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Chapter 4 ENSURING A MANAGEABLE STRUCTURE FOR NIH Overall Coordination and Accountability The complex organizational structure of NIH--with categorical institutes and tiaciplinary study aectiona--reflecta both its mission ant its environment. In any institution, however, organizational arrangements Resigner to enhance communication along certain timenaiona tent to diminish it along other timenaiona. There will always be research arena, both basic ant applied, that crosa institute lines. As Appendix B teacribea, NIH has been Successful in introducing a number of coordinating mechanisms to alleviate the problem of communica- tion across organizational bountariea.31 The disciplinary study sections, because they cut across the categorical institutes, con- tribute some degree of integration ant aafeguart scientific quality. Other means of coordination include the program planning and budgetary processes; trana-NIH ant other coordinating committees; weekly, biweekly, or monthly meetings of officers from the bureaus, institutes, divisions, and the Director'a office with common interests ant reaponaibilitisa (intramural research, extramural research, planning and evaluation, ant so on); ant various in-house publications. In addition, the abilities both of the NIH Staff and its external advisors have helped to counter the communication difficulties inherent in a growing, increasingly elaborate organization. Authority in NIH has become increasingly decentralized over the years for a variety of reasons. The institutes have become more autonomous, with their own congressional appropriations ant their own Specific conatituencica. The Symbiotic relationship that evolves in the late 19408 between NIH, the congressional committees overseeing it, ant outsits interest groups has tented to break up into a number of Smaller alliances, organized around more restricted areas of reaearch.32 In addition, since the late 19608, the Department of Health, Education, ant Welfare (ant now, Health ant Human Services) ant the Executive Office of the President have asserted greater actual as well as nominal authority over NIH. A Striking example is the independent Presitent'a Cancer Panel, which wee eatabliahet in a time of perceived emergency. This anomaly, the committee believes, should at Same point be reconaitered. Given the current budgetary constraints and increasing congressional ant public demand upon the agency, decentralization puts additional prea sure on the NIH Director. When budgetary growth barely keeps pace

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31 with inflation, and when Presidential budget proposals often call for extremely Small increases because Congress has historically voted large increases, the task of determining overall priorities in a highly decentralized organizational ~tructure--and making those dec is ions stick--becomes extraordinarily difficult. Thus, there are now strong incentives both for professional societies ant the voluntary health associations to seek to enhance the power and position of "their" institute. There are no analogous special constituencies for the NIH Director, who has overall responsibility for the health of the entire NIH system. In order to balance the appropriate, but potentially destabilizing, centrifugal forces associated with the categorical institutes, there should be a strong central force to ensure coordination of crose-cutting research activities, to oversee orderly long-range evolution, and to maintain public accountability for NIH's overall program. The Office of the Director is the logical locus for these functions. The Authority of the NIH Director The following series of recommendations is aimed at providing the Director with adequate authority and resources to effectively lead NIH in an increasingly complex environment. Delegation of Authority to the Director The committee recommends: The Secretary of Health and Human Services should delegate to the _ ._ . . . Director of NIH 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 limitations, as _ _ in_ _ _ recommended to be modified below. The Director of NIH is nominated by the Secretary of Health and Human Services and appointed by the President, subject to confirmation by the Senate. The authority of the Director, however, is not clearly defined. There is a ~ izable collection of very specif ic authorities delegated to the Director by the Secretary, but these are largely housekeeping duties and do not get to the core of the Directory institutional responsibilities. There is no official delegation to the Director of the overall authority, direction, and control of NIH. Such a delegation would give the Director the means for ensuring the coordination of cros~-cutting research activities and for overseeing the long-range evolution of NIH. It would also make it clear that the Director has the responsibility for keeping the whole of NIH's research program responsive to national health needs.

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32 Enhanced Budgetary Authority The committee recommends: The Director of NIH should hay; greater but etary authority and discretion in two regards: 1 a tiacretionary fund, not to exceed 1.0 percent or the NIH budgets with which to seed selected areas through existing inatitutes 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 emergency. Once Congress passes an appropriation and the President signs it into law, the Director of NIH has no authority to adjust the NIH research agenda, either with discretionary funds or by reallocation across appropriations categories. The Director can make adjustments among institutes in the budget formulation stage, but only at the margin and subject to action by the Department of Health and Human Services, the Office of Management and Budget, and Congress. Any work supported by the proposed discretionary fund should be subject to peer review, ant there should be no permanent commitment that would imbet the new effort in the budget before it got an appropriate trial. The discretionary fund should be an add-on, not a tax on existing activities. It would be used to promote emerging and crosa-cutting research areas, especially those that are not obviously categorical. The White House Science Council has made a similar proposal for all federal research laboratories,33 and the National Academy of Public Administration for all government agencies.34 The idea for emergency transfer authority is not new, but the AIDS (Acquired Immune Deficiency Syndrome) episode provides an example of how it could be valuable. Although Some scientists fount the response of NIH to the crisis appropriate, others did not. In any case, there seems to have been a failure adequately to inform the public of the steps that were taken. There was a considerable period of time during which the institutes, the NIH leaterahip, the Public Health Service, ant the Congress debated the appropriate financial response to the AIDS threat.35 Although Same scientists began research almost immediately on already existing grants, ant others Sent in new applications on their own, NIH wee Stow in formally responding with requests for applications.36 Episodes like this may be rare, but emergency transfer authority would be helpful in avoiding confusion ant ensuring a prompt ant appropriate response. NIH Policy and Planning Council The committee recommence: I. The current Director's Advisory Committee Should be converted to a stronger and more independent NIH Policy and Planning ounce .

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33 2. 3. The council should provide,for the Director a continuous evaluation of the re ~ notion of NIH and of its component institutes, w ~ t affect NIH as a whole or the interrelationship among the institutes. It should advise the DO ~ ation of long-term plans and in setting research Priorities. The council should function both as a sensing mechanism and mayor consensus-builder for the Director. 4. The council should be composed of twelve members appointed b _ ~ Y the Secretary of Health and Human Services from a list prepared by the Director of NIH. 5. Appointments should be made for a single term of six years with one-third of the council's membership replaced every two years. 6. Members of the council should be selected on the basis of scientific and professional competence and distinction. The council should elect its own chair, prep-are its own agenda, meet at least four times a year and whenever requested by the Director of NIH, be assigned its own staff and have a defined budget, and report annually to the Director of NIH. The present 16-member Director's Advisory Committee, appointed by the Secretary of Health and Human Services and chaired by the Director, responds to specific requests from the Director, who also sets its agenda. It has no independent staff or budget. The proposed name change is intended to underscore this study committee' intention that there be a qualitative change in the council's nature and functions. Increasing its independence and responsibility, the committee believes, will help make it more effective in support of the Director's essential role of coordinating and overseeing cross-cutting research areas. On the other hand, giving the Director full authority to nominate the members should result in a council with whom the Director could work more effectively. The council would advise the Director on NlH-wide policy issues, such as research training, the management of the peer review system, and the personnel and salary structure for intramural scientists. It would also consider long-range research priorities among the institutes, and the effectiveness of mechanisms to coordinate crose-cutting research areas. The committee intends that the council and the Health Science Board complement each other. The council would concern itself exclusively with the NIH and its components; the board would concern itself with the NIH only in the context of the spectrum of Public Health Service agencies ant the full range of their health research.

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34 Structure of the Director's Office The committee recommence: Extramural research and intramural research (and the related su rt _ . . ppo activities of each _shcu~c be grouped under two deputy NIH directors ~ 3_ L_ Individual institutes and staff responsibility for extramura1 and ~ the staff functions in the Director's . . . o: :r~ce enoulc be reorganized to improve span of control. As Appendix B shows, there currently are 25 separate activities that report to the Director of NIH. These include the IB bureaus, instituter, and divisions, ant 7 functions in the Office of the Director itself. The NIH Director has a team of three staff officer deputies: one is a generalist, one deals with extramural and training programs, and one deals with intramural programs. None of the current deputy directors has line authority. The committee proposes that the deputies for extramural research and intramural research be given line authority over the support activities related to their responsibilities, and that they continue to have staff authority to advise the Director on the coordination and direction of the research programs within the institutes. Such a reorganization could improve the Director' ~ capacity to manage, and free his time and attention from the day-to-day exigencies of bureaucratic life. It could also reduce the Director's span of control to more manageable proportions. One possible reorganization plan appears in Appendix B. The organization of the Director's office should continue to emphasize the centrality of the planning and budgeting functions. They need to work together closely, and have direct access to the Director in connection with resource planning and allocation decisions. The same should be true at the institute level as well. Clustering of Institutes The committee recommend" Where appropriate, support functions of individual institutes and other components should be clustered to reduce unnecessii}~7~5337~[a7~~~ ~~ expense. At present, each institute at NIH has both a program staff (the director and his immediate office, program officers, planning officers, and so on) and a support staff (personnel management, grants and contracts management, budgeting, public information, and so on). The current system is designed to maximize the effectiveness of the individual institutes in carrying out their own research programs, but can lead to unnecessary duplication. In some cases it may be possible for institutes to share support staffs. One way is to create a cluster of institutes with common

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35 interests and approaches Each instituted director would retain responsibility for its scientific program, and have direct access to the NIH Director. The cluster would provide support services, and even scientific coordination if there were significantly overlapping research interests. If a new institute is necessary, it might share the support services of an existing institute but have an independent scientific program and direct access to the NIH Director. Such an arrangement could serve as an incubator for emerging research areas. For instance, rather than establishing an independent National Institute on Aging in 1974, this institute could have been clustered with the National Institute on Child Health and Human Development. Although the new institute would have had its own scientific program, budget, and director, a cluster could have facilitated cooperation on common scientific interests, such as basic research on human development and social science approaches, as well as reduced administrative costs. Clustering is a useful intermediate between complete centralization of support services and their full replication in all institutes. It has two benefits. First, it would help improve the NIH Director's span of control by reducing the number of decisions that have to be made at the NIH level. Second' it would reduce administrative costs. Together, these mean that clustering could increase ability of NIH to respond to emerging needs and opportunities by reducing the administrative and financial costs of establishing new institutes. Public and Scientific Accountability The foregoing recommendations have dealt with improving the efficiency and effectiveness of NIH. The following recommendations are intended to facilitate accountability, both to the scientific community and to the larger public, as well as to ensure a manageable structure for NIH. National Advisory Councils The committee recommends: Each institute should Provide its National AdvisorY Council members with full and easily understandable information on its entire Portfolio of currently funded grants and grant proposals; institute directors should more uniformly involve their advisory councils in broad program and . pa Icy Issues . An institute's National Advisory Council has two major roles. One stems from its statutory authority and responsibility to approve research grants made by the institute it advises. In this capacity the councils serve as a second level of review, approving grants initially recommended by study sections. ~In most instances, the councils endorse study section actions. Only rarely (1 to 2 percent of all grants for most institutes) do councils modify study section recommendations,

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36 either by assigning high priority statue to grants deemed to have high-relevance to the inatitute'a program or, lesa often, by assigning low-priority atatus to grants with low program relevance.37 The councils spent a large percentage of their time and energy on the review of research grant proposals, and the committee believes the reviews are carried out fairly and thoroughly. If the councils are to act accountably, their membera must receive sufficient information about their institutes' entire portfolio of currently funded and competing grants. This information is particularly important if council membera are to evaluate those applications that fall at the border. The second role of the councils is to provide the institutes with broad program or policy advice. Our interviews with peat and present council membera, however, indicate that this function is carried out unevenly. Some institutes have developed a variety of ways to obtain advice from council membera (special sessions, ad hoc committees, public meetings, workshops, etc.), but other institutes make little use of their councils in this regard. In fact, same council membera are barely aware that they have this Second responsibility. This heterogeneity of understanding is accentuated because the advisory role of councils is not spelled out in detail in NIR documents, and because there is no parent group (like the Division of Research Grants for study sections) that focuses on their activities. To facilitate the councils' involvement in this second role, the NIH Director's Office, through the deputy director for extramural research, should provide all council membera, at the time of their appointment, with a clearly written statement informing them of their advisory role and the various means used by NIH councils to facilitate that role. Boards of Scientific Counselors The committee recommends: The NTH Director should assume overall resPonsibi1 ~ _._. by for informing membera of each institute's Board of Scientific Counselors of that institute 8 response to its recommendations-about intramural research . . The Boards of Scientific Counselors review and evaluate the intramural research programs for their respective inatitutea. Based on discussions with past and present counselors, the committee believes that the intramural programs usually are reviewed in a timely and rigorous fashion by the boards. The board members expressed considerable concern, however, about the lack of feedback to them on the institutes' implementation of their recommendations. NIH has ant occasionally employs procedures for phasing out or reducing support for intramural laboratories that fail to Satisfy counselors of their productivity. This is true even for tenured scientists. This practice is essential for maintaining the high quality of the intramural research program. Counselors usually are not informed of such actions, but should be.

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37 Co~unicat ion The committee recommends: The role and staffing of the Office of Communications should be strengthened. The Director of NIH should establish an AdvisorY Panel on Public Information2 to aS8iSt the of distribution of current publications, and in employing additional media. NIH needs to make the public more aware of its work. The committee was impresses by NIH's present communications program, with its array of publications and other communications services. The committee has seen no evidence, however, that this information is reaching wider audiences in a timely and regular fashion. Quality of Scientific Advice Lastly, the committee eurne to the issue of the quality and independence of scientific advice rendered to NIH. The committee recommends: Quality should continue to be the overriding consideration in selecting all NlH advisory croup members--ncientific clinical and lay. The . , , expertise of the advisory groups must be of the highest possible quality ~ fill their statutory responsibilities and to have credibility within the scientific commu~nitY,~~with Congress, and _ . . ~ with the public at large. Further every effort should be made to , reduce the levels of review and to expedite the selection process so . . .. that advisory groups can always funct ion at full ~ trength. The quality of NIH's performance depends upon many factors, but one of the most important is the ability and integrity of the members of the many advisory bodies that are an essential part of NIH. The committee has received information, however, that the advisory bodies are sometimes not able to operate at full strength because vacancies are not filled in a timely manner. This delay is usually the result of multilevel reviews of nominations put forward by NIH. Further, the committee has found a widespread perception in the scientific community that members of advisory groups are often selected, at levels above NIH in the federal hierarchy, for reasons other than quality, expertise, or eminence. The perception by many, including members of Congress, that the scientific capacity of the advisory groups is being eroded points to a continuing problem for NIH and the Department of Health and Human Services. If the facts behind this perception are accurate, the situation is unacceptable. Even the existence of the perception is a matter of grave concern.