The Nuremberg Code

The Nuremberg Code was the first internationally recognized code of research ethics developed after World War II by the Nazi War Crimes Tribunal in 1946. Twenty-three Nazi physicians were tried at Nuremberg because of research atrocities performed on prisoners of war. For more information about these events, see the Historic Research page.

The following ethical principles emphasized by Federal Regulations and IRB guidelines are based on the Nuremberg Code:

1. Voluntary Consent
2. Minimization of risks and harm
3. Favorable risk / benefit ratio
4. Qualified researchers using appropriate research design
5. Freedom to withdraw from research

1. Voluntary Consent

Human subjects should always have the capacity to consent, should comprehend the risks and benefits of participation and be protected from coercion. The policy of informed consent goes further than signing a document that describes the study. Investigators need to ensure that subjects fully understand what all the implications of the research are and that they never mislead as to the benefits. Health care providers are in a unique position of power and run the risk of implicitly persuading patients to participate based on the trust that is placed in them. If you access the war crimes reports these are some of the worst examples of subjects having no choice to participate. However, there are examples of studies where patients believe that the study is the best treatment option rather than an experimental intervention. All subjects should be completely willing and fully aware of the purposes and effects of the research.

2. Minimization of risks & harm

The research design and safety considerations are of paramount importance in the protection of human subjects. (See Section 5). This also involves continual monitoring of the progress of the study and the ethical responsibility to discontinue the study if significant adverse events occur. Although the IRB may discontinue a study if the study is deemed to be demonstrating high risk or adverse events are a pattern, it is the principal investigators that are responsible for stopping the study if negative results are experienced. It is also the ethical responsibility for all research assistants to promptly report adverse events or negative consequences to the principal investigators. Research Assistants or subjects may also report negative consequences to the IRB. In a recent melanoma vaccine study, the study was discontinued after the research nurse reported the serious adverse effects being experienced by patients. The principal investigator had not responded to concerns about the effects, with the hope that this was cure for the disease.

3. Favorable risk/benefit ratio

The risk/benefit ratio will change with the nature of the study and the morbidity of the disease. However, a high risk/benefit ratio is not acceptable and there are strong ethical dilemmas with provision of experimental procedures or drugs for conditions where there is no accepted treatment. The scientific basis for any new solution needs to be well founded and carefully considered.

4. Qualified researchers using appropriate research design

The research process becomes more complex and more difficult with the vast amount of knowledge available and the skills required for valuable research are therefore increasing. The value of an IRB is to add to the pool of knowledge available to assist with appropriate research design and to ensure that novice researchers are guided in the right directions. We are fortunate at Henry Ford Health System to have premier researchers available for both mentoring and peer review.

5. Freedom to withdraw from research

Subjects should always feel free to discontinue their participation with no negative consequences that would jeopardize their medical care or future participation in health studies.

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