Enhancement of NIDDK-Supported Center Grant Programs: Principles
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), in concert with the National Diabetes and Digestive and Kidney Diseases Advisory Council (NDDKAC), has identified four areas for enhancement for NIDDK-supported Centers:
- Shared Resources (Cores)
- Pilot and Feasibility (P&F) Programs
- Clinical and Translational Research
- Interactions with Research Training and Career Development Programs
The first two areas (Cores and P&F Programs) represent structural components of the Centers programs. The section on Shared Resources also includes a sub-section on "multi-institutional collaborations." The latter two areas, while not structural components of Center grants, are programmatic areas that potentially could be enhanced through the Center grant programs.
In this document, the areas of enhancement are framed as "Principles," with subsections devoted to "Background" and "Opportunities for Enhancement." These general principles or "vision statements" are designed to serve as guidelines for the development of specific requests for applications (RFAs). Clearly, individual Center programs have unique needs, and therefore not all of the Principles will apply to all Center grant programs. Rather than creating standard language for all types of Centers supported by NIDDK, Centers guidelines and review criteria should be crafted according to the specific goals of the various NIDDK Center programs.
1. Shared Resources (Cores)
Shared resources are core facilities or other cooperative arrangements that enhance productivity, or in other ways benefit research programs by investigators working to accomplish common goals. Examples include: equipment, samples, reagents, research services, or scientific consultative services. The NIDDK supports shared resources through a variety of mechanisms that include not only Centers programs, but also cooperative agreements, program project grants and contracts.
Some of the principal reasons to establish shared resources are to:
- Avoid duplication of effort and to enhance cost-effectiveness;
- Promote optimum utilization and improve availability of scarce or expensive resources or scarce expertise;
- Provide technical assistance, training and other staff enrichment;
- Achieve standardization of reagents or methods to improve comparability of research findings
Examples of types of shared resources provided by Centers include:
- Collection, storage and distribution of data and samples;
- Provision of specialized tools and technologies or access to specialized expertise;
- Development, standardization and distribution of reagents and/or protocols;
- Provision of technical assistance, training, and enrichment programs;
- Recruitment of patients and coordination of patient studies;
- Beta-testing and dissemination of specialty assays, methods, and services on an institutional level;
- Increase interdisciplinary interactions at the institution through cross-project/ laboratory exchange;
- Sharing of specialized tools, technologies and expertise between collaborating investigators.
Three major categories of shared resources have been identified:
- National Shared Resources - these represent cores that serve specific scientific communities on a national level.
- Institutional Cores - these cores serve the scientific communities at the level of a single institution or sometimes a set of cooperating institutions, similar to the National Shared Resources.
- Project Cores - these facilities serve a specific group of investigators working on interacting projects.
The above characteristics of shared resources depend primarily on the organizational structure of the investigators using the services, and whether the Center supports a large existing research base or specifically identified projects.Support of any of these three types of shared resources in the context of Centers programs may be appropriate when consistent with the overall goals of the specific Centers program. Requests for applications for Centers need to clearly delineate the potential needs of the research community and the types of common facilities to be supported.
Opportunities for Enhancement
- Selection of the most appropriate grant mechanism
The nature of the research base and the shared resources to be supported should influence the choice of Center grant mechanism. If the research base is small, mechanisms such as R24, P01, or P50 should be considered. For projects with a large funded research base, the P30 and P60 mechanisms are most appropriate.
When NIDDK staff develop new initiatives, mechanisms other than Centers should be considered, particularly for highly targeted objectives. Examples of alternatives would be multi-institutional R24 grants, NIGMS U54 "glue grants" (see http://grants2.nih.gov/grants/guide/rfa-files/RFA-GM-02-007.html), or other consortia supported through cooperative agreements.
- Multi-institutional collaborations
For multi-institutional utilization of shared resources, the following principles should be considered when NIDDK staff construct RFAs:
- Explicitly define whether multi-institutional applications are accepted or encouraged (or not), and precisely define the requirements for a multi-institutional center and regional or national use of cores. In addition, the RFA needs to explicitly define which investigators can be included in a research base.
- A new category of research base for cores that are used as a regional or national resource should be considered the "extended research base" or perhaps the "regional/national core investigator list." The extended research base for a regional or national core could include all investigators who might expect to use the core in some way. This might include investigators who would be expected to fully compensate the core service through a charge-back, and thus would not be obtaining direct financial assistance from the Center. The list could include investigators who use the core services but otherwise have no collaborative interactions with other Center investigators. The extended research base should be defined as an entity separate from the institutional research base. For review purposes, it should be evaluated as part of the core, in order to distinguish it from the local institutional research base.
- Access and reimbursement
Core resources must precisely define the issues regarding access to core services, including: investigator eligibility requirements for services; policies and procedures for prioritization of services when demand exceeds capacity; and financial considerations, such as calculations that justify investment of funds in core services and policies regarding charges to investigators for use of services.
- Changes in services
Project cores need to develop policies and procedures for change. Examples include: new technologies or services that should be supported might appear; existing technologies might become less important; or economic changes might obviate the need for core services, such as the availability of cost-effective commercial services or core services provided by the research institution. Cores should address the issue of allocation of resources to development of new technologies in comparison to provision of services with existing technologies.
- Intellectual property (IP) policies
Cores must have well defined policies to ensure that intellectual property is identified and appropriately protected, but that IP issues do not impede sharing of resources.
2. Pilot and Feasibility ProgramsBackground
The Pilot and Feasibility (P&F) program is a vital component of P30, P50 and P60 Center grant programs. P&F projects can have a major impact on the visibility of a Center at an institution and should provide a means of developing new ideas and encouraging new members to join the Center. P&F programs traditionally accomplish three major program goals: 1) provide opportunities for new investigators to develop preliminary data that become the basis for an application for further support; 2) provide opportunities for established investigators outside the Center to apply their expertise to a research area of interest to the Center; and 3) provide established investigators within the Center an opportunity to pursue high impact/high risk projects, or projects that are a significant departure from their usual work. In general, P&F programs have utilized their limited funds to accomplish all of these goals, with emphasis on goal #1.
Opportunities for Enhancement
- Target P&F funds to specific areas of research (see Section 3: "Clinical and Translational Research").
- Tailor P&F review criteria to needs of specific programs
Centers RFAs should include one or more of the three P&F focus areas (as listed above in the "Background" section) appropriate to the goals of the Center program. In each case, a Centers RFA should announce separate review criteria for each of the three types of P&F programs. Similarly, the application must indicate clearly the type of P&F program for which the projects are requesting support.
Leverage P&F funds at the institutional level (i.e. using GCRCs, matching funds, etc.) to make the program more effective (see Section 3: "Clinical and Translational Research").
3. Clinical and Translational ResearchBackground
NIDDK-supported Center grants offer multiple opportunities to facilitate clinical and translational research. However, P30 Center resources typically provide shared access to specialized technology for basic research to a much greater extent than for clinical or translational research. In part, this reflects the very strong base of fundamental research that is characteristic of sites with P30 Centers. Moreover, while Centers often are led by physician scientists and include strong clinical researchers among their senior faculty, P&F projects traditionally have provided support primarily for basic research.Opportunities for Enhancement
- Include a range of shared resource options, appropriate to the research base
As stated in Section 1, cores provide shared resources that enhance efficiency, productivity, and multi-disciplinary collaboration among groups of investigators. Cores useful for clinical and translational research could provide biostatistical expertise for study design and data management and analysis; bioinformatics support; infrastructure for recruiting and managing clinical research subjects and/or tracking and analyzing clinical samples; technologies useful for phenotyping and characterizing subjects or exploring clinical pathophysiology; and expertise for behavioral assessment or intervention.
- Enhance collaborations with General Clinical Research Centers (GCRCs)
The National Center for Research Resources (NCRR) supports approximately 80 GCRCs nationwide, which provide services and resources to enhance clinical research (www.ncrr.nih.gov/clinical/cr_gcrc.asp). Research Centers supported by the NIDDK and other NIH Institutes are encouraged to collaborate with GCRCs to avoid duplication of effort and enhance utilization of services and resources.
- Target pilot and feasibility funds to the support of clinical and translational research
In some Centers, the P&F program could be used to encourage clinical projects or translational research. By establishing ties with the institution's GCRC, the P&F project funds could be leveraged effectively to pursue such projects. This interaction has not been specifically encouraged in the past, but could be catalyzed in the future through a separate pool of Center P&F funds for clinical projects.
Pilot and feasibility projects provide short term, modest support for new investigators or established investigators pursuing a new line of inquiry. Since the career development of new clinical investigators is a high priority of the NIDDK, Centers are encouraged to use P&F support to provide opportunities for new clinical investigators to develop preliminary data for further support (see Section 2: "Pilot and Feasibility Programs"). The NIDDK also strongly encourages the use of P&F support to foster bench to bedside translation of fundamental discoveries. For this purpose, the high impact/high risk P&F programs described in Section 2 could be effective.
- Design enrichment components to enhance clinical and translational research efforts
This type of shared resource provides flexible funds for activities such as educational initiatives for investigators. Such programs could include seminars and didactic sessions focused on enhancing training relevant to clinical research, and on fostering collaborations between basic and clinical researchers. Institutions that have K12 and K30 programs (http://grants2.nih.gov/training/k30.htm) are encouraged to integrate clinical enrichment activities at the Center with courses and other activities supported by the K program.
4. Interactions with Research Training and Career Development Programs Background
Authorizing language for NIH Centers programs precludes the use of Center funds for the training of pre- or postdoctoral fellows, but this does not mean that 'training' is not essential to the vitality of a Center.
Most NIDDK-funded Centers are at institutions where the training of new investigators is a priority. The presence of a Center, with the resources it provides, should enrich any training experience and should be a positive factor when recruiting postdoctoral fellows and junior faculty.
Opportunities for Enhancement
- Access to shared resources
The NIDDK encourages the use of Center core facilities by both trainees and junior faculty. While postdoctoral fellows and Research Career Grant (K series) awardees are not part of the research base of a Center, the development of a cadre of future independent investigators is essential for the continued vitality of NIDDK-supported research. Core facilities, and the expertise, services, instruction, and opportunities for collaboration that they offer provide a rich environment for new investigators. When appropriate, a Center may waive, or significantly reduce, fee-for-service payments for Core services for fellows and junior faculty.
- Enrichment Programs
Students, fellows, and junior faculty should be encouraged to take full advantage of all Center-sponsored seminars, courses, workshops, and symposia. If appropriate, Centers may waive fees for attendance at such events for interested students, fellows, and junior faculty members. Enrichment program-sponsored mini-sabbaticals, or other instructional opportunities, also may be appropriate for postdoctoral fellows. Stipends for fellows are never an allowable Center expense, but travel, per diem, and registration expenses may be paid from enrichment program funds.
- Pilot and Feasibility Programs
Fellows supported by National Research Service Awards (e.g., T32 and F32 fellows) may apply for P&F funds only in the final year of their training. In addition, the fellow must be sponsored by a Center member. Other postdoctoral fellows, if they otherwise meet the P&F eligibility requirements for the Center, may apply. While K-awardees are eligible for P&F funds, junior faculty without extramural funding should be the primary target for the limited funds available. As stated in Section 2 of this document ("Pilot and Feasibility Programs"), P&F programs are of several types, each with distinct goals. Fellows and new faculty would usually benefit most from programs that provide opportunities to develop preliminary data than from P&F programs to pursue high impact/high risk projects.
- Development of New Programs
In FY2002, the NIDDK launched a pilot program at six institutions to provide the opportunity for highly motivated medical students, interested in a research career, to be supported for a year of research while putting their medical classes on hold. These pilot sites were selected because each of the three extramural program divisions of the NIDDK supports both a Center and a training grant (T32) at the institution. The six institutions are: University of Michigan; University of Pennsylvania; University of Washington; Vanderbilt University; Washington University in St. Louis; and Yale University. A prerequisite for inclusion in this Medical Student Research Training (MSRT) program is assurance from a Center Director that the student will have full access to the facilities and resources of the Center. Each student submits a research project proposal and is mentored by a member of the training faculty of the T32. Awards are issued as supplements to the appropriate training grant. In Fiscal Years 2002 and 2003, a total of 13 students were supported at five of the participating sites.
Skills Development Cores - the National Heart, Lung, and Blood Institute (NHLBI) recently established a program called the Specialized Centers of Clinically Oriented Research (www.nhlbi.nih.gov/funding/policies/sccor_skill.htm) that provides additional funds to NHLBI Centers to support activities to assist new clinical investigators in progressing to more senior status. This program mechanism includes support for research skills enhancement activities. The NIDDK is considering the establishment of a similar program.
Page last updated: November 25, 2008