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Chapter 3 NIH AND THE HEALTH POLICY ENVIRONMENT The Need for Communication and Coordination If NIH ant its seater agencies in the Public Health Service are to be responsive to health needs and to promote scientific excellence, there must be clear channels of communication between them, the public, and Congress to make sure that policies are coordinated and well in tune with health research needs. Such communication has always taken place, but generally in a highly informal manner. It is now time, the committee believes, to formalize certain aspects of this process. In particular, the process must respond to changes in recent years con- cerning the scope of health research and governmental patterns and practices, which together have increased external pressures for organizational change within the Public Health Service. The Scope of Health Research Many of the most recent proposals for organisstional change at NIH reflect interests in improving and strengthening research areas at the boundaries of NIH's current mission. In recent years, for instance, there have been legislative and other proposals for a National Institute of Nursing Research and a National Institute of Public Health. There also have been proposals for the transfer into NIH of the National Center for Health Services Research, the National Institute for Occupational Safety and Health, the National Center for Health Statistica, and the National Institute of-Mental Health. Ant there have been calls for NIH to do more on technology assesement and transferring research results into practice. These "boundary isauea" share many common feaeurea. First, they are all examples of health research, broadly defined. As acientiata' perceptions about the determinants of health widen, as the federal government's role in the provision of health care expands, and as the nation becomes more concerned about health care expenditures, health research that include a more than traditionally conceived biomedical research is increasingly recognized as necessary to the nation'a well- being. Second, although the research mission of NIH does not totally include any of the research arena mentioned above, it also toes not totally exclude them. Third, not all of these areas enjoy the same

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25 prestige and visibility as does the biomedical research now carried out by NIH. Finally, some of the agencies proposed for transfer have regulatory or health service delivery mi88ion8 that, while of great importance, are distinctly different from that of NIH. Because of the complexity of the individual cases, it was not possible for the committee to decide whether the nation'a needs would be best served by expanding the NIH mandate to include particular areas, by having them addressed by other agencies, or by devising improved methods of coordinating functions that inevitably cut across organizational lines. The committee believes that such boundary issues and the challenges of improved coordination and priority setting are crucial both for NIH and the integrity of the federal health structure, and that there must be a mechanism to assist the Assistant Secretary for Health to investigate these matters systematically and to propose workable solutions. Governmental Patterns and Practices For many years, Congress has been highly supportive of NIH and deeply involved in shaping its research priorities in broad terms. Over time, however, the nature of the relationship between NIH and Congress has changed. In the 1950s and 1960s, the relationship between NIH and the public was focused in Congress by close working relationships among Senator Lister Hill, chairman of the authorization committee and the appropriations subcommittee in the Senate with authority over the budget of the NIH; Representative John Fogarty, chairman of the appropriations subcommittee in the House of Representatives; and James Shannon, the Director of NIH.27 Public interest, to a large extent, was exerted through the lon~-term involvement ant commitment of Mary Lasker and her associates.2 The result was unified and organized public and congressional interest in NIH. This strong central focus depended partly on the personalities involved, but also on the way that congressional affairs were conducted in those years. Since then, these relationships have changed. First, the members and committees of Congress now have staff numbering about 17,000, more than five times as many as in 1947.29 This has led to increased involvement in day-to-day Executive Branch activities, and the knowledge, ability, and incentive to write very specific directives into law or legislative reports. Second, partly because of legislation enacted in the pant decade, authorization committees as well as appro- priations committees now have substantial impact on NIH activities. Some of the institutes, for instance, must now be periodically reauthorized by Congress. The result of these and other changes in governmental operations is that NIH management has gradually become more fragmented ant less coordinated.

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26 In response to constituent pressures and sometimes because of a perception that NIH would not initiate action on its own, Congress often has proposed new institutes or other organizational changes to emphasize particular diseases or health problems. NIH has consistently opposed these changes, ant thus has acquired an image of being opposed to Innovations proposed from outaide~the agency. Organizational changes should not be the only means, or even the primary means, of Implementing changes in research priorities. Therefore, there should be an effective mechanism for judging the need for organizational changes as a means of addressing priorities, using the criteria suggested above, and for suggesting appropriate alternatives. The Health Science Board To address there changes in the NIH policy environment, and to deal with the increased pressures for organizational change documented in the previous chapter, the committee recommence: 1. A Health Science Board should be established in the Department or nealtn and Human Services to oversee the health research organization, missions, priorit ies, ~e- ment of the several elemen ~ e National Institutes of Health; the Ce~;~; ~ Drug Abuse and ~ _~8 Administration; the Nationa ~ the National Center for Health Services Research. 2. On the basis of periodic reviews, the Health Science Board should advise the Secretary of through the Assistant Secret ~ ~ these elements, such as the initiatio ~ of the National Institutes of ~ e Public Health Service, or the reassignment of responsibilities among institutes and units. 3. 4. ix members om a ~ i~ t~~ National Acat Appointments should be mate for a term of six years, with one-third of the board' 8 membership r~nl Abbe ^~ - a ~ ~^ ,,^~_o ana_rne reappointment of members limited to one additional . _

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27 5. Members of the Health ~ Id be selected on the basis of a judicious combination of scientific experience, capacity for sound judgment, and knowledge of health policy i88ue8 and the principles of public management. 6. The Health Science Board should elect its own chair, meet at least four times a year and additionally whenever requested by the Assistant Secretary for Health, be assigned its own staff and have a defined budget, and have the ~ es to establish study groups or panels to assist e moo 8 ~on. The Health Science Board should report annually to the man Services through the Assistant _ ~ secretary :or Health. , The Health Sciences Board is intended to communicate public perceptions of health research needs to the scientific establishment and to assure the public that these needs are being adequately and appropriately addressed. In particular, the board would be concerned with the boundaries of the research missions of NIH and the rest of the agencies of the Public Health Service, and with proposals for major organizational changes in those agencies. The board's role is, in many respects, like that of the trustees or regents of a public institution. The National Science Foundation's National Science Board, the Smithsonian Institution's Board of Regents, and the regents of many state universities, for instance, are extremely effective in guiding and protecting these institutions. But unlike true teen or regents, the Health Science Board would not have the ultimate responsibility for the agencies under its aegis; this responsibility belongs to Congress and the Secretary of Health and Human Services. The board would, however, prepare an annual report that would be carefully read by Congress and various scientific and public interest groups as well as the Executive Branch agencies. The publication of a report would make the board's views widely known, and its broad public exposure would ensure that the board members take their responsibility seriously. Six-year terms and frequent regular meetings would make them fully aware of the important health and health science issues under discussion. Because of~the proposed board's role in communicating with the public and serving as an independent review group, it is essential that its members be widely respected persons, both scientists and non-scientiste. The committee feels that appointment by the Secretary of Health and Human Services is necessary to enhance the prestige and sense of responsibility of the board and its members. The members must have individual expertise as scientists and administrators, and knowledge and interest in health policy issues. Partisan political considerations should have no place in the choice of members for the

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28 board. In order to guarantee excellence in appointments to the board, the committee recommends that the National Academy of Sc fences and the National Academy of Public A~miniatration (both of which have congres- sional charters and responaibilities to advise the federal government on matters within their expertise) be involved in the nomination prOCe88 e The members of the board should be capable of considering the national interest in health research in the broad sense. They should not be chosen to represent any particular group or constituency. In order to promote the development of conaenaua and to emphasize the fact that the members are not representatives, the committee recommends that the board have only six members. Successful institutions tend to cling to their past successes and resist change. Periodic review by an independent outside group can help counter this tendency. In this respect, the Health Science Board could be a potent force for organizational renewal and vitality for NIB and the other agencies of the Public Health Service. The committee recommends that, to preserve its independence, the board elect a chair from among its members, and have its own budget and sufficient staff to prepare agenda and compile background materials. Many of the issues that would come before the board, such as proposals for new institutes, terminations, or tranafera, require more intense and thorough attention than the board alone could provide. In such cases, the board must have the authority ant resources to establish appropriate study groups or pane 18 e To deal with the full range of health research, the Health Science Board must be located in the Public Health Service of the Department of Health and Human Service a. Many agencies ant departments of the federal government have a health research mission, but much of this research--almose 80 percent in 1982--is concentrated in the Public Health Service.30 As the fiat of the Public Health Service units indicates, the range of issues covered and approaches used is quite broad. And unlike other governmental departments, the Public Health Service has the improvement of health as its central mission. For these reasons, the Public Health Service is the key locus of coordination and control of health research in the United States. But because many of the organizational iasuea described above concern the boundaries of the research missions of the NIB and the rest of the agencies of the Public Health Service, the committee feels that more effective coordination of their missions is necessary. The Health Science-Board proposed here is intended to provide such coordination. Organizational issues are prominent among those that involve the total mission of the Public Health Service. These include the creation of new institutes at NIH and the transfer of units or functions among the elements of the Public Health Service. Because of its broad perspective, the board would be able to provide useful and unbiased advice on such matters, and to interpret the criteria suggested in the previous chapter.

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29 The Secretary of Health and Human Services, through the Assistant Secretary for Health, has the responsibility for managing and setting long-tenm policies for the Public Health Service research agencies. The board should not become involved in day-to-day management of the research agencies, but rather would advise the Secretary through the Assistant Secretary on issues that involve the spectrum of agencies of the Public Health Service on the full range of their research missions. The Health Science Board would advice on issues that cross agency boundaries as now defined. Prevention research is one example. Research on health promotion and disease prevention-necessarily includes a spectrum of approaches ranging from basic to applied, drawing on the biomedical, behavioral, and social sciences. Most of the Public Health Service agencies, including NIH, have expertise and explicit responsibilities for prevention research an part of their basic missions. Thus a single institute or agency cannot coordinate this research. But coordination is necessary, and the Health Science Board court help to ensure that the government's total approach is complete, coordinated, and appropriate. The board is not intended to replace the current Advisory Committee to the Director of NIH, or-other advisory committees in NIH or other Public Health Service agencies. These have important roles to play in overseeing the research programs of individual agencies. Instead, the board would ensure that the individual agencies are making adequate contributions to the total effort. The committee known of no alternative that would be more effective in serving these purposes than a board at the level of the Assistant Secretary for Health. No advisory board or other entity in any of the Public Health Service agencies would have the necessary perspective or the credibility to deal with such issues. At a level higher than the Assistant Secretary, health research is only one of many important issues, and the board's advice would not get full attention. And because of its permanence, the board would be more effective than many past ad hoc efforts to review the structure, research mission, or _ ~ priorities of NIH and its sister agencies e These include many congressional investigations, the Bayne-Jones committee in 1956, the Wooldridge committee in 1965, the Presidene's Biomedical Research Panel in 1976, the National Conference on Health Research Principles in 1978 and 1979, and the committee writing this report. There have been proposals for similar oversight mechanisms in the past. The closest example is the President's Council for the Health Sciences, proposed by Senator Edward Kennedy in 1979. This council would have prepared for Congress and the President a five y ear plan for funding health sciences research. The committee feels that the preparation of budgets is the responsibility of the officials of the Department of Health and Human Services , the Office of Management and Budget , and Congress. The Health Science Board, however, would be able to provide advice on these matters, especially on the determination of priorities among the various agencies and broad areas of health science.