tion is appropriate. Unlike most adults, children usually lack the legal right and the intellectual and emotional maturity to consent to research participation on their own behalf. Their vulnerability demands special consideration from researchers and policymakers and additional protections beyond those provided to mentally competent adult participants in research.

As discussed later in this chapter, instances of unethical research practices involving children have prompted public criticism and concern that has contributed to the development of current federal regulations to protect both child and adult participants in research. Since the 1960s, policymakers, researchers, research institutions, and research sponsors have taken a number of steps to strengthen ethical standards and policies for human research and to create formal programs, including institutional review boards (IRBs), to approve and monitor research. Clinical studies funded, conducted, or regulated by the government are now subject to a (mostly) common set of provisions for the protection of human participants in research, including special protections for children. One result is that some potentially important clinical studies that would be approved for adult participation cannot be approved for participation by children.

At the same time, the challenges in implementing human research protection policies consistently and effectively have multiplied as clinical research has increased in size, scope, and complexity. For example, multisite studies are now the norm for much research involving children, with a consequent increase in opportunities for delays and variations in protocol reviews and approvals across different sites.

Scientific advances, such as those emerging from the Human Genome Project, have created new challenges for the assessment of risk and benefit in research involving children. As new knowledge about genetic risk emerges, the psychological consequences of knowledge may become more or less serious for children and families, as may the social and economic harms that could follow a breach of confidentiality.

Despite the strengthening of human research protection policies and programs and in the face of highly complex advances in biomedical science, deficiencies in the conduct of research—some resulting in deaths or serious injuries—continue to be exposed. The 1999 death of 18-year-old Jesse Gelsinger, legally an adult, in a gene transfer trial at the University of Pennsylvania led to widely publicized investigations and discoveries of numerous deficiencies in gene transfer trials (see, e.g., Thompson, 2000a and Weiss and Nelson, 2000). These deficiencies included the substantial underreporting of serious health problems involving participants in the trials. As one recent report concluded, “the system intended to protect [Jesse Gelsinger] from unacceptable risks in research instead failed him” (IOM, 2001, p. 4).

Less dramatic examples of deficiencies in the conduct or review of

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