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. 2014 Oct 10:771–819. doi: 10.1016/B978-0-12-415766-8.00015-X

TABLE 15.7.

Ethical Issues of Medical Research Derived from the Nuremberg Trials, the Universal Declaration of Human Rights, and the Declaration of Helsinki

Nuremberg Doctors Trial, 1946–47 The voluntary consent of a human subject is absolutely essential, with the exercise of free power of choice without force, fraud, deceit, duress, or coercion
Experiments should be such as to bear fruitful results, based on prior experimentation and the natural history of the problem under study. They should avoid unnecessary physical and mental suffering
The degree of risk should not exceed the humanitarian importance of the experiment
Persons conducting experiments are responsible for adequate preparations and resources for even the remote possibility of death or injury resulting from the experiment
The human subject should be able to end his participation at any time
The scientist in charge is responsible to terminate the experiment if continuation is likely to result in injury, disability, or death
Universal Declaration of Human Rights, 1948 Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing, and medical care and necessary social services
United Nations covenants for protection of human rights Covenant on Civil and Political Rights
Optional Protocol to the Covenant on Civil and Political Rights
Covenant on Economic, Social, and Cultural Rights
Convention Against Torture
Convention Against Genocide
The Geneva Conventions
Convention on the Rights of the Child
Convention on Elimination of Discrimination Against Women
Charter of the United Nations
Declaration of Helsinki, 1964 Research must be in keeping with accepted scientific principles, and should be approved by specially appointed independent committees
Biomedical research should be carried out by scientifically qualified persons, only on topics where potential benefits outweigh the risks, with careful assessment of risks, where the privacy and integrity of the individual is protected, and where the hazards are predictable. Publication must preserve the accuracy of research findings
Each human subject in an experiment should be adequately informed of the aims, methods, anticipated benefits, and hazards of the study. Informed consent should be obtained, and a statement of compliance with this code
Clinical research should allow the doctor to use new diagnostic or therapeutic measures if they offer benefit as compared to current methods
In any study, the patient and the control group should be assured of the best available methods. Refusal to participate should never interfere with the doctor–patient relationship. The well-being of the subject takes precedence over the interests of science or society

Website sources include: World Medical Association. Available at: http://www.wma.net/

United Nations. A Summary of United Nations Agreements on Human Rights. Available at: http://www.hrweb.org/legal/undocs.html (accessed 10.1.14).

US Food and Drug Administration. World Medical Association Declaration of Helsinki. Available at: http://www.fda.gov/ohrms/dockets/dockets/06d0331/06D-0331-EC20-Attach-1.pdf (accessed 10.1.14).

Source: Summarized from the Nuremberg Trials (1948) and World Medical Association, Declaration of Helsinki.