NIH Extramural Center Programs: Criteria for Initiation and Evaluation (2004)

The normal National Institutes of Health (NIH) process for setting priorities, in which the initiation of new programs, such as research centers, is considered, is complex (NIH, 2001). It is highly decentralized and mostly involves a bottom-up process within each institute. No two institutes employ exactly the same priority-setting procedures. NIH program planning is driven by the annual federal budget process, however, which imposes some top-down structure and higher-level priorities.

At several points, new initiatives have to be fitted within an overall budget figure for NIH; first, within the total the NIH director decides to submit to the Department of Health and Human Services (DHHS), second, the amount allowed by DHHS in its request to the Office of Management and Budget (OMB), third, within the mark for the President’s budget request set by OMB, and fourth, within the final appropriation amounts set by Congress and signed into law by the President. In this process, proposals for new programs, such as extramural research centers, well up from program staff, advisory groups of scientific and medical experts and members of the public, professional and scientific organizations, voluntary health associations (VHAs) and patient groups, and other agencies.

NIH also may be asked or directed to establish centers from above by DHHS, the White House, or, most often, by Congress. If centers are mandated, NIH must establish them regardless of what their priority would have been within the NIH planning system.

The annual federal budget process is the principal driver of the program planning and priority-setting process, resulting in decisions about the

existence and funding of programs. A number of pathways converge to feed into this process beyond internal staff initiatives, however, including the views of constituency groups of many kinds, the Administration, and Congress. The institutes also engage in long-range strategic planning, periodic program reviews, and research agenda-setting exercises, all involving outside advice from standing and ad hoc advisory groups. NIH-wide planning and program collaboration and coordination are less well developed, although the increasing focus of research on complex biological phenomena that cross institute boundaries is resulting in more multi-institute center (and other) programs and more NIH director-level advisory and planning mechanisms. All proposals to establish new programs of centers compete with other new and existing programs for funding in the budget process (unless Congress specifies the amount of funding for a center program in the appropriations process, in which case NIH must accommodate that amount in its budget).

In 1998 the NIH director asked the institutes to submit five-year strategic plans. This request followed the tenor of an Institute of Medicine (IOM) report, Scientific Opportunities and Public Needs (IOM, 1998), which recommended that the NIH director take steps to more systematically identify cross-cutting scientific opportunities and needs and to foster unified or joint programs to address them.¹ Some institutes were already engaged in longrange planning to assist in priority setting, such as the National Eye Institute (NEI), which has produced multiyear plans for vision research since 1975 (for the most recent plan, see NEI, 1999). The other institutes produced plans in 1999 or 2000. In all cases, there was extensive participation of nonfederal scientists and nonscientists representing health groups.

A survey of recent strategic plans shows that they differ from institute to institute in their scope and level of detail. Some are just a few pages in length. Several are 75 pages or more. All the plans identify areas of promising research in which advances would help achieve each goal, but only some discuss possible programs or mechanisms, such as new center programs, as possible program initiatives.

For example, the strategic plan of National Institute of Allergy and Infectious Diseases (NIAID) has four major goals and also four “selected

crosscutting elements.” One crosscutting element is “translation of research” from fundamental discoveries to new and improved treatments. The plan mentions a number of research mechanisms employed by NIAID to support translational and clinical research. “In extramural laboratories, for example, when transitional and applied research require shared resources, and/or a cross-disciplinary research team, program projects and center grants (P01, P30, P50) can facilitate the necessary linkages.” NIAID also uses U01 and U19 cooperative agreements to support centers, which permit substantial involvement of NIAID program staff (examples include the STD [sexually transmitted disease] and Hepatitis C Cooperative Research Center Programs) (NIAID, 2000:89).

The National Cancer Institute (NCI) has the unique authority, termed the bypass budget, to submit a budget to the President without change by DHHS or OMB. The process for producing the bypass budget was changed in fiscal year (FY) 1998 to become more like a strategic planning exercise. Every three years, the plans identify and discuss in some detail a set of major research opportunities, including research goals, possible program initiatives, and suggested funding levels. Several new center programs were proposed in bypass budgets, including the In Vivo Cellular and Molecular Imaging Centers, Transdisciplinary Tobacco Use Research Centers, and Centers of Excellence in Cancer Communications Research, all supported by P50 center grants. “Building the nation’s cancer research capacity” is a goal in the latest plan, in which the expansion of the P30 cancer centers, Specialized Programs of Research Excellence, and other P50 centers of excellence would play a major role (NCI, 2002).

The strategic plan of the National Heart, Lung, and Blood Institute (NHLBI) is organized around seven major program areas, each containing about five goals. For NHLBI, like NIAID, the center mechanism facilitates translational research, and one potential FY2003 initiative was to establish centers for translational research in peripheral and pulmonary vascular diseases. “A program of closely integrated, multidisciplinary research projects linking basic and clinical investigations is needed to lead to the development of improved therapeutic and preventive approaches for these diseases” (NHLBI, 2000).

The National Institute of Neurological Disorders and Stroke (NINDS) plan has a section on research infrastructure, which has new funding mechanisms as one goal. “For many of the exciting scientific opportunities described above, the current culture of individual investigators carrying out all phases of a project must be complemented by one in which collaboration among laboratories with different expertise is the norm” (NINDS, 1999). The plan listed a number of ways to facilitate research collaborations, such as core grants to groups of funded investigators at an institution, regional facilities for large-scale resources not fully justified at a single institution,

small grants to support the development of collaborations by funded investigators at different institutions, and grants to support the organization and functioning of consortia formed to address a specific problem.

Some institutes also develop strategic plans for specific problems. The National Institute of Child Health and Human Development (NICHD) has several focused plans for topics such as developmental biology, reproductive health, and SIDS (sudden infant death syndrome). NIAID has developed a strategic plan for biodefense research that lays out goals in six areas, for example, biology of the microbe, vaccines, and diagnostics. Another area is research resources, in which the plan says that the development of centralized sources of expertise in bioterrorism areas will be needed to speed the development of new products, tools, and interventions. The first goal in research resources is “Developing 6 to 12 Centers of Excellence for Bioterrorism and Emerging Diseases Research” (NIAID, 2002). A Request for Applications (RFA) for such centers was issued later in 2002, to be supported by U54 cooperative agreements, along with an RFA for Cooperative Centers for Translational Research on Human Immunology and Biodefense, to be supported by U19 cooperative agreements or R21 exploratory/developmental research project grants.

The institutes begin to plan two years before the fiscal year begins, because NIH has to send a preliminary budget to the Secretary of Health and Human Services each June for the fiscal year beginning nearly 16 months later. For example, institute directors had to decide on changes they wanted in existing programs and new initiatives for FY2004 during the latter half of 2002 and early 2003 to be ready to work with the NIH director on their budget requests during April and May 2003. Each institute has its own process for program planning and decision making, culminating in a proposed budget request to the NIH director. In each case, the process is complex and includes input from a number of outside sources, including NIH advisory bodies, scientific workshops and conferences, and professional and consumer health groups (see next section). The institute directors, however, working with the NIH director, make the final decisions on what goes forward to the department and White House.

Each institute has its own system. Examples are described briefly here to impart a sense of what happens in a few concrete cases.

NIAID, in 1988, was one of the first to develop a formal planning process. “The structured process involves a progression of decision-making

events, informed by a continuous stream of reviews, evaluations, and consultations” (NIAID, 2000). The NIAID planning process is organized around two major events attended by the institute director, scientific program heads, and senior management staff (IOM, 1998:50). The Summer Policy Retreat is held to discuss and reach consensus on future scientific directions. At the second meeting, the Winter Policy Review, NIAID division directors make formal presentations on the state of knowledge, emerging public health needs, and research opportunities in their areas, and propose approaches for responding to the needs and opportunities that have been identified. At this time, specific initiatives are ranked in priority order within a budget target provided by the institute budget office. At their fall meeting, the NIAID national advisory council is provided an overview of the concepts and ideas discussed at the Summer Policy Retreat and asked for input, as are the council’s subcommittees for the three extramural program divisions. After the Winter Policy Review, the divisions submit fully developed proposals for their high-priority initiatives, and the director of NIAID selects the initiatives that will be in the institute’s budget submission. At the next meeting of the national advisory council, the divisions present the concepts for research initiatives for approval that are expected to be implemented through Program Announcements (PAs), RFAs, or Requests for Proposals (RFPs). Throughout the process, the NIAID director, division directors, and program staff interact with the institute’s scientific and lay stakeholders; consider the results of scientific workshops, blue-ribbon panels, and program reviews; and respond to the priorities of the NIH director, the department, and Congress.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has a similar process organized around two documents presented to the institute’s national advisory council each year. Together, they constitute the NIDDK Program Plan. Research Progress Reviews, which report on recent major scientific accomplishments, are presented to the council in February. Program Initiative Concepts are the second part of the Program Plan and are basically a list of potential new programs put forth by NIDDK’s three extramural scientific operating divisions (NIDDK, 2000). Preliminary program initiatives are discussed with each division’s subcommittee of the national advisory council. In September, after final selections by the institute director, Program Initiative Concepts are presented to the full national advisory council for review and approval.

The NIH director works with the institutes to prepare the NIH-wide budget request, which goes to the department for consideration in June. The director has final approval authority on the distribution of funds among

mechanisms and institutes. At all stages of the budget, the amount of funding for Research Project Grants, especially for new and competing renewal grants, is scrutinized closely, relative to the amounts for other mechanisms, such as centers and contracts.

In recent years, NIH directors have increasingly used their budget authority to stimulate trans-NIH programs. Harold Varmus, when he was director of NIH, identified crosscutting research opportunities, called Areas of Research Emphasis, and looked more favorably on requests for increases that addressed them. Since FY1991, NIH directors have had a director’s discretionary fund and authority to transfer up to 1 percent of an institute’s budget to adjust to changing priorities such as health emergencies. Dr. Varmus used these authorities to address NIH-wide priorities, for example, expansion of the mouse genetic sequencing center program.

The current NIH director, Elias Zerhouni, undertook a strategic planning exercise soon after he became director in May 2002. He convened intramural and extramural scientists from academia and industry to identify needed resources, roadblocks, and gaps in knowledge that no single NIH institute could provide in areas such as bioinformatics, molecular libraries, systems biology, and clinical research. The result was a “Roadmap Initiative” with three broad themes to guide NIH: (1) finding new pathways to discovery, (2) creating the research teams of the future, and (3) reengineering the clinical research enterprise. The Roadmap areas were published in the NIH budget request for FY2004 but will affect the FY2005 budget more, because the former was largely completed when the Roadmap came out.

Dr. Varmus also promoted the use of multi-institute and, in some cases, all-institute PAs and RFAs. Increasingly, trans-NIH and interagency coordinating committees are established to oversee the development of multiinstitute initiatives, including the center programs for autism, muscular dystrophy, neuroinformatics, and Parkinson’s disease research. More recently, trans-NIH working groups and task forces, including extramural researchers and representatives of VHAs as well as NIH staff, have been appointed to provide advice, for example, on implementation of the Parkinson’s disease research agenda and development of initiatives in muscular dystrophy research.

In working with the institutes, the NIH director takes account of the program priorities and initiatives of the Secretary of Health and Human Services. The director then interacts with the department as it reviews NIH’s preliminary budget estimate. In August the department gives NIH a budget “mark” for submission to OMB. The main submission is the NIH

mechanism table. After OMB gives NIH its budget mark in late November, the NIH director consults with the institute directors and departments to decide whether to appeal the initial OMB mark in budget hearings held by OMB, and later, to the President.

After the final budget amount for NIH is settled, NIH revises the budget to fit and 26 detailed Congressional Justification Budgets (CJs) are prepared and submitted to Congress (one each for the 24 grant-making institutes and centers, Office of the Director, and Buildings and Facilities).

In the spring, the NIH director and institute directors present the President’s budget to the House and Senate Labor, Health and Human Services, and Education Appropriations Subcommittees. During the summer and fall, the appropriations subcommittees mark up the President’s budget by institute and center. After the appropriations bills are passed, differences between the House and Senate are resolved in a conference committee. The NIH budget is adjusted again, at which point the final decisions on new program initiatives are made by the institute directors.

The appropriations process may have its own impact on new programs. The appropriations subcommittees for NIH do not put much detail in law, usually just the total appropriation amount for each institute. Instead, they use the reports that accompany bills to influence NIH, up to and including mandatory directives, for example, to establish a center program. When the budget becomes law, there are three reports—the House report, Senate report, and report of the conference committee negotiated between the House and Senate on the final appropriations bill—and any directives in the report of one committee remain in effect unless contradicted in the report of the other subcommittee or the conference committee report. Although report language does not have the force of law, NIH tries hard to comply, because they have to appear before the appropriations subcommittees every year for funding.

In recent years, the appropriations subcommittees have generally avoided being very directive in report language, although the degree of directiveness has varied by congressional branch, individual chairmen, and, occasionally, the chairman of the full appropriations committee.

There were more specifications, or “earmarking,” of amounts of funding for a particular program, and of mechanisms such as centers, in earlier years, but earmarks created conflict in the early 1990s. NIH was experiencing flat budget growth, and earmarks had to be paid for with cuts in other programs. The 1988 IOM committee on priority setting at NIH analyzed report language accompanying the FY1993 and FY1998 budgets and found there were many more specific items in 1998, but they were much less

directive than in 1993 (IOM, 1998), and that approach has continued. The FY2002 report of the House subcommittee, for example, says:

The Senate appropriations report for FY2002 said the subcommittee did not earmark specific funding levels for individual diseases and conditions, although there were some earmarks for funding certain programs. The Senate subcommittee said it strongly supported NIH “in the firm belief that sustained and sufficient funding is essential to accelerate the pace of research advances, ensure the timely application of new discoveries into clinical practice, and maintain the Nation’s research infrastructure,” but, it added, “an investment of this magnitude demands accountability” (U.S. Congress, 2001b).

The House and Senate reports for FY2002 appropriations refer to approximately 15 and 25 specific center programs, respectively. The House report generally urges an institute or the NIH director to “enhance” research in an area “through all available mechanisms, as appropriate, including establishing centers of excellence;” “commends” the institute for supporting existing centers; or “encourages” establishment or expansion of center programs. The Senate report also commends and encourages use of centers but also uses somewhat stronger language (“The Committee strongly supports the creation of new interdisciplinary centers to focus on…”) or “encourages” or “strongly urges” funding of a specific number of new or additional centers. The report strongly urged establishment of at least three centers of excellence for muscular dystrophy research, although a specific number had been dropped from the authorization bill before it became the law.

Interpreting report language is done by those experienced in the legislative process, who must decide whether a particular phrasing means NIH must do something, should do it if possible, or can safely ignore an item in a report. NIH officials may contact the appropriations subcommittees to clarify intent. In the case of muscular dystrophy research, NIH (through an interinstitute task force) decided to set aside funding for two to three centers in the first RFA, issued in December 2002, and announced its intention to reissue another RFA in 2004 to reach a total of at least three centers. In addition, NIH decided to issue an RFA in early 2003 to award four to five planning grants to increase the number of places able to submit full center grant applications in 2004. NICHD has also issued an RFA to establish

three fragile X research centers, the number mandated in the Children’s Health Act of 2000. In that case, however, after consultation with Congress, the institute decided to limit applicants to existing Mental Retardation Research Centers supported by NICHD. In the other cases where report language urged the establishment or expansion of center programs, NIH has decided not to do so, although it may take other initiatives, such as an RFA for individual-investigator or program project grants or to establish a clinical trials network.

In recent years, the House and Senate authorizing committees have become much more active in passing laws affecting NIH. Earlier, the committees passed an NIH reauthorization bill every three to four years, but they have not been able to pass one since the 1993 NIH Revitalization Act expired in 1996, because of conflicts over amendments to ban use of fetal tissue and similar issues. At that point, the authorization committees began to pass narrow bills addressing specific problems. These authorization bills have been the source of recent congressional mandates to create new center programs (e.g., for research on Parkinson’s disease, autism, fragile X syndrome, muscular dystrophy, and rare diseases).

The appropriations subcommittees do not have to fund programs created or expanded by the authorizing committees, but typically they try to support newly authorized activities. For example, the Senate subcommittee strongly urged establishment of at least three centers for muscular dystrophy research and encouraged the institute “to provide sufficient funds for this purpose.” The subcommittee called for the establishment of the three fragile X centers authorized by the Children’s Health Act of 2000 and strongly urged NICHD “to allocate sufficient funds for that purpose.” Regarding autism, the subcommittee 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” and urged the NIH director “to allocate sufficient resources” to advance research on autism spectrum disorders (U.S. Congress, 2001b).

NIH has an elaborate structure of outside advisory groups and other mechanisms for obtaining outside advice on health needs and scientific opportunities and ideas for new program initiatives. Some advisory groups are standing bodies with rotating memberships from the scientific community and the public, who play a regular role in the annual program planning and budgeting process and reviewing programs and new initiatives. NIH maintains more than 140 chartered advisory committees, more than any other federal agency.² Most of these committees are peer review groups

engaged in evaluating applications for funding. Some are standing program advisory committees, and many are ad hoc groups, formed to provide advice on a specific topic, review a particular program, or develop a research agenda for a major area of science. Sometimes, advisory groups recommend establishment of research centers, or they may recommend initiatives the NIH staff decides would best be implemented through centers.

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 Secretary of Health and Human Services appoints the members except in the case of the National Cancer Advisory Board (NCAB), which is appointed by the President.

The national advisory councils, although advisory, have an unusual role in government decision making. By law, they must review and approve all research grants and contracts 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. In the examples described above, the national advisory councils participate at several points, providing feedback on priorities and needs early in the process and reviewing and approving new concepts for PAs, RFAs, and RFPs. At NCI, the chair of NCAB and chairman of NCAB’s Planning and Budget Subcommittee serve on the Bypass Budget Planning Committee.

The NIH director has a number of advisory committees, including the Advisory Committee to the Director (ACD), Director’s Council of Public Representatives, Office of AIDS Research Advisory Council, and Advisory Committee on Research on Women’s Health (the last two advise the heads of program offices in the Office of the Director, the Office of AIDS Research, and Office of Research on Women’s Health).

The ACD was created in 1966 in response to a review of NIH conducted by a blue-ribbon panel appointed by the White House Office of Science and Technology. According to its charter, the ACD advises the director on biomedical research, medical science, and biomedical communications and can make recommendations concerning program development, resource allocation, administrative regulation and policy, and other aspects

of NIH policy.³ ACD working groups have studied and reported on gene transfer, clinical research, construction of research facilities, and biomedical computing. The last study resulted in a PA for planning National Programs of Excellence in Biomedical Computing, supported by 17 institutes, using a center mechanism (P20 developmental grants).

The Director’s Council of Public Representatives was established in 1998 in response to a recommendation by an IOM committee (IOM, 1998). Its function is to consult with, advise, and make recommendations to the NIH director on issues and concerns important to the broad development of NIH programmatic and research priorities.⁴

Some of the institutes have standing program advisory committees. 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. 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). NICHD and the National Institute of Environmental Health Studies have advisory bodies for medical rehabilitation research and alternative toxicological methods, respectively.

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. Some groups consider mechanisms and may recommend the establishment of centers. For example, when medical imaging was identified as a priority in NCI’s planning process, the NCI director appointed an Imaging Sciences Working Group. The Working Group report contained a number of recommendations, one of which was to create interdisciplinary “imaging centers of excellence.”⁵ The recommendation resulted in the establishment of In Vivo Cellular and Molecular Imaging Centers in 2000.

NCI has also convened a series of Progress Review Groups to assess the state of science concerning a particular type of cancer, develop a research agenda, and recommend high-priority programs needed to make progress in addressing the disease. Some have recommended center programs. The Pancreatic Cancer Progress Review Group, for example, identified three key strategies to speed research and treatments, one of them the establishment of centers of excellence for pancreatic cancer research and care. “Centers of excellence in pancreatic cancer would optimize both research and

patient outcomes and facilitate the diffusion of knowledge into the community. These centers would offer broad clinical expertise, thereby attracting significant patient volume; provide state-of-the-art diagnosis and treatment; and bring together scientific investigators evaluating issues critical to this disease” (NCI, 2002).

In 1997 the NIH Office of Rare Diseases convened a Special Emphasis Panel to develop recommendations for stimulating and coordinating research on rare diseases. The panel’s January 2001 report recommended that NIH support the establishment of Specialized Research and Diagnostic Centers of Excellence for Rare Diseases to stimulate research, provide research training, and aid in the diagnosis of rare diseases. The panel also suggested using established centers, such as General Clinical Research Centers, as the infrastructure for creating research and diagnostic services related to rare diseases.⁶ As a result, NIH issued an RFA in early 2003 to establish a network of clinical centers for research on rare diseases.⁷

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. Many workshop reports are posted on institute websites and are referred to in program descriptions and in PAs, RFAs, and RFPs. 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, and Autism Centers of Excellence.⁸

Each institute’s director and extramural program heads meet regularly with representatives of VHAs, patient advocacy groups, and scientific and medical associations. The NIH director and NCI director have formal consumer advisory groups that meet 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. The institutes each have an Office of Public Liaison, and the NCI director has a Consumer Liaison Group. The NIH director has several advisory committees, the Advisory Committee to the Director, and the Director’s Council of Public Representatives.

The institutes have extensive ongoing arrangements for obtaining external views and advice from both the research community and the public, and consult with their national advisory councils on program priorities and balance among mechanisms. In some areas of research, external committees have created research plans that identify research needs and consider mechanisms for addressing 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.

NIH implements new center programs by publishing invitations to apply for funding in the NIH Guide for Grants and Contracts, which is published daily. The invitation can be in several forms. It may be a PA, which notifies the research community that NIH is interested in funding quality applications for centers in specific areas. Most new center programs are launched with an RFA, which differs from a PA in several important ways. It has a one-time deadline, and it must state how much money has been set aside and approximately how many centers NIH expects to fund. In a few cases, centers are funded by contract, and RFPs are issued. If a PA is used to initiate a new center program, it is either a PAR, in which the applications are reviewed by the institute rather than the Center for Scientific Review, or a PAS, in which the applications are reviewed by the institute and the funding is formally set aside, as with an RFA.

Institutes wishing to use a PA or RFA must follow certain common procedures laid out in the NIH Manual. The institute must submit a package with the draft PA or RFA to the Office of Extramural Programs in the Office of the NIH Director for review to see that certain steps were taken and that the document is in the proper format and contains the required provisions. (The NIH contracts office oversees a similar process for clearing RFPs.)

The key procedural requirements are:

• The institute must document the clearance of PA and RFA concepts (i.e., purpose, scope, and objectives) for “relevance, priority, and need. This clearance must include advice from the public and may be obtained through,

for example, consultation with national advisory councils and advisory boards, Congressional mandate, or workshops convened specifically for advisory purposes” (NIH, 1994).

• If the concept is approved and funded, the institute’s grants management officer must review and comment on the proposed PA or RFA, including certification that the proper mechanism of support was chosen, and the institute’s chief scientific review official, who will be responsible for the review of the applications, is also supposed to review the proposed PA or RFA.

• At least a month before the planned publication date, the institute uses an electronic early notification system to alert other institutes and let them express any concerns about significant overlap with their programs. If so, an accommodation is worked out. An affected institute may, for example, cosponsor and jointly publish a PA, agree to fund certain RFA applications after they have been reviewed by the peer review group in the lead institute, or agree to cofund each award (which involves a transfer of funding to the lead institute).

• The extramural program policy officer in the Office of Extramural Programs checks to see that proper procedures have been followed and that the PA or RFA is consistent with NIH and Public Health Service policies (i.e., if it is an RFA, the estimated set-aside for funding and approximate number of centers are specified).

• Cooperative agreements, because they entail substantial participation by NIH staff, undergo additional central scrutiny. The institute is required to submit a justification memorandum, along with a draft of the RFA, to the associate director for extramural affairs of NIH. The memorandum must justify the rationale and need for the cooperative agreement rather than the contract mechanism and for the substantial scientific and programmatic involvement by NIH staff. The cooperative agreement RFA has to have language that outlines the responsibilities and rights of the grantee, nature and extent of institute staff involvement, and collaborative responsibilities, as well as a mechanism for arbitrating disagreements between grantees and the institute (NIH, 1993).

Each institute has its own policies and procedures for deciding whether or how to establish a new program or initiative and develop the PA, RFA, or RFP, including review and approval of the concept paper. In most cases, this is done by the national advisory council as an integral part of the annual program planning and budgeting process within an institute. In this way, approval of a new center program is fulfilled by review and approval of the concept paper for a PA, RFA, or RFP. As shown above, for example, the second part of NIDDK’s annual Program Plan is called Program Initiative Concepts, which is the final set of initiatives approved by the institute

director and submitted to the NIDDK national advisory council each September.

At NIAID, an “initiative” is a PA, RFA, or RFP.⁹ A “concept” is the earliest planning stage of an initiative.

At NIAID, “concept clearance” is a mandatory review of each initiative, generally performed by the subcommittees of NIAID’s national advisory council that oversee each of the institute’s extramural divisions. “For each concept, the subcommittee looks deeply at its scientific merit, relative priority, appropriate budget, and funding mechanism.¹¹ “After hearing staff presentations, Council recommends approval of an initiative, its budget, and mechanism (e.g., grant or contract, and grant type) and advises on scientific matters.¹² Not all concepts approved by the council are implemented (i.e., published as initiatives). Implementation depends on the institute-wide scientific and programmatic priority of the initiative and the amount of funds available.

The national advisory council of the National Center for Complementary and Alternative Medicine approved the concepts for Complementary and Alternative Medicine Research Centers and Developmental Complementary and Alternative Medicine Research Centers in August 2002. The reasons for establishing centers appear in several places. The background discussion section says: “Research centers provide a special opportunity to bring together the resources necessary for the rigorous scientific investigation of CAM [Complementary and Alternative Medicine].” The section on purpose reads: “The purpose of this initiative is to promote innovative, high quality, multidisciplinary basic research through clinical research in the area of complementary and alternative medicine. This will be accomplished by providing support for research centers to conduct integrated studies….” There is a justification of the proposed funding mechanism, in this case the program project (P01) grant:

Concept clearance does not have to be performed by a national advisory council. As already seen, concept clearance at NIAID is performed by subcommittees for each program division during regular council meetings and ratified by the full council. NIDDK has a similar system. According to the NIH Manual, concepts for initiatives can be reviewed and approved by any chartered advisory body, including program advisory committees and special emphasis panels (NIH, 1994).

At NCI, concepts are reviewed by the Board of Scientific Advisers (BSA), which was established to advise on extramural programs. It is linked to the institute planning process by membership of the BSA chairman on the Bypass Budget Planning Committee. The NCI executive committee and then the BSA see a document that contains the narrative material for the proposed PA or RFA and additional information. The narrative justification for Centers of Excellence in Cancer Communications Research, for example, was 10 pages in length, with an overview, background, RFA purpose, and research questions (including a detailed list of potential research topics). The text of these sections of the concept paper appeared in the RFA.¹⁴ In addition, there was an analysis of NCI’s portfolio of cancer communications grants, justification of the award mechanism, budget information, and timeline (the last two also appear in the RFA). There was a list of 24 scientific references. According to the mechanism justification:

Not all concepts submitted by the institutes are approved. For example, there was a debate about the proposed Centers of Excellence in Chemical Methodology and Library Development at the September 2000 meeting of the National Institute of General Medical Sciences (NIGMS) council. The proposal was sent back to “be reformulated to focus on the basic research component, to clarify the role of biologists in a program targeted to developing chemical methodologies, and to reassess the mechanism by which this program should be supported.¹⁶ After the concept was modified by adding a requirement for a library synthesis core to clarify the intended focus on combinatorial chemistry methods development and be a clear point of contact for the biology research community, it was passed at the next NIGMS council meeting in January 2001 (the RFA was published in June 2001).

If an RFA or PA is reissued, some but not all institutes require another concept approval by the national advisory council or other advisory body, while others rely on the initial approval, although the RFA or PA is often revised. Also, from time to time, a center program is changed substantially or discontinued entirely, although in the latter case, it is usually replaced by a new center program. Recent examples include changes in the NHLBI Specialized Centers of Research program, symbolized by a name change to Specialized Centers of Clinically Oriented Research; discontinuation of the National Institute of Arthritis and Musculoskeletal and Skin Diseases Multipurpose Arthritis and Musculoskeletal Diseases Centers, replaced by Multidisciplinary Clinical Research Centers for Arthritis and Musculoskeletal and Skin Diseases; and a change from supporting Population Research Centers with a P30 center core grant or a P50 specialized center grant to supporting their research infrastructure with the R24 resource-related research project grant. These and similar cases of changes in or discontinuations of center programs often result from outside reviews, which are addressed more fully in Chapter 5 on evaluation.

IOM (Institute of Medicine). 1998. Scientific Opportunities and Public Needs: Improving Priority Setting and Public Input at the National Institutes of Health. Washington, DC: National Academy Press.

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