National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
U54 Specialized Center- Cooperative Agreements
Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
This Notice of Funding Opportunity (NOFO) requests applications for Polycystic Kidney Disease (PKD) Core Centers that are designed to support and enhance the national research effort in PKD through developing and broadly sharing innovative research tools and resources (e.g., reagents, data, services, and expertise that would be difficult or impractical to support by individual research project grants or within individual laboratories. The PKD Core Centers are expected to work collaboratively with the Central Coordinating Site as part of a national PKD Research Resource Consortium (PKD RRC).
This NOFO is open to new applications and renewals.
This Notice of Fuding Opportunity (NOFO) requires a Plan for Enhancing Diverse Perspectives (PEDP).
October 14, 2024
Application Due Dates | Review and Award Cycles | ||||
---|---|---|---|---|---|
New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
November 14, 2024 | November 14, 2024 | Not Applicable | March 2025 | May 2025 | July 2025 |
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
Background
Understanding and ameliorating autosomal dominant PKD and autosomal recessive PKD are central to the mission of NIDDK. The clinical course of these diseases is highly variable: some patients develop only a modest number of renal cysts, while others develop a massive number of renal cysts and renal failure at an early age. The diseases have extra-renal manifestations, including liver and systemic vasculature, with variable penetrance. Despite important advances in elucidating causative genetic defects, many challenges remain in determining the mechanisms of cyst development and enlargement, and the progressive loss of renal function in PKD that could potentially be targeted for therapeutic interventions.
In 2020, a national PKD Research Resource Consortium (PKD RRC, https://www.pkd-rrc.org) was established with NIDDK funding with the goal of creating a framework for collaboration that develops and broadly shares research resources, core services and expertise to support innovation in research related to PKD. At present the PKD RRC consists of three national Research and Translation Core Centers and a Central Coordinating Site that collaborate to offer research resources, including cell and animal models, antibodies, and human PKD biological samples to the broader research community upon request. The PKD RRC has also developed a multi-center, longitudinal observational cohort of adults and children with PKD with linked biospecimens. In addition, the PKD RRC has developed a PKD Genome browser which serves as a repository of variants across the exomes and targeted panel sequencing of individuals with PKD. These resources are available to the broader research community upon request. Through this NOFO, NIDDK aims to continue to support the development and sharing of existing resources while encouraging innovation of new and valuable resources to the PKD research community.
Scientific discovery is often catalyzed by technological innovations, and it can also be stifled by lack of appropriate research resources. The PKD Core Centers are designed to support and enhance the national research effort in PKD through development and broad sharing of innovative research tools and resources including reagents, data, services, expertise that would be difficult or impractical to support by individual research project grants or within individual laboratories.
The present NOFO is issued to support the PKD Core Centers. A companion NOFO (RFA-DK-25-015) is issued to support a Central Coordinating Site to provide centralized administrative support to the PKD Core Centers and are expected to work collaboratively with the Central Coordinating Site as part of the PKD RRC.
Objectives and Scope
The overarching goal of the PKD RRC is to support the entire PKD research community by creating a framework for collaboration that develops and broadly shares research resources, core services, and expertise to support innovation in research related to PKD. In addition, the PKD RRC will provide Pilot and Feasibility funding for projects targeting discovery (hypothesis-generating) and innovative research in areas of science of interest to the PKD research community.
All PKD Core Centers within the PKD RRC are expected to work collaboratively to develop and share research resources such as reagents, technologies, tools, animal and cell models, biological samples, tissues, software, data, etc.) and other research services and expertise that would be difficult or impractical to develop in individual labs. Being a current member of the PKD RRC is not an expectation for applicants; this NOFO invites investigators with existing shareable resources and the potential to develop novel resources to apply.
The PKD Core Centers will be awarded to institutions with a strong track record of developing and sharing research resources and that demonstrate a plan to engage new and established investigators including those from outside the traditional areas of PKD research. PKD Core Centers may be located at a single institution or may span multiple institutions with complementary and diverse scientific perspectives and expertise.
The expected outcomes from the PKD RRC will be:
NIDDK recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust. NIDDK recognizes that many investigators share these values and endeavor to incorporate diverse perspectives into their projects and change the culture in science.
Project Organization
The PKD RRC will consist of approximately four PKD Core Centers and a single Central Coordinating Site. PKD Core Centers will be comprised of an Administrative Core and 1-3 Biomedical Resource Cores each centered around a theme (e.g., experimental models, clinical data, biological reagents, etc.). In addition, applicants may propose an optional Resource Development Core with the capacity and expertise to develop novel research resources not already available through the proposed Biomedical Resource Cores. These novel resources will be developed through a coordinated response by the PKD RRC to the evolving needs of the research community rather than the preferences or capacity of any single PKD Core Center. It is expected that all resources developed by the PKD Core Center will be made available as soon as quality control procedures have been completed so they can be rapidly shared with the broader research community.
PKD Core Centers must be an identifiable organizational unit within a university or a defined consortium of cooperating institutions. The Central Coordinating Site will coordinate communications between the PKD RRC and the greater research community, organize and facilitate the education and outreach activities of the PKD RRC, and support and administer the Pilot and Feasibility Program. Applications for the Central Coordinating Site are solicited through a separate, companion NOFO (RFA-DK-25-015). Principal Investigators with appropriate expertise may apply to both RFA-DK-25-015 and RFA-DK-25-016. An Associate Director may be included if scientifically justified. Potential applicants are encouraged to contact the Program Official(s) named in Section VII to discuss their potential application(s).
The coordinated efforts of the PKD Core Centers and the Central Coordinating Site will be overseen by PKD RRC Steering Committee composed of PKD Core Centers Director(s), the Central Coordinating Site Director(s), and NIDDK program staff. The PKD Core Centers will meet at minimum once yearly for a face-to-face Steering Committee meeting in the Bethesda, MD area that will be coordinated by the Central Coordinating Site. The first meeting will be held on September 29, 2025, and all PKD Core Center Director(s), including the Biomedical Resource Core Director(s), Resource Development Core Director(s), and the Central Coordinating Site Director(s) are required to attend. The NIDDK may engage an External Experts Panel to advise the Institute on the progress of the PKD RRC.
Administrative Core
The Administrative Core will serve as the primary managerial component for all activities of the PKD Core Centers, including communication with the Central Coordinating Site. It will be responsible for the management of resources within the PKD Core Centers to ensure success in the integrated activities of the PKD Core Centers and collaborate with the Central Coordinating Site in meeting the goals of the PKD RRC.
Key responsibilities of the Administrative Core are to:
Biomedical Resource Core
The Biomedical Resource Cores are defined as unique shared resources that provide specialized and essential services, techniques, or instrumentation to PKD RRC investigators and the outside research community, allowing studies to be conducted efficiently and effectively. It is expected that the resources generated by a Biomedical Resource Core will be regularly improved or refined during the PKD Core Centers award period. The Biomedical Resource Cores must demonstrate utility as a national resource for supporting PKD research within and outside the PKD RRC. Biomedical Research Cores that engage investigators from outside the PKD research community are strongly encouraged.
Biomedical Resource Core resources may include some of the following but are not limited to:
Resource Development Core
The overall goal of the (optional) Resource Development Core is to establish and nurture a dynamic incubator space that promotes innovation and ensures robust validation of new resources. If proposed, a Resource Development Core is expected to demonstrate innovative strategies and capabilities to develop novel tools, models, and technologies. At the time of application, these novel resources are not expected to have been developed by the PD(s)/PI(s). Instead, these resources will be developed through active collaboration with investigators from diverse scientific fields and other members of the PKD RRC. The PKD RRC Steering Committee will prioritize and approve the development of new resources in anticipation of future needs and based upon input from the wider PKD research community.
Other Considerations
The National Center for Advancing Translational Sciences (NCATS) currently supports a national network of medical research institutions, i.e. hubs, via Clinical and Translational Science Awards (CTSA), which provide services and resources to enhance clinical research (https://ncats.nih.gov/ctsa). The Biomedical Resource Cores and the Resource Development Core are encouraged to collaborate with CTSAs and other NIDDK-supported consortia (e.g. George M. O'Brien Kidney National Resource Centers) but should not overlap effort or services.
NIDDK recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust. NIDDK recognizes that many investigators share these values and endeavor to incorporate diverse perspectives into their projects and change the culture in science.
See Section VIII. Other Information for award authorities and regulations.
Plan for Enhancing Diverse Perspectives (PEDP)
The NIH recognizes that teams comprised of investigators with diverse perspectives working together and capitalizing on innovative ideas and distinct viewpoints outperform homogeneous teams. There are many benefits that flow from a scientific workforce rich with diverse perspectives, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.
To support the best science, the NIH encourages inclusivity in research guided by the consideration of diverse perspectives. Broadly, diverse perspectives can include but are not limited to the educational background and scientific expertise of the people who perform the research; the populations who participate as human subjects in research studies; and the places where research is done.
This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Assessment of applications containing a PEDP are based on the scientific and technical merit of the proposed project. Consistent with federal law, the race, ethnicity, or sex of a researcher, award participant, or trainee will not be considered during the application review process or when making funding decisions. Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.
The PEDP will be submitted as Other Project Information as an attachment (see Section IV). Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance materials.
Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.
The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO.
Not Allowed: Only accepting applications that do not propose clinical trials.
NIDDK intends to commit $3.44M in FY 2025 to fund approximately four PKD Core Center Awards.
Application budgets are anticipated to be approximately $600,000 in direct costs per year. Application budgets should reflect the actual needs of the proposed work.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
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
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019. See also, Notice of NIH's Interest in Diversity, NOT-OD-20-031.
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 How to Apply - Application Guide.
Eligible Individuals (Program Director/Principal Investigator)
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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.
PKD Core Center Director
The PKD Core Center Director must be an investigator with demonstrated research expertise who can provide effective administrative and scientific leadership. The PKD Core Center Director is expected to work closely with the Central Coordinating Site, other PKD Core Centers, and NIDDK, including through participation on the PKD RRC Steering Committee, regular teleconference calls, and at relevant meetings and workshops supporting the PKD RRC goals. An Associate Director may be named if scientific justification is provided. The PKD Core Center Director will be responsible for scientific and administrative leadership. This includes, but is not limited to, the following duties:
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.
Number of Applications
Only one application per institution (normally identified by having a unique entity identifier (UEI) or NIH IPF number) is allowed.
Only one application per institution (normally identified by having a unique entity identifier (UEI) or NIH IPF number) is allowed.
The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.
It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - 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:
The letter of intent should be sent to:
John F. Connaughton, Ph.D.
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7797
Email: NIDDKletterofintent@mail.nih.gov
All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.
Component | Component Type for Submission | Page Limit | Required/Optional | Minimum | Maximum |
---|---|---|---|---|---|
Overall | Overall | 12 | Required | 1 | 1 |
Administrative Core | Admin Core | 6 | Required | 1 | 1 |
Biomedical Research Core | Core | 6 | Required | 1 | 3 |
Resource Development Core | Core | 6 | Optional | 0 | 1 |
The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.
The application should consist of the following components:
When preparing the application, use Component Type ‘Overall.
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.
Complete entire form.
Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.
Other Attachments:
Statement of Willingness: Please title this attachment "Willingness to Participate" and provide a statement indicating a willingness to:
Follow standard instructions.
Plan for Enhancing Diverse Perspectives (PEDP)
Examples of items that advance inclusivity in research and may be appropriate for a PEDP can include, but are not limited to:
Examples of items that are not appropriate in a PEDP include, but are not limited to:
For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see PEDP guidance materials.
Enter primary site only.
A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.
Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.
A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.
The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.
Budget must include travel costs for the Project Director/Principal Investigator (PD/PI), Biomedical Research Core Director(s), Resource Development Core Director (if included) and an Associate Director (if included) and at least one other member of the project to attend the annual, in-person PKD RRC Steering Committee meeting.
PEDP implementation costs:
Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7): https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm.
A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.
Specific Aims: State the overall goals of the PKD Core Center and their significance to PKD research. Summarize the general approach, the types and purposes of research resources and service cores to be generated, their expected value and the impact of the resources and outcomes to achieving the goals of the PKD RRC as outlined in Section I. Notice of Funding Opportunity Description.
Research Strategy:
Progress Report for Renewal Applications:
Note that the Progress Report falls within the Research Strategy and is therefore included in the page limits for the Research Strategy.
For renewal applications, provide a Progress Report. Provide the beginning and ending dates for the period covered since the last competitive review. In the Progress Report, you should:
Letters of Support:
The Letters of Support attachment should begin with a table of letter authors, their institutions, and the type of each letter (institutional commitment or resources; collaboration or role in the project). Letters of support should be provided to demonstrate institutional commitments, collaboration, and access to key resources, if such plans are listed in application. The applicants should not include letters of support from any internal or external core users. Letters of support for the overall PKD Core Center should be included with the Overall Component. For program activities to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional official, must be submitted with the application. In addition, applicants should address the potential for integration, harmonization, and enhancement of PKD Core Center activities through cooperation with other NIH-supported Core facilities at the applicant institution. Other NIH-supported cores at the institution(s) 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 PKD Core Center.
Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.
Other Plan(s):
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply - Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
When preparing your application, use Component Type ‘Admin Core.
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the ‘Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Budget forms appropriate for the specific component will be included in the application package.
The overall PKD Core Center PD/PI will serve as the Director of the Administrative Core and will oversee all scientific and administrative activities of the PKD Core Center. Support for the PKD Core Center PD/PI should be provided within the budget of the Administrative Core. The minimum level of effort for the PKD Core Center PD/PI (as Administrative Core Director) is 1.2 person months (10%). An Administrative Core Associate Director may be named as well, if adequately justified, but the total, combined Administrative Core Directorship efforts may not exceed 1.8 person months (15%). The Administrative Core may also include an administrative assistant(s), if justified.
The Administrative Core budget must include at least $25,000 of direct costs every year specifically devoted to supporting a summer student enrichment program.
The Administrative Core Budget will support the activities outlined in Section I, including travel of PKD Core Center investigators to learn new laboratory techniques, develop new collaborations, or engage in scientific information exchange. The Administrative Core budget must include funds to support travel of the PKD Core Center PI, Biomedical Resource Core Director(s), Resource Development Core Director (if included in application) and key personnel, to attend the annual face-to-face Steering Committee meetings of the PKD RRC. The first meeting will be held on September 29, 2025 in Bethesda, MD. The Administrative Core Budget should also include costs, if any, of implementing the PEDP.
Budget Justification: Describe the specific functions of all key personnel, consultants, collaborators, and support staff. For all years, explain and justify any unusual items such as major equipment or alterations and renovations. For years 2-5 of support requested, justify any significant increase or decrease in any category over the initial budget period. Identify such changes with asterisks against the appropriate amounts.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Specific Aims: Clearly state how the Administrative Core will set the overall direction of the PKD Core Center, ensure optimal utilization of PKD Core Center resources and work with the PKD Central Coordinating Site to promote collaboration within and across the PKD Core Centers.
Research Strategy: The role of the Administrative Core is to develop and maintain the vision and goals of the PKD Core Center; coordinate, manage, and integrate the PKD Core Center components and activities, which includes coordinating ongoing research between Biomedical Resource Core(s) and optional Resource Development Core; harmonizing with the other PKD Core Centers within the PKD RRC; and collaborating with NIDDK. In addition, the Administrative Core is responsible for carrying out the Summer Student Enrichment Program.
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.
When preparing your application, use Component Type ‘Biomedical Resource Core.
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the ‘Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
A Biomedical Resource Core Director should be named and is expected to contribute a minimum level of effort of 0.6 person months (5%). An Associate Director may also be named, if scientifically justified. The salary amount charged to the Biomedical Resource Core must be commensurate with the time spent on Core activities and is subject to institutional and NIH salary policies. A Biomedical Resource Core Director with requisite expertise may devote a greater effort to the core. Salary support for technicians and other core personnel are allowable in accordance with the volume and type of work in the core. Stipends (and tuition) for research trainees (e.g. graduate students, postdoctoral fellows) are not available through Biomedical Resource Cores.
Budget Justifications: Describe the specific functions of all Biomedical Resource Core key personnel, consultants, collaborators and support staff. For all years, explain and justify any unusual items such as major equipment or alterations and renovations. For years 2-5 of support requested, justify any significant increases or decreases in any category over the initial budget period. Identify such changes with asterisks against the appropriate amounts.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Specific Aims: Describe the major function, capability, and objectives of the Biomedical Resource Cores.
Research Strategy: Each Biomedical Resource Cores should be centered around a theme (e.g., experimental models, clinical data, biological reagents, etc.). A Biomedical Resource Core must function as a unique, shared resource that provides specialized and essential services, techniques, data, or instrumentation to the PKD Core Centers, to the PKD RRC and to the wider PKD research community. The capacity for the Biomedical Resource Cores to serve as a national resource for the larger PKD community should be described.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply- Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.
(Optional)
(When preparing your application use Component Type 'Resource Development Core'
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the ‘Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
A Resource Development Core Director should be named and is expected to contribute a minimum level of effort of 0.6 person months (5%). An Associate Director may also be named, if adequately justified. The salary amount charged to the Resource Development Core must be commensurate with the time spent on Core activities and is subject to institutional and NIH salary policies. A Resource Development Core Director with requisite expertise may devote a greater effort to the core. Salary support for technicians and other core personnel are allowable in accordance with the volume and type of work in the core. Stipends (and tuition) for research trainees (e.g. graduate students, postdoctoral fellows) are not available through Biomedical Research Cores. Half of the funds allocated for the Resource Development Core will be restricted at the time of award and will be released by NIDDK when plans for Resource Development are approved by the PKD RRC Steering Committee.
Budget Justifications: Describe the specific functions of all Resource Development Core key personnel, consultants, collaborators and support staff. For all years, explain and justify any unusual items such as major equipment or alterations and renovations. For years 2-5 of support requested, justify any significant increases or decreases in any category over the initial budget period. Identify such changes with asterisks against the appropriate amounts.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Specific Aims: Describe the goals, capability, and objectives of the Resource Development Core.
Research Strategy: The Directors of the PKD Core Center and of the Resource Development Core, in collaboration with the PKD RRC Steering Committee, will identify future resource needs through communication and broad input from the PKD research community. The Resource Development Core will develop new and enhanced research resources that will be vetted and validated within the PKD RRC and then shared broadly with the PKD research community.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply- Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.
See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIHs electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in How to Apply- Application Guide.
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 Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.
Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organizations profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.
See more tips for avoiding common errors.
Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Use of Common Data Elements in NIH-funded Research
Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.
Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.
Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.
Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular Funding Opportunity Announcement, note the following:
Reviewers will be asked to evaluate the following individual sections. The overall impact score is not the average for these components.
Center Director(s) (PD(s)/PI(s)), including leadership and commitment to the stated goals of the PKD RRC.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the PKD Core 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 PKD Core Center proposed). As part of the overall impact score, reviewers should consider and indicate how the Plan to Enhance Diverse Perspectives affects the scientific merit of the project.
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.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project 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?
Specific to this NOFO: Evaluate how this PKD Core Center will support the broader PKD research community. Evaluate the likelihood that the resources generated and shared by the Biomedical Resource Core(s) will promote new research opportunities and directions. If a Resource Development Core is proposed, evaluate the appropriateness of the proposed plan for establishing a dynamic incubator space that promotes innovation and ensures robust validation of new resources.
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?
Specific to this NOFO: Determine if appropriate multi- or interdisciplinary expertise is represented to achieve the goals of the PKD Core Center. Evaluate the expertise, experience, capabilities, and accomplishments of the key personnel in generating relevant research resources and working within and management of complex multi-institution projects, including consortia.
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?
Specific to this NOFO: Evaluate whether the techniques or methods represent novel approaches that have not previously been used in the PKD research field. Evaluate whether the resources being offered by the Cores are novel and not otherwise available to the broader PKD research community. If a proposed Biomedical Resource Core by its nature is not innovative, determine if it is essential to advance the field. If a Resource Development Core is proposed, evaluate the innovative strategies to bring tools, models, methods, and technologies to the development of new resources.
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:
1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Specific to this NOFO: Determine if the PKD Core Center will create opportunities for investigators new to PKD research. Evaluate the PKD Core Center plans to promote collaboration within the applicant institution and the larger research community. Determine if the responsibilities of all personnel and the lines of communication are clearly established. Evaluate the plan that describes how the resources will be made available to the other PKD Core Centers within the PKD RRC and to the wider PKD research community. Evaluate the plans for assessing the evolving needs of the PKD research community to decide what resources will be developed in the future. Evaluate the plans for internal quality control of shared resources, validation of new resources, and the plans for updating the resources. Evaluate the prioritization plan for developing new resources and services.
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?
Specific to this NOFO: Evaluate the institutional commitment to the PKD Core Center such as space, protected time, and/or financial support to determine if is conducive to the success of the Center. Determine if there a suitable environment for PKD Core Center interactions and cross-fertilization with scientists from other areas of expertise.
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Specific to this NOFO: The overall PKD Core Center will also be evaluated as an integrated research effort focused on the PKD research mission of the NIDDK. The relationship and contributions of each proposed Biomedical Resource Core(s) and Resource Development Core (if proposed) to the overall PKD Core Center goals will be evaluated and contribute to the overall impact score. This assessment will consider the following:
For research that involves human subjects but does not involve one of the 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 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 Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals 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.
Not Applicable.
Specific to this NOFO: Evaluate the usage of the resources the PKD Core Center provided to external users during the prior award period. Determine if the PKD Core Center demonstrated a commitment to quality control of shared resources, validation of new resources, and updating of available resources. Determine if the PKD Core Center continued to refine existing resources and develop novel resources during the prior award period.
Not Applicable.
Additional Review Considerations - Overall
As applicable for the project 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 score.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed PKD Research and Translation Core Center involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Not Applicable
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).
Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
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, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. 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:
Please note that reviewers will not consider race, ethnicity, age, or sex (including gender identity, sexual orientation or transgender status) of a researcher, award participant, or trainee, even in part, in providing critiques, scores, or funding recommendations. NIH will not consider such factors in making its funding decisions.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.
Prior to making an award, NIH reviews an applicants federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicants integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
After the peer review of the application is completed, the PD/PI will be able to access their Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.
A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipients business official.
In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk. For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.
Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. NIH may terminate awards under certain circumstances. See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the Recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the Recipients for the project as a whole, although specific tasks and activities may be shared among the Recipients and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The IC Project Scientist/Coordinator/Collaborators scientific-programmatic involvement (i.e., the NIH partner) will participate in discussions and decision-making regarding the development and sharing of resources, the planning of annual meetings, and the awarding of Pilot and Feasibility grants during the conduct of the activity. Staff involvement must reflect that the dominant role and prime responsibility for the activity reside with the Recipient(s) for the project as a whole, but not necessarily for each task.
The NIDDK will designate program staff, including a Program Official and a Grants Management Specialist to provide normal program stewardship and administrative oversight of the cooperative agreement. The Program Official and Grants Management Specialist will be named in the Notice of Grant Award (NOA).
An NIH IC Project Scientist will be substantially involved in this project above and beyond the normal stewardship of an NIH IC Program Official as follows:
1. Serve as the contact point for all facets of the scientific interaction with the recipient(s). As required for the coordination of activities and to expedite progress, NIDDK may designate additional NIDDK staff to provide advice to the recipient on specific scientific and/or analytic issues.
2. For multi-center studies, participate in the Steering Committee that oversees study conduct. The NIDDK Project Scientist will be a full participant and voting member of the Steering Committee and, if applicable, subcommittees.
3. Serve as a resource to study investigators with respect to other ongoing NIDDK activities that may be relevant to the study to facilitate compatibility with the NIDDK missions and avoid unnecessary duplication of effort.
4. Have substantial involvement assisting in the design and coordination of research activities for Recipients as elaborated below:
a. Assisting by providing advice in the management and technical performance of the investigations, coordinating required regulatory clearances for investigational agents used in the study, which are held by NIDDK. The NIDDK may reserve the right to cross file or independently file an Investigational New Drug Application or an Investigational Device Exemption form with the FDA.
b. The NIDDK Project Scientist or Project Coordinator may coordinate activities among recipients by assisting in the design, development, and coordination of a common research or clinical protocol and statistical evaluations of data; in the preparation of questionnaires and other data recording forms; and in the publication of results.
c. Reviewing procedures for assessing data quality and study performance monitoring.
d. The NIDDK Project Scientist or Project Coordinator may be co-authors on study publications. In general, to warrant co-authorship, NIDDK staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; (c) participation in analysis and interpretation of study results and (d) preparation and authorship of pertinent manuscripts.
The NIDDK Program Official identified in the Notice of Award will:
1. Interact with the Program Director(s)/Principal Investigator(s) on a regular basis to monitor study progress. Monitoring may include regular communications with the Program Director/Principal Investigator and staff, periodic site visits, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at Steering Committee, data safety and monitoring board, and related meetings. The NIDDK retains, as an option, periodic review of progress by researchers not involved with the study.
2. Review and approve protocols prior to implementation to ensure they are within the scope of peer review, for safety considerations, as required by federal regulations.
3. The NIDDK Program Official will monitor protocol progress, and may request that a protocol study be closed to accrual for reasons including: (a) accrual rate insufficient to complete study in a timely fashion; (b) accrual goals met early; (c) poor protocol performance; (d) participant safety and regulatory concerns; (e) study results that are already conclusive; (f) low likelihood of showing a benefit of the intervention (futility); and (g) emergence of new information that diminishes the scientific importance of the study question. The NIDDK will not permit further expenditures of NIDDK funds for a study after requesting closure except as specifically approved by the NIDDK.
4. Make recommendations for continued funding based on: a) overall study progress, including sufficient patient and/or data accrual; b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or c) maintenance of a high quality of research, which will allow pooling of data and comparisons across multiple cooperative agreement awards for common data elements.
5. Appoint an independent Data and Safety Monitoring Board (DSMB) as appropriate for Phase III clinical trials or other high-risk studies, or an Observational Study Monitoring Board (OSMB) for observational/epidemiologic studies; these Boards will review study progress, safety data, and interim results, as appropriate, and provide guidance to the NIDDK. The NIDDK Program Official or their Project Coordinator will serve as the Executive Secretary and/or NIDDK program representative on the DSMB/OSMB.
Areas of Joint Responsibility include:
PD/PI(s) and NIH staff will jointly participate in the discussions and the operations of committees, such as a Steering Committee and other central coordinating components in which there is substantial scientific-programmatic involvement.
Through the Recipient, Steering Committee and NIH staff, the study members will cooperatively develop and implement processes to submit information and data to the Central Coordinating Site, determine criteria and processes for quality control of information and data to be posted for the research community, refine scientific objectives, and implement research advances to facilitate the goals of the study, consistent with NIH policies and achieving the goals of the program as described in the NOFO.
Steering Committee
A Steering Committee organized by the study investigator(s) will be the main governing body of the study.
The Steering Committee has primary responsibility to design research activities, establish priorities, develop common protocols and manuals, questionnaires and other data recording forms, establish and maintain quality control among recipients, review progress, monitor patient accrual, coordinate and standardize data management, and cooperate on the publication of results. Major scientific decisions regarding the core data will be determined by the Steering Committee. The Steering Committee will document progress in written reports to the NIDDK Program Official and will provide periodic supplementary reports upon request.
The Steering Committee will be composed of all Program Director(s)/Principal Investigator(s), (including those of data coordinating/statistical centers, if any) and co-investigator(s) as deemed necessary, and the NIDDK Project Scientist. The final structure of the Steering Committee and voting procedures will be established at the first meeting. The NIDDK Project Scientist will have voting membership on the Steering Committee, and as appropriate, its subcommittees. The frequency of Steering Committee meetings will be dictated by a vote of the members of the Steering Committee. The NIDDK Program Official may serve as a non-voting member on the Steering Committee.
A Chairperson of the Steering Committee will be selected and voted on by the Steering Committee members. The Chairperson provides leadership to the Committee by conducting the Steering Committee meetings and by interacting closely with the recipients during protocol development and implementation. The NIDDK Project Scientist may not serve as Chairperson. The NIDDK program official will review the Committees selection for potential bias, conflicts of interest, or lack of required expertise. If the Program Official has concerns regarding selection of the Chairperson which are not satisfactorily resolved, the Program Official may withhold concurrence if approved by the Director, Division of Extramural Activities, NIDDK based on written justification. In cases where Program Official concurrence is withheld, the Steering Committee will be required to make another selection.
External Consultants
An independent panel of External Consultants may be established by the Steering Committee. The External Consultants may periodically review interim progress of the project(s) and provide reports to the Steering Committee. Members of the panel of External Consultants may be asked, on an ad hoc basis, to participate in the peer review of applications for new research initiatives that utilize special opportunity pool funds. The NIDDK Program Official will review the Committees selections for potential bias, conflicts of interest, or lack of required expertise. If the NIDDK Program Official has concerns regarding selection of one or more External Consultants which are not satisfactorily resolved, the NIDDK Program Official may withhold concurrence if approved by the Director of NIDDK Division of Extramural Activities based on written justification. In cases where NIDDK Program Official concurrence is withheld, the Steering Committee will be required to make another selection.
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual Recipient. This special dispute resolution procedure does not alter the Recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Christine Maric-Bilkan, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-435-0486
Email: christine.maric-bilkan@nih.gov
Susan R. Mendley, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-827-1861
Email: susan.mendley@nih.gov
Xiaodu Guo, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4719
Email: guox@niddk.nih.gov
Krystle Nicholson
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8860
Email: nicholsonk@niddk.nih.gov
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 2 CFR Part 200.