Bureau of Justice Statistics, U.S. Department of Justice, Bulletin: Prison and Jail Inmates at Midyear 2003 (NCJ 203947) (Washington, D.C.: Government Printing office, 2004).Google Scholar

National Commission For The Protection Of Human Subjects Of Biomedical And Behavioral Research (“National Commission”), The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Washington, D.C.: U.S. Government Printing Office, 1979) (“Belmont Report”); National Commission, Report and Recommendations: Research Involving Prisoners (Washington, D.C.: U.S. Government Printing Office, 1976).Google Scholar

45 Code of Federal Regulations §46.302 (2003).Google Scholar

45 CFR §46.306(a)(2)(A).Google Scholar

45 CFR §46.306(a)(2)(B).Google Scholar

45 CFR §46.306(a)(2)(A), (B).Google Scholar

National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants (Bethesda, Maryland: National Bioethics Advisory Commission, 2001): at 69–96; National Human Research Protections Advisory Committee, Report: Clarifying Specific Portion of 45 CFR 46 Subpart D that Governs Children’s Research (Bethesda, Maryland: National Human Research Protections Advisory Committee, 2003): at 1–4.Google Scholar

45 CFR §§46.101–124 (2003).Google Scholar

45 CFR §§46.301–306 (2003).CrossRefGoogle Scholar

45 CFR §46.306(a)(2)(A).Google Scholar

45 CFR §46.306(a)(2)(B).Google Scholar

45 CFR §46.306(a)(2)(A),(B). Note that the other two categories of permitted research involving prisoners as human subjects, “research on conditions particularly affecting prisoners as a class…” [45 CFR 46.306(a)(2)(C)] and “research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject” [45 CFR 46.306(a)(2)(D)], are not limited to minimal risk studies.Google Scholar

45 CFR §46.303(d).Google Scholar

43 FR 53655 (1978); 56 FR 28003 (1991). The 1991 revision has no relevance to the discussion of minimal risk.Google Scholar

45 CFR §46.102(i). The Subpart A definition of minimal risk is identical to that used in regulations of the Food and Drug Administration that pertain to, respectively, the protection of human subjects, and institutional review boards. 21 CFR §50.3(k); 21 CFR §56.102(i).Google Scholar

National Commission, supra note 2, at page 7.Google Scholar

Office for Protection from Research Risks (“OPRR”), Protecting Human Research Subjects: Institutional Review Board Guidebook (Washington, D.C.: U.S. Government Printing Office, 1993): 3–3 to 3–5.Google Scholar

Id., at 6–33; Office for Human Research Protections, OHRP Guidance on the Involvement of Prisoners in Research (Rockville, Maryland: Office for Human Research Protections, U.S. Department of Health and Human Services, May 23, 2003).Google Scholar

National Commission, Supra note 2: at 7 (describing “probability” and “magnitude”); see also Prentice, E. D. and Gordon, B. G., Institutional Review Board Assessment of Risks and Benefits Associated with Research, in National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants (Vol. II: Commissioned Papers) (Bethesda, Maryland: National Bioethics Advisory Commission, 2001), at L-7.Google Scholar

The Belmont Report further states that “[w]hile the most likely types of harms to research subjects are those of psychological or physical pain or injury, other possible kinds should not be overlooked.” Belmont Report, supra note 2: at 7. The OPRR has described the risks to which subjects may be exposed as “physical, psychological, social and economic.” OPRR, supra note 17: at 3–3 to 3–5; see also Levine, R. J., Ethics and Regulation of Clinical Research (2d ed.) (New Haven, Connecticut: Yale University Press, 1998): 42–51 (describing the same taxonomy of risks).Google Scholar

Of course, these other risks are still subject to other 45 CFR 46 provisions, including that these other risks be “commensurate with risks that would be accepted by nonprisoner volunteers” (45 CFR §46.305(a)(3), and that, importantly, “risks to subjects are minimized….” (45 CFR §46.111(a)(1)).Google Scholar

Id. (emphasis added).Google Scholar

63 FR 60364 (1998).Google Scholar