A group of researchers are proposing a framework for evaluating payments to reimburse, compensate and incentivize volunteers to participate in clinical trials and other studies involving human subjects.
The framework, detailed in an article in the New England Journal of Medicine last week, describes what investigators and institutional review boards (IRBs) should consider when proposing or reviewing payment offers with the aim of dispelling some of the confusion surrounding paying research participants.
While US regulations covering human-subjects research do not specifically discuss payment, they require IRBs to "minimize the possibility of coercion or undue influence" during the consent process and regulatory guidance from both the Office for Human Research protections (OHRP) and the US Food and Drug Administration (FDA) associate payments with the potential for undue influence.
For instance, OHRP writes in its guidance: "IRBs must be sensitive to whether any aspect of the proposed remuneration will be an undue influence, thus interfering with the potential subjects' ability to give voluntary informed consent."
Similarly, FDA writes that while "paying research subjects in exchange for their participation is a common and, in general, acceptable practice," it cautions that IRBs should be sensitive to whether payments other than those reimbursing for travel and lodging expenses could present an undue influence on participants.
"Given the ambiguity in the bioethics literature and regulatory landscape, the design and evaluation of offers of payment to research participants can be challenging," the authors write, noting that until now there has not been a widely accepted framework for evaluating such payments.
Specifically, the framework includes nine considerations for investigators to weigh when developing payment offers, such as considering increasing safeguards for participant comprehension and informed consent when payment amounts are higher, and ten considerations for IRBs to consider when reviewing proposed payment offers, such as acknowledging the potential benefits of improved recruitment through the use of incentives.
By developing the framework, the authors say they hope to clarify the ethical issues and practical considerations surrounding payments to research participants.
Speaking to Focus, bioethicist Holly Fernandez Lynch of the University of Pennsylvania and one of the paper's authors said that guidance from FDA and OHRP tells IRBs and investigators to be careful around the types and amounts of payment offered to participants, which "gives reason for IRBs and investigators to take a better-safe-than-sorry approach."
What this leads to, Lynch said, is a situation where there is more concern about paying participants too much, and not enough concern about paying them too little.
"You do need to pay attention to the ethical problems of paying people too little, because if you pay them too little you might not adequately recruit for your trial, which means you're not going to be able to answer your scientific question, and it means that you might be being unfair to research participants because you're not fairly compensating them for their contribution," she said.
Lynch also pointed to a recent update to FDA's information sheet on payment and reimbursement to research subject participants as a missed opportunity for the agency to clarify ethical issues around payments.
"FDA issued some clarification that reimbursing participants for their costs of participating is fine, but when they come out and say reimbursement is fine but then fail to say that compensation and incentives are also fine, that implication suggests that those other types of payment are problematic," Lynch said.