search funded by one of those other departments or agencies may voluntarily extend their protections to include those under the other subparts (including Subpart C), the OHRP estimates that only about 60 percent of institutions holding an FWA have done so.

Moreover, prisoner research that is funded by another department or agency (other than DHHS) falls outside of the protections of OHRP oversight even if the institution has requested in its FWA that Subpart C apply, because the OHRP does not monitor the institution’s compliance with a voluntary assurance regarding Subpart C. Additionally, an organization that does not receive its funding from any of these sources generally will not hold an FWA and would not be required to comply with the Common Rule or any of the subparts.26

In evaluating the effectiveness of Subpart C, it is useful to compare other human research subjects protections to these regulations. In particular, Subpart D contains DHHS’s regulations regarding children, and provides a different framework for assessing the risks and benefits (and according appropriate protections). Within the DHHS, the FDA has promulgated additional human subjects protections regarding research conducted on drugs and medical devices (but has not succeeded in attempting to regulate such research in the prison context). In contrast, the BOP has established a set of regulations regarding all research conducted with the prisoners in its custody.

Subpart D

Recall that there are four categories of permissible research established in Subpart C: (1) study of the possible causes, effects, and processes of incarceration (presenting no more than minimal risk); (2) study of prisons as institutional structures or of prisoners as incarcerated persons (presenting no more than minimal risk); (3) research on conditions particularly affecting prisoners as a class (after consultation with experts and notice in the Federal Register); and (4) research on practices, both innovative and accepted, that have the intent and reasonable probability of improving the health or well-being of the subjects, when there is a control group that is nontherapeutic, after consultation with experts and notice in the Federal Register.27 If biomedical or behavioral research does not fall into one of these categories as described, it is not permitted.28

Subpart D, although similar in some ways to Subpart C, takes a different approach to the definition of categories of permissible research involv-

26

See Figure 3-1. However, various human subjects protections may still apply, independently of the funding source, as discussed in more detail below. See Table 3-3.

27

45 C.F.R. § 46.306(a)(2).

28

45 C.F.R. § 46.306(b).



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