Some practices for paying research participants can spark debate, including whether it’s even ethical to pay participants at all. In the clinical research landscape, you will find widely varying opinions on these issues across stakeholders, partly due to a lack of clear-cut guidelines.
Here are four scenarios that may arise due to vague guidance documents, leaving research sites uncertain and questioning what they can do.
1. Can you offer study completion payments to research participants?
Technically, yes. The FDA accepts study completion payments, though any bonus payment for study completion should be modest and not unduly influence participants to stay in the study when they otherwise would have withdrawn. In the Payment to Research Subjects – Information Sheet Guidance for Institutional Review Boards and Clinical Investigators, the FDA states:
“While the entire payment should not be contingent upon completion of the entire study, payment of a small proportion as an incentive for completion of the study is acceptable to FDA, providing that such incentive is not coercive.”
The IRB is tasked with determining that the amount paid as a bonus for completion is reasonable and not too large. Similarly, all the information concerning payment, including the amount and schedule of payment(s), should be included in the informed consent document.
2. Are you allowed to add, delete or change stipend amounts mid-study?
In the article Ten Subject Stipend Issues by David Vulcano, it’s mentioned that there are certain scenarios when it may make sense to revise stipends after they’ve been established, such as when a protocol is amended. An example of an appropriate protocol amendment is when the amendment is made to combat poor enrollment. In this case, increasing the stipend may be essential for successful recruitment. However, this will need to be approved by the IRB.
Vulcano writes, “If the stipend amounts are ‘hard wired’ into the consent form, e.g., ‘$35 per visit,’ the IRB is more likely to require re-consent of active subjects.” The article also notes that it’s unlikely a participant would withdraw consent because of a stipend increase, unless he or she is near an income limit for a government benefit program.
3. Is it acceptable to pay a bonus to enrolled participants who refer other participants to a trial?
The article Good Clinical Practice Q&A: Focus on Referral Fees (based on Barnett International’s “Good Clinical Practice: A Question & Answer Reference Guide”) addresses referral fees offered to existing participants in an ongoing trial. The article notes a February 2009 response to this question from the FDA’s Good Clinical Practice program:
“There is nothing in FDA regulations or guidance that would prohibit this. That does not, of course, indicate that it is a prudent method of recruiting potential study subjects. As you note, the reviewing IRB would need to review this, and they are the ones who will decide whether or not it is appropriate for the particular study and, if so, if the proposed compensation is appropriate. It would definitely require IRB approval, and it is most likely they would require a full discussion of it in the informed consent document so everyone participating in the study is aware of it.”
Also know as “snowball recruitment,” the practice of subjects referring other subjects can be an unconventional way to reach new patients.
4. What are you supposed to do with unclaimed stipends?
As another featured issue in the article Ten Subject Stipend Issues, Vulcano writes about how some stipends go unclaimed – whether it’s a check that’s never cashed or a debit card that’s never used – and what should be done about it.
The simple answer is, in general, unclaimed stipends are not funds a research site can keep for itself. Whatever the reason the money hasn’t been claimed, each state has its own laws and regulations on unclaimed property, many of which require public-notice postings and eventually turning the funds over to the state.
Vulcano mentions that, whenever money is involved, careful documentation is essential and suggests that if the accounting department determines a check has not been cashed after roughly three months, a study coordinator should attempt to contact the participant to troubleshoot (e.g., for an un-cashed check, confirm the participant’s mailing address and determine what happened to the check).
If a check has not cleared after an additional few months, state laws for unclaimed property apply. For best practice, refer to your institution’s financial officer for state and institution-specific requirements regarding the process and rules.
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