By David Forster, JD, MA, CIP, Chief Compliance Officer, WCG
Paying participants for the essential role that they play in clinical trials is important, but the amount given, and how it is paid, require careful consideration.
Appropriately compensating clinical trial participants lessens the financial burden placed on them by participation in research and increases the pool of possible contributors. As a result, sponsors can increase diversity in their clinical trials, and make sure that they are truly representative of the patient population. Compensation increases recruitment, allowing studies to be completed efficiently, saving time, money, and staff resources. It also recognizes participants for their contribution to advancing medical science.
But how can sponsors strike the right balance between compensating research participants to achieve those benefits, while minimizing the potential for the payments to have an undue influence on their behavior?
The U.S. Food and Drug Administration (FDA) states that an investigator can only seek a person’s consent to join a clinical trial if the prospective participant has “sufficient opportunity to consider whether or not to participate” under circumstances that “minimize the possibility of coercion or undue influence.”1 As coercion involves a threat of force, payments can never be coercive, but they could be unduly influential.
Primary concerns are that payments might interfere with participants’ ability to give voluntary informed consent, by encouraging them not to fully consider the risks, burdens, and discomforts associated with the research, or to ignore side effects during the trial due to their desire to complete the study and get paid.