http://ethics.iit.edu/codes/coe/nuremberg.

html, Feb 09

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
reasonable 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 seems 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 probable 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.

[Source: National Institute of Health Office of Human Subjects Research

Regulations and Ethical Guidelines
Date Approved: Published in Trials of War Criminals before the Nuremberg
Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181-182..
Washington, D.C.: U.S. Government Printing Office, 1949n ]
 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.

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.

12. 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.
http://www.who.int/bulletin/volumes/85/8/07-045443/en/print.html, Feb 09

Nuremberg code turns 60

Michel Thierena, Alexandre Mauronb

This month marks sixty years since the Nuremberg code1 – the basic text of modern medical ethics –
was issued. The principles in this code were articulated in the context of the Nuremberg trials in
1947. We would like to use this anniversary to examine its ability to address the ethical challenges of
our time. One of these is the question of scientific misconduct downstream to medical research,
particularly when biased interpretations of clinical studies lead to an overoptimistic assessment of a
new drug, which ends up being withdrawn from the market after harming many individuals, as
happened with rofecoxib.2 A second development is one that the Nuremberg judges could hardly
have foreseen. In the age of AIDS, human research ethics began to be invoked not only to offer
protection from research, but also to gain access to it. The AIDS crisis turned the fact of becoming a
research subject into a kind of privilege, as it carried the hope of early access to treatment. Ethics
must now reconcile two antagonistic objectives: protecting research subjects from possible harm,
while ensuring non-discriminatory access to research for potential subjects; a tough balancing act.

The Nuremberg code evokes a dark time for medicine, yet remains a powerful symbol in inspiring
the medical profession to stand up for its Hippocratic values and protect individuals from harmful
medical experiments.

For the past 60 years, a series of ethical texts and instruments have relayed the Nuremberg court’s
opinion,3 and completed or interpreted the code in the multifaceted context of medical
experimentation. The medical profession thus draws on a vast body of ethical reflection to ensure
that scientific advances do not prevail over the health and safety of individuals without their fully
informed consent in medical experiments. However, we ask whether modern ethics and its binding
instruments can always secure full protection to experimental subjects and beyond them, to the
recipients of health care. In a context of relentless competition for resources among scientific
institutions, ethical vigilance is a permanent necessity. Falsification of scientific results and the
premature release of drugs on the market show that modern ethics does not in itself provide full
protection against scientific misconduct, especially when it occurs beyond the critical step of
malevolent or unsafe experiments involving human beings.

Bioethics experts Paul Weindling and Volker Roelcke suggest that current bioethical thinking may
use an incomplete picture of the historical context of the Nuremberg code. Volker Roelcke writes:
“rather than being the result of a coercive state, Nazi medicine illustrates how medical researchers
and their representative bodies […] co-operated with and even manipulated a totalitarian state and
political system relying on expert opinion, in order to gain resources for the conduct of research
without any moral and legal regulation.” He states that Nazi doctors “followed the intrinsic logic of
their scientific disciplines and used the legally and ethically unrestricted access to human beings
created by the context of the political system and the conditions of war.”4 By centring exclusively on
the war crimes and not on their broader context, the judges at Nuremberg issued the code in order
solely to set the boundaries for “permissible experiments” and tackle the difficult question of the
biomedical research conducted on human subjects outside Germany during the war. The court thus
failed to produce a broader legal doctrine protecting individuals against harm induced by scientific
practices at large, including not only human beings as subjects of medical experiments but also as
consumers and beneficiaries of science’s outcomes. ■

References

1. Permissible Medical Experiments. Trials of War Criminals before the Nuremberg Military Tribunals under
Control Council Law No. 10: Nuremberg October 1946–April 1949. Washington: U.S. Government
Printing Office (n.d.), vol. 2, pp. 181-182.
2. A Cahana, A Mauron. The story of Vioxx – no pain and a lot of gain: ethical concerns regarding conduct
of the pharmaceutical industry. J Anesth 2006; 20: 348-51.
3. L Alexander. Medical science under dictatorship. N Engl J Med 1949; 40: 241-.
4. Roelcke V, Maio G, editors. Twentieth Century Ethics of Human Subjects Research. Historical
Perspectives on Values, Practices, and Regulations, p.162, Stuttgart, Franz Steiner Verlag, 2004.

Affiliations

a. Information, Evidence and Research Cluster; Member of the WHO Ethics Review Committee. World
Health Organization, 20 avenue Appia, 1211 Geneva 27, Switzerland.

Institut d’éthique biomédicale, Centre médical universitaire, Université de Genève, Switzerland

http://www.hhs.gov/ohrp/irb/irb_appendices.htm, Feb 7, 2009

Return to Index Page

Institutional Review Board

Guidebook
* APPENDICES *

• Appendix 1: General Bibliography

• Appendix 2: HHS, PHS and NIH Organizational Diagrams
• Appendix 3: Department and Agency Persons to Contact
• Appendix 4: The Federal Policy and 45 CFR 46
• Appendix 5: Agency Documents - "OPRR Reports"
• Appendix 6: The Nuremberg Code, Declaration of Helsinki, and Belmont Report
• Appendix 7: Local IRB Documents

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 are
"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.

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.

Beauchamp, Tom L., and Childress, James F. Principles of Biomedical Ethics, 3d ed. New York: Oxford University
Press, 1989.
 Beecher, Henry K. "Ethics and Clinical Research." New England Journal of Medicine 274 (1966):1354-1360.

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.

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

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.

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.
 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.

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.

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.

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

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.

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.

• Appendix 2: HHS, PHS and NIH Organizational Diagrams

• Appendix 3: Department and Agency Persons to Contact
• Appendix 4: The Federal Policy and 45 CFR 46
• Appendix 5: Agency Documents - "OPRR Reports"
• Appendix 6: The Nuremberg Code, Declaration of Helsinki, and Belmont Report
• Appendix 7: Local IRB Documents

APPENDIX 6

THE NUREMBERG CODE

1. The voluntary consent of the human subject is absolutely essential.

o 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.
o 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
13. 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.
14. 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.
15. 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.
16. 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.
17. 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.
18. 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.
19. 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.
20. 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.
21. 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.
22. 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.
23. 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.

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.

24. 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)
7. 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.
8. The potential benefits, hazards and discomfort of a new method should be weighed against the
advantages of the best current diagnostic and therapeutic methods.
9. 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.
10. The refusal of the patient to participate in a study must never interfere with the physician-
patient relationship.
11. 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).
12. 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)
5. 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.
6. The subjects should be volunteers--either healthy persons or patients for whom the
experimental design is not related to the patient's illness.
7. 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.
8. In research on man, the interest of science and society should never take precedence over
considerations related to the well being of the subject.

Return to Top of Page

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.

________________________
Appendices
http://www.brown.edu/Courses/Bio_160/Projects2000/Ethics/THENUREMBURGCODE.html, Feb
09

THE NUREMBERG CODE

Wartime Experiments on the Inmates of Nazi

Concentration Camps
The idea of, "state before individual" was typical of the Nazi era and physicians
began to lose sight of their moral obligations as they were swept into the
dehumanizing Nazi political culture. The slew of exotic diseases and afflictions, a
condition of the war environment, were seen as a, "national threat," and it was to
these "threats" that German doctors began to assume the responsibility of acting
on behalf of the state in order to imporve the health of the nation. On the basis of
national thought and utilitarianism doctors no longer acted as caretakers but as
puppets of a government obsessed with racial and genetic purity. Medical
experiments committed under the disguise of scientific research fell into three
basic categories: (1) Medico-Military Research; (2) Miscellaneous, Ad Hoc
Experiments; and (3) Racially Motivated Experiments. (1)

Dr. Josepf Mengele, more familiarly known as the 'Angel of death,' is

probably the most famous of the Nazi doctors who used the
prisoners in Nazi concentration camps for medical experimentation.
Mengele sought to unlock the genetic basis for a superior race and
conducted goulish experiments with precision going even beyond
the limits of scientific inquiry. He was fanatical about twin studies, obsessing over
the differences between twins, and would make them sit together in the nude for
hours while he personally examined them leaving no bady part untouched.
Furthermore, drawing blood from identical twins was routine, which often left
them bleeding to death. Mengele was also involved in other studies that sought
to design better equipment for the Nazi soldiers, and for this purpose naked
prisoners were placed in ice cold vats to determine the lowest possible
temperature in which a human could survive. However, Mengele wasn't alone in
his medical exploits, many German doctors made trips to Nazi concentration
camps where they could use the large potential subject pool without concern for
the harm of the subjects.

The Aftermath
Following World War II, leading Nazi doctors were brought to justice before the
International Military Tribunal at Nuremberg. 20 doctors (unfortunately Dr. Josepf
Mengele was not among these twenty. He fled Auschwitz in 1945, before the
liberation of the camps by the Americans.), were charged with War Crimes and
Crimes Against Humanity. The Nuremberg trial of doctors, which began in 1946,
revelaed evidence of sadistic human experiments conducted at the Dachau,
Auschwitz, Buchenwald and Sachsenhausen concentration camps.

The Nuremberg Code is the most important document in the history of the ethics
of medical research and the first of its kind to ensure the rights of subjects.
Formulated 50 years ago, in August 1947, by the
American judges heading the trial of Nazi doctors
accused of conducting macabre human experiments in
the concentration camps. During the course of the trial
the judges at Nuremberg correctly recognized that more
than the Hipporatic ethics and the maxim primum non
nocere, were necessary to ensure and protect the rights
of human research subjects. Thus the judges defined a
set of 10 research principles that were centered on the
research subject rather than the physician. The judges
were emphatic about the necessity and quality of the
subject's consent, explicitly adding the subject' s right to
withdraw from the experiment. The Nuremberg Code
insists that the medical investigators alone cannot set the rules for the ethical
conduct of research, even when guided by beneficience and the Hippocraric
ethics. In the traditional doctor-patient relationship, the silent and dutiful patient
trusted the physician to act in their best interests or atleast do no harm. However,
more often than not scientific research lies outside the beneficient context of the
physician-patient relationship whereby the physician's primary goal is now
motivated by a scientific hypothesis and not to treat the patient. This breach of
trust led the judges heading the Nuremberg trials to merge Hippocratic ethics and
the protection of human rights into a single code.
 courtesy of USHMM Photo Archives

Hx. CASE DISCUSSION

INTRODUCTION BIOETHICS
BACKGROUND STUDIES FORUM

REFERENCES

(1) http://www.jlaw.com/Articles/NaziMedEx.html
(2) Shuster, E : Fifty Years Later: The Significance of the Nuremberg Code. NEJM 337
(3) "Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law
No. 10", vol. 2, pp 181-182. Washington, D.C. : U.S.
Government Printing Office, 1949.

http://ethics.iit.edu/codes/coe/nuremberg.html, Feb 09

CS
EP
Center for the Study of Ethics in the
Professions at IIT
Home >> Codes of Ethics Online >> Nuremberg Code
Organization: Nuremberg Code
Source: National Institute of Health Office of Human Subjects Research
Regulations and Ethical Guidelines
Date Approved: Published in Trials of War Criminals before the Nuremberg
Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181-182..
Washington, D.C.: U.S. Government Printing Office, 1949n

Other Version(s) in our Codes of Ethics Online Collection: None

Disclaimer: Please note the codes in our collection might not necessarily be the most recent versions.
Please contact the individual organizations or their websites to verify if a more recent or updated code of
ethics is available. CSEP does not hold copyright on any of the codes of ethics in our collection. Any
permission to use the codes must be sought from the individual organizations directly.

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
reasonable 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 seems 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 probable 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.
______________________

Reprinted from Trials of War Criminals before the Nuremberg Military Tribunals
under Control Council Law No. 10, Vol. 2, pp. 181-182.. Washington, D.C.: U.S.
Government Printing Office, 1949.

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