Clinical trials cannot take place without the participation of volunteer patients who give up their time to take part in studies. But difficulties in finding, and recruiting, willing and eligible volunteers means that they are often paid for their participation. The ethics of this practice, are often a topic of debate within the industry, and the amount participants should be paid is often a topic of contention.
What Does the Regulation Say?
From a legal viewpoint, there is little regulation concerning payment for participation in clinical trials. Much of it is concerned only with preventing coercion or undue influence when encouraging participation. Clarity when seeking consent is also a main concern, with the federal regulations address in 45 CFR 46.116(a) which states: “For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.” Primarily the regulations suggest that provided participants are properly informed of the terms and nature of the payment, and that it doesn’t coerce them into participating longer than they might wish, amounts are at the discretion of both parties.
So, what payments amounts are acceptable?
When it comes to determining the amounts of payments, there are a few variables to consider. Generally, it is accepted that participants should be paid sufficiently to compensate for time spent, loss of earnings, travel time, inconvenience, and depending on perceived level of risk they are bearing by participating in the trial.
Several different models for determining payment are used across the industry, and the main ones include:
A standard wage payment structure
Payment based on supply of volunteers and demand in the participant’s locality.
A reward model where the patient receives a one-off payment on the conclusion of the study as a token of thanks.
A model of reimbursement where receipts are provided and the participant is refunded for any expenses they incur during their participation
Of course, some studies may require the use of a combination of these methods, and some may even use none. As the Office of Human Research Protections (OHRP) states, it is also acceptable not to offer payment for participation in clinical trials. The decision to do so should be made based on a consideration of the type of study, the levels of commitment and participation required by participants, and any relevant organizational guidelines.
When it comes to answering to your IRB or ethics committee, it is not the amount of payment that needs to be stressed, but rather the ethics surrounding the payment and the justification for offering it. In a research proposal, you should outline the rationale behind paying participants and the intended type of payment. The IRB will look to ensure that there is no coercion involved and that the participants are clearly informed about what is being offered and how. As Federal regulation states: “An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.” They will generally view any payments as incentives to boost recruitment rather than ways of offsetting research risks and expenses, and will seek to make sure that the payment is not so large that it is coercing participants to stay in the study longer than they might have without it.
Once you gain IRB approval, all payment information, the agreed amounts and the payment schedule should be discussed with and clearly explained to all participants in the consent stage.
Do you need help with recruiting the right and/or enough patients for your trial? Get in touch!