Payment to Participants in Pediatric Research: Variation in IRB Members' Attitudes

Much has been written on the ethics of compensating parents and/or children who participate in pediatric studies, and there is general consensus about the need for heightened scrutiny regarding such payments. Neither the Department of Health and Human Services's regulations governing research with humans nor the Food and Drug Administration's (FDA) regulations prohibit payment to research participants. The final responsibility for assessing the appropriateness of payment approaches in specific studies falls to institutional review boards (IRBs). Guidance from the Office for Human Research Protections and the FDA is limited to telling IRBs to ensure that payments are not coercive or unduly influential. Yet a recent national survey indicates that IRB members have difficulty determining when a payment approach constitutes undue inducement or coercion. Here, Crites et al describe the findings from a small exploratory investigation about how IRB members approach their review of payment approaches in pediatric research.