sponse to public outcries over publicized instances of unethical or questionable research practices. The first stages of that evolution involved recognizing problems, placing them within an ethical framework, and developing standards and public policies for the ethical conduct of human research. Over time, policies became more formal as the government adopted regulations and expanded their scope, for example, by adding special protections for vulnerable populations, such as children and prisoners.

In the last decade and a half, concern has increasingly focused on the implementation of the regulations at all levels—the investigator, IRB, research institution, and government levels—and on the adequacy of resources devoted to this task. A series of reports have noted progress in human research protections but have also described deficiencies in their implementation and have made recommendations for improvement.

No report has, however, focused explicitly on problems in implementing the federal regulations protecting child participants in research. In the committee’s experience, however, the problems identified for human research protection programs generally extend to implementation of research protections for children. Indeed, the problems may be amplified in pediatric research for the reasons identified throughout this report. These reasons include the particular challenges of designing and conducting pediatric research, the limited amount of such research in many institutions, and the difficult or ambiguous concepts included in the regulations governing child participants in research.

Government Reports on Human Research Protection Regulations and Programs

A 1996 report by the General Accounting Office (GAO; an arm of the U.S. Congress) concluded that the regulatory oversight of biomedical and behavioral research had reduced the likelihood of abuses of human research participants. Nonetheless, it warned that no system of research protections can be foolproof and that limited resources and other constraints threatened the effectiveness of both local review boards and federal oversight (GAO, 1996). The report stressed the need for continued vigilance in protecting human participants in research and warned against overreliance on investigators’ voluntary compliance with regulatory requirements. A 2001 statement from the GAO noted several areas of progress since its earlier report but expressed continuing concern that the “pace of some actions is too slow” and “gaps remain” (Heinrich, 2001, p. 12). In addition to reiterating concerns about inadequate oversight resources at both the federal and local levels, it cited problems with insufficient guidance on informed consent and unclear requirements for adverse event reporting. That same year, another GAO report urged more forceful direction from the U.S. Depart-

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