Tuesday, April 17, 2012

Concerns Over Coercion and Undue Influence are Slowing the Pace of Valuable Clinical Research

by Emily A. Largent and Alan Wertheimer, PhD

In a recent post, we presented some of the key results from a 2010 survey we conducted with randomly selected PRIM&R members. As described in our article in IRB: Ethics and Human Research, “Money, Coercion, and Undue Inducement: Attitudes about Payments to Research Participants,” the survey explored their attitudes as to whether and why payment of research participants constitutes coercion or undue influence. We were interested in asking these questions because institutional review board (IRB) members are crucial gatekeepers in the research enterprise. As a result, how they understand and apply the concepts of coercion and undue influence will have marked effects on the approval and conduct of research protocols.

In this follow-up post, we seek to outline the central argument of a follow-up article, now available online from Bioethics. We believe that our findings reflect views about offers of payment – widespread in the research community – that are based on misconceptions about coercion and undue influence.

Following the Belmont Report, which states, “coercion occurs when an overt threat of harm is intentionally presented by one person to another,” we believe that coercion always involves the threat of harm. On that view, offers of payment are never coercive. Moreover, and contrary to what a majority of our subjects believed, offers are not coercive simply because they get people to participate in research when they would otherwise not, or because people feel they have no reasonable alternative but to participate in research.

It is more difficult to provide a practically useful definition of undue influence. Many of the survey respondents expressed a belief that offers of payment constitute undue influence if they get people to participate in research when they otherwise would not do so or when subjects feel that they have no reasonable alternative but to participate. We disagree and instead argue that offers of payment constitute undue influence only when they distort a subject’s ability to perceive accurately the risks and benefits of research participation.

Although we did not explicitly ask survey respondents how they distinguish between coercion and undue influence, our reading of their responses suggests a third misconception: many seem to understand coercion and undue influence as lying on a continuum. By contrast, our view is that although both coercion and undue influence render consent invalid, they do so in ways that are quite distinct. Whereas coercion compromises the voluntariness of consent by the threat of harm, undue influence compromises the validity of consent by creating a cognitive deficiency or distortion in reasoning. The target of coercion may act involuntarily but perfectly rationally; individuals who are unduly influenced may act voluntarily, but their reasoning is distorted.

We do not know the extent to which these three misconceptions influence IRB decision-making.  If, as seems likely, these views do affect the decisions made by IRBs, they may limit payment offered to research subjects and could therefore slow the pace of valuable clinical research for ethically unjustifiable reasons.

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