mainly from the possibility of injury to offspring resulting from women's participation in clinical drug trials.

INSTITUTIONAL FRAMEWORK

Health-related research and development in the United States is supported by the federal government (predominantly through the National Institutes of Health [NIH]), the pharmaceutical industry, and private foundations. This institutional structure can affect the conduct of research because it is the source not only of funding, but also of procedures for reviewing the ethics of scientific research-including whether a proposed plan for selecting research participants is just-and of the legal requirements applicable to research.

NIH, located within the Public Health Service (PHS) of the Department of Health and Human Services (DHHS), is the single largest supporter of biomedical and behavioral research and development (health R&D) in the world. NIH underwrites approximately 73 percent of all health R&D supported by the U.S. federal government, and about 30 percent of all health R&D in the United States. In fiscal year 1992 the projected NIH health R&D budget was $8.4 billion (NIH, 1992).

NIH is an extraordinarily complex organization. It includes a federation of 16 institutes, the National Library of Medicine, two divisions, and four centers. All of these components are coordinated by the Office of the Director. NIH policies have a profound effect on other organizations that have health-related missions, including other federal agencies, awardee institutions, and private foundations and corporations that support or conduct health R&D. Many institutions simply adopt NIH policies and procedures. Other organizations, both public and private, adapt NIH policies to suit their own structures and needs.

Most NIH funding components have a twofold structure. Extramural programs support health R&D projects carried out by research institutions throughout the United States and in at least 80 nations worldwide. Intramural programs, operated by federal employees, conduct research on the NIH campus in Bethesda, Maryland, and at a number of other locations throughout the country (Maryland, North Carolina, Colorado, Florida, and other states). Approximately 88 percent of the NIH research budget is disbursed to nonfederal institutions through grants-in-aid, contracts, and cooperative agreements (NIH, 1992). Awards are made by NIH funding components operating with the advice of a large and carefully regulated peer review system. Grant applications submitted to NIH by extramural institutions are typically reviewed by initial review groups (IRGs), commonly called study sections, that conduct scientific merit review and assign a priority score to each application that it recommends for funding. Approximately 20 percent



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