keywords: bioethics, bioethique

It is widely accepted that for clinical research with humans to be ethical, it must fulfill 8 fundamental ethical principles 1,2:

1) Collaborative Partnership-that is there must be collaboration between the researchers and the community in which the research is being conducted.

2) Social Value-the research must generate valuable knowledge that will directly or through additional research lead to improvements in health.

3) Scientific Validity-the research must be conducted in a scientifically sound manner to produce reliable and interpretable data.

4) Fair Subject Selection-participants in the research should be selected based on the scientific objectives of the study and then in a way to minimize risks and enhance benefits. Being vulnerable or powerful are not valid grounds for selecting a certain population.

5) Favorable Risk-Benefit Ratio-the overall anticipated benefits of the study for individuals should exceed the potential risks. If the risks exceed the benefits, the study must generate valuable data that cannot be obtained any other way.

6) Independent Review-all research studies should be reviewed by an independent body to ensure these ethical principles are fulfilled.

7) Informed Consent-all participants in research should provide informed consent; if they are mentally incapacitated a surrogate should provide consent except in select conditions such as emergency situations.

8) Respect for enrolled subjects-requires monitoring the health of participants, maintaining confidentiality of records, providing additional information learned by the study, etc.

Importantly, these principles are universal; they apply in Europe, the United States as well as Africa, India and Asia. These principles may conflict; what is socially valuable may increase risks, scientific validity might be in tension with informed consent, etc. Thus, there may be disagreements about how to specify or balance these principles; this must be distinguished from clearly violating a fundamental principle-a distinction not often made.

That some individuals or groups claim clinical research is unethical or exploitative, does not make it so. All such charges must be carefully evaluated. Furthermore, it is important to distinguish research that is unethical from situations in which people disagree about how to balance the various ethical principles when they conflict which is the more common phenomena. Such disagreements can best be resolved by negotiations and deliberation about how to specify the principles, rather than exaggerated charges about being unethical. This would emphasize the principle of collaborative partnership, one of the most important principles for productive research between developed and developing countries.

Ezekiel J. Emanuel, M.D., Ph.D.

Department of Clinical Bioethics

The Clinical Center

National Institutes of Health

Bethesda, Maryland 20892-1156