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1. Introduction
Pages 17-32

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From page 17...
... There is broad agreement among the American people, Congress, and the Executive Branch that investing in biomedical research is socially desirable because of its health benefits, its capacity to increase understanding of the human condition, and its potential to directly or indirectly yield economic dividends. The assumption that federally funded scientific research generates economic and other benefits for the country has been fundamental to US science policy since the end of 1Biomedical research in this report includes all the following categories of research: fundamental (basic)
From page 18...
... To ensure its continued effectiveness, NIH must respond in a rapidly changing environment that is characterized by a renewed appreciation of the complexity of human biology; the increasing need for cooperation among biomedical and related disciplines and scientists working in different sectors; growing investments in biomedical research by the US corporate sector and other countries; the need to deal 2The other seven are the Agency for Healthcare Research and Quality, the Agency for Toxic Substances and Disease Registry, the Centers for Disease Control and Prevention, the Food and Drug Administration, the Health Resources and Services Administration, the Indian Health Service, and the Substance Abuse and Mental Health Services Administration.
From page 19...
... He acknowledged the political advantages of establishing new institutes and centers but argued that NIH would be more effective scientifically and more manageable if it were organized into a far smaller number of larger institutes 3For example, congress recommended that NIH establish an office of sioimaging and sioengineering' an idea that former NIH Director Harold varmus welcomed. However, varmus cautioned that establishing a new Institute of sioengineering and sioimaging was not a good idea because such activities benefit more by being distributed among the full range of institutes and centers at NIH (NIH, 1999)
From page 20...
... Five of these would be categorical institutes, committed mainly to groups of diseases the National cancer Institute, the National Brain Institute, the National Institute for Internal Medicine Research, the National Institute for Human Development, and the National Institute for Microbial and Environmental Medicine. Each of these would contain several major divisions for extramural research and an intramural research program.
From page 21...
... created a uniform patent policy among the many federal agencies that fund research, enabling small businesses and nonprofit organizations, including universities, to retain title to inventions made in federally funded research programs, thereby creating a new congressionally mandated responsibility of NIH to 5These trends have been cited by NIH leaders. See, for example, the remarks of Director Elias Zerhouni at a field hearing held by a subcommittee of the House Science Committee (Jenkins, 2002a)
From page 22...
... As a result of the steady stream of change, there have been persistent and growing concerns in Congress and in some parts of the scientific community about whether NIH has become too fragmented to address effectively the most important biomedical and health challenges or to respond quickly enough to health emergencies or economic challenges. Despite those persistent concerns, NIH has never been administratively reorganized in any substantial way, but only added to, despite vast changes in the landscape of science and the nation's health concerns during the last half century.
From page 23...
... The Committee on the Organizational Structure of the National Institutes of Health was formed to ensure that the views of the basic science, clinical medicine, and health advocacy communities were all adequately represented. The Committee also included persons who were experienced in the management of large and complex organizations, including a former NIH director, two former NIH institute directors, a former university president, two individuals with backgrounds as senior managers of major industrial entities, and a specialist in organizational issues.
From page 24...
... Even a relatively narrowly defined focus on the organizational structure of NIH was challenging because of the need to disentangle structure, procedure, policies, achievements, criticisms, and priorities. For example, the Committee debated whether its charge referred solely to the number of institutes and centers that can be effectively and responsibly managed or could it also assess the role and authority of the NIH director?
From page 25...
... Therefore the Committee considered numerous proposals for restructuring NIH in great detail7 but did not focus exclusively on whether or not there should be a widespread consolidation of NIH's institutes and centers. Rather, it took a more general approach, namely to inquire if there were any significant organizational changes including the widespread consolidation of institutes and centers that would allow NIH to be even more successful in the future.
From page 26...
... At a minimum, because Congress created the institutes, dissolving or merging institutes would require congressional action. Any thoughtful major reorganization would necessitate a lengthy and complex information gathering and decision making process that would include numerous congressional hearings involving members of Congress, congressional staff, and a wide variety of interests in the various health advocacy and scientific communities.
From page 27...
... The intent of this report is to assess the current organizational structure of NIH and to suggest modifications that might be appropriate to make NIH even more effective in supporting research essential to the long-term goal of improving human health. GENERAL PRINCIPLES BY WHICH NIH SHOULD BE ORGANIZED NIH accomplishes its objectives through the design, organization, administration, and management of extramural and intramural research and training programs and the provision of specialized research facilities that support the programs.
From page 28...
... Most important in this respect is an understanding of the evolving nature of the scientific enterprise, which includes not only the changing nature of science itself, but also the evolving role of other institutions and disciplines, both here and abroad, that have generally similar aims as well as the changing nature of our health concerns. Recognition of the global nature of medical and health problems and their relevance to the interests and health of the people of the United States warrants special mention.
From page 29...
... Moreover, NIH is but one of eight DHHS agencies charged with a health-related mission. The other agencies Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, the Agency for Toxic Substances and Disease Registry, the Food and Drug Administration, the Health Resources and Services Administration, the Indian Health Service, and the Substance Abuse and Mental Health Services Administration also focus on health and complement the research mission of NIH.
From page 30...
... The chapter proposes changes that would enhance the NIH director's authority, particularly as related to trans-NIH initiatives that should begin to constitute a larger proportion of NIH activities, mechanisms for fostering high-risk research, and the intramural research program. Chapter 6 discusses issues related to NIH's need to be publicly and financially accountable through its advisory and review processes, data systems, leadership,
From page 31...
... Independently of budget issues, NIH is increasingly called on to perform in a coordinated way to address key research subjects that involve multiple institutes and to respond to immediate public health needs. An important question is whether NIH's federated and decentralized structure, as currently configured, can respond adequately and in a timely manner to those challenges.
From page 32...
... , and Office of Medical Applications of Research (1977) Office of Behavioral and 1995 Social Sciences Research Major Focus Planning, coordination, evaluation, and funding of all NIH AIDS research and support of trans-NIH coordinating committees in areas of AIDS research Focal point for women's health research at NIH, including establishment of a research agenda; inclusion of women as participants in NIH-supported research; and support of women in biomedical careers Coordination of disease prevention activities, advice to director on disease prevention research; promotion and coordination of NIH-wide research on rare or orphan diseases and on the role of dietary supplements in health; work with institutes and centers to assess, translate, and disseminate results of biomedical research that can be used in delivery of health services Stimulation of behavioral and social science research throughout NIH and its integration with other research conducted or supported by NIH The Budget Process To understand how NIH has evolved, it is important to unclerstand its funding environment and budget process (see Figure 2.2~.


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