Part 1. Overview Information

This Notice of Fuding Opportunity (NOFO) requires a Plan for Enhancing Diverse Perspectives (PEDP).

Key Dates

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.

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.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

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:

• A broad-based effort to advance PKD research.
• Successful sharing of unique and relevant resources, data, tools, technologies, services, and expertise that address fundamental challenges in PKD research.
• A lowering of barriers to entry for new investigators and those who are from fields not traditionally involved in PKD research.
• Identification of emerging areas of science and development of appropriate resources to enable research into these novel areas of PKD research.
• Periodic evaluation of the usefulness of shared resources and emphasis/deemphasis as appropriate.
• A broadening of the PKD research workforce to include more diverse perspectives.
• Incorporation of PKD patient perspectives into the work of the PKD RRC.

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:

• Establish access to and monitor use of each Biomedical Resource Core and the Resource Development Core.
• Create mechanisms for internal monitoring and planning, including for PKD Core Centers budget and personnel considerations.
• Implement a Plan for Enhancing Diverse Perspectives (PEDP).
• Coordinate with the other PKD Core Centers and the Central Coordinating Site to solicit and incorporate PKD patient perspectives into the work of the PKD RRC.
• Establish and maintain internal communication and cooperation among all PKD Core Center investigators, the larger PKD RRC, the Central Coordinating Site, outside research community, and the NIDDK.
• Work with the Central Coordinating Site to execute Material Transfer Agreements (MTA) and Data Use Agreements (DUA) between the Central Coordinating Site, other PKD Core Centers and investigators outside the PKD RRC.
• Administer the Summer Student Enrichment Program with the purpose of exposing students to PKD research.
• Develop reports on PKD Core Centers activities and progress for external review.
• If applicable, identify fixed and variable costs and establish procedures for negotiation of third-party agreements or selection of subawards/subcontractors (i.e. clinical/research laboratories, biospecimen repositories, etc.) with involvement of NIDDK Technology Advancement Office, and develop processes to efficiently administer and manage same throughout the project.

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 Center’s 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:

• Development, standardization and distribution of animal models, antibodies, cells, and/or protocols.
• Development, beta-testing, and dissemination of specialty assays, methods, and services.
• Development of models for high throughput screening of promising new therapeutic targets for PKD.
• Development of models (including mathematical models) to identify novel pathways in the pathogenesis of PKD.
• Genomic analysis of PKD patients to elucidate causative or contributory mutations. A Biomedical Resource Core that collects or performs genomic analysis will make them available to the PKD Genome Browser that is hosted by the Central Coordinating Site, which is broadly shared with external users.
• Recruitment, retention and evaluation of PKD patients using novel and traditional methods of phenotyping; collection and sharing of de-identified participant clinical data, phenotyping protocols, biological samples and imaging through a unified, consortium-wide approach. A Biomedical Resource Core that includes the collection of patient-participant samples will share them, upon request, with qualified investigators within and outside of the PKD RRC. A Biomedical Resource Core that collects data and imaging will make them available to the PKD RRC clinical database which is broadly shared with external users to allow the study of the full range of disease phenotypes and outcomes.

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.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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.

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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:

• Maintaining the PKD RRC vision and ensuring the relevance of the PKD Core Center’s goals to NIDDK mission interests in PKD.
• Oversight of the Administrative Core, the Biomedical Research Core(s), and the Resource Development Core, if proposed.
• Ensuring productivity, internal communication and cooperation among PKD Core Center investigators, including performance of all personnel.
• Ensuring equitable access to PKD Core Center resources across the PKD RRC and the wider research community.
• Communicating with the larger PKD RRC, NIDDK Program Staff and the outside research community.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility

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.

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Letter of Intent

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 activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

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: [email protected]

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications

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:

• Overall: required
• Administrative Core: required
• Biomedical Resource Core(s): required
• Resource Development Core: optional
• Progress Report: for renewal applications only.

Overall Component

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.

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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:

• Work with NIDDK and the PKD RRC to participate in the initial and annual meetings thereafter during the course of the grant award;
• Cooperatively interact with NIDDK and the PKD RRC in support of the projects and activities;
• Actively seek input from NIDDK and the PKD RRC regarding resource or expertise needs that may arise during the performance of the project;
• Develop and execute Material Transfer Agreements and Data Use Agreements to permit sharing of biological specimens, molecules, cells, animals, genetic material, de-identified patient samples, de-identified patient data and imaging;
• Participate in regularly scheduled conference calls.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Plan for Enhancing Diverse Perspectives (PEDP)

• In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of actionable strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity.
• Applicants should align their proposed strategies for PEDP with the research strategy section, providing a holistic and integrated view of how enhancing diverse perspectives and inclusivity are buoyed throughout the application.
• The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured.
• The PEDP may be no more than 2 pages in length and should include:
  • Actionable strategies using defined approaches for the inclusion of diverse perspectives in the project;
  • Description of how the PEDP will advance the scientific and technical merit of the proposed project;
  • Anticipated timeline of proposed PEDP activities;
  • Evaluation methods for assessing the progress and success of PEDP activities.

Examples of items that advance inclusivity in research and may be appropriate for a PEDP can include, but are not limited to:

• Partnerships with different types of institutions and organizations (e.g., research-intensive; undergraduate-focused; HBCUs; emerging research institutions; community-based organizations).
• Project frameworks that enable communities and researchers to work collaboratively as equal partners in all phases of the research process.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as human subjects in clinical trials, including those from underrepresented backgrounds.
• Description of planned partnerships that may enhance geographic and regional diversity.
• Outreach and recruiting activities intended to diversify the pool of applicants for research training programs, such as outreach to prospective applicants from groups underrepresented in the biomedical sciences, for example, individuals from underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Plans to utilize the project infrastructure (i.e., research and structure) to enhance the research environment and support career-advancing opportunities for junior, early- and mid-career researchers.
• Transdisciplinary research projects and collaborations among researchers from fields beyond the biological sciences, such as physics, engineering, mathematics, computational biology, computer and data sciences, as well as bioethics.

Examples of items that are not appropriate in a PEDP include, but are not limited to:

• Selection or hiring of personnel for a research team based on their race, ethnicity, or sex.
• A training or mentorship program limited to certain researchers based on their race, ethnicity, or sex.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see PEDP guidance materials.

Project/Performance Site Locations (Overall)

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.

Research and Related Senior/Key Person Profile (Overall)

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.

Budget (Overall)

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.

PHS 398 Research Plan (Overall)

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:

• Describe the major themes, goals, and objectives of the PKD Core Center, including relevant background information. Summarize the individual components of the PKD Core Center, including the Administrative Core, Biomedical Resource Core(s), and Resource Development Core, (if such a core is proposed) and explain their importance, innovation, and contributions.  For a Biomedical Resource Core, describe how it is essential to advance the field.
• Describe how the Cores will interact collaboratively to achieve the goals and objectives of the PKD RRC as outlined in Section I. Outline the existing skills, resources, capacity, and technologies that will be available to the PKD Core Center. If a Resource Development Core is proposed, describe the special expertise, resources, and capabilities that will be drawn upon to develop and share innovative resources. Do not describe the specific resources to be developed as this will be decided by the PKD RRC Steering Committee throughout the course of the award Describe internal Quality Assurance/Quality Control plans for all resources provided by the PKD Core Centers.
• Describe how the PKD Core Center will create opportunities for investigators within and outside the PKD research field and promote collaborations leading to advances in PKD research. Describe how the PKD Core Center engage new and established investigators including those from outside the traditional areas of PKD research.
• Describe the overall scientific and administrative framework of the PKD Core Center. Include an organizational chart. Note research and/or administrative leadership of PKD Core Center personnel. Provide a leadership plan for oversight and operations of the overall PKD Core Center, including conflict resolution for Center personnel.
• Provide a brief description and rationale for any proposed collaborations or additional consultants. Include information on the support and commitment of the parent institution for the PKD Core Center, and the authority of the PD(s)/PI(s).  If any collaborations or linkages of resources or services (e.g. CTSA, George M. O'Brien Kidney National Resource Centers) are planned, a letter of agreement should be included that addresses optimization of resources and areas of potential overlap.

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:

• Briefly describe the Center’s contributions to the PKD RRC made during the prior project period. Describe sharing of the Center resources outside the applicant's home institution. 
• Summarize the specific aims of the previous project period and the importance of the findings, and emphasize the progress made toward their achievement.
• Explain any significant changes to the specific aims and any new directions, including changes resulting from significant budget reductions.
• Discuss previous participant enrollment (e.g., recruitment, retention, inclusion of women, minorities, children, etc.) for any studies meeting the NIH definition for clinical research.
• Use the Progress Report section to discuss, but not duplicate information collected elsewhere in the application.
• Do not include a list of publications, patents, or other printed materials in the Progress Report. That information will be included in the "Progress Report Publication List" attachment.

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.

• All applications are expected to provide plans that address sharing and demonstrate commitment to making resources, models, reagents, tools and methods available to the PKD RRC and the broader research community.  

Other Plan(s): 

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

•  All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
• All applications are expected to provide plans that address sharing and demonstrate commitment to making resources, models, reagents, tools and methods available to the PKD RRC and the broader research community. The terms and timelines for sharing within the PKD RRC, validation of models and methods, and sharing with the broader research community will be established by the PKD RRC Steering Committee in a manner consistent with achieving the goals of the program and NIH policies. All participants are expected to adhere to these terms as a condition of award.
• If appropriate, applications are expected to provide plans that address sharing and demonstrate commitment to making de-identified participant data and imaging available to the PKD RRC and the broader research community. The terms and timelines for sharing within the PKD RRC sharing with the broader research community will be established by the PKD RRC Steering Committee in a manner consistent with achieving the goals of the program and NIH policies. All participants are expected to adhere to these terms as a condition of award.
• Applicants should include their plans to assure that all resources will be made available nationally as soon as quality control procedures have been completed at the local institution. Any sharing plans by the institution represent a commitment by the institution (and its subcontractors, if any) to support and abide by the plan.

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.

PHS Human Subjects and Clinical Trials Information (Overall)

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.

PHS Assignment Request Form (Overall)

All instructions in the How to Apply- Application Guide must be followed.

Administrative Core

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. 

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

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.

Project /Performance Site Location(s) (Administrative Core)

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.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Administrative Core Director’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Administrative Core)

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.

PHS 398 Research Plan (Administrative Core)

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.

• Describe the strategy by which the Administrative Core will effectively lead, organize, and provide (1) fiscal and resource management for the PKD Core Center; (2) management of the Biomedical Resource Core(s); and (3) coordination of research efforts within the PKD Core Center, the Central Coordinating Site, the NIDDK, and with the broader research community.
• If a Resource Development Core is proposed, describe how the Administrative Core will evaluate the appropriateness of generating novel resources for the PKD research community and if it is within the capabilities of the PKD Core Center. Explain how the evaluation process will occur and how a recommendation for new resource(s) would be brought to the PKD RRC Steering Committee for discussion and approval.  Indicate who will be responsible for these activities.
• Describe the plan for monitoring and reporting QA/QC for all resources.
• Describe strategies for building and maintaining a functioning multi- and interdisciplinary team (bringing scientists out of their research silos).
• Describe how the Administrative Core will coordinate with the Central Coordinating Site and the other PKD Core Centers to solicit and incorporate PKD patient perspectives into the work of the PKD RRC. 
• Describe the relationship and lines of authority and sanction by appropriate institutional officials.
• Include plans for development and execution of Material Transfer Agreement and Data Use Agreements between PKD Core Center institution, the Central Coordinating Site, and outside investigators as indicated in Overall Component.
• Outline the approaches to be utilized for (1) internal monitoring of PKD Core Center operations management, fiscal administration, personnel management, planning, budgeting, and other appropriate capabilities; (2) establishing and maintaining internal communication and cooperation among PKD Core Center investigators; and (3) reviewing productivity and effectiveness of PKD Core Center activities, conflict resolution, and improving or terminating ineffective Biomedical Resource Core(s).
• Describe how the Summer Student Enrichment Program will be administered.
• Describe how the PEDP plan will be implemented.

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.

Biomedical Resource Core

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. 

SF424 (R&R) Cover (Biomedical Resource Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Biomedical Resource Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Biomedical Resource Core)

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.

Project /Performance Site Location(s) (Biomedical Resource Core)

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.

Research & Related Senior/Key Person Profile (Biomedical Resource Core)

• In the PD/PI section of the form, use Project Role of ‘Other’ with Category of ‘Biomedical Resource Core Director’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Biomedical Resource Core)

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.

PHS 398 Research Plan (Biomedical Resource Core)

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.

• Describe the purpose and objectives of the Biomedical Resource Cores and its administration, organization, and operations. Include a description of services provided and their significance to accomplishing the scientific goals of the PKD RRC, plans for quality control, and how it will adapt to new technology and to the needs of the PKD Core Center members. Describe how access to the Biomedical Research Cores by PKD Core Center investigators and the larger PKD research community will be prioritized, operationalized, and any fee structure.
• Describe the novelty of services and resources generated and offered by the Biomedical Resource Cores. For a Biomedical Resource Core that by its nature is not innovative, describe how it is essential to advance the field. Describe the potential for interdisciplinary collaborations among PKD Core Center investigators.
• Describe plans for monitoring and reporting QA/QC for resources generated by this core.
• Describe how existing institutional resources may be leveraged, particularly when this provides a range of services or efficiency that would not otherwise be available. Furthermore, applicants should demonstrate that support for the existing resource through the PKD Core Center provides added value to the resource beyond that which would be provided by paying for use of the resource through a fee for service. Applicants from institutions that have a CTSA funded by the NIH may wish to identify the CTSA as a resource for conducting the proposed research, if appropriate. For any collaborative linkages between the CTSA or other NIDDK-supported resource cores (e.g George M. O'Brien Kidney National Resource Centers) and a specific Biomedical Resource Core, a letter of support should be included with other letters in the application and the collaborative linkage described within the Biomedical Resource Core section.
• If a Clinical Biomedical Resource Core is proposed, describe how de-identified participant biological samples will be shared, upon request, with qualified investigators within and outside of the PKD RRC. Describe how de-identified participant data and imaging will be shared across the Consortium and added to a common PKD RRC database that will be made available to the broader PKD research community.
• If genomic analysis of PKD patients is proposed, describe how the Biomedical Resource Core will make those data available to the PKD Genome Browser that is hosted by the Central Coordinating Site for sharing with external users.
• Provide a description of how the Biomedical Resource Cores contribute to the goals of the Administrative Core and the overall PKD Core Center. In addition, provide the following information:
  • Brief description of the Biomedical Resource Core scientific, technical, and support staff functions.
  • A summary of projected usage of Core services (e.g., assays performed, animals supplied, etc.) by the PKD Core Center team or other users, including PD/PI, name of grant, and funding source.

PHS Human Subjects and Clinical Trials Information (Biomedical Resource Core)

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.

Resource Development Core

(Optional)

(When preparing your application use Component Type 'Resource Development Core'

SF424 (R&R) Cover (Resource Development Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Resource Development Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Resource Development Core)

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.

Project /Performance Site Location(s) (Resource Development Core)

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.

Research & Related Senior/Key Person Profile (Resource Development Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Resource Development Core Director’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Resource Development Core)

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.

PHS 398 Research Plan (Resource Development Core)

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.

• Describe the capabilities, capacity, approach, expertise, and resources that the Resource Development Core will bring to the PKD Core Center. Do not propose or describe specific resources, tools, or technologies that the Core may develop: these will be determined in collaboration with the PKD RRC Steering Committee over the course of the project period.
• Describe how the Resource Development Core leadership will anticipate future needs by engaging a broad range of scientific experts within and outside of the PKD research community.
• Describe how the Resource Development Core leaders will establish and nurture a dynamic “incubator space” that fosters a robust community of investigators with diverse scientific backgrounds and promotes innovation.
• Describe how the Resource Development Core will validate new resources.
• Explain how the Resource Development Core leadership will collaborate with the PKD RRC to prioritize and implement new resources, which may include the de-prioritization of existing resources.

PHS Human Subjects and Clinical Trials Information (Resource Development Core)

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. 

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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, NIH’s 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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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 organization’s 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 [email protected].

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Section V. Application Review Information

1. Criteria

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.

• Administrative Core:
  • The focus on promoting collaborations among PKD Core Center members;
  • Abilities of key personnel to lead, manage and harmonize all aspects of the PKD Core Center;
  • Plans to attract early-stage investigators and people new to PKD research;
  • Plans to administer the summer student program;
• Biomedical Resource Core:
  • Resources, tools, technologies, services, and/or expertise that will address a fundamental challenge in PKD research;
  • Capacity to train other investigators, who wish to learn the unique procedures or technologies developed by the Core, thus lowering the barrier to entry for early-stage investigators and people outside of PKD research;
  • Ability and willingness to broadly share specialized resources and methods;
  • Likelihood that the resources generated by this core will promote new research directions;
  • If a proposed Biomedical Resource Core by its nature is not innovative, determine if it is essential to advance the field;
  • Plans for internal quality control of shared resources and the plans for updating the resources;
  • Complementary and diverse expertise, experience, and accomplishments of key personnel; 
  • Experience of the key personnel in working within complex multi-institution projects, including consortia
• Resource Development Core (optional):
  • The capabilities, capacity, expertise and resources that the Resource Development Core will bring to the PKD Core Center. Specific resources, tools, or technologies will not be evaluated in review;
  • The plans to anticipate future resource needs by engaging scientific experts;
  • The plans to establish and nurture a dynamic “incubator space” that fosters a robust community of investigators with diverse scientific backgrounds and promotes innovation;
  • The plans to validate new resources;
  • The plans to collaborate with the PKD RRC to prioritize and implement new resources, which may include the de-prioritization of existing resources.
     

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.

Significance

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.

Investigator(s)

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. 

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

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.

Approach

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.

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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.

Additional Review Criteria - Overall

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.

Center Integration

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:

• Evaluate the coordination, interrelationships, and synergy among the Administrative Core, the Biomedical Resource Core(s), and the Resource Development Core (if submitted) within the PKD RRC.
• If proposed, determine if there is strong justification for a multi-institution PKD Core Center.
• Evaluate the appropriateness of the mechanisms proposed for regular communication among the Program Director, Administrative Core Leader, Biomedical Resource Core Project Leader(s) and Resource Development Core leader (if proposed) within the Center and with the Central Coordinating Site and the entire PKD RRC.
• Determine if there are appropriate administrative structures in place for daily management of the PKD Core Center, including oversight of the Biomedical Resource Core(s) and the Resource Development Core (if proposed).

Protections for Human Subjects

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.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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.

Vertebrate Animals

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.

Biohazards

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.

Resubmissions

Not Applicable.

Renewals

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.

Revisions

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.

Applications from Foreign Organizations

Not Applicable

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 Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

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.

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.

2. Review and Selection Process

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:

• Scientific and technical merit of the proposed project, including the PEDP, as determined by scientific peer review
• Availability of funds.
• Relevance of the proposed project to program priorities.

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 applicant’s 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 applicant’s 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.

3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information

1. Award Notices

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 recipient’s 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.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

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:

• Recipient(s) will be primarily responsible for defining the objectives and approaches, planning, conduct, analysis, and publication of results, interpretations, and conclusions of studies conducted under the terms and conditions of the cooperative agreement award.
• The Program Director/Principal Investigator (PD/PI) will assume responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of the research supported under this Funding Opportunity Announcement (NOFO) in accordance with the terms and conditions of award, as well as all pertinent laws, regulations and policies.
• Recipient(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current DHHS, PHS, and NIH policies.
• PD/PI’s will be responsible for providing, at least annually, reports on progress regarding the Plan for Enhancing Diverse Perspectives (PEDP).
• Recipients are responsible for their staff in maintaining confidentiality of the information as developed by the network/consortium, including, without limitation, study protocols, data analysis, conclusions, etc. per policies approved by the Steering Committee (SC) as well as any confidential information received by third party collaborators.
• Recipients must analyze, publish and/or publicly release and disseminate results, data and other products of the study in a timely manner, concordant with the approved plan for making quality-assured data and materials available to the scientific community and the NIH, consistent with NIH policies and achieving the goals of the NOFO.
• Data Management and Sharing Plan: In accordance with the NIH Policy for Data Management and Sharing (NIH NOT-OD-21-013), the NIDDK approved plan will become a term and condition of award, be routinely monitored during the award period, and compliance may factor into future funding decisions. By the end of the funding or proprietary period, a recipient or study group may not continue to exclusively use or share study generated resources until those resources are available to the public via a NIDDK approved repository per the NIDDK approved plan.
• Recipient(s) will be required to participate in a cooperative and interactive manner with members of the network/consortium including designated NIH staff (e.g., Program Official, Project Scientist, Project Coordinator).
• Recipient(s) agree to establish agreements amongst themselves that address the following issues: (1) procedures for data sharing among network/consortium members and data sharing with industry partners; (2) procedures for safeguarding confidential information, including without limitation, any data generated by the network/consortium as well as information and/or data received from external collaborators; (3) procedures for addressing ownership of intellectual property that result from aggregate multi-party data; (4) procedures for sharing bio-specimens under an overarching Material Transfer Agreement (MTA) amongst network/consortium members that operationalizes material transfer in an efficient and expeditious manner; (5) procedures for reviewing publications, determining authorship, and industry access to publications.
• Any third-party collaboration (including but not limited to interactions with organizations from industry, academia, and nonprofit institutions) should be governed by a research collaboration agreement (e.g., Clinical Trial Agreement, Research Collaborative Agreement, etc.) or any third-party contract mechanism(s) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, applicable NIH/NIDDK policies and procedures, applicable network/consortium policies, and with written approval from NIDDK Program staff. Any relevant proposed third-party agreements related to the network/consortium studies between grantee and third-party will be provided to the NIDDK Program staff and NIDDK Technology Advancement Office for review, comment, and approval to assure compliance with NIH/NIDDK policies and network/consortium policies. Further, at the request of the NIDDK Program staff, any other network/consortium-relevant third-party agreements must be shared with NIDDK. Failure to comply with this term may prompt action in accordance with NIH Grants Policy Statement, Section 8.5 titled: “Special Award Conditions and Remedies for Noncompliance (Special Award Conditions and Enforcement Actions)”, and Section 8.5.2, titled: “Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding Support”, noncompliance with the terms and conditions of award will be considered by the funding IC for future funding and support decisions and may result in termination of the award.”
• Any involvement of a third-party (including but not limited to industry, academia, and nonprofit institutions) in the study and network/consortium activities that includes access to any network/consortium generated resources (i.e., data and biosamples), or study results that are not publicly available, or using the name of the network/consortium or study or the name of the NIH or NIDDK, is permitted only after written permission by the NIDDK Program staff who will consult with others at NIH and NIDDK Technology Advancement Office.
• Recipients must agree to comply with the processes and goals as delineated within the NOFO.
• Recipient(s) agree to the governance of the study through a Steering Committee:
• The PD/PI, or contact PD/PI in the case of multi-PD/PI awards, will serve as a voting member of the Steering Committee and will attend all meetings of the Steering Committee.
• Each full member will have one vote.
• The Recipient will be responsible for accepting and implementing the goals, priorities, procedures, protocols, and policies agreed upon by the Steering Committee and subcommittees.
• Recipients must serve on Subcommittees as needed. Subcommittees will report progress at Steering Committee Meetings and/or lead discussions at the Annual PKD RRC meeting.
• Recipients must share data, materials, models, methods, information and unique research resources that are generated by the projects in concordance with Network/Consortium policies in order to facilitate progress. When appropriate, and in accordance with NIH policies, as well as NIDDK policies, Recipients will be expected to collaborate; share novel reagents, biomaterials, methods and models and resources; and share both positive and negative results that would help guide the research activities of other members.
• Provide updates at least annually on progress in PEDP implementation.
• Upon completion or termination of the research project(s), the Recipients are responsible for making all study materials and procedures broadly available (e.g., putting them into the public domain) or making them accessible to the research community according to the NIH-approved plan submitted for each project, for making all study materials and procedures available to the scientific community and the NIH for the conduct of research. The Data Management and Sharing Plan should include a plan to accomplish aforementioned at the end of the study. 

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/Collaborator’s 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 Committee’s 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 Committee’s 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.

3. Data Management and Sharing

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. 

• When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

• Recipients will provide updates at least annually on implementation of the PEDP.

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.

Section VII. Agency Contacts

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: [email protected] (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: [email protected]

Christine Maric-Bilkan, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-435-0486
Email: [email protected]

Susan R. Mendley, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-827-1861
Email: [email protected]

Xiaodu Guo, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-4719
Email: [email protected]

Krystle Nicholson
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8860
Email: [email protected]

Section VIII. Other Information

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.