Weise Kathryn L, Smith Martin L, Maschke Karen J, Copeland H Liesel
Department of Pediatric Critical Care, Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA.
Pediatrics. 2002 Sep;110(3):577-82. doi: 10.1542/peds.110.3.577.
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.
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.
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.
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.
据报道，向参与研究的受试者支付报酬很常见，但尚无已发表的数据记录这种做法的性质。机构审查委员会（IRB）负责确保研究受试者的安全和自愿参与，然而，来自联邦和儿科专家的关于适当支付方式的指导意见相互冲突。成人与儿科研究受试者参与支付的伦理问题可能有所不同。这项实证研究旨在调查IRB报告的当前儿科研究参与支付做法。
向美国儿童医院及相关机构协会成员机构的IRB主席，以及从保护研究风险办公室列出的IRB主席系统随机样本发送了一份关于儿科研究参与支付做法的18个问题的调查问卷。使用描述性、非参数和定性分析来描述机构类型、支付做法以及回答之间的相关性。
来自128个进行儿科研究的机构的数据显示，66%的回应机构允许为参与儿科研究支付报酬，且各机构做法差异很大。大多数允许支付的回应IRB要求在入组前（同意过程中）披露支付情况，比美国儿科学会的指南更严格地遵循联邦指南。IRB对一项研究潜在益处或危害的认知与批准的支付金额相关。
IRB必须在招募儿科研究受试者的需求与招募过程中不当影响的风险之间取得平衡。联邦指南和儿科专家意见在支付建议方面存在差异；回应的IRB似乎比美国儿科学会提出的指南更严格地遵循联邦指南。
