The amendments also required the informed consent of participants in the testing of investigational drugs, although permissible exemptions applied, and they emphasized the need for investigators to control the drug supply. The amendments are best known for requiring FDA to evaluate new drugs for efficacy in addition to safety (P.L. In 1962, Congress passed the Kefauver-Harris amendments to the Federal Food, Drug, and Cosmetic Act. policy makers were concerned about intruding into the doctor-patient relationship, and until national attention focused on some research scandals in the 1960s, specific human protections in that context seemed unnecessary. Some believed that the Nuremberg Code was meant to apply only to research with healthy individuals and not to research with patients as participants. However, widespread adoption of ethical principles in the conduct of human studies was slow to develop. In 1954, these dual protections of independent review and written informed consent were extended to all NIH intramural research involving “normal volunteers.” Also in 1953, the National Institutes of Health (NIH) Clinical Center established a policy requiring independent review of research and participants' written consent, at least for research involving patient volunteers and/or “unusual hazard” (NIH, 1953). Wilson's policy included a prohibition on research involving prisoners of war and a requirement that the secretary of the appropriate military service approve human research studies. In 1953, Department of Defense Secretary Charles Wilson issued a directive outlining a policy for human research related to atomic, biological, and chemical warfare (Wilson, 1953). According to the code, investigators alone are responsible for obtaining informed consent and deciding whether their research is in accord with the ethical principles.įollowing the issuance of the Nuremberg Code, several federal agencies began establishing policies for human research. The first principle of the Nuremberg Code states that, “the voluntary consent of the human subject is absolutely essential.” This absolute requirement reflects the code's origins in discussions about research with healthy individuals, particularly those who had no opportunity to refuse. 2 In 1946, the American Medical Association adopted its first code of research ethics (AMA, 1946), which ultimately influenced the Nuremberg Tribunal's standards for ethical research (Moreno, 1999), embodied in the ten “basic principles” for human research, now known as the Nuremberg Code. Public policies regarding the ethical treatment of humans in research began forming in the late 1940s, largely in response to atrocities committed by Nazi investigators who were tried before the Nuremberg Military Tribunal ( United States v. HISTORY OF THE DEVELOPMENT OF FEDERAL REGULATIONS Were EPA to include such studies in its oversight system, it would be useful to consider how those regulations might apply. ![]() Of note, EPA previously has not applied the Common Rule protections to privately sponsored (third-party) studies of regulated substances. In considering the appropriate oversight of third-party human research conducted for Environmental Protection Agency (EPA) regulatory purposes, it is useful to understand the development of the system of protections to which EPA must adhere under the Common Rule, as well as the practices of other federal agencies in this regard, as lessons learned from the past and in other research contexts can inform the development and improvement of EPA regulatory policy for third-party studies. ![]() Such assurances cover all of the institution's research involving humans that is conducted or supported by one of the federal departments or agencies that have adopted the Federal Policy. Many institutions hold assurances of compliance to the Common Rule, which are negotiated with the federal government. This system of protections, however, applies only to research that is conducted or funded by an agency that is subject to the Common Rule or that is subject to Food and Drug Administration (FDA) review and approval. Eighteen federal agencies and departments adhere to the Federal Policy for the Protection of Human Subjects, or the Common Rule (45 CFR 46), 1 which is a set of identical regulations codified by each agency. government has established a system of protections for research participants.
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