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The Evolution of NTH's Organizational Structure The National Institutes of Health (NIH) began as a modest set of federal research laboratories supporting the public health mission of the Public Health Service. As a result of the nation's steady determination to increase its commitment to research in the biomedical and related sciences, NIH has evolved into a large and complex decentralized organization that sponsors research throughout the United States and at some sites abroad. NIH now consists of 20 institutes (including the National Library of Medicine, NLM), 7 centers, and 4 programmatic offices in the Office of the Director (OD) that are intended to coordinate activities in specific fields across NIH (Figure 2.1~. Only institutes and some centers have authority to award research grants; the Clinical Center, Center for Information Technology, and Center on Scientific Review do not award research grants. The 20 institutes and 4 of the 7 centers have their own appropriations.] More than 40 unit heads report directly to the NIH director: the directors of the 27 institutes and centers, 12 staff offices, and four program offices. The size and expanse of the agency are impressive. In FY 2002, NIH's budget funded 43,600 research grants and 1,600 contracts in universities, medical schools, and other research and training institutions in the United States and abroad and supported 16,700 full-time training positions.2 NIH employs about 17,700 full- 1In addition, there are appropriations for the Office of the Director and for Buildings and Facilities, for a total of 26 separate appropriations for NIH in the Labor/Health and Human Services Appropria- tions Act. 2These figures are based on the President's budget request for FY 2003 to the Labor/Health and Human Services/Education Appropriations committees. NIH also receives some funding under the 33
34 Enhancing the Vitality of the National Institutes of Health time personnel. The intramural research program consists of more than 2,000 re- search projects conducted by more than 9,000 government scientists and technical support staff. The agency occupies 75 buildings on more than 300 acres in Bethesda, MD, including laboratories and a 267-bed clinical research facility. One of the institutes, the National Institute of Environmental Health Sciences (NIEHS), is in North Carolina. Additional facilities are in Baltimore, Frederick, and Poolesville, MD; Hamilton, MT; and other locations. NIH supports about 50,000 researchers at 2,000 universities and colleges, health professional schools (medicine, dental, public health, pharmacy, and nursing), teaching hospitals, independent nonprofit research institutes, and industrial laboratories in all 50 states and some other countries. There have been unsuccessful efforts to bring other health research agencies under the NIH umbrella. For example, the National Institute for Occupational Safety and Health and the National Center for Health Services Research (now the Agency for Healthcare Research and Quality) have, at times, been considered good candidates for integration into NIH, but they were perceived as too far removed from the biomedical research mission of NIH. INSTITUTES The institutes are highly varied and reflect not only their particular foci and budgets but also the varied circumstances of their creation, how long they have been in existence, the nature of the scientific opportunities available, the strength of support by their advocates, and the priorities of the administration and of Congress. They are broadly similar to each other in their relationships with the NIH director, Congress, and the other institutes and centers. The NIH institutes can be thought of as being in five general categories, although there is no optimal taxonomy for this purpose. Some are organized by disease (for example, cancer; mental health; diabetes and digestive and kidney disorders; arthritis and musculoskeletal and skin disorders; neurological diseases; allergies and infec- tious diseases; deafness and other communication disorders; and drug and alcohol abuse). Some are organized by organ system (for example, heart, lung and blood; and eye); some by life stage (child and human development and aging); some by field of science (for example, general medical sciences, environmental health sciences, and the human genome); and some by profession or technology (nursing, dental, biomedical imaging and bioengineering) (Morris, 1984~.3 Those institutes organized Department of Veterans Affairs and Housing and Urban Development appropriation ($76 million is requested for environmental research in FY 2003) and the Balanced Budget Act of 1997 ($97 million for type 1 diabetes research is requested in FY 2003). See on-line table at http://www4.od.nih.gov/ of ficeofbudget/CJ2003/Mechanism%20-%20Total%20Proposed%20Law.PDF. 3The categories and assignments through 1984 follow Morris, 1984:67. The last category, for nurs- ing, dentistry, and imaging, has been added.
The Evolution of NIH,s Organizational Structure Department of Health & Human Services Secretary of Health and Human Services PHS Divisions Food & Drug Administration Centers for Disease Control & Prevention Indian Health Service | | Agency for Health Research & Quality Substance Abuse & Mental Health Services Administration National Cancer Institute National Institute on Aging National Institute of Biomedical Imaging & Bioengineering National Institute of Diabetes & Digestive & Kidney Diseases National Institute of Mental Health Fogarty International Center National Institutes of Health Office of the Director -- Office of Disease Prevention -- Office of AIDS Research -- Office of Research on Womens Health -- Office of Behavioral & Social Sciences Research NIHInstitutes and Centers National Eye Institute National Institute on Alcohol Abuse & Alcoholism National Institute of Child Health & Human Development National Heart, Lung & Blood Institute National Institute of Allergy & Infectious Diseases National Institute on Deafness & Other Communication Disorders National Institute on Drug Abuse National Institute of Neurological Disorders & Stroke National Center for Complementary & Alternative Medicine National Institute of Environmental Health Sciences National Institute of Nursing Research National Center on Minority Health & Health Disparities Clinical Center* Center for Information Technology* Center for Scientific Review* *These centers do not make research grants. FIGURE 2.1 Current Organization of NIH Institutes | | Assistant Secretary for Health -- Surgeon General Health Resources & Services Administration Agency for Toxic Substances . & Disease Registry National Human Genome Research Institute National Institute of Arthritis & Musculoskeletal & Skin Diseases National Institute of Dental & Craniofacial Research National Institute of General Medical Sciences National Library of Medicine National Center for Research Resources 35
36 Enhancing the Vitality of the National Institutes of Health by life stage have complex relationships to those organized by disease group or organ system with extensive overlap with the missions of other institutes; for ex- ample, the National Institute of Child Health and Human Development (NICHD) overlaps in nearly all of its research with other categorical institutes and in many ways serves as an institute for the profession of pediatric research and, to some extent, obstetrics research. Such overlaps can create tensions among institutes- some that are likely to be beneficial and some that are likely to be detrimental, depending on how they are acknowledged and responded to. The most common mechanism of origin of the institutes has been the congres- sional mandate responding to the health advocacy community. Some, however, have developed in their own special circumstances. The National Human Genome Research Institute was established by NIH around a particular scientific objective. NIEHS, which focuses on the health effects of environmental exposures, was orga- nized around a health problem, but not at the urging of health advocacy groups. NICHD and the National Institute on Aging (NIA) were organized around popula- tion groups (in 1962 and 19741; more recently, units focused on the health of women and minority groups were established in the l990s and may be candidates for eventual elevation to institute status. The National Institute of Nursing Research was organized around a professional group nurses in 1993, and the establish- ment of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) was authorized in 2000 after a 5-year advocacy campaign by radiologists and . . . uloenglneers. Each institute except for the National Cancer Institute (NCI) has a director with a research background who is appointed by the Secretary of Health and Human Services. (The director of NCI was made a presidential appointee by the National Cancer Act of 1971; see Box 2A.) Each institute has a national advisory council to advise the institute director on policies and priorities and to provide a second level of review for extramural grant applications recommended for funding. All but one of those councils are appointed by the Secretary of Health and Human Services. (The National Cancer Advisory Board and the President's Cancer Pane! of NCI are appointed by the President.) All institutes but one (the National Institute of General Medical Sciences) have intramural programs that perform basic and clinical re- search at the Clinical Center, in laboratory facilities on the NIH Bethesda campus, or elsewhere. Boards of Scientific Counselors advise each institute director on and oversee the performance of the intramural program and its researchers. Until re- cently, each director had a staff that mirrored the staff of the NIH director, includ- ing deputies for intramural and extramural research and offices for budget, admin- istration, communications, legislation, and personnel. (Some of these functions have been or may be consolidated under the One HHS initiative discussed below.) The extramural grant programs of the institutes receive the largest share of their budgets. As measured by their budgets, institutes have grown at different rates over time. Starting from a small base, new institutes tend to receive large percentage budget increases in their early years.
The Evolution of NIH,s Organizational Structure CENTERS There are two types of centers. Some do not fund or conduct research, but rather provide operational support to the rest of NIH. The Center for Scientific Review (CSR), for example, is concerned solely with coordinating the activities of the set of scientific peer review panels called study sections, which review and score applications submitted to NIH for research grants and fellowships and recommend the most promising ones to the institutes for funding. Other centers conduct or support research and have been established as a result of legislation, for example, the Fogarty International Center. OFFICE OF THE DIRECTOR To carry out responsibilities that include planning, coordinating, and managing the programs of the 27 institutes and centers, the NIH director is assisted by units in OD known collectively as OD Operations. In addition, several offices and programs in OD address problems that the director or Congress believe need high-level NIH- wide attention. In all, 12 staff offices and 4 program offices report to the Director,4 in addition to the 27 institute and center directors. 4see OD organization chart at http //wwwl.od.nih.gov/oma/manualchapters/management/1123/nih.pdf and ``Organization and Functions, NIH, OD" at http://odeo.od.nih.gov/about/org/tocodo~1.htm. 37
38 Enhancing the Vitality of the National Institutes of Health The 1980s and 1990s saw the development of program offices in OD to help to promote and coordinate activities that are not solely in the portfolios of any of the individual institutes (Table 2-11. The Office of Disease Prevention, which includes the Office of Rare Diseases (ORD), the Office of Dietary Supplements (ODS), and the Office of Medical Applications of Research, was created in 1985 as a response to a congressional desire to increase disease prevention research. It is headed by an associate director for disease prevention. The Office of AIDS Research was estab- lished in 1988 to coordinate AIDS research and is also headed by an associate director. The Office of Research on Women's Health and the Office of Behavioral and Social Sciences Research were created in 1990 and 1995, respectively. Two program offices also created in the 1990s (alternative medicine and minority health) have since been elevated to center status, which gives them national advisory coun- cils and the authority to award research grants. The Office of Bioengineering and Bioimaging has become an institute, NIBIB. Funding for OAR is specified in the appropriation act, and the funding of several other offices is earmarked in the OD TABLE 2.1 Current Program Offices in the Office of the Director Office Year Established Major Focus Office of AIDS Research 1988 Office of Research on 1990 Women's Health Office of Disease Prevention, which includes the Office of Rare Diseases (1993), Office of Dietary Supplements (1995), and Office of Medical Applications of Research (1977) 1985 Office of Behavioral and Social 1995 Sciences Research 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 Evolution of NIH,s Organizational Structure appropriation in the conference committee report, for example, $10.4 million for ORD and $17.0 million for the ODS in FY 2002. The NIH director reports directly to the Secretary of Health and Human Services. Although the NIH director has considerable influence with Congress and the Administration with respect to the overall budget of each institute and center, he or she does not have strong formal authority with respect to the operation of the institutes. Institute and center directors have considerable autonomy, but they probably recognize the benefits of having a strong NIH director in securing in- creased support from Congress and the administration. Ideally, the NIH director is not only a distinguished scientist and a person with compelling ideas, but also an able leader with the ability to recruit other effective leaders and work well with the Secretary of Health and Human Services, other members of the administration, and Congress. The director has a small ($10 million) discretionary fund and, in prin- ciple, the authority to transfer up to 1 % of an institute's or center's appropriation to another unit as long as the transfer does not increase any one appropriation by more than 3°/O. The federal budget and appropriation process, which culminates in a set of appropriations to NIH and its various institutes and centers, is the most impor- tant management too! available to the NIH director, who may use it to influence priorities and ensure that NIH is responding to opportunities and problems as he or she sees them develop. The budget and appropriation process, which begins inter- nally, ultimately involves substantial interaction with the Department of Health and Human Services (DHHS), the Office of Management and Budget (OMB), and, on rare occasions, the President. Because of the central and historically generous role of Congress in the appropriations process, health advocacy groups are most likely to direct their lobbying efforts at the legislature. THE BUDGET PROCESS To understand how NIH has evolved, it is important to understand its funding environment and budget process (see Figure 2.21. NIH's statutory authority comes from the Public Health Service Act (PHSA) of 1944, as amended (42 U.S.C., et seq.~. Some institutes and several programs (training and facilities construction) are sub- ject to time and dollar authorizations that require periodic renewal by Congress.5 The last authorization, the NIH Revitalization Act of 1993, lapsed in 1996 (P.L. 103-431; the effort to renew the authorization in 1996 failed because of conflict over provisions about the use of fetal tissue in research. There have been no further efforts to pass a general reauthorization of NIH.6 5The war on cancer Act of 1971 was the first to impose time and dollar limits on an institute. 6The 1994 authorization for the National Institute of Mental Health, the National Institute on Alcohol Abuse and Alcoholism, and the National Institute on Drug Abuse (P.L. 102-321) has also lapsed. see Congressional Budget Office, 2002. 39
40 Enhancing the Vitality of the National Institutes of Health ........ ::.:.:. ::.. ...... | Office of | the Director ...:.: :.... _' Investigators and Institutions Investigator not appr;_ Approved - ~ ICs negotiate ........................................................................ ICs prepare ~ ngressional justification and NIH submits request to OMB ~ allocation ue~e~o' t Seri~i~ President's signature negotiations among NIH, HHS, OMB~ Am_ reconciliation, amendment, and conference :.& Executive Office House and Senate |/K' appropriation , 1~ committees ~ 1: ~ ::. ~ ~ ~ ~ . President=_ budges committees I ~ Congress Budget FIGURE 2.2 This figure illustrates the complex processes involved in NIH's budget. To begin the process, the institutes and centers work with the NIH director to develop their budget requests using guidance from OMB and HHS. The resulting budget is submitted through HHS and OMB to the President, and then appropriated by Congress, although numerous changes may be negotiated at many points along the way. After the institutes and centers receive their funding allocations, money is awarded to individual investigators and institutions through the peer review system under the administration of individual institutes and centers. Investigators may initiate proposals for funding on topics of their own choos- ing or may submit proposals in response to solicitations on specific topics from the institutes and centers.
The Evolution of NIH,s Organizational Structure Since 1996, NIH has operated on the basis of annual appropriation bills, although technically appropriations amounting to nearly half of NIH's funding are unauthorized. In the absence of authorizations, the appropriation committees, in their legislation and report language, have provided guidance that is similar to the guidance that authorizing committees enact. From time to time, bills to make specific changes in the PHSA are introduced; sometimes they are passed, such as the one that established NIBIB in 2000 (P.L. 106-580) and the one that established centers of excellence for research on the muscular dystrophies in 2001 (P.L. 107-84~. NIH, DHHS, OMB, and Congress manage the NIH appropriation primarily through a mechanism budget, that is, a set of budget functions that aggregate similar types of expenditures across NIH. Most of the budget (more than 80%) funds extramural activities, including research, training, and construction of ~ . . . 7 taco sties. ~ Six congressional committees affect NIH funding: the authorizing and appro- priating committees for DHHS in each house and the House and Senate Budget Committees. Officially, the budget committees set targets for NIH appropriations in the DHHS budget. The role of the authorizing committees is to set a level of funding that the appropriations committees may not exceed, although historically NIH has benefited from having an open-ended authorization, that is, Congress authorized "such sums as may be necessary" without a time limit. During a period of conflict between the President and Congress in the 1970s, Congress began to exert tighter control over some institutes by imposing time and dollar limits in the authorizing legislation. Currently, NCI, the National Heart, Lung, and Blood Insti- tute, NIA, the National Institute of Mental Health (NIMH), the National Institute on Drug Abuse (NIDA), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), NLM, and the National Research Service Awards (training and fellow- ship programs) are subject to time-and-dollar limits. As noted above, those pro- grams have been operating with unauthorized appropriations since 1996, which underlines the fact that currently the appropriations committees exert the most influence on NIH. The authorizing committees can and do originate specific pieces of legislation affecting the organization of NIH, such as the law creating NIBIB. But the appropriations committees are not required to fund mandates in authorizing legislation. The appropriations committees tend to have substantial influence on all aspects of NIH, including its organization, because of the rather open-ended grants of authority by the authorizing committees. Although they do not put much detail into law usually just the total for each appropriation they can use the reports that accompany bills to mandate NIH actions, including establishment of new organiza- tional units. Report language does not have the force of law, but agencies try to 7The extramural share of the NIH budget is a little larger than the 80.9% accounted for by research grants, training awards, research and development contracts, and extramural construction in FY 2002 because the National Library of Medicine, Cancer Prevention and Control, and Office of the Director budgets also include some extramural support. 41
42 Enhancing the Vitality of the National Institutes of Health follow it because they know that they will be before the appropriations committees again each year. The main impact of the congressional budget process on NIH has been to reinforce the autonomy of the institutes and centers through their separate appro- priations. That means that the NIH director has no formal role in the budget execution stage, except for the seldom-used authority to transfer up to 1% of each . . . . nstltute's appropriation. ADVISORY COMMITTEES Like other federal science agencies, NIH makes extensive use of advisory com- mittees (see Box 2B). The committees are composed of nonfederal scientists, health advocates, and laypersons to ensure that scientific expertise and public input are considered in making policies and evaluating programs. Advisory committees also foster a broader understanding of public concerns by the scientific community and increase public understanding of the scientific and technical impediments to research progress (NIH, 2001~. NIH had over 140 chartered advisory committees as of May 2002 more than any other federal agency.8 In total these advisory groups have 4,298 members, of whom 75% are members of the scientific review groups that evaluate applications for research funding. All the groups operate under the guide- lines of the Federal Advisory Committee Act of 1972, as amended. NIH uses advisory committees for initial and second-level peer review of appli- cations for research grants and for policy and program advice. The overall purpose of the committees is to help to ensure that NIH programs are responsive to both scientific opportunity and health needs. The system of advisory committees is also an important mechanism for coordination and management. They include the Advi- sory Committee to the Director (ACD), the director's Council of Public Representa- tives (COPR), and the advisory councils established by law for each institute. The director's level advisory groups and ad hoc groups appointed to address particular issues provide NIH leaders with external views and advice on overall research needs and program priorities. The national advisory councils to the institutes, which include scientists and laypeople, provide a similar function to institute directors. PEER REVIEW SYSTEM If the institutes and centers are the public face of NIH, the study sections and peer review system are its scientific face. The fact that the research proposed by extramural scientists must pass muster with experts in their field and that all extra- mural awards, which account for more than 80% of NIH expenditures, are peer reviewed has been and continues to be central to NIH's success. The peer review 8See overview and list of committees by appointing officials at http://wwwl.od.nih.gov/cmo/about/ index.html.
The Evolution of NIH,s Organizational Structure 43
44 Enhancing the Vitality of the National Institutes of Health system is not perfect but it is the best guarantee we have that scientists will carry out research that is of high quality and has high potential for scientific progress. The state of scientific understanding and the potential for near-term progress are always difficult to assess and may vary considerably across disciplines and diseases. At any given time, some areas of research are riper for progress than others. The interaction of the two systems institute-based assessment of need on the one hand and the study section/peer review system on the other enables NIH to reconcile the some- times conflicting goals of addressing the most important health needs through re- search and funding the best science. Although the categorical nature of the insti- tutes helps policy makers to allocate funding among broad areas of health research (such as cancer, heart disease, arthritis, brain disorders, child development, and genomics), the structure and process of peer review are intended to ensure that research that is likely to be the most productive is funded. The intramural program uses a retrospective process for reviewing the research of NIH's own scientists rather than the prospective peer review described above. The intramural program has been the subject of several reviews (Institute of Medi- cine, 1988; NIH, 19941. CSR was established in 1946 to administer the review and evaluation of pro- posals for the rapidly expanding grant program, and peer review has been the centerpiece of this operation. Like institutes and centers, study sections established by CSR proliferated over the years, from 20 in 1946 to more than 100 in 1994, plus many ad hoc and special emphasis panels. By that time, it became apparent that the peer review system needed restructuring to respond to changes in the way science is conducted. According to CSR, more and more applications address complex bio- logical problems with broad, multidisciplinary research programs that are collabo- rative, multi-investigator, and multi-center, thus calling for a greater breadth of expertise. "There are also more trans-NIH initiatives that involve extensive col- laborations within and across disciplines and institutions. The CSR peer review system, designed many years ago with a focus on individual investigator-initiated research, may no longer provide the one size that fits all. More flexible ways of operation are likely required...." (CSR, 1999 and 2000a). By the mid-199Os, pressure for a comprehensive reexamination of the structure of the study sections and the organization of CSR had grown. In 1998, the Pane! on Scientific Boundaries for Review recommended a substantial change in the structure of review groups. The pane! suggested that as much science as possible be reviewed on an organ-system or disease basis, rather than discipline-related study sections. It called for grouping study sections into 24 clusters called Integrated Review Groups (IRGs), most of them addressing basic, translational, and clinical research within the context of the biological problem being addressed, such as a particular disease or physiological function (CSR, 2000b).9 9See the CSR website for detailed information about the restructuring of CSR and the peer review process at http://www.csr.nih.gov/about.htm. Also at http://www.nih.gov/archives/renamed.htm.
The Evolution of NIH,s Organizational Structure This recommendation acknowledges the advent of molecular medicine, where bio- chemistry, genetics, molecular and cellular biology have become tools applied to virtually all fields of health-related research. Molecular medicine applications will be reviewed in the context of the biological questions addressed rather than lumped in discipline-related study sections where they will compete against each other. " (CSR, 2000c). The panel also recommended IRGs for basic scientific discovery and methods development not associated with a particular disease, and clusters addressing cross- cutting fields such as aging and development. Of the 24 IRGs, 7 were recently reorganized and will be retained as is, 6 will be new, and 11 will be modified from existing IRGs.~° In addition, when the Alcohol, Drug Abuse, and Mental Health Administration's three institutes NIHM, NIDA, and NIAAA were reintegrated into NIH in 1993, the number of institutes with large neuro- and behavioral science research portfolios increased to five. This necessitated the complete restructuring of neuroscience and behavioral science review in 1996, which involved substantial participation by the extramural research community. In the second phase of the restructuring, which began in February 2001, exter- nal advisory teams were brought in to assess and recommend changes in the study group structure of each IRG.~i Currently there are 159 study sections, an average of 8, but ranging from 3 to 12, per IRG. After the process of reviewing and restructuring the study sections is completed in 2003, ad hoc external advisory groups will review each IRG every 5 years. Periodic evaluation is intended to keep the structure of study sections current with the changing landscape of science and is an important development. If the plan for regular review is carried forward, it should prevent the need for a major overhaul in the future of the kind that is being undertaken by CSR at present. The Committee commends NIH for proceeding with these ongoing reforms. HISTORICAL FORCES BEHIND ORGANIZATIONAL COMPLEXITY The establishment of NCI in 1937 began the long history of creating categorical institutes that organized research in the context of particular diseases. Citizen advocacy for NIH funding and growth grew in scale and sophistication after World War II and changed national health policy. The wartime experiences of leading government scientists and the success of the Office of Scientific Research and Development brought about wide acceptance of a broad federal role in supporting research in our nation's universities. In addition, military recruitment and mobiliza- tion produced greater recognition of the roles of health and disease in determining resee htip://www.csr.nih.gov/events/implementplan.htm. iiAs of May 16, 2002, meetings had been held and proposed guidelines posted for 10 TRGs at harp:// www.csr.nih.gov/PSBR/IRGComments.htm. 45
46 Enhancing the Vitality of the National Institutes of Health the physical fitness of American military personnel. For example, during the early 1940s about 21% of the 2 million potential military recruits could not meet Selec- tive Service dental requirements. This observation led President Truman to sign legislation that created the National Institute of Dental Research (NIDR) on Tune 24, 1948. At that time, NIH consisted of three institutes cancer, heart, and dental. From the middle 1940s to 1974' health advocates were successful in persuading Congress to establish additional institutes, often against the wishes of administra- tions, which generally opposed creation of new categorical institutes. Elizabeth Drew (1967) described the interactions among the NIH leadership, congressional committees, and voluntary health associations. The philanthropist Mary Lasker, her associates, Florence Mahoney and Mike Gorman, and her friends in the medical research community, including Sidney Farber and Michael DeBakey, played an enormous facilitating role. Drew called Lasker, Mahoney, and their allies "noble conspirators. " Substantial post-Watergate changes in the political organization of Congress in the 1970s changed the relationships between the executive and legislative branches and marked a new era in activism generally. Congress assumed more oversight of executive agency programs an oversight that often resulted in highly specific instructions regarding organizational details. The changes in Congress also eroded the traditional strong roles of committee chairs and dispersed power to sub- committee chairs and members. That enabled the health advocacy groups to lobby more widely and successfully for the creation of new organizational units at NIH. In the 1980s' mass advocacy techniques pioneered by AIDS activists inspired other groups to organize at the grass roots as well as at the national level, creating an even more effective way to influence politicians in Washington. Some of the groups have continued the long established pattern of pushing for creation of named entities at NIH to create focal points for developing more research funding for particular diseases. That has often resulted in the establishment by Congress of a named program at the office level. Through continued pressure, offices may then be elevated to centers and, in some cases, to institute status. In addition, the practice of pressing for increased funding for specific diseases in existing institute programs, such as Parkinson's and Alzheimer's, became more prevalent in the l990s. Public need and scientific opportunity are not necessarily compatible or congru- ent. In the face of good intentions, some consider it risky to invest in research on a disease if the science is not ready and the ability to make progress is unclear. It is possible to argue that the tension between disease-based advocacy and scientific opportunity has been productive and has led to more funding for basic research while making scientists more sensitive to public expectations of reducing the burden of disease by investing tax dollars in research. Achieving the appropriate balance between need and opportunity is difficult, however, and results in understandable tensions among the scientific community, health advocacy groups, NIH management, the Executive Branch, and Congress about who should determine NIH priorities.
The Evolution of NIH,s Organizational Structure Over the last 25 years, the scientific community largely through professional and university associations has also become a part of the dynamic that drives the growth of the NIH budget. As a result, the political environment has become a quadrilateral relationship among scientific associations, voluntary health organiza- tions, Congress, and administrations all with an interest in improving health through research. But they do not always agree on how, or on how much relative to other national needs. The activism of scientific societies generally focuses on appro- priations and on specific programs or problems, such as the need for informatics support or specific fundamental research initiatives. The scientific societies have generally opposed the creation of new units and pressed for increasing the numbers and amounts of grant awards, training programs, and improvements in the opera- tion of the study section system. NIH AND THE DEPARTMENT OF HEALTH AND HUMAN SERVICES During the course of the Committee's work, several other independent activities focusing on administrative aspects of NIH were underway, most of which are related to NIH's responsibilities as an agency of DHHS. Over its history, NIH has rarely been directed to add new organizational units by an administration. Indeed, most often DHHS, OMB, and other parts of the Executive Office of the President oppose creating new institutes and centers, and OMB, in its institutional oversight role, usually attempts to enforce this. At the departmental level, the same desire to rationalize and order the subcomponents of the department apply. Over the years, DHHS secretaries and NIH directors have generally not favored expansion. Given this history, it is not surprising that DHHS Secretary Tommy Thompson has issued instructions to consolidate administrative functions, such as personnel management, communications, congressional liaison, and travel, throughout DHHS. The "One HHS" initiative has the stated goal of better integrating DHHS manage- ment functions across its operating and staff divisions. The initiative has already resulted in consolidation of some administrative functions. Although all the operat- ing divisions of DHHS are involved, NIH is especially affected because of its highly decentralized structure. Of 40 personnel offices in DHHS, for example, NIH previously accounted for 27. These have now been consolidated into one for NIH and three for the rest of the department (DHHS, 20011.12 Plans to consolidate the communications, legislative, and congressional affairs offices of NIH have been only partly carried out because of objections from Con- gress. Many of those offices, which focus on outreach to the public and Congress, were established in the institutes and centers by statute and therefore may be less subject to departmental consolidation policies. DHHS has plans for consolidating other functions at NIH, such as budgeting, finance, and procurement, and is encour- 12The plan contains several principles, including "managing HHS as one department." 47
48 Enhancing the Vitality of the National Institutes of Health aging NIH to consider outsourcing some of its administrative functions (for example, grants management), citing the goals of the President's Management Agenda (OMB, 20021. Late in its deliberations, the Committee chair was able to meet with DHHS officials to discuss centralization. Also in early 2003, the House Energy and Commerce Committee and the House Oversight and Investigations Subcommittee initiated examinations of how NIH manages and polices its research portfolio, particularly how it reviews and manages grants (Ochs, 20031. While the Committee believes that it is critical for initiatives to eliminate ineffi- ciencies to continue, centralization of administrative functions is not always the most effective way of proceeding, especially when these functions are difficult to separate from the performance of the primary mission (Sclar, 20001. It would not serve anyone's interests if well meaning efforts to increase efficiency undermined the effectiveness of NIH's programs and its ability to recruit talented leaders at all levels. Assembling the Nation's best talent to work on the biomedical frontier is both very challenging and a qualitatively different operation than hiring for more routine and common administrative tasks. The Committee believes that initiatives to centralize or outsource from NIH key science-related functions, such as aspects of grants management, fail to appreciate how closely this so-called administrative function is tied to NIH's primary mission. Treating crucial science management functions as general administrative services could do great harm to the NIH research enterprise. Moreover, the Committee finds the prospect of mandatory centralization of some administrative aspects of NIH's scientific mission contrary to a stated intent of the President's Management Agenda (OMB, 2002), which is "Freedom to Manage": Federal managers are greatly limited in how they can use available financial and human resources to manage programs; they lack much of the discretion given to their private sector counterparts to do what it takes to get the job done. Red tape still hinders the efficient operation of government organizations; excessive control and approval mechanisms afflict bureaucratic processes. Micro-management from various sources Congressional, departmental, and bureau imposes unnecessary . . . . Operat~ona r~g~c sty. Recommendation 1: Centralization of Management Functions Any efforts to consolidate or centralize management functions at NIH, either within NIH or at the DHHS level, should be considered only after careful study of circumstances unique to NIH and its successes in carrying out its research and training mission. A structured and studied approach should be used to assure that centralization will not undermine NIH's ability to identify, fund, and manage the best research and training proposals and programs in support of improving health. In response to DHHS and OMB administrative efforts to reduce duplication and overlap and to ensure resource redirection toward mission-critical areas, NIH
The Evolution of NIH,s Organizational Structure senior management announced the formation of the NIH Administrative Restruc- turing Advisory Committee in April 2003. The Advisory Committee will include broad NIH representation and focus on trans-NIH proposals to change NIH admin- istrative management functions (NIH, 2003a). The Committee believes that NIH is being responsive to justifiable concerns about improved efficiencies and encourages DHHS to work with the NIH Advisory Committee as it conducts its work. NIH'S LOCATION IN THE FEDERAL GOVERNMENT The Committee also briefly discussed one other recurrent issue surrounding NIH's place in the Executive Branch. Since 1952, NIH has been housed in the equivalent of DHHS. However, as the structure of the department has changed and as NIH's budget and prominence have grown, the appropriateness of NIH's place- ment has been questioned by some. NIH is now responsible for over 50°/O of federal nondefense R&D expenditures. Moreover, other large science-supporting agencies, such as the National Science Foundation (NSF) and the National Aeronautics and Space Administration, enjoy independent agency status. That status enables them to interact more directly with the leadership of the Executive Branch, including OMB and the rest of the Executive Office of the President, and with appropriate committees of Congress. Some argue that the fact that NIH is subsumed in DHHS and therefore unable to have such direct interactions potentially compromises its ability to carry out its mission most expeditiously and effectively. Those who oppose making NIH independent of DHHS argue that it is impor- tant to keep NIH embedded in the department because the NIH mission of health research is an integral part of the DHHS mission and is analogous to the arrange- ment in other departments, such as the co-location of the Defense Advanced Research Projects Agency and other defense R&D organizations with the service organizations in DOD. Independent agency status for NIH would also risk eroding the strong political support that it enjoys in Congress and among the voluntary health organizations and might upset the productive relationships that exist among NIH's various constituencies, which may be very difficult to reestablish under new circumstances. Furthermore, many fee! that NIH needs more, not less, connection with the Food and Drug Administration, the Centers for Disease Control and Pre- vention, and other PHS agencies. Although not clearly in the purview of this study, the issue of NIH's location in the Executive Branch was raised by a few people during the Committee's delibera- tions. The concern deserves more extensive consideration than could be provided by this Committee. SUMMARY NIH is a distinctive organization that is best thought of as a federation of units tied together by common processes and overall objectives. The processes are those 49
so Enhancing the Vitality of the National Institutes of Health for deploying federal research funding across a wide array of institutions and indi- viduals to mobilize the nation's best scientific capabilities to focus on NIH's priorities. The overall objectives are to advance the scientific frontier and to support research training in fields of special relevance to the nation's health needs. Despite the similar processes and shared goal of its components, however, NIH is highly decentralized, and its priorities are influenced by a wide variety of key constituencies concerned with health and the vitality of the nation's biomedical research and development system. As a result, NIH's scientific portfolio is spread across a very large number of topics and fields among which it may be difficult to discern overall strategic goals or distinctive functions. In chapters 4 through 6, the Committee addresses the implications of this highly decentralized structure both in terms of the strengths it brings to certain endeavors and the obstacles it can raise for others. The next chapter addresses the changing landscape for biomedical research and how this might affect NIH's organizational structure.