also examines accreditation programs and quality improvement initiatives that promote voluntary efforts to exceed and not just to meet regulatory requirements.
Technically, the federal regulations on protections for human participants in research apply only to federally conducted, supported, or regulated research. Many research institutions have gone further to establish the regulations as the standard for all human research. One of the recommendations in the final chapter of this report is that all clinical research involving children should occur under the umbrella of a formal human research protection program regardless of source of funding or regulation under the Federal Food, Drug, and Cosmetic Act. (Consistent with earlier chapters, this report refers to the regulations found in 45 CFR 46 as the DHHS regulations and the regulations found in 21 CFR 50 and 56 as the FDA regulations.)
Some of the failure to comply with the federal regulations is not due to obvious shortcomings on the part of investigators, members of institutional review boards (IRBs), or others. Rather, it reflects, in part, the ambiguity and lack of clarity in the regulations themselves. The federal government must bear some responsibility for the wide range of interpretations of important elements of the regulations. This report, particularly Chapter 4, attempts to clarify some key terms and concepts in the regulations. It also recommends that the government provide more interpretive guidance and provide examples of procedures and studies that illustrate permissible research involving infants, children, and adolescents. Such guidance should help investigators and IRBs better understand their responsibilities and the boundaries between acceptable and unacceptable practices, although differences in judgment will undoubtedly remain.
Unfortunately, the committee found a particular dearth of information about compliance with the regulations as they relate to children. As a result, the group could not reach firm conclusions about compliance. One of the recommendations in this chapter is for government agencies and IRBs to collect and analyze information specific to children that will begin to allow assessment of the performance of investigators, IRBs, research institutions, research sponsors, and federal regulators. Having used its authority to establish regulations, the federal government has an obligation to collect information and take other actions to assess the extent to which they are being appropriately monitored and implemented.
As described in Chapter 1, policies and programs to protect human participants in research have evolved over several decades, often in re-