Currents in Contemporary Ethics

45 C.F.R. § 46.111(b) (2003) (emphasis added).

45 C.F.R. §§ 46 et seq. (2003).

Subpart A is described as the “Common Rule,” due to the regulation's adoption by a number of federal agencies other than HHS. Id.

Id. § 46.111(b) (2003). Some commentators have criticized the categorization of persons into different vulnerable groups, and have instead urged that in place of such categorization, investigators and institutional review boards take steps to recognize—as well as to avoid — situations in which a person's vulnerability to harm or coercion is created. See National Bioethics Advisory Commission, Report and Recommendations of the National Bioethics Advisory Commission, vol. 1 of Ethical and Policy Issues in Research Involving Human Participants (2001), available at <http://www.georgetown.edu/research/nrcbl/nbac/human/overvoll.pdf>.

45 C.F.R. § 46.111(a)(3) (2003) (including, in the list of vulnerable populations, children, prisoners, pregnant women, mentally disabled persons, and economically or educationally disadvantaged persons). For purposes of this article, mentally disabled persons as a vulnerable group are not addressed, although the absence of additional protections under 45 C.F.R. pt. 46 or through HHS guidance documents with respect to mentally disabled persons is no less problematic. We address economically or educationally disadvantaged persons in part because of the increasing marginalization in society of these persons. See, e.g., Proctor B. D. Dalaker J. , U.S. Census Bureau, Poverty in the United States: 2001, Current Population Reports, Pub. No. P60–219 (2002), available at <http://www.census.gov/prod/2002pubs/p60-219.pdf>; Office of Minority Health, U.S. Department of Health and Human Services, Good Health for All: Eliminating Racial and Ethnic Disparities in Health (2002).

45 C.F.R. § 46.302 (2003). In fact, under 45 C.F.R. §§ 46.301 et seq., research involving prisoners is strictly limited to certain rypes of research, generally research related to prisoners or to prisons. 45 C.F.R. § 46.306(a)(2)(A)-(D) (2003).

45 C.F.R. § 46.302 (2003).

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979): At 7, available at <http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm>; 45 C.F.R. §§ 46 et seq. (2003).

45 C.F.R. §§46.301 et seq. (2003).

Id. As one example, an IRB must find, in part, that “any possible advantage accruing to the prisoner through his or her participation in the research, when compared to the … opportunity for earnings in the prison, are not of such magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired.” 45 C.F.R. § 46.305(a)(2) (2003). As another example, an IRB must include a “prisoner” or a “prisoner representative” as a member of the IRB when reviewing a research project involving a prisoner as a human subject. 45 C.F.R. § 46.304(b) (2003).

Office for Protection from Research Risks, U.S. Department of Health and Human Services, Protecting Human Research Subjects: Institutional Review Board Guidebook (1993), available at <http://ohrp.osophs.dhhs.gov/irb/irb_guidebook.htm> [hereinafter cited as OPRR 1993]; Office for Protection from Research Risks, U.S. Department of Health and Human Services, OPRR Guidance on Approving Research Involving Prisoners (May 19, 2000), available at <http://ohrp.osophs.dhhs.gov/humansubjects/guidance/prison.htm> [hereinafter cited as OPRR 2000]. To illustrate, OPRR's May 2000 guidance letter, unlike Subpart C, describes the types of persons who may serve as a “prisoner representative,” as that term is used in Subpart C; these include former prisoners, prison chaplains, prison social workers, persons who have conducted advocacy for the rights of prisoners, or any individual who is qualified to represent the rights and welfare of prisoners by virtue of appropriate background and experience. See OPRR 2000 at Section C.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, supra note 8; 45 C.F.R. § 46.402(a) (2003).

45 C.F.R. §§ 46.401 et seq. (2003).

OPRR 1993, supra note 11; National Institutes of Health, U.S. Department of Justice, NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects, NIH Notice 98–024 (March 6, 1998), available at <http://grants.nih.gov/grants/guide/notice-files/not98-024.html>.

45 C.F.R. § 46.303(c) (2003).

45 C.F.R. § 46.402(a) (2003).

45 C.F.R. § 46.111(a)(3) (2003).

45 C.F.R. § 46.111(b) (2003).

45 C.F.R. § 46.111(a)(3) (2003).

45 C.F.R. § 46.111(b) (2003).

See, e.g., Grossman S.A. Piantadosi S. Covahey C. , “Are Informed Consent Forms that Describe Clinical Oncology Research Protocols Readable by Most Patients and Their Families?,” Journal of Clinical Oncology, 12 (1994): 2211–15; Handelsman M.M. , “Can Informed Consent to Psychotherapy be Legally Mandated? The Colorado Experience,” Ethics & Behavior, 5 (1995): 119–29. However, there is scant literature exploring the connection between the readability of consent documents used in clinical research and functional literacy skills or educational attainment, particularly among persons who are educationally disadvantaged.

Tuskegee Syphilis Study Ad Hoc Advisory Panel, U.S. Department of Health Education and Welfare, Final Report of the Tuskegee Syphilis Study Ad Hoc Advisory Panel (1973); Heller J. , “Syphilis Victims in U.S. Study Went Untreated for 40 Years,” New York Times, July 26, 1972, at 1, 8.

Auerbach S. , “Pentagon Has Contract to Test Radiation Effect on Humans,” Washington Post, October 8, 1971, at A1, A17; In re Cincinnati Radiation Litigation, 874 F. Supp. 796 (S.D. Ohio 1995), 187 F.R.D. 549 (S.D. Ohio 1999) (class certification granted); “OH Judge Gives Final OK to $3.5 Million Radiation Exposure Class Settlement,” Toxic Chemicals Litigation Reporter, 17 (June 7, 1999): § 1:10.

45 C.F.R. § 46.305(a)(2) (2003).

National Bioethics Advisory Commission, supra note 4, at 90. Additional undue inducement might be caused by offering economically disadvantaged persons free health care that is otherwise not related to the condition under study. Id.

Id. at 5; Marwick C. , “Protecting Subjects of Clinical Research,” JAMA, 282, no. 6 (1999): 516–17; Sengupta S. , “Factors Affecting African-American Participation in AIDS Research,” Journal of Acquired Immune Deficiency Syndrome, 24 (2000): 275–84.

45 C.F.R. § 46.305(a)(2) (2003).

Of course, the lack of such a requirement under the Common Rule should not prevent IRBs from considering this issue, and some do.

Office of the Inspector General, U.S. Department of Health and Human Services, Institutional Review Boards: A Time for Reform, Pub. No. OEI-01-97-00193 (1998): At ii.

Id. at 8.

Bell J. Whiton J. Connelly S. , Final Report: Evaluation of NIH Implementation of Section 491 of the Public Health Service Act, Mandating a Program of Protection for Research Subjects, prepared for the Office of Extramural Research (1998): At 46.

Alternatively, two new subparts might be developed and implemented, one for economically disadvantaged persons, and another for educationally disadvantaged persons.

This determination is similar to what is already required of IRBs with regards to the review of research involving prisoners. 45 C.F.R. § 46.305(a)(2) (2003).