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Clinical Research Ethics in Vulnerable Populations

AHLA Connections

October 2013

People in vulnerable populations, which often include diverse communities, have found themselves subject to inappropriate research over the decades. Several reports both internationally and domestically address research atrocities.[1] The Nuremberg Code[2] addresses research on World War II prisoners who could not consent to the research. In the United States the Tuskegee Experiment described herein exemplifies lack of protection of research subjects. The Belmont Report later codified as the Common Rule provides further guidance and regulatory protection to research subjects in the United States. This article reviews the fundamentals of clinical research ethics in the context of vulnerable populations, including existing protections for human research subjects and implications of the proposed revisions to the Common Rule.

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[1] Nuremberg Code, Nuremberg Military Tribunal decision in United States v. Brandt, 1947; Declaration of Helsinki, World Medical Association, 1964, 1975, 1983, 1989, 1996; International Ethical Guidelines for Biomedical Research involving Human Subjects, Council for International Organizations of Medical Sciences in collaboration with World Health Organization, proposed in 1982, revised 1993.

[2] Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181-182. Washington, D.C.: U.S. Government Printing Office, 1949.

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