Sites Look to Compensate Trial Participants While Avoiding Undue Influence
Compensating clinical trial participants for their time, effort and risk is a practice commonly accepted by regulators and IRBs, although regulations do not specifically mention the concept. Instead, they require only that a trial’s informed consent process be free of any coercion or undue influence although many questions remain about what’s allowed and what isn’t.
The words “payment” and “incentive” do not appear in either FDA regulations for clinical trials or in the Common Rule, said David Borasky, vice president of IRB compliance for WCG IRB. “But what you are going to find is language that says informed consent must be obtained under circumstances ‘that minimize the possibility of coercion or undue influence,’” he said.
Because the issues are complex and there is little guidance for sponsors, sites or IRBs, sites and sponsors should work out compensation details before the budget is finalized or the clinical trial agreement is signed, making sure that all questions of influence are answered. Only then should the site begin work on the informed consent for the trial, says Jennifer Peterson, executive director for site startup and regulatory for the Americas at Syneos Health. Peterson offered some “Do” and “Don’t” pointers to attendees at a recent WCG webinar on participant compensation.
- Do negotiate the payment compensation line item in the trial budget first whenever possible;
- Do communicate the agreed compensation amount to the regulatory staff that will work on informed consent preparation;
- Do consult with the IRB for any questions or concerns related to compensation and reimbursement;
- Do take population, age, demographics and other factors into account when determining the amount of compensation because it costs more to incentivize some participants than others and the effort to enroll as diverse a population as possible can lead to different rates or forms of compensation; and
- Do pay similar amounts to participants involved in similar activities but be flexible enough to allow variation when it is based on indications or procedures that some participants undergo while others don’t.
On the list of things not to do, Peterson included:
- Don’t finalize the review of informed consent documents before the site’s budget is set;
- Don’t submit informed consent documents — or any documents — to the IRB without making sure that everyone involved in the trial is in agreement on the details of the compensation scheme; and
- Don’t frontload or backload compensation — providing payments either before the trial starts or after it has concluded — to avoid any appearance of coercion.
Peterson says compensation for loss of wages is variable but offered some payment ranges for specific trial participant activities, including $75 to $100 for an office visit, $75 for completion of an online questionnaire, $250 for a liver biopsy and $50 for an MRI.
The clinical trials industry has seen many changes to participant compensation over the years. Compensation for caregivers in addition to participants is one idea that is gaining traction. Sites are more aware of the financial impact on those who assume the role of an elderly, pediatric or spousal participant caregiver, Peterson said. Compensation to such caregivers is being made to cover for loss of wages and for transportation costs. “Loss of wages is something kind of new to the U.S.,” she said. “It had been used more significantly in Europe.”
Borasky says caregiver compensation presents no problem for IRBs. “There is no prohibition on compensating caregivers,” he told CenterWatch Weekly, “particularly when a subject’s ability to participate is dependent on caregiver assistance or even obtaining information/data via the caregiver. It would be reasonable for the IRB to examine proposed caregiver compensation to ensure that it would not lead to the caregiver putting pressure on the potential subject, but I think that this is rare in reality.”
Peterson added that sites have been getting more creative in compensating pediatric participants, with games, gift cards and electronics, for example. And concierge services for adult participants, such as sites providing transportation and making travel and hotel arrangements as part of a compensation package, became very popular during the pandemic.
According to site partners and trial participants she has talked to, Peterson said most independent sites pay their trial participants on the day of a particular procedure or visit or on a designated day of the week, while participants at academic sites could be waiting upward of a few weeks for payment.
But some transactions can be almost immediate, she said. “I talked to one participant in a clinical trial who had just completed a visit, and by the time he got to his car he had already received a text that said his debit card had been loaded with funding for his participation,” she said. “There aren’t any true regulations or guidances governing the payment schedule, but it is recommended that it’s within at least a business week.”