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ResourcesHuman Research EthicsReform of Clinical Research Regulations, Finally (PAPERS: E. J. Emanuel, M.D. 2015)

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Reform of Clinical Research Regulations, Finally (PAPERS: E. J. Emanuel, M.D. 2015)

 


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“In 1972, Jean Heller of the Associated Press reported on a 40-year-old research study that had followed black Alabama sharecroppers, some of whom had syphilis. The revelation of deception, withholding of appropriate treatment, and other unethical practices exploded into the Tuskegee scandal. Tuskegee led to the National Research Act of 1974, which authorized the Department of Health, Education, and Welfare (now the Department of Health and Human Services [HHS]) to augment government policies for protecting human research subjects.1 The protections, ultimately codified as 45 Code of Federal Regulations 46 (45 CFR 46), specify requirements for valid institutional review board (IRB) assessment of most human-subjects research and informed consent by research participants.2

In the decade after 1974, specific safeguards were added for pregnant women, fetuses, neonates, children, and prisoners. For instance, research involving prisoners, such as commonly conducted early-phase drug studies, was severely restricted; only research on “possible causes, effects, and processes of incarceration, and of criminal behavior, prisoners as incarcerated persons, [and] . . . conditions particularly affecting prisoners as a class” was permitted. In 1991, many other (though not all) federal departments and agencies adopted the main part of 45 CFR 46 for their human-subjects research, which became known as the Common Rule.”

Emanuel, E. J. (2015). Reform of Clinical Research Regulations, Finally. New England Journal of Medicine.
Retrieved from http://www.nejm.org/doi/full/10.1056/NEJMp1512463



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