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
Standard NIH Review criteria that must be used are:
Overall Impact - Overall
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the Center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Center proposed).
Standard NIH Review criteria that must be used are:
Overall Impact - Overall
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the Center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Center proposed).
Significance
Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s)
Are the PD/PIs, collaborators, and other researchers well suited to the Center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the Center involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Review criteria specific for the scientific evaluation of DDRCC applications supplement the standard criteria:
Significance
What are the strengths of the Center's research base (its breadth and depth)? Do the focus, relevance, interrelationships, quality, productivity, and, to some extent, quantity of the research base support the stated theme of the center? What is the likelihood that the DDRDC will increase efficiency; promote new research directions and meaningful collaborations among center investigators; facilitate interactions and collaborations among the investigators; and prove cost-effective?
Investigator(s)
Are the center investigators responsible for the individual research projects willing to interact with each other and contribute to the overall objectives of the DDRCC? What are the scientific and administrative leadership abilities of the proposed center Director and Associate Director(s) and their commitment and ability to devote adequate time to the effective management of the DDRCC? Are the Core Directors well-qualified and appropriate? If requested, does the Named New Investigator appear well qualified and appropriate for support?
Innovation
Are no more than four Pilot & Feasibility (P&F) studies submitted for evaluation as part of the review of the P&F program? Are the P&F applicants eligible and does the selection process by which the individual studies were selected appear appropriate? Does the center appear to encourage ‘high-risk’, innovative ideas through their P/F program? Do the Cores provide new methods, techniques, and/or resources and demonstrate the ability to adapt when needed to support investigators in emerging areas of digestive and/or liver diseases research, as appropriate to the purpose of the Core and the research supported by the Center?
Approach
How appropriate and relevant are the proposed cores and the modes of operation (such as prioritization of requests for services)? Will at least two funded investigators use each core? Will the cores provide opportunities not otherwise available to the investigators; represent appropriate cost savings/cost sharing advantage; and stimulate the development of new approaches? Is appropriate administrative organization proposed for the following:(a) coordination of ongoing research between the separately funded projects and the center, including mechanisms for internal monitoring;(b) establishment and maintenance of internal communication and cooperation among the center investigators;(c) mechanism for selecting and replacing professional or technical personnel within the cores;(d) mechanism for reviewing the use of, and administering funds for, the P&F program;(e) management capabilities, including fiscal administration, procurement, property and personnel management, planning, budgeting, and other appropriate capabilities? Is there efficient and effective use and/or planned use of the limited enrichment funds, including the contribution of these activities to the stated goals of the DDRCC?
Environment
Is there evidence of institutional support? Is there institutional commitment to the program, including lines of accountability, regarding management of the center grant and the institution's contribution to the management capabilities of the center? Is there clear potential for interaction with scientists from other departments and institutions?
Renewal Applications
For Renewals, the committee will consider the progress made in the last funding period, including: Have the benefits of the Center been documented in the forms of increased collaboration, new research directions, and cost savings to its members and the institution? Have the Cores provided appropriate methods, techniques, and/or resources and developed ways to support investigators in new areas of digestive and/or liver diseases research, as appropriate to the purpose of the Core and the research supported by the Center? Have the Cores adapted to the changing needs of the investigators? Is the use, utility, quality control, and cost effectiveness of each Core requested to continue as part of the Center documented? Are Cores no longer needed appropriately being discontinued in response to the changing needs of Center investigators? Is there a significant list of publications arising from each Core? Has the administrative structure proven effective? Are data provided to document the outcome of all completed P/F projects, including those that failed to lead to further funding? Has the enrichment program been effective?
Scored Sections of Application:
For DDRCC applications, reviewers will be asked to evaluate the following individual sections, and the Scientific Review Officer will record these scores:
Overall Research base, including the focus, quality of research, collaborations among members, relevance to the Center's stated research focus, and, for renewal applications, the growth or evolution of the research base.
Each scientific core, as regards need for proposed services; number of users; qualifications of personnel; management, including prioritization and responsiveness to the needs of the users; quality control management; and any appropriate developmental work
The administrative core, including committee structure, center membership criteria, and lines of communication. The enrichment program and Named New Investigator, if requested, will also enter into this evaluation.
Pilot and Feasibility program, including the quality and appropriateness of the four submitted P/F applications as well as the organization of the P/F overall process of solicitation, review, and monitoring of projects.
Center Director (PI) as regards leadership and commitment to the stated goals fo the DDRCC.
The overall impact score is not the average of the scores for all these components.
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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:
Sharon Bourque
Senior Grants Management Specialist
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
Two Democracy Plaza, Room 719
6707 Democracy Blvd., MSC 5464
BETHESDA MD 20892-5464
Telephone: (301) 594-8846
Email: bourques@extra.niddk.nih.gov
This document affects all new and renewal applications effective July 15, 2011.
E. Sample Exhibits
I: Consolidated Budget for 1st Year of Requested Support
II: Distribution of Professional Effort (in Calendar Months) 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
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Page last updated: July 15, 2011
