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Appendix
Volume II
The Belmont Report
Ethical Principles
and Guidelines for the Protection of
Human Subjects
of Research
The National Commission
for the Protection of Human Subjects of Biomedical and Behavioral
Research
This Appendix contains (in two volumes)
the full text of the papers that were prepared to assist the Commission in its consideration of the basic ethical principles that should underlie the conduct of research involving human subjects.
DHEW Publication No. (OS) 78-0014
For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402
TABLE OF CONTENTS
APPENDIX TO BELMONT REPORT
Volumes I and II
Volume II
I. PRELIMINARY PAPERS PREPARED FOR THE COMMISSION
BY ROBERT J. LEVINE, M.D.
1. The Boundaries Between Biomedical or
Behavioral Research and the Accepted
and Routine Practice of Medicine
The Role of Assessment of Risk Benefit
Criteria in the Determination of the
Appropriateness of Research Involving
Human Subjects
Consent in Various Research Settings
Appropriate Guidelines for the Selection
of Human Subjects for Participation in
Biomedical and Behavioral Research
2.
3. The Nature and Definition of Informed
4. II. BASIC ETHICAL PRINCIPLES RELATING TO RESEARCH
INVOLVING HUMAN SUBJECTS
5. Ethical Principles and Their Validity . . . . . . . Kurt Baier, D. Phil.
6. Differences . . . . . . . . . . . . . . . . . . . Tom Beauchamp, Ph.D.
7. The Identification of Ethical Principles
. . . . . . James Childress, B.D., Ph.D.
8. Basic Ethical Principles in the Conduct of
Biomedical and Behavioral Research
Involving Human Subjects. . . . . . . . . . . . . H. Tristram Engelhardt,
Distributive Justice and Morally Relevant
Jr., Ph.D., M.D.
9. Medical Ethics and the Architecture of
Clinical Research . . . . . . . . . . . . . . . . Alvan R. Feinstein, M.D.
Jeffrey L. Lichtenstein,
10. How to Identify Ethical Principles . . . . . . . . Alasdair MacIntyre, M.A.
M.D.
Belmont Appendix 2
11. Some Ethical Issues in Research Involving
Human Subjects. . . . . . . . . . . . . . . . . . . LeRoy Walters, B.D., Ph.D.
Volume II
III. BOUNDARIES BETWEEN RESEARCH AND PRACTICE
12. Protection of the Rights and Interests of Human Subjects in the Areas of Pro
gram Evaluation, Social Experimenta- tion, Social Indicators, Survey Re- search, Secondary Analysis of Research
Data, and Statistical Analysis of Data
From Administrative Records . . . . . . . . . . . . . Donald T. Campbell, Ph.D.
Joe Shelby Cecil, Ph.D.
13. Response to Commission Duties as Detailed
On the Usefulness of Intent for Distinguishing
in P.L. 93-348, Sec. 202(a)(1)(B)(i). . . . . . . . Donald Gallant, M.D. 14.
Between Research and Practice, and Its Replace-
ment by Social Contingency. . . . . . . . . . . . . Israel Goldiamond, Ph.D. Especially in Mental Health . . . . . . . . . . . . Perry London, Ph.D.
15. Boundaries Between Research and Therapy,
Gerald Klerman, M.D.
16. Legal Implications of the Boundaries
Between Biomedical Research Involving
Human Subjects and the Accepted or
Routine Practice of Medicine. . . . . . . . . . . . John Robertson, J.D.
17. The Boundaries Between Biomedical Re-
search Involving Human Subjects and the Accepted or Routine Practice of
Medicine, with Particular Emphasis on
Innovation in the Practice of Surgery . . . . . . . . David Sabiston, M.D.
18. What Problems are Raised When the Current
DHEW Regulation on Protection of Human
Subjects is Applied to Social Science
Research? . . . . . . . . . . . . . . . . . . . . . Richard A. Tropp
Belmont Appendix 3
IV. RISK/BENEFIT CRITERIA
19. Some Perspectives on the Role of Assess-
ment of Risk/Benefit Criteria in the
Determination of the Appropriateness of
Research Involving Human Subjects . . . . . . . . Bernard Barber, Ph.D. Conduct of Psychological Research . . . . . . . . Gregory Kimble, Ph.D. ment of Risk -Benefit Criteria in Connection with Research Involving Human Subjects. . . . . . Maurice Natanson, Ph.D. Analysis in Clinical Pharmacology . . . . . . . . Lawrence C. Raisz, M.D.
20. The Role of Risk/Benefit Analysis in the
21. A Philosophical Perspective on the Assess
22. Essay on Some Problems of Risk-Benefit
V. INFORMED CONSENT
23.
24. Some Complexities and Uncertainties Nature and Definition of Informed
Consent in Research Involving Deception . . . . . Diana Baumrind, Ph.D.
Regarding the Ethicality of Deception
in Research with Human Subjects . . . . . . . . . Leonard Berkowitz, Ph.D.
25. Selected Issues in Informed Consent and
Confidentiality with Special Reference
to Behavioral/Social Science Research/
Inquiry . . . . . .
. . . . . . . . . . . . . . . Albert Reiss, Jr., Ph.D.
Philosophical Foundations and Pol icy
Implications. . . . . . . . . . . . . . . . . . . Robert Veatch. Ph.D.
26. Three Theories of Informed Consent:
III
BOUNDARIES BETWEEN RESEARCH AND PRACTICE
12
PROTECTION OF THE RIGHTS AND INTERESTS
OF HUMAN SUBJECTS IN THE AREAS OF PROGRAM EVALUATION,
SOCIAL EXPERIMENTATION, SOCIAL INDICATORS,
SURVEY RESEARCH, SECONDARY ANALYSIS OF
RESEARCH DATA, AND STATISTICAL ANALYSIS OF DATA
FROM ADMINISTRATIVE RECORDS
Donald T. Campbell, Ph.D.
and
Joe Shelby Cecil, Ph.D.
Protection of the Rights and Interests of Human Subjects in the Areas of Program Evaluation, Social Experimentation, Social Indicators, Survey Research, Secondary Analysis of Research Data, and Statistical Analysis of Data From Administrative Records
Donald T. Campbell and Joe Shelby Cecil
Northwestern University
An important task facing the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research is the establishment of standards for the burgeoning new areas of program evaluation, social in dicators, and related activities (to be collectively designated "program evaluation " in this manuscript unless greater specificity is needed). All of these activities are "research" (usually behavioral research) in the sense of Public Law 93
348; thus they fall within the scope of the commission's
assignments. As Institutional Review Boards become increasingly involved in approving such research, they could benefit from guidelines prepared by the
NCPHSBBR for this novel set of problems.
While the participants in such research clearly have rights and interests which may be violated, the nature of these threats is somewhat unique. Rarely will risk to physical health be involved.
Indeed, the experimental group par
ticipants often receive an apparent boon which the control group participants may well feel they equally deserve, so that control group rights may often be the greater problem. The more frequent danger in program evaluation is the risk that the research data will be misused since sensitive information is often collected. Such data may be subpoenaed by prosecutors searching for evidence of crimes, or become a source of malicious gossip or blackmail. Federally funded program evaluations frequently require auditing, verifica- tion, and reanalysis. These activities may preclude a promise of complete confidentiality to the respondents and increase the risk that the informa tion they provide will be used improperly. However, if respondents are fully informed of these risks, the quality of the research data may be diminished. From these few examples it is apparent that these areas of social research present a different set of problems from those encountered in medical and laboratory research. This problem area has already received attention from several national organizations. For instance, the Social Science Research Council's Committee on Social Experimentation considered these issues at length over a four -year period, producing a short chapter on "Human Values and Social Experimentation" (Riecken, Boruch, et al., 1974, pp. 245-269). The contemporaneous National
Academy of Science
- National Research Council "Committee on Federal Agency
Evaluation Research
" addressed these issues in its report entitled Protecting Individual Privacy in Evaluation Research (Rivlin, et al., 1975). (One of the present authors participated in both of these committees.) The Privacy Protec tion Study Commission, established by the Privacy Act of 1974, has extensively considered the problem of maintaining confidentiality of research information (Notice of Hearing and Draft Recommendations: Research and Statistics, January
6, 1977).
The Social Science Research Council has a longstanding committee 12-1 and special staff devoted to Social Indicators, and is establishing a new committee on program evaluation.
The Brookings Panel on Social Experimenta
tion recently published a series of papers on this topic (Rivlin and Timpane,
1975). Special committees with this concern exist in many professional organ
izations. This recent activity provides the National Commission with a unique opportunity to integrate these diverse findings into a general code protecting the rights of subjects participating in these new areas of research.
Background Comments:
Lake the others who have agreed to write background papers for the Commission, the present writers have volunteered to do so because of strong concerns on this matter. In these areas of research, two widely cherished valued are in potential conflict. The subject's right of privacy may conflict with the researcher's need to gather sensitive information necessary for mean ingful program evaluation. We wish to make explicit our manner of resolving this conflict. In agreement with the dominant mood in Washington, we recognize the right to privacy of individuals participating in these areas of research. This paper includes several suggestions which would result in increased pro tection for the privacy of research participants. However, our greater fear is that Congress and the administration will needlessly preclude important program evaluation and access to research information through ill -considered efforts to protect individual privacy.
For example, special procedures of file
linkage permit inexpensive and highly relevant program evaluation. Although these procedures require the retrieval of administrative records, they may be employed without jeopardizing the privacy of program participants. (The case for such procedures will be presented in the context of specific recommenda tions.) We urge that special caution be exercised to avoid creating rules that unnecessarily restrict these procedures. Before providing our recommendations we wish to set the scope of this report by defining some of the major terms that will be employed: Program Evaluation: Assembly of evidence bearing on the effectiveness and side effects of ameliorative programs, social innovations, etc. These programs have usually been initiated by governments. Social Indicators: Statistical summaries, often in time series form, bearing on the well -being of the nation or smaller social units. Social indicators may be viewed in contrast to more common economic indicators. Many social indicators are generated from statistical summaries of adminis trative records. Others, such as indicators based on the Census, are produced by institutionalized survey procedures. Increasing attention is being given to "subjective" social indicators, in which representative samples of the public report on their "happiness" or satisfaction with various aspects of their lives in public opinion surveys.
Social Experimentation:
This will be narrowly defined, as it was in the
SSRC volume (Riecken, et al., 1974), to refer to an experimental form of policy research and/or program evaluation, experiments carried out in social (as op posed to laboratory) settings evaluating governmental or other social inter ventions. (This definition excludes experiments in public settings to test social science theories, an important form of social experimentation that the National Commission is attending to through other background papers.) 12-2 Respondents: Participants, interviewees, anthropological "informants," the persons whose responses are recorded, the "subjects" of research, etc.
Many social scientists prefer the terms
"respondent" or "participant" to the term "subject," since the term "subject" has been associated with an exploi- tative attitude neglecting the rights and interests of the research cooperator.
Statistical Data:
The Privacy Act of 1974 uses this term to refer to information collected originally for research rather than administrative purposes. This usage will be avoided here in favor of research data Statistical Analysis, Statistical Product, and Statistic: These terms refer to summary indices no longer containing individually identifiable data that may be based on either research data or administrative records. Means, standard deviations, correlation coefficients, t ratios, F ratios, probabil ity levels, etc., exemplify statistical products. Frequency counts and per centages usually qualify as statistical products precluding individual identi fication, but not if the identities of individuals can be deduced through as sociation of research data with public records. Administrative Records: Refer to data collected originally for bureau cratic purposes rather than research purposes. School grades, achievement test scores, earnings subject to withholding tax, unemployment insurance pay ments, days hospitalized, incidence of serum hepatitis, auto insurance claims, all represent administrative records that can be of great value in program evaluation if they are used in ways safeguarding individual privacy.
Record , File
, Data Bank : These are terms used for collections of data on individuals, either administrative or research data.
Reanalysis and Data Analysis by Outsiders:
Refer to the use of research
data or administrative records for purposes other than were originally under stood by the respondents, and by persons other than the regular custodians of the data.
File Merging:
Refers to combining individual data from two files contain ing data about the same respondents, so that one or both of the files, or a third file, ends up containing individually identified data originating in another file.
Unified data banks involve file merging.
File Linkage: Refers to linking data from two or more files so that File statistical products are generated involving data from both files. merging is the most complete form of file linkage, and where permissible, the most statistically efficient. are restricted forms of file linkage that do not involve file merger, and where no individually identified data are transferred from any file to any other (e.g., the "mutually insulated" file linkage to be discussed below).
Recommendations:
1. Review and Review Boards It is important to note, however, that there
Let us start with a concrete recommendation:
12-3 la. Evaluation research, social indicator research, social survey research, secondary analysis of research data, and statistical analysis of data from administrative records, are to conform to rights of subjects legislation (in particular, PL93 -348) and to the guidelines and regulations developed to implement these laws by the National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research.
This coverage includes all such research regard
less of auspices or funding: private, unfunded, university-related, profit and nonprofit research groups, research by govemmental employees, etc. There is general agreement that these areas of research are and should be covered by PL93 -348 and other rights-of-subjects legislation.
99% of such research already is conforming to such standards in the sense of
not violating the rights of subjects s pecified. publicized cases of violations in these areas. is the monstrous bureaucratic burden of requiring this vast area of low -risk research to go through formal institutional review processes. pendices that present sponse to this problem, we are suggesting a process of conditional clearance by affidavit. This procedure provides an expeditious means of reviewing certain low -risk research areas. Sample verification, such as is done for income tax reports, and the threat of subsequent prosecution for actions in violation of the clearance affidavit should discourage abuses. The suggested procedure will be superior to the kind of mass -produced perfunctory clearance that institutional Review Boards would tend to employ in these areas. affidavit clearance requires a revision of PL93
348, or other laws, we recom
mend such revisions be enacted. Probably
There are essentially no
The problem raised by PL93
-348 (See the two Ap reactions to an earlier draft of this report.) In re- If lb. Rights of Subjects Clearance Procedures: Conditional Clearance by Affidvait and Full Review by Institutional Review Boards. Before soliciting funding or initiating a research activity in the low -risk areas of evaluation research, social experimentation, social indicator research, social survey research, secondary analysis of research data, or statistical analysis of data from administrative records, the Principal Investigator(s) should file with the Institutional Review Board concerned with protecting the rights of the participants in the planned study, a full research proposal and a "clearance affidavit," constituting a detailed affimation that the rights of the participants and subjects are not jeopardized in any of the ways specified by the National Comission for the Protection of Human Subjects of Biomedical and Behavioral Research in implementing PL93 -348. the Review Board and the request of the Principal Investigator, this affidavit may constitute a conditional rights -of-subiects clearance, permitting funding requests and research to proceed forthwith, unless or until the Principal Investigator, the Institutional Review Board, or the funding source, requests delay for a full review by the Insti tutional Review Board. The Institutional Review Board may conduct such a full review at any time during a research proceeding under conditional affidavit clearance, and may order the cessation of research found to be violating rights -of-subjects regulations. We envisage this conditional clearance by affidavit, for these low risk areas of research, being implemented through a long, detailed question
At the discretion of
12-4 naire that the Principal Investigator(s) would fill out, sign, and have notar- ized. and guidelines that the National Commission on Protection of Human Subjects of Biomedical and Behavioral Research is now developing, including regulations such as those suggested below. be kept on file by the Review Board for the length of the research project and the subsequent period of project liability for participant injury. designated low -risk areas, the funding and/or research process could proceed as soon as the proposal and clearance affidavit were filed, if the Principal Investigator(s) had affirmed it as lacking in participant jeopardies and did not wish a Board review. The Board would have the right to examine these on a spot check, sample, or systematic basis, and to request at any point the cessation of activity (funding applications, data collection, data analysis, etc.) until a Board clearance had been achieved. For these low -risk areas such a delayed decision to hold full review or a veto of the research would be rare, lations that a principal investigator would opt for conditional affidavit clear ance rather than requesting a full Board review. to have a staff or Board member examine each affidavit for combinations of features that might indicate possible risks. technique for quality control, perhaps a Board should give full review to a random one -tenth of conditional affidavit clearances. The contents of the questionnaire would be based on the rules, issues,
These affidavits and research proposals would
For these
and it would be upon such an estimate and understanding of the regu
Certainly a Board would want
Since sampling is an efficient
From the investigator's point of view, affidavit clearance prolongs the project's vulnerability to a negative Review Board decision and may in crease its liability to legal damage claims brought against it by participants. The relative advantage of prior Board clearance may easily be overestimated however. Even for projects they have approved, Review Boards will want the right to determine that the project is restricting itself to the approved activities, and will use that right if it receives complaints. Consideration should be given to the effects of including program evalua tion, etc., on the constitution of Review Boards. This raises a number of problems that were not fully presented in the initial draft of this paper and thus have not received comments. One recommendation is obvious:
1c. Rights-of-Subjects Review Boards should be available to
handle program evaluation, etc., on research done by independent investigators, profit and nonprofit research organizations, governmental agencies, etc., as well as for research conducted through universities. Note that while the Statistical Policy Division of the Office of Management and Budget reviews questionnaire forms for governmental and govern ment contract research, and may consider respondents' rights in the process, this does not necessarily provide the equivalent of Institutional Review Board clearance. The proper location of these Review Boards becomes a problem. It would
This role for Review Boards
be desirable for them to be locally available to the research participants so that complaints can easily be placed and heard. becomes particularly important in monitoring the conditional affidavit clear ance procedure. 12-5 To date, Institutional Review Boards have been set up in the institutions doing the research. ities and hospitals, the participants in such research have had easy access to Since most of this research has been conducted in univers- the Board. However, a program evaluation may be conducted by a more distant institution. Thus local institutions (such as public schools) whose members are frequent subjects of evaluation research may wish to set up their own
Rights-of-Subjects Review Boards.
Local Review Boards seem impractical for broad public opinion surveys. While city, county, and state boards are conceivable, and should be given juris- diction if they request it (local jurisdictions that require licensing of opin- ion survey interviewers could insist on approval by Review Boards), it would be unreasonable to require local Review Boards for national surveys interviewing only a few people in any one local jurisdiction.
Board is necessary.
quotesdbs_dbs49.pdfusesText_49
PROTECTION DES SUJETS HUMAINS RAPPORT BELMONT : PRINCIPES