Country Report USA

Abstract

For practical purposes, the history of protection of human research subjects in the United States begins with the Nuremberg Trial and Code.¹ Though the trial, of course, addressed NAZI experiments during the Second World War, the prosecutors and the primary ethical witness at the trial (Dr. Andrew C. Ivy) were Americans, and the code they attempted to articulate drew heavily on American ideals.² In the two decades following Nuremberg there was a growing awareness in the United States of the ethical challenges posed by human subjects research. Though the United States was largely spared the ravages of the Thalidomide Tragedy, publicity attending the disaster led to 1962 amendments to the Food, Drug and Cosmetic Act requiring informed consent from research subjects for testing of investigational drugs.³ Disclosure of several research scandals, including one in which indigent elderly patients had been injected with live cancer cells in the Brooklyn Jewish Chronic Disease hospital, led to the creation of a Public Health Service Policy in 1966 that became the forerunner of federal human subject protection regulation.⁴