protect human subjects. It required prospective review of human subjects research, focusing on the rights of potential participants by balancing risks and benefits while ensuring appropriate informed consent procedures (Public Health Service [PHS], 1966).

These NIH policies, which initially applied only to extramural research, were later raised to regulatory standards for the entire Department of Health, Education, and Welfare (DHEW) in 1974. These regulations were later modified in 1981 and codified as Title 45 Part 46 of the Code of Federal Regulations. Revisions have occurred several times since then; the most recent changes took effect in 1991 with the development of the Federal Policy for the Protection of Human Subjects, also known as the Common Rule.

The Common Rule

The Common Rule is incorporated as Subpart A of 45 C.F.R. Part 46, the basic DHHS regulations for the protection of human research subjects. The regulatory framework outlined in the Common Rule applies to 17 federal agencies that are involved in conducting or funding human subjects research.2 The Common Rule provides guidelines on conducting certain types of research with human subjects. Specifically, it discusses issues such as review by institutional review boards (IRBs), informed consent, balancing risks and benefits, protecting privacy, and additional requirements for approval. Failure to adhere to these regulations can result in sanctions. Agency or department support of the research can be suspended or terminated, or additional conditions can be imposed on the individual project or on the research organization or institution.

Human subjects are defined as persons about whom a research investigator obtains either (1) identifiable private information or (2) data as a result of an intervention or interaction with the person.3 The Common Rule defines research as any “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”4

The Common Rule also identifies certain categories of research that are exempt. Notably, these exemption categories cannot be applied to any research involving prisoners; therefore, both the general protections (Subpart A) and the heightened protections (Subpart C) provided under 45 C.F.R. Part 46 still apply.5

2

See Figure 3-1. The FDA adopted a modified version of the Common Rule applicable to research involving all products it regulates.

3

45 C.F.R. § 46.102(f).

4

45 C.F.R. § 46.102(d).

5

45 C.F.R. § 46.101(i), n.1.



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