federal regulations and the roles and responsibilities of investigators, institutional review boards (IRBs), research institutions, research sponsors, and policymakers in implementing federal regulations and, more generally, sustaining an effective system of protections for human participants in research.

This chapter presents an overview of current federal regulations. The overview is mainly descriptive, with more analysis as well as recommendations and other guidance offered in subsequent chapters. Later sections of this chapter briefly describe other policies for protecting the safety of participants in certain clinical studies and, in addition, policies relating to research conducted in other countries.

Appendix B discusses state policies relevant to the conduct of research involving children. These policies include laws defining the age of majority (when minors become adults) and the circumstances when individuals under the age of majority can provide consent to medical care or research participation. Most states do not have specific policies and regulations on the protection of human participants in research. Appendix C summarizes conflict-of-interest and privacy policies (including the Health Insurance Portability and Accountability Act) that also contribute to the protection of research participants.

Overall, the committee concluded that the federal regulations providing special protections for child participants in research are generally appropriate for children of different ages. They reasonably defer to state laws defining the age at which individuals become entitled to make decisions about their medical care and the special circumstances under which minors may make decisions in their own right. For the most part, the problems with the regulations relate to variability in the interpretation of criteria for approving research that include inherently subjective elements that the committee doubts would be substantially and predictably clarified by the time-consuming process of revising the regulations. As discussed in Chapter 5, one change the committee does recommend is that the Food and Drug Administration (FDA) make its policies on the waiver of parental permission consistent with the U.S. Department of Health and Human Services (DHHS) regulations that permit such waivers under certain circumstances.

A number of commissions and committees have recommended that federal policymakers formally extend regulatory protections for human participants in research to all research, regardless of the source of funding or the regulatory status (see, e.g., NBAC, 2001b and IOM, 2003a). As discussed in Chapter 8, this committee agrees. It recognizes, however, that the federal government may not have the authority to do this, so it also encourages state governments to exercise their authority to regulate research in ways that are consistent with federal regulations and supportive of multistate studies.

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