The Nuremburg Code, established in 1948, was developed from the Trials of War Criminals before the Nuremberg Military Tribunals. It defines ethical behavior in the conduct of research using human subjects. Its development grew from the atrocities in human research conducted in Nazi Germany. The Nuremberg Code was the first international document that advocated voluntary participation and informed consent.
Declaration of Helsinki
In 1964, the World Medical Association (WMA) developed the as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving humans subjects, including research on identifiable human material and data. The code of ethics has been widely adopted by medical associations in various countries. It is regularly revised and amended by the WMA, most recently in October 2013, and is the basis for Good Clinical Practices used today.
National Research Act
The National Research Act was passed by Congress in 1974 after the unethical U.S. Public Health Service Syphilis Study at Tuskegee ended. The Act established the existence of IRBs to review biomedical and behavioral research involving human subjects. It also created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission was tasked in identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects, and developing guidelines to assure that such research is conducted in accordance with those principles.
The Commission published The Belmont Report in 1978, which sets forth basic ethical principles for the conduct of research involving human subjects. Those principles, respect for persons, beneficence, and justice, have been formally adopted by Northwestern University through its , for all research at Northwestern involving human subjects. The Belmont Report is the foundation of the U.S. human subjects regulatory system.