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:  The literature review and analysis revealed compelling arguments suggesting that incentive payments do not unduly influence research participants, especially in cases where participants are not exposed to risk. However, several authors raised concerns about the lack of clear, consistent guidance from regulatory bodies such as OHRP and FDA, suggesting that current regulations and existing guidelines do not adequately address undue influence with respect to appropriate levels of monetary compensation and the fine line between acceptable inducements and problematic offers. Other authors questioned the extent to which such regulations and guidelines (a) ensure that research participants fully understand risks in the context of financial inducements that may alter risk perception, and (b) provide sufficient protection for economically disadvantaged study populations. Although some of the journal articles we reviewed suggest that IRBs are overly strict in their approach to assessing undue influence, SACHRP recommendations demonstrate that the IRB community is well aware of the nuances involved in paying research participants.

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.

Discussion:  It is important to scientifically evaluate whether monetary incentives have an undue influence on research participants and, if so, to identify the circumstances under which this occurs. Given that IRBs are tasked with reviewing scientific research, they should allow science to guide policymaking on issues such as the appropriateness of incentive payments. In addition, there is a tangible need for situation-specific guidance that incorporates empirical evidence regarding participants’ perspectives and economic behavior.