31
Jan2012

by Emily A. Largent and Alan Wertheimer, PhD

How do institutional review board (IRB) members and human research protections professionals think about the relationship between payment, coercion, and undue influence? 

This is a topic of obvious interest to the research community: Researchers routinely offer payment to prospective research participants as an incentive to enroll or as compensation for their participation in research. IRBs are, in turn, asked to review these payments for their ethical implications.  Yet, there is little systematic data about attitudes toward payment in general, and specifically, when IRB members consider payment coercion or undue influence.

To address these questions, in 2010, we surveyed randomly selected PRIM&R members who had previously self-identified as interested in IRBs and human subjects research. Our complete results have recently been published in IRB: Ethics and Human Research.

Here, we’ll highlight three of our findings:

  1. We found persistent ethical concern about the effect of offering payment to research subjects.  Sixty-one percent of respondents reported feeling somewhat, moderately, or very concerned that payment of any amount might influence a participant’s decisions or behaviors regarding research participation. 

  2. Virtually all respondents agreed that an offer of payment constitutes undue influence if it “distorts a subject’s ability to perceive accurately the risks and benefits of research.” However, a surprising 80% also judged that the offer of payment constitutes undue influence simply because it motivates someone to do something they otherwise would not.

    Although more than 90% of respondents agreed with a definition of coercion tied to threat of harm, a substantial majority also agreed that research participants are coerced when an offer of payment—not a threat of harm—gets them to participate when they otherwise would not or when they feel they have no alternative but to participate.

    There was, however, notable divergence between how individuals viewed the meaning of coercion and undue influence in the abstract and how they applied these concepts to the concrete scenarios included in the survey.

  3. The majority of respondents expressed acceptance of payment as reimbursement for expenses or as compensation for time, effort, and incon¬venience—regardless of the study population.  By contrast, fewer respondents accepted payment as an incentive to participate (about half) or as compensation for risk (about one-third). 
Although survey respondents endorsed limiting the amount of payment offered to research participants, the connection between attitudes toward payment and actual IRB practices is unclear.  Not only is further research needed, but we also believe that policy guidance and educational efforts should clarify the concepts of coercion and undue inducement.  We would love to see PRIM&R’s leadership and members continue engaging in these important conversations. 

Stay tuned for a forthcoming blog post in which we will argue that some of our findings reflect misconceptions about coercion and undue inducement!

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2 thoughts on “What do PRIM&R members think about payment, coercion, and undue influence?

  1. Laura

    I attended a seminar recently and this topic was discussed.

    I'll admit that I hadn't given it much thought because the studies I am involved in have never offered monetary compensation for a subject's participation. With that said, others in the group discussion had experienced payment for participation and voiced their concerns and opinions.

    Most everyone agreed that offering payment was not the most ethical way to go about recruiting. Under some circumstances (mainly very physically invasive studies), it was understandble, but generally, it was frowned upon.

    Some of the reasons the group gave were:
    – An insult to the participant – did we think that they need money at all or that badly?
    – An insult in terms of how much was offered to participate – did we think that they'd do anything for such a little amount or for that matter, such a large sum of money?
    – Other forms of "payment" – offering savings bonds if a parent enrolled their child in a vaccine study – again, an insult to the parents: an outdated compensation, or assuming that the parents would put their child through a study by "using" them for their own financial gain?

    These are the main examples that were brought up. We then focused on if it's ethical at all to offer any compensation whatsoever? Because, like the article states above, one would imagine participants see dollar signs and don't care what the study entails = undue influence and coercion in most people's eyes.

    To play devils' advocate for a minute, what if the study is a tough one to recruit? What if it involves painful procedures, overnight stays in the hospital, or many, long trips to the testing facility? (I do know of one study that pays for a cab ride if the subject doesn't have reliable transportation.) Would it be acceptable then? I think a great deal of ethical souls would say yes.

    I look forward to other thoughts!

    Reply
  2. Alan Wertheimer

    Thanks for your comments. Reasonable people disagree about some of these issues, but our views are these:
    1. We see nothing inherently unethical about paying people to participate. Is it unethical to recruit researcher/scientists by paying them?
    2. Inadequate compensation is a legitimate issue.
    3. As you note, payment to parents raises special problems.
    4. The evidence suggests that payment does NOT cause subjects to see only $$ signs and overlook the risks of participation.
    5. We believe that coercion always involves a threat and that offers of payment are therefore never coercive.
    6. We’ll have more to say in our next blog that is based on a forthcoming article.

    Reply