WCG IRB recently presented a webinar entitled, Compensating Research Participants, led by David Borasky, MPH, CIP, WCG’s vice president of IRB Compliance and Jennifer Peterson, Syneos Health’s executive director of site startup.
We were unable to address all the many questions from more than 1,000 attendees, so we are posting here answers to some of the questions that commonly arose or are more difficult to source elsewhere.
Q. Is it acceptable to make a participant pay to participate in a clinical trial? For example, if they receive a procedure as part of the study protocol that would cost them less than if they had that procedure as part of their clinical care?
A. The issue of “pay-to-participate” (P2P) studies can be ethically problematic. The FDA has requirements when sponsors wish to charge subjects for investigational products. In general, WCG IRB will not review P2P studies without justification for why participants should have to pay for access to an experimental intervention.
Q. Does WCG have a position on having the same payment for a study across all sites over the country? Or does the payment have to be adjusted based on the location of each site?
A. WCG IRB does not have a specific policy addressing compensation adjusted for geographic location. We understand that there can be significant geographical differences that affect the costs of participation, and we routinely see differences in reimbursement across sites.
Q. Is it okay to pay the intervention group and the control group for different actions? If the intervention group must use a device and then fill out a questionnaire, but the control group only must fill out the questionnaire, would this be considered a difference of standard and would that be an issue?
A. There is nothing wrong with this approach. It should be clear, however, to the IRBand of course must be explained in the consent form.
Q. Does the IRB consider it unethical to pay a referral fee to both the referring participant and the referred participant as well?
A. Not necessarily. Paying the referring participant likely needs reasonable controls so that current participants don’ t unduly influence others to participate. This can beachieved by limiting the number of referrals that will result in a payment or by keeping the amount low.
Q. Is it okay to compensate participants in a long-duration study in a way that incentivizes retention?
A. It is certainly reasonable to calibrate incentives to help with retention / adherence. FDA also allows this. The conditions for payment do need to be described clearly in the consent form.
Q. Is it possible to over-compensate someone to participate in a clinical trial?
A. It is difficult to cite a specific amount that would constitute over-compensating due to the variables at play. However, some bioethicists like Holly Fernandez Lynch at UPENN would say that you can’t overpay people.
Q. Since most visits are now being conducted virtually via telemedicine (15% before the COVID pandemic; 61% post pandemic) will compensation even be needed in the future?
A. I think compensation will still be needed. Even with reduced or eliminated travel from some studies, you are still asking people to give their time and you may need to incentivize them for the purposes of retention/adherence.
Q. With the increase in decentralized clinical trials and provisioning trial participants with devices for a variety of data collections, what is the IRB’s position on provisioning devices?
A. We see this happening in a variety of ways and should not present a problem for the IRB. Depending on the nature of the device and the data it collects there may be questions that need to be address surrounding data security. Also, there are sometimes issues related to retrieving devices from participants.
Q. If you compensate a subgroup, do you have to compensate the main population group?
A. No. Compensation needs to be clear in the consent form. If there is a subgroup, then payments related to sub-studies need to be clear in the consent form for the sub-study.
Q. Can there be a difference at the site for compensation of a “diverse” patient and that of a patient not considered as “diverse”?
A. It is possible to structure compensation as you describe. The challenge would be in implementation and managing this since compensation must be described in detail in the consent form. If diversity is the goal, it may be worth considering other approaches, including placing sites in diverse communities or adopting patient engagement strategies to facilitate the recruiting of more diverse populations.
Q. Are there indications that are more, or less, likely to have compensation?
A. Studies that have a therapeutic component, such as oncology trials, tend to pay fewer incentives, but still routinely compensate for things like parking or other out-of-pocket expenses.
Q. Can there be an amendment to the CTA or ICF for compensation to research subjects after a study is in progress?
A. Yes. This happens all the time and does not present a problem for IRB.
Q. From IRB perspective, should informed consents disclose that participant earnings (not reimbursement) $600 or more are reportable to IRS as earned income?
Q. What are your thoughts around paying (either compensation/reimbursement) participants in low resource countries (e.g.,Africa) that are often involved in collaborative studies with US sites. Are there any special considerations that US IRBs / African RECs should consider?
A. That can be complicated because there are always concerns about exploitation. The local RECs are in the best position to determine what is appropriate. And of course, there are some regulatory authorities like the South African MCC that required certain levels of compensation at one time.
Q. If a 3rd party is processing patient payments, do they need explicit consent to process the patient’s data? Can consent for this data sub-processor be captured in the study consent? Does the 3rd part need to be named?
A. This can be captured in the main consent form. Typically, language in the confidentiality section refers to the sponsors and their partners or similar, and we tend to see this as covering this use of payment vendors.
Q. Can you expound on “front loading” or “back loading” subject compensation and how that can be seen as overtly coercive?
A. Front loading compensation is when the participant receives a large upfront payment to begin the trial. Back loading is when the participant receives a large payment after or near the end of their participation in the trial. Front loading is seenas coercive to joining and back loading is seen as coercive to remaining in the study.
Q. What are the most often used approaches / methodologies in US and EUto determine Fair Market Value for reimbursement to clinical trial participants?
A. At Syneos Health, we use 75% of FMV to begin in the US. In EMEA, reimbursement is usually capped to avoid instances of high amounts, exceeding well into the $1,000’s in some cases.
Q. How is the appropriate amount of payment determined for more invasive tests (e.g. skin biopsies)? Also, if these more invasive tests are optional, i.e. related to secondary/exploratory study endpoints, would it
be okay to give this as an additional payment to the main study compensation?
A. In these instances, we rely a lot on consultancy with our Investigators. We also look at PICAs data, historical budgets and data from Medidata Grants Manager to configure compensation. For optional studies, it is generally frowned upon to provide additional payment as those studies are deemed altruistic on the participant’s part, and thus, payment would be considered incentive to participate.
Q. How do you work out budgetary discrepancies in patient payments between the US and Canada? Canada is often swept into the US’ budgets/procedures/etc.
A. At Syneos, we do country specific budgets and contract templates for each country–inclusive of Canada. Medidata Grants Manager allows us to input country as well as currency.
Q. What do you typically see for 1099 preparation responsibility? Does it fall with the sites or the sponsors/CROs?
A. It is the study site’s responsibility to send the 1099. But remember this is only for compensation. It is not required for reimbursement for expenses such as transportation meals etc.