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, (2) Subpart A (3) ("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 "vulnerable" 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." (4) 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.
Oddly enough, and despite their acknowledged vulnerability as human research subjects, persons who are economically or educationally disadvantaged are not--as are children, prisoners, and pregnant women--accorded specific additional protections under 45 C.F.R. pt. 46. Nor have economically or educationally disadvantaged persons been the subject of additional and carefully crafted HHS guidance documents made available to investigators, research reviewers, and research sponsors. In essence, persons who are economically or educationally disadvantaged remain the invisible vulnerable. The lack of additional protection or specific guidance is troubling because of the history of pernicious abuse of economically and educationally disadvantaged persons as subjects of research, as well as the well-documented weaknesses in the current scheme of human subjects protection. More must be done by research sponsors, research reviewers, and investigators than the vague admonitions provided in 45 C.F.R. pt. 46 to protect persons who are economically or educationally disadvantaged in the context of clinical research. This article suggests the need for both a framework and a process to guide the consideration of involving persons who are economically or educationally disadvantaged as subjects in clinical research.
Protecting vulnerable subjects
The vulnerability of subjects of research is inextricably tied to the efficacy of their consent to participate in a given research protocol. A person's individual circumstances, together with the particulars of a specific research project--both of which may be continuously variable--may therefore at any given time render such person more or less vulnerable as a subject of research. This suggests that prior to and while any person serves as a subject of research, consent be individualized to take into account a person's circumstances with respect to the research project. Regardless of individualized vulnerability, some persons are grouped into categories considered especially vulnerable, and for some categories public policy requires additional protections. (5)
For example, persons who are incarcerated...
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