The History of the Informed Consent Requirement in United States Federal Policy

Abstract

The informed consent provision in United States federal policy serves a crucial function by protecting human subjects participating in medical research experiments. This paper will trace the development of informed consent as a legal doctrine. The paper will first consider numerous landmark cases, including those that established the basic consent requirement and those that extended the requirement to medical research. In addition to case law, the major scholarly publications and social incidents that spurred the American government to draft protective legislation will be examined. Finally, the paper will explore the numerous efforts by US policymakers to arrive at acceptable legislation. After taking an in-depth look at both two government agencies’ attempts to adequately define informed consent, the analysis will conclude with a discussion of the current rule regarding informed consent in medical research.