OBJECTIVE: Payment to subjects for participation in research is reportedly common, but no published data documents the nature of this practice. Institutional review boards (IRBs) are responsible for ensuring both the safety and voluntary participation of research subjects, yet guidance from federal and expert pediatric sources regarding appropriate payment approaches is conflicting. Ethical issues of payment for participation of adult versus pediatric research subjects may differ. This empirical study sought to examine current payment practices for participation in pediatric research as reported by IRBs. DESIGN: An 18-question survey regarding payment practices for participation in pediatric research was sent to IRB chairs at member institutions of the National Association of Children's Hospitals and Related Institutions, and to a systematic random sample of IRB chairs listed with the Office for Protection From Research Risks. Descriptive, nonparametric, and qualitative analyses were used to describe institution types, payment practices, and correlations among responses. RESULTS: Data from 128 institutions that conduct pediatric research revealed that payment for participation in pediatric research was allowed by 66% of responding institutions, and practices varied widely among institutions. Most responding IRBs that allowed payment required disclosure of payment before enrollment (during the consent process), following federal guidelines more closely than American Academy of Pediatrics guidelines. An IRB's perception of potential benefits or harms of a study correlated with the amount of payment approved. CONCLUSIONS: IRBs must balance the need to recruit pediatric research subjects against the risk of undue influence during the recruitment process. Federal guidelines and expert pediatric opinion differ in recommendations regarding payment; responding IRBs appeared to follow federal guidelines more closely than guidelines proposed by the American Academy of Pediatrics.
OBJECTIVE: Payment to subjects for participation in research is reportedly common, but no published data documents the nature of this practice. Institutional review boards (IRBs) are responsible for ensuring both the safety and voluntary participation of research subjects, yet guidance from federal and expert pediatric sources regarding appropriate payment approaches is conflicting. Ethical issues of payment for participation of adult versus pediatric research subjects may differ. This empirical study sought to examine current payment practices for participation in pediatric research as reported by IRBs. DESIGN: An 18-question survey regarding payment practices for participation in pediatric research was sent to IRB chairs at member institutions of the National Association of Children's Hospitals and Related Institutions, and to a systematic random sample of IRB chairs listed with the Office for Protection From Research Risks. Descriptive, nonparametric, and qualitative analyses were used to describe institution types, payment practices, and correlations among responses. RESULTS: Data from 128 institutions that conduct pediatric research revealed that payment for participation in pediatric research was allowed by 66% of responding institutions, and practices varied widely among institutions. Most responding IRBs that allowed payment required disclosure of payment before enrollment (during the consent process), following federal guidelines more closely than American Academy of Pediatrics guidelines. An IRB's perception of potential benefits or harms of a study correlated with the amount of payment approved. CONCLUSIONS: IRBs must balance the need to recruit pediatric research subjects against the risk of undue influence during the recruitment process. Federal guidelines and expert pediatric opinion differ in recommendations regarding payment; responding IRBs appeared to follow federal guidelines more closely than guidelines proposed by the American Academy of Pediatrics.
Entities:
Keywords:
Biomedical and Behavioral Research; Empirical Approach