covering the risks incurred
p.(None): by research subjects due to the investigation?
p.(None): In biomedical research, French law requires promoters to take out insurance (Art.
p.(None): L. 209-7) guaranteeing its civil liability in the event of harmful consequences of research for the
p.(None): person who lends itself to it. We know that this provision of the law poses no problem when the promoter is
p.(None): the pharmaceutical industry, but that it poses a problem for research conducted by university teams
p.(None): and / or in small hospitals, which find it difficult to find a promoter with a seat
p.(None): sufficient financial resources to purchase insurance.
p.(None): In behavioral research, are the major research organizations (CNRS, university laboratories)
p.(None): able to act as research promoters? In the absence of identifying the promoter, we cannot in fact ask the
p.(None): insurance problem satisfactorily.
p.(None): One could argue that in the case of minimal risk behavior research, insurance is not
p.(None): essential, although there are physical risks to take into account, which, without being a consequence
p.(None): direct from the search, occur during the search (falls, commuting accidents). We
p.(None): could also argue that, for higher risk research, as proposed only
p.(None): to adult volunteers and responsible, fully consenting, it is up to these volunteers to subscribe a
p.(None): insurance, as for other risky activities (eg sports activities). But in the event of a dispute, he can always
p.(None): be argued that the researchers responsible for the project should not have offered volunteers such a situation
p.(None): at risk. And to our knowledge, there is at least one example of suicide following research in France
p.(None): behavioral risk (prolonged isolation "out of time").
p.(None): The problem of insurance for behavioral research on humans must therefore at least be posed. Solve it
p.(None): for the generality of the cases is the business of the legislator.
p.(None): Review of protocols. What would the CCPPRC (Consultative Committees for the Protection of Individuals in
p.(None): behavioral research)?
p.(None): It seems excluded that the CCPPRB in their current composition could examine research protocols
p.(None): in human sciences. They were not designed for this.
p.(None): It is not the role of the technical section of the CCNE to carry out a systematic review of
p.(None): humanities research.
p.(None): The French experience prior to law n ° 88-1138 of December 20, 1988 (ex. AP de Paris), as well as the
p.(None): North American model, would go in the direction of the creation of "Ethics committees for research in the humanities"
p.(None): with institutions which, in fact, conduct behavioral research on human subjects: CNRS, Universities.
p.(None): According to R.J. Levine (1986), these Committees are "the conscience of the institution", and the expression of its concern
p.(None): to ensure quality research within it and adequate protection for those who lend themselves to it. Rules
p.(None): affecting the composition of these committees (which should include a certain proportion of members from outside
p.(None): the institution, and / or outside the human sciences: ex. jurists, philosophers, doctors) could
...

Health / Mentally Disabled

Searching for indicator mentally:

(return to top)
p.(None): Levine Carol (1982), Former soldier denied compensation for damage in army LSD tests, IRB, 4 (3): 7.
p.(None): Levine Robert J. (1986), Ethics and Regulation of Clinical Research, Baltimore-Munich: Urban & Schwarzenberg,
p.(None): 2nd edition.
p.(None): Macklin Ruth (1989), The paradoxical case of payment as benefit to research subjects, IRB, 11 (6): 1-3.
p.(None): Marini James L. (1980), Methodology and ethics: research on human aggression, IRB, 2 (5): 1-4.
p.(None): Mead Margaret (1969), Research with human beings: a model derived from anthropological field practice, Daedalus, 98:
p.(None): 361-386.
p.(None): Meyer Roger E. (1977), Subjects' rights, freedom of inquiry, and the future of research in the addictions, Am J
p.(None): Psychiatry, 134 (8): 899-903.
p.(None): Menard Joël (1990), Report from the INSERM think tank on certain aspects of protecting subjects
p.(None): healthy volunteers and people who lend themselves to biomedical research, Paris: INSERM.
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 and
p.(None): Recommendations, and Appendix (1977). Research Involving Those Institutionalized as Mentally Infirm:
p.(None): Report and Recommendations, and Appendix (1978). The Belmont Report: Ethical Principles and Guidelines
p.(None): for Research Involving Human Subjects (1978), Washington D.C .: US Govt Printing Office (DHEW); tr. Fr.
p.(None): in: Medicine and experimentation (1982), Cahiers de bioéthique, 4, Québec: Presses de l'Université Laval, 233-250.
p.(None): Newton Lisa H. (1982), Dentists and pseudo-patients: further meditations on deception in research, IRB, 4 (8): 6-8.
p.(None): Park L.C., Covi L., Uhlenhuth E.H. (1967), Effects of informed consent on research patients and study results, J Nerv
p.(None): Ment Dis, 145: 349-357.
p.(None): Pattulo E.L. (1980), Who risks what in social research ?, IRB, 2 (3): 1-3, 12.
p.(None): Queheillard Jean-Louis (1989), Professional secret: the great forgotten?, Psychologists and psychologies, n ° 89.
p.(None): Redlich Fritz (1973), The anthropologist as observer; ethical aspects of clinical observations of behavior, J Nerv Ment
p.(None): Say, 157: 313-319.
p.(None): Robertson John A. (1981), Ethical review of social experiments, IRB, 3 (7): 10-11.
p.(None): Royal College of Physicians (1986), 'Research on healthy volunteers', J Roy Coll Physicians, London, 20: 243-257.
p.(None): Schafer Arthur (1981), The ethics of research on human beings; a critical review of the issues and
p.(None): arguments, Res Adv Alcohol Drug Probl, 6: 471-511.
p.(None): Schiff Michel (1991), The dead ends of research in psychology, Psychologists and psychologies, n ° 104.
p.(None): Schmutte Gregory T. (1980), Using students as subjects without their knowledge, IRB, 2 (10): 5-6.
...

Health / Mentally Incapacitated

Searching for indicator incapable:

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p.(None): is problematic (limited competence, dependence)?
p.(None): The general rule is that people whose consent is precarious must be protected against
p.(None): the possibility of serving as "subjects" of research, in proportion to their incapacity and their dependence.
p.(None): Some vulnerable categories to be protected especially in behavioral research are: children, infirm
p.(None): mental, people easily manipulated by their own weakness or dependence
p.(None): (e.g. drug addicts), institutionalized captive populations (prisoners, pupils, adolescents under
p.(None): supervised education, young people in shelters, soldiers).
p.(None): - For minors and adults under guardianship, the accepted rule for biomedical research (L. 209-10) can be
p.(None): generalized: consent of parents or legal guardians, information of the child or the incapable person throughout the
p.(None): as far as possible, respect for a possible refusal by the child or the incapable person.
p.(None): - For institutionalized captive populations (prisoners, pupils, adolescents from
p.(None): recovery ', young people in homes), the usual rule is to consider admissible only research (1)
p.(None): "minimal risk", and (2) non-discriminatory. Consent must be obtained from those responsible for
p.(None): the institution, on the other hand of each subject individually (if the subjects are minor, of the person who
p.(None): has parental authority).
p.(None): - The use of "rewards" must be subject to special attention at the time of the ethical review
p.(None): (eg recruiting tramps or Indians as research subjects through an offer of alcohol).
p.(None): - With regard to detainees, the law of 20 December 1988 excludes research without direct individual benefit
p.(None): in persons deprived of their liberty. In behavioral sciences, this research can be without
p.(None): harmful to the people concerned, and socially useful, even necessary; therefore they cannot be
p.(None): prohibited without further examination.
p.(None): - How to reconcile the obligation of consent which should be informed with the methodological necessity (which can
p.(None): appear in certain experimental protocols) not to say everything?
p.(None): This is a question raised about biomedical research, but mostly known about
p.(None): psychology, social psychology (5), and research on sports performance.
...

Health / Physically Ill

Searching for indicator sick:

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p.(None): investigators. "
p.(None): - Consent is informed if the subject has been sufficiently informed, if he has understood
p.(None): the information, if it has had a period of reflection before making its choice known. So that the information is
p.(None): sufficient, the law of 20 December 1988 specifies that the investigator must make known to the subject:
p.(None): - the objective of the research, its methodology and its duration,
p.(None): - the expected benefits, the constraints and the foreseeable risks, including in the event of stopping the research before
p.(None): his term,
p.(None): - the opinion of the CCPPRC.
p.(None): - Consent is free if the investigator abstains from any pressure, coercion, or incitement
p.(None): strong (money, passing an exam, career advantage, emotional blackmail, etc.).
p.(None): Furthermore, consent to research is revocable. Subjects should be informed that they can at any
p.(None): moment stop participating, without incurring any sanction or reproach.
p.(None): Security. The human cost
p.(None): In biomedical research it is admitted that certain research protocols imply for the people who are there
p.(None): lend a "direct individual benefit" (Art. L. 209-1). This notion of (potential) benefit for the subject
p.(None): is used in medicine to authorize inclusion in research protocols, under certain conditions (Art. L.
p.(None): 209-6) of persons whose consent is precarious or even impossible (minors, adults under guardianship,
p.(None): people staying in a health or social establishment, sick in an emergency).
p.(None): In behavioral research, there may exist cases of investigation "with direct individual benefit", for example
p.(None): example in clinical psychology during a comparative study of two psychotherapeutic methods (if for subjects
p.(None): which lend themselves to the benefit of at least one of the methods is established), or in cognitive psychology (if doing so for
p.(None): children to participate in a study gives them an educational advantage, as was discussed in the
p.(None): CNRS file on the Lautrey protocol). But the absence of vital emergencies forcing the practitioner to intervene, and
p.(None): the difficulty of arguing that research is conducted "for the good" of the subjects included, or "in the interest of their
p.(None): health ", fact that the distinction" with / without direct individual benefit "is not relevant in research
p.(None): behavior to relax the conditions of consent, even when it comes to applied research. The
p.(None): distinction is only relevant in the context of the risk / benefit balance.
p.(None): CCNE noted in its 1990 report that, in general, people who lend themselves to a
p.(None): investigation whose objective is the acquisition of knowledge about the human being do not find there
p.(None): personal benefit. CCNE considered that this is admissible, "on condition of a balance sheet
...

Health / addiction

Searching for indicator addicts:

Health / alcoholism

Searching for indicator alcoholic:

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p.(None): modification of the law "IT and liberties", and of the law on access to administrative documents.
p.(None): Equity issues
p.(None): - How to reconcile research on discriminating traits with the imperative of non-discrimination?
p.(None): This is a delicate problem, because the identification of significant differences and discriminating traits
p.(None): is precisely a plausible research objective. So it is interesting, and important for
p.(None): assessing LDC techniques, to ask whether
p.(None): there is a significant difference between the cognitive development of children born with an IAD and the others (dossier
p.(None): CNRS, Duyme project). But if we find that IAD children develop less well than others, and
p.(None): that the result of the research is made public, children already born of IAD (or their parents) are put in position
p.(None): difficult, even if the secret of the origins is well kept (danger of guilt).
p.(None): In the case of the Duyme protocol, every precaution was taken so that research was not a source of
p.(None): discrimination by its methodology.
p.(None): In addition to the methodology, research may involve a risk of explicit or implicit discrimination against
p.(None): individuals by the assumptions on which it is based (eg experimentation with "aversion therapies" to
p.(None): caring for homosexuals; psychosocial monitoring of a cohort of children born to alcoholic mothers). A search can also
p.(None): entail a risk of discrimination against an entire population by the interpretation which will be made of its results
p.(None): (e.g. highlighting statistically worse results in some intelligence tests)
p.(None): among blacks than among whites).
p.(None): In the United States at the end of the 1960s, the concern for a "science for the people" caused investigations to be halted,
p.(None): reason that their theoretical implications were infamous for certain categories of individuals. We
p.(None): even cites attempts to coerce researchers to "revise" their findings and / or publish only
p.(None): redacted results.
p.(None): The risks of discrimination depend on the level of social tolerance for this or that "difference". We can
p.(None): propose the rule: the risks of discrimination must be identified, and weighed against the collective interest and
p.(None): theoretical interest in obtaining the desired result.
p.(None): - Should the promoters of behavioral research take out insurance covering the risks incurred
p.(None): by research subjects due to the investigation?
p.(None): In biomedical research, French law requires promoters to take out insurance (Art.
p.(None): L. 209-7) guaranteeing its civil liability in the event of harmful consequences of research for the
p.(None): person who lends itself to it. We know that this provision of the law poses no problem when the promoter is
p.(None): the pharmaceutical industry, but that it poses a problem for research conducted by university teams
p.(None): and / or in small hospitals, which find it difficult to find a promoter with a seat
p.(None): sufficient financial resources to purchase insurance.
...

Health / ill

Searching for indicator ill:

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p.(None): 5. cf. experiences of Stanley Milgram, evoked in the film "I" like Icarus. Reference publication: Milgram S.
p.(None): (1963), 'Behavioral study of obedience ", J Abnorm Psychol, 67: 371-378.
p.(None): 6. Engl. "Deception", "deceptive research".
p.(None): 7. In English: "debriefing"
p.(None): 8. The French law of 20 Dec. 1988 says "serious risk" and states that for people belonging to categories
p.(None): vulnerable research "without direct individual benefit" is admissible only if it presents "no risk
p.(None): foreseeable seriousness "(Art. L.209-6).
p.(None): 9. The Royal College of Physicians of London Report (1986) shows that the risk is considered minimal, either because the
p.(None): disorder is of very low severity, either because the
p.(None): accident probability is very low. In the latter case, the risk "is comparable to the risk incurred by a passenger
p.(None): plane using a regular flight "(cf. Ménard Report, 1990).
p.(None): 10. Art. 226.13 - "The revelation of secret information by a person who is its custodian either
p.(None): by state or by profession, either because of a temporary function or mission, is punished by one year
p.(None): imprisonment and a fine of 100,000 francs. "
p.(None): Art.226.14 - "Article 226.13 is not applicable in cases where the law requires or authorizes the disclosure of the secret.
p.(None): In addition, it does not apply: 1) To one who informs the judicial, medical or administrative authorities of
p.(None): ill-treatment or hardship of which he has knowledge and which has been inflicted on a minor of fifteen years or on a person who
p.(None): is unable to protect himself because of his age or his physical or mental state; 2) To the doctor who, with
p.(None): the victim's agreement, brings to the attention of the Public Prosecutor the ill-treatment he has noted in
p.(None): the exercise of his profession and which allow him to presume that sexual violence of any kind has been
p.(None): committed. "
p.(None): Law No. 92.684 of July 22, 1992, published in the Official Journal of July 23, 1992, reforming the Penal Code.
p.(None): comes into force March 1, 1994.
p.(None): 11. An amendment to the law of 1978 is provided for in favor of epidemiological research by the Bill
p.(None): relating to the processing of personal data for the purpose of research for the protection of, or
p.(None): improvement of health, adopted at first reading in the National Assembly on Nov. 25, 1992.
p.(None): This bill does not retain the concept of professional secrecy shared for the purpose of research between
p.(None): physicians and non-physicians.It authorizes the sharing of secrecy between physicians for the purpose of research.
p.(None): research in psychology is not taken into account by the bill, which aims
p.(None): essentially the statistical processing of personal data for public health research purposes.
p.(None): Data transmission outside a hospital service to a research institution with a view
p.(None): of an investigation (eg statistical processing) is authorized by the bill, provided that the
p.(None): future "National Advisory Committee on Information Processing in Health Research"
p.(None): has agreed to the study, that the persons concerned have been informed individually and
p.(None): have been able to exercise their right of opposition (unless this is impossible), that the data be received by a
p.(None): doctor designated by the research organization and responsible for ensuring the security of this data and compliance with
p.(None): research purposes.
...

Health / patients in emergency situations

Searching for indicator emergencies:

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p.(None): strong (money, passing an exam, career advantage, emotional blackmail, etc.).
p.(None): Furthermore, consent to research is revocable. Subjects should be informed that they can at any
p.(None): moment stop participating, without incurring any sanction or reproach.
p.(None): Security. The human cost
p.(None): In biomedical research it is admitted that certain research protocols imply for the people who are there
p.(None): lend a "direct individual benefit" (Art. L. 209-1). This notion of (potential) benefit for the subject
p.(None): is used in medicine to authorize inclusion in research protocols, under certain conditions (Art. L.
p.(None): 209-6) of persons whose consent is precarious or even impossible (minors, adults under guardianship,
p.(None): people staying in a health or social establishment, sick in an emergency).
p.(None): In behavioral research, there may exist cases of investigation "with direct individual benefit", for example
p.(None): example in clinical psychology during a comparative study of two psychotherapeutic methods (if for subjects
p.(None): which lend themselves to the benefit of at least one of the methods is established), or in cognitive psychology (if doing so for
p.(None): children to participate in a study gives them an educational advantage, as was discussed in the
p.(None): CNRS file on the Lautrey protocol). But the absence of vital emergencies forcing the practitioner to intervene, and
p.(None): the difficulty of arguing that research is conducted "for the good" of the subjects included, or "in the interest of their
p.(None): health ", fact that the distinction" with / without direct individual benefit "is not relevant in research
p.(None): behavior to relax the conditions of consent, even when it comes to applied research. The
p.(None): distinction is only relevant in the context of the risk / benefit balance.
p.(None): CCNE noted in its 1990 report that, in general, people who lend themselves to a
p.(None): investigation whose objective is the acquisition of knowledge about the human being do not find there
p.(None): personal benefit. CCNE considered that this is admissible, "on condition of a balance sheet
p.(None): acceptable risk-benefit, that is, definite benefit to the community, little or no risk to the individual "
p.(None): (p. 70).
p.(None): Taking a risk-benefit assessment is asking yourself whether the risks, constraints or
p.(None): inconvenience imposed on subjects ("human cost") are sufficiently justified by the importance
p.(None): scientist of the question asked, and by the assurance that the protocol gives to resolve this question.
p.(None): In behavioral research, in addition to making an explicit assessment of physical risks,
p.(None): one must be particularly attentive to the psychological risks of the experiences and their consequences
p.(None): possible (no humiliating, degrading or traumatic experiences).
p.(None): Justice. Human dignity
...

Health / sensory impairment

Searching for indicator sensory:

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p.(None): counter argument that the hypotheses on which research is based are based on knowledge
p.(None): already acquired, and that this background knowledge allows at least an approximate appreciation
p.(None): risks incurred by subjects subjected to the experiment. The same reasoning applies to psychology.
p.(None): Reminder: technically a risk is the product of gravity by a probability. Risk assessment
p.(None): therefore involves a double assessment: of the seriousness of the disorders likely to be provoked in the subject
p.(None): experience, the probability of occurrence of these disorders.
p.(None): The distinction between "minimal risk" (negligible) and "non minimal risk" (significant, serious (8)) has been
p.(None): introduced in 1978 by the American National Commission. "No risk" does not exist in companies
p.(None): human. The "minimal" risks are risks of the same order of magnitude as the risks taken
p.(None): fluently without thinking about it in everyday life. So, for children, the minimum risk is defined
p.(None): like the one whose "probability and severity are of the same order as those of physical damage or
p.(None): psychological problems to which healthy children are normally exposed in their lives, or in medical examinations
p.(None): or routine psychological "(National Commission ..., 1978-12, App. 1) (9).
p.(None): Examples of serious risks: experiences of isolation "out of time", sensory deprivation, endurance at
p.(None): "extreme" conditions, etc.
p.(None): For categories of vulnerable subjects, only experiences whose risks are of a level can be proposed
p.(None): minimal, or to use the terms of the French law of 1988, experiences which present "no risk
p.(None): seriously predictable. "
p.(None): Only healthy, adult subjects in full possession of their mental faculties, and
p.(None): fully informed, that we can offer to lend ourselves for the needs of research in the humanities to
p.(None): experiences involving risks from a level higher (as little as it is) to the minimum level.
p.(None): - How to reconcile the imperative of confidentiality of data with communication to non-medical researchers, in
p.(None): view of research, confidential medical records?
p.(None): The problem of ethics is a problem of respect for the personal sphere, and of non-disclosure of
p.(None): confidential data of which the attending physician is the custodian. We can trust sections 7 to 13 of the Code
p.(None): of ethics of psychologists (3), modeled on the rules of medical confidentiality.
p.(None): Beyond the ethical problem, there is a legal and regulatory problem in France. Some texts by
p.(None): reference are: Art. 226.13 and 226.14 (former Art. 378) of the Criminal Code (10), Law No. 78-17 of January 6
p.(None): 1978 relating to data processing, files and freedoms, Decree n ° 79-506 of June 28, 1979 relating
p.(None): Code of medical ethics. These texts exclude the communication by the doctor of personal data to
...

Searching for indicator access:

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p.(None): One could imagine that researchers psychologists (or statisticians, or biologists, or anthropologists ...) (not
p.(None): doctors) are henceforth entitled to take cognizance of certain nominative medical data with a view to
p.(None): research, and to treat them under their own responsibility. For the sake of equity, this would imply that conversely
p.(None): Doctors may be empowered to examine, for the purpose of research, data
p.(None): nominative psychological.
p.(None): This would entail (1) an authorization procedure, (2) a modification of the legislative texts in order to make
p.(None): admissible the notion of professional secrecy shared between doctors and non-doctors.
p.(None): It should be noted that the "information technology and freedoms" law of 6 January 1978 does not authorize exceptions to medical confidentiality for the benefit of
p.(None): research only on condition that the persons concerned have given their agreement. The Code of Ethics
p.(None): French medical service does not provide that the patient can release the doctor from secrecy (the only cases of exemption
p.(None): to secrecy are those prescribed by law) (cf. Villey, 1986, p. 135). The Code of Ethics for Psychologists Goes More
p.(None): far: "Apart from cases of legal obligation, the psychologist cannot be released from his secret by anyone, even by
p.(None): those to whom this secrecy concerns "(Art. 13). The justification of the rule that even the person concerned cannot untie
p.(None): doctor or psychologist of the secret is that, to untie someone from the secret, you have to know what it is. Now the
p.(None): clinical psychologist is not required to communicate his cards to his client. And the French patient has only one access
p.(None): indirect to his medical file, of which he generally ignores what it contains.
p.(None): If French law is moving towards a new derogation from medical confidentiality, with a view to scientific research,
p.(None): this therefore also implies a modification of the Code of medical ethics, a modification of the Code of ethics of
p.(None): psychologists, and undoubtedly in the long term for all patients a right of direct access to their medical file, therefore a
p.(None): modification of the law "IT and liberties", and of the law on access to administrative documents.
p.(None): Equity issues
p.(None): - How to reconcile research on discriminating traits with the imperative of non-discrimination?
p.(None): This is a delicate problem, because the identification of significant differences and discriminating traits
p.(None): is precisely a plausible research objective. So it is interesting, and important for
p.(None): assessing LDC techniques, to ask whether
p.(None): there is a significant difference between the cognitive development of children born with an IAD and the others (dossier
p.(None): CNRS, Duyme project). But if we find that IAD children develop less well than others, and
p.(None): that the result of the research is made public, children already born of IAD (or their parents) are put in position
p.(None): difficult, even if the secret of the origins is well kept (danger of guilt).
p.(None): In the case of the Duyme protocol, every precaution was taken so that research was not a source of
p.(None): discrimination by its methodology.
p.(None): In addition to the methodology, research may involve a risk of explicit or implicit discrimination against
p.(None): individuals by the assumptions on which it is based (eg experimentation with "aversion therapies" to
p.(None): caring for homosexuals; psychosocial monitoring of a cohort of children born to alcoholic mothers). A search can also
...

Searching for indicator age:

(return to top)
p.(None): 8. The French law of 20 Dec. 1988 says "serious risk" and states that for people belonging to categories
p.(None): vulnerable research "without direct individual benefit" is admissible only if it presents "no risk
p.(None): foreseeable seriousness "(Art. L.209-6).
p.(None): 9. The Royal College of Physicians of London Report (1986) shows that the risk is considered minimal, either because the
p.(None): disorder is of very low severity, either because the
p.(None): accident probability is very low. In the latter case, the risk "is comparable to the risk incurred by a passenger
p.(None): plane using a regular flight "(cf. Ménard Report, 1990).
p.(None): 10. Art. 226.13 - "The revelation of secret information by a person who is its custodian either
p.(None): by state or by profession, either because of a temporary function or mission, is punished by one year
p.(None): imprisonment and a fine of 100,000 francs. "
p.(None): Art.226.14 - "Article 226.13 is not applicable in cases where the law requires or authorizes the disclosure of the secret.
p.(None): In addition, it does not apply: 1) To one who informs the judicial, medical or administrative authorities of
p.(None): ill-treatment or hardship of which he has knowledge and which has been inflicted on a minor of fifteen years or on a person who
p.(None): is unable to protect himself because of his age or his physical or mental state; 2) To the doctor who, with
p.(None): the victim's agreement, brings to the attention of the Public Prosecutor the ill-treatment he has noted in
p.(None): the exercise of his profession and which allow him to presume that sexual violence of any kind has been
p.(None): committed. "
p.(None): Law No. 92.684 of July 22, 1992, published in the Official Journal of July 23, 1992, reforming the Penal Code.
p.(None): comes into force March 1, 1994.
p.(None): 11. An amendment to the law of 1978 is provided for in favor of epidemiological research by the Bill
p.(None): relating to the processing of personal data for the purpose of research for the protection of, or
p.(None): improvement of health, adopted at first reading in the National Assembly on Nov. 25, 1992.
p.(None): This bill does not retain the concept of professional secrecy shared for the purpose of research between
p.(None): physicians and non-physicians.It authorizes the sharing of secrecy between physicians for the purpose of research.
p.(None): research in psychology is not taken into account by the bill, which aims
p.(None): essentially the statistical processing of personal data for public health research purposes.
p.(None): Data transmission outside a hospital service to a research institution with a view
p.(None): of an investigation (eg statistical processing) is authorized by the bill, provided that the
p.(None): future "National Advisory Committee on Information Processing in Health Research"
p.(None): has agreed to the study, that the persons concerned have been informed individually and
...

Searching for indicator child:

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p.(None): by letter dated 15 January 1993, submitted for opinion to the Chairman of the National Advisory Committee
p.(None): of ethics for the life sciences and health (CCNE) five files describing research in
p.(None): psychology carried out in university laboratories supported by the CNRS or carried out in part by
p.(None): CNRS researchers, as well as a description of the research carried out in psychology at the CNRS. Among the five files
p.(None): submitted, which had the approval of the competent scientific commission of the CNRS, two (Duyme and
p.(None): Carlier2) come from the laboratory directed by Pr. Roubertoux and correspond to research that has been
p.(None): interrupted, following an article published in the newspaper L'Express on December 17, 1992.
p.(None): CCNE has set up a working group.
p.(None): The working group took note of the wide variety of research carried out at the CNRS in the humanities.
p.(None): For psychology: fifteen research units (URA in general), i.e. 150 researchers and around 200
p.(None): teacher-researchers, are grouped in Section 29 "Mental functions, integrative neuroscience and
p.(None): behaviors ", co-managed by the Department of Life Sciences, and the Department of Life Sciences
p.(None): man and society. The objective of research is to "understand the skills and performance of being
p.(None): human during different periods of his life, in usual situations as well as in
p.(None): exceptional situations ". The methods range from simple observation in a natural situation or
p.(None): standardized, to test reactions in "borderline situations". Subjects are recruited on the basis of
p.(None): volunteering. The sub-disciplines identified are: child and developmental psychology,
p.(None): social psychology, cognitive psychology, work psychology, ergonomics, psycholinguistics,
p.(None): psychopathology, clinical psychology, neuropsychology, psychopharmacology. Interfaces with
p.(None): neighboring disciplines are frequent: anthropology, neuroscience, psychiatry, linguistics, sociology,
p.(None): educational sciences, artificial intelligence, etc.
p.(None): The working group met approximately once a month between January and June 1993. It met with the Committee
p.(None): operational on ethics in the life sciences of the CNRS (COPE,
p.(None): January 22, 1993). He heard from several researchers. He inquired about the specific problems of
p.(None): humanities research, professional codes of ethics, how investigations
p.(None): experimental studies in the humanities are supervised in other countries.
p.(None): CCNE notes that in France, since the "law on the protection of persons who lend themselves to research
p.(None): biomedical "of December 20, 1988, the" tests or experiments organized and practiced on the being
p.(None): human for the development of biological or medical knowledge "takes place in a legal framework
p.(None): precise and binding. In contrast, the legislator did not pay attention to the protection of persons who
p.(None): lend themselves to behavioral research, and investigations carried out on human beings with a view to
p.(None): development of knowledge in the disciplines called "human sciences" remained in a situation
p.(None): fuzzy legal.
p.(None): CCNE summarizes below:
...

p.(None): is problematic (limited competence, dependence)?
p.(None): The general rule is that people whose consent is precarious must be protected against
p.(None): the possibility of serving as "subjects" of research, in proportion to their incapacity and their dependence.
p.(None): Some vulnerable categories to be protected especially in behavioral research are: children, infirm
p.(None): mental, people easily manipulated by their own weakness or dependence
p.(None): (e.g. drug addicts), institutionalized captive populations (prisoners, pupils, adolescents under
p.(None): supervised education, young people in shelters, soldiers).
p.(None): - For minors and adults under guardianship, the accepted rule for biomedical research (L. 209-10) can be
p.(None): generalized: consent of parents or legal guardians, information of the child or the incapable person throughout the
p.(None): as far as possible, respect for a possible refusal by the child or the incapable person.
p.(None): - For institutionalized captive populations (prisoners, pupils, adolescents from
p.(None): recovery ', young people in homes), the usual rule is to consider admissible only research (1)
p.(None): "minimal risk", and (2) non-discriminatory. Consent must be obtained from those responsible for
p.(None): the institution, on the other hand of each subject individually (if the subjects are minor, of the person who
p.(None): has parental authority).
p.(None): - The use of "rewards" must be subject to special attention at the time of the ethical review
p.(None): (eg recruiting tramps or Indians as research subjects through an offer of alcohol).
p.(None): - With regard to detainees, the law of 20 December 1988 excludes research without direct individual benefit
p.(None): in persons deprived of their liberty. In behavioral sciences, this research can be without
p.(None): harmful to the people concerned, and socially useful, even necessary; therefore they cannot be
p.(None): prohibited without further examination.
p.(None): - How to reconcile the obligation of consent which should be informed with the methodological necessity (which can
p.(None): appear in certain experimental protocols) not to say everything?
p.(None): This is a question raised about biomedical research, but mostly known about
...

Searching for indicator children:

(return to top)
p.(None): (hyperbaric, hypobaric, microgravity, extreme climates, phase shift of the nycthemeral rhythms, sporting exploits of
p.(None): competition or endurance, civil or military), on quality of life and environmental pollution.
p.(None): The protection of people who lend themselves to biomedical research depends in France on law n ° 88-1138 of
p.(None): December 20, 1988 (modified n ° 90-86). The protection of persons who lend themselves to research
p.(None): Behavioral depends for the moment on the ethics of researchers (eg code of ethics of psychologists3).
p.(None): CCNE's recommendations on the ethics of behavioral research
p.(None): must, for the sake of consistency, be in continuity with Law No. 88-1138 of 20 Dec 1988. The major
p.(None): lines of guidelines for human research that were formulated in the United States by the National
p.(None): Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-78), or in Canada by the
p.(None): Medical Research Council (1986), then by the National Council on Bioethics in Human Research (CNBRH), are the
p.(None): same for all research on human beings, in the biomedical sciences and in the sciences
p.(None): human, even if secondarily special problems are identified according to the disciplines
p.(None): (cancerology, psychiatry, ethnology, etc.), or for different categories of subjects studied (children,
p.(None): captive or asylum populations, elderly people losing their autonomy, etc.).
p.(None): It will therefore be admitted that the main ethical principles which govern research on human beings (called
p.(None): by the American National Commission: principles of justice, beneficence, respect for autonomy
p.(None): of persons), as well as the rules ensuing therefrom (equity or non-discrimination rule,
p.(None): risk minimization and profit optimization, consent rule), are the same, that
p.(None): be biomedical research, or behavioral research. It will also be recognized that the procedure consisting
p.(None): to submit research protocols on humans, before their execution, to the examination of a committee
p.(None): independent ', or' ethics committee ', or' personal protection committee, is applicable to research
p.(None): behavioral. In what follows we will speak of "CCPPRC" (Consultative committees for the protection of persons in the
p.(None): behavioral research), without prejudging their relationship with the CCPPRB instituted by law n ° 88-1138 of 20 December
p.(None): 1988 (which will be considered later).
p.(None): Broad outlines
p.(None): Freedom of the people
p.(None): Freedom has a negative aspect (independence): not being led to do what you don't want, and a positive aspect
...

p.(None): his term,
p.(None): - the opinion of the CCPPRC.
p.(None): - Consent is free if the investigator abstains from any pressure, coercion, or incitement
p.(None): strong (money, passing an exam, career advantage, emotional blackmail, etc.).
p.(None): Furthermore, consent to research is revocable. Subjects should be informed that they can at any
p.(None): moment stop participating, without incurring any sanction or reproach.
p.(None): Security. The human cost
p.(None): In biomedical research it is admitted that certain research protocols imply for the people who are there
p.(None): lend a "direct individual benefit" (Art. L. 209-1). This notion of (potential) benefit for the subject
p.(None): is used in medicine to authorize inclusion in research protocols, under certain conditions (Art. L.
p.(None): 209-6) of persons whose consent is precarious or even impossible (minors, adults under guardianship,
p.(None): people staying in a health or social establishment, sick in an emergency).
p.(None): In behavioral research, there may exist cases of investigation "with direct individual benefit", for example
p.(None): example in clinical psychology during a comparative study of two psychotherapeutic methods (if for subjects
p.(None): which lend themselves to the benefit of at least one of the methods is established), or in cognitive psychology (if doing so for
p.(None): children to participate in a study gives them an educational advantage, as was discussed in the
p.(None): CNRS file on the Lautrey protocol). But the absence of vital emergencies forcing the practitioner to intervene, and
p.(None): the difficulty of arguing that research is conducted "for the good" of the subjects included, or "in the interest of their
p.(None): health ", fact that the distinction" with / without direct individual benefit "is not relevant in research
p.(None): behavior to relax the conditions of consent, even when it comes to applied research. The
p.(None): distinction is only relevant in the context of the risk / benefit balance.
p.(None): CCNE noted in its 1990 report that, in general, people who lend themselves to a
p.(None): investigation whose objective is the acquisition of knowledge about the human being do not find there
p.(None): personal benefit. CCNE considered that this is admissible, "on condition of a balance sheet
p.(None): acceptable risk-benefit, that is, definite benefit to the community, little or no risk to the individual "
p.(None): (p. 70).
p.(None): Taking a risk-benefit assessment is asking yourself whether the risks, constraints or
p.(None): inconvenience imposed on subjects ("human cost") are sufficiently justified by the importance
p.(None): scientist of the question asked, and by the assurance that the protocol gives to resolve this question.
p.(None): In behavioral research, in addition to making an explicit assessment of physical risks,
...

p.(None): the study (e.g. serum library).
p.(None): The federal American directives (DHHS, 1981) provided for three categories of research on
p.(None): humans: exempt from ethical review ("exempted research"), subject to an ethical review procedure
p.(None): simplified ("expedited review", by the office of an IRB), subject to in-depth ethical discussion (discussion in session
p.(None): by an IRB).
p.(None): We could propose for the human sciences a distinction between simple observation and situation
p.(None): experimental to provide for a rapid procedure (simple examination of the protocol), and a normal procedure
p.(None): ethical review (may require the effective presence of investigators). However, this distinction is
p.(None): delicate handling: there are indeed, as D. Widlöcher pointed out to us, "very harmless experiments",
p.(None): and possibly traumatic observations.
p.(None): Problems specific to behavioral research, identified using protocols submitted by the CNRS
p.(None): Consent
p.(None): - Under what conditions is behavioral research admissible on subjects including the ability to consent
p.(None): is problematic (limited competence, dependence)?
p.(None): The general rule is that people whose consent is precarious must be protected against
p.(None): the possibility of serving as "subjects" of research, in proportion to their incapacity and their dependence.
p.(None): Some vulnerable categories to be protected especially in behavioral research are: children, infirm
p.(None): mental, people easily manipulated by their own weakness or dependence
p.(None): (e.g. drug addicts), institutionalized captive populations (prisoners, pupils, adolescents under
p.(None): supervised education, young people in shelters, soldiers).
p.(None): - For minors and adults under guardianship, the accepted rule for biomedical research (L. 209-10) can be
p.(None): generalized: consent of parents or legal guardians, information of the child or the incapable person throughout the
p.(None): as far as possible, respect for a possible refusal by the child or the incapable person.
p.(None): - For institutionalized captive populations (prisoners, pupils, adolescents from
p.(None): recovery ', young people in homes), the usual rule is to consider admissible only research (1)
...

p.(None): data
p.(None): identifiers concerning persons who refuse to consent to the use that we want to make of it will be destroyed
p.(None): or returned to interested parties.
p.(None): security
p.(None): - How to assess the psychological risks, and the possible after-effects for the subjects, of a research
p.(None): behavioral?
p.(None): It has been argued about biomedical research that, by definition, when looking,
p.(None): risks are unknown, and therefore cannot be assessed. This argument is usually opposed to
p.(None): counter argument that the hypotheses on which research is based are based on knowledge
p.(None): already acquired, and that this background knowledge allows at least an approximate appreciation
p.(None): risks incurred by subjects subjected to the experiment. The same reasoning applies to psychology.
p.(None): Reminder: technically a risk is the product of gravity by a probability. Risk assessment
p.(None): therefore involves a double assessment: of the seriousness of the disorders likely to be provoked in the subject
p.(None): experience, the probability of occurrence of these disorders.
p.(None): The distinction between "minimal risk" (negligible) and "non minimal risk" (significant, serious (8)) has been
p.(None): introduced in 1978 by the American National Commission. "No risk" does not exist in companies
p.(None): human. The "minimal" risks are risks of the same order of magnitude as the risks taken
p.(None): fluently without thinking about it in everyday life. So, for children, the minimum risk is defined
p.(None): like the one whose "probability and severity are of the same order as those of physical damage or
p.(None): psychological problems to which healthy children are normally exposed in their lives, or in medical examinations
p.(None): or routine psychological "(National Commission ..., 1978-12, App. 1) (9).
p.(None): Examples of serious risks: experiences of isolation "out of time", sensory deprivation, endurance at
p.(None): "extreme" conditions, etc.
p.(None): For categories of vulnerable subjects, only experiences whose risks are of a level can be proposed
p.(None): minimal, or to use the terms of the French law of 1988, experiences which present "no risk
p.(None): seriously predictable. "
p.(None): Only healthy, adult subjects in full possession of their mental faculties, and
p.(None): fully informed, that we can offer to lend ourselves for the needs of research in the humanities to
p.(None): experiences involving risks from a level higher (as little as it is) to the minimum level.
p.(None): - How to reconcile the imperative of confidentiality of data with communication to non-medical researchers, in
p.(None): view of research, confidential medical records?
p.(None): The problem of ethics is a problem of respect for the personal sphere, and of non-disclosure of
p.(None): confidential data of which the attending physician is the custodian. We can trust sections 7 to 13 of the Code
p.(None): of ethics of psychologists (3), modeled on the rules of medical confidentiality.
p.(None): Beyond the ethical problem, there is a legal and regulatory problem in France. Some texts by
p.(None): reference are: Art. 226.13 and 226.14 (former Art. 378) of the Criminal Code (10), Law No. 78-17 of January 6
...

p.(None): those to whom this secrecy concerns "(Art. 13). The justification of the rule that even the person concerned cannot untie
p.(None): doctor or psychologist of the secret is that, to untie someone from the secret, you have to know what it is. Now the
p.(None): clinical psychologist is not required to communicate his cards to his client. And the French patient has only one access
p.(None): indirect to his medical file, of which he generally ignores what it contains.
p.(None): If French law is moving towards a new derogation from medical confidentiality, with a view to scientific research,
p.(None): this therefore also implies a modification of the Code of medical ethics, a modification of the Code of ethics of
p.(None): psychologists, and undoubtedly in the long term for all patients a right of direct access to their medical file, therefore a
p.(None): modification of the law "IT and liberties", and of the law on access to administrative documents.
p.(None): Equity issues
p.(None): - How to reconcile research on discriminating traits with the imperative of non-discrimination?
p.(None): This is a delicate problem, because the identification of significant differences and discriminating traits
p.(None): is precisely a plausible research objective. So it is interesting, and important for
p.(None): assessing LDC techniques, to ask whether
p.(None): there is a significant difference between the cognitive development of children born with an IAD and the others (dossier
p.(None): CNRS, Duyme project). But if we find that IAD children develop less well than others, and
p.(None): that the result of the research is made public, children already born of IAD (or their parents) are put in position
p.(None): difficult, even if the secret of the origins is well kept (danger of guilt).
p.(None): In the case of the Duyme protocol, every precaution was taken so that research was not a source of
p.(None): discrimination by its methodology.
p.(None): In addition to the methodology, research may involve a risk of explicit or implicit discrimination against
p.(None): individuals by the assumptions on which it is based (eg experimentation with "aversion therapies" to
p.(None): caring for homosexuals; psychosocial monitoring of a cohort of children born to alcoholic mothers). A search can also
p.(None): entail a risk of discrimination against an entire population by the interpretation which will be made of its results
p.(None): (e.g. highlighting statistically worse results in some intelligence tests)
p.(None): among blacks than among whites).
p.(None): In the United States at the end of the 1960s, the concern for a "science for the people" caused investigations to be halted,
p.(None): reason that their theoretical implications were infamous for certain categories of individuals. We
p.(None): even cites attempts to coerce researchers to "revise" their findings and / or publish only
p.(None): redacted results.
p.(None): The risks of discrimination depend on the level of social tolerance for this or that "difference". We can
p.(None): propose the rule: the risks of discrimination must be identified, and weighed against the collective interest and
p.(None): theoretical interest in obtaining the desired result.
p.(None): - Should the promoters of behavioral research take out insurance covering the risks incurred
p.(None): by research subjects due to the investigation?
p.(None): In biomedical research, French law requires promoters to take out insurance (Art.
p.(None): L. 209-7) guaranteeing its civil liability in the event of harmful consequences of research for the
p.(None): person who lends itself to it. We know that this provision of the law poses no problem when the promoter is
p.(None): the pharmaceutical industry, but that it poses a problem for research conducted by university teams
p.(None): and / or in small hospitals, which find it difficult to find a promoter with a seat
...

p.(None): Katz Jay (1972), Experimentation with Human Beings? The Authority of the Investigator, Subject, Professions and State
p.(None): in the Human Experimentation Process, New York: Russell Sage Foundation.
p.(None): Levine Carol (1982), Former soldier denied compensation for damage in army LSD tests, IRB, 4 (3): 7.
p.(None): Levine Robert J. (1986), Ethics and Regulation of Clinical Research, Baltimore-Munich: Urban & Schwarzenberg,
p.(None): 2nd edition.
p.(None): Macklin Ruth (1989), The paradoxical case of payment as benefit to research subjects, IRB, 11 (6): 1-3.
p.(None): Marini James L. (1980), Methodology and ethics: research on human aggression, IRB, 2 (5): 1-4.
p.(None): Mead Margaret (1969), Research with human beings: a model derived from anthropological field practice, Daedalus, 98:
p.(None): 361-386.
p.(None): Meyer Roger E. (1977), Subjects' rights, freedom of inquiry, and the future of research in the addictions, Am J
p.(None): Psychiatry, 134 (8): 899-903.
p.(None): Menard Joël (1990), Report from the INSERM think tank on certain aspects of protecting subjects
p.(None): healthy volunteers and people who lend themselves to biomedical research, Paris: INSERM.
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 and
p.(None): Recommendations, and Appendix (1977). Research Involving Those Institutionalized as Mentally Infirm:
p.(None): Report and Recommendations, and Appendix (1978). The Belmont Report: Ethical Principles and Guidelines
p.(None): for Research Involving Human Subjects (1978), Washington D.C .: US Govt Printing Office (DHEW); tr. Fr.
p.(None): in: Medicine and experimentation (1982), Cahiers de bioéthique, 4, Québec: Presses de l'Université Laval, 233-250.
p.(None): Newton Lisa H. (1982), Dentists and pseudo-patients: further meditations on deception in research, IRB, 4 (8): 6-8.
p.(None): Park L.C., Covi L., Uhlenhuth E.H. (1967), Effects of informed consent on research patients and study results, J Nerv
p.(None): Ment Dis, 145: 349-357.
p.(None): Pattulo E.L. (1980), Who risks what in social research ?, IRB, 2 (3): 1-3, 12.
p.(None): Queheillard Jean-Louis (1989), Professional secret: the great forgotten?, Psychologists and psychologies, n ° 89.
p.(None): Redlich Fritz (1973), The anthropologist as observer; ethical aspects of clinical observations of behavior, J Nerv Ment
p.(None): Say, 157: 313-319.
p.(None): Robertson John A. (1981), Ethical review of social experiments, IRB, 3 (7): 10-11.
p.(None): Royal College of Physicians (1986), 'Research on healthy volunteers', J Roy Coll Physicians, London, 20: 243-257.
p.(None): Schafer Arthur (1981), The ethics of research on human beings; a critical review of the issues and
p.(None): arguments, Res Adv Alcohol Drug Probl, 6: 471-511.
...

Searching for indicator elderly:

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p.(None): competition or endurance, civil or military), on quality of life and environmental pollution.
p.(None): The protection of people who lend themselves to biomedical research depends in France on law n ° 88-1138 of
p.(None): December 20, 1988 (modified n ° 90-86). The protection of persons who lend themselves to research
p.(None): Behavioral depends for the moment on the ethics of researchers (eg code of ethics of psychologists3).
p.(None): CCNE's recommendations on the ethics of behavioral research
p.(None): must, for the sake of consistency, be in continuity with Law No. 88-1138 of 20 Dec 1988. The major
p.(None): lines of guidelines for human research that were formulated in the United States by the National
p.(None): Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-78), or in Canada by the
p.(None): Medical Research Council (1986), then by the National Council on Bioethics in Human Research (CNBRH), are the
p.(None): same for all research on human beings, in the biomedical sciences and in the sciences
p.(None): human, even if secondarily special problems are identified according to the disciplines
p.(None): (cancerology, psychiatry, ethnology, etc.), or for different categories of subjects studied (children,
p.(None): captive or asylum populations, elderly people losing their autonomy, etc.).
p.(None): It will therefore be admitted that the main ethical principles which govern research on human beings (called
p.(None): by the American National Commission: principles of justice, beneficence, respect for autonomy
p.(None): of persons), as well as the rules ensuing therefrom (equity or non-discrimination rule,
p.(None): risk minimization and profit optimization, consent rule), are the same, that
p.(None): be biomedical research, or behavioral research. It will also be recognized that the procedure consisting
p.(None): to submit research protocols on humans, before their execution, to the examination of a committee
p.(None): independent ', or' ethics committee ', or' personal protection committee, is applicable to research
p.(None): behavioral. In what follows we will speak of "CCPPRC" (Consultative committees for the protection of persons in the
p.(None): behavioral research), without prejudging their relationship with the CCPPRB instituted by law n ° 88-1138 of 20 December
p.(None): 1988 (which will be considered later).
p.(None): Broad outlines
p.(None): Freedom of the people
p.(None): Freedom has a negative aspect (independence): not being led to do what you don't want, and a positive aspect
p.(None): (autonomy): act in accordance with what you really want for yourself. It is usually accepted that respecting the
...

p.(None): the study intended for these people, and the consent form (consent to the study, and, if applicable,
p.(None): when using the results).
p.(None): References
p.(None): American Psychological Association (1986), Ethical issues in psychological research in AIDS, Committee for the
p.(None): protection of human participants in research, IRB, 8 (4): 8-10.
p.(None): Barber B. (1976), The ethics of experimentation with human subjects, Scientific American, 234 (2): 25-31.
p.(None): Baumrind Diana (1979), IRBs and social science research: the costs of deception, IRB, 1 (6): 1-4.
p.(None): Bourdieu Pierre, ed. (1993), The misery of the world, Paris: Seuil.
p.(None): Medical Research Council of Canada (1986), Guidelines for Research on Subjects
p.(None): humans, Ottawa.
p.(None): Cupples Brian & Gochnauer Myron (1985), The investigator's duty not to deceive, IRB, 7 (5): 1-6.
p.(None): De Sola Pool Ithiel (1983), Do social scientists have unlimited research rights ?, IRB, 5 (6): 10.
p.(None): Desportes Jean-Pierre (1974), Manipulations du behavior, La Recherche, 47: 654-661.
p.(None): Fagot-Largeault A. (1985), The bio-ethical man. For an ethics of research on living organisms, Paris: Maloine.
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): Gosselin Gabriel (1992), An ethics of the social sciences, Paris: L'Harmattan.
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): Katz Jay (1972), Experimentation with Human Beings? The Authority of the Investigator, Subject, Professions and State
p.(None): in the Human Experimentation Process, New York: Russell Sage Foundation.
p.(None): Levine Carol (1982), Former soldier denied compensation for damage in army LSD tests, IRB, 4 (3): 7.
p.(None): Levine Robert J. (1986), Ethics and Regulation of Clinical Research, Baltimore-Munich: Urban & Schwarzenberg,
p.(None): 2nd edition.
p.(None): Macklin Ruth (1989), The paradoxical case of payment as benefit to research subjects, IRB, 11 (6): 1-3.
p.(None): Marini James L. (1980), Methodology and ethics: research on human aggression, IRB, 2 (5): 1-4.
p.(None): Mead Margaret (1969), Research with human beings: a model derived from anthropological field practice, Daedalus, 98:
p.(None): 361-386.
p.(None): Meyer Roger E. (1977), Subjects' rights, freedom of inquiry, and the future of research in the addictions, Am J
p.(None): Psychiatry, 134 (8): 899-903.
p.(None): Menard Joël (1990), Report from the INSERM think tank on certain aspects of protecting subjects
p.(None): healthy volunteers and people who lend themselves to biomedical research, Paris: INSERM.
p.(None): National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Research
...

Searching for indicator ethnic:

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p.(None): (p. 70).
p.(None): Taking a risk-benefit assessment is asking yourself whether the risks, constraints or
p.(None): inconvenience imposed on subjects ("human cost") are sufficiently justified by the importance
p.(None): scientist of the question asked, and by the assurance that the protocol gives to resolve this question.
p.(None): In behavioral research, in addition to making an explicit assessment of physical risks,
p.(None): one must be particularly attentive to the psychological risks of the experiences and their consequences
p.(None): possible (no humiliating, degrading or traumatic experiences).
p.(None): Justice. Human dignity
p.(None): In biomedical research, the principle of justice serves first to remind us that scientific research must not
p.(None): be an opportunity for exploitation (for example, exploitation by researchers from developed countries,
p.(None): poor people in developing countries, who serve as "guinea pigs" for the acquisition of knowledge including
p.(None): the therapeutic benefits mainly benefit the populations of rich countries: cf. WHO-CIOMS, 1982). It serves
p.(None): then recall, as CCNE did in its 1990 report (p. 72), that participation in a protocol
p.(None): research calls for "fair compensation" or "compensation" for subjects, but excludes any compensation.
p.(None): In behavioral research, cases of exploitation (north-south) have been mentioned (in ethnology, in
p.(None): anthropology), but there was, in general, in the background a problem of ethnic or cultural discrimination
p.(None): (relation of "developed" to "wild"). Frank risks of discrimination have been raised in connection with
p.(None): the investigation of distinctive features which are a source of social valuation or devaluation ("intelligence quotient",
p.(None): "crime chromosome", etc.). On the other hand, in behavioral research, the practice of paying subjects
p.(None): (on vacations, for example) has so far raised few objections. There are salaried professionals
p.(None): (test pilots, scuba divers) who agree to be guinea pigs in the exercise of their profession.
p.(None): Conversely, many volunteers are not compensated (when their contribution is minimal, or when, as
p.(None): in the case of students, they derive an intellectual or didactic benefit). It is therefore not possible to say,
p.(None): neither that all volunteers should be compensated, nor that any remuneration is unethical.
p.(None): From the equity point of view, the central problem in behavioral research therefore seems to be that of a possible
p.(None): discrimination, whether related to the research protocol itself, or to research results and
p.(None): how they will be understood and used (socio-cultural "spin-offs").
p.(None): Ethical review by "independent" bodies
p.(None): For bio-medical research, French law subjects the CCPPRB to "tests or experiments". She
p.(None): exempt "studies" (research work carried out on file, or on samples taken independently of
p.(None): the study (e.g. serum library).
p.(None): The federal American directives (DHHS, 1981) provided for three categories of research on
...

Searching for indicator liberty:

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p.(None): interest is recognized could be made as part of a shared professional secret. If
p.(None): psychologists were to, in the context of research, treat under their own responsibility certain
p.(None): nominative medical data, these psychologists should be authorized to do so, and the doctor should have
p.(None): has been expressly authorized by the persons concerned to communicate this data. Likewise, if
p.(None): medical researchers were required, in the context of research, to use personal data
p.(None): collected by practicing psychologists during their practice, these researchers should
p.(None): doctors are empowered to do so, and that the psychologist has been explicitly authorized by the people
p.(None): concerned to communicate this data. Authorization could be given by a body
p.(None): multidisciplinary under the aegis of the ministries in charge of Research and Health. In the event that the law
p.(None): would allow this sharing of professional secrecy for the purpose of research, the conditions under which
p.(None): a person can untie his doctor or his psychologist from a secret should be specified with care.
p.(None): CCNE believes that research protocols in the human behavioral sciences should be submitted for
p.(None): advice, before their execution, to Consultative Committees for the Protection of Persons in Research
p.(None): Behavioral (CCPPRC) whose composition would ensure a satisfactory diversity of skills for
p.(None): the examination of research protocols in the different human sciences other than medical.
p.(None): These committees would have the following functions in particular:
p.(None): (1) to assess the scientific relevance of research projects,
p.(None): (2) to ensure that the liberty and security of the subject is protected:
p.(None): - by ensuring that the experiments envisaged do not threaten the security or the dignity of the people who lend themselves to them,
p.(None): - by assessing the methods provided for the information and consent of individuals
p.(None): participating in the study, especially when this information must, at the initial stage, remain incomplete,
p.(None): (3) to hear, if they request it, the researchers or the subjects in case there is a problem
p.(None): of particular ethics during the study.
p.(None): Provisionally, while waiting for the legislator, drawing on the experience of the CCPPRBs, to decide on
p.(None): the advisability of creating such Committees, and on the principles according to which they would exercise their mission, the experience
p.(None): French law prior to the law of 1988 would go in the direction of the creation of "Ethics Committees of the
p.(None): research in the sciences of human behavior "with the institutions where this is done
p.(None): research: CNRS, INSERM, Universities ... These Committees would be the conscience of these institutions, and
p.(None): the expression of their desire to ensure quality research and adequate protection within them
p.(None): people who lend themselves to it.
p.(None): This opinion is a first step in CCNE's reflection, which must be developed in concert with
p.(None): social sciences and humanities researchers, the scientific institutions that conduct research in the sciences
p.(None): human (whether this research is fundamental or finalized), the competent administrative authorities, and the
...

p.(None): - For minors and adults under guardianship, the accepted rule for biomedical research (L. 209-10) can be
p.(None): generalized: consent of parents or legal guardians, information of the child or the incapable person throughout the
p.(None): as far as possible, respect for a possible refusal by the child or the incapable person.
p.(None): - For institutionalized captive populations (prisoners, pupils, adolescents from
p.(None): recovery ', young people in homes), the usual rule is to consider admissible only research (1)
p.(None): "minimal risk", and (2) non-discriminatory. Consent must be obtained from those responsible for
p.(None): the institution, on the other hand of each subject individually (if the subjects are minor, of the person who
p.(None): has parental authority).
p.(None): - The use of "rewards" must be subject to special attention at the time of the ethical review
p.(None): (eg recruiting tramps or Indians as research subjects through an offer of alcohol).
p.(None): - With regard to detainees, the law of 20 December 1988 excludes research without direct individual benefit
p.(None): in persons deprived of their liberty. In behavioral sciences, this research can be without
p.(None): harmful to the people concerned, and socially useful, even necessary; therefore they cannot be
p.(None): prohibited without further examination.
p.(None): - How to reconcile the obligation of consent which should be informed with the methodological necessity (which can
p.(None): appear in certain experimental protocols) not to say everything?
p.(None): This is a question raised about biomedical research, but mostly known about
p.(None): psychology, social psychology (5), and research on sports performance.
p.(None): The Canadian MRC treated this issue as follows:
p.(None): Deception (6)
p.(None): "... Given the critical importance of free and informed consent, it seems incongruous to consider the
p.(None): question of deception.
p.(None): "Deception is understood to mean deliberately misleading potential subjects or hiding them from
p.(None): information, in such a way as to lead them to believe that the objectives of the research or of the procedure to be followed are
p.(None): different from what they really are. The
p.(None): deception may also consist in deliberately presenting false information to them, concealing information
p.(None): important information, or to reveal only bits of information, in order to mislead the interested parties.
p.(None): "Since the deception was so contrary to the principle of respect for the individual, the Committee had great difficulty
p.(None): to accept the idea that it can sometimes be justifiable from an ethical point of view. The fact remains that, for some reason
p.(None): or another, it was essential that the subjects were not made aware of the nature of the
p.(None): For scientific integrity, it should be ensured that the following rules are observed.
...

Searching for indicator institutionalized:

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p.(None): We could propose for the human sciences a distinction between simple observation and situation
p.(None): experimental to provide for a rapid procedure (simple examination of the protocol), and a normal procedure
p.(None): ethical review (may require the effective presence of investigators). However, this distinction is
p.(None): delicate handling: there are indeed, as D. Widlöcher pointed out to us, "very harmless experiments",
p.(None): and possibly traumatic observations.
p.(None): Problems specific to behavioral research, identified using protocols submitted by the CNRS
p.(None): Consent
p.(None): - Under what conditions is behavioral research admissible on subjects including the ability to consent
p.(None): is problematic (limited competence, dependence)?
p.(None): The general rule is that people whose consent is precarious must be protected against
p.(None): the possibility of serving as "subjects" of research, in proportion to their incapacity and their dependence.
p.(None): Some vulnerable categories to be protected especially in behavioral research are: children, infirm
p.(None): mental, people easily manipulated by their own weakness or dependence
p.(None): (e.g. drug addicts), institutionalized captive populations (prisoners, pupils, adolescents under
p.(None): supervised education, young people in shelters, soldiers).
p.(None): - For minors and adults under guardianship, the accepted rule for biomedical research (L. 209-10) can be
p.(None): generalized: consent of parents or legal guardians, information of the child or the incapable person throughout the
p.(None): as far as possible, respect for a possible refusal by the child or the incapable person.
p.(None): - For institutionalized captive populations (prisoners, pupils, adolescents from
p.(None): recovery ', young people in homes), the usual rule is to consider admissible only research (1)
p.(None): "minimal risk", and (2) non-discriminatory. Consent must be obtained from those responsible for
p.(None): the institution, on the other hand of each subject individually (if the subjects are minor, of the person who
p.(None): has parental authority).
p.(None): - The use of "rewards" must be subject to special attention at the time of the ethical review
p.(None): (eg recruiting tramps or Indians as research subjects through an offer of alcohol).
p.(None): - With regard to detainees, the law of 20 December 1988 excludes research without direct individual benefit
p.(None): in persons deprived of their liberty. In behavioral sciences, this research can be without
p.(None): harmful to the people concerned, and socially useful, even necessary; therefore they cannot be
p.(None): prohibited without further examination.
p.(None): - How to reconcile the obligation of consent which should be informed with the methodological necessity (which can
p.(None): appear in certain experimental protocols) not to say everything?
p.(None): This is a question raised about biomedical research, but mostly known about
p.(None): psychology, social psychology (5), and research on sports performance.
p.(None): The Canadian MRC treated this issue as follows:
p.(None): Deception (6)
...

p.(None): in the Human Experimentation Process, New York: Russell Sage Foundation.
p.(None): Levine Carol (1982), Former soldier denied compensation for damage in army LSD tests, IRB, 4 (3): 7.
p.(None): Levine Robert J. (1986), Ethics and Regulation of Clinical Research, Baltimore-Munich: Urban & Schwarzenberg,
p.(None): 2nd edition.
p.(None): Macklin Ruth (1989), The paradoxical case of payment as benefit to research subjects, IRB, 11 (6): 1-3.
p.(None): Marini James L. (1980), Methodology and ethics: research on human aggression, IRB, 2 (5): 1-4.
p.(None): Mead Margaret (1969), Research with human beings: a model derived from anthropological field practice, Daedalus, 98:
p.(None): 361-386.
p.(None): Meyer Roger E. (1977), Subjects' rights, freedom of inquiry, and the future of research in the addictions, Am J
p.(None): Psychiatry, 134 (8): 899-903.
p.(None): Menard Joël (1990), Report from the INSERM think tank on certain aspects of protecting subjects
p.(None): healthy volunteers and people who lend themselves to biomedical research, Paris: INSERM.
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 and
p.(None): Recommendations, and Appendix (1977). Research Involving Those Institutionalized as Mentally Infirm:
p.(None): Report and Recommendations, and Appendix (1978). The Belmont Report: Ethical Principles and Guidelines
p.(None): for Research Involving Human Subjects (1978), Washington D.C .: US Govt Printing Office (DHEW); tr. Fr.
p.(None): in: Medicine and experimentation (1982), Cahiers de bioéthique, 4, Québec: Presses de l'Université Laval, 233-250.
p.(None): Newton Lisa H. (1982), Dentists and pseudo-patients: further meditations on deception in research, IRB, 4 (8): 6-8.
p.(None): Park L.C., Covi L., Uhlenhuth E.H. (1967), Effects of informed consent on research patients and study results, J Nerv
p.(None): Ment Dis, 145: 349-357.
p.(None): Pattulo E.L. (1980), Who risks what in social research ?, IRB, 2 (3): 1-3, 12.
p.(None): Queheillard Jean-Louis (1989), Professional secret: the great forgotten?, Psychologists and psychologies, n ° 89.
p.(None): Redlich Fritz (1973), The anthropologist as observer; ethical aspects of clinical observations of behavior, J Nerv Ment
p.(None): Say, 157: 313-319.
p.(None): Robertson John A. (1981), Ethical review of social experiments, IRB, 3 (7): 10-11.
p.(None): Royal College of Physicians (1986), 'Research on healthy volunteers', J Roy Coll Physicians, London, 20: 243-257.
p.(None): Schafer Arthur (1981), The ethics of research on human beings; a critical review of the issues and
p.(None): arguments, Res Adv Alcohol Drug Probl, 6: 471-511.
p.(None): Schiff Michel (1991), The dead ends of research in psychology, Psychologists and psychologies, n ° 104.
...

Searching for indicator mothers:

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p.(None): Equity issues
p.(None): - How to reconcile research on discriminating traits with the imperative of non-discrimination?
p.(None): This is a delicate problem, because the identification of significant differences and discriminating traits
p.(None): is precisely a plausible research objective. So it is interesting, and important for
p.(None): assessing LDC techniques, to ask whether
p.(None): there is a significant difference between the cognitive development of children born with an IAD and the others (dossier
p.(None): CNRS, Duyme project). But if we find that IAD children develop less well than others, and
p.(None): that the result of the research is made public, children already born of IAD (or their parents) are put in position
p.(None): difficult, even if the secret of the origins is well kept (danger of guilt).
p.(None): In the case of the Duyme protocol, every precaution was taken so that research was not a source of
p.(None): discrimination by its methodology.
p.(None): In addition to the methodology, research may involve a risk of explicit or implicit discrimination against
p.(None): individuals by the assumptions on which it is based (eg experimentation with "aversion therapies" to
p.(None): caring for homosexuals; psychosocial monitoring of a cohort of children born to alcoholic mothers). A search can also
p.(None): entail a risk of discrimination against an entire population by the interpretation which will be made of its results
p.(None): (e.g. highlighting statistically worse results in some intelligence tests)
p.(None): among blacks than among whites).
p.(None): In the United States at the end of the 1960s, the concern for a "science for the people" caused investigations to be halted,
p.(None): reason that their theoretical implications were infamous for certain categories of individuals. We
p.(None): even cites attempts to coerce researchers to "revise" their findings and / or publish only
p.(None): redacted results.
p.(None): The risks of discrimination depend on the level of social tolerance for this or that "difference". We can
p.(None): propose the rule: the risks of discrimination must be identified, and weighed against the collective interest and
p.(None): theoretical interest in obtaining the desired result.
p.(None): - Should the promoters of behavioral research take out insurance covering the risks incurred
p.(None): by research subjects due to the investigation?
p.(None): In biomedical research, French law requires promoters to take out insurance (Art.
p.(None): L. 209-7) guaranteeing its civil liability in the event of harmful consequences of research for the
p.(None): person who lends itself to it. We know that this provision of the law poses no problem when the promoter is
p.(None): the pharmaceutical industry, but that it poses a problem for research conducted by university teams
p.(None): and / or in small hospitals, which find it difficult to find a promoter with a seat
p.(None): sufficient financial resources to purchase insurance.
p.(None): In behavioral research, are the major research organizations (CNRS, university laboratories)
...

Searching for indicator coerce:

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p.(None): CNRS, Duyme project). But if we find that IAD children develop less well than others, and
p.(None): that the result of the research is made public, children already born of IAD (or their parents) are put in position
p.(None): difficult, even if the secret of the origins is well kept (danger of guilt).
p.(None): In the case of the Duyme protocol, every precaution was taken so that research was not a source of
p.(None): discrimination by its methodology.
p.(None): In addition to the methodology, research may involve a risk of explicit or implicit discrimination against
p.(None): individuals by the assumptions on which it is based (eg experimentation with "aversion therapies" to
p.(None): caring for homosexuals; psychosocial monitoring of a cohort of children born to alcoholic mothers). A search can also
p.(None): entail a risk of discrimination against an entire population by the interpretation which will be made of its results
p.(None): (e.g. highlighting statistically worse results in some intelligence tests)
p.(None): among blacks than among whites).
p.(None): In the United States at the end of the 1960s, the concern for a "science for the people" caused investigations to be halted,
p.(None): reason that their theoretical implications were infamous for certain categories of individuals. We
p.(None): even cites attempts to coerce researchers to "revise" their findings and / or publish only
p.(None): redacted results.
p.(None): The risks of discrimination depend on the level of social tolerance for this or that "difference". We can
p.(None): propose the rule: the risks of discrimination must be identified, and weighed against the collective interest and
p.(None): theoretical interest in obtaining the desired result.
p.(None): - Should the promoters of behavioral research take out insurance covering the risks incurred
p.(None): by research subjects due to the investigation?
p.(None): In biomedical research, French law requires promoters to take out insurance (Art.
p.(None): L. 209-7) guaranteeing its civil liability in the event of harmful consequences of research for the
p.(None): person who lends itself to it. We know that this provision of the law poses no problem when the promoter is
p.(None): the pharmaceutical industry, but that it poses a problem for research conducted by university teams
p.(None): and / or in small hospitals, which find it difficult to find a promoter with a seat
p.(None): sufficient financial resources to purchase insurance.
p.(None): In behavioral research, are the major research organizations (CNRS, university laboratories)
p.(None): able to act as research promoters? In the absence of identifying the promoter, we cannot in fact ask the
p.(None): insurance problem satisfactorily.
p.(None): One could argue that in the case of minimal risk behavior research, insurance is not
p.(None): essential, although there are physical risks to take into account, which, without being a consequence
p.(None): direct from the search, occur during the search (falls, commuting accidents). We
p.(None): could also argue that, for higher risk research, as proposed only
...

Searching for indicator army:

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p.(None): Baumrind Diana (1979), IRBs and social science research: the costs of deception, IRB, 1 (6): 1-4.
p.(None): Bourdieu Pierre, ed. (1993), The misery of the world, Paris: Seuil.
p.(None): Medical Research Council of Canada (1986), Guidelines for Research on Subjects
p.(None): humans, Ottawa.
p.(None): Cupples Brian & Gochnauer Myron (1985), The investigator's duty not to deceive, IRB, 7 (5): 1-6.
p.(None): De Sola Pool Ithiel (1983), Do social scientists have unlimited research rights ?, IRB, 5 (6): 10.
p.(None): Desportes Jean-Pierre (1974), Manipulations du behavior, La Recherche, 47: 654-661.
p.(None): Fagot-Largeault A. (1985), The bio-ethical man. For an ethics of research on living organisms, Paris: Maloine.
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): Gosselin Gabriel (1992), An ethics of the social sciences, Paris: L'Harmattan.
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): Katz Jay (1972), Experimentation with Human Beings? The Authority of the Investigator, Subject, Professions and State
p.(None): in the Human Experimentation Process, New York: Russell Sage Foundation.
p.(None): Levine Carol (1982), Former soldier denied compensation for damage in army LSD tests, IRB, 4 (3): 7.
p.(None): Levine Robert J. (1986), Ethics and Regulation of Clinical Research, Baltimore-Munich: Urban & Schwarzenberg,
p.(None): 2nd edition.
p.(None): Macklin Ruth (1989), The paradoxical case of payment as benefit to research subjects, IRB, 11 (6): 1-3.
p.(None): Marini James L. (1980), Methodology and ethics: research on human aggression, IRB, 2 (5): 1-4.
p.(None): Mead Margaret (1969), Research with human beings: a model derived from anthropological field practice, Daedalus, 98:
p.(None): 361-386.
p.(None): Meyer Roger E. (1977), Subjects' rights, freedom of inquiry, and the future of research in the addictions, Am J
p.(None): Psychiatry, 134 (8): 899-903.
p.(None): Menard Joël (1990), Report from the INSERM think tank on certain aspects of protecting subjects
p.(None): healthy volunteers and people who lend themselves to biomedical research, Paris: INSERM.
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 and
p.(None): Recommendations, and Appendix (1977). Research Involving Those Institutionalized as Mentally Infirm:
p.(None): Report and Recommendations, and Appendix (1978). The Belmont Report: Ethical Principles and Guidelines
...

Searching for indicator military:

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p.(None): fuzzy legal.
p.(None): CCNE summarizes below:
p.(None): - the ethical principles which must guide any investigation into human subjects,
p.(None): - the particular problems he identified with regard to behavioral research, and the elements of solutions
p.(None): that he offers.
p.(None): At the end of this work, the CCNE invites all researchers in human sciences, institutions
p.(None): scientists who conduct research in the humanities, the competent administrative authorities, and
p.(None): the legislator, to a common reflection, and to a broad consultation, with a view to developing the ethical framework
p.(None): and legal in which our society wants experimental investigations into human behavior
p.(None): be performed in the future.
p.(None): In its Ethics and Knowledge report (1990), the CCNE writes: "seek to know human beings scientifically
p.(None): is a good, but it cannot be done at the cost of justice, security or personal autonomy "(p. 74).
p.(None): This applies to research on humans, both in the behavioral sciences and in the sciences
p.(None): biomedical. Moreover, in the 1990 report (Ch. 2), the CCNE took into account a set of research to
p.(None): the intersection of the biomedical and behavioral domains: studies on learning, on adaptation to
p.(None): environment and work tasks (ergonomics), on the reactions of the human organism to extreme conditions
p.(None): (hyperbaric, hypobaric, microgravity, extreme climates, phase shift of the nycthemeral rhythms, sporting exploits of
p.(None): competition or endurance, civil or military), on quality of life and environmental pollution.
p.(None): The protection of people who lend themselves to biomedical research depends in France on law n ° 88-1138 of
p.(None): December 20, 1988 (modified n ° 90-86). The protection of persons who lend themselves to research
p.(None): Behavioral depends for the moment on the ethics of researchers (eg code of ethics of psychologists3).
p.(None): CCNE's recommendations on the ethics of behavioral research
p.(None): must, for the sake of consistency, be in continuity with Law No. 88-1138 of 20 Dec 1988. The major
p.(None): lines of guidelines for human research that were formulated in the United States by the National
p.(None): Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-78), or in Canada by the
p.(None): Medical Research Council (1986), then by the National Council on Bioethics in Human Research (CNBRH), are the
p.(None): same for all research on human beings, in the biomedical sciences and in the sciences
p.(None): human, even if secondarily special problems are identified according to the disciplines
p.(None): (cancerology, psychiatry, ethnology, etc.), or for different categories of subjects studied (children,
p.(None): captive or asylum populations, elderly people losing their autonomy, etc.).
...

Searching for indicator soldier:

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p.(None): Barber B. (1976), The ethics of experimentation with human subjects, Scientific American, 234 (2): 25-31.
p.(None): Baumrind Diana (1979), IRBs and social science research: the costs of deception, IRB, 1 (6): 1-4.
p.(None): Bourdieu Pierre, ed. (1993), The misery of the world, Paris: Seuil.
p.(None): Medical Research Council of Canada (1986), Guidelines for Research on Subjects
p.(None): humans, Ottawa.
p.(None): Cupples Brian & Gochnauer Myron (1985), The investigator's duty not to deceive, IRB, 7 (5): 1-6.
p.(None): De Sola Pool Ithiel (1983), Do social scientists have unlimited research rights ?, IRB, 5 (6): 10.
p.(None): Desportes Jean-Pierre (1974), Manipulations du behavior, La Recherche, 47: 654-661.
p.(None): Fagot-Largeault A. (1985), The bio-ethical man. For an ethics of research on living organisms, Paris: Maloine.
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): Gosselin Gabriel (1992), An ethics of the social sciences, Paris: L'Harmattan.
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): Katz Jay (1972), Experimentation with Human Beings? The Authority of the Investigator, Subject, Professions and State
p.(None): in the Human Experimentation Process, New York: Russell Sage Foundation.
p.(None): Levine Carol (1982), Former soldier denied compensation for damage in army LSD tests, IRB, 4 (3): 7.
p.(None): Levine Robert J. (1986), Ethics and Regulation of Clinical Research, Baltimore-Munich: Urban & Schwarzenberg,
p.(None): 2nd edition.
p.(None): Macklin Ruth (1989), The paradoxical case of payment as benefit to research subjects, IRB, 11 (6): 1-3.
p.(None): Marini James L. (1980), Methodology and ethics: research on human aggression, IRB, 2 (5): 1-4.
p.(None): Mead Margaret (1969), Research with human beings: a model derived from anthropological field practice, Daedalus, 98:
p.(None): 361-386.
p.(None): Meyer Roger E. (1977), Subjects' rights, freedom of inquiry, and the future of research in the addictions, Am J
p.(None): Psychiatry, 134 (8): 899-903.
p.(None): Menard Joël (1990), Report from the INSERM think tank on certain aspects of protecting subjects
p.(None): healthy volunteers and people who lend themselves to biomedical research, Paris: INSERM.
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 and
p.(None): Recommendations, and Appendix (1977). Research Involving Those Institutionalized as Mentally Infirm:
...

Searching for indicator violence:

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p.(None): 9. The Royal College of Physicians of London Report (1986) shows that the risk is considered minimal, either because the
p.(None): disorder is of very low severity, either because the
p.(None): accident probability is very low. In the latter case, the risk "is comparable to the risk incurred by a passenger
p.(None): plane using a regular flight "(cf. Ménard Report, 1990).
p.(None): 10. Art. 226.13 - "The revelation of secret information by a person who is its custodian either
p.(None): by state or by profession, either because of a temporary function or mission, is punished by one year
p.(None): imprisonment and a fine of 100,000 francs. "
p.(None): Art.226.14 - "Article 226.13 is not applicable in cases where the law requires or authorizes the disclosure of the secret.
p.(None): In addition, it does not apply: 1) To one who informs the judicial, medical or administrative authorities of
p.(None): ill-treatment or hardship of which he has knowledge and which has been inflicted on a minor of fifteen years or on a person who
p.(None): is unable to protect himself because of his age or his physical or mental state; 2) To the doctor who, with
p.(None): the victim's agreement, brings to the attention of the Public Prosecutor the ill-treatment he has noted in
p.(None): the exercise of his profession and which allow him to presume that sexual violence of any kind has been
p.(None): committed. "
p.(None): Law No. 92.684 of July 22, 1992, published in the Official Journal of July 23, 1992, reforming the Penal Code.
p.(None): comes into force March 1, 1994.
p.(None): 11. An amendment to the law of 1978 is provided for in favor of epidemiological research by the Bill
p.(None): relating to the processing of personal data for the purpose of research for the protection of, or
p.(None): improvement of health, adopted at first reading in the National Assembly on Nov. 25, 1992.
p.(None): This bill does not retain the concept of professional secrecy shared for the purpose of research between
p.(None): physicians and non-physicians.It authorizes the sharing of secrecy between physicians for the purpose of research.
p.(None): research in psychology is not taken into account by the bill, which aims
p.(None): essentially the statistical processing of personal data for public health research purposes.
p.(None): Data transmission outside a hospital service to a research institution with a view
p.(None): of an investigation (eg statistical processing) is authorized by the bill, provided that the
p.(None): future "National Advisory Committee on Information Processing in Health Research"
p.(None): has agreed to the study, that the persons concerned have been informed individually and
p.(None): have been able to exercise their right of opposition (unless this is impossible), that the data be received by a
p.(None): doctor designated by the research organization and responsible for ensuring the security of this data and compliance with
p.(None): research purposes.
...

Searching for indicator victim:

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p.(None): vulnerable research "without direct individual benefit" is admissible only if it presents "no risk
p.(None): foreseeable seriousness "(Art. L.209-6).
p.(None): 9. The Royal College of Physicians of London Report (1986) shows that the risk is considered minimal, either because the
p.(None): disorder is of very low severity, either because the
p.(None): accident probability is very low. In the latter case, the risk "is comparable to the risk incurred by a passenger
p.(None): plane using a regular flight "(cf. Ménard Report, 1990).
p.(None): 10. Art. 226.13 - "The revelation of secret information by a person who is its custodian either
p.(None): by state or by profession, either because of a temporary function or mission, is punished by one year
p.(None): imprisonment and a fine of 100,000 francs. "
p.(None): Art.226.14 - "Article 226.13 is not applicable in cases where the law requires or authorizes the disclosure of the secret.
p.(None): In addition, it does not apply: 1) To one who informs the judicial, medical or administrative authorities of
p.(None): ill-treatment or hardship of which he has knowledge and which has been inflicted on a minor of fifteen years or on a person who
p.(None): is unable to protect himself because of his age or his physical or mental state; 2) To the doctor who, with
p.(None): the victim's agreement, brings to the attention of the Public Prosecutor the ill-treatment he has noted in
p.(None): the exercise of his profession and which allow him to presume that sexual violence of any kind has been
p.(None): committed. "
p.(None): Law No. 92.684 of July 22, 1992, published in the Official Journal of July 23, 1992, reforming the Penal Code.
p.(None): comes into force March 1, 1994.
p.(None): 11. An amendment to the law of 1978 is provided for in favor of epidemiological research by the Bill
p.(None): relating to the processing of personal data for the purpose of research for the protection of, or
p.(None): improvement of health, adopted at first reading in the National Assembly on Nov. 25, 1992.
p.(None): This bill does not retain the concept of professional secrecy shared for the purpose of research between
p.(None): physicians and non-physicians.It authorizes the sharing of secrecy between physicians for the purpose of research.
p.(None): research in psychology is not taken into account by the bill, which aims
p.(None): essentially the statistical processing of personal data for public health research purposes.
p.(None): Data transmission outside a hospital service to a research institution with a view
p.(None): of an investigation (eg statistical processing) is authorized by the bill, provided that the
p.(None): future "National Advisory Committee on Information Processing in Health Research"
p.(None): has agreed to the study, that the persons concerned have been informed individually and
p.(None): have been able to exercise their right of opposition (unless this is impossible), that the data be received by a
...

Searching for indicator minor:

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p.(None): (e.g. drug addicts), institutionalized captive populations (prisoners, pupils, adolescents under
p.(None): supervised education, young people in shelters, soldiers).
p.(None): - For minors and adults under guardianship, the accepted rule for biomedical research (L. 209-10) can be
p.(None): generalized: consent of parents or legal guardians, information of the child or the incapable person throughout the
p.(None): as far as possible, respect for a possible refusal by the child or the incapable person.
p.(None): - For institutionalized captive populations (prisoners, pupils, adolescents from
p.(None): recovery ', young people in homes), the usual rule is to consider admissible only research (1)
p.(None): "minimal risk", and (2) non-discriminatory. Consent must be obtained from those responsible for
p.(None): the institution, on the other hand of each subject individually (if the subjects are minor, of the person who
p.(None): has parental authority).
p.(None): - The use of "rewards" must be subject to special attention at the time of the ethical review
p.(None): (eg recruiting tramps or Indians as research subjects through an offer of alcohol).
p.(None): - With regard to detainees, the law of 20 December 1988 excludes research without direct individual benefit
p.(None): in persons deprived of their liberty. In behavioral sciences, this research can be without
p.(None): harmful to the people concerned, and socially useful, even necessary; therefore they cannot be
p.(None): prohibited without further examination.
p.(None): - How to reconcile the obligation of consent which should be informed with the methodological necessity (which can
p.(None): appear in certain experimental protocols) not to say everything?
p.(None): This is a question raised about biomedical research, but mostly known about
p.(None): psychology, social psychology (5), and research on sports performance.
p.(None): The Canadian MRC treated this issue as follows:
p.(None): Deception (6)
p.(None): "... Given the critical importance of free and informed consent, it seems incongruous to consider the
p.(None): question of deception.
p.(None): "Deception is understood to mean deliberately misleading potential subjects or hiding them from
p.(None): information, in such a way as to lead them to believe that the objectives of the research or of the procedure to be followed are
p.(None): different from what they really are. The
p.(None): deception may also consist in deliberately presenting false information to them, concealing information
...

p.(None): (1963), 'Behavioral study of obedience ", J Abnorm Psychol, 67: 371-378.
p.(None): 6. Engl. "Deception", "deceptive research".
p.(None): 7. In English: "debriefing"
p.(None): 8. The French law of 20 Dec. 1988 says "serious risk" and states that for people belonging to categories
p.(None): vulnerable research "without direct individual benefit" is admissible only if it presents "no risk
p.(None): foreseeable seriousness "(Art. L.209-6).
p.(None): 9. The Royal College of Physicians of London Report (1986) shows that the risk is considered minimal, either because the
p.(None): disorder is of very low severity, either because the
p.(None): accident probability is very low. In the latter case, the risk "is comparable to the risk incurred by a passenger
p.(None): plane using a regular flight "(cf. Ménard Report, 1990).
p.(None): 10. Art. 226.13 - "The revelation of secret information by a person who is its custodian either
p.(None): by state or by profession, either because of a temporary function or mission, is punished by one year
p.(None): imprisonment and a fine of 100,000 francs. "
p.(None): Art.226.14 - "Article 226.13 is not applicable in cases where the law requires or authorizes the disclosure of the secret.
p.(None): In addition, it does not apply: 1) To one who informs the judicial, medical or administrative authorities of
p.(None): ill-treatment or hardship of which he has knowledge and which has been inflicted on a minor of fifteen years or on a person who
p.(None): is unable to protect himself because of his age or his physical or mental state; 2) To the doctor who, with
p.(None): the victim's agreement, brings to the attention of the Public Prosecutor the ill-treatment he has noted in
p.(None): the exercise of his profession and which allow him to presume that sexual violence of any kind has been
p.(None): committed. "
p.(None): Law No. 92.684 of July 22, 1992, published in the Official Journal of July 23, 1992, reforming the Penal Code.
p.(None): comes into force March 1, 1994.
p.(None): 11. An amendment to the law of 1978 is provided for in favor of epidemiological research by the Bill
p.(None): relating to the processing of personal data for the purpose of research for the protection of, or
p.(None): improvement of health, adopted at first reading in the National Assembly on Nov. 25, 1992.
p.(None): This bill does not retain the concept of professional secrecy shared for the purpose of research between
p.(None): physicians and non-physicians.It authorizes the sharing of secrecy between physicians for the purpose of research.
p.(None): research in psychology is not taken into account by the bill, which aims
p.(None): essentially the statistical processing of personal data for public health research purposes.
p.(None): Data transmission outside a hospital service to a research institution with a view
p.(None): of an investigation (eg statistical processing) is authorized by the bill, provided that the
p.(None): future "National Advisory Committee on Information Processing in Health Research"
...

Searching for indicator education:

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p.(None): delicate handling: there are indeed, as D. Widlöcher pointed out to us, "very harmless experiments",
p.(None): and possibly traumatic observations.
p.(None): Problems specific to behavioral research, identified using protocols submitted by the CNRS
p.(None): Consent
p.(None): - Under what conditions is behavioral research admissible on subjects including the ability to consent
p.(None): is problematic (limited competence, dependence)?
p.(None): The general rule is that people whose consent is precarious must be protected against
p.(None): the possibility of serving as "subjects" of research, in proportion to their incapacity and their dependence.
p.(None): Some vulnerable categories to be protected especially in behavioral research are: children, infirm
p.(None): mental, people easily manipulated by their own weakness or dependence
p.(None): (e.g. drug addicts), institutionalized captive populations (prisoners, pupils, adolescents under
p.(None): supervised education, young people in shelters, soldiers).
p.(None): - For minors and adults under guardianship, the accepted rule for biomedical research (L. 209-10) can be
p.(None): generalized: consent of parents or legal guardians, information of the child or the incapable person throughout the
p.(None): as far as possible, respect for a possible refusal by the child or the incapable person.
p.(None): - For institutionalized captive populations (prisoners, pupils, adolescents from
p.(None): recovery ', young people in homes), the usual rule is to consider admissible only research (1)
p.(None): "minimal risk", and (2) non-discriminatory. Consent must be obtained from those responsible for
p.(None): the institution, on the other hand of each subject individually (if the subjects are minor, of the person who
p.(None): has parental authority).
p.(None): - The use of "rewards" must be subject to special attention at the time of the ethical review
p.(None): (eg recruiting tramps or Indians as research subjects through an offer of alcohol).
p.(None): - With regard to detainees, the law of 20 December 1988 excludes research without direct individual benefit
...

p.(None): in human sciences. They were not designed for this.
p.(None): It is not the role of the technical section of the CCNE to carry out a systematic review of
p.(None): humanities research.
p.(None): The French experience prior to law n ° 88-1138 of December 20, 1988 (ex. AP de Paris), as well as the
p.(None): North American model, would go in the direction of the creation of "Ethics committees for research in the humanities"
p.(None): with institutions which, in fact, conduct behavioral research on human subjects: CNRS, Universities.
p.(None): According to R.J. Levine (1986), these Committees are "the conscience of the institution", and the expression of its concern
p.(None): to ensure quality research within it and adequate protection for those who lend themselves to it. Rules
p.(None): affecting the composition of these committees (which should include a certain proportion of members from outside
p.(None): the institution, and / or outside the human sciences: ex. jurists, philosophers, doctors) could
p.(None): be drawn up by a joint commission (CNRS-Universities-CCNE-Ministries-Professional organizations). A
p.(None): procedure for enabling these committees could be defined by a text from the Ministry of Research. It would be
p.(None): probably an interim solution, but one that could be implemented fairly quickly.
p.(None): In the French context, it seems difficult not to envisage in the longer term the establishment by law of
p.(None): a few regional CCPPRCs, along the lines of the CCPPRBs, but with a composition which ensures their competence
p.(None): required to review human research protocols in the humanities other than
p.(None): bio-medical: anthropology, ethnology, psychology (s), sociology, linguistics, history, sciences of
p.(None): education, etc. This is the business of the legislator.
p.(None): The dossier submitted to a CCPPRC should provide at least the following information: 1) the objectives of the research
p.(None): and the working hypotheses, 2) the population targeted by the study, and the methods of recruiting subjects (including
p.(None): including any advertising text), 3) details of the methodology, 4) the arrangements made for
p.(None): anonymize the collected data, store it and allow it to be viewed, 5) risk assessment,
p.(None): costs, constraints and constraints, potential benefits, 6) informing people
p.(None): participating in the study and the terms of their consent, including the presentation document of
p.(None): the study intended for these people, and the consent form (consent to the study, and, if applicable,
p.(None): when using the results).
p.(None): References
p.(None): American Psychological Association (1986), Ethical issues in psychological research in AIDS, Committee for the
p.(None): protection of human participants in research, IRB, 8 (4): 8-10.
p.(None): Barber B. (1976), The ethics of experimentation with human subjects, Scientific American, 234 (2): 25-31.
p.(None): Baumrind Diana (1979), IRBs and social science research: the costs of deception, IRB, 1 (6): 1-4.
p.(None): Bourdieu Pierre, ed. (1993), The misery of the world, Paris: Seuil.
p.(None): Medical Research Council of Canada (1986), Guidelines for Research on Subjects
p.(None): humans, Ottawa.
p.(None): Cupples Brian & Gochnauer Myron (1985), The investigator's duty not to deceive, IRB, 7 (5): 1-6.
...

Searching for indicator educational:

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p.(None): CNRS researchers, as well as a description of the research carried out in psychology at the CNRS. Among the five files
p.(None): submitted, which had the approval of the competent scientific commission of the CNRS, two (Duyme and
p.(None): Carlier2) come from the laboratory directed by Pr. Roubertoux and correspond to research that has been
p.(None): interrupted, following an article published in the newspaper L'Express on December 17, 1992.
p.(None): CCNE has set up a working group.
p.(None): The working group took note of the wide variety of research carried out at the CNRS in the humanities.
p.(None): For psychology: fifteen research units (URA in general), i.e. 150 researchers and around 200
p.(None): teacher-researchers, are grouped in Section 29 "Mental functions, integrative neuroscience and
p.(None): behaviors ", co-managed by the Department of Life Sciences, and the Department of Life Sciences
p.(None): man and society. The objective of research is to "understand the skills and performance of being
p.(None): human during different periods of his life, in usual situations as well as in
p.(None): exceptional situations ". The methods range from simple observation in a natural situation or
p.(None): standardized, to test reactions in "borderline situations". Subjects are recruited on the basis of
p.(None): volunteering. The sub-disciplines identified are: child and developmental psychology,
p.(None): social psychology, cognitive psychology, work psychology, ergonomics, psycholinguistics,
p.(None): psychopathology, clinical psychology, neuropsychology, psychopharmacology. Interfaces with
p.(None): neighboring disciplines are frequent: anthropology, neuroscience, psychiatry, linguistics, sociology,
p.(None): educational sciences, artificial intelligence, etc.
p.(None): The working group met approximately once a month between January and June 1993. It met with the Committee
p.(None): operational on ethics in the life sciences of the CNRS (COPE,
p.(None): January 22, 1993). He heard from several researchers. He inquired about the specific problems of
p.(None): humanities research, professional codes of ethics, how investigations
p.(None): experimental studies in the humanities are supervised in other countries.
p.(None): CCNE notes that in France, since the "law on the protection of persons who lend themselves to research
p.(None): biomedical "of December 20, 1988, the" tests or experiments organized and practiced on the being
p.(None): human for the development of biological or medical knowledge "takes place in a legal framework
p.(None): precise and binding. In contrast, the legislator did not pay attention to the protection of persons who
p.(None): lend themselves to behavioral research, and investigations carried out on human beings with a view to
p.(None): development of knowledge in the disciplines called "human sciences" remained in a situation
p.(None): fuzzy legal.
p.(None): CCNE summarizes below:
p.(None): - the ethical principles which must guide any investigation into human subjects,
p.(None): - the particular problems he identified with regard to behavioral research, and the elements of solutions
p.(None): that he offers.
p.(None): At the end of this work, the CCNE invites all researchers in human sciences, institutions
p.(None): scientists who conduct research in the humanities, the competent administrative authorities, and
...

p.(None): - Consent is free if the investigator abstains from any pressure, coercion, or incitement
p.(None): strong (money, passing an exam, career advantage, emotional blackmail, etc.).
p.(None): Furthermore, consent to research is revocable. Subjects should be informed that they can at any
p.(None): moment stop participating, without incurring any sanction or reproach.
p.(None): Security. The human cost
p.(None): In biomedical research it is admitted that certain research protocols imply for the people who are there
p.(None): lend a "direct individual benefit" (Art. L. 209-1). This notion of (potential) benefit for the subject
p.(None): is used in medicine to authorize inclusion in research protocols, under certain conditions (Art. L.
p.(None): 209-6) of persons whose consent is precarious or even impossible (minors, adults under guardianship,
p.(None): people staying in a health or social establishment, sick in an emergency).
p.(None): In behavioral research, there may exist cases of investigation "with direct individual benefit", for example
p.(None): example in clinical psychology during a comparative study of two psychotherapeutic methods (if for subjects
p.(None): which lend themselves to the benefit of at least one of the methods is established), or in cognitive psychology (if doing so for
p.(None): children to participate in a study gives them an educational advantage, as was discussed in the
p.(None): CNRS file on the Lautrey protocol). But the absence of vital emergencies forcing the practitioner to intervene, and
p.(None): the difficulty of arguing that research is conducted "for the good" of the subjects included, or "in the interest of their
p.(None): health ", fact that the distinction" with / without direct individual benefit "is not relevant in research
p.(None): behavior to relax the conditions of consent, even when it comes to applied research. The
p.(None): distinction is only relevant in the context of the risk / benefit balance.
p.(None): CCNE noted in its 1990 report that, in general, people who lend themselves to a
p.(None): investigation whose objective is the acquisition of knowledge about the human being do not find there
p.(None): personal benefit. CCNE considered that this is admissible, "on condition of a balance sheet
p.(None): acceptable risk-benefit, that is, definite benefit to the community, little or no risk to the individual "
p.(None): (p. 70).
p.(None): Taking a risk-benefit assessment is asking yourself whether the risks, constraints or
p.(None): inconvenience imposed on subjects ("human cost") are sufficiently justified by the importance
p.(None): scientist of the question asked, and by the assurance that the protocol gives to resolve this question.
p.(None): In behavioral research, in addition to making an explicit assessment of physical risks,
p.(None): one must be particularly attentive to the psychological risks of the experiences and their consequences
...

Searching for indicator parents:

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p.(None): Consent
p.(None): - Under what conditions is behavioral research admissible on subjects including the ability to consent
p.(None): is problematic (limited competence, dependence)?
p.(None): The general rule is that people whose consent is precarious must be protected against
p.(None): the possibility of serving as "subjects" of research, in proportion to their incapacity and their dependence.
p.(None): Some vulnerable categories to be protected especially in behavioral research are: children, infirm
p.(None): mental, people easily manipulated by their own weakness or dependence
p.(None): (e.g. drug addicts), institutionalized captive populations (prisoners, pupils, adolescents under
p.(None): supervised education, young people in shelters, soldiers).
p.(None): - For minors and adults under guardianship, the accepted rule for biomedical research (L. 209-10) can be
p.(None): generalized: consent of parents or legal guardians, information of the child or the incapable person throughout the
p.(None): as far as possible, respect for a possible refusal by the child or the incapable person.
p.(None): - For institutionalized captive populations (prisoners, pupils, adolescents from
p.(None): recovery ', young people in homes), the usual rule is to consider admissible only research (1)
p.(None): "minimal risk", and (2) non-discriminatory. Consent must be obtained from those responsible for
p.(None): the institution, on the other hand of each subject individually (if the subjects are minor, of the person who
p.(None): has parental authority).
p.(None): - The use of "rewards" must be subject to special attention at the time of the ethical review
p.(None): (eg recruiting tramps or Indians as research subjects through an offer of alcohol).
p.(None): - With regard to detainees, the law of 20 December 1988 excludes research without direct individual benefit
p.(None): in persons deprived of their liberty. In behavioral sciences, this research can be without
p.(None): harmful to the people concerned, and socially useful, even necessary; therefore they cannot be
p.(None): prohibited without further examination.
...

p.(None): indirect to his medical file, of which he generally ignores what it contains.
p.(None): If French law is moving towards a new derogation from medical confidentiality, with a view to scientific research,
p.(None): this therefore also implies a modification of the Code of medical ethics, a modification of the Code of ethics of
p.(None): psychologists, and undoubtedly in the long term for all patients a right of direct access to their medical file, therefore a
p.(None): modification of the law "IT and liberties", and of the law on access to administrative documents.
p.(None): Equity issues
p.(None): - How to reconcile research on discriminating traits with the imperative of non-discrimination?
p.(None): This is a delicate problem, because the identification of significant differences and discriminating traits
p.(None): is precisely a plausible research objective. So it is interesting, and important for
p.(None): assessing LDC techniques, to ask whether
p.(None): there is a significant difference between the cognitive development of children born with an IAD and the others (dossier
p.(None): CNRS, Duyme project). But if we find that IAD children develop less well than others, and
p.(None): that the result of the research is made public, children already born of IAD (or their parents) are put in position
p.(None): difficult, even if the secret of the origins is well kept (danger of guilt).
p.(None): In the case of the Duyme protocol, every precaution was taken so that research was not a source of
p.(None): discrimination by its methodology.
p.(None): In addition to the methodology, research may involve a risk of explicit or implicit discrimination against
p.(None): individuals by the assumptions on which it is based (eg experimentation with "aversion therapies" to
p.(None): caring for homosexuals; psychosocial monitoring of a cohort of children born to alcoholic mothers). A search can also
p.(None): entail a risk of discrimination against an entire population by the interpretation which will be made of its results
p.(None): (e.g. highlighting statistically worse results in some intelligence tests)
p.(None): among blacks than among whites).
p.(None): In the United States at the end of the 1960s, the concern for a "science for the people" caused investigations to be halted,
p.(None): reason that their theoretical implications were infamous for certain categories of individuals. We
p.(None): even cites attempts to coerce researchers to "revise" their findings and / or publish only
p.(None): redacted results.
p.(None): The risks of discrimination depend on the level of social tolerance for this or that "difference". We can
p.(None): propose the rule: the risks of discrimination must be identified, and weighed against the collective interest and
p.(None): theoretical interest in obtaining the desired result.
...

Searching for indicator opinion:

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p.(None): Opinion on research ethics in the sciences of human behavior. Report.
p.(None): N ° 38 - October 14, 1993
p.(None): Summary Notice Report
p.(None): Broad outlines
p.(None): Freedom of the people
p.(None): Security. The human cost Justice. Human dignity
p.(None): Ethical review by "independent" bodies
p.(None): Problems specific to behavioral research, identified using protocols submitted by the CNRS
p.(None): Consent Security Equity issues
p.(None): Review of protocols. What would the CCPPRC (Consultative Committees for the Protection of Persons in Research
p.(None): behavioral)?
p.(None): Notice
p.(None): The Director of the Life Sciences Department of the National Center for Scientific Research (CNRS)
p.(None): consulted the National Consultative Ethics Committee for Life Sciences and Health (CCNE) regarding
p.(None): the ethics of research on human beings in the behavioral sciences, and particularly in psychology.
p.(None): CCNE notes that in France, since the "opinion on trials of new treatments in humans" given by CCNE
p.(None): October 9, 1984, then the "Law on the Protection of Persons Lending themselves to Biomedical Research"
p.(None): of December 20, 1988, the "tests or experiments organized and practiced on the human being with a view
p.(None): of the development of biological or medical knowledge "takes place in an ethical and legal framework
p.(None): specific. By contrast, the legislator does not seem to have paid attention to the protection of persons who
p.(None): lend themselves to behavioral research, and investigations carried out on human beings with a view to
p.(None): Knowledge development in the behavioral sciences has less explicit ethical references.
p.(None): The CCNE recalls that any experimental investigation on the human being, that it is with a view to the development of
p.(None): bio-medical knowledge, or for the development of behavioral knowledge, must be done
p.(None): according to an irreproachable scientific approach, while respecting the freedom of action of individuals,
p.(None): their security, the principle of justice; and that the free, informed and express consent of those who lend themselves
p.(None): to research does not relieve researchers of their moral and scientific responsibility.
p.(None): CCNE has been attentive to the particular methodological and ethical difficulties of the investigations
p.(None): scientists on human behavior. Instructed by the researchers he heard, he recalls that a study
p.(None): on human beings should not be the occasion for manipulation or discrimination, and that the chain of secrecy
p.(None): professional must be flawless.
...

p.(None): the examination of research protocols in the different human sciences other than medical.
p.(None): These committees would have the following functions in particular:
p.(None): (1) to assess the scientific relevance of research projects,
p.(None): (2) to ensure that the liberty and security of the subject is protected:
p.(None): - by ensuring that the experiments envisaged do not threaten the security or the dignity of the people who lend themselves to them,
p.(None): - by assessing the methods provided for the information and consent of individuals
p.(None): participating in the study, especially when this information must, at the initial stage, remain incomplete,
p.(None): (3) to hear, if they request it, the researchers or the subjects in case there is a problem
p.(None): of particular ethics during the study.
p.(None): Provisionally, while waiting for the legislator, drawing on the experience of the CCPPRBs, to decide on
p.(None): the advisability of creating such Committees, and on the principles according to which they would exercise their mission, the experience
p.(None): French law prior to the law of 1988 would go in the direction of the creation of "Ethics Committees of the
p.(None): research in the sciences of human behavior "with the institutions where this is done
p.(None): research: CNRS, INSERM, Universities ... These Committees would be the conscience of these institutions, and
p.(None): the expression of their desire to ensure quality research and adequate protection within them
p.(None): people who lend themselves to it.
p.(None): This opinion is a first step in CCNE's reflection, which must be developed in concert with
p.(None): social sciences and humanities researchers, the scientific institutions that conduct research in the sciences
p.(None): human (whether this research is fundamental or finalized), the competent administrative authorities, and the
p.(None): legislator, with a view to developing the ethical and legal framework in which it seems desirable that
p.(None): experimental investigations of human behavior will be carried out in the future.
p.(None): Report
p.(None): The Director of the Life Sciences Department of the National Center for Scientific Research (CNRS),
p.(None): by letter dated 15 January 1993, submitted for opinion to the Chairman of the National Advisory Committee
p.(None): of ethics for the life sciences and health (CCNE) five files describing research in
p.(None): psychology carried out in university laboratories supported by the CNRS or carried out in part by
p.(None): CNRS researchers, as well as a description of the research carried out in psychology at the CNRS. Among the five files
p.(None): submitted, which had the approval of the competent scientific commission of the CNRS, two (Duyme and
p.(None): Carlier2) come from the laboratory directed by Pr. Roubertoux and correspond to research that has been
p.(None): interrupted, following an article published in the newspaper L'Express on December 17, 1992.
p.(None): CCNE has set up a working group.
p.(None): The working group took note of the wide variety of research carried out at the CNRS in the humanities.
p.(None): For psychology: fifteen research units (URA in general), i.e. 150 researchers and around 200
p.(None): teacher-researchers, are grouped in Section 29 "Mental functions, integrative neuroscience and
p.(None): behaviors ", co-managed by the Department of Life Sciences, and the Department of Life Sciences
p.(None): man and society. The objective of research is to "understand the skills and performance of being
p.(None): human during different periods of his life, in usual situations as well as in
p.(None): exceptional situations ". The methods range from simple observation in a natural situation or
p.(None): standardized, to test reactions in "borderline situations". Subjects are recruited on the basis of
p.(None): volunteering. The sub-disciplines identified are: child and developmental psychology,
...

p.(None): behavioral research), without prejudging their relationship with the CCPPRB instituted by law n ° 88-1138 of 20 December
p.(None): 1988 (which will be considered later).
p.(None): Broad outlines
p.(None): Freedom of the people
p.(None): Freedom has a negative aspect (independence): not being led to do what you don't want, and a positive aspect
p.(None): (autonomy): act in accordance with what you really want for yourself. It is usually accepted that respecting the
p.(None): freedom of people implies that we accept the rule: no investigation will be conducted on people
p.(None): without these people having given their "free, informed and
p.(None): express "(L. 209-9).
p.(None): By adapting the law n ° 88-1138 of December 20, 1988 (Art. L. 209-9):
p.(None): - Consent is express if it is "given in writing or, if impossible, attested by an independent third party ...
p.(None): investigators. "
p.(None): - Consent is informed if the subject has been sufficiently informed, if he has understood
p.(None): the information, if it has had a period of reflection before making its choice known. So that the information is
p.(None): sufficient, the law of 20 December 1988 specifies that the investigator must make known to the subject:
p.(None): - the objective of the research, its methodology and its duration,
p.(None): - the expected benefits, the constraints and the foreseeable risks, including in the event of stopping the research before
p.(None): his term,
p.(None): - the opinion of the CCPPRC.
p.(None): - Consent is free if the investigator abstains from any pressure, coercion, or incitement
p.(None): strong (money, passing an exam, career advantage, emotional blackmail, etc.).
p.(None): Furthermore, consent to research is revocable. Subjects should be informed that they can at any
p.(None): moment stop participating, without incurring any sanction or reproach.
p.(None): Security. The human cost
p.(None): In biomedical research it is admitted that certain research protocols imply for the people who are there
p.(None): lend a "direct individual benefit" (Art. L. 209-1). This notion of (potential) benefit for the subject
p.(None): is used in medicine to authorize inclusion in research protocols, under certain conditions (Art. L.
p.(None): 209-6) of persons whose consent is precarious or even impossible (minors, adults under guardianship,
p.(None): people staying in a health or social establishment, sick in an emergency).
p.(None): In behavioral research, there may exist cases of investigation "with direct individual benefit", for example
p.(None): example in clinical psychology during a comparative study of two psychotherapeutic methods (if for subjects
p.(None): which lend themselves to the benefit of at least one of the methods is established), or in cognitive psychology (if doing so for
p.(None): children to participate in a study gives them an educational advantage, as was discussed in the
...

p.(None): or another, it was essential that the subjects were not made aware of the nature of the
p.(None): For scientific integrity, it should be ensured that the following rules are observed.
p.(None): - Deception should never be used when there is another way to achieve the objectives of the
p.(None): research. The researcher must show in the protocol that there is no other way to proceed.
p.(None): - We must refrain from conducting misleading research when there could be risks for them.
p.(None): subjects: imposing risks on a subject who has not given his consent is impossible to justify.
p.(None): - The C.D.R. must be assured that no information will be withheld which, if disclosed,
p.(None): would result in a refusal to participate.
p.(None): - The C.D.R. must be assured that research could lead to scientific progress
p.(None): considerable, to justify the use of the slightest deception.
p.(None): - Deception should only be admitted when it is possible to inform the subjects and give them a report
p.(None): of experience after the research is completed, and to obtain their consent for the use of the data
p.(None): collected. The reporting method must be indicated in the research protocol and this
p.(None): approach must take place immediately after participation in the research, when the data
p.(None): still allow to identify the subjects. However, it should not be forgotten that it does not cancel out the
p.(None): deception. Data regarding subjects who refuse to give consent to the study should be
p.(None): destroyed or returned to interested parties. This condition will, in our opinion, have a dissuasive effect on the use of
p.(None): deception. "(CRM, 1986, A, Ch. 5,
p.(None): § F)
p.(None): The following rules can be proposed:
p.(None): - The protocol must provide arguments proving that the acquisition of the knowledge sought presents
p.(None): scientific interest, that the concealment of certain aspects of the protocol is essential for
p.(None): achieve the intended objective, and that none of the aspects hidden from the subjects is likely to threaten their safety or
p.(None): their dignity, or to dissuade them from consenting if they were revealed to them.
p.(None): - The CCPPRC must have accepted these arguments, judged that the situation in which the subjects of the study will be placed is
p.(None): acceptable, and having given a favorable opinion to the study.
p.(None): - The subjects are informed at the time of the initial collection of their consent that certain aspects of the methodology
p.(None): are deliberately hidden from them, that it is necessary for the study, that it is "the rule of the game", that the CCPPRC judged that
p.(None): nothing that is hidden from them threatens them either in their security or in their dignity, and that at the end of the study
p.(None): will enlighten them and answer all their questions.
p.(None): - At the end of the study, the subjects, if they wish, are made fully aware of the subject of the research
p.(None): and observations made about themselves (7), and all their questions are answered. They are informed of
p.(None): the use that will be made of the data collected. In the event that identifying data (e.g. photos, films) have been
p.(None): collected, the persons concerned must give explicit consent to their use. The
p.(None): data
p.(None): identifiers concerning persons who refuse to consent to the use that we want to make of it will be destroyed
p.(None): or returned to interested parties.
p.(None): security
p.(None): - How to assess the psychological risks, and the possible after-effects for the subjects, of a research
p.(None): behavioral?
p.(None): It has been argued about biomedical research that, by definition, when looking,
p.(None): risks are unknown, and therefore cannot be assessed. This argument is usually opposed to
p.(None): counter argument that the hypotheses on which research is based are based on knowledge
p.(None): already acquired, and that this background knowledge allows at least an approximate appreciation
p.(None): risks incurred by subjects subjected to the experiment. The same reasoning applies to psychology.
...

p.(None): minimal, or to use the terms of the French law of 1988, experiences which present "no risk
p.(None): seriously predictable. "
p.(None): Only healthy, adult subjects in full possession of their mental faculties, and
p.(None): fully informed, that we can offer to lend ourselves for the needs of research in the humanities to
p.(None): experiences involving risks from a level higher (as little as it is) to the minimum level.
p.(None): - How to reconcile the imperative of confidentiality of data with communication to non-medical researchers, in
p.(None): view of research, confidential medical records?
p.(None): The problem of ethics is a problem of respect for the personal sphere, and of non-disclosure of
p.(None): confidential data of which the attending physician is the custodian. We can trust sections 7 to 13 of the Code
p.(None): of ethics of psychologists (3), modeled on the rules of medical confidentiality.
p.(None): Beyond the ethical problem, there is a legal and regulatory problem in France. Some texts by
p.(None): reference are: Art. 226.13 and 226.14 (former Art. 378) of the Criminal Code (10), Law No. 78-17 of January 6
p.(None): 1978 relating to data processing, files and freedoms, Decree n ° 79-506 of June 28, 1979 relating
p.(None): Code of medical ethics. These texts exclude the communication by the doctor of personal data to
p.(None): anyone, except to another doctor and in the strict interest of the health of a patient (e.g. specialist consultation
p.(None): for a therapeutic opinion).
p.(None): The problem of communication of data for research has been studied extensively in
p.(None): 1980s on cancer registers and epidemiological research, between the CNIL, the CCNE, the Order of
p.(None): doctors. The solution proposed had been that of shared professional secrecy. This solution is not yet
p.(None): legal (11).
p.(None): In the current state of the law, only is admissible (in the hospital setting, for example) a
p.(None): study using nominative medical data within the department where the patients were treated, and under the
p.(None): responsibility of a doctor of the service. The procedure followed by Pr. M. Carlier (CNRS file, Carlier project) is not
p.(None): not right. It is the doctor in charge of the service (and not the research psychologist) who should have
p.(None): contact the families and seek their consent to the research. Families could
p.(None): legitimately complain that a psychologist contacted them (by phone, then directly) for a
p.(None): research on their twins, which implied that this psychologist had read their medical records
p.(None): before any consent from them, and therefore that the head of department concerned has not respected medical confidentiality.
p.(None): The use of nominative medical data for research is therefore necessarily under
p.(None): medical liability, the persons concerned having the right to be informed beforehand of the use that
p.(None): wants to make their data, and the right to object.
p.(None): One could imagine that researchers psychologists (or statisticians, or biologists, or anthropologists ...) (not
p.(None): doctors) are henceforth entitled to take cognizance of certain nominative medical data with a view to
...

Economic / Economic/Poverty

Searching for indicator poor:

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p.(None): behavior to relax the conditions of consent, even when it comes to applied research. The
p.(None): distinction is only relevant in the context of the risk / benefit balance.
p.(None): CCNE noted in its 1990 report that, in general, people who lend themselves to a
p.(None): investigation whose objective is the acquisition of knowledge about the human being do not find there
p.(None): personal benefit. CCNE considered that this is admissible, "on condition of a balance sheet
p.(None): acceptable risk-benefit, that is, definite benefit to the community, little or no risk to the individual "
p.(None): (p. 70).
p.(None): Taking a risk-benefit assessment is asking yourself whether the risks, constraints or
p.(None): inconvenience imposed on subjects ("human cost") are sufficiently justified by the importance
p.(None): scientist of the question asked, and by the assurance that the protocol gives to resolve this question.
p.(None): In behavioral research, in addition to making an explicit assessment of physical risks,
p.(None): one must be particularly attentive to the psychological risks of the experiences and their consequences
p.(None): possible (no humiliating, degrading or traumatic experiences).
p.(None): Justice. Human dignity
p.(None): In biomedical research, the principle of justice serves first to remind us that scientific research must not
p.(None): be an opportunity for exploitation (for example, exploitation by researchers from developed countries,
p.(None): poor people in developing countries, who serve as "guinea pigs" for the acquisition of knowledge including
p.(None): the therapeutic benefits mainly benefit the populations of rich countries: cf. WHO-CIOMS, 1982). It serves
p.(None): then recall, as CCNE did in its 1990 report (p. 72), that participation in a protocol
p.(None): research calls for "fair compensation" or "compensation" for subjects, but excludes any compensation.
p.(None): In behavioral research, cases of exploitation (north-south) have been mentioned (in ethnology, in
p.(None): anthropology), but there was, in general, in the background a problem of ethnic or cultural discrimination
p.(None): (relation of "developed" to "wild"). Frank risks of discrimination have been raised in connection with
p.(None): the investigation of distinctive features which are a source of social valuation or devaluation ("intelligence quotient",
p.(None): "crime chromosome", etc.). On the other hand, in behavioral research, the practice of paying subjects
p.(None): (on vacations, for example) has so far raised few objections. There are salaried professionals
p.(None): (test pilots, scuba divers) who agree to be guinea pigs in the exercise of their profession.
p.(None): Conversely, many volunteers are not compensated (when their contribution is minimal, or when, as
p.(None): in the case of students, they derive an intellectual or didactic benefit). It is therefore not possible to say,
p.(None): neither that all volunteers should be compensated, nor that any remuneration is unethical.
...

General/Other / Impaired Autonomy

Searching for indicator autonomy:

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p.(None): CCNE notes that in France, since the "law on the protection of persons who lend themselves to research
p.(None): biomedical "of December 20, 1988, the" tests or experiments organized and practiced on the being
p.(None): human for the development of biological or medical knowledge "takes place in a legal framework
p.(None): precise and binding. In contrast, the legislator did not pay attention to the protection of persons who
p.(None): lend themselves to behavioral research, and investigations carried out on human beings with a view to
p.(None): development of knowledge in the disciplines called "human sciences" remained in a situation
p.(None): fuzzy legal.
p.(None): CCNE summarizes below:
p.(None): - the ethical principles which must guide any investigation into human subjects,
p.(None): - the particular problems he identified with regard to behavioral research, and the elements of solutions
p.(None): that he offers.
p.(None): At the end of this work, the CCNE invites all researchers in human sciences, institutions
p.(None): scientists who conduct research in the humanities, the competent administrative authorities, and
p.(None): the legislator, to a common reflection, and to a broad consultation, with a view to developing the ethical framework
p.(None): and legal in which our society wants experimental investigations into human behavior
p.(None): be performed in the future.
p.(None): In its Ethics and Knowledge report (1990), the CCNE writes: "seek to know human beings scientifically
p.(None): is a good, but it cannot be done at the cost of justice, security or personal autonomy "(p. 74).
p.(None): This applies to research on humans, both in the behavioral sciences and in the sciences
p.(None): biomedical. Moreover, in the 1990 report (Ch. 2), the CCNE took into account a set of research to
p.(None): the intersection of the biomedical and behavioral domains: studies on learning, on adaptation to
p.(None): environment and work tasks (ergonomics), on the reactions of the human organism to extreme conditions
p.(None): (hyperbaric, hypobaric, microgravity, extreme climates, phase shift of the nycthemeral rhythms, sporting exploits of
p.(None): competition or endurance, civil or military), on quality of life and environmental pollution.
p.(None): The protection of people who lend themselves to biomedical research depends in France on law n ° 88-1138 of
p.(None): December 20, 1988 (modified n ° 90-86). The protection of persons who lend themselves to research
p.(None): Behavioral depends for the moment on the ethics of researchers (eg code of ethics of psychologists3).
p.(None): CCNE's recommendations on the ethics of behavioral research
p.(None): must, for the sake of consistency, be in continuity with Law No. 88-1138 of 20 Dec 1988. The major
p.(None): lines of guidelines for human research that were formulated in the United States by the National
p.(None): Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-78), or in Canada by the
p.(None): Medical Research Council (1986), then by the National Council on Bioethics in Human Research (CNBRH), are the
p.(None): same for all research on human beings, in the biomedical sciences and in the sciences
p.(None): human, even if secondarily special problems are identified according to the disciplines
p.(None): (cancerology, psychiatry, ethnology, etc.), or for different categories of subjects studied (children,
p.(None): captive or asylum populations, elderly people losing their autonomy, etc.).
p.(None): It will therefore be admitted that the main ethical principles which govern research on human beings (called
p.(None): by the American National Commission: principles of justice, beneficence, respect for autonomy
p.(None): of persons), as well as the rules ensuing therefrom (equity or non-discrimination rule,
p.(None): risk minimization and profit optimization, consent rule), are the same, that
p.(None): be biomedical research, or behavioral research. It will also be recognized that the procedure consisting
p.(None): to submit research protocols on humans, before their execution, to the examination of a committee
p.(None): independent ', or' ethics committee ', or' personal protection committee, is applicable to research
p.(None): behavioral. In what follows we will speak of "CCPPRC" (Consultative committees for the protection of persons in the
p.(None): behavioral research), without prejudging their relationship with the CCPPRB instituted by law n ° 88-1138 of 20 December
p.(None): 1988 (which will be considered later).
p.(None): Broad outlines
p.(None): Freedom of the people
p.(None): Freedom has a negative aspect (independence): not being led to do what you don't want, and a positive aspect
p.(None): (autonomy): act in accordance with what you really want for yourself. It is usually accepted that respecting the
p.(None): freedom of people implies that we accept the rule: no investigation will be conducted on people
p.(None): without these people having given their "free, informed and
p.(None): express "(L. 209-9).
p.(None): By adapting the law n ° 88-1138 of December 20, 1988 (Art. L. 209-9):
p.(None): - Consent is express if it is "given in writing or, if impossible, attested by an independent third party ...
p.(None): investigators. "
p.(None): - Consent is informed if the subject has been sufficiently informed, if he has understood
p.(None): the information, if it has had a period of reflection before making its choice known. So that the information is
p.(None): sufficient, the law of 20 December 1988 specifies that the investigator must make known to the subject:
p.(None): - the objective of the research, its methodology and its duration,
p.(None): - the expected benefits, the constraints and the foreseeable risks, including in the event of stopping the research before
p.(None): his term,
p.(None): - the opinion of the CCPPRC.
p.(None): - Consent is free if the investigator abstains from any pressure, coercion, or incitement
p.(None): strong (money, passing an exam, career advantage, emotional blackmail, etc.).
p.(None): Furthermore, consent to research is revocable. Subjects should be informed that they can at any
p.(None): moment stop participating, without incurring any sanction or reproach.
p.(None): Security. The human cost
...

p.(None): everything that the psychologist "saw, heard or understood" during his practice or research. "
p.(None): "10 Secrecy must be safeguarded both in words and in the conservation and
p.(None): dissemination of documents.The psychologist must ensure that the elements resulting from his work (reports,
p.(None): conclusions, reports, presentations, etc ...) are always written, presented and classified in a way to prevent and
p.(None): keep that secret. "
p.(None): "11 In its cooperation with other specialists, also subject to professional secrecy, the
p.(None): psychologist shares with them the information strictly necessary for the team management of a "client". "
p.(None): "12 He shall safeguard the secrecy of the identity of persons during the creation of data files, in
p.(None): compliance with the law of April 6, 1978, relating to information and freedoms. "
p.(None): "13 Apart from cases of legal obligation, the psychologist cannot be released from its secrecy by anyone, even by those
p.(None): that this secret concerns. "
p.(None): Two rules concern scientific work, through the duty of training:
p.(None): "17 All psychologists, whatever their specialty, must be constantly informed of scientific progress
p.(None): discipline and train accordingly. He takes these advances into account in his work and strives to
p.(None): to compete. He will accept all the rules, requirements and constraints imposed by scientific work. "
p.(None): "19 All psychologists endeavor to research and apply scientifically controlled criteria and methods and
p.(None): communicative, thereby excluding the principle of authority. "
p.(None): A rule may apply to the request for informed consent:
p.(None): "18 The psychologist is careful not to limit the autonomy of others and, in particular, their possibilities
p.(None): of information, freedom of judgment and decision. "
p.(None): A special rule applies to the treatment of experimental animals:
p.(None): "26 When its activities relate to animal behavior with a view to understanding human behavior,
p.(None): it strives to ensure the well-being and survival of the animals studied. "
p.(None): The absence of an equivalent rule for the treatment of persons suitable for research
p.(None): behavioral implies that research subjects are not treated differently from other subjects
p.(None): that the psychologist is dealing with in his professional activity (therefore, for example, that a treatment
p.(None): different in "therapeutic" and "non-therapeutic" situation is not envisaged).
p.(None): 4. On the concept of consent and its ambiguities, see: Thouvenin (1992).
p.(None): 5. cf. experiences of Stanley Milgram, evoked in the film "I" like Icarus. Reference publication: Milgram S.
p.(None): (1963), 'Behavioral study of obedience ", J Abnorm Psychol, 67: 371-378.
p.(None): 6. Engl. "Deception", "deceptive research".
p.(None): 7. In English: "debriefing"
p.(None): 8. The French law of 20 Dec. 1988 says "serious risk" and states that for people belonging to categories
p.(None): vulnerable research "without direct individual benefit" is admissible only if it presents "no risk
p.(None): foreseeable seriousness "(Art. L.209-6).
p.(None): 9. The Royal College of Physicians of London Report (1986) shows that the risk is considered minimal, either because the
p.(None): disorder is of very low severity, either because the
...

General/Other / Incapacitated

Searching for indicator incapacity:

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p.(None): Ethical review by "independent" bodies
p.(None): For bio-medical research, French law subjects the CCPPRB to "tests or experiments". She
p.(None): exempt "studies" (research work carried out on file, or on samples taken independently of
p.(None): the study (e.g. serum library).
p.(None): The federal American directives (DHHS, 1981) provided for three categories of research on
p.(None): humans: exempt from ethical review ("exempted research"), subject to an ethical review procedure
p.(None): simplified ("expedited review", by the office of an IRB), subject to in-depth ethical discussion (discussion in session
p.(None): by an IRB).
p.(None): We could propose for the human sciences a distinction between simple observation and situation
p.(None): experimental to provide for a rapid procedure (simple examination of the protocol), and a normal procedure
p.(None): ethical review (may require the effective presence of investigators). However, this distinction is
p.(None): delicate handling: there are indeed, as D. Widlöcher pointed out to us, "very harmless experiments",
p.(None): and possibly traumatic observations.
p.(None): Problems specific to behavioral research, identified using protocols submitted by the CNRS
p.(None): Consent
p.(None): - Under what conditions is behavioral research admissible on subjects including the ability to consent
p.(None): is problematic (limited competence, dependence)?
p.(None): The general rule is that people whose consent is precarious must be protected against
p.(None): the possibility of serving as "subjects" of research, in proportion to their incapacity and their dependence.
p.(None): Some vulnerable categories to be protected especially in behavioral research are: children, infirm
p.(None): mental, people easily manipulated by their own weakness or dependence
p.(None): (e.g. drug addicts), institutionalized captive populations (prisoners, pupils, adolescents under
p.(None): supervised education, young people in shelters, soldiers).
p.(None): - For minors and adults under guardianship, the accepted rule for biomedical research (L. 209-10) can be
p.(None): generalized: consent of parents or legal guardians, information of the child or the incapable person throughout the
p.(None): as far as possible, respect for a possible refusal by the child or the incapable person.
p.(None): - For institutionalized captive populations (prisoners, pupils, adolescents from
...

General/Other / Manipulable

Searching for indicator manipulated:

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p.(None): humans: exempt from ethical review ("exempted research"), subject to an ethical review procedure
p.(None): simplified ("expedited review", by the office of an IRB), subject to in-depth ethical discussion (discussion in session
p.(None): by an IRB).
p.(None): We could propose for the human sciences a distinction between simple observation and situation
p.(None): experimental to provide for a rapid procedure (simple examination of the protocol), and a normal procedure
p.(None): ethical review (may require the effective presence of investigators). However, this distinction is
p.(None): delicate handling: there are indeed, as D. Widlöcher pointed out to us, "very harmless experiments",
p.(None): and possibly traumatic observations.
p.(None): Problems specific to behavioral research, identified using protocols submitted by the CNRS
p.(None): Consent
p.(None): - Under what conditions is behavioral research admissible on subjects including the ability to consent
p.(None): is problematic (limited competence, dependence)?
p.(None): The general rule is that people whose consent is precarious must be protected against
p.(None): the possibility of serving as "subjects" of research, in proportion to their incapacity and their dependence.
p.(None): Some vulnerable categories to be protected especially in behavioral research are: children, infirm
p.(None): mental, people easily manipulated by their own weakness or dependence
p.(None): (e.g. drug addicts), institutionalized captive populations (prisoners, pupils, adolescents under
p.(None): supervised education, young people in shelters, soldiers).
p.(None): - For minors and adults under guardianship, the accepted rule for biomedical research (L. 209-10) can be
p.(None): generalized: consent of parents or legal guardians, information of the child or the incapable person throughout the
p.(None): as far as possible, respect for a possible refusal by the child or the incapable person.
p.(None): - For institutionalized captive populations (prisoners, pupils, adolescents from
p.(None): recovery ', young people in homes), the usual rule is to consider admissible only research (1)
p.(None): "minimal risk", and (2) non-discriminatory. Consent must be obtained from those responsible for
...

General/Other / Public Emergency

Searching for indicator emergency:

(return to top)
p.(None): the information, if it has had a period of reflection before making its choice known. So that the information is
p.(None): sufficient, the law of 20 December 1988 specifies that the investigator must make known to the subject:
p.(None): - the objective of the research, its methodology and its duration,
p.(None): - the expected benefits, the constraints and the foreseeable risks, including in the event of stopping the research before
p.(None): his term,
p.(None): - the opinion of the CCPPRC.
p.(None): - Consent is free if the investigator abstains from any pressure, coercion, or incitement
p.(None): strong (money, passing an exam, career advantage, emotional blackmail, etc.).
p.(None): Furthermore, consent to research is revocable. Subjects should be informed that they can at any
p.(None): moment stop participating, without incurring any sanction or reproach.
p.(None): Security. The human cost
p.(None): In biomedical research it is admitted that certain research protocols imply for the people who are there
p.(None): lend a "direct individual benefit" (Art. L. 209-1). This notion of (potential) benefit for the subject
p.(None): is used in medicine to authorize inclusion in research protocols, under certain conditions (Art. L.
p.(None): 209-6) of persons whose consent is precarious or even impossible (minors, adults under guardianship,
p.(None): people staying in a health or social establishment, sick in an emergency).
p.(None): In behavioral research, there may exist cases of investigation "with direct individual benefit", for example
p.(None): example in clinical psychology during a comparative study of two psychotherapeutic methods (if for subjects
p.(None): which lend themselves to the benefit of at least one of the methods is established), or in cognitive psychology (if doing so for
p.(None): children to participate in a study gives them an educational advantage, as was discussed in the
p.(None): CNRS file on the Lautrey protocol). But the absence of vital emergencies forcing the practitioner to intervene, and
p.(None): the difficulty of arguing that research is conducted "for the good" of the subjects included, or "in the interest of their
p.(None): health ", fact that the distinction" with / without direct individual benefit "is not relevant in research
p.(None): behavior to relax the conditions of consent, even when it comes to applied research. The
p.(None): distinction is only relevant in the context of the risk / benefit balance.
p.(None): CCNE noted in its 1990 report that, in general, people who lend themselves to a
p.(None): investigation whose objective is the acquisition of knowledge about the human being do not find there
p.(None): personal benefit. CCNE considered that this is admissible, "on condition of a balance sheet
p.(None): acceptable risk-benefit, that is, definite benefit to the community, little or no risk to the individual "
p.(None): (p. 70).
...

General/Other / Relationship to Authority

Searching for indicator authority:

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p.(None): supervised education, young people in shelters, soldiers).
p.(None): - For minors and adults under guardianship, the accepted rule for biomedical research (L. 209-10) can be
p.(None): generalized: consent of parents or legal guardians, information of the child or the incapable person throughout the
p.(None): as far as possible, respect for a possible refusal by the child or the incapable person.
p.(None): - For institutionalized captive populations (prisoners, pupils, adolescents from
p.(None): recovery ', young people in homes), the usual rule is to consider admissible only research (1)
p.(None): "minimal risk", and (2) non-discriminatory. Consent must be obtained from those responsible for
p.(None): the institution, on the other hand of each subject individually (if the subjects are minor, of the person who
p.(None): has parental authority).
p.(None): - The use of "rewards" must be subject to special attention at the time of the ethical review
p.(None): (eg recruiting tramps or Indians as research subjects through an offer of alcohol).
p.(None): - With regard to detainees, the law of 20 December 1988 excludes research without direct individual benefit
p.(None): in persons deprived of their liberty. In behavioral sciences, this research can be without
p.(None): harmful to the people concerned, and socially useful, even necessary; therefore they cannot be
p.(None): prohibited without further examination.
p.(None): - How to reconcile the obligation of consent which should be informed with the methodological necessity (which can
p.(None): appear in certain experimental protocols) not to say everything?
p.(None): This is a question raised about biomedical research, but mostly known about
p.(None): psychology, social psychology (5), and research on sports performance.
p.(None): The Canadian MRC treated this issue as follows:
p.(None): Deception (6)
p.(None): "... Given the critical importance of free and informed consent, it seems incongruous to consider the
p.(None): question of deception.
p.(None): "Deception is understood to mean deliberately misleading potential subjects or hiding them from
p.(None): information, in such a way as to lead them to believe that the objectives of the research or of the procedure to be followed are
p.(None): different from what they really are. The
p.(None): deception may also consist in deliberately presenting false information to them, concealing information
p.(None): important information, or to reveal only bits of information, in order to mislead the interested parties.
...

p.(None): when using the results).
p.(None): References
p.(None): American Psychological Association (1986), Ethical issues in psychological research in AIDS, Committee for the
p.(None): protection of human participants in research, IRB, 8 (4): 8-10.
p.(None): Barber B. (1976), The ethics of experimentation with human subjects, Scientific American, 234 (2): 25-31.
p.(None): Baumrind Diana (1979), IRBs and social science research: the costs of deception, IRB, 1 (6): 1-4.
p.(None): Bourdieu Pierre, ed. (1993), The misery of the world, Paris: Seuil.
p.(None): Medical Research Council of Canada (1986), Guidelines for Research on Subjects
p.(None): humans, Ottawa.
p.(None): Cupples Brian & Gochnauer Myron (1985), The investigator's duty not to deceive, IRB, 7 (5): 1-6.
p.(None): De Sola Pool Ithiel (1983), Do social scientists have unlimited research rights ?, IRB, 5 (6): 10.
p.(None): Desportes Jean-Pierre (1974), Manipulations du behavior, La Recherche, 47: 654-661.
p.(None): Fagot-Largeault A. (1985), The bio-ethical man. For an ethics of research on living organisms, Paris: Maloine.
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): Gosselin Gabriel (1992), An ethics of the social sciences, Paris: L'Harmattan.
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): Katz Jay (1972), Experimentation with Human Beings? The Authority of the Investigator, Subject, Professions and State
p.(None): in the Human Experimentation Process, New York: Russell Sage Foundation.
p.(None): Levine Carol (1982), Former soldier denied compensation for damage in army LSD tests, IRB, 4 (3): 7.
p.(None): Levine Robert J. (1986), Ethics and Regulation of Clinical Research, Baltimore-Munich: Urban & Schwarzenberg,
p.(None): 2nd edition.
p.(None): Macklin Ruth (1989), The paradoxical case of payment as benefit to research subjects, IRB, 11 (6): 1-3.
p.(None): Marini James L. (1980), Methodology and ethics: research on human aggression, IRB, 2 (5): 1-4.
p.(None): Mead Margaret (1969), Research with human beings: a model derived from anthropological field practice, Daedalus, 98:
p.(None): 361-386.
p.(None): Meyer Roger E. (1977), Subjects' rights, freedom of inquiry, and the future of research in the addictions, Am J
p.(None): Psychiatry, 134 (8): 899-903.
p.(None): Menard Joël (1990), Report from the INSERM think tank on certain aspects of protecting subjects
p.(None): healthy volunteers and people who lend themselves to biomedical research, Paris: INSERM.
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 and
...

p.(None): criminal. "
p.(None): "9 In particular, it is recalled that this secrecy must extend, in the private domain of persons, to
p.(None): everything that the psychologist "saw, heard or understood" during his practice or research. "
p.(None): "10 Secrecy must be safeguarded both in words and in the conservation and
p.(None): dissemination of documents.The psychologist must ensure that the elements resulting from his work (reports,
p.(None): conclusions, reports, presentations, etc ...) are always written, presented and classified in a way to prevent and
p.(None): keep that secret. "
p.(None): "11 In its cooperation with other specialists, also subject to professional secrecy, the
p.(None): psychologist shares with them the information strictly necessary for the team management of a "client". "
p.(None): "12 He shall safeguard the secrecy of the identity of persons during the creation of data files, in
p.(None): compliance with the law of April 6, 1978, relating to information and freedoms. "
p.(None): "13 Apart from cases of legal obligation, the psychologist cannot be released from its secrecy by anyone, even by those
p.(None): that this secret concerns. "
p.(None): Two rules concern scientific work, through the duty of training:
p.(None): "17 All psychologists, whatever their specialty, must be constantly informed of scientific progress
p.(None): discipline and train accordingly. He takes these advances into account in his work and strives to
p.(None): to compete. He will accept all the rules, requirements and constraints imposed by scientific work. "
p.(None): "19 All psychologists endeavor to research and apply scientifically controlled criteria and methods and
p.(None): communicative, thereby excluding the principle of authority. "
p.(None): A rule may apply to the request for informed consent:
p.(None): "18 The psychologist is careful not to limit the autonomy of others and, in particular, their possibilities
p.(None): of information, freedom of judgment and decision. "
p.(None): A special rule applies to the treatment of experimental animals:
p.(None): "26 When its activities relate to animal behavior with a view to understanding human behavior,
p.(None): it strives to ensure the well-being and survival of the animals studied. "
p.(None): The absence of an equivalent rule for the treatment of persons suitable for research
p.(None): behavioral implies that research subjects are not treated differently from other subjects
p.(None): that the psychologist is dealing with in his professional activity (therefore, for example, that a treatment
p.(None): different in "therapeutic" and "non-therapeutic" situation is not envisaged).
p.(None): 4. On the concept of consent and its ambiguities, see: Thouvenin (1992).
p.(None): 5. cf. experiences of Stanley Milgram, evoked in the film "I" like Icarus. Reference publication: Milgram S.
p.(None): (1963), 'Behavioral study of obedience ", J Abnorm Psychol, 67: 371-378.
p.(None): 6. Engl. "Deception", "deceptive research".
p.(None): 7. In English: "debriefing"
p.(None): 8. The French law of 20 Dec. 1988 says "serious risk" and states that for people belonging to categories
p.(None): vulnerable research "without direct individual benefit" is admissible only if it presents "no risk
p.(None): foreseeable seriousness "(Art. L.209-6).
...

General/Other / belmont

Searching for indicator belmont:

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p.(None): Levine Robert J. (1986), Ethics and Regulation of Clinical Research, Baltimore-Munich: Urban & Schwarzenberg,
p.(None): 2nd edition.
p.(None): Macklin Ruth (1989), The paradoxical case of payment as benefit to research subjects, IRB, 11 (6): 1-3.
p.(None): Marini James L. (1980), Methodology and ethics: research on human aggression, IRB, 2 (5): 1-4.
p.(None): Mead Margaret (1969), Research with human beings: a model derived from anthropological field practice, Daedalus, 98:
p.(None): 361-386.
p.(None): Meyer Roger E. (1977), Subjects' rights, freedom of inquiry, and the future of research in the addictions, Am J
p.(None): Psychiatry, 134 (8): 899-903.
p.(None): Menard Joël (1990), Report from the INSERM think tank on certain aspects of protecting subjects
p.(None): healthy volunteers and people who lend themselves to biomedical research, Paris: INSERM.
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 and
p.(None): Recommendations, and Appendix (1977). Research Involving Those Institutionalized as Mentally Infirm:
p.(None): Report and Recommendations, and Appendix (1978). The Belmont Report: Ethical Principles and Guidelines
p.(None): for Research Involving Human Subjects (1978), Washington D.C .: US Govt Printing Office (DHEW); tr. Fr.
p.(None): in: Medicine and experimentation (1982), Cahiers de bioéthique, 4, Québec: Presses de l'Université Laval, 233-250.
p.(None): Newton Lisa H. (1982), Dentists and pseudo-patients: further meditations on deception in research, IRB, 4 (8): 6-8.
p.(None): Park L.C., Covi L., Uhlenhuth E.H. (1967), Effects of informed consent on research patients and study results, J Nerv
p.(None): Ment Dis, 145: 349-357.
p.(None): Pattulo E.L. (1980), Who risks what in social research ?, IRB, 2 (3): 1-3, 12.
p.(None): Queheillard Jean-Louis (1989), Professional secret: the great forgotten?, Psychologists and psychologies, n ° 89.
p.(None): Redlich Fritz (1973), The anthropologist as observer; ethical aspects of clinical observations of behavior, J Nerv Ment
p.(None): Say, 157: 313-319.
p.(None): Robertson John A. (1981), Ethical review of social experiments, IRB, 3 (7): 10-11.
p.(None): Royal College of Physicians (1986), 'Research on healthy volunteers', J Roy Coll Physicians, London, 20: 243-257.
p.(None): Schafer Arthur (1981), The ethics of research on human beings; a critical review of the issues and
p.(None): arguments, Res Adv Alcohol Drug Probl, 6: 471-511.
p.(None): Schiff Michel (1991), The dead ends of research in psychology, Psychologists and psychologies, n ° 104.
p.(None): Schmutte Gregory T. (1980), Using students as subjects without their knowledge, IRB, 2 (10): 5-6.
p.(None): Schuler Heinz (1980), Ethische Probleme psychologischer Forschung, Göttingen.
...

General/Other / cioms guidelines

Searching for indicator cioms:

(return to top)
p.(None): investigation whose objective is the acquisition of knowledge about the human being do not find there
p.(None): personal benefit. CCNE considered that this is admissible, "on condition of a balance sheet
p.(None): acceptable risk-benefit, that is, definite benefit to the community, little or no risk to the individual "
p.(None): (p. 70).
p.(None): Taking a risk-benefit assessment is asking yourself whether the risks, constraints or
p.(None): inconvenience imposed on subjects ("human cost") are sufficiently justified by the importance
p.(None): scientist of the question asked, and by the assurance that the protocol gives to resolve this question.
p.(None): In behavioral research, in addition to making an explicit assessment of physical risks,
p.(None): one must be particularly attentive to the psychological risks of the experiences and their consequences
p.(None): possible (no humiliating, degrading or traumatic experiences).
p.(None): Justice. Human dignity
p.(None): In biomedical research, the principle of justice serves first to remind us that scientific research must not
p.(None): be an opportunity for exploitation (for example, exploitation by researchers from developed countries,
p.(None): poor people in developing countries, who serve as "guinea pigs" for the acquisition of knowledge including
p.(None): the therapeutic benefits mainly benefit the populations of rich countries: cf. WHO-CIOMS, 1982). It serves
p.(None): then recall, as CCNE did in its 1990 report (p. 72), that participation in a protocol
p.(None): research calls for "fair compensation" or "compensation" for subjects, but excludes any compensation.
p.(None): In behavioral research, cases of exploitation (north-south) have been mentioned (in ethnology, in
p.(None): anthropology), but there was, in general, in the background a problem of ethnic or cultural discrimination
p.(None): (relation of "developed" to "wild"). Frank risks of discrimination have been raised in connection with
p.(None): the investigation of distinctive features which are a source of social valuation or devaluation ("intelligence quotient",
p.(None): "crime chromosome", etc.). On the other hand, in behavioral research, the practice of paying subjects
p.(None): (on vacations, for example) has so far raised few objections. There are salaried professionals
p.(None): (test pilots, scuba divers) who agree to be guinea pigs in the exercise of their profession.
p.(None): Conversely, many volunteers are not compensated (when their contribution is minimal, or when, as
p.(None): in the case of students, they derive an intellectual or didactic benefit). It is therefore not possible to say,
p.(None): neither that all volunteers should be compensated, nor that any remuneration is unethical.
p.(None): From the equity point of view, the central problem in behavioral research therefore seems to be that of a possible
p.(None): discrimination, whether related to the research protocol itself, or to research results and
...

Orphaned Trigger Words

p.(None): of December 20, 1988, the "tests or experiments organized and practiced on the human being with a view
p.(None): of the development of biological or medical knowledge "takes place in an ethical and legal framework
p.(None): specific. By contrast, the legislator does not seem to have paid attention to the protection of persons who
p.(None): lend themselves to behavioral research, and investigations carried out on human beings with a view to
p.(None): Knowledge development in the behavioral sciences has less explicit ethical references.
p.(None): The CCNE recalls that any experimental investigation on the human being, that it is with a view to the development of
p.(None): bio-medical knowledge, or for the development of behavioral knowledge, must be done
p.(None): according to an irreproachable scientific approach, while respecting the freedom of action of individuals,
p.(None): their security, the principle of justice; and that the free, informed and express consent of those who lend themselves
p.(None): to research does not relieve researchers of their moral and scientific responsibility.
p.(None): CCNE has been attentive to the particular methodological and ethical difficulties of the investigations
p.(None): scientists on human behavior. Instructed by the researchers he heard, he recalls that a study
p.(None): on human beings should not be the occasion for manipulation or discrimination, and that the chain of secrecy
p.(None): professional must be flawless.
p.(None): In cases where subjects suitable for study cannot be fully lit before the experiment,
p.(None): because their complete information would modify the behaviors that we want to study, CCNE recommends:
p.(None): (1) at the time of the initial collection of their consent, subjects are warned that certain aspects
p.(None): objectives or methodology are deliberately hidden from them for the sake of study, which they can
p.(None): any time interrupt their participation, and all their questions will be answered at the end of the study,
p.(None): (2) that at the end of the experiment, the subjects receive complete explanations on the objective of the work, on the
p.(None): observations made on themselves, and on the use that will be made of the data collected, allowing them, as well
p.(None): fully informed, confirm or deny their consent. In the event that researchers collect
p.(None): identifying (direct or indirect) data, the express consent of the data subjects is
p.(None): essential for any use that will be made of this data.
p.(None): The sharing, for research, of medical and / or psychological information on people, is currently
p.(None): in France prohibited by law, and by ethics. CCNE believes, however, that certain research including
p.(None): interest is recognized could be made as part of a shared professional secret. If
p.(None): psychologists were to, in the context of research, treat under their own responsibility certain
p.(None): nominative medical data, these psychologists should be authorized to do so, and the doctor should have
p.(None): has been expressly authorized by the persons concerned to communicate this data. Likewise, if
p.(None): medical researchers were required, in the context of research, to use personal data
p.(None): collected by practicing psychologists during their practice, these researchers should
p.(None): doctors are empowered to do so, and that the psychologist has been explicitly authorized by the people
p.(None): concerned to communicate this data. Authorization could be given by a body
p.(None): multidisciplinary under the aegis of the ministries in charge of Research and Health. In the event that the law
p.(None): would allow this sharing of professional secrecy for the purpose of research, the conditions under which
p.(None): a person can untie his doctor or his psychologist from a secret should be specified with care.
p.(None): CCNE believes that research protocols in the human behavioral sciences should be submitted for
p.(None): advice, before their execution, to Consultative Committees for the Protection of Persons in Research
p.(None): Behavioral (CCPPRC) whose composition would ensure a satisfactory diversity of skills for ...

p.(None): research, Hospital management - Research - The hospital, n ° 320.
p.(None): Thouvenin D. (1992), Consent and subjugation, in: Gros & Huber, eds., Vers un anti-destin? Heritage
p.(None): genetics and human rights, Paris: Editions Odile Jacob, pp. 471-478.
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): Villey Raymond (1986), History of medical secrecy, Paris: Seghers.
p.(None): Warwick Donald P. (1975), Deceptive research: social scientists ought to stop lying, Psychology Today, Feb:
p.(None): 38-.
p.(None): Swiss scientific academies, 22-26 March 93, Symposium "Freedom and responsibility: Moral issues facing the
p.(None): humanities and social sciences "(Acts to appear).
p.(None): American Anthropological Association, Code of Ethics.
p.(None): Anthropology and societies, Department of anthropology of Laval University, Quebec, special issue
p.(None): "Understanding and Modifying", 1984, vol. 8, n ° 3, including a code of professional ethics.
p.(None): Code of ethics of the Brazilian Association of Anthropology, adopted at its 16th meeting, in Campinas (Sâo
p.(None): Paulo), March 30, 1988 ("Codico de Etica").
p.(None): Current Anthropology, Chicago, vol. IX, 5, 1968, then vol. XI, 1, 1970, finally vol. XII, 1, 1971 (to
p.(None): from a symposium "On the social responsabilities in social anthropology".
p.(None): Journal of anthropologists, winter 92-spring 93, n ° 50-511, devoted to "professional ethics" and
p.(None): "field experiences" (EHESS, 1 r of November 11, 92120 Montrouge).
p.(None): Contemporary societies (IRESCO, CNRS), special issue "Professional ethics", September 1991, n ° 7
p.(None): (ethics of statisticians, geneticists, anthropology, etc.).
p.(None): Sociology, November 1992, "BSA Statement of Ethical Practice".
p.(None): Notes
p.(None): 1. It is accepted in all that follows that speaking is behavior, and that the denomination "sciences
p.(None): of human behavior "does not exclude clinical disciplines, such as inspirational psychology
p.(None): This denomination has the advantage of emphasizing that this is research on human beings other than
p.(None): biomedical.
p.(None): 2. See report written by Y. Laporte.
p.(None): 3. A Code of ethics was adopted in 1961 (rev.1976) by the French Psychological Society. It applied
p.(None): to the members of the Society. This code has been taken up and updated, following "the evolution of the profession and its legislation"
p.(None): (law of July 25, 85) by the National Association of Organizations of Psychologists (ANOP). The Code of Ethics
p.(None): des psychologues (1987) applies to all French psychologists, and to psychology students.
p.(None): This is a professional code of ethics, analogous to the doctors' code of ethics
p.(None): French. It is not a research ethics code (as the declaration is for doctors
p.(None): Helsinki-Tokyo of the World Medical Association).
p.(None): This code contains rules which, applying to all activities of psychologists, also apply
p.(None): research activities. General rules: "use only means which respect dignity
p.(None): human "(Art.2)," avoid harm "(Art.15). Special rules relating to professional secrecy (Arts 7 to 12): ...

Appendix

Indicator List

Indicator	Vulnerability
access	Access to Social Goods
addicts	addiction
age	Age
alcoholic	alcoholism
army	Soldier
asylum	Refugee Status
authority	Relationship to Authority
autonomy	Impaired Autonomy
belmont	belmont
captive	Captive/Exiled Population
child	Child
children	Child
cioms	cioms guidelines
coerce	Presence of Coercion
cognitive	Cognitive Impairment
crime	Illegal Activity
criminal	criminal
dependence	Drug Dependence
drug	Drug Usage
education	education
educational	education
elderly	Elderly
emergencies	patients in emergency situations
emergency	Public Emergency
ethnic	Ethnicity
healthy volunteers	Healthy People
ill	ill
incapable	Mentally Incapacitated
incapacity	Incapacitated
influence	Drug Usage
institutionalized	Institutionalized
liberty	Incarcerated
manipulated	Manipulable
mentally	Mentally Disabled
military	Soldier
minor	Youth/Minors
mothers	Mothers
opinion	philosophical differences/differences of opinion
parents	parents
party	political affiliation
poor	Economic/Poverty
prisoners	Criminal Convictions
sensory	sensory impairment
sick	Physically Ill
soldier	Soldier
victim	Victim of Abuse
violence	Threat of Violence
volunteers	Healthy People
vulnerable	vulnerable

Indicator Peers (Indicators in Same Vulnerability)

Indicator	Peers
army	['military', 'soldier']
child	['children']
children	['child']
drug	['influence']
education	['educational']
educational	['education']
healthy volunteers	['volunteers']
influence	['drug']
military	['army', 'soldier']
soldier	['army', 'military']
volunteers	['healthyXvolunteers']

Trigger Words

coercion

consent

cultural

developing

ethics

harm

justice

protect

protection

risk

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	Captive/Exiled Population	captive	3
Political	Criminal Convictions	prisoners	3
Political	Illegal Activity	crime	1
Political	Refugee Status	asylum	1
Political	criminal	criminal	2
Political	political affiliation	party	1
Political	vulnerable	vulnerable	3
Health	Cognitive Impairment	cognitive	3
Health	Drug Dependence	dependence	3
Health	Drug Usage	drug	2
Health	Drug Usage	influence	1
Health	Healthy People	healthy volunteers	2
Health	Healthy People	volunteers	5
Health	Mentally Disabled	mentally	1
Health	Mentally Incapacitated	incapable	2
Health	Physically Ill	sick	1
Health	addiction	addicts	1
Health	alcoholism	alcoholic	1
Health	ill	ill	2
Health	patients in emergency situations	emergencies	1
Health	sensory impairment	sensory	1
Social	Access to Social Goods	access	3
Social	Age	age	1
Social	Child	child	3
Social	Child	children	10
Social	Elderly	elderly	2
Social	Ethnicity	ethnic	1
Social	Incarcerated	liberty	2
Social	Institutionalized	institutionalized	3
Social	Mothers	mothers	1
Social	Presence of Coercion	coerce	1
Social	Soldier	army	1
Social	Soldier	military	1
Social	Soldier	soldier	1
Social	Threat of Violence	violence	1
Social	Victim of Abuse	victim	1
Social	Youth/Minors	minor	2
Social	education	education	2
Social	education	educational	2
Social	parents	parents	2
Social	philosophical differences/differences of opinion	opinion	8
Economic	Economic/Poverty	poor	1
General/Other	Impaired Autonomy	autonomy	5
General/Other	Incapacitated	incapacity	1
General/Other	Manipulable	manipulated	1
General/Other	Public Emergency	emergency	1
General/Other	Relationship to Authority	authority	3
General/Other	belmont	belmont	1
General/Other	cioms guidelines	cioms	1

Opinion on the Ethics of Research in the Science of Human Behavior No. 38

Applicable Type / Vulnerability / Indicator Overlay for this Input

Political / Captive/Exiled Population

Political / Criminal Convictions

Political / Illegal Activity

Political / Refugee Status

Political / criminal

Political / political affiliation

Political / vulnerable

Health / Cognitive Impairment

Health / Drug Dependence

Health / Drug Usage

Health / Healthy People

Health / Mentally Disabled

Health / Mentally Incapacitated

Health / Physically Ill

Health / addiction

Health / alcoholism

Health / ill

Health / patients in emergency situations

Health / sensory impairment

Social / Access to Social Goods

Social / Age

Social / Child

Social / Elderly

Social / Ethnicity

Social / Incarcerated

Social / Institutionalized

Social / Mothers

Social / Presence of Coercion

Social / Soldier

Social / Threat of Violence

Social / Victim of Abuse

Social / Youth/Minors

Social / education

Social / parents

Social / philosophical differences/differences of opinion

Economic / Economic/Poverty

General/Other / Impaired Autonomy

General/Other / Incapacitated

General/Other / Manipulable

General/Other / Public Emergency

General/Other / Relationship to Authority

General/Other / belmont

General/Other / cioms guidelines

Orphaned Trigger Words

Appendix

Indicator List

Indicator Peers (Indicators in Same Vulnerability)

Trigger Words

Applicable Type / Vulnerability / Indicator Overlay for this Input