The current ethical framework for the conduct of human subjects research dates back to the 1940s. Below are important milestones that influence ethical conduct in human subjects research. For additional information regarding each topic, click on the title.
Modern human subjects protections begin with the Nuremberg Code. The Code (1949) was was developed following the Nuremberg Military Tribunal as a standard by which to judge human experimentation conducted by the Nazis. It addresses many of the basic principles governing the ethical conduct of human subjects research, including the voluntary consent of human subjects.
The World Medical Association adopted the Declaration of Helsinki (1964) as guidance for medical doctors undertaking biomedical research involving human subjects. The Declaration has been continuously revised (most recently in 2008). It addresses important issues including the principle of risk to benefit ratio in research, human studies based on laboratory and animal studies, review of research by independent committees and informed consent.
Additionally, the US Congress commissioned the Belmont Report (1979) in response to public outrage over the Tuskegee syphilis study conducted by the US Public Health Service. The report addresses the three ethical principles of respect for persons, beneficence and justice.
In addition to complying with the federal regulations governing human subjects, researchers should also follow codes of ethics and regulations within their profession and area of research.
