27
Jun2018

Authors: Brandon Brown1*, Jerome T. Galea2, Karine Dubé3, Logan Marg1

Affiliations:
1University of California, Riverside, Center for Healthy Communities.
2Harvard Medical School, Department of Global Health and Social Medicine.
3University of North Carolina, Chapel Hill, Gillings School of Global Public Health.

Providing payment for participation in research studies is an accepted practice1, but until recently little guidance existed on the ethical aspects when deciding research payments. Gelinas et al2 recently presented a framework that researchers and IRBs can use when deciding ethical payments, categorizing them as:

  1. Reimbursement for out-of-pocket expenses
  2. Compensation for time burdens
  3. Incentives for participation

Of the three types, the authors point out that incentives are the most controversial since they have an ethical dimension intrinsically tied to the type or amount. Yet one major gap remains beyond the framework: data on the types and amounts of incentives provided historically in research studies.

Today, consumers can rapidly compare prices for identical items across multiple providers to determine a fair price. But researchers, IRBs, and study participants have no resource other than their personal experience to determine adequate incentive amounts because—incredibly, even in the era of big data—no such database exists, and as a result we have no sense of what is appropriate. Therefore, while we applaud working towards a framework for ethical payment, we believe that little will change without adequate data to help drive and inform real-time payment decisions. We need concrete incentive data to avoid the potential for both underpayment (possibly exploitative) and undue influence (excessive payment)3,4.  

If we focus on incentives, excessive payment may be more important than underpayment. While the Belmont report states that “undue influence” in research must be avoided, no practical definition of “undue influence” has been agreed upon in the 40 years since the report’s inception5,6. In the absence of a definition, the presumption is “I’ll know it when I see it” which relies on individual perceptions and can lead to negative study implications7. Decisions on acceptable payment should not be made without a clear understanding of currently offered incentives or else we will continue to utilize personal biases without critical assessment.

References and Notes:

  1. U.S. Food and Drug Administration, (FDA), "Payment to Research SubjectsInformation Sheet" (FDA, 2016, https://www.fda.gov/RegulatoryInformation/Guidances/ucm126429.htm).
  2. L, Gelinas, E.A. Largent, I.G. Cohen, S. Kornetsky, B.E. Bierer, H. Fernandez Lynch, A framework for ethical payment to research participants. N Engl J Med. 378, 766-771 (2018).
  3. E.A. Largent, H.F. Lynch, Paying research participants: the outsized influence of "undue influence". IRB. 39, 1-9 (2017).
  4. B. Brown, J.T. Galea, K. Dubé, P. Davidson, K. Khoshnood, L. Holtzman, L. Marg, J. Taylor, The need to track payment incentives to participate in HIV research. IRB: Ethics & Human Research. 40, (2018).
  5. E.J. Emanuel, X.E. Currie, A. Herman, P. Project, Undue inducement in clinical research in developing countries: is it a worry? Lancet. 366, 336-340 (2005).
  6. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research" (Department of Health, Education, and Welfare, 1979).
  7. E.G. Devine, M.E. Waters, M. Putnam, C. Surprise, K. O'Malley, C. Richambault, R.L. Fisherman, C.M. Knapp, E.H. Patterson, O. Sarid-Segal, C. Streeter, L. Colanari, D.A. Ciraulo, Concealment and fabrication by experienced research subjects. Clin Trials. 10, 935-948 (2013).

Guest contributors to Ampersand are valued members of the PRIM&R community, willing to share their insights. The views expressed in their posts do not necessarily reflect those of PRIM&R or its employees.

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3 thoughts on “Applying the Ethical Payment Framework: We Need Data

  1. Cynthia Brown

    What a massive undertaking it would be to create a database! With the great number of variables existing, it would be both time consuming and evolving. Would it deter unethical research projects? I believe it would to a large degree. Would it create fair and balanced payments to participants? Again, I believe it would to a large degree.

    Reply
  2. Geoffrey Madeira

    That’s really true and it would make a great impact in our practice. Excellent work for the team

    Reply