dearth of information about pediatric research and protection programs for research involving children makes it difficult to adequately describe how well federal regulations are working, and impedes efforts to improve policies and practices, the report says. HHS should develop and carry out a plan for collecting and reporting data on pediatric research and its oversight. Plus, local and national professional organizations and research institutions should voluntarily promote quality-improvement efforts in the design, review, and conduct of clinical research.
IRBs that review protocols for pediatric clinical studies should include at least three members with expertise in children's health care and research, psychosocial dimensions of child health, and pediatric research ethics or the boards should bring in people with this knowledge, the committee said. And IRBs should educate reviewers and investigators about their ethical and legal obligations to protect child participants in research. Educational materials and policy guidance should be easy to find and understand.
Federal officials should play key roles in improvement efforts. OHRP, FDA, NIH, and other relevant agencies should provide review boards and investigators with comprehensive, consistent, and easily accessible documents that explain how to interpret and apply federal regulations, the report says. Likewise, federal agencies should cooperate in the continued development of education programs for researchers, IRBs, pediatric academic societies, and other groups at all levels.
The report was sponsored by the U.S. Department of Health and Human Services. The Institute of Medicine is a private, nonprofit institution that provides health policy advice under a congressional charter granted to the National Academy of Sciences. A committee roster follows.
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Contact: Vanee Vines
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