National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
U24 Resource-Related Research Projects Cooperative Agreements
- December 21, 2021 - Notice of Pre-Application Webinar for RFA-DK-21-034. See Notice NOT-DK-22-006.
- October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. See Notice NOT-OD-22-018.
- September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice NOT-OD-21-181.
- August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. See Notice NOT-OD-21-169
- August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170
- April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109
This Funding Opportunity Announcement intends to support the creation of an Analysis, Technology, Leadership, Administration and Science (ATLAS) Center that has the overarching goal of building the "go-to" open-access resource for the research community of mouse and human renal and genitourinary development and disease. The ATLAS Center will have scientific and administrative responsibilities including: 1) integrating and visualizing disparate datatypes and organs of the renal and genitourinary tract; 2) developing, adopting, or improving state-of-the-art computational tools and approaches to carry out analyses of multi-modal molecular and imaging data; 3) building interactive 2D/3D atlases and molecular maps with FAIR principles (findable, accessible, interoperable, and reusable) to promote data retrieval, exploration, discovery, and analysis by the community; 4) developing, designing, maintaining, and enhancing an open-access, interactive public data and analysis portal; and 5) coordinating internal and external activities of the GenitoUrinary Development Molecular Anatomy Project (GUDMAP) and (Re)Building a Kidney (RBK) consortia, including administration of an opportunity pool to address scientific gaps and opportunities.
February 24, 2022
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| March 24, 2022 | Not Applicable | Not Applicable | July 2022 | October 2022 | December 2022 |
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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 SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
Background
Over the past decade, there has been an explosion in the development of state-of-the-art molecular technologies such as single-cell transcriptomics, single-cell epigenomics, and spatial transcriptomic methods, as well as advances in 2D/3D imaging techniques including CODEX and MALDI-MSI that have transformed biomedical research. In parallel, rapid advances in data science technologies and the development of new approaches for data storage, data integration, and analysis of large, heterogeneous datasets, along with innovations in computational methods in advanced machine learning and artificial intelligence, have created new opportunities to answer fundamental biological questions and accelerate discovery. Indeed, the confluence of these technologies promises to enable unprecedented insight into developmental processes and disease mechanisms, through understanding tissue organization and complex cell-cell interactions, uncovering new distinct cell-types, and deciphering complex gene regulatory networks.
The NIDDK supports several research consortia and basic research projects that are employing state-of-the-art technologies and generating large, diverse, and complex datasets, consisting of genomics/omics, clinical, and imaging data to study mouse and human renal and genitourinary development and disease. For example, GUDMAP Atlas projects employ single-cell RNA-seq, single-cell ATAC-seq, spatial transcriptomics as well as advanced imaging technologies such as CODEX and nano-computed tomography. The breadth and quantity of data generated presents researchers with significant computational challenges in processing, accessing, and analyzing data, and has emerged as one of the major obstacles and bottlenecks to fully address fundamental questions in renal and genitourinary biology. In addition, there are limitations in the availability of bioinformatic and computational tools that can be utilized by basic, translational, and clinical researchers with minimal computational experience that limit the exploration of data and fully unlock the potential in these datasets. Consequently, there is a critical need for the development and improvement of advanced computational, statistical, and bioinformatic approaches and tools to handle these multi-omic and imaging datasets through novel approaches in data management and storage, integration, and analysis. More importantly, there is a fundamental necessity to continually improve, adapt, and develop computational platforms that provide access to user-friendly bioinformatic and analytical tools to democratize data analysis and data usage.
In response to these data challenges, and to more effectively utilize the molecular data generated by various NIDDK consortia and research programs in renal and genitourinary systems, this FOA seeks to establish a new Analysis, Technology, Leadership, Administration and Science (ATLAS) Center. The vision for this funding opportunity is to create the go-to knowledgebase and public resource for the research community that focuses on renal and genitourinary development and disease in humans and mice to expand on NIDDK’s commitment to promote bioinformatic solutions that harness the power of data science and accelerate biomedical discoveries.
Research Objectives
The ATLAS Center will ensure that this resource, which will contain the most comprehensive molecular profiles of the cells in renal and genitourinary tissues, is freely available to the research community. It is expected that the ATLAS Center will ingest, clean and harmonize new and existing data from GUDMAP and RBK, maintain these databases, as well as incorporate select external data (e.g., those produced by the Kidney Precision Medicine Project (KPMP), the Human BioMolecular Atlas Program (HuBMAP), and the Human Cell Atlas (HCA)), in order to generate comprehensive tissue reference maps and interactive 2D/3D molecular atlases of renal and genitourinary tissues, develop tools to perform integrative analyses, and support a knowledgebase that follows FAIR principles.
To achieve these goals, the applicant is expected to provide an overall vision for the ATLAS Center, and describe data management, the development of tools for data integration and visualization, as well as program coordination, as detailed below:
1) Vision
- Provide scientific vision and leadership for an interactive knowledgebase that integrates multiple datasets and datatypes and provides tools for analysis and visualization as the go-to open-access resource for the research community regarding mouse and human renal and genitourinary development and disease.
- Participate in and leverage research community efforts (e.g., involving ontology development) that will facilitate connections between other databases or knowledgebases (KPMP, HUBMAP, HCA).
- Understand the research community needs and adapt resources to meet those needs from the super-user familiar with large and complex datasets, to the basic scientist, clinician, or student with varied computational experience.
- Support a collaborative bioinformatics community across the GUDMAP and RBK consortia, as well as the external research community that promotes the analysis and usage of data.
2) Data Management
- Develop, maintain, and enhance an open-access, public knowledgebase website.
- Ingest, clean, harmonize, store, and archive all GUDMAP and RBK consortia data and adhere to FAIR principles.
- Build and manage internal and external facing IT tools for the GUDMAP and RBK consortia, and external research community, to include communications, file sharing, data access and data analysis.
- Build and incorporate QA/QC tools that can determine missing, incomplete, and erroneous data and sources of technical noise to ensure that only high-quality data is released and displayed to the public.
- Submit all data to public databases (e.g., GEO and/or dbGaP) on a regular basis in compliance with NIH Genomic Data Sharing Policy (https://osp.od.nih.gov/scientific-sharing/policies/) and archive data at the NIDDK Central Repository.
- Optimize platforms for data integrity, dimensionality reduction, harmonization, scalability, security, accessibility and re-use and potential migration to a cloud-based environment.
- Use and enhance existing GUDMAP and other developed ontologies, controlled vocabularies, and semantically indexed data across technologies, development, and disease in order to maintain a computational framework for the exploration of data and enable discovery.
- Provide support to create relevant citable Digital Object Identifiers (DOIs) and for the collaborative management and sharing of research methods and protocols (protocols.io).
- Ensure that the GUDMAP and RBK datasets and documentation are in a "standard format" that is mutually agreed upon by the Steering Committee for maximum use (open access) prior to the close out of the project.
- Ensure data security with a backup strategy.
3) Tools, Data Integration and Data Visualization
- Implement and improve upon state-of-the-art computational and systems-level approaches to integrate multi-modal molecular data, spatial and imaging data from GUDMAP and RBK, and select external data to create well-annotated and searchable 2D/3D molecular atlases and reference maps.
- Utilize or enhance off-the-shelf tools that allow users of various bioinformatics skill levels to interrogate, explore and effectively analyze and visualize the data.
- Manage a suite of visualization and analysis tools for 2D/3D imaging data that facilitate computational access, navigation and downloading data to maximize broad usability and incentivize interrogation by the broader research community. These tools should allow users with various computational experience to perform several diverse tasks, including but not limited to:
- Visualize key molecular pathways, regulatory networks, marker genes, and/or gene targets present in renal and genitourinary development and disease.
- Identify molecular and cellular composition, cell-cell interactions, tissue organization, and anatomical structures.
- Determine tissue-level and cell-level, spatial, functional, and/or temporal relationships, including mechanisms for identifying novel cell types, cell-states, molecular or cellular marks (e.g., anchor genes), and anatomic relationships of each cell type relative to its neighbors.
- Utilize existing software packages and analysis methods, such as R-based or Python-based solutions, that would enhance reproducibility and re-use where possible. Consideration should be given to containerize the entire pipeline and utilize open standards, such as Common Workflow Language (CWL), for describing analysis, workflows, and tools, to make them more portable, scalable, and sustainable across a variety of software and hardware environments.
4) Program Coordination
The ATLAS Center will provide administrative functions to facilitate and coordinate the GUDMAP and RBK consortia and will be expected to:
- Facilitate and promote interactions between members of GUDMAP and RBK and the broader research community.
- Coordinate the planning, arrangement and technical, administrative, operational support of teleconferences, meetings, and site visits of these consortia.
- Prepare and distribute meeting minutes. Meetings may include weekly executive committee meetings, Steering Committee meetings, Consortium Management Board meetings, monthly webinars, working group meetings, and ad hoc meetings.
- Coordinate common research activities and harmonize aspects of the work conducted by GUDMAP and RBK members to promote synergy and reproducibility.
- Develop and implement agreements to support interactions within the consortia and with collaborators (e.g., confidentiality and sharing agreements).
- Advertise and develop a system for the distribution of induced pluripotent stem cell (iPSC) reporter lines through a contract with a third party.
- Develop and execute an Opportunity Pool funding program to address gaps or catalyze new partnerships in renal and genitourinary research. The program will be flexible as the available funds, knowledge gaps, or opportunities may change over time. This application should allow for both animal and human studies and international collaboration via the Opportunity Pool.
- Develop creative approaches such as hack-a-thons, data jamborees or kaggles and other collaborative efforts to promote data reuse and data analysis from the ATLAS knowledgebase to the wider research community.
Essential objectives from the project period will be:
- Establish a go-to , web-based public resource and knowledgebase for data retrieval, visualization, and discovery analysis related to mouse and human renal and genitourinary development and disease.
- Develop computational platforms and pipelines for data ingestion, quality control, cleaning, harmonization, scale-up, curation, and archiving of data.
- Integrate GUDMAP, RBK and select external data (e.g., KPMP, HuBMAP, HCA) to generate comprehensive tissue reference maps and interactive 2D/3D molecular atlases of renal and genitourinary tissues.
- Implement intuitive query, analysis, and visualization tools which are available to end-users with varying computational abilities.
- Form collaborative bioinformatic interactions across GUDMAP and RBK and other relevant stakeholders (e.g., KPMP, HuBMAP, HCA).
- Follow and strictly adhere to FAIR principles.
- Develop and package data and analytic workflows appropriately for possible mobilization to a cloud environment or transfer to the next ATLAS Center.
- An Opportunity Pool to address research gaps and opportunities or form new partnerships.
- Due to the rapidly changing biological and biomedical research landscape it will be essential for the ATLAS Center to be flexible and adapt to changes in data types and technologies, software for analysis and visualization.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Not Allowed: Only accepting applications that do not propose clinical trials.
Need help determining whether you are doing a clinical trial?
The NIDDK intends to commit $1,621,000 to support one award under this FOA in Fiscal Year 2022.
Direct costs are expected to be approximately $850,000 per year (excluding the Opportunity Pool). Applicants must ask for at least $300,000 or more per year for the Opportunity Pool. All Opportunity Pool costs are inclusive of any F&A for the ATLAS Center and the subrecipients. As such, the ATLAS Center should not calculate F&A on the Opportunity Pool set aside.
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 FOA.
1. Eligible Applicants
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Local Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
Federal Governments
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
- Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
- System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
- NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
- eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
- Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
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 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
- A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
- A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
- An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).
1. Requesting an Application Package
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
2. Content and Form of Application Submission
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
- Descriptive title of proposed activity
- Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
- Names of other key personnel
- Participating institution(s)
- Number and title of this funding opportunity
The letter of intent should be sent to:
John F. Connaughton, Ph.D.
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7797
Email: NIDDKLetterofintent@mail.nih.gov
Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Instructions for Application Submission
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide must be followed.
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:
- Work with NIDDK to participate in the initial and semi-annual meetings during the course of the grant award;
- Cooperatively interact with NIDDK in support of the projects and activities;
- Actively seek input from NIDDK regarding resource or expertise needs that may arise during the performance of the project;
- Participate in weekly conference calls; and
- Work closely with other relevant stakeholders (e.g.KPMP, HuBMAP, HCA) to achieve the goals of this FOA.
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.
The applicants should describe the key personnel (with the appropriate expertise and necessary effort) to implement a vision for the ATLAS Center including responsibilities pertaining to tools, data integration and data visualization, data management, and program coordination, as outlined in Section I. The NIDDK anticipates expertise in the following areas, which may be held by 3-6 key personnel, will be needed to carry out the functions of the ATLAS Center:
- Data management and QA/QC expertise to lead efforts to clean, harmonize, store, and curate data.
- Renal and genitourinary research expertise to lead efforts in biocuration and ontology development.
- Computational expertise in data visualization, spatial mapping, systems biology and bioinformatics.
- User-experience design, website creation and software development expertise, to build a knowledge base with FAIR principles to promote data retrieval, exploration, discovery, and analysis by the community.
- Program management background to carry out the administrative functions of both consortia.
R&R Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
- PD(s)/PI(s) will be required to declare a minimum effort of 2.4 person-months (20 percent) effort per year. Applications proposing Multiple PD(s)/PIs(s) must have a minimum combined PD/PI effort of 2.4 person-months.
- Clearly indicate costs associated with website and software development and data storage, including costs of making data and analytic workflows ready to migrate to a cloud-based environment in the final budget period or sooner.
- The budget should include funds to support community outreach efforts including the hosting of hack-a-thons, data jamborees and/or kaggles.
- The budget should request $50,000 to support the cost of distributing and advertising the iPSC reporter lines through a third party.
The in-person meetings and the audio/video calls of the GUDMAP and RBK consortia are the responsibility of the ATLAS Center. There will be semi-annual meetings of the RBK consortium and an annual meeting of the GUDMAP consortium. It is anticipated that all meetings will take place in Bethesda, MD. The ATLAS Center application should request a budget for the costs of the consortia meetings (except for the costs of travel and attendance of the GUDMAP and RBK project investigators and NIDDK staff) and should include costs for travel and attendance of five Consortia Management Board (CMB) members, including consulting costs ($200/day) for each in-person meeting.
Applicants must request support for an Opportunity Pool of $300,000 or more per year (inclusive of all F&A costs) to address gaps and scientific opportunities. The ATLAS Center should not calculate F&A on the Opportunity Pool set aside. Rather, the ATLAS Center should budget for costs associated with the administration of the Opportunity Pool (including key personnel) within the ATLAS Center. In addition, the ATLAS Center is entitled to F&A costs on the first $25,000 of each subaward made from the Opportunity Pool. It is anticipated that the Opportunity Pool will support about 20 subawards over the 5-year project period of the CH (with each subaward being about $50,000 total costs per year). Please note that the F&A costs for the sub-recipient institution are included in the total costs of each subaward.
R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy:
The Research Strategy should describe how the applicants will achieve goals in four categories: 1) Vision, 2) Data Management, 3) Tools, Data Integration, and Data Visualization, and 4) Program Coordination, as outlined in Section I.
The Research Strategy should include a section labeled Research Concepts that also addresses the vision for the knowledgebase and demonstrates the applicant’s capabilities:
- Provide examples of queries that users of varying computational experience may wish to use and what integration, analysis, and curation will be needed to enable those queries.
- Describe at least one potential graphical tool that will be developed or adapted to enter the data and how it could be extended to the renal and genitourinary systems.
- Describe how 2D and 3D molecular data and imaging will be integrated, and what tools will be developed or adapted to analyze, query, and visualize data.
- Describe how portable reference datasets will be developed as a community standard for comparison with experimental or disease datasets.
- Describe plans to integrate, harmonize, and analyze select external and complementary data to maximize discovery (e.g., KPMP, HuBMAP, HCA, etc.)
- Describe how user-friendly bioinformatic platforms, analytic pipelines, and visualization tools will be implemented that are accessible to the expert and lay-user to maximize data usage.
Describe how the ATLAS will create and administer an Opportunity Pool to address research gaps or form new partnerships. The organization of the Opportunity Pool Program should be flexible as the size and use of the pool may change, but at a minimum, it should:
- Work with the Consortium’s Steering Committee, NIDDK staff, and potential other funding partners to perform a yearly assessment to identify emergent needs of infrastructure and resources.
- Publicly announce solicitations, manage acceptance of proposals, organize peer-review, prioritize proposals for funding.
- Disburse and track subcontracts and integrate new investigators into each Consortium.
- .
- Establish procedures, formats, and timelines for integrating recipients and monitoring and reporting progress and outcomes (e.g., publications, subsequent awards).
- Establish a plan to integrate and harmonize the activities of supported projects with ongoing activities of GUDMAP, RBK and/or other relevant stakeholders.
- Allow for both animal and human studies and international collaboration via the Opportunity Pool.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
- To advance the goal of supporting FAIR data and services, and enhance reproducibility, investigators will be expected to share code/scripts, analytic tools/statistical models, protocols/processes and metadata -- used or developed for harmonization, integration, visualization, curation, and analysis -- through open-access repositories, such as protocols.io and GitHub. Investigators are strongly encouraged to use open-source software, analytic tools, and programming languages to promote interoperability as well as reproducibility.
- All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan that include plans to ensure datasets and documentation are in a mutually agreed upon "standard format" for maximum use (open access) and in accordance with FAIR Principles. This plan should also address methods for continuing to make data available to the NIH and the research community upon completion or termination of the project so that accumulated data remain accessible, for example through public repositories, if available.
- Applicants are expected to include a plan addressing if, or how, they will exercise their intellectual property rights while making available to the broader scientific community patentable research resources, consistent with achieving the goals of this program. These plans must be fully supported by the applicant's institution.
Letters of Support: Letters of Support should describe the institutional support for the program and commit to supporting the goals of the Analysis, Technology, Leadership, Administration and Science (ATLAS) Center, as well as support for plans pertaining to intellectual property and sharing.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
- No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.
PHS Human Subjects and Clinical Trials Information
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.
3. Unique Entity Identifier and System for Award Management (SAM)
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
4. Submission Dates and Times
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
5. Intergovernmental Review (E.O. 12372)
This initiative is not subject to intergovernmental review.
6. Funding Restrictions
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
7. Other Submission Requirements and Information
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. 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 FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by 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 datasets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.
Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
1. Criteria
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
Overall Impact
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
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 FOA:
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How well do the Research Concepts demonstrate a vision for developing a knowledgebase that is the go-to open-access resource for the research community investigatingmouse and human renal and genitourinary development and disease?
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How well do the proposed bioinformatic and computational tools to enable basic, translational, and clinical researchers with minimal computational experience the ability to explore data and fully unlock the potential in the data?
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How well does the project maximize opportunities for sharing of knowledge, resources, and tools generated by GUDMAP Atlas and RBK Research Projects?
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 FOA:
- How appropriate is the domain expertise in program management, bioinformatics and computational analysis, website and software development, biocuration and ontology development (including specific expertise in appropriate organ anatomy and physiology) for the defined key personnel?
- How appropriate is the evidence that the investigators will abide by the expectations pertaining to sharing as defined by the FOA and the priorities and policies agreed upon by the SC of each consortium?
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 FOA:
- How innovative are the computational methods and systems-level approaches to integrate multi-modal data to generate reference maps and 2D/3D atlases?
- How innovative and novel are the tools for visualizing 2D/3D molecular, spatial, and imaging data?
- How useful are the tools to:
- Query data across multiple datatypes or improve the representation of relationships of structures/cells across data types?
- Enable users with varying computational abilities to explore the data (i.e., casual user to savvy user)?
- How creative are the approaches to invite and incentivize the research community to participate in the analysis of knowledgebase data such as the formation of hack-a-thons, data jamborees or kaggles?
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 FOA:
- How robust and appropriate are the plans for the proposed ATLAS Center to generate a go-to open-access resource for the research community ofmouse and human renal andgenitourinary development and disease?
- How appropriate are the proposed integration strategies to enable novel analyses across multiple-omic and imaging datasets by the research community?
- How appropriate are the plans to implement FAIR principles?
- Will the overall methodologies allow for efficient maintenance and upgrading the knowledgebase and be adaptable to new data types?
- How complete and adequate are the plans to continue to develop ontology for components of the renal and genitourinary system?
- To what extent will the proposed plan for incorporating select external data to generate tissue reference maps add value to the ATLAS?
- How will plans for the Opportunity Pool Program augment the goals of the
- How appropriate are the plans to administer an Opportunity Pool of funds, including criteria for solicitation, evaluation by rigorous peer review, and selecting projects to support GUDMAP and RBK consortia and address gaps and scientific opportunities?
- How well will the plans promote data use and analysis from the ATLAS knowledgebase?
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?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal 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.
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 following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDDK, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council (NDDKAC). The following will be considered in making funding decisions:
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
3. Anticipated Announcement and Award Dates
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
1. Award Notices
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:
- Federalwide Research Terms and Conditions
- Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
- Acknowledgment of Federal Funding
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
- Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
- Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
- HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
- Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
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 Parts 75, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
- All aspects of the scientific activities, including defining the objectives and approaches, planning, conduct, analysis, and publication of results, interpretations, and conclusions of studies conducted under the terms and conditions of the cooperative agreement award.
- Collaborating with other investigators in the program for protocol development, sharing of samples, reagents and data, as well as developing data quality control standards, and data and metadata standards.
- Sharing of analytical pipelines, software and visualization tools with the consortium and broader community.
- Accountability towards the applicant organization officials and to the NIDDK for the performance and proper conduct of the research supported by the project in accordance with the terms and conditions of the award.
- Serving as a voting member of the GUDMAP SC and the RBK SC and will attend the Planning Meeting and a SC meeting for both consortia and the monthly GUDMAP and RBK teleconference calls.
- Accepting and implementing the goals, priorities, procedures, protocols, and policies agreed upon by the SCs and subcommittees and be responsible for close coordination and cooperation with the GUDMAP Atlas and RBK Research Projects and with NIH staff.
- Adhering to PHS policy for the distribution of unique research resources produced with PHS funding as described under Special Requirements.
- Establishing written milestones for the project, in negotiation with NIDDK Project Staff prior to funding.
- Release all study design materials and procedure manuals into the public domain and/or make them available to other investigators, according to the approved plan for making data and materials available to the scientific community and the NIDDK, for the conduct of research at no charge other than the costs of reproduction and distribution, consistent with achieving the goals of this program initiative.
- In accordance with the NIH Policy for Data Management and Sharing (NIH NOT-OD-21-013), the NIDDK approved plan will become a term and condition of award, be routinely monitored during the award period, and compliance may factor into future funding decisions. By the end of the funding or proprietary period, an recipient or study group may not continue to use or share study generated resources until those resources are available to the public via an NIDDK approved repository per the NIDDK approved sharing plan.
- The NIDDK has established a Central Repository to support the receipt, storage, and distribution of data, biosamples, and other resources generated in clinical studies funded by the NIH/NIDDK. When the NIDDK Central Repository is to be utilized, prior to enrolling participants, the PI or his/her designee will coordinate with the NIDDK Program and Central Repository staff to prepare for eventual archiving and distribution of the study generated resources that are to be maintained in the Central Repository. All resources transferred to the Central Repository will be under the custodianship of the NIDDK.
- Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
- Any involvement of a third-party (including industry, academia, and foundations) in the study and network activities that includes access to any network study data and biosamples, or study results that are not publicly available, or using the name of the network or study or the name of the NIH or NIDDK, is permitted only after written permission by the NIDDK Program staff who will consult with others at NIH and NIDDK Technology Advancement Office.
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Any third-party (including industry, academia, and foundations) collaboration should be governed by a research collaboration agreement (e.g. Clinical Trial Agreement, Research Collaborative Agreement, etc.) or any third-party contract mechanism(s) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, applicable NIH/NIDDK policies and procedures, and with written approval from NIDDK Program staff. Any relevant proposed third-party agreements related to the network studies between grantee and third-party will be provided to the NIDDK Program staff and NIDDK Technology Advancement Office for review, comment, and approval to assure compliance with NIH/NIDDK policies and network policies. Further, at the request of the NIDDK Program staff, any other network-relevant third-party agreements must be shared with NIDDK. Failure to comply with this term may prompt action in accordance with NIH Grants Policy Statement, Section 8.5 titled: Special Award Conditions and Remedies for Noncompliance (Special Award Conditions and Enforcement Actions , and Section 8.5.2, titled: Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding Support , noncompliance with the terms and conditions of award will be considered by the funding IC for future funding and support decisions and may result in termination of the award.
NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
- A NIH/NIDDK Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. However, the dominant role and prime responsibility for the project as a whole resides with the recipients, although specific tasks and activities in carrying out the studies will be shared by recipients and the NIDDK.
- NIDDK will designate a Project Officer and a Grants Management Specialist to provide normal program stewardship and administrative oversight of the cooperative agreements for the GUDMAP and RBK consortia.
- NIDDK will form a separate Consortium Management Board (CMB) for the GUDMAP and the RBK consortia. The CMB will be comprised of a NIH/NIDDK Project Scientist and other NIH extramural staff with relevant scientific expertise or who manage research grant programs that relate scientifically to the goals of the GUDMAP and RBK consortia, and outside advisors selected by the NIDDK.
- The CMB will meet annually with the GUDMAP SC and semi-annually with the RBK SC, to review and assess progress and to advise NIDDK of scientific developments and opportunities that may enhance the achievement of the GUDMAP and RBK goals.
- A NIH/NIDDK Project Scientist will attend and participate as a voting member in all meetings of the SC, and provide liaison between the SC and the CMB.
- A NIH/NIDDK Project Scientist will help the SC develop and draft operating policies.
- The appropriate NIDDK Project Officer will review separately the ATLAS Center and the scientific progress of the GUDMAP Atlas Projects and will review ATLAS Center and the scientific progress of RBK Research Projects, for compliance with operating policies developed by the SC, and may recommend to the NIDDK to withhold support, suspend, or terminate an award for lack of scientific progress or failure to adhere to policies established by the SC.
- An agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
Areas of Joint Responsibility include:
- The CMB will meet annually with the GUDMAP SC and semi-annually with the RBK SC to review and assess the progress of the consortia and to advise NIDDK of scientific developments and opportunities that may enhance the achievement of the GUDMAP or RBK goals.
- There will be two separate SCs, one for the GUDMAP consortium and one for the RBK consortium - The NIH/NIDDK Project Scientist, PIs from the project funded through this FOA and RFA-DK-20-013 (GUDMAP) and PIs from the project funded through this FOA and RFA-DK-19-007 (RBK) will be responsible for forming the GUDMAP and the RBK SC, respectively. An arbitration system, as detailed below, will be available to resolve disagreements among members of the SC. The respective SCs will be the main governing board of the GUDMAP and RBK consortia. It will develop collaborative protocols, identify technological impediments to success and strategies to overcome them, develop shared software tools for disseminating information about the projects, and identify opportunities for sharing techniques and tools that might be developed in future GUDMAP Atlas and RBK Research Projects
- The GUDMAP SC will be composed of the PIs from the project funded through this FOA, RFA-DK-20-013, and a NIDDK Project Scientist. The RBK SC will be composed of the PIs from the project funded through this FOA and RFA-DK-19-007, and a NIH/NIDDK Project Scientist. The SC PIs will each have one vote. The NIDDK Project Scientist will have one vote. Each SC will select a chairperson who will be someone other than an NIH staff member.
- Each SC may, as it deems necessary, invite additional, non-voting scientific advisors to meetings at which research priorities and opportunities are discussed. The NIH reserves the right to augment the scientific or consumer expertise of the SC when necessary.
- There will be two annual SC meetings for the RBK consortium and a single annual meeting for the GUDMAP consortium. The first meeting will be a Planning Meeting where the SC will be formed, and a chairperson selected from among the members. The SC may: (a) draft a charter to detail policies and procedures, a process for monitoring compliance with the policies and procedures, and a process for recommending that the NIH Project Administrators act on evidence of non-compliance of any Consortium component with SC policies; (b) agree upon the terms of the charter; and (c) devise separate plans for interactions between the ATLAS Center and GUDMAP Atlas and the RBK Research Projects, respectively.
- At the second and subsequent meetings, the SC for GUDMAP will refine the GUDMAP scientific objectives and implementation as necessary, consistent with data produced by former and possible future GUDMAP atlas projects and from other laboratories, while the RBK SC meeting will share scientific advances and establish collaborative activities between projects.
- The GUDMAP and RBK SCs will plan workshops, to inform the research community of the progress made toward development of the GUDMAP atlas or the efforts of the RBK, and to inform the research community of any technological advances related to the implementation of the consolidated GUDMAP/RBK data repository. The NIH/NIDDK Project Scientist(s), the CMB, and other NIH staff as appropriate will provide the SC with advice on participants for the workshops and symposia.
- The SC may establish subcommittees as it deems appropriate recipient members of the SC will be required to accept and implement policies approved by the SC.
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 will have three members: a designee of the SC chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.
3. Reporting
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.
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: http://grants.nih.gov/support/ (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: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Eric W. Brunskill, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-215-1698
Email: eric.brunskill@nih.gov
Anna B. Sadusky, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-827-7036
Email: anna.sadusky@nih.gov
Ryan Morris, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-480-1296
Email: ryan.morris@nih.gov
Charlette Kenley
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8847
Email: ck128i@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 45 CFR Part 75 and 2 CFR Part 200.
and Human Services (HHS)
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