The Significance of the Nuremberg Code
by Vera Sherav
Alliance for Human Research Protection
The universal right of Informed Consent to medical interventions has been recognized in US law since at least 1914.
That year, the New York Court of Appeals established the right to informed consent to medical intervention in a case involving non-consensual surgery. Schloendorff v. Society of New York Hospital 105 N.E. 92, 93 N.Y. (1914)
Justice Benjamin Cardozo articulated the court’s reasoning:
“Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages.”
The 1947 Nuremberg Code is the most important legal document in the history of medical research ethics.
It established 10 foundational principles of ethical clinical research.
The first and foremost principle is unequivocal: “The voluntary consent of the human subject is absolutely essential”.
It prohibits research to be conducted on human beings without the informed consent of the individual.
The significance of the Nuremberg Code is as follows:
The Nuremberg Code was formulated by prominent US government jurists in consultation with prominent US medical consultants.
- It had the multilateral agreement of the governments of the US, USSR, France and the UK;
- The Nuremberg Code extended human rights beyond the borders of individual countries;
- The right of Informed Consent is recognized in time of peace and in time of war.
- The Nuremberg Code provides legal justification to litigate violations of informed consent.
- Under the Nuremberg Code, responsibility for violations of informed consent rests upon individual doctors, government officials – and their aiders and abettors – each of who can be prosecuted for crimes against humanity.
Public disclosure of the U. S. government Tuskegee Syphilis experiment (1932-1972)
In the wake of public disclosure of the U. S. government Tuskegee Syphilis experiment (1932-1972), the government convened the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission issued The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979).
The Belmont Report acknowledges at the outset that the Nuremberg Code “became the prototype of many later codes intended to assure that research involving human subjects would be carried out in an ethical manner.”
However, federal regulations only apply to government-sponsored human research and, unlike the Nuremberg Code these regulations have been “modified” in response to political pressure.
For example, 45 CFR 46.408(c) waives parental consent for the use of children as human subjects. “This waiver is usually but not always limited to minimal risk research…”