II. A Brief History of Research Ethics Violations and Regulation

While the Nuremberg Code was an important development in regulating ethical research, it clearly was not enough to prevent tragedies like Tuskegee.

The Helsinki Declaration was another key historical moment in regulating research on human beings. It was developed by the World Medical Association in 1964 in Helsinki, Finland as an elaboration of Nuremburg Code, with a focus on biomedical research.

One of the key differences between the Helsinki Declaration and the Nuremberg Code was that Helsinki allowed for proxy consent from individuals who were unable to give informed consent to research (such as children and the mentally disabled).

Another key development was the 1975 revision of the Helsinki Declaration, which introduced the concept of independent oversight committees to review the ethics of research. In Australia these are "Human Research Ethics Committees" (HRECs).

The Helsinki Declaration has been formally revised 5 times between 1964 and 2000. The most recent revision takes into account debates over differing standards applied to research conducted in wealthy and less developed countries.

p11The Declaration of Helsinki on the World Medical Association website.