3
Initiation and Management of Center Programs

This chapter examines the current procedures for initiating new programs of extramural research support at the National Institutes of Health (NIH), including new center programs, and how NIH manages center programs after they have been launched. The chapter also contains recommended changes that would make the decision-making process more explicit and systematic, which in turn would make the process more understandable to NIH’s attentive publics. These changes in process, along with more explicit and uniform criteria—as recommended in the next chapter—will help ensure that the center mechanism is used when it is most appropriate.

The decision to create a new center program must be well justified. Centers should promise to have a substantial positive impact in their area of research because they represent a relatively large and longer-term investment than most other types of NIH awards to support research, they are more complex to manage in terms of peer review of proposals and staff oversight than a program of individual-investigator grants, and because of their size, they are more visible at the local level and can be politically difficult to terminate if the original purpose of the program is achieved or becomes obsolete.

Centers are established to achieve specific goals in a particular NIH initiative or program, for example, to help solve a specific problem such as cancer, AIDS, disabilities of the elderly, or bioterrorism; accelerate progress in a new field such as genomics and proteomics; or develop a new scientific technique such as bioinformatics and molecular imaging. This means that



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NIH Extramural Center Programs: Criteria for Initiation and Evaluation 3 Initiation and Management of Center Programs This chapter examines the current procedures for initiating new programs of extramural research support at the National Institutes of Health (NIH), including new center programs, and how NIH manages center programs after they have been launched. The chapter also contains recommended changes that would make the decision-making process more explicit and systematic, which in turn would make the process more understandable to NIH’s attentive publics. These changes in process, along with more explicit and uniform criteria—as recommended in the next chapter—will help ensure that the center mechanism is used when it is most appropriate. The decision to create a new center program must be well justified. Centers should promise to have a substantial positive impact in their area of research because they represent a relatively large and longer-term investment than most other types of NIH awards to support research, they are more complex to manage in terms of peer review of proposals and staff oversight than a program of individual-investigator grants, and because of their size, they are more visible at the local level and can be politically difficult to terminate if the original purpose of the program is achieved or becomes obsolete. Centers are established to achieve specific goals in a particular NIH initiative or program, for example, to help solve a specific problem such as cancer, AIDS, disabilities of the elderly, or bioterrorism; accelerate progress in a new field such as genomics and proteomics; or develop a new scientific technique such as bioinformatics and molecular imaging. This means that

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation the design of the program must be carefully considered in the initiation phase. A number of important decisions must be made to ensure that the stated goals are realistic and can be met. These decisions include determining the number of centers, type of award, size of award, eligible institutions, program components to be required, institutional commitments expected, relationships with other NIH-supported activities, reporting elements needed for evaluation of the program as a whole as well as of individual centers, and program location and structure at NIH. Careful initial program design, such as developing procedures and criteria for peer review, reporting of results, and program evaluation, also simplifies management of the program once it is launched. INITIATION OF CENTER PROGRAMS The initial decision to establish a center program is a very important step in program planning at NIH. That is the point at which the program must be justified in the context of the other mechanisms that NIH has to achieve its goals concerning a particular disease or scientific opportunity. The series of events culminating in the establishment of a new program of centers is highly varied and complex. There are many sources of ideas for new center programs and multiple ways such ideas are recommended to NIH, but before a proposal to establish centers can be implemented, it must go through the process of planning and budgeting that NIH and its institutes use to develop and decide on new program initiatives. Proposals for new center programs are also part of a broader set of planning and budgeting activities resulting in NIH’s annual budget request. After the appropriations are made by Congress and approved by the President, if funding permits, the new program is established and the process of soliciting applications for center awards begins. The varied origins of center programs are described first, followed by a description of the planning and budgeting process through which center and other programs are adopted. ORIGINS Proposals to establish centers may originate from any of a number of sources. An analysis of 21 recent center programs established at NIH (based on all Requests for Applications [RFAs] and Program Announcements [PAs] issued for the first or second time between the beginning of 2002 and the end of February 2003) shows that proposals for new center programs come from many places and follow a variety of routes. The sources of origin of these 21 center programs (listed in Table 3-1) include:

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation NIH external advisory groups NIH institute strategic plans Scientific workshops supported by NIH NIH program staff Federal interagency coordinating group Advocacy organizations Congress National commission Institute of Medicine report NIH External Advisory Groups External advisory groups to NIH have suggested the establishment of centers in a number of cases. For example, a special emphasis panel convened by the NIH Office of Rare Diseases in 1997 was instrumental in establishing the Rare Diseases Clinical Research Centers network, as mentioned above in Chapter 1. In 1995, a working group appointed by NIH on the state of science in autism recommended “creation of centers for long-term engagement in the field of biological clinical research” on autism (NICHD, 1995), and Congress mandated five such centers in 2001. In 1999, the report of the Task Force on the NIH Women’s Health Research Agenda for the 21st Century recommended encouraging multidisciplinary work on women’s health by, among other means, creating “core centers to encourage close cooperation, communication, and collaboration among investigators with similar interests,” and the report is cited in the RFA for Specialized Centers of Research on Sex and Gender Factors Affecting Women’s Health issued in 2001.1 External advisory groups also may be involved in the implementation of center programs after they have been initiated elsewhere or mandated by Congress. NIH relies on such advisory groups to advise on the purpose and structure of center programs and to suggest appropriate research topics. In some cases, the advisory group is asked to develop an overall research plan in an area that addresses all possible mechanisms, not just centers. An example would be the NIH Muscular Dystrophy Research Task Force, which held its first meeting in May 2002 and identified the role, functions, and structure of centers for muscular dystrophy research. They suggested additional mechanisms to increase the training of clinical and basic science 1   The report, Agenda for Research on Women’s Health for the 21st Century, is at http://www4.od.nih.gov/orwh/report.pdf. An Institute of Medicine report, Exploring the Biological Contributions to Health: Does Sex Matter? (2001), also contributed to the initiation of this center program (http://www4.od.nih.gov/orwh/02SpecialProjects.pdf).

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation researchers; encourage cooperative research, innovative research, and translational research; establish repositories of tissue, DNA, cell lines, and other shared materials; create forums for the exchange of information and data; develop animal models; and develop informatics (NIAMS, 2002). NIH Institute Strategic Plans A number of center programs have emerged from the National Cancer Institute’s (NCI) strategic planning process in recent years. In 1998 NCI changed the process for producing its annual “bypass” budget into a strategic planning exercise involving a large number of people inside and external to NCI.2 In 2002, an RFA to establish a network of research teams conducting translational research in optical imaging was included among the “Extraordinary Opportunities” in imaging identified in the bypass budget (several workshops held by NIH had also identified opportunities in optical imaging). The Centers of Excellence in Cancer Communications Research program was part of another strategic plan initiative to take advantage of extraordinary opportunities in cancer communications. Earlier center programs developed in the bypass budget strategic planning process include the In Vivo Cellular and Molecular Imaging Centers and Transdisciplinary Tobacco Use Research Centers. In 2002 the National Institute of Allergy and Infectious Diseases (NIAID) assembled a blue-ribbon panel on bioterrorism to develop a strategic plan for biodefense research. The plan calls for the development of 6 to 12 Regional Centers of Excellence for Bioterrorism and Emerging Diseases Research (NIAID, 2002). In August 2002 NIAID released an RFA inviting applications for up to four Regional Centers of Excellence for Bioterrorism and Emerging Infectious Diseases Research in fiscal year (FY) 2003. Scientific Workshops Several recent center programs trace their origins to scientific workshops sponsored by NIH. In some cases, the consensus report of a workshop had explicitly recommended centers. Centers with human embryonic stem cell core facilities, for example, were suggested by a workshop on the basic biology of mammalian stem cells held by the National Institute of 2   The War on Cancer Act of 1971 authorized NCI to submit its annual budget directly to the President. It is called the bypass budget because it bypasses the Department of Health and Human Services and the Office of Management and Budget (NCI also submits a regular budget request).

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation TABLE 3-1 Origins and Intended Purposes of Recent Center Programs   Origins   Program Proposed by Outside Group(s) Mandated by Congress Rare Disease Clinical Research Network (U19) X X Excellence in Partnerships for Community Outreach, Research on Disparities in Health and Training (Project EXPORT) (P60/P20/R24)   X Comprehensive Centers on Health Disparities (U54)     Transdisciplinary Prevention Research Centers (P50/P20)     Centers of Excellence in Chemical Methodologies and Library Development (P50) X   Centers of Excellence for Research on Complementary and Alternative Medicine (P01/U19/R21) X   Research Core Centers for Advanced Neuroinformatics Research (P30) X   Breast Cancer and the Environment Research Centers (U01) X   Muscular Dystrophy Cooperative Research Centers (U54/R21) X X Exploratory Center Grants for Human Embryonic Stem Cell Research (P20) X   Regional Centers of Excellence for Biodefense and Emerging Infections (U54/U56) X   Cooperative Centers for Translational Research on Human Immunology and Biodefense (U19/R21) X   Network for Translational Research: Optical Imaging (U54) X   Centers of Excellence in Complex Biomedical Systems Research (P50) X   Autoimmunity Centers of Excellence (U19)   X

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation   Intended Purpose   PriorNIH Initiative(s) Interdisciplinary Translational Training Shared Resources X X   X     X   X X   X   X     X X X X   X     X X X   X X X X X X X X X X     X X X X X   X   X X   X X X X   X X X X   X X X X X X   X X X X X X X

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation   Origins   Program Proposed by Outside Group(s) Mandated by Congress Cooperative Reproductive Science Research Centers at Minority Institutions (U54) X   Centers for Population Health and Health Disparities (P50) X   Centers of Excellence in Cancer Communications Research (P50) X   Autism Research Centers for Excellence (U54/R21) X X Institutional Core Grants to Support Neuroscience Research (P30)     Fragile X Research Centers (P30)   X NOTE: External idea means that centers were recommended by an external advisory body or other outside group. Prior initiatives are earlier PAs, RFAs, or Requests for Proposals (RFPs) inviting applications for research project grants, program project grants, or other noncenter research mechanisms to address a problem or condition. General Medical Sciences (NIGMS) in 2002 (NIGMS, 2002). Another NIGMS workshop, held in 2000, concluded that improvements in chemical methodology for the development of chemical diversity libraries were needed for biological research and that a “center-like” mechanism would be an effective means of encouraging collaborative research between chemists and biologists (NIGMS, 2000). The result was RFAs for Centers of Excellence in Chemical and Library Development through which four centers were funded in 2002 and 2003. In other instances, NIH staff members have determined that centers would be an appropriate response to the research opportunities identified in a workshop, if workshop participants had not addressed the question of mechanisms (see below). NIH Program Staff Transdisciplinary Prevention Research Centers is an internally generated program proposed in 2001 by a staff committee that had been charged by the director of the National Institute of Drug Abuse with identifying nonincremental initiatives. In some cases, after an external advisory committee has identified research needs and opportunities but not specific

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation   Intended Purpose   PriorNIH Initiative(s) Interdisciplinary Translational Training Shared Resources   X X X X   X X   X   X X X X X X X   X   X     X   X   X X   SOURCE: Lists of RFAs and PAs by year and week in online NIH Guide for Grants and Contracts. Available at http://grants.nih.gov/grants/guide/index.html. The table includes all center programs with the first or second RFA or PA published between January 1, 2002, and February 27, 2003. mechanisms, staff may suggest that centers and perhaps other mechanisms be established to carry out the research agenda. For example, a 1997 workshop convened by NIGMS on approaches to the study of complex biological processes concluded that the institute should launch an initiative to support cross-disciplinary and collaborative research projects aimed at understanding fundamental aspects of complex biological phenomena, such as questions of complex multigene and gene product interactions, membrane signal transduction and responses to subtle environmental factors, and differentiation and development in model systems. Workshop participants did not recommend centers or any other specific mechanisms, but they called for ways to encourage physicists, mathematicians, engineers, computer scientists, and other experts with quantitative skills to collaborate with biomedical scientists, for programs to increase the number of biomedical scientists with the requisite quantitative and computational expertise, and for support of research resources, such as new software and databases, and expensive instrumentation (NIGMS, 1998). NIGMS undertook a number of initiatives to promote and support research on complex biological systems in 1998 and 1999 (e.g., RFAs inviting applications for R01 and P01 grants for quantitative approaches to the analysis of complex

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation biological systems and R21 grants for integrative and collaborative approaches to research). The number of applications and awards in response to the initiatives was disappointing, however, and staff recommended a program of centers to encourage interdisciplinary research and training in computational biology and bioinformatics. In 2001 NIGMS issued an RFA for Centers of Excellence in Complex Biomedical Systems Research, which was reissued in 2002, and four centers have been funded.3 Federal Interagency Coordinating Group In 2002 a federal interagency coordinating committee (FICC), chaired by the director of the National Institute of Mental Health (NIMH) and including representatives from 16 agencies, initiated Research Core Centers for Advanced Neuroinformatics Research with a PAR.4 The FICC was appointed by the Secretary of Health and Human Services to administer the Human Brain Project. The project has been implemented in phases, beginning with Phase I feasibility studies in 1993, followed by Phase II development and testing in 1999. Phases I and II used R01, P01, and P20 grants as mechanisms of research and infrastructure support. Phase III, the distribution of neuroinformatics tools to the scientific community, will include P30 core centers. Advocacy Organizations Many voluntary health organizations representing patients and their families lobby for larger NIH budgets in general and more funding for their disease or condition in particular. Sometimes, they advocate the creation of research centers. In some cases, an institute may agree that centers would be a useful mechanism to add to a research program and proceed to initiate a center program (the NIH planning and budgeting process is described in the next section of this chapter). In other cases, the institute may decide that centers would not be the best way—at least at that time—to make progress against a disease but might propose other initiatives, such as an RFA inviting investigators to apply for funding set aside for research project or program project grants, establishment of a network of clinical trial sites, and/or for supplements to existing grants. If the institute does not create a 3   NIGMS also funded three P20 planning grants in 2002 to help promising research groups develop centers and apply for full center funding in response to the second RFA. 4   A PAR is a Program Announcement in which applications are reviewed by an initial peer review group appointed by the originating institute rather than reviewed by a study section under the Center for Scientific Review.

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation center program, advocates may ask Congress to urge or require NIH to establish such centers, a situation discussed in the next section. Advocacy groups pushed for several recent center programs, including Autism Research Centers of Excellence, Fragile X Research Centers; Muscular Dystrophy Cooperative Research Centers, Breast Cancer and the Environment Research Centers, and centers of excellence for research on rare diseases (Rare Diseases Clinical Research Network). A representative of the National Fragile X Foundation told Congress that curing fragile X syndrome requires interdisciplinary research and cooperative clinical trials, which centers could provide. “Collaborative efforts thrive in centers that are specifically designed and funded for such interactions. Thus far, individual grants in the field of fragile X have not led to treatment research” (Hagerman, 1999). Muscular dystrophy groups testified that centers provide an environment in which a critical mass of researchers could be assembled and that centers would promote rapid translation of research into treatments (U.S. Congress, 2001c). Advocates of autism centers presented the same rationale, and the language mandating muscular dystrophy centers in the muscular dystrophy bill of 2001 was the same as that mandating autism centers in the Children’s Health Act of 2000. A representative of the National Organization for Rare Disorders (NORD) asked Congress “to consider the creation of four regional extramural diagnostic and research centers to expand patient outreach activities and facilitate the development of postdoctoral training fellowships,” because “rare disease patients are particularly impacted by the cost of diagnosis, treatment, and ancillary support services that can reduce a family to poverty, and because patients must often travel long distances to academic hospitals to see the few specialists who work on their particular disease” (Dorman, 2001). Congress The appropriations committees often urge the NIH director or an institute director to consider using centers in appropriations report language, and periodically the authorizing committees mandate the establishment of a centers program by amending the Public Health Service Act. Congressional action on centers generally results from lobbying by advocacy organizations, although some members also take a personal interest in a particular disease. The annual appropriations laws rarely include more than the total budget amount approved for each institute, but the appropriations committees can influence NIH decision making through the reports that accompany the bills. Report language does not have the force of law, and usually it “urges” or “encourages” rather than mandates NIH to create centers. NIH, however, tries to comply with report language as much as possible.

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation The reports with the FY2002 appropriation bills, for example, contained a number of items about centers, both existing and proposed. The House report (U.S. Congress, 2001a) included the following items: The Committee also encourages NCI to fully fund the four ovarian cancer SPOREs [Specialized Programs of Research Excellence] and accelerate research in this area through all available mechanisms, as appropriate, including the establishment of additional ovarian cancer SPOREs. NIDDK [National Institute of Diabetes and Digestive and Kidney Diseases] is also urged to enhance research in such areas as basic bladder disease, pediatric urology, and urinary tract infection through all available mechanisms, as appropriate, including establishing centers of excellence…The Committee requests that the Director of the Institute be prepared to report on the progress in this area at the fiscal year 2003 appropriations hearing. The Committee also urges ORWH [Office of Research on Women’s Health] to enhance research on multisystemic diseases in women through all available mechanisms, as appropriate, including the establishment of interdisciplinary research centers. The Director [of NIH] should be prepared to provide a progress report at the fiscal year 2003 appropriations hearing. The Senate report (U.S. Congress, 2001b) included these items: The Committee encourages NCI to fund at least three Specialized Programs of Research Excellence in Brain Tumors grants in the upcoming fiscal year, with particular emphasis on those proposals which include both basic research and clinical treatment applications. The Committee strongly urges the formation of prostatitis research centers under the direction of infectious disease specialists as separate and distinct entities from the urological centers. The Committee is also aware of the significant progress made at the George M. O’Brien Kidney and Urology Research Centers of the NIDDK. The Committee urges continued and increased funding for their activities. In addition, the Committee encourages the creation of two new urologic centers, both of which should have a clinical component and a research training component. The Committee further strongly urges the NIEHS [National Institute of Environmental Health Sciences] to establish centers to conduct multidisciplinary and multi-institution research on environmental factors that may be related to breast cancer. NIH responses to such language in congressional reports have included issuance of RFAs and PAs for Specialized Centers of Research on Sex and Gender Factors Affecting Women’s Health (December 2001), a Chronic

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation the three fragile X centers authorized by the Children’s Health Act of 2000 and said it wished to see “meaningful implementation of the new Centers of Excellence in Autism Research, mandated in the Children’s Health Act of 2000,” including the allocation of “sufficient resources” (U.S. Congress, 2001b).10 Advisory Group Input NIH has a standing structure of outside advisory groups and other mechanisms for obtaining outside advice on health needs and scientific opportunities and ideas for new program initiatives. Sometimes, advisory groups recommend establishment of research centers, or they may recommend initiatives the NIH staff decides would best be implemented through centers. Some advisory groups are standing bodies with rotating memberships from the scientific community and the public, and they play a regular role in the annual program planning and budgeting process and in reviewing programs and new initiatives. These are primarily the national advisory councils, because the substructure of standing program advisory committees has been drastically reduced. Most advisory groups are ad hoc, formed to provide advice on a specific topic, review a particular program, or develop a research agenda for a major area of science. Each institute and center has a national advisory council or, in the case of NCI, a national advisory board. In most cases, there are 18 members, 12 from the health and scientific disciplines and 6 representatives of the public. The national advisory councils, although advisory, must recommend all research grants awarded by NIH. They are also charged with providing advice on policies and programs, although the arrangements for this are left to the discretion of each institute director (NIH, 1995). Each institute involves its council in the annual program planning and budgeting process and strategic planning exercises in some way. Generally, they participate at several points, providing feedback on priorities and needs early in the process and reviewing and approving concepts for PAs and RFAs to implement new initiatives, including center programs. NIH leaders also have a number of external advisory committees. The NIH director has the Advisory Committee to the Director (ACD) and the Director’s Council of Public Representatives. ACD working groups have reported on gene transfer, clinical research, construction of research facili- 10   NIH funded three cooperative research centers for the muscular dystrophies in October 2003 and announced plans to establish two more. Two Autism Research Centers of Excellence were funded in May 2002 and seven more in September 2003.

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation ties, and biomedical computing. The last report resulted in a PAR for planning National Programs of Excellence in Biomedical Computing, supported by 17 institutes, which uses a center mechanism (P20 developmental grants). Some of the institutes have standing program advisory committees. For example, NCI has an advisory committee to the director, a Board of Scientific Advisers (to oversee extramural programs), and the NCI Director’s Consumer Liaison Group. The National Heart, Lung, and Blood Institute (NHLBI) has advisory committees for specific programs (sickle cell disease and sleep disorders). NIAID has similar advisory committees for AIDS research and chronic fatigue syndrome. The institutes used to have more program review committees, but most of these were disbanded in several rounds of advisory committee trimming imposed by several past Administrations. All the institutes appoint ad hoc bodies (committees, working groups, task forces, or panels) to evaluate programs, assess the state of the science, and develop research agendas. The reports of these groups are another input into the planning process. Sometimes, these groups consider mechanisms and recommend the establishment of centers. For example, an Imaging Sciences Working Group appointed by the NCI director recommended interdisciplinary “imaging centers of excellence,”11 which resulted in the establishment of In Vivo Cellular and Molecular Imaging Centers. The institutes convene workshops on a regular basis to help them plan activities in a particular area of science or to address a specific disease or condition. Workshop reports were involved in the genesis of several recent center programs, for example, Centers of Excellence in Chemical and Library Development, Centers for Human Embryonic Stem Cell Research, and Centers of Excellence in Complex Biomedical Systems Research. Each institute’s director and extramural program heads meet regularly with representatives of voluntary health agencies, disease patient advocacy groups, and scientific and medical associations. The NIH director and NCI director meet with their formal consumer advisory groups several times a year. Program staff at all levels participate in annual meetings of scientific and medical associations and some hold focus sessions at these meetings on topics of interest. In addition, some program advisory groups have members representing voluntary health agencies and disease advocacy groups. In principle, the institutes have extensive ongoing arrangements for obtaining external views and advice from both the research community and the public, and they consult with their national advisory councils on pro- 11   http://www3.cancer.gov/dip/ISWG3.htm.

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation gram priorities and balance among mechanisms. In some cases, external committees have created research plans that identify research needs in a particular area and consider the set of mechanisms required to address them, including centers. Increasingly, the strategic plans the institutes develop with external professional and public participation are addressing implementation strategies, including the appropriate mix of mechanisms needed. Assessment of new program initiatives requires adequate expert advice. The national advisory councils, consisting of scientists, health care providers, and representatives of the public, spend most of their time reviewing applications. They review initiatives and consider the balance among mechanisms, but by the time an initiative reaches the council, it should have been reviewed by expert panels and affected parties consulted. In most cases, the expert review function is carried out by ad hoc advisory groups and either subcommittees of the council or, in several cases (NCI and NHLBI), a board of scientific advisers. DESIGN AND MANAGEMENT OF CENTER PROGRAMS During the development of the concept paper and the subsequent PA, RFA, or RFP, NIH staff must make a number of important decisions about the design and management of a center program. These decisions include: how the centers should be organized to achieve the program’s goals; how many centers should there be; the maximum award length and size; the mechanism of support to be used; the application review process and criteria; where and by whom will the program be administered within NIH; whether there will be time limits on the program or individual centers; and how the program and individual centers will be evaluated. Type of Center NIH supports many types of centers. The center mechanism is very flexible, because the institutes have broad discretion to tailor the goals, requirements, and review criteria in the PA, RFA, or RFP to the specifics of each situation. Broadly speaking, however, NIH offers several major types of center awards, as noted in Chapter 1. One type supports center infrastructure, including the center director and shared services and perhaps other components, such as developmental project funding, leaving it to the center to fund the research by competing for research project funds from NIH and other agencies and organizations. Another type funds research projects as well as shared services and perhaps other programs (e.g., community outreach or professional education). The third type, which is not the focus of this report, supports national or regional centers that provide

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation research tools (e.g., research resources and materials) to the scientific community in general. The type of center should, of course, be designed to achieve the program’s goals. It should be considered in the process of deciding to establish a center program in the first place. Number, Size, and Length of Awards Center grants are, on average, substantially larger than most other awards, and although the award period is usually five years, only a little longer than the award period for RPGs, there are upfront costs of getting a center up and running that make it desirable to maintain it for longer than five years. Centers are intended to provide a stable, long-term focus on an area of research, and they pay for shared facilities and services (cores) if not research projects. The number of centers is sometimes mandated by Congress, but otherwise depends on what the program purpose is, whether related programs exist, and the institute’s assessment of the amount of funding needed to assure program effectiveness and whether that level of funding will be available. Mechanism of Support NIH has a number of award mechanisms, denoted by activity codes. Some are specifically for centers, such as P30 core grants, P50 and U54 specialized centers, and P60 comprehensive centers. As shown in Chapter 2, however, activity codes are not always used consistently in terms of the types of centers they fund. There appear to be recent trends, however, toward using cooperative agreements (e.g., U54) and toward using noncenter activity codes (e.g., U01 and U19 cooperative agreements, P01 program project grants, and R24 resource-related RPGs). The trend toward cooperative agreements reflects the desire to facilitate collaborative research among the centers in a program and the desire of NIH to be more involved in programs of great interest to Congress and advocacy groups. Examples among the most recent center programs include the Rare Disease Clinical Research Network (U54), Autism Research Centers of Excellence (U54), and Muscular Dystrophy Cooperative Research Centers (U54). Some are funded by noncenter cooperative agreements, including Breast Cancer and the Environment Research Centers (U01), Centers for Reducing Asthma Disparities (U01), and Cooperative Centers for Translational Research on Human Immunology and Biodefense (U19). The trend toward awards not classified as center awards stems in part from reviews of center programs that have recommended a shift toward

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation awards with greater investigator autonomy. Examples include support of population research (from P50 to R24) and research on complementary and alternative medicine (from P50 to P01) (NCCAM, 2002; NICHD, 1999). In most respects, the activity code does not matter, nor does the presence or absence of the word “center” in the title of the RFA or PA, because the detailed specifications in the PA or RFA determine what the centers will do. There is a significant difference, however, between grants and cooperative agreements. NIH staff are more involved in program planning and decision making in cooperative agreements. But if the center program is expected to include collaborative research, common protocols, and/or development of a national database, the cooperative agreement may be more suitable than grants. Review Process and Criteria The review process and criteria for choosing which centers to fund are specified in the PA or RFA or, in the case of some long-standing and wellknown programs such as the Cancer Centers, in institute guidelines. In the case of PAs, there are three receipt dates a year for center awards, although the institute may specify a single date. For example, the receipt date for applications for Environmental Health Sciences Core Center Grants is February 1 of each year. RFAs always have a specific one-time receipt date. All applications for center grants and cooperative agreements are reviewed by peer review panels organized by the institute. In some cases, these are standing committees. In most, special emphasis panels are formed on an ad hoc basis to review a particular set of applications. There may be site visits or “reverse” site visits in which the applicant team travels to NIH to make a presentation. There have been fewer site visits over time, because the funding for administrative overhead has increased less quickly than funding for extramural programs, and the ratio of staff to awards has fallen by nearly half. On the other hand, as mentioned above, there seems to be an increase in the use of cooperative agreements, in which staff participate in project planning and decision making. The PAs/RFAs differ in how directive they are about research topics to be addressed, how many and what kind of components a center must have, and administrative structure. In the least directive case, they may list potential research areas, but expect each applicant to focus on one, which may be one that was not listed, and then say it is up to the applicant to propose the administrative structure. Or they may be very specific about topics for research projects, the minimum and maximum number of projects, the cores (shared services) that must be provided, and the administrative structure. The RFA for Breast Cancer and the Environment Research Centers,

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation for example, requires every center to include the same two collaborative research projects, an administrative core, and a community outreach and translation core. There is also a range of specificity in the review criteria. In a few cases, the only criteria are the basic ones NIH uses for all individual investigator grants, i.e., significance, approach, innovation, investigator, and environment. An example is the RFA for centers of excellence on rare diseases (Rare Diseases Clinical Research Network). In most cases, there are additional criteria. The RFA for the muscular dystrophy centers of excellence has separate criteria for research projects and the shared resource cores, as well as another dozen criteria specific to the Muscular Dystrophy Cooperative Research Centers program. The RFA for Cooperative Research Centers for Translational Research on Human Immunology and Biodefense has separate criteria for (1) organization and scientific potential of the center, (2) research resource technical development component, (3) research project component, (4) core facilities component, (5) pilot project component; and (6) education component. Program Administration There are several models of extramural center program administration. In some cases, there is a central office responsible for administering the center program. This is generally the case in which the institute has a single center program that is meant to be a platform for all the institute’s extramural programs. Examples include NCI’s Cancer Centers and NEI’s Vision Centers. The Alcohol Research Centers were recently moved to the National Institute on Alcohol Abuse and Alcoholism’s (NIAAA’s) Office of Collaborative Research Activities. In other cases, institutes have several center programs, each administered in the relevant extramural program division. The advantage of the latter arrangement is that all the mechanisms the institute uses in a specific area—e.g., individual investigator grants, program projects, centers, small business grants, career development grants, and research and development contracts—are planned and administered together, which should increase program coherency and help assure appropriate use of centers. NIGMS, for example, established a Structural Genomics and Proteomics Technology Branch in the Division of Cell Biology and Biophysics to administer the research centers and research grants constituting the Protein Structure Initiative. The disadvantage of putting centers with other programs in separate divisions and branches may be the limited time and resources the program staff has to oversee the centers along with other types of grants and contracts. In centralized center programs, full-time staff may manage the pro-

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation gram more effectively, but the coordination of centers with related activities is more difficult. Sometimes, there is an external advisory body to the center program. There is a Cancer Centers subcommittee of the National Cancer Advisory Board. For NIAAA’s alcoholism centers, a separate advisory committee was set up under the National Advisory Council on Alcohol Abuse and Alcoholism. Time Limits or Sunset Provisions Some institutes (e.g., NIMH) have adopted a general policy of allowing one five-year renewal after the first five-year award to an individual center. For example, in the case of Centers of Excellence in Chemical Methodologies and Library Development, the RFA says no center will receive more than 10 years of funding, “either because the project goals will have been accomplished or the Center will have developed to the point that support from other sources will be more appropriate.”12 In another case—Centers of Excellence in Genomic Science—the PA says the institute will conduct an administrative site visit in the third year of a center grant to determine if there will be a fifth year of funding and to advise the Principal Investigator about the “interest” of the National Human Genome Research Institute “in accepting a competing renewal application to extend the initial award.”13 No institutes have sunset provisions for center (or other) programs, except NHLBI, which in 1993 adopted a policy of limiting each Specialized Center of Research (SCOR) program to 10 years of funding “unless a thorough evaluation of research needs and opportunities uncovered extraordinarily compelling reasons to continue a specific SCOR program” (Lenfant, 2002). Funding Limits Institutes usually impose a limit on the amount of first-year funding for direct costs or total costs for new centers and the percentage increases they may request in subsequent years of the award period. Competing renewal centers are usually limited in the percentage increase they may ask for. Evaluation Requirements Evaluation of center programs as programs is addressed in Chapter 5. Concerning evaluation of individual centers, the main tool is prospective 12   RFA-GM-03-004. 13   PAR-02-021.

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation evaluation, that is, review of the application for competitive renewal at the end of each award period, which is usually five years. The focus of the evaluation is on the merit of the proposed activities to be supported by the renewal grant, although past productivity, especially publications in peer-reviewed journals, is also considered. There may be a site visit or, because of budget constraints on NIH administration, a reverse site visit. There is an annual noncompetitive renewal decision, but it is based on a written annual report and perhaps a site visit by the NIH program officer. Some RFAs require the application to include an evaluation plan and require formation of an external advisory committee, one of whose duties is to oversee the evaluation plan process. FINDINGS AND RECOMMENDATIONS NIH has long supported research centers to achieve a number and variety of defined scientific and programmatic objectives that cannot be achieved, or achieved as well or as quickly, by individual laboratories or informal collaboration. These objectives include encouraging interdisciplinary research and research training, fostering translational research, providing research resources and facilities cost-effectively to individual investigators, developing research infrastructure in fields or institutions that have not been research intensive, providing a regional resource for health care providers or first responders, and supporting a network of centers able to recruit adequate numbers of patients for clinical research and clinical trials. Finding. Proposals to establish center programs originate from many sources within and outside NIH, including scientific workshops, internal program reviews, national advisory councils and other advisory bodies, NIH professional staff, professional scientific societies, citizen groups, the executive branch, and Congress. Although each of the institutes has a planning process for setting priorities and developing programs, the procedures and criteria for assessing the appropriateness of centers in an area of research are not explicit or uniform. The national advisory councils are currently required to review all initiatives, but given the small amount of time they can devote to the task, effective arrangements for soliciting external advice in the approval process and clear and consistent criteria for program approval (see next recommendation) are critical elements of center program initiation. Recommendation 2. NIH should make explicit its process for deciding whether establishment of a new center program is appropriate to meet a specified goal. The key elements of the process, which should be

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation consistent across institutes, necessarily involve broad input from the extramural scientific community and incorporation of the views of the public. NIH needs to inform Congress and advocacy groups of the process and of the opportunities they will have to provide input. Implementation of the new process should be overseen by the NIH director or someone he or she designates. The process (and criteria) for establishing center programs would, however, continue to be applied at the institute level. Currently the program planning process is driven by the annual federal budget process, which fosters incrementalism rather than broad, long-term planning. The virtue of a long-range strategic planning process is the broad context it provides in which to consider the balance among mechanisms (e.g., research program grants, centers, training, contracts, etc.). The question becomes one of the best mix of approaches to take to major problems rather than whether one mechanism is “better” than another. The institutes should consider making it standard practice in their strategic plans to include an assessment of the mechanisms needed to achieve the strategic goals identified in the plans. This is similar to but not the same as portfolio analysis, which is an approach to priority setting and program balancing that should focus on the content of the scientific program, not the mechanisms which implement them. Given the decentralized process for program planning at NIH, the new process should lead to more consistency in justifications of new center program initiatives, clearer identification of the number and funding of center program awards, and better evaluations of the effectiveness of center programs. The process will benefit NIH by being more open and understandable to the public. At the same time, the specifics of the PA or RFA will leave adequate flexibility to tailor requirements to the particular needs in each case. REFERENCES Bilirakis M. 2001. Remarks at “Advancing the Health of the American People: Addressing Various Public Health Needs.” Hearing before Subcommittee on Health of the House Committee on Energy and Commerce, June 27, 2001, as reported by the NIH Office of Legislative Policy and Analysis. [Online]. Available: http://olpa.od.nih.gov/OLPAReports/062701PubHlth.htm [accessed October 30, 2001]. Dorman D. 2001. Statement of the Senior Director for Public Policy of the National Organization for Rare Disorders at the March 14, 2001, hearing of the Subcommittee on Labor, Health and Human Services, Education and Related Agencies of the U.S. House Committee on Appropriations, U.S. House of Representatives. [Online]. Available: http://www.rarediseases.org/news/speeches/house [accessed December 15, 2003].

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation Hagerman RJ. 1999. On behalf of H.R. 1445, Fragile X Research Breakthrough Act of 1999. Statement before a 1999 hearing of the House Subcommittee on Health and Environment. Reprinted in: National Fragile X Foundation Quarterly, Fall 1999. Pp. 9-10. [Online.] Available: http://www.nfxf.org/html/news1999.htm# [accessed December 15, 2003]. IOM (Institute of Medicine). 1991. Mapping the Brain and Its Functions: Integrating Enabling Technologies into Neuroscience Research. Washington, DC: National Academy Press. Kennedy EM. 2001. Statement on the Senate floor when introducing the Rare Diseases Act of 2001. Congressional Record, 107th Congress, 1st Session, August 3, 2001. Pp. S8952-S8953. Lenfant C. 2002. Strengthening commitment to clinical research: The National Heart, Lung, and Blood Institute’s Specialized Centers of Research program. Circulation 105(4):400-401. [Online]. Available: http://www.nhlbi..nih.gov/funding/fromdir/circ-1-02.htm [accessed December 15, 2003]. National Commission on Orphan Diseases. 1989. Report of the National Commission on Orphan Diseases. Publication Number HRP-090-7248. Washington, DC: U.S. Government Printing Office. NCCAM (National Center for Complementary and Alternative Medicine). 2002. Research Centers Program Expert Panel Review. [Online]. Available: http://nccam.nih.gov/about/plans/centers/report.pdfx [accessed January 8, 2003]. NIAID (National Institute of Allergy and Infectious Diseases). 2002. NIAID Strategic Plan for Biodefense Research. [Online]. Available: http://www.niaid.nih.gov/biodefense/research/strategic.pdf [accessed December 15, 2003]. NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases). 2002. “Summary of the First Meeting of the NIH Muscular Dystrophy Research Task Force, held May 15-16, 2002,” Bethesda, MD. [Online]. Available: http://www.niams.nih.gov/ne/reports/sci_wrk/2002/mdmeet.htm#agenda [accessed December 15, 2003]. NICHD (National Institute of Child Health and Human Development). 1995. “Recommendations of the Working Group on Medical Intervention,” in State of the Science in Autism: Report to the National Institutes of Health. [Online]. Available: http://www.nichd.nih.gov/publications/pubs/autism/sub8.htm [accessed December 15, 2003]. NICHD. 1999. “Report of the Demographic and Behavioral Sciences Branch Population Centers Review.” [Online.] Available: http://www.nichd.nih.gov/about/cpr/dbs/pubs/report.pdf [accessed December 15, 2003]. NIGMS (National Institute of General Medical Sciences). 1998. New Approaches to the Study of Complex Biological Processes. Report of a workshop held by NIGMS in November 1997. [Online]. Available: http://www.nigms.nih.gov/news/reports/complexbio.html [accessed December 15, 2003]. NIGMS. 2000. Diversity-Oriented Synthesis Meeting. Report of a workshop held by NIGMS in August 2000. [Online]. Available: http://www.nigms.nih.gov/news/reports/chemical_diversity.html [accessed December 15, 2003]. NIGMS. 2002. Workshop on the Basic Biology of Mammalian Stem Cells. Report of a workshop held by NIGMS in June 2002. [Online]. Available: http://www.nigms.nih.gov/news/reports/stemcellworkshop.html [accessed December 15, 2003]. NIH (National Institutes of Health). 1995. Management and procedures of national advisory councils and boards in their review of extramural activities. In: NIH Policy Manual, Chapter 4513. Bethesda, MD: NIH (Available from the Office of Extramural Programs, Office of the Director, NIH).

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NIH Extramural Center Programs: Criteria for Initiation and Evaluation NIH. 1999. Report on Steps to Coordinate Rare Diseases Research Programs: Analysis by and Recommendations of the Special Emphasis Panel of the National Institutes of Health on the Coordination of Rare Diseases Research. [Online]. Available: http://rarediseases.info.nih.gov/html/reports/fy1999/SEP.html [accessed December 15, 2003]. NIH. 2001a. Congressional Justification for FY2002. Bethesda, MD: NIH. Office of Financial Management: Vol. 1, Overview. NIH. 2001b. Setting Research Priorities at the National Institutes of Health. Revised edition. [Online]. Available: http://www.nih.gov/about/researchpriorities.htm [accessed December 15, 2003]. U.S. Congress. 2001a. H.R. 3061, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Bill, 2002. House Report 107-229. Washington, DC. U.S. Congress. 2001b. S. 1536, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Bill, 2002. Senate Report 107-84. Washington, DC. U.S. Congress. 2001c. “Muscular Dystrophy,” Hearing before the Senate Appropriations Subcommittee on Labor, Health and Human Services, and Education, February 27, 2001.