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10/12/2015

Human Subjects Research “Vulnerability”

by J.S. Blumenthal-Barby, Ph.D., MA

Revisions are being suggested to the Federal Policy for the Protection of Human Subjects through the Notice of Proposed Rulemaking (NPRM). The changes being suggested are numerous (helpful summaries can be found here http://blogs.law.harvard.edu/billofhealth/2015/10/01/nprm-symposium-more-resources-now-from-ohrp/ and here http://blogs.law.harvard.edu/billofhealth/2015/09/30/nprm-symposium-resources-from-primr/). My aim is not to review those changes, but to point out a curious conceptualization of vulnerability affirmed in the NPRM.

Consider the following section (regarding conditions for IRB approval) of the original regulations:

46.111(b) – When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

In the NPRM, this section is proposed to stay the same, and another section is being modified slightly to be consistent with it (suggested modifications to that section are bold italicized):

Section__.107 IRB membership.

(a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of its members, including race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments (including policies and resources) and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a category of subjects that is vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, or physically or mentally disabled persons, or economically or educationally disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these categories of subjects.

Thus what is being affirmed in the NPRM are a.) the categories of “vulnerable” populations—including the new category of physically disabled persons, and b.) “vulnerability” being conceptualized in terms of vulnerability to coercion or undue influence.

Problem 1: Why are pregnant women and physically disabled persons especially vulnerable to coercion or undue influence? This type of vulnerability is conceivable for the other categories where there are potential inherent or situational impairments in autonomy that might leave the persons more at risk for coercion or undue influence. But the assumption that pregnant women or physically disabled persons have these impairments is problematic and unjustified. Now, there are perhaps vulnerabilities that both of these populations have. For example, pregnant women’s fetuses may be vulnerable to harm given that they cannot “protect themselves” (we can set aside personhood debates by focusing on end of term fetuses). Pregnant women may be vulnerable to harm because they are an understudied research population and so the risks and benefits of a particular intervention being tested may be less clear in their case. And persons with physical disabilities may be vulnerable to unequal access to physical spaces where research is to take place or to misunderstanding/misrepresentation (or ironically, to false assumptions about cognitive abilities). But these vulnerabilities are much different from the vulnerability to coercion or undue influence focused on and asserted in the original regulations and the NPRM.

Problem 2: Why the focus on vulnerability to coercion or undue influence in the conceptualization of vulnerability? As Margaret Meek Lange, Wendy Rogers, and Susan Dodds argued in their 2013 paper, “Vulnerability In Research Ethics: A Way Forward,” published in Bioethics, “vulnerability” is an ambiguous term. Firstly, on the one hand all us have a shared vulnerability or susceptibility to harm, which is what makes universal protections of research participants important. But even if one focuses on specific persons or groups who are particularly vulnerable, one needs to be clear about the type and source of that vulnerability. As the Belmont Report outlines, there are three types of vulnerability: lack of capacity to consent, increased susceptibility to coercion or exploitation, and increased risk of harms. Sources of these vulnerabilities, according to Lange et al., can be inherent, situational, or pathogenic (a subtype of situational arising from dysfunctional relationships). It is the sources that offer an explanation for why an individual is vulnerable in the way that they are. The main duty of the researcher is to understand this not exacerbate or create new vulnerabilities. Thus, on this analysis, we see a more nuanced approach to conceptualizing and analyzing vulnerability—one that goes far beyond a narrow focus on coercion and undue influence affirmed in the NPRM.

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