Institutional Review Board Guidance on Pediatric Research: Missed Opportunities.

Objective: To examine whether and how institutional review boards (IRBs) are using their web-sites to provide guidance to investigators conducting pediatric research. Study design: We studied guidance on pediatric research from IRB web-sites at the 25 US medical schools, plus affiliated hospitals, research centers, and public health schools, and the top National Institutes of Health-funded (>$5 million) children''s hospitals with separate IRBs. We also included 1 IRB that was not otherwise eligible because other IRBs use its web-based research ethics training program. Our final study population was 39 IRB web-sites. Results: IRB web-sites generally provide basic information about pediatric research. However, few IRBs discuss important ethical issues on which the regulations are silent. Moreover, some IRBs provide incorrect advice about the regulations. More detailed IRB guidance may help pediatric investigators think through ethical issues and protect children in clinical research. Helpful approaches we identified include checklists and “points to consider,” concrete examples to illustrate regulatory requirements, and discussion of areas of controversy. Conclusion: Few IRBs present the kind of detailed guidance that investigators might need to ensure ethically designed protocols. IRBs should revise their web-sites to ensure that they provide accurate, comprehensive, and sufficiently detailed guidance. [Copyright &y& Elsevier]