A recent update has been made by the FDA to clarify their specific position on reimbursements and compensation to participants in clinical trials. Payments to participants are regulated and require submission to and approval by an Institutional Review Board (IRB) to ensure participants have the ability to provide voluntary informed consent and to eliminate coercive behavior and undue influence. Historically, the FDA did not specify the difference between compensation and reimbursement, which made evaluation of potential coercion and undue influence difficult for sponsors and clinical investigators. According to the Office of Good Clinical Practice (GCP), “In contrast to payment for participation, [the] FDA does not consider reimbursement for travel expenses to and from the clinical trial site and associated costs such as airfare, parking, and lodging to raise issues regarding undue influence.”1
Why is Specificity Meaningful?
Not only does this communication provide clarity to sponsors and investigators who are responsible for ensuring GCP, it also indicates a shift towards an evolving clinical industry that must balance patient centricity without undue influence. By openly allowing lodging and travel reimbursements within GCP, sites are able to reach beyond their previous recruitment radius and ensure equitable participation in clinical trials. “We don’t want the subject to incur those expenses, and we also want to look at it from the concept of justice and equitable subject selection,” said Chief Medical Officer of WIRB-Copernicus Group, Lindsay McNair, in a recent discussion with Center Watch Weekly. “If only the people who can participate in research are those who can afford the travel expenses upfront, that could greatly limit who can be recruited into a study.”2
What are Best Practices for Reimbursements?
With this clarity from the FDA, we may wonder, how should my organization conduct patient reimbursements? It’s a reminder that your organization should always adhere to what is best for your participant, and less about what is most convenient for your site. If your site pays participants via checks, you may adhere to lump sum reimbursement and payments to save time and effort processing checks, regardless of a patient’s circumstances and actual out-of-pocket expenses.
However, with automated research participant payment systems available, time intensive, error-prone and expensive manual check processing can be easily overcome. New technology, such as Forte’s Participant Payments, allows each protocol’s stipend amounts per visit to be pre-set in the system, while also allowing out-of-pocket expenses by reimbursement type (from mileage to parking) to be pre-set, including maximum allowable amounts. For reimbursable expenses, some situations may require a patient to incur costs over the approved allowable amount. In these situations, a study coordinator can explain the patient’s specific scenario to the finance department via comments in the system, allowing finance to make a final determination of reimbursable amount dependent on each patient’s particular circumstance. Learn more about how Forte Participant Payments can help your research organization make payments participant-centric.
- Center Watch Weekly, FDA Clarifies Stance on Clinical Trial Reimbursements for Patient Travel, Lodging, February, 5, 2018.