National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Funding Opportunity Title
Diabetes Research Centers (P30)
P30 Center Core Grants
Reissue of RFA-DK-08-008
Funding Opportunity Announcement (FOA) Number
Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestics Assistance (CFDA) Number(s)
This Funding Opportunity Announcement (FOA) invites new and renewal applications for Diabetes Research Centers, formerly named Diabetes Endocrinology Research Centers (DERCs) and Diabetes Research and Training Centers (DRTCs). Diabetes Research Centers are designed to support and enhance the national research effort in diabetes and related endocrine and metabolic diseases. Diabetes Research Centers support three primary research-related activities: Research Core services, a Pilot and Feasibility (P&F) program, and an Enrichment program. All activities pursued by Diabetes Research Centers are designed to enhance the efficiency, productivity, effectiveness and multidisciplinary nature of research in Diabetes Research Center topic areas. The NIDDK Diabetes Centers program in 2011 consists of 16 Centers each located at outstanding research institutions with documented programs of research excellence in diabetes, endocrine and metabolic diseases. Information about the Diabetes Centers may be found at the following URL: http://www2.niddk.nih.gov/Research/Centers/CenterPrograms/.
March 17, 2011
Letter of Intent Due Date
May 31, 2011
Application Due Date(s)
June 30, 2011, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)
Scientific Merit Review
Advisory Council Review
Earliest Start Date(s)
July 1, 2011
Due Dates for E.O. 12372
Required Application Instructions
It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
1. Program Objectives
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Diabetes Research Center grants to support research in diabetes mellitus and its complications, and related areas of endocrinology and metabolism.
The prevalence of diabetes mellitus in the United States is reaching epidemic proportions and accounts for a huge national burden of morbidity, mortality, and health care expenditures. The mission of the Diabetes Centers is to serve as a key component of the NIDDK-supported research effort to develop new therapies and improve the health of Americans with, or at risk for, diabetes and related endocrine and metabolic disorders. The Centers promote new discoveries and enhance scientific progress through support of cutting-edge basic and clinical research related to the etiology and complications of diabetes, with the goal of rapidly translating research findings into novel strategies for the prevention, treatment and cure of diabetes and related conditions.
To accomplish this mission, the Diabetes Research Centers:
• Create an environment that supports important and innovative research;
• Raise awareness and interest in fundamental and clinical diabetes research at their institutions as well as locally, regionally, and nationally;
• Enhance diabetes research education and training opportunities for patients, students, scientists, and clinicians;
• Attract and retain early stage investigators and investigators new to diabetes research;
• Provide core services that leverage funding and unique expertise;
• Foster interdisciplinary collaborations, especially in the emerging areas of research, to catalyze new ideas and scientific approaches;
• Promote the translation of scientific discoveries from bench to bedside to community to improve public health.
2. Center Structure and Activities
The NIDDK Diabetes Research Centers are part of an integrated program of research support designed to enhance multidisciplinary cutting-edge research in diabetes and in related areas of endocrinology and metabolism. Diabetes Research Centers are intended to improve the efficiency and collaborative nature of diabetes research by providing shared access to specialized technical resources and expertise. In addition, Centers enhance translational research by providing a framework for fostering synergy between basic scientists and clinical investigators, with the goal of promoting rapid progress toward a treatment or cure for diabetes and its complications. Diabetes Research Centers support three primary research-related activities: (1) Research Core Services that provide resources to enhance the efficiency, productivity, and multidisciplinary nature of research in designated topic areas; (2) a Pilot and Feasibility Program designed to foster the development of new investigators and to provide seed-support for innovative high-risk projects; and (3) an Enrichment Program to promote interdisciplinary interaction and training of investigators in areas of NIDDK interest.
Institution and Research Base
A Diabetes Research Center must be an identifiable unit within a single institution such as a university medical center, or within a consortium of cooperating institutions. In either case, Diabetes Center applications must be associated with an existing program of excellence in biomedical research in diabetes and in related areas of metabolism and endocrinology. Program excellence is measured through a consistent and outstanding record of productivity and peer-reviewed research funding in diabetes and related research areas. A high level of integration and close collaboration among Center personnel from diverse scientific disciplines is an important feature of a successful Diabetes Research Center. Accordingly, the applicant should clearly state considerations for Center membership with specific reference to the potential of members to form interactive, collaborative and synergistic relationships. Center applicants should identify one or more central themes or focus areas that link Center investigators and their research programs.
Diabetes research often requires the use of specialized technologies and resources to support a cohesive research effort. The goal of the Diabetes Research Center program is to make state-of-the art technologies and resources readily accessible to a broad spectrum of investigators who are pursuing studies in relevant topic areas.
Diabetes Research Center applications must include an administrative core that will be responsible for allocation and oversight of Center resources. The Administrative core will also be responsible for planning an enrichment program and for implementing a process for solicitation, review and selection of projects for the Pilot and Feasibility Program within the Center. In addition, all Diabetes Research Centers will be required to maintain a Center website, with the administrative core taking primary responsibility for its curation and oversight, as well as for ensuring proper and seamless integration of the Center website with the NIDDK Center program website. The Core Center Director should provide at least 1.2 person months (calendar year) effort on the Administrative Core and a total of 2.4 person months (calendar year) effort distributed among the Administrative and other components of the Center. One or more Associate Directors should be named who will be involved in the administrative, scientific, or training efforts of the Center and who will serve as Acting Center Director in the absence of the Director. A process must be in place that would be used to recommend a successor to the Director, if needed. An administrative assistant may also be proposed.
Biomedical Resource Cores
Diabetes Research Centers are designed around research cores that provide shared, specialized technical resources and/or expertise that enhance the efficiency, productivity, and multidisciplinary nature of research performed by Center-affiliated investigators. In a Diabetes Research Center, cores are intended to facilitate basic, clinical and translational research in diabetes, endocrinology and metabolic diseases in order to accomplish the stated goals of the individual Center and of the NIDDK Centers program.
Each research core should provide state-of-the art services to multiple funded research projects. A Center may support research at a single or set of cooperating institutions through an Institutional Core. In addition, Diabetes Center applicants may propose to share core services or functions with other Centers in the Diabetes Center program in order to expand, enhance, or increase the cost-effectiveness of research activities at the Center institution. Examples of biomedical cores that would be considered responsive to this Request for Applications include, but are not limited to:
These cores are not listed in any particular order, nor do they represent a comprehensive list of possibilities. In responding to this FOA, applicants are encouraged to propose cores that address specific objectives based on the unique requirements of investigators at the applicant institutions. Particular emphasis should be placed on services that support and foster interdisciplinary, integrated and translational approaches to research in Diabetes Center topic areas. Preference will be given to core support services that are not readily available or cost-effective when supplied from commercial sources, and techniques or technologies that may be technically challenging or require specialized expertise, equipment or infrastructure. Proposed Diabetes Center research cores may be an institutional shared research core. In such cases, the research core support provided by the Diabetes Center should be proportional to the use of the institutional research core by Diabetes Research Center members. As with other research cores, details about access and prioritization of center members to the shared research core(s) should be provided. Moreover, the applicant should document that the Diabetes Center will be in a position to have some input to, and oversight of, the shared institutional core with respect to its management, planning for future changes and improvements, etc.
The need for core support from the Diabetes Research Center must be well justified, with clear documentation of a broad user base of NIDDK-funded investigators pursuing research activities in Center topic areas, as well as diabetes investigators with other sources of peer-reviewed support. Participants in the Diabetes Center program are encouraged to become fully integrated into, and synergistic with, other NIDDK- and NIH-funded Core Centers within their institutional setting. This includes the clinical research homes being established by the Clinical and Translational Science Awards supported by the National Institutes of Health (http://www.ctsaweb.org/) and other related NIH roadmap activities, and any related NIDDK-funded Center programs such as the Nutrition Obesity Research Center (NORC) Program http://www3.niddk.nih.gov/centers/norc.shtml) and the Centers for Diabetes Translation Research (CDTR; http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-10-009.html). Applicants should provide information on other programs supporting related resources at their institution and describe the nature of synergy and integration between the Diabetes Research Center and these other activities. Applicants must also clearly describe how duplication or redundancies of effort, services and resources will be avoided.
Pilot and Feasibility Program
The Diabetes Research Center Pilot and Feasibility (P&F) program provides seed support for new and innovative research projects directed at basic biomedical, clinical and translational research questions relevant to diabetes and its complications. Typically at least 20-25% of the Center direct costs, exclusive of equipment, should be for support of P&F projects.
Funding and Duration of Support: It is anticipated that up to $50,000 in direct costs per year for up to two years will be provided for the majority of approved P&F projects. However, a limited number of proposals may be selected for support as enhanced P&F awards with prior NIDDK approval. Enhanced P&F awards require prior approval from NIDDK and will be selected from worthy proposals in the following three project categories: clinical and translational research awards, clinical and basic research innovative partnership awards, or technology research and development awards. These enhanced awards may be funded at up to $100,000 direct costs per year and for up to 2 years. Efforts to increase the number of P&F awards and availability of funds for the program through the use of program income or alternative funding sources are particularly encouraged.
Eligibility: The P&F program is particularly directed at new investigators and established investigators new to diabetes research. Established diabetes investigators pursuing high impact/high risk projects or projects that are a significant departure from their usual work are also eligible for support under the Diabetes Research Center P&F program. P&F programs may also be structured to provide support for establishing interdisciplinary collaborations and to help forge new partnerships between basic scientists and clinical researchers. While the distribution of P&F funds to be used in each award category is ultimately at the discretion of the Center P&F committee, it is expected that the Center P&F program will, where possible, place particular emphasis on funding innovative clinical and translational research projects.
Named New Investigator [optional]
Each Diabetes Research Center may provide salary support for a P&F project recipient whom they designate a Named New Investigator. Support for this individual is generally for 2 years, and cannot exceed $90,000 per year, additional appropriate fringe benefits, and 9.0 to 12.0 calendar months effort. These funds are included in the Administrative Core budget, and the initial Named New Investigator should be clearly identified in the application. The individual selected should be a New Investigator who meets the P&F project eligibility criterion 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 program director.
The Diabetes Research Center enrichment program should be designed to advance translational research in diabetes, endocrinology and metabolism and promote scientific exchange among investigators with research interests in these topic areas, and to enhance interactions between diabetes researchers and investigators from other fields with relevant expertise. The enrichment program can support activities such as seminars, guest speakers, visiting scientists, consultants, and workshops. Applicants should describe any training opportunities afforded by the Diabetes Research Center for Center participants, and document ways the Center may facilitate, enhance or foster the institutional training environment. Specifically, Center applicants should provide information on related NIDDK T32 training programs at the Center institution(s), and describe how the Diabetes Center will help to integrate, facilitate and enhance activities of T32-supported trainees. A letter from the PI of any related NIDDK-funded T32 at the Center institution should be included that acknowledges and details how the PI of the T32 intends to promote cohesive interactions between the two programs.
Training postdoctoral fellows to conduct research in diabetes is an associated activity of a Diabetes Research Center. While stipends for fellows cannot be funded from the Center, the establishment of a Center should provide an enhanced environment for research training. Just as in the case of funding for individual research projects, funding for fellowships should be sought from NIH NRSA institutional training grants (e.g. T32, T35) and individual fellowships (e.g. F30, F32), and other sources such as private foundations, and commercial companies.
Additional Opportunities for Resource Cores (opportunities to exceed the $1M direct costs cap, but not to exceed $1.25M in direct costs)
The principal goal of the opportunities listed below is to provide NIDDK Diabetes Center research core services (and pilot and feasibility grant opportunities) to diabetes researchers at institutions that are not currently served by an NIDDK Diabetes Research Center.
1) To broaden the scope and reach of current research core services, a Center may propose to serve a wider scientific community on a geographic or national level through the establishment of a Regional/National Shared Resource Core that is located at a different institution. Such a Regional/National Core may not be established with an affiliated hospital of the applicant organization; such an arrangement would be considered an institutional, rather than a regional/national, core for the purposes of this FOA. If the Center is primarily located at an affiliated hospital, core(s) based at another affiliated hospital of the same academic institution will not be considered Regional/National Shared Resource Cores. With a regional or national core located at a different institution, the Center will service a specific research base that is expanded beyond investigators at the academic institution and/or affiliated hospitals where the Center is primarily located. Support for the expansion of the Center P&F program to investigators at the institution where the Regional/National Shared Resource Core is located may also be requested (see below).
2) A Diabetes Research Center Core may serve a wider scientific community on a geographic or national level through the establishment of a Regional/National Shared Resource Core that is located at the applicant institution or an affiliated hospital. Such a Regional/National Shared Resource Core should provide a plan for expanding core services to investigators outside of the parent academic institution and its affiliated hospitals. Applicants should document that there is sufficient demand by the wider scientific community for the expansion (or establishment) of the proposed core services. The research base in diabetes at the institution(s) that would use the regional core(s) should also be documented. Plans for prioritization of research core services, as well as training to the broader research community, should be provided. Support for the expansion of the Center P&F program to the partnering institution(s) may also be requested (see below).
3) To broaden the scope and reach of the Diabetes Research Center P&F program, a Center may propose to serve a wider scientific community by expanding the Diabetes Center P&F program to a different institution(s). Expansion of the P&F program to an affiliated institution/hospital is encouraged, but will not be considered a Regional/National program for purposes of expanding the allowable requested funds. In general, NIDDK currently expects Diabetes Research Centers to allow investigators at affiliated hospitals or institutions to participate in the Center P&F program. Applicants may request funds to expand their P&F program to researchers at non-Diabetes Research Center institutions, and the applicant should provide details on how F&A costs for P&F grants will be handled with the partnering institution(s).
Subcontracts (subcontracts for this funding opportunity have no direct costs cap)
Diabetes Research Centers may propose partnerships that establish research cores and/or P&F programs at institutions of higher education (i.e., rural institutions, historically black colleges and universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs) and Hispanic-serving Institutions (HSIs) and Alaska Native and Native Hawaiian Serving Institutions), or other agencies that focus on underserved or health disparity populations. The primary goal of such partnerships is to foster scientific collaborations and to provide access to the Diabetes Research Center infrastructure to investigators at these institutions or organizations in order to foster health disparities research in populations disproportionately affected by diabetes. All funds exceeding the cap proposed for this purpose must be awarded to the institution that serves underserved or health disparity populations. Funding for activities supporting the collaboration at the Diabetes Center institution must be included with the Diabetes Research Center cap.
Cooperation, Coordination and Integration: applicants from institutions with an NIH Clinical and Translational Science Award program (http://www.ctsaweb.org/) are strongly encouraged to utilize the CTSA as a resource for enhancing clinical research programs within the Diabetes Research Center. In such cases, appropriate letters of support from the CTSA program director or principal investigator should be included with the application detailing plans for appropriate integration and synergy of the Diabetes Research Center and CTSA activities. In addition, applicants should address the potential for integration, harmonization, and enhancement of Diabetes Research Center activities through cooperation with other NIH-supported core facilities at the applicant institution. Other NIH-supported Centers and associated cores at the institution should be identified, and assurances provided that overlap or redundancy in core services will be avoided unless expressly required to fulfill the mission of the Diabetes Research Center.
The Diabetes Research Center must provide support for enrichment activities to foster multidisciplinary approaches to diabetes research and to attract new investigators or investigators with relevant expertise to diabetes research. While many of these activities occur at the grantee institution, applicants are encouraged to suggest coordinated efforts, such as educational activities, that might operate on a regional or national level and involve multiple Diabetes Research Centers. The application should include a statement regarding willingness to participate in such activities.
The proposed budget should include travel for the Program Director/Principal Investigator (PD/PI) and Associate Center Director, or other key personnel, to attend an annual Diabetes Research Centers meeting. The application should include a statement of willingness to attend this annual meeting of Diabetes Research Center Directors.
Core access and Cost Recovery: core resources must precisely define issues regarding access to core services, including investigator eligibility requirements for services, and policies and procedures for prioritization of services when demand exceeds capacity. Financial considerations such as calculations that justify investment of funds in core services (e.g. comparative costs of other sources of proposed core services) and policies for cost recovery from investigators for use of services should also be included.
Center Evolution: Centers must document policies and procedures for ensuring continuing evolution of core services in response to changing needs. New technologies or services might appear that should be supported, existing technologies might become less important, or economic changes might obviate the need for core services, such as the availability of cost-effective commercial services or core services provided by the research institution. Cores should address the issue of allocation of resources to development of new technologies versus provision of services with existing technologies. In addition, cores must have well-defined policies to insure that intellectual property is identified and appropriately protected, but that intellectual property issues do not impede sharing of resources.
Application Types Allowed
The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards
The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
The NIDDK plans to commit $5.0M for 3 awards in FY2012.
Application budgets are limited to $1.0M per year in direct costs unless the applicant organization proposes to provide regional or national core services as described in the Funding Opportunity Announcement. Applications proposing a Regional/National Shared Research Resource Core are limited to $1.25M per year in direct costs. These budget limits are exclusive of: (a) first year equipment costs, (b) direct costs on subcontracts, health departments, community health centers or other agencies that focus on underserved or health disparity populations for the purpose of establishing collaborations and providing access to the research infrastructure to investigators at these institutions to foster health disparities research in populations disproportionately affected by diabetes, and (c) F&A costs on consortium and subcontract arrangements. It is anticipated that the award budget will be directly correlated to the breadth, quality and relevance to diabetes and related areas of the research base being served by the Center.
Award Project Period
The project period for an application submitted in response to this funding opportunity may not exceed five years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions:
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For profit Organizations
Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are not allowed.
Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.
Because a Diabetes Research Center has a large and complex administrative structure, the Project Director/Principal Investigator must have strong leadership abilities and demonstrated proficiency in managing large, multi-component projects.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Only one application per institution is allowed.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.
Research Base: Successful Diabetes Research Center applications require an existing program of excellence in biomedical research in the area of diabetes, its complications, and in related research in endocrine and metabolic diseases. To justify Center support, the Diabetes Research Center must serve a large research base of NIDDK-funded investigators pursuing research activities in Center topic areas, as well as diabetes investigators with other sources of peer-reviewed support. Suggestions for describing and presenting this research base in the application are included in the Administrative Guidelines for NIDDK Diabetes Research Centers (http://www.niddk.nih.gov/fund/other/guidelines.pdf).
Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.
It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Number and title of this funding opportunity
The letter of intent should be sent to:
Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Applications must be prepared using the PHS 398 research
grant application forms and instructions for preparing a research grant
application. Submit a signed, typewritten original of the application,
including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
At the time of submission, two additional paper copies of
the application and all copies of the appendix files must be sent to:
Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Rm. 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
All page limitations described in the PHS398 Application Guide must be followed, with the following exceptions or additional requirements:
All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:
Supplemental Instructions for the Preparation of Diabetes Research Center Applications
Content and order of information to be provided should be presented in the form and format as described in the Diabetes Center administrative guidelines (http://www.niddk.nih.gov/fund/other/guidelines.pdf) with adjustments as indicated in this FOA. An overview of the structure of a responsive Center application is provided below. Every effort should be made to provide information in tabular or chart form where indicated in the guidelines to facilitate application preparation and review. Failure to comply with these instructions may result in return of the application without review.
SECTION 1: CENTER OVERVIEW
1. Detailed Budget for Initial Budget Period (398- Form Page 4)
2. Budget for Entire Proposed Project Period (398- Form Page 5);
3. Consolidated budget for first year of requested support (See Guidelines Illustration I; budgets for each individual Core should immediately precede the narrative for each Core)
4. Distribution of Professional Effort (see Guidelines Illustration II)
Biographical sketches for principal investigators on proposed P&F projects should be included within the P&F program section.
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.
SECTION 2: ADMINISTRATIVE COMPONENT (Research Strategy is limited to 6 pages)
SECTION 3: BIOMEDICAL RESEARCH COMPONENT
New applications: Emphasize the anticipated impact of the establishment of a Diabetes Research Center on the research base. Include an indication of how the establishment of a Diabetes Research Center will provide added dimensions and new opportunities for diabetes and related research, along with increased cooperation, communication, and collaboration among investigators.
For Renewals: Progress including description of significant findings and new participants.
Document collaborative efforts using a format such as Guidelines Illustration IV to aid in the review process.
SECTION 4: REGIONAL/NATIONAL SHARED RESOURCE CORES & EXPANSION OF THE PILOT & FEASIBILITY PROGRAM [OPTIONAL]
SECTION 5: SHARED RESEARCH CORES AND/OR EXPANSION OF THE PILOT & FEASIBILITY PROGRAM TO SUPPORT UNDERSERVED OR HEALTH DISPARITY POPULATIONS [OPTIONAL]
SECTION 6: CENTER-RELATED INFORMATION (suggested Illustrations only)
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398 Application Guide.
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.
Part I. Overview Information contains information about Key Dates.
Information on the process of receipt and determining if
your application is considered “on-time” is described in detail in the PHS398
Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NIDDK, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
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).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a Center that by its nature is not innovative may be essential to advance a field.
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?
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?
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?
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?
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?
As applicable for the Center proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.
The following additional review criteria apply to all new and renewal Diabetes Research Center applications. Foremost, does the research base to be supported by the Center show evidence of a strong and consistent record of productivity and peer-reviewed funding in Center-related research areas? Is the requested budget directly correlated to the breadth, quality and relevance to diabetes and related areas of the research base being served by the Center? Do the proposed cores fill a need present in the diabetes research community, and will they provide services that would otherwise be unavailable, or be more cost-effective to conduct centrally? Is the necessary technical and analytical expertise available? Does the application demonstrate ability to monitor use and utility of the cores, and provide approaches to ensure continuing development and evolution of services as needs of the community change? Do the existing Centers show clear evidence of successful implementation of a recharge structure to support expanded and/or evolving Center activities? Do the new proposals document a clear intent to implement a recharge structure to support expanded and/or evolving Center activities?
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed Center involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Renewals, the committee will consider the progress made in the last funding period.
Pilot & Feasibility Program:
As applicable for the Center proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
Applications from Foreign Organizations
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by NIDDK (assignments will be shown in the eRA Commons), in accordance with NIH peer
review policy and procedures, using the stated review
As part of the scientific peer review, all applications:
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA . Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. . More information is provided at Award Conditions and Information for NIH Grants.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
eRA Commons Help Desk(Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
James F. Hyde, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases(NIDDK)
Francisco O. Calvo, Ph.D.
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Senior Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases(NIDDK)
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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and Human Services (HHS)
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