Printer Friendly, PDF & Email

SACHRP: Payment for Food, Income, Don't Compromise Research Consent

Individuals who participate in research trials make some sacrifice to do so, there can be little argument, even if they expect to benefit personally—and many do not. So shouldn’t they be compensated in some way, with payments or gifts that recognize their contributions?

But investigators, institutional review boards (IRBs) and institutions have struggled with how to offer payments and tokens without providing “undue influence,” as this is not permitted under regulations enforced by the Food and Drug Administration (FDA) or the HHS Office for Human Research Protections (OHRP).

As requested by FDA and OHRP, a federal advisory committee has now weighed in.[1] The Secretary’s Advisory Committee on Human Research Protections (SACHRP) recently submitted detailed recommendations on the topic to HHS.

As the committee explains, “SACHRP has been asked to consider whether there is a need for additional updates to guidance related to payments that go beyond reimbursement of participant expense.” In particular, “recommendations are sought as to whether and when payments to study participants may constitute an undue influence” as included in FDA regulations 21 C.F.R. § 50.20 and HHS regulations 45 C.F.R. § 46.116.

In 2018, FDA added some nuance to its regulations,[2] noting that an “information sheet” provides “explicit recognition that reimbursement payments do not raise concerns about undue influence.”

SACHRP’s view is that this document “does not go far enough,” and that both FDA and OHRP should issue new guidance that both addresses the fact that “compensation and token appreciation payments [also] do not raise concerns about undue influence.”

This document is only available to subscribers. Please log in or purchase access.