The Belmont Report: Ethical Principles and Guidelines for ...
[Pages:705]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
2. The Role of Assessment of Risk Benefit Criteria in the Determination of the Appropriateness of Research Involving Human Subjects
3. The Nature and Definition of Informed Consent in Various Research Settings
4. Appropriate Guidelines for the Selection of Human Subjects for Participation in Biomedical and Behavioral Research
II. BASIC ETHICAL PRINCIPLES RELATING TO RESEARCH INVOLVING HUMAN SUBJECTS
5. Ethical Principles and Their Validity . . . . . . . Kurt Baier, D. Phil.
6. Distributive Justice and Morally Relevant 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, Jr., Ph.D., M.D.
9. Medical Ethics and the Architecture of Clinical Research . . . . . . . . . . . . . . . . Alvan R. Feinstein, M.D. Jeffrey L. Lichtenstein, M.D.
10. How to Identify Ethical Principles . . . . . . . . Alasdair MacIntyre, M.A.
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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 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. Joe Shelby Cecil, Ph.D.
13. Response to Commission Duties as Detailed in P.L. 93-348, Sec. 202(a)(1)(B)(i). . . . . . . . Donald Gallant, M.D.
14. On the Usefulness of Intent for Distinguishing Between Research and Practice, and Its Replacement by Social Contingency. . . . . . . . . . . . . Israel Goldiamond, Ph.D.
15. Boundaries Between Research and Therapy, Especially in Mental Health . . . . . . . . . . . . Perry London, Ph.D. 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 Research 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
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IV. RISK/BENEFIT CRITERIA
19. Some Perspectives on the Role of Assessment of Risk/Benefit Criteria in the Determination of the Appropriateness of Research Involving Human Subjects . . . . . . . . Bernard Barber, Ph.D.
20. The Role of Risk/Benefit Analysis in the Conduct of Psychological Research . . . . . . . . Gregory Kimble, Ph.D.
21. A Philosophical Perspective on the Assessment of Risk-Benefit Criteria in Connection with Research Involving Human Subjects. . . . . . Maurice Natanson, Ph.D.
22. Essay on Some Problems of Risk-Benefit Analysis in Clinical Pharmacology . . . . . . . . Lawrence C. Raisz, M.D.
V. INFORMED CONSENT
23. Nature and Definition of Informed Consent in Research Involving Deception . . . . . Diana Baumrind, Ph.D.
24. Some Complexities and Uncertainties 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.
26. Three Theories of Informed Consent: Philosophical Foundations and Pol icy Implications. . . . . . . . . . . . . . . . . . . Robert Veatch. Ph.D.
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