Should IRBs standardize payments to subjects?
Payments to research subjects is common practice, but a recent report appearing on the abcnews.com web site raises the question: When does the payment become coercive? Clearly some research subjects volunteer because of compensation. Take Bob Helms, for example, the subject of the abcnews.com story and author of Guinea Pig Zero, a book detailing his and others’ experience as research subjects in clinical trials. By his own admission, he volunteered for clinical trials as a way to make extra money. His case may be extreme, but it does raise interesting questions, such as when is compensation appropriate and how much is too much?
Federal guidelines do not address the issue of compensation other than to state that IRBs must determine "whether the rewards offered for participation in research constitute undue inducement."1
Compensation matters need more review
"Most research involves some kind of compensation for the time and inconvenience that goes into it, particularly in drug development research," says Greg Koski, MD, PhD, director of the Office for Human Research Protections’ Department of Health and Human Services in Rockville, MD. "Clearly, if you offer people money to do something they would not otherwise do, and if it’s large enough, it could be coercive. What IRBs have to do is to consider what is appropriate compensation. It’s an area where there could be further development."
Koski explains that most institutions have established guidelines concerning what’s appropriate. For example, subjects submitting to simple blood draws may be compensated $10-$25.
Marc Rogers, PhD, associate professor of kinesiology at the University of Maryland and co-chair of the university’s IRB, says that his institution’s IRB does not have formal guidelines. Decisions regarding compensation are made on a case by case basis. "Typically, the payment is determined by the principal investigator [PI] based on whether the project is funded or not," he explains.
"We have never, to my recollection, ever said to a PI that the remuneration was excessive," Rogers says. "Usually, payments for the types of projects that we review are small — $15-$25 per study or per visit to a lab for testing. One project, the subjects were paid $700 for an experiment that lasted 12 months and required multiple visits to a lab for testing and three times per week for exercise training over that time."
He says they have also had several vaccine studies that paid participants $150-$220, "but again, the investment in time for the subjects is substantial in terms of visits to the lab, collection of biological specimens and filling our diaries, etc.," Rogers explains.
Cincinnati-based Schulman Associates’ IRB has requested that PIs reconsider their payment plans in research involving children where they thought payments were excessive, explains John Isidor, JD, CEO, Schulman Associates IRB and a member of IRB Advisor’s editorial board. Another area where they have requested changes is in the area of compensation for screening visits.
"Sometimes for screening visits, principal investigators want to pay for completion of the screening visit only if candidates qualify for the study. We think it’s inappropriate and ask them to reconsider," Isidor says. He explains that in all cases the PI does indeed change the compensation amount or parameters.
Kaiser Permanente Center for Health Research (KPCHR) views its research participants as volunteers and instead of compensating them for the value of their time, KPCHR seeks to "recognize" participants for their spirit of volunteerism. "Part of our mission is to produce new knowledge, so it’s part of the social contract [with Kaiser members] to be open to public domain research," says Mark C. Hornbrook, PhD, associate director. "What we’re finding is people like to be recognized for what they are contributing, and birthday reminders, personalized thank-you notes, T-shirts, pens, coffee mugs all say, You’re part of something important.’" For long-term studies, Kaiser may sponsor lunches and reunion parties to keep participants tied in.
Financial incentives are offered by Kaiser, but Hornbrook stresses that the amounts are modest, in the $15-$20 range. These "thank-you gifts" typically are in the form of gift certificates. Kaiser’s IRB does not have established guidelines regarding the types or amounts of incentives awarded to participants. "We try to recognize that every research project has different needs and comes from a different field. We look at it and say, What’s appropriate for the kind of people who are going to be approached?’ We always want to make it very clear that gifts should not be overwhelming, rather they should be modest and symbolic."
Regardless of the form of the remuneration, Isidor stresses that compensation to study subjects should be based on time and inconvenience and not risk related to the study.
"You should never base compensation on risk level," says Ernest Prentice, PhD, associate vice chancellor for academic affairs and co-chair of the University of Nebraska Medical Center (UNMC) IRB. "I think you’re really getting into trouble when people enroll just to get compensation. The more risky the study, the more the compensation would be, and the more enticing."
Compensation for time, effort acceptable
The UNMC IRB considers compensation acceptable if it’s based on time and effort required of the research participant, Prentice explains. "It is not acceptable if it’s based on risk levels of a protocol. We look at how much time is devoted to a procedure, travel time and post-procedure periods." For example, if a patient were to undergo a bronchoscopy, he or she would likely experience residual effects, so the UNMC IRB would allow that they be compensated for that.
"We will not base compensation on risk; we think that’s coercive. We try to use a fair-market wage so that we’ll compensate so many dollars per hour of time required of the research subject," he adds. To that end, UNMC’s IRB is establishing compensation guidelines. "We found that we were inconsistent and we found ourselves constantly debating on whether a compensation was reasonable. The pendulum swung from meeting to meeting," Prentice says.
The guidelines, which have not yet been finalized, will include a list of procedures and associated fees based on a rate of about $10 per hour. "We’re basing compensation on a list of procedures such as routine blood draw, physical exam, and CAT scan, etc.," Prentice explains. "We have some general guidelines in terms of total compensation not exceeding $1,000 without significant justification," but individual procedures will be assigned a dollar amount, and principal investigators will be asked to adhere to the guidelines.
References
1. Office of Human Research Protections. Protecting Human Research Subjects: Institutional Review Board Guidebook. Rockville, MD: Office of Human Research Protections; 1993.
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