16 - Participant Payments and Undue Influence

Background:  IRBs assess if proposed research methods present undue influence to participants. Some IRB discussions consider if proposed monetary incentives present undue influence. This poster analyzes literature on monetary incentives and undue influence and contrasts it with federal guidance (OHRP, FDA, SACHRP) on avoiding undue influence.

Methods:  This conceptual analysis consisted of a literature review of peer-reviewed journal articles on incentive payments and undue influence on research participants. Common themes were identified. Additionally, federal guidance documents from OHRP, FDA, and SACHRP were analyzed. Federal guidance outlines situations where incentive payments are problematic. The themes identified from journal articles and federal guidance were compared.

Conclusion:  In general, themes identified during the literature review suggest that the authors did not consider monetary incentives to pose undue influence to potential participants in most situations. In general, the authors find many undue influence concerns typically discussed by IRBs not to be based on empirical findings. Instead, research shows that limiting payments due to concerns of undue influence may unnecessarily hinder a research project without mitigating any risks. Further, some argue that the practice of having low payments may be less respectful of the effort participants make while in a study. OHRP and FDA guidance provide few specifics about when incentive payments can cause undue influence but imply that incentives can be problematic. SACHRP provides a nuanced position and offers recommendations to OHRP and FDA. In general, SACHRP considerations acknowledge many of the themes identified in the literature review but still caution IRBs to carefully consider the study-specific reasons for providing payments.

Limitations: A limitation of the literature review is a bias toward articles that conclude that incentive payments do not present undue influence. Some of the authors directly oppose common IRB prohibitions against high incentive payments or advertisements that include the amount of incentives. There may be ethicists who believe incentive payments can have undue influence, but since these align with common IRB positions, they are less likely to publish articles in support of their position.

Discussion:  The literature review revealed many compelling arguments that participant payments do not have undue influence on participants. Given that IRBs are tasked with reviewing scientific research, it makes sense that they should allow science to guide policymaking on such issues as the appropriateness of incentive payments. Even though the literature review suggests that IRBs have overly strict approaches to assessing undue influence, the SACHRP recommendations demonstrate that the IRB community is aware of the nuances of when or if payments present undue influence for a specific study.