Human subject research legislation in the United States

Human subject research legislation in the United States can be traced to the early 20th century. Human subject research in the United States was mostly unregulated until the 20th century, as it was throughout the world, until the establishment of various governmental and professional regulations and codes of ethics. Notable – and in some cases, notorious – human subject experiments performed in the US include the Tuskegee syphilis experiment, human radiation experiments, the Milgram obedience experiment and Stanford prison experiments and Project MKULTRA. With growing public awareness of such experimentation, and the evolution of professional ethical standards, such research became regulated by various legislation, most notably, those that introduced and then empowered the institutional review boards.

Aside from the Pure Food and Drug Act of 1906 and the Harrison Act of 1914 banning the sale of some narcotic drugs, there was no federal regulatory control ensuring the safety of new drugs. Thus the early calls for regulation of human experimentation concerned medicine, and in particular, testing of new pharmaceutical drugs and their release on the market.

In 1937, a drug known as Elixir Sulfanilamide was released without any clinical trials. Reports in the press about potentially lethal side effects led to a public outcry. Investigation by the American Medical Association showed that a poisonous compound, diethylene glycol, was present in the drug. The AMA concluded that the drug caused more than a hundred deaths – yet the contemporary law did not require the company that released it to test it (the existing laws required only that a drug be clearly labeled, no false claims be made about it, and that it was not adulterated). A new legislation was proposed by the Secretary of Agriculture to address the issue but was weakened after opposition from business interests. It was finally included in the Federal Food, Drug, and Cosmetic Act of 1938.

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