NIH Extramural Center Programs Criteria for Initiation and Evaluation (2004) / Chapter Skim
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3 Initiation and Management of Center Programs
3 Initiation and Management of Center Programs
Pages 62-91
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From page 62... ...
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.
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From page 63... ...
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.
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From page 64... ...
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.
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From page 65... ...
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)
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From page 66... ...
X Breast Cancer and the Environment Research Centers (U01) X Muscular Dystrophy Cooperative Research Centers (U54/R21)
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From page 67... ...
INITIATION AND MANAGEMENT OF CENTER PROGRAMS 67 Intended Purpose PriorNIH Shared Initiative(s) Interdisciplinary Translational Training 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 Continued
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From page 68... ...
Fragile X Research Centers (P30) X NOTE: External idea means that centers were recommended by an external advisory body or other outside group.
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From page 69... ...
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.
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From page 70... ...
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.
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From page 71... ...
. 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.
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From page 72... ...
to establish centers to conduct multidisci plinary 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)
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From page 73... ...
. In 2001 an NIH special emphasis panel convened at the request of the Senate Appropriations Committee recommended "regional centers of excellence for rare diseases research and training." In response, Senator Kennedy introduced the Rare Diseases Act "to greatly enhance the prospects for developing new treatments and diagnostics, and even cures for literally thousands of rare diseases and disorders (Kennedy, 2001)
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From page 74... ...
The RFA for Breast Cancer and the Environment Research Centers was released in November 2002, inviting applications for centers working cooperatively as a national network.7 Voluntary responses by NIH do not always satisfy Congress and the advocates. In response to strong interest in autism research and recommendations of a 1995 NIH conference on autism convened at the request of Congress, the National Institute of Child Health and Human Development established a network of 10 program project grants called Collaborative Programs of Excellence in Autism (CPEA)
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From page 75... ...
. Institute of Medicine Reports Research Core Centers for Advanced Neuroinformatics Research were initiated by the federal interagency coordinating committee for the Human Brain Project, but the Human Brain Project, including the phased approach adopted by the FICC, was initially proposed in a 1991 report of the Institute of Medicine, Mapping the Brain and Its Functions: Integrating Enabling Technologies into Neuroscience Research (IOM, 1991)
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From page 76... ...
Legislation authorizing centers was introduced later in 2001 as "the fruition of a long, deliberative process involving both the Congress and the NIH." The Rare Diseases Act of 2002 was passed in the next session of Congress. In February 2003 the RFA for the rare diseases center program was released, inviting applications for up to four clinical research centers and a data coordinating center to form a Rare Diseases Clinical Research Network.9 9 NIH funded seven Rare Diseases Clinical Research Centers and a Data and Technology Coordinating Center on November 3, 2003.
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From page 77... ...
Appendix D contains a more detailed description of program planning and budgeting at NIH, with many examples involving center program initiatives. Strategic Planning Each NIH institute prepares five-year strategic plans with input from nonfederal scientists and nonscientists representing health groups.
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Annual Program Planning and Budgeting Process Each institute has its own process for program planning and decision making, culminating in a budget request to the NIH director each spring. In each institute, the process is complex and includes input from a number of outside sources, including advisory bodies, scientific workshops and conferences, and professional and consumer health groups.
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From page 79... ...
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 to comply with directives, because it has to appear before the appropriations subcommittees every year for funding.
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From page 80... ...
Instead, they 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)
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From page 81... ...
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.
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From page 82... ...
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.
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From page 83... ...
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.
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From page 84... ...
Examples among the most recent center programs include the Rare Disease Clinical Research Network (U54) , Autism Research Centers of Excellence (U54)
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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.
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From page 86... ...
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)
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From page 87... ...
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.
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From page 88... ...
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.
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From page 89... ...
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.
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From page 90... ...
2001. Statement on the Senate floor when introducing the Rare Diseases Act of 2001.
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From page 91... ...
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.
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