Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Office of Strategic Coordination (Common Fund)

This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (http://commonfund.nih.gov/) through the NIH Office of the NIH Director, Office of Strategic Coordination (https://dpcpsi.nih.gov/). All NIH Institutes and Centers participate in Common Fund initiatives. The FOA will be administered by the National Human Genome Institute (NHGRI/NIH), (http://genome.nih.gov) on behalf of the NIH.

Funding Opportunity Title
The Human BioMolecular Atlas Program (HuBMAP) Demonstration Project (U01 Clinical Trial Not Allowed)
Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type
New
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-RM-21-027
Companion Funding Opportunity
RFA-RM-21-026 , U54 Specialized Center (Cooperative Agreements)
Assistance Listing Number(s)
93.310
Funding Opportunity Purpose

The goal of this funding opportunity announcement is to solicit applications that will creatively use datasets and resources from the Human BioMolecular Atlas Program (HuBMAP: https://commonfund.nih.gov/hubmap) to demonstrate their use to address significant biomedical and biological questions. Projects are expected to work closely with the other funded projects as part of the HuBMAP Consortium to provide specific and actionable feedback, validations, tools, software and other resources back to the consortium.

Key Dates

Posted Date
September 10, 2021
Open Date (Earliest Submission Date)
October 19, 2021
Letter of Intent Due Date(s)

October 18, 2021

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
November 19, 2021 Not Applicable Not Applicable March 2022 May 2022 July 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.

Expiration Date
November 20, 2021
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the 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.

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

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

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


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Human BioMolecular Atlas Program (HuBMAP)

The vision for the Human BioMolecular Atlas Program (HuBMAP) is to catalyze development of a framework for mapping of the human body at high resolution to transform our understanding of tissue organization and function. This will be achieved by:

  • Accelerating the development of the next generation of tools and techniques for constructing high resolution spatial tissue maps that quantify multiple types of biomolecules either sequentially or simultaneously;
  • Generating foundational 3D tissue maps using validated high-content, high-throughput imaging and omics assays;
  • Establishing an open data platform that will develop novel approaches to integrating, visualizing and modelling imaging and omics data to build multi-dimensional maps, and making data rapidly findable, accessible, interoperable, and reusable by the global research community;
  • Coordinating and collaborating with other funding agencies, programs, and the biomedical research community to build the framework and tools for mapping the human body;
  • Supporting pilot projects that demonstrate the value of the resources developed by the program to study individual variation and tissue changes across the lifespan and the health-disease continuum.

This program is funded through the NIH Common Fund as a short-term, goal-driven strategic investment, with deliverables intended to catalyze research across multiple biomedical research disciplines. The NIH Common Fund supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.

The HuBMAP Consortium will scale-up the range of tissues, technologies, data management and its community engagement activities throughout the duration of the program.

The five research initiatives that compose the program are:

  • Transformative Technology Development (TTD) - This set of initiatives, issued in FY2018 and FY2020, has focused on establishing proof-of-principle with initial validation of transformative new tools, techniques and methods for mapping the human body at high resolution.
  • Rapid Technology Integration (RTI) - This initiative, issued in FY2019, has focused on improving the quality and throughput of map generation at key steps of the production pipeline including sample collection, tissue mapping, and data integration and analysis.
  • Tissue Mapping Centers (TMC) – This set of initiatives, issued in FY2018, FY2020 and FY2022, seeks to build, benchmark, standardize, validate, and generate extensive data from high-content, high-throughput imaging and omics technologies to produce 3D human tissue maps at high resolution. Centers are expected to integrate and optimize all parts of the data generation pipeline, from tissue collection and preservation through to data integration, analysis and interpretation.
  • The HuBMAP Integration, Visualization and Integration (HIVE) Collaboratory - This set of initiatives issued in FY2018 and FY2022 support a multi-component collaboratory that is responsible for: 1) managing the data generated by the Consortium, 2) coordinating internal and external Consortium activities, 3) developing novel tools for visualizing, searching and modelling data and 4) building an atlas of tissue maps.
  • Demonstration Projects (this FOA)- The goal of this initiative, is to demonstrate how HuBMAP resources, in combination with new or other datasets or biospecimens as needed, can be used to build better statistical and analytic tools and models of cellular organization and communication in tissues.

Background

Understanding how tissue organization influences a cell’s molecular state, interactions, and history is critical for enhancing our understanding of variation in organ function across the lifespan and health-disease continuum. Despite vastly improved imaging and omics technologies as well as many important foundational discoveries, our understanding of how tissues are organized is restricted to a very limited number of microscopic structures. Better insights into the principles governing organization-function relationship will potentially lead to better understanding of the significance of inter-individual variability, changes across the lifespan, tissue engineering, and the emergence of disease at the biomolecular level. However, integrating imaging and omics analysis to comprehensively profile biomolecular distribution and morphology of tissues in a high throughput manner and placing this information into 3D tissue maps amenable to modelling has yet to be fully realized.

In a June 2016 meeting organized by the NIH, experts from the research community identified the following scientific priorities necessary to develop these tissue maps: 1) sourcing high quality tissue from multiple human normal organ sites, 2) processing and preserving tissue for multiple imaging and omics assays, 3) quality control, validation and variation in data generation, 4) data coordination across multiple acquisition techniques, 5) annotation, curation and archiving of the data, 6) browsing, visualizing and searching the data, 7) building statistical and analytic techniques and models for nonlinear analysis of highly multidimensional data and 8) community engagement.

The HuBMAP program was designed to tackle these priorities in four stages: a setup phase in 2018, a scale-up phase from 2019 to 2021, a production phase from 2022 to 2025 including a transition phase in 2025.The Consortium has made significant progress during the setup and scale-up phases and further information can be found on the Consortium’s website. This funding opportunity is designed to support the production phase of the program.

Objectives and Scope

The purpose of this specific FOA is to solicit applications that will utilize HuBMAP data and resources in combination with other resources to address significant biomedical and biological questions. Projects are expected to develop a close working relationship with the whole consortium and provide feedback to strengthen HuBMAP resources thus increasing the relevance and benefit of the outputs of the program to the larger biomedical community. Projects are expected to articulate a compelling use-case, a detailed and practical description of how they will leverage HuBMAP resources alongside other human single cell or other relevant data and specific outputs from the project that will significantly enhance the goals of HuBMAP. Enabling improved access and utility of the reference datasets available from HuBMAP is a major goal of this FOA.

Projects can propose to use HuBMAP data to investigate and understand new biology; or propose improvements or build new tools to process HuBMAP data; to build new APIs for accessing HuBMAP data or jointly analyze HuBMAP and other single-cell datasets in other disease-specific repositories; or build new or improve existing tissue-maps. HuBMAP provides access to unique datasets (e.g., spatial transcriptomics, metabolomics and proteomic data) and methods that integrate these with more common single-cell data are encouraged. Finally, projects can also propose to generate new datasets that will be contributed to the HuBMAP data portal from publicly-available biospecimens that would enhance HuBMAP resources for a specific study relevant to the HuBMAP mission of creating a normal reference map or atlas.

All proposed projects must utilize HuBMAP data. Use of additional data from other sources is strongly encouraged where appropriate. Applicants are encouraged to review the companion FOA (RFA-RM-21-026) and communicate with program staff to understand the range of data types that may be generated as part of HuBMAP production phase.

HuBMAP demonstration project awardees are expected to become key members of the HuBMAP consortium. Thus, the goals of the proposed projects must include openly sharing methods, algorithms, data, software and tools (see resource sharing below) and ensure comprehensive documentation of any tools, data or resources and utilizing consortium standards and practices already in place. Details about the consortium standards and practices are available on the website (https://hubmapconsortium.org/) including information about the technology stack, APIs, metadata and ontologies, etc. that make up the HuBMAP data portal can be found at this page. The HuBMAP HIVE program in consultation with NIH Program Staff will consider deploying tools and applications developed as part of this FOA on the HuBMAP portal for community use or make it available through APIs or other methods. Applicants with specific questions about the portal should email them to the scientific contact(s) listed in this document.

The following list, which is not intended to be comprehensive, describes examples of demonstration activities:

  • Software engineering focus:
  • Systematic testing and enhancement of HuBMAP APIs, data standards, pipelines and tools or development of new ways to access HuBMAP data.
  • Applications that use machine learning or other methods on advanced computational resources like the ones provided through the NSF XSEDE (https://portal.xsede.org/allocations/research)
  • Methods and standards that can potentially be used by single cell resources around the world to support cross-querying and other applications that enhance such interactivity.
  • Enabling access to HuBMAP resources for individual labs with limited computational support by developing suitable R/Python or other similar software. Other related challenges may need harmonizing the multi-omics data.
  • Biomedical focus:
  • Investigate the utility of HuBMAP "normal" data to study of disease e.g., all the different single cell data obtained from diseased tissues. This might need work mapping to relevant ontologies.
  • HuBMAP has some unique metabolite and lipid datasets that are challenging to integrate with genomics data and the community needs new methods development.
  • New methods of creating spatial maps that use single or multiple datatypes or data modalities.
  • Novel methods to visualize maps, data, constrained by prior biomedical knowledge.
  • New methods for identification of cell types and cell states coupled with experimental validation.
  • Methods along with the combination of HuBMAP and non-HuBMAP datasets that will strengthen the HuBMAP as a "normal" human single cell reference.
  • Methods that improve the community's ability to use the HuBMAP reference.
  • Demonstrate the utility of HuBMAP data and/or tools to answer an important biological question
  • Projects that propose a focused experimental validation of specific HuBMAP data sets

Applications addressing the following topics will be deemed non-responsive and will not be reviewed:

  • Projects where HuBMAP data and resources are incidental and not core.
  • Projects whose focus is not the study of human organs, tissues and cells.
  • Projects that do not propose well-defined outputs of their project that will improve HuBMAP data portal or other resources.
  • Projects that do not include a detailed Resource Sharing Plan and Plan for Enhancing Diverse Perspectives
  • The FOA is open to all investigators. Investigators who are currently not part of HuBMAP Consortia are especially encouraged to apply. One of the priorities of HuBMAP is to ensure as broad a representation of researchers as possible. This FOA requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application (see below). Applicants are strongly encouraged to view the available PEDP guidance material (look for HuBMAP: Plan for Enhancing Diverse Perspectives (PEDP) FAQ) on the HuBMAP website.

Technical Assistance Webinar

All applicants are strongly encouraged to contact NIH Staff to discuss the alignment of their proposed work with the goals of this FOA and the HuBMAP Program. A Technical Assistance teleconference will be held for potential applicants from 12-1pm Eastern Time on October 1, 2021. NIH staff will be available to answer questions related to this FOA. Dial in information for the call is posted on the HuBMAP website and slides will be made available on the website for those unable to attend. A list of frequently asked questions (FAQs) related to the program are also posted on the website: https://commonfund.nih.gov/hubmap/generalfaqs. The information session is open to all prospective applicants, but participation is not a prerequisite to apply.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed
New

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.

Clinical Trial?

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

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIH intends to commit $3M in FY 2022 to fund 5-9 awards. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are limited to $300,000 in direct costs (excluding subcontract F&A) per year and need to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 4 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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 - including the NIH Intramural Research Program
  • 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
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Required Registrations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH 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.
  • 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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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.

3. Additional Information on Eligibility

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 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).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this 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:

Ajay Pillai, Ph.D.
National Human Genome Research Institute (NHGRI)
Email: hubmap@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.

Other Attachments:

Plan for Enhancing Diverse Perspectives (PEDP)

In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

  • Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
  • Description of any planned partnerships that may enhance geographic and regional diversity.
  • Plan to enhance recruiting of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce.
  • Proposed monitoring activities to identify and measure PEDP progress benchmarks; indication of willingness to participate in NIH evaluations of PEDPs.
  • Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
  • Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
  • Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
  • Publication plan that enumerates planned manuscripts and proposed lead authorship.
  • Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see the HuBMAP: Plan for Enhancing Diverse Perspectives PEDP FAQ.

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

  • For single PD/PI applications, the PD/PI is expected to devote at least 1.2 person months, based on a 12-month calendar. If multi-PDs/PIs are proposed, then at least one PD/PI is expected to commit at least 0.7 person months annually and the other(s) should devote sufficient time to serve his/her proposed role and these should add up to at least 1.2 person months. The appropriateness of the effort of key personnel must be justified in the budget justification.
  • Budgets should include funds for the PD(s)/PI(s) and key personnel to attend the annual consortium meetings.
  • Budgets should include any funds required to support sharing of data under this FOA to HIVE (e.g., for broad data sharing or satisfying other Consortia requirements).

PEDP implementation costs:

  • Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7: https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm).

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: Applicants should describe

  • how the project will make use of existing HuBMAP data.
  • how the project will enhance the utility of the HuBMAP resources.
  • how the project will use and/or enhance existing HuBMAP APIs, data formats and standards or otherwise provide feedback that will improve HuBMAP as a resource.
  • plans to abide by HuBMAP policies (www.hubmapconsortium.org/policies) and software and data releases and/or demonstrate a commitment to improve these
  • plans to use best practices on data and software interoperability and scalability of tools and approaches.
  • their commitment and capability to undertake development of good, usable software.
  • their willingness to abide by software release policies agreed to by the HuBMAP consortia.
  • Applicants are encouraged to integrate PEDP aspects in the research strategy as PEDP will be reviewed under all scoring/review criteria (note a separate attachment in required summarizing the PEDP activities).

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

The following modifications also apply:

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan.
  • Data Sharing: Implementation of FAIR (Findable, Accessible, Interoperable, Reusable) Principles is essential for the success of HuBMAP. Consistent with achieving these principles, the NIH expects that information such as collected data, technical protocols, and any other metadata collected under this FOA is to be rapidly deposited as appropriate into the HIVE and in a recognized and reusable format. The HIVE will serve as the central access point for information regarding data, tools, and reagents being developed by the HuBMAP Consortium. If applicable, applicants must abide by the NIH Genomic Data Sharing Policy (https://osp.od.nih.gov/scientific-sharing/genomic-data-sharing/) and should indicate their agreement to abide by it in the data sharing plan.
  • Consortium Policies: Applicants should indicate their willingness to abide by all data deposition, quality control metrics, standardization, metadata requirements, data and software release, and public copyright license policies developed by the HuBMAP Consortium and approved by NIH staff (https://hubmapconsortium.org/policies/). A primary goal of the HuBMAP is to lay the foundation for a widely accessible atlas of tissue maps and this will require data and resources to be shared quickly and openly once validated, consistent with achieving the goals of the program.  Restrictive licensing and sharing practices for HuBMAP-generated data, tools, and resources could substantially diminish their value and public benefit. Accordingly, awardees should manage data, resources, protocols, tools, and software in a way that achieves this goal. Sharing practices that would prevent or block access to or use of HuBMAP program data, tools, and resources for research purposes will be hindering the goals of the HuBMAP. The development of policies, methods, and standards for such sharing is critically important. The NIH expects that the awardees will adhere to current and future policies, methods, and standards developed by the HuBMAP Steering Committee (SC), in concert with the NIH. These policies, methods, and standards will remain consistent with NIH-wide policies on data and resource sharing. Prior to funding, NIH Program Staff may negotiate modifications to the Resource Sharing Plan with the applicant.
  • Public Access: The NIH Common Fund intends to maximize the availability of publications and the sharing of underlying data for HuBMAP Projects and encourages publication of preprints and the use of open access journals. Applicants should describe their proposed process for making resulting publications and to the extent possible, the associated data immediately and broadly available to the public or provide a justification if such sharing is not possible. Underlying primary data is expected to be made as widely and freely available as possible while safeguarding the privacy of participants and protecting confidential and proprietary data. Applicants are encouraged to use existing, open licensing approaches and preprint repositories, and may include anticipated charges for publication or data sharing and resources that may be needed to support a proposed Resource Sharing Plan in the budget plan of their application.
  • Protocol, Tool, and Reagent Sharing: As one of the primary goals of this program is to advance research through development, establishment, broad dissemination and use of community resources across the research community, NIH intends that protocols, tools, and reagents generated by the HuBMAP Consortium be broadly available and distributed at minimal cost, and without undue intellectual property constraints, so that they can be as widely used as possible, thus enabling downstream investigations of understudied biomolecules by the larger scientific community. For all applications and where otherwise applicable, the applicant should discuss plans for sharing and distribution of non-data resources that will be generated by the proposed project, including models, protocols, biomaterials, and reagents. The HIVE will work with all HuBMAP Consortium investigators to collect, curate, and disseminate information regarding tools and reagents being developed by the HuBMAP Consortium to be disseminated through the HIVE and other sources as appropriate.
  • Intellectual Property: Intellectual property rights asserted by proposers must be aligned with the open source regime used to distribute software made under the award. Exceptions to open source technology will be considered only in compelling cases. Awardees will own the software and data developed under this award, subject to the Government’s royalty-free, nonexclusive, irrevocable right to use, disclose, reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, in any manner and for any purpose, and to have or permit others to do so. In addition, inventions, technical solutions and methods developed under this solicitation will remain the property of the awardees, who may freely use them for their own commercial purposes, subject to a nonexclusive, nontransferable, irrevocable, paid-up license to the Government to practice, or have practiced for or on its behalf, the inventions, technical solutions and methods throughout the world. Applicants should also be familiar with the NIH statements regarding intellectual property of resources developed with Federal funds (NIH Research Tools Policy (http://grants.nih.gov/grants/intell-property_64FR72090.pdf) and other related NIH sharing policies at http://sharing.nih.gov).
  • Sharing Software: Applicants are asked to propose a plan to manage and disseminate the improvements or customizations of their tools and resources by others and to have a plan for versioning software. This proposal may include a plan to incorporate the enhancements into the “official” core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution. There is no prescribed single license for software produced in this project; however, the terms of software availability should include the ability of researchers outside HuBMAP and its collaborating projects to modify the source code and to share modifications with other colleagues as well as with HuBMAP and reviewers will be asked to evaluate the software sharing and dissemination plan based on its likely impact. Any software dissemination plans represent a commitment by the institution (and its subcontractors as applicable) to support and abide by the plan. A software sharing plan guided by the following principles is thought to promote the largest impact:
    • The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
    • The terms should also permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
    • To preserve utility to the community, the software should be transferable such that another individual or team can continue development if the original investigators are unwilling or unable to do so.

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 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.

Applications Involving the NIH Intramural Research Program

Should intramural scientists submit an application through this FOA, or should an extramural application include a collaboration with NIH intramural scientists, the requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided by the Common Fund through the NIH Intramural Program. NIH intramural scientists will participate in this program as PD/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above in the NIH Intramural Source Book.

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.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA:

  • Will the proposed effort enhance the HuBMAP data or resource, its access, usability and general utility for the scientific community?
  • To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this FOA:

  • To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project?

Innovation

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

Specific to this FOA:

  • To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

Specific to this FOA:

  • Does the application make use of HuBMAP data as a core part of the aims?
  • Is the application likely to increase the utility of HuBMAP data or resource, maps, APIs etc?
  • Is the experimental validation, if proposed, reasonable and likely to be useful?
  • Does the application show commitment to sharing & documenting the software and tools to the community?
  • Does the application demonstrate leveraging a variety of perspectives from the applicants team and/or will a successful project help increase the diversity of those who will be able to use the HuBMAP resources?
  • Does the application demonstrate a commitment to work within a Consortia environment?
  • Does application show an appreciation of the challenges of interoperability and scalability and the methods adopted to handle these challenges are adequate?
  • Do the PD/PI, collaborators and other researchers indicate a willingness to abide by Consortia policies and to (potentially) making the tools available in the HuBMAP portal?
  • Are the timeline, milestones and benchmarks associated with the Plan for Enhancing Diverse Perspectives well-developed, feasible, and likely to improve over the period of the proposal?
  • Is the Data Sharing Plan adequate? Does it address good software engineering practices so that it can be shared widely?

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?

Environment

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

Specific to this FOA:

  • To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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.

Vertebrate Animals

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.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Sharing Model Organisms; and (2)  Genomic Data Sharing Plan (GDS), 3) Plan for Public Access, 4) Plan for Protocol, Tool, and Reagent Sharing, 5) Plan for Sharing Software.

Authentication of Key Biological and/or Chemical Resources

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by convened by the Center for Scientific Review, 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 appropriate national Advisory Council or Board. 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.
  • Evidence that the applicant and investigators are committed to policies as established by the Consortium Steering Committee including confidentiality, publications, sharing of information and resources, and collaboration.
  • Evidence of previous productive, cooperative, collaborative interactions as part of a Consortium.
  • Evidence that the Center will contribute to the diversity of technical and intellectual approaches and to the overall goals of the HuBMAP program.
  • Programmatic balance, including approaches to the diversity of analytical approaches.
  • Relevance of the PEDP proposed.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

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

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

Any application awarded in response to this 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.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

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

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

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.

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.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 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, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

Definitions

NIH Working Group (NIH WG): Consists of NIH programmatic staff from multiple Institutes and Centers of the NIH as well as the Office of the Director. This group will be primarily responsible for the stewardship of the HuBMAP Program and will participate as non-voting members in the Consortium committees. The HuBMAP WG is led by the HuBMAP Program Manager and co-chaired by the Directors of NIBIB, NHLBI, and NIDDK. It reports to the Directors of the Office of Strategic Coordination/Common Fund and the Division of Program Coordination, Planning, and Strategic Initiatives for final funding decisions.

HuBMAP Program Manager: The HuBMAP Program Manager is an NIH extramural scientist who is responsible for overall coordination of the Consortium and chairs the NIH WG. They will have substantial involvement in assessing progress and making recommendations about future funding. The HuBMAP Program Manager will have substantial scientific programmatic involvement in the direction of all the HuBMAP awards and may consult other NIH and non-NIH experts in making determinations. They will participate as a non-voting member of all Consortium committees and will review and approve Consortium policies. The HuBMAP Program Manager will not co-author publications with project investigators.

HuBMAP Program Coordinator: One or more NIH Program Staff will serve as Program Coordinators. The HuBMAP Coordinator will have substantial programmatic involvement that is above and beyond the normal stewardship role. The Coordinator will provide cooperation or coordination with, or assistance to, recipients in performing project activities. If feasible, the Coordinator will connect recipients with NIH-supported research resources and identify other researchers or resources that may accelerate the project. The Coordinator will also assist with connecting investigators to other federal agencies, similar consortiaand related fields of research. The Coordinator will not co-author publications with project investigators.  

Steering Committee (SC): The purpose of the SC is to recommend direction for the HuBMAP Consortium consistent with the program goals, develop Consortium policies and projects to build synergy and improve communication and collaboration between the projects, and provide a forum for discussing progress, challenges, and opportunities for the Consortium. The SC will include PDs/PIs of each of the awards and NIH WG members. The SC will be chaired by two PD/PIs that are approved by the NIH WG. An Executive Committee (EC) composed of the co-chairs and the NIH Program Team Leads will meet to set the agenda for SC meetings. The SC will establish subcommittees to oversee the development and implementation of Consortium policies including data release, publications, and standards.  It is expected that most of the decisions on the activities of the HUBMAP Steering Committee will be reached by consensus.  If a vote is needed, each project PD/PI (or Contact PI in the case of multi-PI projects) will have one vote.   NIH staff will be non-voting members of the SC but will review and approve policies developed by the Steering Committee. When a vote is required, at least 60% of the votes will be required for approval. Steering Committee recommendations will go to the HuBMAP Program Manager and the NIH Working Group for approval.

External Program Consultants (EPCs): As part of the HuBMAP program, NIH staff will engage 5-10 external program consultants (EPCs) not funded as part of the program but with relevant scientific and consortium experience to provide input and advice to the NIH WG. This could include reviewing and evaluating the progress of the entire HuBMAP Program or individual recipients as well as recommending changes in priorities for the HuBMAP Program based on scientific advances within and outside of the Consortium. The EPCs will be senior, scientific experts who are not directly involved in the activities of the HuBMAP Program and who agree to a confidentiality policy, engaged on an as-needed basis to advise on specific issues.  NIH is solely responsible for appointing EPCs for variable durations of service. EPCs are invited to participate in Consortium meetings and Steering Committees calls and the annual investigators’ meeting. A subset of EPCs may also meet by phone or web at other times of the year, as needed. Annually, the EPCs will provide individual assessments to the NIH of the progress of the Consortium and will present individual expert recommendations regarding any changes in the HuBMAP Program as necessary. The assessments and recommendations will be provided through the NIH WG to the Director of the Office of Strategic Coordination, NIH

HuBMAP Consortium:  The HuBMAP Consortium is made up of HuBMAP recipients, the NIH WG and other scientists and groups the SC agrees to include within the Consortium. The Consortium structure is meant to efficiently and effectively guide all the funded projects to meet the overall goals of the HuBMAP Program.

For each individual award, NIH staff has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NIH Program Officer - A NIH Program Officer (PO) is responsible for the normal scientific and programmatic stewardship, including monitoring progress and compliance with general statutory, regulatory, or policy requirements; discussing and approving milestones and significant changes to the project; and technical assistance to correct performance and facilitate interactions. The PO must approve in advance and in writing annual milestones and any significant changes to the award. The PO also has the option to recommend to the HuBMAP Program Manager, following consultation with the Project Scientist(s), ESCs or the NIH WG, restricting an award based on progress towards milestones, to incentivize rapid development and implementation of policies or collaboration between members of the consortium, or generation of data or resources for use by Consortium members or the wider community. NIH also reserves the right to modify the budget or duration of funding or to curtail an award in the event of: (a) substantive changes in the project not approved in advance, (b) use of funds for activities not within the scope of the specific aims, (c) failure to make sufficient progress toward the project milestones, including timely pre-publication deposition of data or reagents in accordance with approved Consortium Policies, (d) failing to comply with the terms and conditions of the award or establish necessary statutory, regulatory, policy approval required for conducting the project, or (e) ethical or conflict of interest issues. The Program Officer will not co-author publications with project investigators.

NIH Project Scientist(s) - One or more NIH Program Staff will serve as Project Scientists (PSs), for each HuBMAP award and, as appropriate, to oversee collaborative projects amongst recipients and/or other Consortium members. The PSs will serve as the scientific representatives of the NIH to the investigators in accordance with the policies and the procedures of the cooperative agreement mechanism. If there is more than one PS, one of them will be designated as the Lead PS.  The PSs will provide substantial NIH scientific programmatic involvement with the recipient that is anticipated during the performance of the activities supported by this Cooperative Agreement, including review of milestones. PSs will work closely with the PD/PI, the Steering Committee, and the PIs of all projects/cores to maximize progress towards the goals of the project and the program.

PD(s)/PI(s) Responsibilities

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

  • All aspects of the study, including any modification of study design, conduct of the study, quality control, data analysis and interpretation, setting project milestones, preparation of publications, and collaboration with other investigators, unless otherwise provided for in these terms.
  • Recipient(s) will provide goals and progress toward those goals at regular intervals as requested by NIH staff and ensure that the data produced meets the quality standards agreed to by the Consortium.
  • Recipient(s) will ensure that data and details of biospecimens are submitted in a timely fashion to the HIVE, that resources developed as part of this project are made publicly available according to Consortium policies, and that results are disseminated in a timely manner. The PD/PI is responsible for the proper stewardship of the data, including accurate annotation, disclosure of any pre-processing, data use limitations, data provenance and other associated metadata as determined by any Consortium policies.
  • Ensuring that software and other tools and resources developed as part of this project are made publicly available according to HuBMAP policies, and that research products of the project are published in a timely manner. The PD/PI is expected to fully disclose data, algorithms, softwaresource code, and experimental methods to the other members of the Consortium or the EPCs for the purpose of scientific evaluation and use by other consortium members in collaborative projects.
  • Recipient(s) will agree to accept close coordination, cooperation, and participation of NIH staff in those aspects of scientific and technical management of the project as described under "NIH Program Staff Responsibilities."
  • Agreeing to the governance of the Consortium through the SC and the NIH WG, including accepting approved recommendations from the EPCs.
  • Actively participating in the SC, including attending both in-person and teleconference meetings, and participating in collaborative activities and subcommittees. At least one in-person SC meeting will be held per year, for which HuBMAP recipients will pay the travel for their attending members. The PD/PI is expected to attend at least one Consortium meeting in person each year.
  • Updating goals and milestones at the time of award and providing summaries of progress toward those goals at least yearly, as requested by NIH.  The milestones will be reviewed annually (and at other times, if necessary), and new milestones will be negotiated, as needed by working with the NIH WG and Project Scientists as appropriate.
  • Agreeing to abide by any policies and maintaining documentation of compliance -- including those regarding intellectual property, data and software sharing, publication of HuBMAP Consortium papers, reagent and protocol sharing, standards and calibration, metadata requirements, data use limitations and public copyright licensing -- that are recommended by the SC and approved by the NIH WG, as well as applicable NIH policies, laws, and regulations.
  • Being prepared for annual administrative site visits by NIH staff.
  • Agreeing to participate in the collaborative activities of the Consortium and agreeing not to disclose confidential information obtained from other members of the Consortium including, without limitation, unpublished data, informatics tools, protocols, data analysis, confidential exchanges between members of the Consortium, as well as any confidential information received by third party collaborators.
  • 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.

NIH Staff Involvement

The NIH will designate program staff, including a Program Officer and/or Project Scientist to provide stewardship and administrative oversight of the cooperative agreement.  The Program Officer and/or Project Scientist will be named in the Notice of Grant Award. NIH staff willhave substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

  • NIH staff (HuBMAP Program Manager, HuBMAP Coordinator, Project Scientist(s), and Program Officer) have substantial programmatic involvement in oversight of project management.
  • The Program Officer is the NIH point-of-contact for the project, except for special circumstances designated by NIH. The Program Officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The Program Officer must approve in advance: (i) changes in the roster and effort of the PD(s)/PI(s) and key personnel, (ii) changes in the goals and milestones for the project, (iii) changes in the scientific scope of the project, (iv) changes to the frequency of business meetings, (v) changes in goals of collaborative projects, and (v) any exceptions to the Consortium's policies. The Program Officer will not co-author publications with project investigators.
  • The Project Scientists(s) will provide advice and guidance to ensure that the project adheres to the objectives of the FOA, the Terms and Conditions of the award, and other agreements between the recipients and NIH. The Project Scientist(s) will keep the PD(s)/PI(s) informed of any issues and concerns involving the project and provide advice on how to address them. The Project Scientist may provide scientific and programmatic assistance to the PD/PI, including contributing to data analysis, key personnel selection, and promoting the availability of data and resources. The Project Scientist(s) will attend all official business meetings of the project's leadership and must be kept informed of all substantive deliberations and developments affecting the project. The Project Scientist(s) will not make decisions about the funding of this project and will not be involved in any special reviews of the project that make recommendations about funding.
  • The HuBMAP Program Manager will work closely with the Program Officer and Project Scientist(s) to monitor the progress of the project and coordinate collaborative projects, resource sharing and outreach as part of the Consortium. The Program Manager will keep the PD(s)/PI(s) informed of consortium-wide activities,policies and issues. The HuBMAP Program Manager will not co-author publications with project investigators.
  • NIH staff and their respective Institutes and Centers will manage Conflicts of Interest and Management of Bias as detailed in the NIH Policy Manual.
  • Progress Reviews. The annual evaluation by the Program Officer and Program Manager will be based on the non-competing application and progress report, center records, and assessments by the Project Scientist(s). The Program Officer and Program Manager will review the management, performance, and utilization of the project. If concerns are identified by the Program Officer or Program Manager, the Project Scientist(s) will work with the PD(s)/PI(s) to develop plans to address them in the next year of support and. In addition, NIH staff may conduct interim reviews of scientific progress beyond the normal yearly non-competing progress review to determine progress and use information from progress reviews to inform future funding for the project.
  • Special Reviews. In addition, if concerns are identified about the performance or the management of the project, the Program Officer may conduct special reviews of the project as he/she deems necessary. NIH may engage outside experts to assist in these reviews. If concerns about the project arise and are not resolved, NIH may reduce or restrict the budget or reduce the term of support to phase out the project. In the event of long-term incapacitation of resource facilities, NIH may reduce the budget or term of support to phase out the project. Though the Cooperative Agreement mechanism does provide options for restricting, reducing, or terminating awards, it also provides options for interacting supportively with recipients to help ensure program success. Before any modifications are made, NIH staff will engage with the recipients in a positive manner and as allowed by the Cooperative Agreement mechanism to resolve performance issues where possible in a timely manner. 

Areas of Joint Responsibility

Close interaction among the participating investigators will be required, as well as significant involvement from the NIH during each phase of the program. The recipients, the PSs, and other designated NIH Staff will participate in the annual in-person investigator meeting and scheduled conference calls and share information on data resources, methodologies, analytical tools, as well as data and preliminary results. PDs/PIs, key co-investigators, and pre- and post-doctoral trainees, especially those who are members of under-represented minority groups or those from different but related disciplines, are eligible to attend these meetings. EPCs will attend the annual in-person meetings. Other government staff may also attend the annual investigators' meetings.

The SC will serve as the main scientific body of the Consortium, with the following roles:

  • The SC will be responsible for coordinating the activities of the projects and is the committee through which the NIH WG formally interacts with the investigators. SC membership will include the PI(s) of each Project, (limited to one vote for a Project with multiple PIs) and NIH staff (non-voting members). The SC Chair(s) will be appointed by the HuBMAP Program Manager and drawn from the individual project PIs. The SC may add additional, non-voting, members, as needed
  • All major scientific and policy decisions will be determined by voting policies as established by the Charter for the Steering Committee. Specific activities of the SC will include but are not limited to; developing and reviewing Consortium policies; identifying impediments to program goals and strategies to overcome them; approving and reviewing the development of shared tools and collaborative projects; identifying opportunities for sharing techniques, materials, information, and tools developed within each individual HuBMAP project; facilitating communication and fostering collaboration across the Consortium; reviewing the progress of the Consortium towards meeting the overall Consortium goals; developing, adopting or updating data standards, metadata requirements, data quality standards, and submission and release policies; ensuring the Consortium leverages existing resources and programs to accelerate progress; helping organize the scientific agenda for the annual Investigator Meeting.
  • The SC may choose to open Consortium membership to collaborators not funded through the HuBMAP Program, provided that such members agree to abide by policies enacted by the SC. The SC may generate additional conditions that apply to non-recipient members of the Consortium.
  • The SC may set up subcommittees as needed to address particular issues. These subcommittees will include representatives from the HuBMAP projects, NIH staff, and possibly other experts. The SC will have the overall responsibility of assessing and prioritizing the progress of the various subcommittees. The SC is responsible for recording and archiving decisions made, and for assessing the advice of subcommittees in a methodical manner.

It is anticipated that multiple subcommittees may need to be formed to address important topics. Current working groups include:

  • Policies
  • Communication and Engagement
  • Collaborative Project Planning and Publications
  • Data Coordination Team
  • Integrated Data Analysis & Interpretation
  • Affinity Reagent (mAb) Imaging and Validation
  • Common Coordinate Framework
  • Data Curation

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 be convened. The 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.

Section VII. Agency Contacts

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

Application Submission Contacts

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

Finding Help Online: 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

Scientific/Research Contact(s)

Ajay Pillai, Ph.D.
National Human Genome Research Institute (NHGRI)
Email: hubmap@mail.nih.gov

Peer Review Contact(s)

Center for Scientifc Review (CSR)

Email: FOAReviewContact@csr.nih.gov

Financial/Grants Management Contact(s)

Deanna L. Ingersoll
National Human Genome Research Institute (NHGRI)
Phone: (301) 435-7858
Email: Deanna.Ingersoll@nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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


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