Thus, it is important for organizations such as the American Academy of Pediatrics, the Society for Pediatric Research, and the Society for Adolescent Medicine to remain attentive not only to the need for research but to the need for continued vigilance in protecting infant, child, and adolescent participants in research.
IRBs are the cornerstone of a system in which other entities, such as research sponsors, also have obligations to protect research participants.
Institute of Medicine, 2003a, p. 70
Much of the administrative infrastructure and activity that contribute to competent and ethical IRB and research institution performance will support equally the protection of adult and child participants in research. Beyond this foundation, however, both the research institutions that conduct research involving children and the local, central, or independent IRBs that review such research have further ethical and legal responsibilities that demand special attention. Box 8.2 summarizes these responsibilities, which begin with educating IRB members, investigators, and others about their ethical and legal responsibilities for protecting child participants in research.
The effective performance of IRB responsibilities can be threatened by the accretion of additional responsibilities for activities such as managing institutional risk related to research activities, assessing potential investigator or institutional conflicts of interest, and overseeing institutional compliance with a range of other research-related policies. Given the magnitude of the tasks involved in effectively overseeing the ethical aspects of human research, research institutions will best promote the objectives of this oversight by assigning other tasks to units other than the IRB as recommended in Responsible Research (IOM, 2003a). That report also argued for keeping IRBs (what it termed research ethics review boards) focused on the ethical dimensions of human research through the development of “distinct mechanisms” to provide separate, prior reviews of protocols for scientific merit and financial conflicts of interest. The results of these two separate reviews would then inform the final determinations made by the IRB.
A critical obligation of IRBs is to bring appropriate expertise to the review of research involving infants, children, and adolescents. The federal regulations on children do not, however, explicitly require that IRBs in-