United States Federal Regulations The Common Rule

While the principles described in the Belmont Report provide a basis for ethically conducting human subjects research, the report has been variably interpreted and used (High, D., 1992). Nevertheless, the Belmont Report became the basis for the Code of Federal Regulations Title 45 Part 46 (''Protection of Human Subjects'') issued in 1981 by what is now known as the Department of Health and Human Services (DHHS). Since then, these regulations have undergone a number of modifications. Most, but not all, federal agencies that sponsor and fund research involving human subjects have formally adopted these regulations as the Federal Policy for the Protection of Human Subjects or ''Common Rule'' (45 CFR 46) (Department of Health and Human Services). The Common Rule articulates requirements for compliance by institutions involved in research, informed consent, and for IRB membership and responsibilities. The Common Rule also articulates measures for protecting especially vulnerable research subjects (e.g., children and prisoners).

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