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More on Reform of Clinical Research Regulations

MeSci

MeSci

ME/CFS since 1995; activity level 6?
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8,231
Location
Cornwall, UK
From NEJM again:
Perspective

Reform of Clinical Research Regulations, Finally
Ezekiel J. Emanuel, M.D., Ph.D.

November 4, 2015

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
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