. "2 The Regulatory Framework for Protecting Humans in Research." Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues. Washington, DC: The National Academies Press, 2004.
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Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues
and improvement of EPA regulatory policy for third-party studies. Of note, EPA previously has not applied the Common Rule protections to privately sponsored (third-party) studies of regulated substances. Were EPA to include such studies in its oversight system, it would be useful to consider how those regulations might apply.
HISTORY OF THE DEVELOPMENT OF FEDERAL REGULATIONS
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. Karl Brandt et al.).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.
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. According to the code, investigators alone are responsible for obtaining informed consent and deciding whether their research is in accord with the ethical principles.
Following the issuance of the Nuremberg Code, several federal agencies began establishing policies for human research. 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). 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. 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). In 1954, these dual protections of independent review and written informed consent were extended to all NIH intramural research involving “normal volunteers.”
However, widespread adoption of ethical principles in the conduct of human studies was slow to develop. Some believed that the Nuremberg
The “Medical Case,” United States v. Karl Brandt et al.