How do institutional review boards apply the federal risk and benefit standards for pediatric research?
CONTEXT: Federal regulations allow children in the United States to be enrolled in clinical research only when the institutional review board (IRB) determines that the risks are minimal or a minor increase over minimal, or that the research offers a prospect of direct benefit. Despite this reliance on IRBs, no data exist on how IRBs apply the risk and benefit categories for pediatric research. OBJECTIVE: To determine how IRB chairpersons apply the federal risk and benefit categories for pediatric research. DESIGN, SETTING, AND PARTICIPANTS: Telephone survey, conducted between May and August 2002 of 188 randomly selected chairpersons of IRBs in the Unites States. The survey consisted of 21 questions to assess the application of federal risk standards to research procedures, whether certain interventions offer a prospect of direct benefit to participating children, and the extent to which IRBs use the federal definition of minimal risk when categorizing the risks of research procedures i
Related Questions
- When should an Institutional Review Board (IRB) or institution request a "407" review for research involving children as subjects?
- How do institutional review boards apply the federal risk and benefit standards for pediatric research?
- What categories of research involving children can an Institutional Review Board approve?
