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.
