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By Gary Evans
The authors of a new study on payment to research participants underscored concerns that “undue influence” of higher payments may be overemphasized in compensation to human subjects.
“Considering whether payments are too high should be secondary to considering whether payments are so low that they are exploitative,” the researchers reported.1
They found wide variation of payment practices across studies in the same region and populations, suggesting a “haphazard” approach to compensation for research participation.
“We recommend that study authors describe their reasoning behind the payments they provided in their peer-reviewed manuscripts,” the authors noted. “Currently, rationales behind payments are seldom, if ever, reported, and few institutions may have formal and standard payment policies based on study type and contextual factors of the research setting.”
The researchers analyzed 100 IRB-approved sociobehavioral research protocols at a large research university in Southern California. “The proportion of studies that paid participants differed significantly by type of research and study population,” they wrote. “The average payment amount also differed significantly by study population and type of participation (in-person vs. remote). In addition, studies that required more visits and more time paid significantly more than studies with fewer and shorter visits, respectively.”
The lead author of the study is Brandon Brown, MPH, PhD, associate professor in the department of social medicine, population, and public health at the University of California, Riverside. IRB Advisor asked Brown to comment on the implications of the study in the following interview, which has been edited for length and clarity.
IRB Advisor: Based on your findings, you note that concerns about undue influence have been overemphasized, and that considering whether payments are too high should be secondary to whether they are exploitatively low. Can you elaborate on this point?
Brown: Too much attention has been paid to undue influence — which might happen rarely — while we are not spending enough time on underpayment. We can ask the question: Would it be unethical to pay someone $1,000 to take a 30-minute survey? What about $1,000 to test an experimental treatment in a Phase I trial? When would it be undue influence? Whether research is low or high risk, lack of compensation can be exploitative and disrespectful of participants’ contribution to research, including their time, effort, and their disclosure of information we use as data.
IRB Advisor: Is there some perceived formula that the higher the risk to participants, the greater the compensation? Or, would that raise ethical concerns of undue influence?
Brown: From the IRB’s perspective, payment is not to be used to evaluate the risk/benefit ratio of a study. This is regardless of the fact that participants themselves may view payment as a benefit of participation. I would assume that a simple, anonymous survey study would pay less than a clinical trial, but that doesn’t need to be the case, and may depend on the individual study budget. I also would expect a study with a high level of risk to pay participants more, which can raise ethical concerns of undue influence, depending on the risk and payment. Unfortunately, we have little sense of low or high payment dependent on risk.
IRB Advisor: Your findings suggest that payment decisions are made by study type, participation type, participant type, time, and number of visits. Does your research or review of the literature suggest that payments for biomedical research are similar?
Brown: Yes, our data from sociobehavioral studies at UC Riverside suggest this is how payment decisions are made, due to statistical significance between payment and the variables listed above. We have no idea if this will be the factual case for biomedical research, but it makes sense that payment may differ by study type, participation type, participant type, time, and number of visits for any type of study.
IRB Advisor: You recommend that study authors describe their reasoning behind the payments they provided in their peer-reviewed manuscripts. Is this something that individual IRBs and researchers should emphasize to better inform future decisions and overcome the dearth of data?
Brown: Definitely. We need data to understand how people make decisions; otherwise we will continue making decisions on a case-by-case basis. As a member of my own institutional IRB, I often ask how these decisions are made, and oftentimes there is no specific reason apart from perceived norms. In a perfect setting, we can collect this information in a systematic way so that each institution can formulate norms for payment to study participants based on the numerous factors.
IRB Advisor: SACHRP recently approved some guidelines on the unusual situation where participants pay to be part of research. (For more information, see the December 2019 issue of IRB Advisor.) Can you comment on this from the perspective of your research?
Brown: First, I agree that therapeutic misconception is more apparent in pay-to-participate studies, since people usually pay for things or services rather than to be experimented on. Also, it is true that populations without the ability to pay will be excluded, when they otherwise fulfill all other inclusion criteria. It also may contribute to the historical focus of research on white populations. An obvious risk of joining the pay-to-participate studies is loss of money. Certainly, this is obvious to the participant who must pay to join. But since IRBs do not consider money gained to be a benefit of research that pays participants, they also should not consider money lost as a risk. I personally do not believe that participants should be required to pay to participate in research, unless the potential benefits to the individual are so high that the amount they pay is well below the benefit.
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jonathan Springston, Editorial Group Manager Leslie Coplin, and Physician Editor Lindsay McNair, MD, MPH, MSB, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, is a consultant for Ethicon USA and Mobile Instrument Service and Repair.