Survey IRB Chairs Regarding Interpretation Of Use Fede

为了评估对参加临床研究的儿童的保护，重要的是评估审查此类研究的机构审查委员会（IRB）如何解释和实施45CFR 46子部分d中关于儿童研究的联邦法规。本研究旨在通过与IRB主席的访谈来收集这些信息。该调查特别旨在评估irb如何评估儿童研究的风险/收益水平，当irb允许放弃儿童同意时，irb要求儿童在同意过程中提供哪些信息，以及哪些儿童被排除在高风险研究之外。此外，该调查将试图确定最近NIH关于将儿童作为参与者纳入涉及人类受试者的研究的政策和指南如何影响IRB审查。调查对象包括医学院儿科部门、儿童医院、接受NICHD资助的研究所使用的美国irb的主席，以及目前正在运作的私人irb的主席。本研究已获得NICHD IRB的批准。调查已经完成，我们正在记录调查结果。

In order to assess the protection of children who are enrolled in clinical research, it is important to assess how Institutional Reveiw Boards (IRBs) reviewing such research interpret and implement the Federal Regulations for research with children set forth in 45CFR 46 Subpart D. This study aims to gather this informatin through interviews with IRB chairpersons. In particular, the survey aims to assess how IRBs assess risk/benefit levels of research with children, when IRBs permit children's assent to be waived, what information IRBs require children to be presented during the assent process, and which children are excluded from participation in riskier research. In addition, the survey will attempt to determine how the recent NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects has affected IRB review. The survey will be administered to the chairpersons of the U.S. IRBs used by pediatric departments of medical schools, children's hospitals, institutes that receive NICHD funding, and also the chairpersons of the currently functining private IRBs. This study was approved by the NICHD IRB. Surveying is completed and we are currently writing up the results.