This largely descriptive chapter has provided an overview of federal regulations intended to protect adults and children involved in research. It has noted several issues that are considered further in the remainder of the report. These issues include the uncertainty and confusion over the interpretation of key concepts in the regulations; the adequacy of pediatric expertise in IRB review of research involving children; and the lack of regulatory protections for adults and children participating in research that is not federally conducted, funded, or regulated.

The following chapters highlight a number of additional concerns, including the lack of data on the performance of the system of research protections for children. Without such data, it is impossible to judge how effectively and efficiently the system is working overall and where it may be failing those whom it is supposed to protect.

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