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Vulnerability as a Regulatory Category in Human Subject Research

Published online by Cambridge University Press:  01 January 2021

Extract

The concept of vulnerability has long played a central role in discussions of research ethics. In addition to its rhetorical use, vulnerability has become a term of art in U.S. and international research regulations and guidelines, many of which contain specific provisions applicable to research with vulnerable subjects. Yet, despite the frequency with which the term vulnerability is used, little consensus exists on what it actually means in the context of human subject protection or, more importantly, on how a finding of vulnerability should affect the process of research ethics review.

The Common Rule, the centerpiece of the U.S. human subject protection regulations, uses the word vulnerable three times. First, it provides that institutional review boards (IRBs) that regularly review research involving a vulnerable category of subjects should consider including one or more individuals who are knowledgeable about and experienced in working with these subjects.

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Symposium
Copyright
Copyright © American Society of Law, Medicine and Ethics 2009

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References

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): 191202; 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.CrossRefGoogle Scholar
45 CFR 46.107(a).Google Scholar
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45 CFR 46.201 (subpart b), 45 CFR 46.301 (subpart c), 45 CFR 46.401 (subpart d), respectively.Google Scholar
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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.Google Scholar
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): 743789. 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.Google Scholar
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Cf. Denny, C.C. Grady, C., “Clinical Research with Economically Disadvantaged Populations,” Journal of Medical Ethics 33, no. 7 (2007): 382385.CrossRefGoogle Scholar
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): 1727; 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.Google Scholar
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): 239244.CrossRefGoogle Scholar
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Macklin, R., “Bioethics, Vulnerability, and Protection,” Bioethics 17, nos. 5–6 (2003): 472486, at 480.CrossRefGoogle Scholar
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): 22732274.CrossRefGoogle Scholar
See NBAC, supra note 17, at 92.Google Scholar
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