Compensation and Reimbursement

1. What is Compensation?

1.1. Compensation for Participation

It depends on the sponsor and the given study whether or not compensation is paid to participants. Compensation schemes are more common in Phase I clinical trials. According to one report by the European Forum for Good Clinical Practice (EFGCP) (2), legislation and practice in Europe vary widely from country to country. Some countries exclude compensation entirely, but the most common practice requires that any compensation is reviewed and approved by the ethics committee associated with the given study. The EU Clinical Trial Directive (2001/20/EC) and Regulation 536/2014 (3) specifically prohibit the payment of any compensation for participation - other than the reimbursement of expenses or income lost - to participants who are incapacitated and cannot sign an informed consent form (ICF), or who are pregnant, or minors. Otherwise this EU legislation only provides that ‘no undue influence, including that of a financial nature, [must be] exerted on subjects to participate in the clinical trial.

For example, one clinical research centre in the UK provides detailed guidelines for healthy volunteers who want to participate in clinical trials (4). This assures that a small payment is ensured alongside the reimbursement of travel expenses.

Some research suggests that the amount of money received by participants influences their decision to participate.