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SUMARY The National Institutes of Health (NIH) has earned ~ reputation for excellence in the support and conduct of research to improve the health of the "erican people. It has maintained its leadership position in the international scientific community even in the face of considerable changes in its polic ical and social environment. But pressure continues to amount for change in the mission and organiza- tionst structure of NIH. The future success of NIH depends on it and the rest of the Public Health Service adopting a more unified and coordinated approach to meeting the nation's health rccearch needs. The mission of NIH demands that its leaders pursue two principal objectives: (1) to be responsive to health needs, achieving reductions in the burden of illness by capitalizing on scientific opportunities, and (2' to promote basic science and maintain standards o f sc lent i f ic exce l fence . Al though it some t imce seeme thee these two objectives are contradictory rather than complementary, such is not the case. Both must be pursued with equs1 ~rigor, ~ restive leadership, and hard work if the NIH is to continue its success rul record. The genius of the inse itueion in shaping sciene if ic excellence to health needs is found in the interplay of categorical research institutes and disciplinary study sections. The priority disesse- based institutes enable Congress to understand, appreciate, and support the research accompI ishments and goals of the institutes, ant also to exposes concerns and priorities about the need for further research . The study sect ions, on the other hand, cut across institute lines and ensure that appropriate scientific ealene and items are brought to bear on the prob leme. The committee feels that the NIH categorical structure is an effective tOOi for helping tO shape scientific excellence to - at national needs. ~ society ant its needs continue to evolve, however, NIH mat cloture with it. This report suggests mechanisms, procedures, and institutional patterns to help NIH continue to meet its objectives, "d criteria co guide the organization' ~ future evolution. Organ i28t tonal Evolut ion Since the 1930e NIH has seen the establishment of many new institutes and divisions. These entities grew out of existing

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2 . institutes, were transferred into NIH from elsewhere, or were built up fro the start. In addition, existing institutes have changed their na es and their research focus and have had their organizational status upgraded. Statistical studies have provided no evidence that such cheeses, in themselves, have let to an increased budget for NIH as a whole or thee new institutes have tended to grow faster than the rest of NIH. On the other hant, case studies have shown that establishing a new institute has not hampered the scientific effort, and in some cases even seems to have helped it considerably. However, the same effects also have been achieved without creating a new institute The establishment of the Lung Division in the Heart Institute, for instance, seems to have been scientifically ant politically successful because of the active cooperation of institute leadership with those who were urging greeter attention and resources for funs research The critical elements of success seee co be scientific readiness for major advances and dynamic leadership fro. committed individuals with ~ vision for the field. There are ~ ny ways for NIH to be responsive to health needs and scientific opportunities without changing its organizational structure In the last decade, for instance, NIH's research menasea at style has shifted from one driven primarily by scientific develops nts and individual researchers to one in which NIH staff coop rate with the research community through the planning procces and, on this bests , take ~ more active role in setting research priorities and developing new research areas Concomitantly, most of the institutes have switched from a research mechanism-oriented internal structure to program-oriented one To respond to treat th needs without changing its organizational structure, NIH must improve its ability to · sense the emerging concerns of the pub tic, the research community, and Congress; · ensure through research planning that the emerging needs are addressed by NIH's research program; respond to the identified needs with activities etched to the magnitude and urgency of she teeny ~ pp . 16-19) . The con~itece believes that NIH is now at a s Cage where there should be a presumption against additions at the institute level because such changes (1) fragment the scientific effort and diminish effective co~unicat ion with key sc lent ists in other ins t itutes, (2) add to the burden and difficulty of effective program coordination by the NIH Director and his top staff, and (3) add to administrative costs without ensuring increased appropriations. There may, however, be circumstances in which organizational change is necessary, and it is important to recognize those circumstances.

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3 line co_~ttes reco_nds that cede co aseese proposed senior organizational changes in NIH a~ the need for charm from ~ broad perspective (pp. 20~21~. To focus the debate about the costs and benefits of new institutes, the committee recounts five criteria lo be considered in evalusti~u proposals for orgenizat ione! change 1 The activity of a new institute or ocher oreanizatione1 anti and re nit 1e In resulaelon, in th delivery of service non-research activities' it is not aPp-ropriate for incorporation 2. ~ oust be demonstrable that the research are. of a new institute or other major or`anizatione1 entity (defined either York process related to a health prob lea) is not alreat ~ (p. 22); 5. 3. _~_ =~ c~entific rowth in a other major organizational entity ~ Ye prospects of sufficient funding for a / ant accountability ( p. 23) . NIH and the Health Policy Environment Since NIH was fomed, scientists have widened their view of the determinants of health. At the s an. ti - , the federal government 's roic in health care and related activities has expanded. accordingly, health research thee is broader than traditional biomedical research is increasingly regarded as crucial to the nation's well-being. Thus, the role of NIH and the functions in its mission have come under frequent examination. ~ recent years, for instance, there here been proposals to create in NTH new institutes for disease prevention and nursing research, and to transfer into NIH existing agencies concerned with research on occupational safety and health, health statistics, mental health, and the provision of treat th services. Such organizational changes would expand the boundaries of the NIH research mission, and perhaps involve NIH in the provis ion of health services and research in support of regulatory activities. Because of the complexity of the individual cases it was not possible for the co~ietee to decide

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4 wheth r the nation's needs vault be best serves by expanding NIH's mandate to include particular areas by having these ·reas addressed by other ·~encies or by devising improved methods of coordinating functions Chat inevitably cut across orgenizationa1 lines The committee believes that such boundary issues and the challenges of improved coordination and priority setting are crucial both for NIH and for the integrity of the federe1 health structure and that there must be a mechanism to investigate these matters systemaCiCally and co propose workable solutions For many years Congress has been highly supportive of NIN and its mission, and ·1so deeply involved in shaping its research priorities in broad terms Over time however the nature of the relationship between NIH and Congress has changed. ~ once cloae working relacion- ship that approached a unity of purpose has diffused to ~ state in which different parts of Congress both subco zictees ant individuals exercise a mulciplicicy of often uncoordinated controls. Additionally in response to constituent pressures and ·ooetimes 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 opposes these changes and thus has acquired an image of being opposed to innovations proposed fro. outside the agency O "anizational changes should not be the only Deans or even the primary means of implementing changes in research priorities Therefore there should be an effective mechanism for jutting the need for organizacions1 changes as a means of addressing priorities using the criteria suggested above and for suggesting appropr ate alternatives In order to accommodate changes in the policy environment of NIH the committee recommends that a Health Science Board be established , . within the Department of Health and Human Services to Pr~vid[-~;ight for the health research organizations of the Public Health Service _ . . . This board would regularly review the missions of the respective units study ant advise the Secretary through the Assistant Secretary for Health on the desirability of any proposed change in organizational structure and publish an annual report To increase its prestige and sense of responsibility to ensure the expertise of its members and co promote consensus rather than representation of special constituencies the board would consist of six distinguished scientists and laymen appointed by the Secretary of Health and Human Services from a slate nominated by the Assistant Secretary in consultation with the National Academy of Sciences and the National Academy of Public AdministraCion (pp. 2~--29) Ensuring a Manageable Structure for NIH The NIH has evolved a complex cross-cucting organizational structure that represents health needs through a system of categorical institutes and scientific priorities through disciplinary study

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5 sections. This structure introduces a creative tension between external needs and scientific autonomy that eventually leads to more productive-and useful research. However, there will always be some research areas, both basic and applied, that cross institute lines. Therefore, the activities of the individual institutes need to be coordinated to ensure coverage of all essential research areas and to oversee the organizational evolution of NIH as a whole. The Office of the Director of NIH is the logical locus for a central coordination activity at NIH. To Strengthen the Director's authority, and thereby increase the overall responsiveness of NIH to public concerns, the committee recommends: The Secretary of Health and H''man Services should delegate to _.._ v~reccor or Nln the authority, direction, and control over NIH that the position does not now possess, subject to the Policy direction of the Assistant Secretary for Health and to existing statutory as recommended to be modified below (p. 31) .~ ~ The Director of NIH should have Greater budgetary authority and douche ~ 1 0 _ ~ percent of the NIH budget, with which to seed selected areas through existing instituter in accordance with a rigorous peer review Process; and (2) limited authority to transfer up to 0.5 percent of the NIH budget across institute lines in response to a public health emerzencv p. 32 ; The current Director's Advisory Committee should be converted to a stronger and more independent NIH Policy and Planning Council to provide for the Director a continuous evaluation of the resear_h mission and function of NIH, and to advise the Director in the formulation of long-term plans and in setting research priorities tfull text on pp. 32-33); Extramural research and intramural research ~ and the reload support activities or each) should be grouped under two deputy NIH directors each of whom has line authority over support functions outside of Individual institutes and staff responsibility for extramural and intramural research Programs and that the staff _ , functions in the Director's office should be reorganized to improve span of control (p. 34~. _ other components should be clustered to reduce unnecessary duplication and expense 34-35). To facilitate public and scientific accountability, the committee recommends:

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6 Each institute Should provide its National Advisory Council members with full and easily understandable information on i of currently funded grants ant grant proposals; ins shout more uniformly involve their advisory councils in broad and policy issues (pp. 35-36~. program The NIH Director should assume overall responsibility for informin members of each institute 8 Board of Scientif institute's response to its recommendation) ii7~i ~G]~~ ~ ~ ~~rch p. 36~. The role and staffing of the Office of Communications should be -strengthened (full text on p. 37~. To ensure the quality and independence of the scientific advice rendered to NIH, the committee recommence: QgE]j&~H d continue to be the overbid consideration in cal and —~ ~ possible quality if they are ~ statutory community' with Congres 8 , her , ever I_~= _ ~ _ full strength. (p. 37) ~ -