Payment and Reimbursement for Research Subjects: FDA Updates Guidance

Posted 29 January 2018 | By Zachary Brennan 

Payment and Reimbursement for Research Subjects: FDA Updates Guidance

The US Food and Drug Administration (FDA) on Monday announced that it has updated guidance for institutional review boards (IRBs) and clinical investigators on paying research subjects.

The update, according to FDA, is meant "to clarify that reimbursement for travel expenses to and from the clinical trial site and associated costs such as airfare, parking, and lodging are acceptable under current practices.  This update is in response to inquiries FDA received from stakeholders about appropriate reimbursement practices. The title of this information sheet has been revised to reflect these changes. The new title is Payment and Reimbursement to Research Subjects."


Bioethics experts Holly Fernandez Lynch and Steven Joffe, professors at the University of Pennsylvania School of Medicine, took issue with a section of the updated guidance on payment as a means of coercing patients.

That section says: "Other than reimbursement for reasonable travel and lodging expenses, IRBs should be sensitive to whether other aspects of proposed payment for participation could present an undue influence, thus interfering with the potential subjects’ ability to give voluntary informed consent. Payment for participation in research should be just and fair. The amount and schedule of all payments should be presented to the IRB at the time of initial review. The IRB should review both the amount of payment and the proposed method and timing of disbursement to assure that neither are coercive or present undue influence."

Joffe tweeted at FDA, saying, "Can we please put the myths of payment as undue influence or coercion out to pasture?"

FDA told Focus that this section that Joffe and  Lynch are referring to "is from the previous version of the Information Sheet and was not changed."

Lynch also emailed articles to Focus that she co-authored last summer and in which she found that many IRBs "seem to fear that approving offers of payment that are ‘too high’ runs counter to their regulatory obligation to minimize the possibility of coercion and undue influence.

"As a result, there is a tendency toward payment conservatism: offers of payment to research participants are kept low as a precautionary measure. This better-safe-than-sorry approach, however, fails to reflect the fact that coercion is not a payment problem, that IRB review itself serves as some protection against undue influence," she and co-author Emily Largent, an assistant professor of medical ethics and health policy at the University of Pennsylvania School of Medicine, wrote in the July-August 2017 volume of the Hastings Center’s peer-reviewed journal IRB: Ethics & Human Research.

Ultimately, there is a choice, they wrote: "keep offers of payment low to eliminate even the possibility of undue influence and, as a result, risk potentially undercompensating the vast majority of research participants for whom undue influence is not at all a concern, or offer fair payments (which in many instances are likely to be higher than the status quo), which are ethically preferable for the vast majority of research participants, while allowing for the possibility that a few individuals may be unduly influenced. Both approaches entail some ethical risk, but we argue that the risk-benefit ratio of allowing higher payment to participants is the more favorable of the two."

Payment and Reimbursement to Research Subjects - Information Sheet

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