In response to questions about travel reimbursements, the Food and Drug Administration’s (FDA) Office of Good Clinical Practice published an updated Information Sheet on January 25, 2018, retitled “Payment and Reimbursement to Research Subjects” to reflect the clarifications. Stakeholders for this guidance are Institutional Review Boards (IRB) and Investigators.
In the Information Sheet, the FDA clarifies the difference between payments to subjects and travel expense reimbursement.
- Payments to subjects may be used as an enrollment incentive but may not be considered as a study benefit.
- An IRB must review payments to subjects for participation in a clinical trial to ensure there is no undue influence toward participation.
- The amount of payments must be fair, but small enough so it does not unduly influence participation in the clinical trial.
- Payments should not be contingent upon completion of the clinical trial, although it would be acceptable to pay an additional small amount upon completion.
- Reimbursement for travel expenses related to the clinical trial would not be considered an undue influence to participation.
The FDA recognizes that IRBs must determine what amount of payment would be considered an undue influence based on factors such as the amount of time invested in participation, economic status of the surrounding population, and discomfort experienced while on trial. The guidance removes the concern for expensive travel reimbursement as an undue influence to participation as long as the expenses are reasonable.
- The Clinical Pathways Team
Enjoy this blog? Please like, comment, and share with your contacts.