Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Opportunity Title
Single Source for the Continuation of Cure Glomerulonephropathy (CureGN) Data Coordinating Center (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
Reissue of RFA-DK-18-504
Related Notices
  • October 26, 2022-Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available. See NOT-OD-23-012.
  • August 31, 2022- Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
  • August 8, 2022- New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023. See Notice NOT-OD-22-195.
  • August 5, 2022- Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.
Notice of Funding Opportunity (NOFO) Number
RFA-DK-22-513
Companion Funding Opportunity
RFA-DK-22-512 , U01 Research Project (Cooperative Agreements)
Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)
93.847
Funding Opportunity Purpose

This is a non-competitive funding opportunity intended to fund a single award.  The NIDDK is announcing its intent to issue a single source cooperative agreement award to the University of Michigan. The purpose of this Single Source is to extend the Cure Glomerulonephropathy (CureGN) Network by continuing to support the Data Coordinating Center (DCC). The CureGN Network is a multicenter observational cohort study of glomerular disease patients with the goal of improving care for all glomerular disease patients.  The DCC provides key leadership functions for this study in the areas of study organization, study design and implementation, overall management, data management and analysis, and biosample management. The CureGN Participating Clinical Centers (PCCs) will continue to follow-up previously enrolled participants under a separate NOFO.

Key Dates

Posted Date
July 13, 2023
Open Date (Earliest Submission Date)
September 19, 2023
Letter of Intent Due Date(s)

September 19, 2023

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed Scientific Merit Review Advisory Council Review Earliest Start Date
Not Applicable October 19, 2023 Not Applicable March 2024 May 2024 July 2024

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.

Expiration Date
October 20, 2023
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

This is a non-competitive notice of funding opportunity intended to fund a single award.  The NIDDK is announcing its intent to issue a single source cooperative agreement to the University of Michigan for continuation of the CureGN Data Coordinating Center (DCC). The CureGN network has enrolled the largest number of pediatric glomerular disease participants ever to be assembled in one study with a complementary cohort of adult participants. For the next phase of this study, the CureGN will collect additional data on disease progression of this same cohort. The University of Michigan has unique capabilities for this competition including:

  • existing relationships and data transfer capabilities in place with the CureGN PCCs;
  • uniquely qualified to manage the existing data base for nearly 2600 participants to ensure the successful capture of data from participants in accordance with the study protocol;
  • efficient communications and procedures for coordinating CureGN operations including staff training and material and data transfers;
  • qualified to facilitate and oversee the coordinated sharing of study data and biosamples with investigators from outside the study network; and
  • qualified to implement policies that facilitate access to the data set while ensuring protection of potentially identifiable participant information.

BACKGROUND:  
Primary glomerular diseases such as minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), immunoglobulin A nephropathy (IgAN), and membranous nephropathy (MN) are associated with significant morbidity and mortality in both adults and children. In addition to progressive loss of renal function [resulting in approximately 10% of all incident end stage renal disease (ESRD) cases in the US], primary glomerular disease can result in nephrotic syndrome leading to increased risk of infection, venous thromboembolism, hypercholesterolemia, cardiovascular disease, toxicities associated with immunosuppressive therapy, increased hospitalization rate, decreased quality of life, and mortality.

Despite the significant disease burden associated with these glomerulopathies, relatively little is known regarding their natural history, various underlying pathophysiologic process, predictors of outcomes and response to the existing limited arsenal of therapies. A major hurdle to studying these processes in depth has been the rarity of these conditions relative to diabetic or hypertensive-associated chronic kidney disease (CKD). This has accordingly made it challenging for independent investigators to acquire sufficient cases to comprehensively study these glomerulopathies.

To facilitate the advancement of our understanding of the course, cause, and treatment of glomerular diseases in adults and children, the NIDDK established the CureGN multi-center Study in 2013 and supported a second cycle which started in 2019.  The original aims of this multi-center, prospective, observational study were to:
 Recruit an observational multiethnic cohort of at least 2,400 adult and pediatric glomerular disease patients with biopsy-documented IgAN, FSGS, MN or MCD;

  • Describe the disease trajectories;
  • Estimate event rates for clinically meaningful outcomes and to identify clinical predictors of short- and long-term outcomes;
  • Identify and characterize clinical, histological, molecular, and genetic biomarkers that are linked to glomerular disease, disease outcomes, or that might be used to improve disease classification, or response to therapy;
  • Understand the genetic architecture of the four glomerulopathies, including epigenetic changes, and transcriptomic profile, and their impact on disease presentation and clinical outcomes;
  • Devise systems-based "-omics" approaches to clarify pathogenesis;
  • Describe the full range of the patient experience including, but not limited to Patient Reported Outcomes associated with primary glomerular diseases or disease progression and validate disease-specific instrument(s); and
  • Facilitate the development of translational and clinical ancillary studies that will leverage the cohort to advance the diagnosis and care of patients with glomerular diseases.

The current cohort of about 2,600 participants has been enrolled while approximately 1,900 participants with MN, FSGS, IgA and MCD are actively followed. Continued follow-up of this cohort with a “recruit to replace” strategy to maintain the cohort will permit progress toward achieving the initial aims.

The CureGN study is expected to foster many ancillary studies through investigator initiated (R01) grants, career development (K) awards and to foster careers in both basic and clinical research of glomerular diseases. The study group will also actively collaborate with ongoing studies supported by the NIDDK as well as other funding sources.  The study will continue to pursue collaborations with industry (e.g., pharmaceutical companies), other government agencies (e.g., FDA), and advocacy groups as appropriate to achieve the overarching goal of advancing the diagnosis, understanding of pathophysiology, development of predictive biomarkers and treatments needed to meaningfully improve the care of individuals with glomerular diseases.


OVERALL GOALS:
The objective of the next project period of the CureGN Study to be supported by this NOFO is to identify clinical and molecular features of the diseases useful for diagnosis, identification of disease subtypes, prognosis and identification of risk factors and/or pathways leading to differential outcomes. The in-depth characterization of the biological and behavioral aspects of these glomerulopathies will require careful and extensive assessment of the study participants by both traditional and novel markers.
 

RESEARCH OBJECTIVES:
The CureGN DCC will serve as the administrative center of the consortium. NIDDK expectations for general roles and responsibilities of a DCC are described in the Regulatory Policies and Guidance document on the NIDDK website: https://www.niddk.nih.gov/research-funding/human-subjects-research/policies-clinical-researchers.  The CureGN DCC will support consortial activities through:

Overall organization and management: The DCC will be responsible for the formation and communication of working groups and the Patient Advisory Council; the conduct of Steering Committee meetings (in person or by phone) and conference calls; development and archiving of study materials and work products; and development and maintenance of consortial policies and procedure manuals.

Study design and implementation: The DCC will collaborate with the PCCs to ensure execution of the study in keeping with the approved CureGN protocol and perform site monitoring to ensure protocol compliance and data integrity. The DCC will work closely with the PCCs and lead the development of protocols, in conjunction with the PCCs, to ensure timely visits of CureGN participants who may have challenges attending in person visits with options such as remote or telehealth visits, as well as remote sample and data capture. 

Data management and analysis: The DCC will coordinate data collection, management and cleaning; develop analytical plans, perform analyses and prepare study reports for the PCCs or other entities performing ancillary studies, in addition to preparing the final protocol for Observational Study Monitoring Board (OSMB), External Expert Panel (EEP) and single/central Institutional Review Board (sIRB) review and approval. All data, whether derived through the central protocol or ancillary studies will be sent to the DCC for quality control and analysis. All data collection and analyses (i.e., questionnaires, biochemical measurements, pathological specimens, clinical data) will adhere to the standards of the Clinical Data Interchange Standards Consortium (CDISC) in order to facilitate biomarker, surrogate outcome, and therapy development in accordance with the FDA guidelines.

The DCC should promote data analysis with both traditional and innovative approaches that integrate high levels of data (e.g. data reduction based approaches) as well as systems biology approaches, with the goal of uncovering novel disease features for disease subgroup classification, prognosis, delineation of pathophysiologic pathways, response to therapy, and the identification of novel treatment targets.

Biosample management: The DCC will coordinate collection, tracking and shipping of biological samples (e.g. blood, urine, paraffin embedded biopsy tissue blocks, RNA, DNA) as they move from PCCs to internal or external sites for analyses or to the NIDDK Central Repository.

Cohort and data sustainability: The DCC will develop strategies for linking CureGN participant data to EHRs and other national datasets (e.g., National Death Index, U.S. Renal Data System) to enable future capture of outcomes. All CureGN datasets should be formatted such that the broader research community can access them easily for future analyses. The DCC should also ensure resources and tools to provide easy access, provide tutorials, and disseminate statistical approaches to analyzing the CureGN data.

Community engagement: The DCC will facilitate collaboration with outside scientists and third parties through the development of ancillary studies policies and the management of an opportunity pool. The DCC will serve as the initial point of contact for research collaboration agreements.

STRUCTURE:
The CureGN DCC will consist of four components:

  1. Administrative Core: The administrative core will support organization, implementation and management of the study; develop and publish pilot funding and enrichment opportunities supported by the Opportunity Pool.
  2. Data Management Core: The data management core will oversee data collection, integration, management and cleaning; ensure data sharing.
  3. Biostatistical Core: The biostatistical core will support the development of analytical plans for core and ancillary studies, perform interim analyses, and support the development of manuscripts for publication.
  4. Biorepository Core: The biorepository core will support organization and management of physical biological samples (e.g. blood, urine, paraffin embedded biopsy tissue blocks, RNA, DNA), as well as the maintenance of the digital pathology repository and lead sustainability efforts to ensure accessibility of the CureGN data and sample set in appropriate repositories including the NIDDK Central Repository

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.

Application Types Allowed
Renewal

Renewal applications only for the awards supported under RFA-DK-18-504.

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards

NIDDK intends to commit $5,100,000 in FY 2024 to fund two related funding opportunities, RFA DK-22-512 and RFA DK-22-513. Only recipient organizations funded under RFA-DK-18-504 are eligible to apply to this limited competition.

Award Budget

The direct costs for the U24 award are expected to be approximately $1,000,000 per year. Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Only the following applicant may apply for this single source funding: University of Michigan. Please refer to Section I, Notice of Funding Opportunity Information for more details.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) 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. 

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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. The NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • 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 registrations; 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.

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 their organization to develop an application for support. Individuals from diverse backgrounds, including 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.

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 SF424 (R&R) Application Guide.

Only the PD/PI issued under the previous announcement RFA-DK-18-504 is eligible to apply for this single source notice of funding opportunity.

Only a single award will be issued to the University of Michigan under this single source funding opportunity.  Please refer to Section I. Notice of Funding Opportunity Information for more details.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Only one application per institution (normally identified by having a unique UEI or NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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:NIDDKLetterofIntent@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

1. Clinical Protocol Synopsis: The filename "Clinical Protocol Synopsis.pdf" should be used. The synopsis is meant to supplement the information provided in the Research Strategy and should include the following information:

  • A description of the study population including CureGN participant eligibility, inclusion/exclusion criteria, and baseline characteristics
  • A report on the performance toward implementation of the protocol including visit compliance, biosample collection, submissions to the digital pathology repository, and retention rates for the study overall
  • A description of key study outcomes
  • A description of DCC network sites and local site leadership

2. Network Products Synopsis: The filename "Network Products Synopsis.pdf" should be used. The synopsis is meant to supplement the information provided in the Research Strategy and should include the following information:

  • A Table with the complete listing of ancillary studies approved by the CureGN Ancillary Studies Committee including ancillary study PI, ancillary study title, status (i.e. complete, active, pending funding, rejected), encumbered sample types;
  • A Table of publications and publication concepts approved by the CureGN Publications Committee including corresponding author, manuscript title, status (i.e. in development, submitted or in press);
  • A timeline of completed and proposed network milestones.

3. Willingness Statement: The filename “Willingness Statement.pdf” should be used. The statement should be signed by a business official on organization letterhead and should attest to full participation in the cooperative nature of the CureGN network as outlined in Section VI, "Cooperative Agreement Terms and Conditions of Award" and verify the following:

  • The study investigators will cooperatively interact with the NIDDK in support of the CureGN.
  • The study investigators will actively seek input from the NIDDK regarding resource or expertise needs.
  • The study investigators will work collaboratively with other CureGN investigators on weekly/monthly conference calls, Working Groups, SC meetings, and in the dissemination of research findings consistent with all Publications and Presentations (P&P) policies (as determined by the SC).
  • The institution will select and rely on the CureGN single Institutional Review Board (sIRB).
  • The institution will centrally manage negotiations with industry and external partners in academia and nonprofit institutions on behalf of the consortium.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: Briefly describe the Specific Aims for the CureGN Data Coordinating Center (DCC). The CureGN DCC Specific Aims should be congruent with those of the re-competing CureGN Participating Clinical Centers (PCC) and should address opportunities to improve care for individuals with glomerular disease related to improving individual level disease trajectory and response to treatment, and implementing precision medicine approaches.

Research Strategy: This section should propose plans for organization and management of the CureGN network. Divide the Research Strategy into the follow sections:

  1. Progress report: document progress toward goals in prior funding period.
  2. Administrative Core
    • Describe administrative structure of the DCC and support of network activities (e.g. development of policies and protocols, working groups, study website, etc).
    • Discuss oversight and training to ensure adherence to the highest ethical, research and clinical standards, and any required regulatory standards.
    • Describe the continued engagement of a robust Patient Advocacy Council with wide representation from relevant stakeholders (including patients and their care givers, patient advocacy groups and foundations) willing to inform CureGN research objectives, protocol development, enhance participant retention, support the development of sustainability plans, and to serve as CureGN ambassadors to the larger community.
    • Describe engagement of junior investigators in the conception, execution, and presentation of network activities.
    • Describe the single/central Institutional Review Board (sIRB) or the process for its selection. Include a statement confirming that participating sites will adhere to the sIRB Policy (https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm) and describe how communications between sites and sIRB will be handled.
    • Describe approaches for study monitoring.
      1. Discuss approaches for data quality monitoring.
      2. PCC site monitoring.
      3. Investigator and study coordinator training.
    • Describe the strategy for robust retention and ensuring adequate representation of minority ethnic groups.
    • Describe the strategy to ensure maximum data quality for follow-up of the enrolled participants, including type and frequency of measurements as well as relevant outcomes.
    • Discuss potential approaches to enhance the collection of important non-renal function-based outcomes such as cardiovascular events and immunosuppressive-related morbidity.
    • Describe approaches to capture outcomes of participants lost to follow up (e.g. use of USRDS records, National Death Index, and/or death records).
    • Describe potential approaches to capture participant data and biosamples, for those unable to come for in person visits. This should include options such as tele-visits, medical health record-based data capture, and remote blood and urine capture and/or testing.
  3. Data Management Core
    • Describe approaches for data collection, management, tracking and cleaning.
    • Describe the type and timing of data collected to be sent to the DCC for ultimate deposition to the NIDDK Central Repository and any processing that will occur prior to submission.
    • Provide a timeline for submission of all data to public databases (GEO and/or dbGaP).
  4. Biostatistics Core
    • Describe the analytical plan for baseline, interim, and long-term analyses.
    • Discuss how further follow-up of the primary cohort will lead to reclassification of glomerular disease patients or identification of sub-groups that will inform the care and management of these patients as well future clinical trials.
    • Describe approaches for the development of novel or non-classical outcomes (e.g. disease activity, remission/partial remission/relapse, treatment toxicity, graft survival, disease-specific patient reported outcomes).
    • Describe innovative analytic approaches that integrate high levels of data (e.g. data reduction-based approaches), as well as systems biology approaches with the goal of uncovering novel disease features for disease subgroup classification, prognosis and the delineation of potential pathophysiologic pathways.
  5. Biorepository Core (organization and management of physical biological samples and maintenance of digital pathology repository).
    • Describe approaches for organization, management, and tracking of biosamples including paraffin embedded biopsy tissue blocks between sites and to the NIDDK Repository.
    • Describe the type, frequency, and estimated amounts of biological samples to be sent to the DCC for ultimate deposition to the NIDDK Repository.
    • Describe oversight of the functions of the Digital Pathology Repository. Include alternative approaches to scan and return slides to PCCs, assess quality control, maintain storage, promote community access, and complete core analyses.
    • Describe oversight of obtaining biopsy tissue blocks from the PCCs, assess quality control and maintain storage.
  6. Ancillary studies and Opportunity Pool
    • Describe how investigators outside the current grantees will be brought into the study group to meaningfully supplement expertise to inform study design, data analysis, and interpretation.
    • Describe efforts to educate external investigators on gaining access and using CureGN data.
    • Discuss how ancillary studies, including those related to career development, will continue to be promoted and implemented consistent with study policies.
    • Propose a process for administration of an Opportunity Pool including development, solicitation, and award of pilot funding and enrichment activities. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

 The following modifications also apply:

  • The NIDDK intends the resource sharing plans for the CureGN to cover protocols (including analytical methods), biological samples (including but not limited to blood, urine, glass slides, paraffin embedded biopsy tissue blocks, RNA, DNA) and other research resources are to be made publicly available to the larger community at the time of an associated publication, or the end of the award/support period, whichever comes first, subject to approval by the NIDDK. The NIDDK, in consultation with the CureGN SC, will make all final decisions concerning sample deposition, and all policies are subject to change by the NIDDK as deemed necessary to sustain program principles and priorities, or to ensure the highest standards for responsible research conduct within the project.
  • Awardees will comply with and implement the recommendations and decisions of the SC with respect to the sharing of information, biosamples, protocols, resources, methods, and analyses developed by the CureGN.
  • Awardees will comply with the CureGN policies including the Publications and Presentations (P&P) policies (as determined by the SC).

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) 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 (DMS) Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a DMS Plan.

The following modifications also apply:

  • The NIDDK intends the DMS plans for the samples generated under the CureGN to cover all study data (including, but not limited to, raw data, metadata, digital pathology images, and computational data sets),  to be made publicly available to the larger community at the time of an associated publication, or the end of the award/support period, whichever comes first, subject to approval by the NIDDK. Data derived from participant records linked to biological data will be assessed for reidentification risks. The NIDDK, in consultation with the CureGN SC, will make all final decisions concerning data and sample deposition and data access policies, and all policies are subject to change by the NIDDK as deemed necessary to sustain program principles and priorities, or to ensure the highest standards for responsible research conduct within the project.
  • Awardees will comply with and implement the recommendations and decisions of the SC with respect to the sharing of data developed by the CureGN.
  • Awardees will comply with the CureGN policies including the Publications and Presentations (P&P) policies (as determined by the SC).

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) 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 Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

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

See Part 1. 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. Overview Information 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). 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 the SF424 (R&R) 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.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) 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 SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIDDK, NIH. Applications that are incomplete, non-compliant, and/or non-responsive 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. 

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 the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:
Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project 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 project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

 

Does the proposed DCC address the needs of the research network that it will serve? Is the scope of activities proposed for the DCC appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research program?  

Specific to this NOFO:

How substantial will the DCC contributions be to research on glomerular disease patients if these aims are achieved?

What potential is there for significant insight into the causes, prognosis, complications and long-term outcomes of glomerular disease that can lead to improvement in the treatment of patients based on continued follow up with the proposed study design?

How likely are new opportunities for precision medicine to emerge? How valuable will the samples and data repository generated from the CureGN cohort be to promote and support ancillary studies to expand the scope of the science for the glomerular disease community?

 

Are the PD(s)/PI(s) and other personnel well suited to their roles in the DCC? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing clinical observational research? Do the investigators demonstrate significant experience with coordinating collaborative clinical and translational research? If the DCC is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the DCC? Does the applicant have experience overseeing selection and management of subawards, if needed?   

Specific to this NOFO:

How well are the leaders for the four cores (Administrative, Data Management, Biostatistics, Biorepository) positioned to promote the work of the individual core as well as to work collaboratively with the other DCC core leads?

How effectively does the Administrative Core engage junior investigators? Is an adequate plan included to engage investigators beyond the immediate study group to inform future study designs and analyses? Do the DCC investigators demonstrate appropriate experience with coordinating collaborative clinical and translational research?

How well has the Administrative Core promoted membership in subcommittees of the Steering Committee? Are any areas of expertise lacking? How well have members of the DCC contributed to the success of the network's work products including ancillary studies?

How well has the Data Management Core provided evidence of obtaining complete and high-quality data? How well has the team facilitated sharing of the data set?

How well has the Biostatistical Core supported publications and presentations of the data as well as other key measures of success?

 

Does the application propose novel organizational concepts or management strategies in coordinating the research network the DCC will serve? Are the concepts or strategies novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or management strategies proposed?

Specific to this NOFO:

How well have novel approaches to "remote" or "virtual" study participation been considered?

Does the description of the patient experience reach beyond standardized Patient Reported Outcomes to better characterize the full range of the patient experience?

How well have non-traditional kidney disease outcomes with unique relevance to nephrotic syndrome been considered and addressed? Does the Biorepository Core propose and promote unique uses for biopsy tissue blocks and the Digital Pathology Repository? How appropriate is the emphasis towards achieving precision medicine within the GN domain (e.g. improve disease classification, predict individual level disease trajectory and response to treatment)?

 

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research network the DCC will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the network, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? Are an appropriate plan for work-flow and a well-established timeline proposed?  Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

Specific to this NOFO:

How well has the DCC met the objectives of the prior funding period? How well does the Biostatistics Core propose analytical strategies sufficiently robust to address the specific aims and scientific questions?

Is the recruitment plan sufficient to reach recruitment and retention goals? How well has the Administrative Core harmonized and catalyzed PCC approaches for recruitment, retention, biosample acquisition and data quality? Does the retention plan have a high likelihood of long term success? 

Have novel methods for "virtual" study participation and ecological momentary assessment been adequately considered by the Data Management Core?

Is the Digital Pathology Repository sufficiently robust to address the proposed aims? To support useful ancillary studies? Is the plan for collection of archival tissue biopsy blocks well-reasoned and appropriate? Are the biological samples collected (type, amount, and frequency) sufficient not only for the needs of the CureGN study groups but also for use by the broader scientific community through the NIDDK Central Repository?

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 children, justified in terms of the scientific goals and research strategy proposed?

 

Will the institutional environment in which the DCC will operate contribute to the probability of success in facilitating the research network it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the DCC proposed? Will the DCC benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Additional Review Criteria

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.

 

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

 
 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

 

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

 

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

 

Not Applicable.

 

For Renewals, the committee will consider the progress made in the last funding period concerning participant retention and support of ancillary studies.

 

Not Applicable.

Additional Review Considerations

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.

 

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Not Applicable.

 

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

 

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

 

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

 

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

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 policy and procedures, 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 NIDDK Advisory Council. The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. 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

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.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA. 

Institutional Review Board or Independent Ethics Committee Approval: Recipient 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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that 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.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 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.&##148;

Cooperative Agreement Terms and Conditions of Award

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 (HHS) grant administration regulations at 45 CFR Part 75 and 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 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 NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

  1. Developing the research design and study protocol, including definition of objectives and approaches, sample size and power calculations, and establishing procedures for participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, and publication of results.
  2. Establishing a Steering Committee to implement, coordinate and manage the project(s). Recipient(s) will name investigators to serve as members on a Steering Committee and other subcommittees, as appropriate, meeting periodically. Recipients will be required to accept and implement the common protocol(s) and procedures approved by the Steering Committee.
  3. Designating Protocol Chairs. The Program Directors/Principal Investigators (for studies involving multiple protocols) shall designate a single Protocol Chairperson (if the Program Director/Principal Investigator does not assume this role) for each protocol to be carried out by the study group. The Protocol Chairperson shall function as the scientific coordinator for the protocol and shall assume responsibility for obtaining approval to implement the protocol from the Steering Committee and for developing and monitoring the protocol. Significant modifications to approved protocols must be approved by the Steering Committee.
  4. Implementing collection of data specified by the study protocol.  For a multi-center study, each recipient/site is required to ensure that data will be submitted expeditiously to the Data Coordinating Center. Additionally, individual investigators/sites must demonstrate the ability to implement the strategy specifically designed for their individual study population.
  5. Ensure that all projects involving human subjects have the appropriate clearances (e.g., IRB, Federal-wide Assurance, certification of human subject’s research training, and other required documentation) prior to implementation.
  6. Establishing procedures for data quality, completeness, and security. Recipients are responsible for ensuring accurate and timely assessment of the progress of each study, including development of procedures to ensure that data collection and management are: (1) adequate for quality control and analysis; (2) for clinical trials, as simple as appropriate in order to facilitate cooperation/referral of study participants by physicians to avoid unnecessary expense; and (3) sufficiently staffed across the participating institutions. For research involving multiple sites, a plan for analysis of pooled data will be developed by the Steering Committee.
  7. Submitting interim progress reports, when requested or agreed upon by both parties, to the NIDDK Program Official including as a minimum, summary data on protocol performance. For coordinated multiple awards or a multi-site single award, the NIDDK Program Official may require additional information from individual recipients/sites. Such reports are in addition to the required annual noncompeting continuation progress report.
  8. Reporting of the study findings.  Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.  The recipient must also be adherent to Study Publication and Presentation Policy.  The NIDDK will have access to and may periodically review all data generated under an award. NIDDK staff may co-author publications of findings with recipients consistent with NIH and study policies.
  9. 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, and with written approval from NIDDK Program staff. Any relevant proposed third-party agreements related to the network 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 policies. Further, at the request of the NIDDK Program staff, any other network-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.”
  10. Any involvement of a third-party (including but not limited to industry, academia, and nonprofit institutions) in the study and network activities that includes access to any network generated resources (i.e., data and bio-samples), or study results that are not publicly available, or using the name of the network 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.
  11. Maintaining confidentiality of information: The recipient(s) will maintain the confidentiality of the information developed by the investigators (i.e., protocols, data analysis, conclusions, etc.) as well as proprietary information of an individual company or other entity collaborating with the study. Any exception requires written approval from NIDDK Program staff.
  12. 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 use or share study generated resources until those resources are available to the public via a NIDDK approved repository per the NIDDK approved plan. The NIDDK has established a Central Repository to support the receipt, storage, and distribution of data, bio-samples, and other resources generated in clinical studies funded by the NIH/NIDDK. When the NIDDK Central Repository is to be utilized, prior to enrolling participants, the PI or his/her designee will coordinate with the NIDDK Program and Central Repository staff to prepare for eventual archiving and distribution of the study generated resources that are to be maintained in the Central Repository. These resources will be available to the wider scientific community in accordance with the NIH Data Management and Sharing policy  (http://grants.nih.gov/grants/policy/data_sharing/ and, https://grants.nih.gov/policy/sharing.htm, and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm), per the NIDDK approved data management and sharing plan.
  13. Study investigators are required to publish and to release publicly and disseminate results and other products of the study, in accordance with study protocols, steering committee policies on publications, and the NIDDK approved sharing plan.
  14. Study investigators are required to comply with NIH Policy on the Dissemination of NIH Funded Clinical Trial Information as stated at https://grants.nih.gov/policy/clinical-trials/reporting/understanding/nih-policy.htm. Per policy, the recipient is responsible for meeting the expectations of this policy. Refer to additional information at https://grants.nih.gov/policy/clinical-trials/reporting/index.htm.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

  • An NIDDK Project Scientist with substantial involvement will:   
  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. Such staff may include another Project Scientist , who will provide direct technical assistance to the recipients to optimize the conduct and/or analysis of the study; or who may assist in the coordination of activities across multiple sites.
  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:
  • 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.
  • The NIDDK Project Scientist  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.
  • Reviewing procedures for assessing data quality and study performance monitoring.
  • The NIDDK Project Scientist 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 insure 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) patient 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 will serve as the Executive Secretary and/or NIDDK program representative on the DSMB/OSMB.

Areas of Joint Responsibility include:

In addition to the interactions defined above, NIDDK Project Scientist and Recipients shall share responsibility for the following activities:

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-investigators 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 SC.

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 should be consulted regarding the selection of the Chairperson to provide any feedback regarding concerns regarding potential for bias or conflict of interest or lack of required expertise.

External Consultants

An independent panel of External Consultants may be established by the Steering Committee.   The External Experts will review periodically interim progress of the U24s and report to the Steering Committee members. Members of the panel of External Experts 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.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: 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 HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the 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.

4. Reporting

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.

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. 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 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Afshin Parsa, MD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-827-1375
Email: afshin.parsa@nih.gov

Cindy N. Roy, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8805
Email: cindy.roy@nih.gov

Peer Review Contact(s)

Paul Rushing, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8895
Email: rushingp@extra.niddk.nih.gov

Financial/Grants Management Contact(s)

Diana Ly
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-9249
Email: Diana.Ly@nih.gov

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.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.

NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.