Description and Structure of a Digestive Diseases Research Core Center (DDRCC)
A. Introduction
In fulfilling its mission to support research and research training, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) supports a number of grant programs, including various research, program project, and career development awards; institutional training grants and individual research fellowships; and a number of center grant programs. This document provides a description of and the administrative guidelines for the Silvio O. Conte Digestive Diseases Research Core Center (DDRCC) program. This program provides needed resources for the digestive diseases (DD) research community.
DDRCCs are meant to integrate, coordinate, and foster interdisciplinary research in digestive diseases and related disorders by a group of established investigators actively conducting programs of important, high-quality research that relates to a common DD-relevant theme. At the present time, the Division of Digestive Diseases and Nutrition (DDDN) within the NIDDK supports sixteen DDRCCs.
B. Description and Basic Requirements
A DDRCC must be an identifiable organizational unit within a single university medical center or within a consortium of cooperating institutions with a university affiliation. The overall goal of a DDRCC is to bring together, on a cooperative basis, basic science and clinical investigators to enhance the effectiveness of their research. This goal is achieved using the P30 center grant mechanism, which provides support for shared resources, termed "cores", that enhance productivity and benefit a group of investigators working to accomplish the stated goals of the DDRCC. Thus, the purpose of a DDRCC is to provide the capability for accomplishments greater than those that would be possible by individual research project grant support alone.
To qualify for a DDRCC grant, the applicant institution must already have a substantial base of ongoing, independently supported, peer-reviewed research projects related to digestive diseases. This currently funded research base provides the major support for a group of investigators who would benefit from shared resources. The body of research described as the research base includes only currently funded, peer reviewed research grants awarded to the applicant institution. These may be Federally or privately funded awards; training grants and fellowship awards are not considered part of the research base.
The research base must exist prior to the submission of an application and it is the most important element considered during the peer review process. Focus, relevance, interrelationships, quality, productivity, and, to some extent, quantity, are all considerations in judging the adequacy of the research base. Although collaborations with investigators outside the applicant institution/consortium are encouraged, the research base includes ONLY support for the investigators at the applicant institution/consortium.
The DDRCC must have a central research focus or theme. This central focus must be a digestive disease, group of diseases, or functional studies relating to digestive diseases. At least one-half of the research base must relate to this central focus. Examples of a digestive disease-related central focus include, but are not restricted to, inflammatory bowel disease, functional bowel disease, pancreatic disease, liver disease, or pediatric gastrointestinal disease. Examples of functional studies appropriate for a central focus include, but are not restricted to, gastrointestinal motility, actions of gastrointestinal hormones, or gene therapy for liver or digestive diseases. Applicants should consult with NIDDK staff concerning plans for the development of a DDRCC and the organization of the proposed Center.
Cores are shared facilities that serve to enhance or make more cost effective the services, techniques, or instrumentation used by the investigators within the DDRCC. Cores should extend, support, and contribute to the work of the Center members. A Center should have a minimum of two cores in addition to the Administrative Core (described below). The latter is a required element for every DDRCC.
Three other activities may be supported by DDRCC funds:
1. a pilot and feasibility (P/F) program;
2. an enrichment program; and
3. a clinical component.
The P/F program provides modest support for new initiatives or feasibility projects for either new investigators or for established investigators who are moving into research areas of direct interest to the DDRCC. These areas may include biomedical, epidemiological, clinical, or behavioral research as they pertain to the DDRCC goals.
The enrichment program provides limited funds to sponsor, for example, seminars, visiting scientists, workshops, and mini-sabbaticals for Center members. These activities are aimed at fostering the exchange of ideas with the goal of enhancing the productivity and efficiency of the DDRCC and its members.
The clinical component facilitates translation of research findings into practical treatments for patients and/or provides the opportunity for Center members to obtain clinical samples and patient data needed for their research. In addition to facilitating studies aimed at a better understanding of the natural history and etiology of disease, such components may support biostatistics consultation, assist with clinical study design, foster collaboration among researchers, aid in recruitment of subjects for clinical studies, provide data entry support for epidemiological studies, or provide modest funding for tissue, DNA, or serum storage. The clinical component may serve as the bridge between Center clinical and basic science investigators. In addition, staff within the clinical component may aid investigators in effectively addressing NIH policies and reporting requirements concerning inclusion of women, children, and ethnic/minority participation in clinical studies; data and safety monitoring requirements; and educational requirements for the protection of human research participants. DDRCCs are encouraged to include a clinical component when appropriate for their members.
Eligibility for a DDRCC award is limited to domestic institutions.
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C. Administrative Core
Description
Since a DDRCC involves the interaction of personnel in several departments and the allocation of resources within the institution(s), lines of authority and sanction by the appropriate institutional officials must be clearly specified. The Administrative Core is responsible for maintaining these lines of authority, coordinating the various functions of the DDRCC, and serving as the visible contact point between the university community and the DDRCC. Therefore, each DDRCC must contain an Administrative Core.
Requirements
Director
Each DDRCC must name a Director who is responsible for its organization and operation. The Director is the Principal Investigator of the P30 application for a DDRCC and is the Director of the Administrative Core. The Director must be an experienced and respected researcher who can provide scientific and administrative leadership for the entire program. The Director must be able to coordinate, integrate, and provide guidance in establishing, expanding, or focusing programs of digestive diseases research. An Associate Director should be named who will be involved in both the scientific and administrative aspects of the DDRCC. The Associate Director will serve as acting Director in the absence of the Director.
Organization and Functions
The administrative structure of the DDRCC, for the most part, will be left to the discretion of the applicant institution, as long as minimum requirements are met. The effective development of a Center requires close interaction between the Center Director, the Center investigators, institutional administrative personnel, the staff of the NIDDK, and other members of the institution in which the Center is located.
The organization of the Administrative Core provides a supportive structure for the DDRCC. As part of this structure, for example, an Internal Executive Committee should be named whose duties include: (1) coordinating and integrating the DDRCC components and activities; (2) administering the enrichment program in a productive and efficient manner; (3) reviewing the use of funds for P/F projects; (4) advising the Director as to the productivity and effectiveness of the activities of the DDRCC; and (5) interacting with other Centers, NIDDK, and other appropriate groups and/or individuals, including both the scientific and lay communities.
Formation of an External Advisory Board to the DDRCC is mandatory. This Board advises the Director on budget, policy, scientific focus, core use assessments, and other issues related to the workings of the Center. A group of four to seven members selected for their scientific expertise and administrative oversight skills is recommended. The External Advisory Board should meet at least once a year, on site, to review the DDRCC.
The Administrative Core oversees the P/F program. The review of P/F project applications must include the use of appropriate consultants from the scientific community outside the DDRCC. This may be another function of the External Advisory Board. Further details regarding the selection process for P/F projects can be found in Part I F of these guidelines. Typically the Director designates someone to oversee the P/F program for the DDRCC, e.g. the Associate Director or other Center member.
The Administrative Core also assumes responsibility for the Enrichment Program. The selection, oversight, and management of the Enrichment Program is often best handled by a designee of the Director, typically a Center member, the Internal Executive Committee, or an Associate Director.
Center Membership Criteria
Criteria for designating an investigator as a DDRCC 'member' should be clearly defined. Subsets of members based on their degree of participation or other quantitative measures are acceptable. Suitable criteria include peer-reviewed independent funding, participation in DD-related research, and need for the use of core facilities.
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D. Research Base
Since the DDRCC program is aimed at fostering interdisciplinary cooperation among a group of funded investigators conducting high quality research involving the etiology, treatment, and prevention of digestive diseases and related disorders, the existence of a strong digestive diseases research base is a fundamental requirement for, and the most important aspect of, a DDRCC.
For new DDRCC grant applications, the NIDDK funding must comprise at least 50 percent of the total Federal support for the digestive diseases-related research base to be considered for funding. The absolute level of support must be sufficient to warrant the addition of a Center, typically at least $3 million a year. Since 'Facilities and Administration' costs vary considerably between institutions, these should not be included in the calculations. Because one of the purposes of the DDRCC is to encourage collaborations with investigators in areas of research other than digestive diseases with the goal of enhancing and expanding DD research, renewal applications may fall below the 50 percent level for NIDDK funding. A decrease to less that 50 percent should most often be due to the recruitment of investigators from other fields into the Center. Except in unusual circumstances, the NIDDK portion of the digestive disease-related research base should not fall below 30%. A level this low will be considered acceptable only if the overall tone and direction of the DDRCC is consistent with NIDDK program objectives. More details, and sample tables, can be found in Part II of these guidelines.
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E. Core Facilities
Definition
A biomedical research core in a DDRCC is a shared facility or resource that provides services needed by DDRCC investigators. Core services enable Center members to conduct their research more efficiently and/or more effectively. Cores should be designed to furnish a group of investigators with some technique, determination, service, expertise, or instrumentation that will enhance research progress, consolidate manpower, and contribute to cost effectiveness. Often, services or techniques can be provided at less cost and potentially higher quality when performed within a core facility as opposed to being done infrequently in an individual investigator's own laboratory. A minimum of two service cores, in addition to the Administrative Core, is required to justify the existence of a DDRCC.
A clinical component is encouraged, but the requirements for that component are distinct from those of the biomedical research cores (see below).
Cores may be proposed in relation to any acceptable research activity of the DDRCC, although they usually fall into one of four categories: (1) provision of a technology that lends itself to automation or preparation in large batches (e.g., radioimmunoassay, cell/tissue culture); (2) complex instrumentation (e.g., electron microscopy, mass spectrometry); (3) animal preparation and care; and (4) technical assistance and instruction (e.g., molecular biology, biostatistics).
Cores are not intended to supplant investigator capabilities, but rather to enhance them. When appropriate, core staff should provide instruction for investigators, laboratory personnel, or fellows to learn and then become proficient in technologies that will become part of the repertoire of the laboratory. Teaching complex techniques and methodologies is an important function of a core.
In addition to providing products or services, a core must maintain appropriate quality control and maintain a record of use. Limited developmental research is also an appropriate function of a core facility as long as it is directly related to enhancing the function or usefulness of the core and is not an undertaking that should more appropriately be funded through other mechanisms.
Requirements
Use
The establishment of, and continued support for, a biomedical research core within a DDRCC is justified solely on the basis of need. The minimum requirement is significant use by two or more investigators (including the Core Director if he/she is part of the research base), each with an independently funded peer-reviewed project. Use by two members funded by the same grant does not constitute adequate core use. The number of projects being supported will also be considered in the justification for establishing a core. While investigators holding awards from the DDRCC's P/F program are appropriate users of the core facilities, their use will not contribute substantially to the justification for establishing or continuing a core.
Core Director
A Director must be designated for each core. Core Directors should be acknowledged experts with independently funded research programs who will themselves use the core services. Therefore, the percent effort for the Director requested from the DDRCC will be relatively low, typically 10 to 20 percent. While it is expected that all core Directors and co-Directors will be Center members, occasionally experts in the specialty area required by the core who are not part of the research base may be appropriate. Sufficient and compelling reasons must be given for appointing any Core Director/co-Director who is not a Center member.
A core Director may also be a junior scientist (who may or may not be a part of the research base) with appropriate expertise who devotes a significant effort to the core. However, an established expert must be included as a consultant to the core when a junior scientist assumes the role of core Director. Furthermore, the career potential of, and institutional commitment to, junior scientists who serve as core Directors will be considered in the review of the DDRCC (see Part III).
Personnel
Research assistants, associates, analysts, technicians, and other qualified individuals are acceptable personnel for a core when appropriate for the volume and type of work anticipated. Research fellows supported by Ruth A. Kirschstein National Research Service Awards (NRSA) are not appropriate personnel for a core.
Facilities
Arrangements for sufficient space for core activities or for access to appropriate established facilities must be made. Centers are strongly encouraged to enter into cooperative arrangements with cores already established within their institution, or with other DDRCCs in close proximity, when the existing cores offer the services needed. These arrangements are important whenever greater efficiency or cost savings can be realized by such an agreement. It may be advantageous for a DDRCC to provide support for appropriate personnel to work specifically for DDRCC members in an existing facility/core (e.g. transgenic animal core) at the institution. In this case, the designated DDRCC core Director must work closely with the parent facility core Director to coordinate services, unless the same individual assumes both roles.
Charge-back System
A charge-back system may be developed to allow investigators to utilize any core. Charge-back fees are allowable budgetary items in the investigators' individual research project grants. A system of payment management/accounting must be established such that it is clear to the individual users, the institutional business office, and the NIDDK what the charge-back system covers and how funds recovered are being used. This will enable center investigators to appropriately adjust the budgets on their own grants and ensure accountability.
When a DDRCC is first established, individual investigator-initiated research project grants may include funds for services that will ultimately be available through the cores. At the time of their next competitive or noncompetitive continuation application, investigators should remove from their individual research project grant budgets all costs associated with services received from the cores for which they are not charged. The elapsed time before this adjustment is made generally constitutes a very minor overlap, if any, since it is usually several months before a core is fully functional. Charge back fees to the DDRCC should be included in the budget of the research project grant once the cores are running since these are a necessary expense and are justified by cost savings.
Operational Plan
Each core must have a pre-established plan for its operation. Qualifications required for using the core facility and plans for prioritizing use must be clear. Limited use of cores by established investigators in other fields is encouraged, as is use by trainees, students, and junior faculty. The DDRCC must decide upon the approach to and extent of training being performed in each core; training is an appropriate and worthwhile activity of a core and is encouraged.
Any core with a minimum number of users must develop plans to broaden the number of core users. Such plans should be outlined for any core that is not extensively used but is considered essential by the DDRCC administration.
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F. Clinical Component
All of the above, with the exception of the requirement for the users to be funded for ongoing clinical studies, applies to the clinical component. Since the NIDDK is interested in translating the work supported by the DDRCCs into practical therapies for digestive diseases, the clinical component should serve as a resource, a focal point, and a facilitator for this function. Investigators, therefore, need not be funded directly for clinical studies to use the services or expertise provided by the clinical core NOR to justify the existence of this component. Providing the capability for translating basic research findings into a clinical setting is the ultimate goal of the clinical component.
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G. Pilot and Feasibility Studies
Although research projects associated with a DDRCC are funded from other resources, there is one exception -- pilot and feasibility (P/F) studies.
Definition
P/F project funds provide modest support (typically $10,000 to $50,000) for a limited time to enable eligible investigators to explore a digestive diseases-related research concept. P/F projects are intended to provide support for investigators to collect preliminary data sufficient to support a grant application for independent research support. P/F studies may (1) provide support for new investigators; (2) encourage investigators from other areas of biomedical research to use their expertise for DD research; and (3) allow established DD-investigators to explore innovative new ideas that represent a significant departure from their ongoing, funded projects.
P/F project support is not intended for the extension of projects by established investigators for which it would be appropriate to submit a research project grant application. P/F funds are also not intended to merely fund or supplement ongoing research of an established investigator.
Requirements
Eligibility Criteria
Investigators eligible for P/F funding fall into three categories:
- new investigators without current or past NIH research project support (R01 or P01) as a principal investigator. New investigators current or past support from other sources must have been modest, i.e. typically no more than $75,000 per year, exclusive of salary. Institutional start-up funds are excluded.
- established, funded investigators with no previous work in digestive diseases or DD-related areas who wish to test the applicability of their expertise to a DD-related problem; and
- on rare occasions, established investigators in digestive diseases or DD-related areas who wish to test the feasibility of a new or innovative idea which constitutes a significant departure from their funded research. (Generally, this does not mean repeating an experiment using just a different cell type or animal model.)
The NIDDK expects that the majority of P/F project investigators will fall into the first category and only in exceptional circumstances will category 3 investigators be supported.
Trainees who are recipients of an NRSA individual award (F32) or are supported by an institutional training grant (T32) are eligible for P/F funds only if they are in their last year of training, have had at least one year of research laboratory experience at the postdoctoral level, and have suitable expertise and independence to design and carry out the planned experiments. Trainees requesting P/F funds should have a commitment from a senior scientist to sponsor the project. P/F funds cannot be used to supplement NRSA stipends, but may be used for supplies, technical support, special services, etc.
There is no citizenship requirement for P/F recipients, BUT visiting scientists with whom the DDRCC investigators will not have a long-term collaborative relationship are not considered strong candidates for support. Individuals whose intention is to remain involved in DD research, either in the U.S. or elsewhere, may be supported by P/F funds. Individuals who are intending to remain in the U.S. as citizens or permanent residents may be supported by P/F funds as long as they otherwise meet the eligibility criteria above.
Each P/F project application should clearly identify the eligibility of the investigator using one of the three categories listed above. A proposed P/F project should clearly delineate the question being asked; present a testable hypothesis; detail the procedures to be followed; and discuss how the data will be analyzed. The research must involve a DD-related topic relevant to the current focus of the DDRCC or involve an avenue of new research into which the DDRCC will be moving.
P/F projects should be submitted for Center review in the general format of NIH research project applications (R03). The period of support is limited to three years or less with available funds usually ranging from $10,000 up to $50,000 per year. Investigators may receive P/F support only once in any five-year funding period.
Administration of P/F Program
While the management of the P/F program is left to the discretion of the DDRCC, it must include the elements listed below.
- A mechanism must be established to advertise the availability of P/F funds.
- A mechanism for the scientific merit review of P/F projects must be established. At least one reviewer from outside the DDRCC must be used to evaluate each application. Details of handling the review will be left to the DDRCC, although all reviewers should assign priority scores in accordance with the NIH system. Copies of all of the projects with written documentation of the reviews, priority scores, and final action should be retained by the DDRCC. These records should be available to outside reviewers and NIH staff, if requested.
- A mechanism for making recommendations to the DDRCC Director for initial funding decisions should be outlined.
- A mechanism for the oversight and review of ongoing P/F projects should be developed as a requirement for a second or third year of funding.
- A mechanism to terminate P/F projects must be established. Studies may be terminated by the DDRCC administration before their approved time limit for various reasons such as (1) the investigator receives outside funding for the project; (2) the project was found not to be feasible; or (3) the investigator left the DDRCC institution. When such situations result in the termination of a project, the DDRCC may make new awards for P/F projects with the remaining funds or supplement other ongoing projects.
- A plan for tracking the success of the P/F program should be established. A record of scientific publications, abstracts, and grant applications submitted/funded, as well as information on whether the investigator remains in DD-related research is important. Staff of the NIDDK uses this record to determine whether the P/F program is a useful component of the Center, serving to encourage investigators to remain in DD- related research.
Each DDRCC Director is strongly encouraged to involve the External Advisory Board in the management of the P/F program. P/F grant recipients are encouraged to collaborate or consult with any biostatistics component supported by the DDRCC or otherwise available at the applicant institution and to utilize the core facilities or the clinical component of the DDRCC.
The P/F funds available to a DDRCC are "capped" at $150,000 per year and their use is restricted as indicated in the Notice of Grant Award. Prior approval from the NIDDK is necessary to transfer funds from the P/F category to the cores or from the cores to the P/F program.
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H. Named New Investigator
Each DDRCC may provide salary support for a P/F project recipient whom they designate a Named New Investigator. Support for this individual is limited to 3 years and cannot exceed $75,000 per year, additional appropriate fringe benefits, and 80% effort. These funds are included in the Administrative Core budget. The individual selected should be a junior investigator who meets the P/F project eligibility criterion (1) as noted previously in Part I F of these guidelines and is a permanent resident or US citizen. Individuals are eligible only once for this support. Subsequent candidates for this position are nominated by the Center and reviewed by its External Advisory Board. Appointment of the Named New Investigator is contingent upon the concurrence of the External Advisory Board and the NIDDK DDRCC program director.
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I. Enrichment Program
The DDRCC grant can provide limited support for an enrichment program under the auspices of the Administrative Core. Support for visiting scientists, seminars, and research forum are appropriate items for inclusion in an enrichment program. Also, limited travel support may be requested to allow DDRCC investigators to present scientific findings, to learn new laboratory techniques, to develop new collaborations, or to engage in scientific information exchange. Mini-sabbaticals to allow Center investigators to enhance their scientific and technical expertise are allowable expenses. In all cases, the enrichment program should further the overall aims and objectives of the DDRCC as well as its cores. Creative new programs, not precluded by NIH or NIDDK guidelines, are encouraged.
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