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The Invisible Vulnerable: The Economically and Educationally Disadvantaged Subjects of Clinical Research

Published online by Cambridge University Press:  01 January 2021

T. Howard Stone
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U.S. Department of Health and Human Services (HHS) federal regulations pertaining to the protection of human subjects at Title 45 of the Code of Federal Regulations, Part 46, Subpart A (“the Common Rule”), refer to the need for special precautions when persons characterized as vulnerable are used as human research subjects. Under the Common Rule, persons considered “vulnerablae” are those who are likely to be susceptible to coercive or undue influence; the term “vulnerable” includes “children, prisoners, pregnant women, mentally disabled persons,” or those who are “economically or educationally disadvantaged.” The need for special precautions with some of these vulnerable persons in the context of research has long been addressed by both mandatory additional protections found in Subparts B through D of 45 C.F.R. pt. 46 (that are not, coincidentally, part of the Common Rule) and additional detailed guidance documents provided by HHS or its components to investigators and their respective institutions.

Type
Currents in Contemporary Ethics
Information
Journal of Law, Medicine & Ethics , Volume 31 , Issue 1 , Spring 2003 , pp. 149 - 153
Copyright
Copyright © American Society of Law, Medicine and Ethics 2003

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References

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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>..' href=https://scholar.google.com/scholar?q=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+.>Google Scholar
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