Whether and how a participant is compensated for taking part in a clinical study are two of the decisions an institutional review board (IRB) makes when approving research. The IRB must ensure participants are not unduly influenced to join the research and that the research is just, beneficial, and the participants are respected. Participant payments can include reimbursement of reasonable expenses for travel to and from the research site, fair compensation for the participant’s time, effort, burden, and inconvenience, token payments of appreciation, etc. A detailed description and analysis of participant payments was carried out by the Secretary’s Advisory Council on Human Research Protections (SACHRP),1 and this article uses the terms described by SACHRP.
Protecting Clinical Trial Participants
IRBs are tasked with protecting the rights and welfare of research participants. IRBs came into being as a result of the Belmont Report.2 The Belmont Report established three ethical principles: justice, beneficence, and respect for persons. These principles form the basis of the U.S. Food and Drug Administration (FDA) and Office of Human Research Protections (OHRP) regulations governing research with human participants. Both agencies publish guidance to help IRBs interpret the regulations. In 2022, the DEPICT Act was passed, requiring applications to the FDA for an investigational use exemption for new drugs and devices “to include information about the demographic diversity of the clinical trial population and addresses related issues.”3
The three pillars of the Belmont Report are broad concepts. IRBs have further refined respect for persons to focus on the idea of autonomy. This concept undergirds ideas around informed consent and freedom from undue influences. Participant payments have historically been viewed through the lens of undue influence and that has led IRBs to minimise payments in order to allay those concerns.
More recently, scholars4 and SACHRP have published work supporting the idea that lowering payments does not decrease undue influence. In fact, they report that this approach can negatively impact respect for persons by failing to acknowledge the full context of participants’ lives and the sacrifices in time and effort they must make to participate in a research study.
Research should also be just. The burdens and benefits of research should be accrued by all. As outlined in the DEPICT Act, the industry has fallen short of ensuring that research participant populations reflect the general population, and this is a failure of justice as well as science. As IRBs evaluate diversity plans, one area warranting particular attention is participant payment or compensation.
Appropriate payment to research participants is critical for diversifying clinical research participation. When payments and reimbursements to research participants are limited, those who have less free time, less available income, or more burdensome lives are less likely to participate, resulting in a study with a participant population that does not reflect society. Sponsors, sites, and IRBs all play a role in approving participant payment plans, but payment structures are often not transparent, and decisions may be made without a deep understanding of how differences in payments affect participant enrollment and retention.5