The IRB Guidebook was last updated in 1993. Developments over the intervening years have made portions of the Guidebook information obsolete, while portions of the information remain valid. There is no errata document to indicate which information has been superseded. OHRP cautions users to verify the current validity of any Guidebook information before relying on the information in a program of human subjects protection.

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Institutional Review Board
Guidebook

* APPENDICES *



APPENDIX 1

GENERAL BIBLIOGRAPHY

The sources listed in this Section are important reference works that will be useful for every IRB. In-depth treatment of many of the subjects addressed in this Guidebook are provided (e.g., informed consent, risk/benefit analysis, privacy and confidentiality, background on the IRB system). In addition, a number of the articles listed address issues of general interest to IRBs, but which are not discussed in the Guidebook (e.g., conflicts of interest and the funding of research).

BOOKS AND ARTICLES

All of the books and articles listed will be valuable reference works for IRBs. The items preceded by this symbol bulletare "musts" for any IRB library.

Annas, George; Glantz, Leonard; and Katz, Barbara. Informed Consent to Human Experimentation: The Subject's Dilemma. Cambridge, MA: Ballinger Publishing Company, 1977.

Appelbaum, Paul S., and Rosenbaum, Alan. "Tarasoff and the Researcher: Does the Duty to Protect Apply in the Research Setting?" American Psychologist 44 (No. 6, June 1989): 885-894.

bullet Beauchamp, Tom L.; Faden, Ruth R.; Wallace, R. Jay, Jr.; and Walters, LeRoy, eds. Ethical Issues in Social Science Research. Baltimore, MD: Johns Hopkins University Press, 1982.

bullet Beauchamp, Tom L., and Childress, James F. Principles of Biomedical Ethics, 3d ed. New York: Oxford University Press, 1989.

bullet Beecher, Henry K. "Ethics and Clinical Research." New England Journal of Medicine 274 (1966):1354-1360.

bullet Beecher, Henry K. Research and the Individual: Human Studies. Boston: Little, Brown and Company, 1970.

Benson, P.R. "The Social Control of Human Biomedical Research: An Overview and Review of the Literature." Social Science and Medicine 29 (No. 1, 1989): 1-12.

Berg, Kare, and Tranoy, Knut Erik, eds. Research Ethics. Progress in Clinical and Biological Research, Vol. 128. New York: Alan R. Liss, 1983.

Bernard, Claude. An Introduction to the Study of Experimental Medicine, translated by N.C. Greene. New York: The Macmillan Company, 1927.

Capron, A.M. "Human Experimentation." In Medical Ethics, edited by Robert M. Veatch, pp. 125-172. Boston: Jones and Bartlett, 1989.

Cohen, Carl. "Moral Issues in Medical Experimentation on Humans." Philosophic Exchange 2 (No. 5, Summer 1979): 37-51.

Davidson, Richard A. "Source of Funding and Outcome of Clinical Trials." Journal of General Internal Medicine 1 (No. 3, May-June 1986): 155-158.

bullet Faden, Ruth R. and Beauchamp, Tom L. A History and Theory of Informed Consent. New York: Oxford University Press, 1986.

bullet Freund, Paul A., ed. Experimentation With Human Subjects. New York: George Braziller, 1970.

Greenwald, Robert A.; Ryan, Mary Kay; and Mulvihill, James E., eds. Human Subjects Research: A Handbook for Institutional Review Boards. New York and London: Plenum Press, 1982.

Healy, Bernadine, et al. "Conflict-of-Interest Guidelines for a Multicenter Clinical Trial of Treatment after Coronary-Artery Bypass-Graft Surgery." New England Journal of Medicine 320 (No. 14, April 6, 1989): 949-951.

Herman, Samuel S. "A Noninstitutional Review Board Comes of Age." IRB 11 (No. 2, March/April 1989): 1-6.

Jonas, Hans. "Philosophical Reflections on Experimenting with Human Subjects." Daedalus: Journal of the American Academy of Arts and Sciences 98 (No. 2, Spring 1969): 219-47. Reprinted in Experimentation With Human Subjects, edited by Paul A. Freund, pp. 1-31. New York: George Braziller, 1970.

bullet Katz, Jay (with the assistance of Alexander Morgan Capron and Eleanor Swift Glass). Experimentation with Human Beings: The Authority of the Investigator, Subject, Professions, and State in the Human Experimentation Process. New York: Russell Sage Foundation, 1972.

Kennedy, B.J., and Wigodsky, Herman S. "Impact of Institutional Review Boards on Cancer Research." Journal of Bioethics 5 (No. 1, Spring/Summer 1984): 27-40.

Kimmel, Allan J. Ethics and Values in Applied Social Research. Newbury Park, CA: Sage Publications, 1988.

Kobasic, Dena M. "Institutional Review Boards in the University Setting: Review of Pharmaceutical Testing Protocols, Informed Consent and Ethical Concerns." Journal of College and University Law 15 (No. 2, Fall 1988): 185-216.

Levine, Carol. "Has AIDS Changed the Ethics of Human Subjects Research?" Law, Medicine and Health Care 16 (No. 3-4, Fall/Winter 1988): 167-173.

bullet Levine, Robert J. Ethics and Regulation of Clinical Research, 2d ed. Baltimore: Urban and Schwarzenberg, 1986.

Levine, Robert J. "The Physician-Researcher: Role Conflicts." In Alzheimer's Dementia: Dilemmas in Clinical Research, edited by Vijaya L. Melnick and Nancy N. Dubler, pp. 41-50. Clifton, NJ: Humana Press, 1985.

Maloney, Dennis M. Protection of Human Subjects: A Practical Guide to Federal Laws and Regulations. New York: Plenum Publishing Co., 1984.

Pappworth, M.H. Human Guinea Pigs: Experimentation on Man. Boston: Beacon Press, 1967.

Prentice, Ernest D., and Antonson, Dean L. "A Protocol Review Guide to Reduce IRB Inconsistency." IRB 9 (No. 1, January/February 1987): 9-11.

Relman, Arnold S. "Economic Incentives in Clinical Investigation." New England Journal of Medicine 320 (No. 14, April 6, 1989): 933-934.

Relman, Arnold S. "Dealing with Conflicts of Interest." New England Journal of Medicine 313 (1985): 749-751.

bullet Rothman, David J. Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making. New York: Basic Books, 1991.

Rothman, David J. "Ethics and Human Experimentation: Henry Beecher Revisited." New England Journal of Medicine 317 (No. 19, November 5, 1987): 1195-1199.

bullet Sieber, Joan E. Planning Ethically Responsible Research: A Guide for Students and Internal Review Boards. Applied Social Research Methods Series, vol. 31. Newbury Park, CA: Sage Publications, 1992.

bullet Sieber, Joan E., ed. The Ethics of Social Research: Surveys and Experiments. New York: Springer-Verlag, 1982.

bullet Sieber, Joan E., ed. The Ethics of Social Research: Fieldwork, Regulation, and Publication. New York: Springer-Verlag, 1982.

Silverman, W.A., ed. Human Experimentation: A Guided Step into the Unknown. Oxford: Oxford University Press, 1985.

Spicker, Stuart F.; Alan, Ilai; de Vries, Andre; and Engelhardt, H. Tristam, Jr., eds. The Use of Human Beings in Research. Boston: Kluwer Academic, 1988.

bullet Veatch, Robert M. Medical Ethics. Boston: Jones and Bartlett Publishers, 1989.

JOURNALS

Clinical Research

Evaluation Research

Hastings Center Report

IRB: A Review of Human Subjects Research

Journal of Philosophy and Medicine

Journal of the American Medical Association

Kennedy Institute of Ethics Journal

Law, Medicine and Health Care

New England Journal of Medicine

BIBLIOGRAPHIES/INDEXES

Bibliography of Bioethics (LeRoy Walters and Tamar Joy Kahn, eds.)

Computer Search Services: Medline, BioethicsLine, Lexis, Nexis, Westlaw

Encyclopedia of Bioethics

VIDEORECORDINGS

  • Columbia University Seminars on Media and Society, in association with WNET New York. The Human Experiment. Produced by Betsy Miller and Martha Elliott. Annenberg: CPB Project, 1989.
  • National Library of Medicine. Evolving Concern: Protection of Human Subjects. Produced for the U.S. National Institutes of Health and the U.S. Food and Drug Administration. Bethesda, MD: National Institutes of Health, Office for Protection from Research Risks, 1986.
  • National Library of Medicine. The Belmont Report: Basic Ethical Principles and the Application. Produced and written for the U.S. National Institutes of Health and the U.S. Food and Drug Administration by Michael D. Hamilton. Bethesda, MD: National Institutes of Health, Office for Protection from Research Risks, 1986.
  • National Library of Medicine. Balancing Society's Mandates: IRB Review Criteria. Produced for the U.S. National Institutes of Health and the U.S. Food and Drug Administration. Bethesda, MD: National Institutes of Health, Office for Protection from Research Risks, 1986.

OTHER NATIONAL AND INTERNATIONAL GUIDELINES

  • Australia. National Health and Medical Research Council. Ethics in Medical Research: Report of the National Health and Medical Research Council Working Party on Ethics in Medical Research. Canberra: Australian Government Publishing Service, 1983.
  • Australia. National Health and Medical Research Council. Medical Research Ethics Committee. Report on Ethics in Epidemiological Research. Canberra: Australian Government Publishing Service, 1985.
  • Australia. National Health and Medical Research Council. Ethics in Medical Research Involving the Human Fetus and Human Fetal Tissue: Report of the National Health and Medical Research Council Medical Research Ethics Committee. Canberra: Australian Government Publishing Service, 1983.
  • Canada. Medical Research Council of Canada. Guidelines on Research Involving Human Subjects. Ottawa: Medical Research Council, 1987.
  • Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: Council for International Organizations of Medical Sciences, 1993.
  • Council for International Organizations of Medical Sciences (CIOMS). International Guidelines for Ethical Review of Epidemiological Studies. Geneva: Council for International Organizations of Medical Sciences, 1991. Reprinted in Law, Medicine and Health Care 19 (No. 3-4, Fall/Winter 1991): 247-58.
  • Declaration of Helsinki. See World Medical Association (1989).
  • European Parliament. Committee on Legal Affairs and Citizens' Rights. "Ethical and Legal Problems of Genetic Engineering, and Human Artificial Insemination." Resolution of March 16, 1989. Official Journal of the European Communities 17.4.89, pp. C 96/165-170. Reprinted (slightly abridged) in Bulletin of Medical Ethics 57 (April 1990):8-10.
  • France. Ministry of Social Affairs and Mutual Assistance. Minister Delegate for Health. Protection of Persons Undergoing Biomedical Research: I. Acts of Parliament; II. Delegated Legislation. [English language translation (unofficial) of relevant laws dated December 1988 through January 1991.] Paris: The Ministry of Social Affairs and Mutual Assistance, 1991.
  • France. Comité consultatif national d'éthique pour les sciences de la vie et de la santé. Ethique et recherche biomédicale: Rapport 1988. Paris: La Documentation francaise, 1989
  • France. Direction de la Documentation francaise. Notes et études documentaires, No. 4855 (1988, No. 5): Sciences de la vie: De l'éthique au droit.
  • Great Britain. Medical Research Council. Working Party on Ethical Aspects of AIDS Vaccine Trials. The Ethical Conduct of AIDS Vaccine Trials. MRC Ethics Series. London: Medical Research Council, 1991.
  • Great Britain. Medical Research Council. Working Party on the Mentally Incapacitated. The Ethical Conduct of Research on the Mentally Incapacitated. MRC Ethics Series. London: Medical Research Council, 1991.
  • Great Britain. Medical Research Council. Working Party on Research on Children. The Ethical Conduct of Research On Children. MRC Ethics Series. London: Medical Research Council, 1991.
  • Great Britain. Medical Research Council. "Responsibility in the Use of Personal Medical Information for Research: Principles and Guide to Practice." British Medical Journal 290 (April 13, 1985): 1120-1124.
  • Helsinki Declaration. See World Medical Association (1989).
  • International Committee of Medical Journal Editors. "Statements from the International Committee of Medical Journal Editors." Journal of the American Medical Association 265 (No. 20, May 22/29, 1991): 2697-98.
  • Nuremberg Code, The. Reprinted in Trials of War Criminals before the Nuernberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181-182. Washington, D.C.: U.S. Government Printing Office, 1949. Also reprinted in Ethics and Regulation of Clinical Research, 2d ed., by Robert J. Levine, pp. 425-426. Baltimore: Urban and Schwarzenberg, 1986.
  • U.S. Department of Health and Human Services. Public Health Service. "U.S. Public Health Service Consultation on International Collaborative Human Immunodeficiency Virus (HIV)." Reprinted in Law, Medicine and Health Care 19 (No. 3-4, Fall/Winter 1991): 259-263.
  • World Health Organization and the Council for International Organizations of Medical Sciences. Proposed International Guidelines for Biomedical Research Involving Human Subjects: A Joint Project of the World Health Organization and the Council for International Organizations of Medical Sciences. Geneva: Council for International Organizations of Medical Sciences, 1982.
  • World Medical Association. "Declaration of Helsinki." As amended by the 41st World Medical Assembly, Hong Kong, September 1989. Reprinted in Law, Medicine and Health Care 19 (No. 3-4, Fall/Winter 1991): 264-65.

REPORTS AND RECOMMENDATIONS OF THE NATIONAL COMMISSION

U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Reports and Recommendations:

  • The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, D.C.: U.S. Government Printing Office, 1978. DHEW Publication No. (OS) 78-0012. Reprinted in Federal Register 44 (April 18, 1979): 23192.
  • Appendix (Volumes I and II) to The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, D.C.: U.S. Government Printing Office, 1978. DHEW Publication No. (OS) 78-0013 and (OS) 78-0014.
  • Proceedings of March 14-15, 1975 Meeting.
  • Report and Recommendations: Ethical Guidelines for the Delivery of Health Services by DHEW. Washington, D.C.: U.S. Government Printing Office, 1978. DHEW Publication No. (OS) 78-0010.
  • Appendix to Report and Recommendations: Ethical Guidelines for the Delivery of Health Services by DHEW. Washington, D.C.: U.S. Government Printing Office, 1978. DHEW Publication No. (OS) 78-0011.
  • Report and Recommendations: Institutional Review Boards. Washington, D.C.: U.S. Government Printing Office, 1978. DHEW Publication No. (OS) 78-0008.
  • Appendix to Report and Recommendations: Institutional Review Boards. Washington, D.C.: U.S. Government Printing Office, 1978. DHEW Publication No. (OS) 78-0009.
  • Report and Recommendations: Psychosurgery. Washington, D.C.: U.S. Government Printing Office, 1977. DHEW Publication No. (OS) 77-0001.
  • Appendix to Report and Recommendations: Psychosurgery. Washington, D.C.: U.S. Government Printing Office, 1977. DHEW Publication No. (OS) 77-0002.
  • Report and Recommendations: Research Involving Children. Washington, D.C.: U.S. Government Printing Office, 1977. DHEW Publication No. (OS) 77-0004.
  • Appendix to Report and Recommendations: Research Involving Children. Washington, D.C.: U.S. Government Printing Office, 1977. DHEW Publication No. (OS) 77-0005.
  • Report and Recommendations: Research Involving Prisoners. Washington, D.C.: U.S. Government Printing Office, 1976. DHEW Publication No. (OS) 76-131.
  • Appendix to Report and Recommendations: Research Involving Prisoners. Washington, D.C.: U.S. Government Printing Office, 1976. DHEW Publication No. (OS) 76-132.
  • Report and Recommendations: Research Involving Those Institutionalized As Mentally Infirm. Washington, D.C.: U.S. Government Printing Office, 1978. DHEW Publication No. (OS) 78-0006.
  • Appendix to Report and Recommendations: Research Involving Those Institutionalized As Mentally Infirm. Washington, D.C.: U.S. Government Printing Office, 1978. DHEW Publication No. (OS) 78-0007.
  • Report and Recommendations: Research on the Fetus. Washington, D.C.: U.S. Government Printing Office, 1975. DHEW Publication No. (OS) 76-127.
  • Appendix: Research on the Fetus. Washington, D.C.: U.S. Government Printing Office, 1976. DHEW Publication No. (OS) 76-128.
  • Report and Recommendations: Special Study: Implications of Advances in Biomedical and Behavioral Research. Washington, D.C.: U.S. Government Printing Office, 1978. DHEW Publication No. (OS) 78-0015.

REPORTS OF THE PRESIDENT'S COMMISSION

U.S. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research:

  • Compensating for Research Injuries: The Ethical and Legal Implications for Programs to Redress Injured Subjects. Washington, D.C.: U.S. Government Printing Office, 1982. G.P.O. Stock Number 040-000-00455-6.
  • Deciding to Forego Life-Sustaining Treatment: A Report on the Ethical, Medical, and Legal Issues in Treatment Decisions. Washington, D.C.: U.S. Government Printing Office, 1983.
  • Defining Death: A Report on the Medical, Legal and Ethical Issues in the Determination of Death. Washington, D.C.: U.S. Government Printing Office, 1981.
  • Implementing Human Research Regulations: Second Biennial Report on the Adequacy and Uniformity of Federal Rules and Policies, and of their Implementation, for the Protection of Human Subjects. Washington, D.C.: U.S. Government Printing Office, 1983.
  • Making Health Care Decisions: A Report on the Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship. Volume One: Report. Washington, D.C.: U.S. Government Printing Office, 1982.
  • Making Health Care Decisions: A Report on the Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship. Volume Two: Appendices, Empirical Studies of Informed Consent. Washington, D.C.: U.S. Government Printing Office, 1982.
  • Making Health Care Decisions: A Report on the Ethical and Legal Implications of Informed Consent in the Patient-Practitioner Relationship. Volume Three: Appendices Studies on the Foundations of Informed Consent. Washington, D.C.: U.S. Government Printing Office, 1982.
  • Protecting Human Subjects: The Adequacy and Uniformity of Federal Rules and their Implementation. Washington, D.C.: U.S. Government Printing Office, 1981.
  • Screening and Counseling for Genetic Conditions: The Ethical, Social, and Legal Implications of Genetic Screening, Counseling, and Education Programs. Washington, D.C.: U.S. Government Printing Office, 1983.
  • Securing Access to Health Care: A Report on the Ethical Implications of Differences in the Availability of Health Services. Volume One: Report. Washington, D.C.: U.S. Government Printing Office, 1983.
  • Securing Access to Health Care: The Ethical Implications of Differences in the Availability of Health Services. Volume Two: Appendices, Sociocultural and Philosophical Studies. Washington, D.C.: U.S. Government Printing Office, 1983.
  • Securing Access to Health Care: The Ethical Implications of Differences in the Availability of Health Services. Volume Three: Appendices, Empirical, Legal, and Conceptual Studies. Washington, D.C.: U.S. Government Printing Office, 1983.
  • Splicing Life: A Report on the Social and Ethical Issues of Genetic Engineering with Human Beings. Washington, D.C.: U.S. Government Printing Office, 1982.
  • Summing Up: Final Report on Studies of the Ethical and Legal Problems in Medicine and Biomedical And Behavioral Research. Washington, D.C.: U.S. Government Printing Office, 1983.
  • Whistleblowing in Biomedical Research: Policies and Procedures for Responding to Reports of Misconduct. Proceedings of a Workshop September 21-22, 1981. Edited by Judith P. Swazey and Stephen R. Scher. Washington, D.C.: U.S. Government Printing Office, 1981.


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APPENDIX 6

THE NUREMBERG CODE
  1. The voluntary consent of the human subject is absolutely essential.
    • This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.

    • The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.

  2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
  3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
  4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
  5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.
  6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
  7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
  8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
  9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seemed to him to be impossible.
  10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probably [sic] cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

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WORLD MEDICAL ASSOCIATION
DECLARATION OF HELSINKI

Adopted by the 18th World Medical Assembly
Helsinki, Finland, June 1964
and amended by the
29th World Medical Assembly
Tokyo, Japan, October 1975
35th World Medical Assembly
Venice, Italy, October 1983
and the
41st World Medical Assembly
Hong Kong, September 1989

Introduction

It is the mission of the physician to safeguard the health of the people. His or her knowledge and conscience are dedicated to the fulfillment of this mission.

The Declaration of Geneva of the World Medical Assembly binds the physician with the words, "The health of my patient will be my first consideration," and the International Code of Medical Ethics declares that, "A physician shall act only in the patient's interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient."

The purpose of biomedical research involving human subjects must be to improve diagnostic, therapeutic and prophylactic procedures and the understanding of the aetiology and pathogenesis of disease.

In current medical practice most diagnostic, therapeutic or prophylactic procedures involve hazards. This applies especially to biomedical research.

Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects.

In the field of biomedical research a fundamental distinction must be recognized between medical research in which the aim is essentially diagnostic or therapeutic for a patient, and medical research, the essential object of which is purely scientific and without implying direct diagnostic or therapeutic value to the person subjected to the research.

Special caution must be exercised in the conduct of research which may affect the environment, and the welfare of animals used for research must be respected.

Because it is essential that the results of laboratory experiments be applied to human beings to further scientific knowledge and to help suffering humanity, the World Medical Association has prepared the following recommendations as a guide to every physician in biomedical research involving human subjects. They should be kept under review in the future. It must be stressed that the standards as drafted are only a guide to physicians all over the world. Physicians are not relieved from criminal, civil and ethical responsibilities under the laws of their own countries.

I. Basic principles

  1. Biomedical research involving human subjects must conform to generally accepted scientific principles and should be based on adequately performed laboratory and animal experimentation and on a thorough knowledge of the scientific literature.
  2. The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol which should be transmitted for consideration, comment and guidance to a specially appointed committee independent of the investigator and the sponsor provided that this independent committee is in conformity with the laws and regulations of the country in which the research experiment is performed.
  3. Biomedical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given his or her consent.
  4. Biomedical research involving human subjects cannot legitimately be carried out unless the importance of the objective is in proportion to the inherent risk to the subject.
  5. Every biomedical research project involving human subjects should be preceded by careful assessment of predictable risks in comparison with foreseeable benefits to the subject or to others. Concern for the interests of the subject must always prevail over the interests of science and society.
  6. The right of the research subject to safeguard his or her integrity must always be respected. Every precaution should be taken to respect the privacy of the subject and to minimize the impact of the study on the subject's physical and mental integrity and on the personality of the subject.
  7. Physicians should abstain from engaging in research projects involving human subjects unless they are satisfied that the hazards involved are believed to be predictable. Physicians should cease any investigation if the hazards are found to outweigh the potential benefits.
  8. In publication of the results of his or her research, the physician is obliged to preserve the accuracy of the results. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication.
  9. In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be informed that he or she is a liberty to abstain from participation in the study and that he or she is free to withdraw his or her consent to participation at any time. The physician should then obtain the subject's freely-given informed consent, preferably in writing.
  10. When obtaining informed consent for the research project the physician should be particularly cautious if the subject is in a dependent relationship to him or her or may consent under duress. In that case the informed consent should be obtained by a physician who is not engaged in the investigation and who is completely independent of this official relationship.
  11. In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject in accordance with national legislation.
  12. Whenever the minor child is in fact able to give a consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian.

  13. The research protocol should always contain a statement of the ethical considerations involved and should indicate that the principles enunciated in the present Declaration are complied with.

II. Medical research combined with clinical care (Clinical research)

  1. In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure, if in his or her judgment it offers hope of saving life, reestablishing health or alleviating suffering.
  2. The potential benefits, hazards and discomfort of a new method should be weighed against the advantages of the best current diagnostic and therapeutic methods.
  3. In any medical study, every patient - including those of a control group, if any--should be assured of the best proven diagnostic and therapeutic method.
  4. The refusal of the patient to participate in a study must never interfere with the physician-patient relationship.
  5. If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal should be stated in the experimental protocol for transmission to the independent committee (I, 2).
  6. The physician can combine medical research with professional care, the objective being the acquisition of new medical knowledge, only to the extent that medical research is justified by its potential diagnostic or therapeutic value for the patient.

III. Non-therapeutic biomedical research involving human subjects (Non-clinical biomedical research)

  1. In the purely scientific application of medical research carried out on a human being, it is the duty of the physician to remain the protector of the life and health of that person on whom biomedical research is being carried out.
  2. The subjects should be volunteers--either healthy persons or patients for whom the experimental design is not related to the patient's illness.
  3. The investigator or the investigating team should discontinue the research if in his/her or their judgment it may, if continued, be harmful to the individual.
  4. In research on man, the interest of science and society should never take precedence over considerations related to the well being of the subject.


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APPENDIX 7

LOCAL IRB DOCUMENTS

** This appendix is intentionally blank to allow space in the three-ring binder version for institutions to add their own IRB documents. **

A place to insert documents pertaining to each institution and its IRB: the institutional assurance, current list of IRB members and staff, statements of meeting procedures, review procedures, the institution's standard forms, and so forth.


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________________________
Appendices