In April, PRIM&R hosted the webinar Compensation or Inducement? What IRBs Need to Know about Paying Subjects for Participation. Presented by Alex John London, PhD, and Betsy Ripley, MD, MS, RAC, this webinar provided foundational knowledge about the underlying ethical principles that govern compensating research subjects. Through case studies, examples, and review of existing guidance and regulations, attendees learned strategies for evaluating payment to subjects for their participation in studies.
After the webinar, the presenters answered some of the questions time didn’t permit us to answer live. We’re pleased to share those answers with the readers of Ampersand.
Q: When an IRB is considering payment and the research staff has noted the payment is meant to compensate for subject expenses but these are not listed, should the IRB request more information? What should they do if the amount to be paid does not seem to cover expected expenses?
Alex John London (AJL): In general, if the reason for a payment is to reimburse expenses, it seems reasonable to ask principal investigators (PIs) to list the type of expense they expect the average study participant to incur and to state the rate at which expenses are being reimbursed. If the concern is that the reimbursement may not be sufficient to cover the likely costs of study participation, it seems reasonable to raise this issue with the PI. If their response is that they cannot afford to reimburse for all such expenses, then it may be preferable for the consent form to state this up front and to describe the payment offered as a token of appreciation for the participant’s time and effort. I would also say that this issue would be more important as the potential costs to participants increases.
Betsy Ripley (BR): In order to compensate someone, you have to know what is being compensated and the anticipated cost for this. For example, if you are compensating for travel, you could say that you would provide bus tickets or taxi vouchers and/or xx/mile. If a study cannot afford to reimburse all expenses then it should either state which expenses will be reimbursed, or state the maximum amount they are able to contribute to the subject’s expenses. It is not correct to tell a subject that they will be compensated for a particular activity or cost(s) unless that is what the study intends to do.
Looking at cost coverage analysis can help clarify what expenses a subject may have to pay out of pocket for standard of care activities. These forms usually only cover things that would or would not be billed to Medicare or a third party insurer and not other expenses like time, parking, or meals.
Q: If the risks have been minimized in a study and outlined in the consent form, under what circumstances should an IRB question the amount to be paid to the subject?
AJL: Even under these conditions some concerns about payments could remain. For instance, if payments are made contingent on completing the study then this payment schedule might constitute undue influence. Also, if payments are large and the study involves procedures that might conflict with the values of a reasonable person, then the IRB might ask for a justification for the amount of the payments. One of the case studies presented during the webinar, in which photos of vaginal, rectal, or penile conditions are used to evaluate diagnostics, is an example of a study that might fit this template. The study could be perfectly meritorious, but the IRB may want to ensure that participants do not perceive payments as a means of trying to overcome their possible reluctance to having their genitals photographed.
BR: A competent person given all of the information to understand the risks and incentive to participate should be able to make an informed decision to participate or not. IRB panels also consider vulnerable populations. It is important that the panel addresses each study to assure all of the provisions in 45 CFR §46.111 are met. This also implies that the panel uses their best judgement and knowledge (or a consultant) but does not impose paternalistic approaches. A panel should ask themselves, “Are we asking for change or not approving because we have a concern about part 111 and informed consent?” If so, then ask for changes or do not approve. I agree with Dr. London that it is important that payment only upon completion or completion bonuses be considered for their impact on the subject.
Q: Are the terms “coercion” and "undue inducement" used synonymously or are they different?
AJL: I would say that coercion should be seen as a special case of undue influence. The latter is a larger category in which A’s influence on B is problematic because it might undermine the moral status of B’s consent. An offer that is so large that someone might knowingly participate in a study while failing to disclose that they have a risk factor that puts them at higher risk of an adverse event might be a form of undue inducement. But it would not be coercive, since that usually involves the threat of being made worse off in some way.
Q: What is the difference, ultimately, between offering payment in order to offset risk and offering payment as an incentive to participate in a study?
AJL: One difference is simply in how payments are presented. If the goal is to ensure that participants are willing to accept study-related risks in light of their assessment of the value of the study, then they should not be offered money in order to change their estimation of these risks. On the other hand, one might think that the risks of a study are reasonable but also think that one has better ways of spending one’s time than participating in research. In this case, offering a payment as an incentive to participate doesn’t necessarily alter the participant’s perception of study risks.
Q: The study that Dr. London was a part of found that larger payments increased study participation but also increased the perception of risk. Is it possible that large payments for minimal risk studies could be misleading?
AJL: This question goes beyond our specific findings, but it is a reasonable hypothesis, given what we found. However, if this were the case, it would likely be a perception that could be overcome by adequate information disclosure during the informed consent process.
Q: When is it okay to pay different types of participants different amounts to participate in a study? For example: a focus group on HIV testing options with diverse groups including homeless injection drug users, heart surgeons, students, etc.
BR: For a majority of studies you are not paying someone because of their skill at doing something. For instance, people are not trained to participate in a pharmacokinetic study. Taking a medication and drawing your blood is not dependent on your skill or career choice. With that concept in mind, all subjects would be paid the same.
If, however, you are paying as compensation for the time it takes someone to complete a survey, time away from work for a neurosurgeon would be different than time away for a store clerk. If you say you are compensating for missed work, you would need to take this into consideration.
A survey study of surgeons and homeless individuals that is asking both groups to complete the same survey (same questions, same risk, same time to complete) would have a difficult time justifying a difference in payment. But, the study might propose that enrollment of both populations is critical and that a higher incentive is necessary for the surgeons to get them to enroll. The IRB would need to consider if the rationale provided in the context of that study makes sense.
Q: Some of our recruitment incentives have been adjusted by my institution’s office of management and budget. What are your experiences with this and do you have any suggestions?
BR: If your study budget is being reviewed prior to submission by your institution and they are questioning the payment amount, I would suggest that you have discussions with the reviewer and the IRB chair—or with an ethics consultant if your institution has one. If a funder is questioning the amount, participate in frank discussions about local context (what is usual payment in your area? How difficult is recruitment in your area?) and the importance of recruitment. If they are saying that you must decrease your budget then you need to weigh why you are paying the subjects, in addition to other budget requirements, before making changes. Payment line items in a budget, if determined thoughtfully and considered fair and adequate, should not be the first place that budget cuts are taken. Why did you choose that payment level to start? If it was the right level then you may need to discuss that to keep it in the budget.
There are a variety of underlying factors that may come into play. For example, there have been discussions about what happens when junior faculty do not have funding available to pay subjects, while senior faculty may have the funding to pay the same population. In those situations, the senior faculty member’s study may in reality be competing for the subjects. Some institutions take this into consideration by developing “standards” for payment. Another concern may be that unless a certain payment level is offered, the study will be unable to recruit. Failure to recruit leads to inadequately powered studies, wastes money, and subjects participants to risk for a study that will never be completed and will not contribute to scientific knowledge.
PRIM&R would like to thank our speakers for sharing their expertise!
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