National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
U01 Research Project – Cooperative Agreements
See Part 2, Section III. 3. Additional Information on Eligibility.
This Notice of Funding Opportunity (NOFO) requests applications for Recruitment Sites (RS) to enroll adult and/or pediatric patients with Type 1 diabetes (T1D) with, or at high risk of, diabetic nephropathy into a longitudinal cohort study and perform protocol-based research kidney biopsies. These T1D RS will leverage the existing resources of the Kidney Precision Medicine Project (KPMP). T1D RS will collaborate directly with the KPMP to obtain and evaluate kidney biopsies from participants, create a Kidney Tissue Atlas, define disease subgroups, and identify critical cells, interstitial components, pathways, and targets for novel therapies. Current KPMP RS are not eligible to apply.
November 11, 2024
Application Due Dates | Review and Award Cycles | ||||
---|---|---|---|---|---|
New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
December 10, 2024 | Not Applicable | Not Applicable | March 2025 | May 2025 | July 2025 |
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the 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 How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
Background
Diabetic kidney disease (DKD) imposes the highest social and economic burden among the long-term complications of type 1 diabetes (T1D). Approximately one third of T1D patients develop kidney dysfunction that frequently progresses to end-stage kidney disease (ESKD), requiring dialysis or a kidney transplant for survival. Socially and economically disadvantaged individuals have disproportionately poor outcomes. Unfortunately, progress in the prevention and treatment of T1D nephropathy has remained limited.
Our understanding of T1D nephropathy would significantly improve by identifying key molecular pathways involved in disease etiology and progression. These pathways could potentially offer insights into unrecognized disease heterogeneity. The primary limitation to achieving these goals is lack of access to human tissue and the application of state-of-the-art molecular interrogation techniques to such samples. Such interrogation has the potential to also identify specific drug targets and enable individualized care.
This program will leverage and expand on the established Kidney Precision Medicine Project (KPMP). The KPMP is charged with enrolling adults with acute kidney injury (AKI) and/or chronic kidney disease (CKD) from varied age, sex, racial, ethnic, socioeconomic, and geographic backgrounds into a longitudinal cohort study that includes a research kidney biopsy. A full description of the scope and organization of KPMP can be found here: https://www.kpmp.org/about-kpmp#background.
There are 4 distinct, but highly interactive activities within KPMP which includes:
The goal of this Notice of Funding Opportunity (NOFO) is to add new recruitment sites (RS) to KPMP that are dedicated to enrolling individuals with, or at high risk of, T1D nephropathy. Both adult and pediatric participants are of interest. These new RS will establish a cohort of individuals with T1D, in order to obtain kidney biopsies and then deeply phenotype participants across multiple domains, including clinical, social determinants of health, and molecular characteristics. These data will be integrated to define sub-phenotypes and identify individual-level candidate treatment targets. Existing KPMP RS are not eligible to apply for this NOFO.
The new RS supported by this NOFO will incorporate into the existing governance structure of the KPMP and be governed by the KPMP Steering Committee (SC) and overseen by two NIDDK-appointed boards: (1) a Data Safety Monitoring Board (DSMB) focused on participant safety, study burden, and the scientific validity of the clinical data, and (2) an Observational Study Monitoring Board (OSMB) focused on the overall scientific progress and direction.
Given the risk of complications from kidney biopsy, the sites funded under this NOFO will prioritize ethical and participant safety considerations. The investigators will work closely with diverse patient partners (e.g., patients serving as study investigators) and research subjects (participants) to ensure their viewpoints, priorities, and preferences inform all aspects of the research. Participating medical centers will not charge participants for costs associated with kidney biopsies or complications related to research kidney biopsies.
All de-identified data acquired by sites supported by this NOFO will be subject to both KPMP and NIH data sharing policies. The data will be released to the research community immediately upon validation once the risk of explicit or inferred identification has been mitigated. The KPMP Central Hub will house all personally identifiable data (under the control of an Honest Broker), while the KTACC/KMAP will house all de-identified data.
Applicants should carefully review and understand all KPMP policies, as they will also apply to T1D recruitments sites (For Researchers (kpmp.org). Please refer to Other Plan(s) section below.
Applicants should contact NIDDK staff if an application is being considered.
Purpose
This NOFO requests applications for new T1D RS to enroll individuals with, or at high risk for, T1D nephropathy in a longitudinal cohort study that includes a research kidney biopsy. T1D RS will collaborate with KPMP to conduct longitudinal clinical and physiologic phenotyping, capture demographic information, and collect biological samples linked to relevant metadata in accordance with established KPMP protocols (https://www.kpmp.org/for-researchers#protocols). Biopsy protocols and safety criteria will adhere to KPMP protocols. Inclusion criteria for enrollment and the depth of clinical phenotyping may differ from the current KPMP protocol. Clinical phenotyping for T1D RS is expected to exceed that of current KPMP RS. Existing KPMP RS may not apply for this NOFO.
Each T1D RS is expected to recruit approximately 15 to 20, or more participants per year, justifying their numbers based on the available disease population and anticipated rate of consent. Each applicant for a T1D RS should demonstrate the ability to identify and enroll the expected number of participants, obtain high-quality research kidney biopsies, ensure safety, minimize risk, and conform to the highest ethical, research, and clinical standards.
Projects proposed in response to this NOFO will require a multidisciplinary team, including nephrologists, endocrinologists, radiologists, pathologists, ethicists, researchers with experience partnering with diverse communities, researchers with expertise in social determinants of health, patient partners (e.g., patients serving as study investigators), and patient advocates.
Research Objectives
Establish a cohort of individuals with T1D and diverse backgrounds with, or at high risk of, T1D nephropathy to obtain research kidney biopsies, biospecimens, social determinants of health, and detailed longitudinal clinical data.
Essential objectives include:
1. Recruitment
Collaboration and Sharing
B. Utilization of the KPMP state-of-the-art tissue interrogation resources and expertise (e.g., coordinated single cell level transcriptomic, proteomic, metabolomic including spatial analyses). This will allow the investigative community to optimally leverage precious and limited renal biopsy tissue to facilitate discovery of T1D nephropathy specific molecular pathways, subgroups and identify candidate novel therapeutic targets. Tissue analyses will be performed by KTACC/KMAP and do not need to be directly addressed or budgeted for in this application.
Expected outcomes from the project period will be:
This NOFO is not intended to support hypothesis testing. Applications including animal studies are not responsive and will be withdrawn.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.
The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
Not Allowed: Only accepting applications that do not propose clinical trials.
NIDDK intends to commit $1.3M Total Costs in FY 2025 to fund 2 to 3 awards.
Application budgets are expected to be up to approximately 400K direct costs per year based on the projected clinical recruitment and follow-up. Final budgets will be adjusted based on number of funded sites.
Application budgets are not limited but need to reflect the actual needs of the proposed project.
The scope of the proposed project should determine the project period. The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with 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, and 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.
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
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:
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.
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 How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
John F. Connaughton, Ph.D.
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7797
Email: NIDDKLetterofIntent@mail.nih.gov
All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
Letter of support: A letter of support from the institution acknowledging the cost of $3,500 per research kidney biopsy, which has been agreed upon by the KPMP and their respective institutions, is required. The Letter of support should be signed by a business official on organization letterhead.
Statement of willingness: The filename "Willingness Statement.pdf" should be used. The statement should be signed by a business official on organization letterhead and should attest to the following:
All instructions in the How to Apply - Application Guide must be followed.
A key individual (Pathologist) with expertise to support feature scoring and adjudication of biopsies should be included.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed.
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Specific Aims: Applicants should propose to recruit diverse (with regards to sex, age, race, ethnicity, socioeconomic and geographic backgrounds) individuals with T1D with, or at high risk of, T1D nephropathy, for a longitudinal cohort study that includes a research kidney biopsy. Proposals including adult and/or pediatric participants will be considered.
Research Strategy: Organize the Research Strategy in the subsections identified below.
1) Background and Significance
2) Preliminary Data
3) Approach
4) Milestones and Timelines
5) Activities and Management of the Multidisciplinary Team
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.
The following modifications also apply:
The NIDDK intends the resource sharing plans for the samples generated under the KPMP to follow the policy and objectives stated in the original KPMP NOFOs. Specifically, consistent with achieving the objectives of the KPMP, all study protocols (including analytical methods), ontologies, technologies, biological samples (including but not limited to biopsies, nephrectomy tissue, tissue blocks, all slides in any form, blood, urine and stool) and other research resources are to be shared immediately across the consortium, and made publicly available to the larger community as soon as QA/QC procedures have been completed, and in accordance with KPMP SC policies, subject to approval by the NIDDK. Limited exceptions to the requirement for community dissemination may be identified by the KPMP SC and are subject to approval by the NIDDK. The NIDDK, in consultation with the SC for this project, 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.
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.
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 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 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.
All instructions in the How to Apply - Application Guide must be followed.
See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIHs electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the How to Apply – Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.
Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organizations profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the 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" (https://cde.nlm.nih.gov/home (https://cde.nlm.nih.gov/home)) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.
Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.
Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.
Applicants are required to follow the instructions for post-submission materials, as described in the policy
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
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).
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 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: How well will the biopsies performed adhere to the highest ethical, research, and clinical standards and maximize their value as a precious resource?
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:
How appropriate is the expertise and experience of the investigators in safely obtaining kidney biopsy tissue for research purposes?
How appropriate is the expertise of the proposed multidisciplinary team? Are nephrologists, endocrinologists, primary care physicians, pathologists, radiologists, ethicists, researchers with experience partnering with diverse communities, researchers with expertise in social determinants of health, patient participants, and, if applicable to the proposed project, pediatric expertise involved in the application?
How appropriate is the experience to recruit and follow a diverse (with regards to sex, age, race, ethnicity, socioeconomic and geographic backgrounds) and appropriate population and obtain accurate and complete baseline and longitudinal follow-up data?
How well have the applicants positioned themselves to excel in collaborative team science?
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:
How appropriate are the proposed innovative tools for identification and enrollment of unique and diverse cohorts and/or patients traditionally underrepresented in research?
How comprehensive and/or innovative are the proposed T1D deep phenotyping strategies?
How well does the applicant propose innovative strategies to consent for and obtain repeat research biopsies?
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:
How will the proposed engagement of patient partners and research participants at all levels aid in the conduct of the study?
Are there sufficient plans to minimize risk and enhance safety for participants?
Have the applicants provided sufficient evidence that they can obtain the number of biopsy samples/study participants needed in keeping with inclusion/exclusion criteria?
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:
How appropriately does the environment support the ethical and safe kidney biopsy of patients not usually receiving such procedures?
How appropriate is the evidence of support from the necessary institutional groups, including, endocrinology, nephrology, pathology, and radiology departments (where needed)?
How appropriate is the evidence that the participant EHRs can be linked to samples and shared outside the parent institution?
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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Not applicable.
Not applicable.
Not applicable.
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.
NOTE TO OER: please replace the boilerplate text above with: Not applicable.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Diabetes and Digestive and Kidney Diseases (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 on the basis of established PHS referral guidelines 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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.
Prior to making an award, NIH reviews an applicants federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicants integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
After the peer review of the application is completed, the PD/PI will be able to access 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.
A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipients business official.
In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk. For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.
Institutional Review Board or Independent Ethics Committee Approval: 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.
The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.
Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. NIH may terminate awards under certain circumstances. See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support.
NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
TERMS AND CONDITIONS OF COOPERATIVE AGREEMENT AWARDS RESEARCH PROJECT APPLICATIONS FOR NON-CLINICAL STUDIES
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 45 CFR Part 75, 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.
This program will leverage and expand on the established Kidney Precision Medicine Project (KPMP). The KPMP is charged with enrolling adults with acute kidney injury (AKI) and/or chronic kidney disease (CKD) from varied age, sex, racial, ethnic, socioeconomic, and geographic backgrounds into a longitudinal cohort study that includes a research kidney biopsy. A full description of the scope and organization of KPMP can be found here: https://www.kpmp.org/about-kpmp#background.
The PD(s)/PI(s) will have the primary responsibility for:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The 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:
Areas of Joint Responsibility include:
Through the Recipient, Steering Committee and NIH staff, the study members will cooperatively develop and implement processes to submit information and data to the Coordinating Center (CC), 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.
A Steering Committee organized by the study investigator(s) will be the main governing body of the study.
The Steering Committee has primary responsibility to design research activities, establish priorities, develop common protocols and manuals, questionnaires and other data recording forms, establish and maintain quality control among recipients, review progress, monitor patient accrual, coordinate and standardize data management, and cooperate on the publication of results. Major scientific decisions regarding the core data will be determined by the Steering Committee. The Steering Committee will document progress in written reports to the NIDDK Program Official and will provide periodic supplementary reports upon request.
The Steering Committee will be composed of all Program Director(s)/Principal Investigator(s), (including those of data coordinating/statistical centers, if any) and co-investigator(s) as deemed necessary, and the NIDDK Project Scientist. The final structure of the Steering Committee and voting procedures will be established at the first meeting. The NIDDK Project Scientist will have voting membership on the Steering Committee, and as appropriate, its subcommittees. The frequency of Steering Committee meetings will be dictated by a vote of the members of the Steering Committee. The NIDDK Program Official may serve as a non-voting member on the Steering Committee.
A Chairperson of the Steering Committee will be selected and voted on by the Steering Committee members. The Chairperson provides leadership to the Committee by conducting the Steering Committee meetings and by interacting closely with the recipients during protocol development and implementation. The NIDDK Project Scientist may not serve as Chairperson. The NIDDK program official will review the Committees selection for potential bias, conflicts of interest, or lack of required expertise. If the Program Official has concerns regarding selection of the Chairperson which are not satisfactorily resolved, the Program Official may withhold concurrence if approved by the Director, Division of Extramural Activities, NIDDK based on written justification. In cases where Program Official concurrence is withheld, the Steering Committee will be required to make another selection.
External Consultants
An independent panel of External Consultants may be established by the Steering Committee. The External Consultants may periodically review interim progress of the project(s) and provide reports to the Steering Committee. Members of the panel of External Consultants may be asked, on an ad hoc basis, to participate in the peer review of applications for new research initiatives that utilize special opportunity pool funds. The NIDDK Program Official will review the Committees selections for potential bias, conflicts of interest, or lack of required expertise. If the NIDDK Program Official has concerns regarding selection of one or more External Consultants which are not satisfactorily resolved, the NIDDK Program Official may withhold concurrence if approved by the Director of NIDDK Division of Extramural Activities based on written justification. In cases where NIDDK Program Official concurrence is withheld, the Steering Committee will be required to make another selection.
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual Recipient. This special dispute resolution procedure does not alter the Recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
? The NIH intends the sharing plans for the data generated under the KPMP to follow the policy and objectives stated in the NOFO. Specifically, consistent with achieving the objectives of the KPMP, all study data (including, but not limited to, raw data, metadata, digital pathology images, and computational data sets) are to be shared immediately across the consortium, and made publicly available to the larger community as soon as quality control procedures have been completed, and in accordance with KPMP SC policies, subject to approval by the NIDDK. Data derived from participant clinical records linked to biological data will only be made publicly available once risk of explicit or inferred identification has been mitigated in consultation with the Community Engagement Committee and the DSMB. Limited exceptions to the requirement for community dissemination may be identified by the KPMP SC and are subject to approval by the NIDDK. The NIDDK, in consultation with the SC for this project, will make all final decisions concerning data deposition and data access policies, and all policies are subject to change by the NIH 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 KPMP investigators under the KPMP.
? This plan should also address methods for continuing to make the KPMP data available to the NIH and the research community upon completion of studies or termination of the site so that accumulated data remain accessible, for example, through the NIDDK Central Repositories.
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.
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 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), 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 2 CFR Part 200.113 and Appendix XII to 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 (Responsibility/Qualification in SAM.gov, formerly 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 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Afshin Parsa, MD, MPH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-827-1375
Email: afshin.parsa@nih.gov
Ivonne Schulman, MD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-435-3350
Email: Ivonne.schulman@nih.gov
Ryan Morris, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-480-1296
Email: morrisr@mail.nih.gov
Diana Ly
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-9249
Email: Diana.Ly@nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.