Application Process: Format and Content
A. General Instructions
Pre-Application Process
Applications for DDRCCs are accepted only in response to a Request for Applications (RFA) published in the NIH Guide for Grants and Contracts . The schedule for the publication of DDRCC RFAs is available at http://www2.niddk.nih.gov/Research/Centers/CenterPrograms/DDRC-Review.htm
The receipt date for applications is indicated in the RFA. Individuals from institutions with an interest in applying for a DDRCC grant should contact NIDDK program staff as early as possible in the application preparation process. This consultation is crucial. Applicants should not construe advice given by the NIDDK staff as assurance of a favorable review and/or possible funding. The staff will not evaluate or discuss the merit of the scientific aspects of the application.
Application Format and Content
It is necessary for applications to be arranged in a specific format. This not only makes it easier for NIDDK staff and reviewers to evaluate the application, but also provides a checklist for the applicant institution when preparing the application. Applicants should keep in mind that the written application is the sole basis for the scientific merit review of the proposed DDRCC. It is not possible to conduct a site visit for each application.
The format is described both for new and for renewal applications. In renewal applications, accomplishments and a brief history of the DDRCC's development should be included.
The PHS Form 398 must be used for the application. The arrangement of materials for the DDRCC grant should follow both the instructions in the PHS Form 398 application kit and the more specific instructions detailed below to aid in the review process. The original and three identical copies of the completed application should be mailed to the Center for Scientific Review (CSR) using the address from the 398 instructions.
At the time of submission, two additional copies of the application must be sent under separate cover to Chief, Review Branch, NIDDK; 6707 Democracy Blvd., MSC 5452., Room 752; BETHESDA MD 20817.
****Applicants should read Part III of these guidelines to*****
understand the criteria used for evaluating DDRCC applications.
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B. Specific Instructions--Forms (PHS Form 398)
Face Page:
Items 1- 14 (See PHS Form 398)
NOTE: Awards for DDRCC grants are made for five year project periods.
Form Page 2:
Project Summary and Performance Sites (self-explanatory)
Number the pages consecutively throughout the application.
Form Page 3:
Scientific/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (follow 398 instructions)
Table of Contents: Provide a Table of Contents following the basic format shown in the 398 kit but modified to be appropriate for the items submitted for a center application.
Form Page 4:
Provide a consolidated budget for the first year of requested support (see Sample Exhibit I). Separate budgets for each core and for the clinical component, if requested, should immediately precede the narrative of that section, using form page 4.The funds requested for the P/F program, not to exceed $150,000, should be included in the "other expenses" category of the budget for the Administrative Core.
Form Page 5:
Budget for Entire Proposed Project Period (self explanatory)
.
Biographical Sketches:
Provide biographical sketches for all DDRCC investigators (key personnel, research base investigators, consultants, and collaborators). Biographical sketches for principal investigators on P/F projects should be included with the P/F project. Follow the current NIH 398 instructions.
A summary of the distribution of percent of professional effort for the DDRCC is useful for reviewers and may be included after the Biographical Sketches. (See Sample Exhibit II for a suggested format).
A summary of the current and pending support for all DDRCC investigators, including percent efforts, aids in the review process when presented as suggested in Sample Exhibits III-A through -D, with digestive diseases-related research support listed first followed by non-digestive diseases-related support. K-series awards may be included here. Institutional Training Grants (T32 or T35) and Individual Fellowship Awards (F31 or F32) are not part of the research base but should be listed separately in III A and B.
Resources Format Page:
Facilities and Major Equipment: general overall description of research facilities (space, equipment, collaborations, etc.) and the major, shared pieces of equipment to be used by Center members should be provided.
Specific core facilities, equipment, and special resources should also be listed in each core component.
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C. Page limits.
In keeping with the Enhancing Peer Review initiative, the following page limits are in effect for all DDRCC applications submitted after January 1, 2011:
- Introduction to a resubmission application: 1 page
- Background and Overview: 12 pages
- Research Base: 6 page overview plus 1 page per research base investigator, plus pages needed for tables suggested in Exhibits III and IV in these guidelines
- Cores: 12 pages each plus additional pages for Exhibit V from these guidelines
- Enrichment program: 6 pages (in addition to 12 pages for rest of Administrative core)
- Clinical component: 6 pages (in addition to 12 pages for rest of core in which it resides); if this will be a Clinical Core, then the 12 page limit applies.
- P/F program: 6 pages plus 1 page per each P/F application submitted. In renewals, plus 1 page per each P/F supported in the last 5 year funding period.
D1. Specific Instructions--Research Strategy (NEW Applications)
***Initial (NEW) applications refer to this section. For Renewal applications, see section D2 .***
Administrative Core (New applications)
Include a budget for the Administrative Core with a comprehensive justification. Most Centers find that the size and complexity of a DDRCC warrants inclusion of a full-time program administrator. Other budgetary items that, if requested, should be included here are funds for enrichment programs, travel funds for at least two persons to attend the annual meeting of DDRCC directors, and salary for the Named New Investigator. The P/F project of the Named New Investigator should be included in the P/F program.
Provide a description of the research focus of the DDRCC as well as any unique aspects of the Center. Include a brief narrative describing the qualifications of the Director and associate Director. It is important to include a plan for replacing the Director should this become necessary.
Provide a description of the administrative structure of the DDRCC, including: chain-of-command, committee structures (e.g. Internal Advisory Committee; P/F review; other oversight or management committees), and core and clinical component oversight.
List the areas of expertise necessary for inclusion on the External Advisory Board, not the names of the individuals whom you plan to recruit to serve in this capacity.
Provide an outline of the relationship of the DDRCC to the institution and the reporting lines of the DDRCC Director to appropriate institutional officials. If this is presented in diagrammatic form, also provide a brief explanation in narrative form.
Include a description of the mechanism for monitoring budgetary overlap between the research projects included in the research base and the funds for the core facilities of the DDRCC. Describe a mechanism to monitor the budgetary adjustments made necessary by the use of core services. This will ensure that DDRCC investigators using cores are able to provide a satisfactory explanation of their relationship to the DDRCC and their inclusion of charge-back fees to the cores in their individual grant budgets.
While facilities (space, equipment, library, etc.) must be clearly described for each element of the application, include a more global description of the overall facilities and a statement regarding institutional commitment to the DDRCC in the description of the Administration Core.
Enrichment Program (New applications)
Describe plans for the enrichment program in as much detail as possible. Include funds for the enrichment program in the budget for the Administrative Core.
Research Base (New applications)
Include an overview of the current digestive diseases (DD)-research activities at the institution. An appropriate and clear presentation of the ongoing research base is critical since it will show the research focus of the DDRCC and the interrelationships and potential for collaborations among investigators. Since the research base projects will already have been peer reviewed, the quality of the individual funded projects will have been established and will not be re-evaluated.
Provide sufficient detail to assist reviewers in judging the extent and the interrelatedness of ongoing research. Emphasize the anticipated impact of the establishment of a DDRCC on the research base. Include an indication of how the establishment of a DDRCC will provide added dimensions and new opportunities for DD-related research, along with increased cooperation, communication, and collaboration among investigators.
Group DD-related research projects into aggregates of thematically related studies with similar overall goals and objectives. A majority of the research base should have a central focus or theme that is a digestive disease or related disorder, group of diseases, or functional studies relating to digestive diseases. Overly detailed descriptions of the research base projects are discouraged, therefore the presentation of the research base in the application is best done in two ways: (1) by providing information in a format such as that shown in Sample Exhibits III, and (2) by providing narrative description of no more than one page per research base investigator. These narratives should include: (1) grant numbers, titles, and a few descriptive sentences, and (2) a list of the core(s) which will be used. Include a brief sentence indicating what aspect of the research justifies the use of each core. ONLY those grants awarded to investigators at the applicant institution or the applicant consortium, not to collaborators at other locations, should be included in the description of the research base. It is particularly important to provide a few sentences indicating the relatedness of a cited grant to digestive diseases research when this is not readily apparent from the title of the grant.
Document collaborative efforts by using a format such as Sample Exhibit IV, although pre-existing extensive collaborations are not a prerequisite for new applications.
Biomedical Research Cores (New applications)
For each core, include a budget with detailed justifications for: (1) the initial budget period, and (2) entire project period. Detail the qualifications of the core Director and the duties and qualifications of other personnel, including technical support staff. In the event a core Director is not an established investigator (see Part I), highlight the institutional commitment to and career plans for the individual.
Include the rationale for establishing the core, the facilities to be used, and the activities of the core. Provide short descriptions of the services provided and the projects of the investigators who will use the core. Give special attention to the description of the physical arrangements and instrumentation for the core.
Present the organization and proposed mode of operation of each core. Describe plans for:
- assuring quality control
- prioritization of investigator use
- monitoring core use
- adapting to new technology and to the needs of the DDRCC members.
Include a definition of qualified users. Provide a list of funded Center investigators who will use the core and the expected extent of their proposed use. Sample Exhibit V is given as an example of how this may be accomplished. Emphasize the anticipated benefits that investigators will derive from using core facilities.
Limited use of the core by established investigators in other fields is encouraged, but rules to regulate this use should be defined. If the core is used for training, detail the approach to and extent of the training. Use of the core for training Center members is encouraged.
Describe any plans to use the core for limited developmental research, including the relevance of this research to core services, effectiveness, and adaptability.
Since DDRCCs are strongly encouraged to enter into cooperative arrangements with established cores at the applicant institution or at other DDRCCs offering a similar type of service, describe the nature of any cooperative arrangements, the prioritization plan, and the methods to monitor use under these circumstances.
When cores use human subjects or animals, include sections described in PART II and III of the PHS 398 application as needed.
Pilot and Feasibility (P/F) Program (New applications)
Provide a justification for amount of P/F funds requested. The actual budget request is contained in the "other expenses" category in the budget for the Administrative Core.
Describe the management plans for the P/F program, including both internal and external review mechanisms along with an outline of the plans for future years of the P/F program. This should include how applications will be solicited, reviewed, awarded, and, if required, terminated. Also indicate the number of applications received and evaluated.
Include a 1 page synposis for each of four P/F project applications. These should be the best applications received by the proposed DDRCC and reviewed in the manner proposed for review of all future P/F applications, should the Center be funded. Each synopsis should include:
- budget and number of years requested,
- eligibility of the P/F project (how it fits with the DDRCC's goals)
- name, department affiliation, and eligibility of the P/F investigator (see Part I-G)
- proposed core use
- abstract of the project.
Clearly indicate the Named New Investigator , if such a position is being requested, and how he/she was selected. Include salary support for this position in the Administrative Core personnel section.
Also see Part II-F for Specific Instructions regarding the Budget.
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D2 - SPECIFIC INSTRUCTIONS Research Strategy (RENEWAL applications)
***For Renewal applications, use this section. For Initial applications see Section D1 above.***
Administrative Core (Renewals)
Include a budget for the Administrative Core with a comprehensive justification. In addition to the Center Director and co- or Associate Directors, include a full or part-time administrator as well as funds for the enrichment program, travel funds for at least two persons to attend the annual meeting of DDRCC directors, and salary for the Named New Investigator. The P/F project of the Named New Investigator should be included in the P/F program.
Provide a brief history of the DDRCC including any changes in the research base, the membership, or the focus of the Center, and how such changes affect the DDRCC or are attributed to the DDRCC, as well as a synopsis of accomplishments.
Provide a description of the research focus of the DDRCC as well as any unique aspects of the Center. Include a brief narrative describing the qualifications of the Director and associate Director. It is important to include a plan for replacing the Director should this become necessary.
Provide a description of the administrative structure of the DDRCC, including: chain-of-command, committee structures (e.g. Internal Advisory Committee; P/F review; other oversight or management committees), and core and clinical component oversight.
Since the External Advisory Board is already established, list the names of the members and their areas of expertise. Also, indicate any changes in membership that have occurred during the previous funding period or are anticipated for the upcoming funding period.
Provide an outline of the relationship of the DDRCC to the institution and the reporting lines of the DDRCC Director to appropriate institutional officials. If this is presented in diagrammatic form, also provide a brief explanation in narrative form.
Include a description of the mechanism for monitoring budgetary overlap between the research projects included in the research base and the funds for the core facilities of the DDRCC. Describe the mechanism to monitor the budgetary adjustments made necessary by the use of core services.
While facilities (space, equipment, library, etc.) must be clearly described for each element of the application, include a more global description of the overall facilities and a statement regarding institutional commitment to the DDRCC in the description of the Administration Core.
Provide a master list of all publications (author, full title, and reference) resulting from research supported by the Center in the past funding period. Include peer-reviewed publications ONLY and underline, bold, or otherwise indicate those authors who are DDRCC members. Include PMCID numbers. Invited papers, book chapters, abstracts, symposia proceedings, etc. may be included in a separate list. In addition, the publications arising from the use of a specific core should also be included in the write-up of that core. While not mandatory, this duplication expedites the review process.
Enrichment Program (Renewals)
Briefly describe the enrichment program and indicate the program's value to DDRCC members. Indicate how the program has grown or been adapted to better serve Center members' needs during the past funding period.
Describe future plans for the enrichment program. Include funds for the enrichment program in the budget for the Administrative Core.
Research Base (Renewals)
Provide a summary progress report that encompasses the following areas:
- interactions and interrelationships of the research efforts;
- uses and benefits of core services; and
- plans to develop productive collaboration among DDRCC investigators.
Describe the evolution of the research base and the DDRCC's contribution to this ongoing development.
Present the research base in two ways: (1) by providing information that will assist in the review of the application, in a format such as that shown in Sample Exhibits III, and (2) by a descriptive narrative of the DD-related activities at the applicant institution and any collaborating institutions. Sample Exhibits III-A through D do not substitute for the information contained on the Biographical Sketches requested in the 398 application kit and are not required, but aid greatly in the review process.
Organize the narrative presentation of the research base to emphasize the focus of the research and the interrelationships of the DDRCC investigators. Provide a narrative description of no more than one page per research base investigator. These narratives should include: (1) the grant number, title, and a few descriptive sentences, and (2) a list of the core(s) used with a brief sentence indicating what aspect of the research justifies the use of each core. Include ONLY those grants awarded to investigators at the applicant institution or consortium, not to investigators at other locations, in the description of the research base. It is particularly important to provide a few sentences indicating the relatedness of a cited grant to digestive diseases research when this is not readily apparent from the title of the grant.
Document collaborative efforts using a format such as Sample Exhibit IV to aid in the review process.
Biomedical Research Cores (present each core separately)(Renewals)
For renewal applications, information regarding the cores should generally cover the same points as in the initial application as well as information on past performance of the core and its usefulness to DDRCC investigators. Include the impact of the core services on investigator productivity in meeting stated goals and objectives and in promoting cost effectiveness. Emphasize the past and future benefits to investigators derived from the use of core facilities.
Include budgets with comprehensive budgetary justifications for: (1) initial budget period, and (2) entire proposed project period. Detail the qualifications of the core Director and the duties and qualifications of other personnel, including technical support staff. In the event a core Director is not an established investigator (see Part I), highlight the institutional commitment to and career plans for the individual.
Detail the objectives in continuing/establishing the core facility and describe the core. The description should include the facilities used as well as the activities of the core. Provide short descriptions of the services provided and the projects that use the core. Document any changes that have taken place since the last competitive review.
Provide details of core management, including plans for:
- assuring quality control
- prioritization of investigator use
- monitoring core use
- adapting to new technology and to the needs of the DDRCC members.
Document past use of the core. Sample Exhibit V B may be helpful. Include a list of the investigators who will use the core as well as the extent of their use. Sample Exhibit V A may be helpful. If the core is used for training, detail the approach to and extent of the training. Use of the core for training Center members is encouraged.
Describe any developmental research performed in the core and indicate its relevance to the services offered by the core.
Since DDRCCs are strongly encouraged to enter into cooperative arrangements with established cores at the applicant institution or at other DDRCCs offering a similar type of service, describe the nature of any cooperative arrangements, the prioritization plan, and the methods to monitor use under these circumstances.
Provide a list of publications made possible by use of the core. This should be a subset of the references listed in the Administrative Core 'master list.' Include titles of publications and indicate which core services were utilized. Also, the DDRCC should have been credited as a resource in all publications . This acknowledgement provides evidence to the study section, and the NIDDK, of core use.
Provide information on past use of any core for which further funding is not being requested, (see Sample Exhibit V B) as well as a brief explanation of the reasons for deleting cores, combining facilities, or creating new cores.
When cores use human subjects or animals, include the relevant sections of the 398 application as needed.
Pilot and Feasibility (P/F) Program (Renewals)
The annual budget for the P/F program should be listed in the "other expenses" category in the budget for the Administrative Core.
Include an historical overview of the P/F program since the inception of the DDRCC. For nor more than the most recent 10 years, provide a summary of the P/F recipients (a) who have had publications as a result of the projects, (b) who have received peer-reviewed funding as a result of the studies, and (c) who are still active in the area of digestive diseases. To aid in the review process, a format such as shown in Sample Exhibit VI is helpful in depicting the P/F program outcomes. Identify any lasting collaborations that resulted from each P/F project and describe any new skills acquired by the P/F recipient or other significant outcomes, such as receipt of an R01 grant. The relationship of each P/F project to one of the research themes of the DDRCC should be emphasized.
Include a statement that outlines how the DDRCC has benefited from the P/F grant program, e.g., increased the research base, spawned a new area of research, or enabled an investigator to explore collaborative possibilities.
Do not include supporting documentation in the DDRCC application.
Describe the current management of the P/F program, including its integration with, and its relationship to, the rest of the administrative structure. Describe plans for future years of the P/F program, including how applications will be solicited, reviewed, awarded, and, if required, terminated. Include the number of applications received and reviewed in the current 5 year funding period.
Include a one page report (not just tabulated information) on each of the P/F projects completed during the current five year project period. These reports must be brief (one page) and should provide: (a) the name of the investigator, degree(s), professional career status at the time of the award, and current professional career status (if known); (b) an overview of the project, including its significance and salient results; (c) a list of publications resulting from the project; (d) the current status of the investigator's funding, and whether in the same or a related area; and (e) any other significant and pertinent information (such as amount and time period of support, future plans of investigator).
Include a 1 page synposis for each of four P/F project applications that will be funded by the DDRCC. These should be the best ones reviewed by the procedures in place at the Center. Each P/F synopsis should include:
- budget and number of years requested,
- eligibility of the P/F project (how it fits with the DDRCC's goals)
- name, department affiliation, and eligibility of the P/F investigator (see Part I-G)
- proposed core use
- abstract of the project.
Due to the timing of the RFA, some or all of the P/F projects may be those that are currently funded. If at all possible, however, the P/F projects should be new ones. It is important for the IRG to be able to evaluate the Center's review "process" by the merit of the P/F projects selected for funding. In either case, provide a list of currently funded P/F projects.
Clearly indicate the Named New Investigator , if such a position is being requested, and how he/she was selected. Include salary support for this position in the Administrative Core personnel section. If using Sample Exhibit VI, use an asterisk to indicate previous Named New Investigators.
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E . Specific Instructions - Appendix (PHS 398)
All applications must adhere to the current policy on appendix materials.
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Allowable costs and policies governing the research grant programs of the NIH will prevail for DDRCC applications.
Personnel
This category should include support for salaries of key personnel within the DDRCC who contribute to the allowable activities of the Center. Salary support for a full time administrator for the Center is encouraged. Salaries of professional personnel engaged in research activities supported by P/F funds are an allowable budgetary item, as are salaries of professional and technical personnel in core facilities.. The salary amount charged to the DDRCC grant must be commensurate with the time spent on DDRCC activities. Salary support derived from the grant will depend on the effort provided and on institutional salary policies; however, current NIDDK practice limits annual increases to 3 percent.
The Center Director is expected to devote an appropriate proportion of his/her time to the DDRCC (no less than 20 percent effort) . The application should not include salaries for individual principal investigators on separate research or training grants unless these investigators provide an essential function for DDRCC activities (e.g. Core Director). No overlap of time or effort between a DDRCC activity and separately funded research projects is permitted.
Potentially overlapping support between DDRCC and individual projects, including research project grants (R01), program project grants (P01), Career Development Awards (K-awards), Small Business Technology Transfer awards (R41, R42), and contracts, will be administratively reviewed by the NIDDK and, if appropriate, adjusted to eliminate duplication of funding.
Stipends for research trainees are not available through the DDRCC. Such funding must be sought through other grant mechanisms.
Equipment
If pieces of specialized equipment costing more than $5,000 are requested, the application must identify similar equipment already available within the institution and provide a clear justification for purchase in terms of core service being provided to DDRCC investigators. Requests for general-purpose equipment should be included only after ascertaining the availability of such items within the institution. Justify the request based on this availability. This includes all equipment in future budget years as well as the initial budget period.
Supplies
Consumable supplies directly related to the operational aspects of the DDRCC core facilities are an allowable expense. This includes office materials as well as laboratory supplies. The supply budgets of separately funded individual research projects must be appropriately reduced to reflect such support, thus eliminating duplication.
Research Patient Care Costs
Research patient care costs (both in-patient and out-patient) are an allowable expense. Attempts should be made to utilize existing clinical facilities, such as those supported by Clinical and Translational Awards (CTSAs) and individually supported beds. If the CTSA is to be used, include a letter of agreement from either the CTSA program director at the National Center for Research Resources, NIH, or from the principal investigator of the CTSA.
Request costs relating to the clinical research efforts of DDRCC investigators ONLY if is no overlap with other funding. Costs already budgeted in individual projects should be appropriately reduced if such costs are to be transferred to the DDRCC clinical component. The DDRCC is not intended to be a facility for health care delivery. Thus, only those patient costs directly related to research activities may be charged to the Center.
Alterations and Renovations
Funds for the alteration and renovation of an existing structure to provide suitable space for core facilities may be requested. 'Cosmetic' renovations are not appropriate.
Consultants
Include costs associated with consultants (consultant fees, per diem, and travel) when their services are required by the DDRCC, such as the members of the External Advisory Board.
Travel
Include the costs of domestic and foreign travel for core or clinical component personnel only if the travel is directly related to the activities of the DDRCC in the budgets for the individual cores or the clinical component. Include travel costs for the DDRCC Director, center administrator, and others as appropriate (i.e. co-Director, core Directors) to attend the annual DDRCC Director's meeting in the budget of the Administrative Core.
Total Requested Amount
Total direct costs requested should not exceed $750,000 per year.
Other:
Unsolicited budget supplements to a DDRCC grant are not routinely accepted. If a DDRCC Director determines that a supplement to a DDRCC grant is necessary, consultation with, and approval of, the NIDDK DDRCC program director is required prior to the submission of a formal request through the institution's budget office.
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