Administrative Guidelines for Silvio O. Conte Digestive Diseases Research Core Centers (DDRCCs) Part III
Review and Assessment
A. Review Considerations
Upon receipt, Center for Scientific Review (CSR) staff will screen applications to make sure they adhere to 398 submission guidelines. Rejected applications will be returned to the applicant. NIDDK program staff will screen applications for responsiveness to the program requirements and criteria stated in the RFA. If the application is not responsive to the RFA, NIDDK staff will contact the applicant.
Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NIDDK. The written application must be complete because site visits are not possible.
Following the initial review of both new and renewal applications, all scored applications will undergo a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. Applications recommended for approval by the Advisory Council will be considered for funding on the basis of (1) overall scientific and technical merit as determined by peer review, (2) program needs and balance, and (3) availability of funds.
Review Criteria
Specific review criteria for the scientific evaluation of DDRCC applications are given below.
Research Base
The scientific excellence of the DDRCC's research base (its strengths, breadth, and depth) as well as the relevance and interrelatedness of the funded research projects to the central theme(s) or focus of the DDRCC will be evaluated. The likelihood of meaningful collaboration among DDRCC investigators will be assessed. The existence of a base of established, independently supported biomedical research of high quality is a prerequisite for the establishment of a DDRCC and is considered the MOST IMPORTANT COMPONENT OF THE APPLICATION DURING THE REVIEW. In renewal applications, the degree to which the research base has expanded or been strengthened since the last renewal will be considered.
The qualifications, experience, and commitment of the DDRCC investigators responsible for the individual research base grants, and their willingness to cooperate with each other and contribute to the overall objectives of the DDRCC will be considered. In renewal applications, the degree to which effective collaborations fostered by the Center and the cores have resulted in new projects will be considered.
Cores
The appropriateness and relevance of the proposed cores and their modes of operation (such as how requests for services will be prioritized, quality control measures, and how use will be monitored), facilities, and potential for contribution to ongoing research will be evaluated. Renewal applications will be evaluated on past use, quality control, cost effectiveness, and proposed future use of each core for which continuation is requested. Productivity and appropriateness of each core will be judged in part by the list of publications arising from projects using that core. The acquisition of relevant new services and the appropriate deletion of services no longer required will also factor into the evaluation of existing core facilities.
Although a minimum of two users is sufficient to establish a core, a greater number of users generally should be more cost effective. When a core is proposed for which only the minimum number of users exists, the description of the efforts made (for existing cores in renewal applications) or to be made (for new applications and for new cores in renewal applications) to increase the number of core users, and thus enhance the core's productivity and cost effectiveness, will be carefully considered. When a renewal application is reviewed, this increase in core use will help determine the productivity of, and the need for continuing, the core.
The qualifications of the Core Director and other personnel will be evaluated.
Clinical Component
Since the translation of research findings to the clinical setting is often accomplished without R01 or other Federal support, the clinical component will be evaluated separately from the cores.
The appropriateness of the clinical component to the research themes of the DDRCC will be evaluated.
The services offered and the qualifications of the personnel requested as well as the number of physician scientists, and perhaps basic researchers, who will make use of clinical component services will be evaluated.
The potential for, or past efforts of, the clinical component to develop specialized services, relevant to DDRCC members, such as tissue or serum banks, patient screening or recruitment, or consultation for clinical study/trial development, will be evaluated.
Pilot and Feasibility Studies
For both new and renewal applications, the study section will evaluate four P/F projects in the context of the P/F program as a whole. That is, lengthy review of individual projects will not occur. Of key importance is whether each applicant is eligible (see Part I-F of these guidelines), whether the proposed hypotheses are reasonable, whether the project relates to the focus of the DDRCC, and whether the project appears feasible.
In new applications, the P/F projects will be assumed to be the best selections made using the proposed evaluation procedures described in the application.
In renewal applications, the submitted P/F projects will be assumed to be the best selections made using the Center's existing review procedures as described in the application.
The study section will recommend a level of funding for the P/F program (within the $150,000 cap) based on the quality of the submitted P/F projects, the proposed method for management and review, and the study section's assessment of the potential needs and opportunities for P/F studies at the DDRCC.
In renewal applications, the recommendation of the study section to allow a requested increase in P/F support, to maintain the current level of support, or to reduce the level of support, will be based on their assessment of the DDRCC's overall P/F program. Taken into account in this recommendation will be: (1) the extent to which P/F funds were fully utilized during the previous project period; (2) the extent to which awards were made to investigators who fully met the eligibility criteria for P/F project support as outlined previously; (3) the extent to which the awards made are considered to be relevant to the current or future research themes of the DDRCC; (4) the extent to which previously supported P/F projects were successful (e.g., the P/F recipients are currently funded; a new investigator was attracted into digestive disease-related research; or peer-reviewed publications or presentations resulted); and (5) whether the P/F recipients have remained in DD-related research.
Named New Investigator
The Named New Investigator will be reviewed separately. The associated pilot study must have been evaluated in a manner similar to the P/F projects in general. In a renewal application, the progress of previous Named New Investigators will be considered, i.e. whether their P/F projects led to publications and/or grant awards, and whether the investigator has remained in DD-related research at the DDRCC or elsewhere.
Enrichment Program
Efficient and effective use and/or proposed use of the limited enrichment funds, including the contribution of these activities to fostering the objectives of the DDRCC will be evaluated.
Program Director and Administration
The scientific and administrative leadership abilities of the DDRCC Director and Associate or co-Director(s) and their commitment and ability to devote adequate time to the effective management of the program will be assessed.
The appropriateness of the criteria used to include individuals as center members and associate members will be considered.
The study section will evaluate the organization proposed for the following:
a) coordination of ongoing research between the separately funded projects and the DDRCC, including mechanisms for monitoring collaborative efforts and for encouraging acknowledgements of the DDRCC contributions to the research efforts in all publications arising from the use of core facilities;
b) establishment and maintenance of internal communication channels among the DDRCC investigators;
c) mechanism for selecting and replacing professional and technical personnel within the DDRCC, particularly the Director;
d) approach for administering the P/F program, including soliciting applications, the review process, and making funding decisions, as reflected by the general quality of P/F projects submitted with the application; and
e) management capabilities that include fiscal administration; procurement, property and personnel management; planning; and other appropriate capabilities.
The institutional commitment to the Center, including lines of accountability and contributions to the management of the DDRCC will be assessed. In addition, the institutional commitment to both new staff members and to investigators responsible for conducting essential DDRCC functions as well as the commitment to establish new positions specifically designed to enhance the operation of the DDRCC will be considered.
The academic environment in which the DDRCC activities will be conducted, including the availability of space, equipment, facilities, and the potential for interaction with scientists from other departments and institutions will be considered.
Budget
The appropriateness of the budgets requested for the cores, the clinical component, the P/F program (capped at $150,000 per year), and for enrichment activities will be evaluated. Total Direct Costs are limited to $750,000 per year (including P/F program funds). At times the requested amount may exceed this limit due to facilities and administration costs incurred by contractual arrangements.
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B. Assessment and Reporting Requirements
Background
The DDRCC program as a whole, and each center individually, is evaluated on an ongoing basis by NIDDK staff. The activities and accomplishments of each DDRCC are documented using several approaches. The annual progress report serves to highlight each DDRCC's accomplishments, including productivity of individual investigators; significance of the research conducted by center investigators; enhanced communication and collaboration facilitated by the DDRCC; use of P/F funds; and overall Center impact on the institution and the Center members.
In addition, NIDDK staff members must periodically prepare reports for the NIDDK Director and the National Diabetes and Digestive and Kidney Diseases Advisory Council. These reports are primarily based on progress reports from the DDRCCs and on information solicited prior to the yearly Center Directors' meeting. If necessary, NIDDK staff or consultants may visit individual centers to aid in these evaluation activities. The Annual Center Directors' meeting, usually held at one of the DDRCCs, provides an opportunity for evaluation of the host center's program.
General Plan for Interim Assessment
To assist in interim assessments of the DDRCC, the following are helpful to the NIDDK staff:
a) Yearly Center Directors' meeting - this meeting, attended by NIDDK staff and Senior management, is mandatory for all Center Directors or, if need be, the co-Director. Center administrators are strongly encouraged to attend.
b) Minutes of DDRCC meetings - copies of the minutes of Internal Executive Committee meetings and the External Advisory Board meetings;
c) Newsletters - current newsletters from the DDRCC and from the parent institution, if these mention or highlight the DDRCC.
d) In-House Assessments - The Director of a DDRCC should use Center's External Advisory Board meetings to assess the activities and programs of the DDRCC. The minutes from the Advisory Board meetings may be included as part of the annual progress report OR may be sent in as they become available.
e) Annual Progress Report - The annual Grant Progress Report, which is due two months before the anniversary date of the award, must be submitted as described in the PHS Form 2590 application instructions. Since the DDRCCs are large, multifaceted grants, a uniform reporting format for the annual progress report is desirable.
The format suggested for the narrative portion of the report follows below in Section C. Information such as External Advisory Board meeting minutes, newsletters, and other pertinent items already sent to the NIDDK program director need not be included.
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C. Format for Annual Progress Reports
Use this outline in conjunction with the narrative portion of the Grant Progress Report (PHS Form 2590) to provide information about the DDRCC.
All information should begin from the time of the last Progress Report. Include a Table of Contents.
Biomedical Research Component
Include the following items:
a) concise statement of any changes in the goals and objectives of the DDRCC;
b) summary of any changes in the research base (loss or addition of DDRCC members, as well as change in status from associate to full members), the reason for changes (i.e, left institution, changed research focus), and how these changes affect the DDRCC;
c) significant research advances and accomplishments made possible by the presence of the DDRCC (e.g. through core use, collaborations fostered by the DDRCC, etc.);
d) a consolidated list, including titles, of scientific manuscripts and abstracts published by Center members and/or by investigators funded by the P/F grant program;
e) description of current P/F projects supported by the DDRCC (include beginning date; one page progress reports for ongoing projects and the abstract for new projects are suitable; see sample format at the end of these guidelines); and
f) a list of P/F projects which have ended, for any reason, since the last progress report (i.e. the project was completed, progress was not sufficient for renewal, recipient received other funding or left the center).
Core Facilities
Include the following items for each core:
a) concise statement of any changes in the purpose of the core and the services provided; and
b) utilization (users, frequency and extent of use, collaboration among investigators fostered by the availability of the core facility).
Enrichment Program
Include the following items:
a) list of enrichment activities sponsored by the DDRCC, including lists of speakers and topics; visiting investigators and the purpose of the visit (collaboration, training, information exchange, or other); members taking mini-sabbaticals; etc.;
b) concise statement of any changes in the enrichment program;
c) any special, innovative, or unique aspects of the enrichment program that you wish to highlight; and
d) any examples of how the enrichment program has positively affected the DDRCC.
Administrative Information
Include the following items:
a) concise statement of any changes in eligibility requirements for investigators to use core facilities;
b) list of investigators comprising the DDRCC's research base in the reporting year. If the DDRCC distinguishes between different levels of membership, that should be clearly indicated with appropriate lists. It is important to be concise regarding the DD-related research base. Also provide
c) a list of awards, honors, and special recognition(s) earned by the DDRCC investigators and not mentioned in the previous year's report;
d) a list of grant applications submitted as well as funding obtained based on results of P/F projects since the last report;
e) an indication of other support to the DDRCC from donations, gifts, funds from the institution, or other special sources;
f) a brief summary of External Advisory Board meeting(s) [since the minutes of these meetings should have been sent to the program director previously, it is not necessary to send them again]; and
g) a statement regarding the impact of the DDRCC on the institution/community.
NOTE: An abbreviated version of the progress report may be submitted for the year of support in which the renewal application is being submitted. While the Grant Progress Report may be attenuated, it MUST contain the following elements:
- face page signed by the appropriate University officials;
- budget pages, with justifications;
- list of cores and names of core directors;
- list of faculty, departmental affiliations, and research interests [can be one sentence];
- titles, principal investigator's name, and dates for P/F studies for the last budget period and for those projects that are continuing or are planned for support;
- a brief [2-5 page] summary of Center core activities, including any changes in services offered;
- at least a one page report on the most significant scientific advances from the Center in the past year, along with the appropriate publication citation, in layman's terms;
- all the usual assurances;
- any personnel changes; and
- checklist.
Special Information
Each DDRCC is encouraged to provide a special summary report, in layman's terms, of the most significant research advances made possible by the existence of the Center. The significance of these advances, and their possible relevance to understanding the cause(s) of digestive diseases and related disorders should be discussed. To the extent possible, the report should also describe the relationship of these advances to the early detection, treatment, and possible prevention of digestive diseases and related disorders. Where applicable, the potential for Center advances to impact on improved patient care should be highlighted. NIDDK staff use this information to prepare annual and/or specially requested reports on the DDRCC program and its accomplishments, particularly for preparing responses to Congressional inquiries.
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D. Special Considerations
While each DDRCC develops its own program in accordance with the local talents, interests, and resources available, each DDRCC must be responsive to national needs in digestive diseases and must be willing to work with the NIDDK and other organizations in furthering the overall goals of the DDRCC program. In this regard, DDRCC directors and selected other DDRCC participants may be invited to meet periodically with NIDDK staff and its consultants to review progress, identify emerging needs and opportunities, and plan approaches for future investigations.
In the event that major changes in a DDRCC occur, it may be necessary to have an interim site visit to discuss the changes and possible budget adjustments.
These guidelines update the policies covering DDRCC grants; earlier versions should be discarded. Some redundancy exists within the guidelines to emphasize key issues related to a DDRCC. If questions remain after reading these guidelines, contact the individuals listed below.
Direct inquiries regarding programmatic issues and requests for the Administrative Guidelines to:
Judith Podskalny, Ph.D.
Director, Digestive Diseases Centers Program
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 667
6707 Democracy Blvd., MSC 5450
BETHESDA MD 20892-5450
Telephone: (301) 594-8876
Email: jp53s@nih.gov
Direct inquiries regarding fiscal matters to:
Michael Giza
Senior Grants Management Specialist
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 733
6707 Democracy Blvd., MSC 5453
BETHESDA MD 20892-5453
Telephone: (301) 594-8851
Email: mg54o@nih.gov
This document affects all new and renewal applications effective May, 2008.
E. Sample Exhibits
I: Consolidated Budget for 1st Year of Requested Support
II: Distribution of Professional Effort (%) on This Application
III: Summary of Total Current and Pending Support of all Center Members
IV: Collaboration Between Center Members
V: Use of Core Facilities
VI: Pilot Project Outcome Table
Page last updated: February 21, 2008
