National Institutes of Health (NIH)
National Institutes of Health (NIH (http://www.nih.gov))
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
U24 Resource-Related Research Projects – Cooperative Agreements
The George M. O'Brien Urology Research Centers (U54) and the Fostering Research With Additional Resources and Development (FORWARD) (P20) Centers serve to advance the NIDDKs mission to support highly meritorious, innovative, interdisciplinary research in urological diseases and disorders, and the training of the next generation of researchers. Critical to these broad goals is the ability to promote productive interactions between the U54 and P20 Centers, the institutional career development programs (K12), and the broader urology research and clinical communities. The purpose of this Notice of Funding Opportunity (NOFO) is to solicit applications for a Urology Centers Program Interactions Core (U24). The Interactions Core will serve as focal point for establishing productive collaborations within the Urology Centers Programs and between these Programs and other NIDDK urology training and scientific efforts and the broader research and clinical communities all under the umbrella Collaborating for the Advancement of Interdisciplinary Research in Benign Urology (CAIRIBU) Program.
October 21, 2024
Application Due Dates | Review and Award Cycles | ||||
---|---|---|---|---|---|
New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
November 21, 2024 | November 21, 2024 | Not Applicable | March 2025 | May 2025 | July 2025 |
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
No late applications will be accepted for this Notice of Funding Opportunity (NOFO).
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
Despite advances in the clinical management of many genitourinary conditions, millions of Americans remain afflicted with urological diseases and disorders of the renal collecting system, ureters, bladder and urethra and the male genital organs (prostate, seminal vesicles, testicles, epididymis and penis). Contributing to the inability to adequately treat patients are the gaps in knowledge of the basic physiology, cell biology, and genetics of normal and abnormal urologic function; a lack of objective diagnostic criteria and tests for many urological diseases and conditions; inadequate in-depth characterization (phenotyping) of patients; and the paucity of epidemiological insights. Furthermore, this absence of a basic understanding of the mechanistic changes of the urogenital tract in disease also slows development of clinically-relevant models of genitourinary diseases and disorders.
To address these gaps the NIDDKs George M. O'Brien Urology Research Centers Program was transitioned in 2012 to a Cooperative Research Centers Program (U54). This transition was prompted by a recognized need for more highly-interdisciplinary, integrated approaches and a lack of new research resources for the wider research community. The OBrien Urology Cooperative Research Centers Program fosters broad basic, translational, and clinical research on questions of critical importance; develops resources to support the larger urologic community; engages new and established investigators from urology and other clinical and research disciplines; and promotes the training of junior scientists in the field of genitourinary diseases and disorders within the mission of the NIDDK. The Fostering Research With Additional Resources and Development (FORWARD) Centers (P20) further enhance the infrastructure of the urology research community through establishing teams of diverse expertise, including junior and early stage investigators, and fostering projects that can mature into more comprehensive studies. The U54 and P20 Centers additionally collaborate with the two institutional Career Development Programs (K12), the NIDDK Urologic Research (KURe) Career Development Program and the Urological Epidemiology (UroEpi) Program. All efforts are designed to improve prevention, diagnosis, and treatment of benign genitourinary diseases and disorders within the NIDDKs mission.
Critical to addressing these broad goals is the ability to promote productive interactions between the various Centers, associated Career Development Programs, and the broader urology research and clinical communities. To support this the NIDDK has worked to increase collaborations, resource sharing, and enhanced training opportunities under the umbrella of the CAIRIBU (Collaborating for the Advancement of Interdisciplinary Research in Benign Urology) effort. This includes an annual CAIRIBU meeting that brings together investigators and trainees from the NIDDK Urology Centers and training programs and other expertise inside and outside the urology community.
This Notice of Funding Opportunity (NOFO) seeks applications for a Urology Centers Program Interactions Core (U24). The Interactions Core will greatly enhance efforts to promote meritorious research, collaboration, resource sharing, and training and career development within the Centers Program and the larger urology community, as well as identify opportunities for synergistic interactions with other disciplines.
Research Objectives
The Urology Centers Program Interactions Core (U24) will engage in broad and diverse efforts to enhance collaboration and resource sharing between the George M. OBrien Cooperative Research Centers (U54), the Fostering Research With Additional Resources and Development (FORWARD) Centers (P20), the KURe and UroEpi Career Development Programs (K12), and the urologic clinical and research communities all under the general framework of the CAIRIBU efforts. The Core will additionally promote interactions between these NIDDK programs and investigators outside the traditional urology field in order to introduce critical, new multi-disciplinary expertise into urological research. All efforts will support the larger goals of fostering highly meritorious science, building interdisciplinary research teams, bringing new investigators to research on genitourinary diseases and disorders and training and career development of junior scientists. The synergy created through these collaborations is expected to advance our understanding of non-cancer genitourinary diseases and disorders and build the community of urologic investigators well beyond the capacity of these individual programs.
The Interactions Core will employ both proven and new and innovative approaches to addressing these roles. Specific activities in support of Core goals should include, but are not limited to:
Opportunity Pool Program: The Interactions Core will develop and provide centralized administration (solicitation, submission and review) for the CAIRIBU Opportunity Pool Program whose primary purpose will be to addresses scientific and technological gaps and promote new collaborations, with an emphasis on early-stage investigators and people new to urology research. The interaction core should propose a mechanism to implement the OP program that serves the needs of urology community and how it willevolve to meet emergingneeds. Urology Cooperative Research Centers (U54) Centers and the Interactions Core will collaborateto identify eligible candidates and provide guidance for the development of responsive applications. Opportunity Pool funds are intended to enhance collaborations between U54 and P20 Center investigators and KURe and UroEpi (K12) scholarswith outside investigators who meet one of the following criteria: (a) early stage investigators or (b) established investigators not previously involved in non-cancer genitourinary research. The CAIRIBU Opportunity Pool Program is expected to increase the capacity of the urologic research community by leveraging resources within the Centers and other sources and enhance the base of investigators engaged in urological research. Additionally, it is expected Opportunity Pool projects will generate preliminary data and collaborations that support development of future research grant applications, such as Investigator-Initiated R01s. Research investigating the relationships between biological and clinical characteristics are encouraged. While studies utilizing clinical data and human biological samples are allowed, studies that meet the criteria for an NIH Clinical Trial are outside the scope of the Opportunity Pool Program. Interactions Core activities will include but are not limited to development of standardized announcements for the solicitation of Opportunity Pool applications and administration of an objective peer-review process for assessing the merit of submitted applications. Final policies and criteria will be developed in consultation with the NIDDK and based on scientific priorities and available funds.
Interactions Core Travel and Professional Development Awards Program: The Interactions Core will be responsible for development and administration of a Travel Award Program and a Professional Development Award Program using allocated Core resources. The Travel Award Program should support travel of early stage investigators to attend educational enrichment scientific meetings held by the U54, P20 or K12 programs. The Professional Development Award Program should support short term sabbaticals for Urology U54 and P20 Centers Investigators to travel to other Centers or for outside investigators to travel to U54 and P20 Centers in order to learn new methods that will enhance benign urologic research and training. Final policies and criteria for the Travel and Professional Development awards will be developed in consultation with the NIDDK and based on scientific priorities and available funds.
The Interactions Core will operate in close collaboration with the NIDDKs U54 and P20 Centers and KURe and UroEpi Programs investigators and NIDDK Program Staff. The Interactions Core will lead the CAIRIBU webinar/teleconferences and scientific meetings. The Interactions Core will provide logistical support for NIDDK on progress in addressing Core goals.
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.
The NIDDK intends to commit $6,500,000 Total Costs in Fiscal Year 2025 to support the Urology Centers Program, which will include the Interactions Core.
NIDDK expects to award one Interactions Core under this Notice of Funding Opportunity.
Interactions Core applicant(s) may request funds up to $500,000 Direct Costs per year for Core activities plus an additional $500,000 per year for the centralized Urology Centers Opportunity Pool, Travel Awards, and Professional Development Programs in combination. All Opportunity Pool costs are inclusive of any F&A for the Interactions Core and the sub-awardees. As such, the Interactions Core should not calculate the Facilities and Administration (F&A) costs on the Opportunity Pool portion.
The application budget for the Interactions Core must reflect the actual needs of the proposed study.
The maximum project period is 5 years. The scope of the proposed project should determine the project period.
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 not 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.
The Interactions Core Director (or one or more members of a Multi-PI team) is required to have a track record of research and administrative accomplishments and team building in the field of urologic disease. A record of establishing broad collaborations between diverse research fields in support of urologic research and training is a priority. The Core Director may not serve concurrently as the Center Director for a George M. OBrien Urology Cooperative Research Center (U54) or a Exploratory Center for Interdisciplianry Research in Benign Urology (P20) or a Fostering Research With Additional Resources and Development (FORWARD) (P20) or as a Director of a K12 career development program.
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.
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:
The letter of intent should be sent to:
John 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.
All instructions in the How to Apply - Application Guide must be followed.
The application should reflect the Interactions Core Director's (or one or more members of Multi-PI team) research and administrative accomplishments including team building across diverse research fields in benign urology in the biosketches or research strategy.
All instructions in the How to Apply - Application Guide must be followed.
The NIDDK Urology Centers Program Interactions Core Director will oversee all scientific and administrative activities of the Core. Support for the PD/PIs should be provided within the budget of the Interactions Core. The minimal level of effort for the PD/PI is 6 person months (50%). As part of a Multi-PI application two Co-Directors may be proposed. Each of these Co-Directors must have a minimal level of effort of 4 person months (30%) and the role of each PD/PI should be clearly defined. Additional proposed Core personnel may be included in the budget request in order to address diverse Core activities. All personnel should be justified for their contributions to Core activities.
Applicant(s) should also include:
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:
Research Strategy: NIDDK Urology Centers Program Interactions Core applicants should describe broad and diverse efforts designed to enhance collaboration and sharing between the George M. OBrien Cooperative Research Centers (U54), the Fostering Research With Additional Resources and Development (FORWARD) Centers (P20), the KURe and UroEpi career development programs (K12), and the urologic clinical and research communities. Interactions Core applicants should also describe proposed efforts to promote interactions between these NIDDK programs and investigators outside the traditional urology field in order to introduce critical, new multi-disciplinary expertise into urologic research within the mission of the NIDDK. All efforts should be described in the context of the Core goals to foster highly meritorious science and training and career development.
In addition, applicants should describe approaches for promoting Centers' activities, opportunities, and advances at outside scientific meetings; developing and support for yearly CAIRIBU meeting; administration of regular webinars/teleconferences; increasing interactions with outside professional and scientific organizations to further support the Core goals; and for developing and maintenance of a CAIRIBU website. Plans to identify and attend key Centers and Training and Career Development Program educational enrichment events should be described. Applicants should also describe plans for centralized administration and oversight of the central Urology Centers Opportunity Pool Program and resources allocated to the Core for this Program. Plans for development and administration of the Interactions Core Travel and Professional Development Awards Programs should be detailed. These descriptions should include plans for soliciting, reviewing, and selecting the projects under the opportunity pool including plans for tracking of applications and awards.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.
Other Plan(s):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix: Only limited 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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Use of Common Data Elements in NIH-funded Research
Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.
Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.
Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.
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 proposed Interactions Core address the needs of the research programs that it will coordinate? Is the scope of activities proposed for the Interactions Core appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research programs?
Specific to this NOFO: Interactions Core efforts are proposed to enhance collaboration and sharing between the NIDDK Centers Program (U54 and P20), the KURe and UroEpi training/career development programs, and the broader urology research community and investigators outside the traditional urology field. These collaborations are expected to create synergy to advance our understanding of non-cancer genitourinary diseases and disorders and build the community of investigators beyond the capacity of these individual programs. Proposed efforts will serve to engage trainees and junior investigators.
Are the PD(s)/PI(s) and other personnel well suited to their roles in the Interactions Core? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing benign genitourinary research? Do the investigators demonstrate significant experience with coordinating collaborative basic research? If the Center 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 Interactions Core? Does the applicant have experience overseeing selection and management of subawards, if needed?
Specific to this NOFO: The proposed Interactions Core Director, or one or more members of a proposed Multi-PI team, has a track record of research and administrative accomplishments and team building in the field of non-cancer urological disease.
Does the application propose novel organizational concepts or management strategies in coordinating the research programs the Interactions Core 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: The Interactions Core investigators propose innovative strategies for promoting broad collaborations within U54, P20, K12 programs and external investigators; for development of agendas for yearly CAIRIBU meetings; for gaining visibility for the resources available through the U54 O'Brien Centers; for building links and tracking fruitful collaborations between investigators inside and outside the CAIRIBU community; and for the administrative task of hosting webinars and the CAIRIBU website. Strategies are proposed to provide a social media presence for CAIRIBU activities. Approaches proposed to increase engagement of patients and other community and professional stakeholders.
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research programs the Interactions Core will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the programs, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the programs are in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the programs? 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: Adequate plans in place at the Interactions Core to enhance broad collaboration and sharing. Plans are in place for the promotion of Centers' activities, opportunities, and advances at outside scientific meetings. A strategy for developing and support of the yearly Collaborating for the Advancement of Interdisciplinary Research in Benign Urology (CAIRIBU) meeting and the administration of regular group webinars/teleconferences is presented. Plans are proposed to develop and maintain a CAIRIBU website. An adequate strategy is presented for administration of centralized Opportunity Pool funds and Travel and Professional Development Awards. Adequate plans are proposed to develop and utilize metrics to access the Opportunity Pool Program's operations and successes, as well as metrics for accessing the Interactions Core and CAIRIBU efforts and inform on changes needed to meet evolving needs. Strategies are proposed to develop research interests groups to promote interactions across disciplines.
If the project involves human subjects and/or NIH-defined clinical research, plans are presented 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.
Will the institutional environment in which the Interactions Core will operate contribute to the probability of success in facilitating the research programs it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Interactions Core proposed? Will the Interactions Core benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
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.
For Renewals, the committee will consider the progress made in the last funding period.
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.
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 or cores 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, 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 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.
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 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.
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 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.
Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.
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
Deepak Nihalani, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-6417
Email: deepak.nihalani@nih.gov
Lan Tian, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone 301-496-7050
Email: tianl@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.