Vulnerability as a Regulatory Category in Human Subject Research

For differing approaches to these questions, see, e.g., Hurst S. A. , “Vulnerability in Research and Health Care: Describing the Elephant in the Room?” Bioethics 22, no. 4 (2008): 191–202; Vladeck B. C. , “How Useful Is ‘Vulnerable’ as a Concept?” Health Affairs 26, no. 5 (2007): 1231–1234, Leavitt F. J. , “Is Any Research Population Not Vulnerable?” Cambridge Quarterly of Healthcare Ethics 15, no. 7 (2006): 81–88; Levine C. , “The Limitations of ‘Vulnerability’ as a Protection for Human Research Participants,” American Journal of Bioethics 4, no. 3 (2004): 44–49; Kipnis K. , “Vulnerability in Research Subjects: A Bioethical Taxonomy,” Ethical and Policy Issues in Research Involving Human Participants, Vol. II, 2001, at G1–G13.

45 CFR 46.107(a).

45 CFR 46.111(a)(4).

45 CFR 46.111(b).

45 CFR 46.107(a).

45 CFR 46.111(a)(4) and (b).

45 CFR 46.111(a)(4).

45 CFR 46.201 (subpart b), 45 CFR 46.301 (subpart c), 45 CFR 46.401 (subpart d), respectively.

National Bioethics Advisory Committee (NBAC), “Federal Agency Survey on Policies and Procedures for the Protection of Human Subjects in Research,” Ethical and Policy Issues in Research Involving Human Participants, Vol. II: Commissioned Papers and Staff Analysis, Bethesda, Maryland, 2001, at J-14.

World Medical Association, Declaration of Helsinki, WMA General Assembly, 1964, as amended through 2004, at A(8).

Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva, 2002, at Guideline 13, commentary.

International Conference on Harmonisation (ICH) Harmonized Tripartite Guideline, Guideline for Good Clinical Practice, 1996, at 1.16.

National Bioethics Advisory Commission (NBAC), “Assessing Risks and Potential Benefits and Evaluating Vulnerability,” Ethical and Policy Issues in Research Involving Human Participants, Vol. I: Reports and Recommendations, Bethesda, Maryland, 2001, at 87.

Id., at 88.

Id., at 89.

See NBAC, supra note 17, at 85.

See supra note 6.

See Levine , supra note 1.

See Hurst , supra note 1.

The justice-based dimensions of vulnerability were explicitly recognized in the Belmont Report. See The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report, 1979.

For an attempt at such a justification in connection with decisionally impaired adults, see Coleman C. H. , “Research with Decisionally Incapacitated Human Subjects: An Argument for a Systemic Approach to Risk-Benefit Assessment,” Indiana Law Journal 83, no. 3 (2008): 743–789. For proposed justifications for research with children, see, e.g., Coleman D. L. , “The Legal Ethics of Pediatric Research,” Duke Law Journal 57, no. 3 (2007): 517–624, and Litton P. , “Non-Beneficial Pediatric Research and the Best Interests Standard: A Legal and Ethical Reconciliation,” Yale Journal of Health Policy, Law and Ethics 8 (2008): 359–420.

See CIOMS, supra note 12; NBAC “Guidelines,” supra note 17, respectively.

Cf. Denny C.C. Grady C. , “Clinical Research with Economically Disadvantaged Populations,” Journal of Medical Ethics 33, no. 7 (2007): 382–385.

See Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries, “Moral Standards for Research in Developing Countries: From ‘Reasonable Availability’ to ‘Fair Benefits’,” Hastings Center Report 34, no. 3 (2004): 17–27; Arras J. , “Fair Benefits in International Medical Research,” Hastings Center Report 34, no. 3 (2004): 3; Gbadegesin S. Wendler D. , “Protecting Communities in Health Research from Exploitation,” Bioethics 20, no. 5 (2006): 248–253.

The “mutually advantageous exploitation” model is critiqued by Ballantyne A. , “Fair Benefits Accounts of Exploitation Require a Normative Principle of Fairness: Response to Gbadegesin and Wendler, and Emanuel et al.,” Bioethics 22, no. 4 (2008): 239–244.

London A. J. Kimmelman J. , “Justice in Translation: From Bench to Bedside in the Developing World,” The Lancet 372, no. 9632 (2008): 82–85.

Macklin R. , “Bioethics, Vulnerability, and Protection,” Bioethics 17, nos. 5–6 (2003): 472–486, at 480.

For an example of how persons who initially appear to lack decision-making capacity can be rendered capable through education, see Stephenson J. , “Probing Informed Consent in Schizophrenia Research,” JAMA 281, no. 24 (1999): 2273–2274.

See NBAC, supra note 17, at 92.