The 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-This set of initiatives, the first of which was issued in FY2018, seek to establish proof-of-principle with initial validation of transformative new tools, techniques and methods for mapping the human body at high resolution.
• Rapid Technology Integration- This set of initiatives, which starts in FY2019, will focus on enhancing, large-scale validation, and integration of emerging new technologies into the HuBMAP Consortium. The goal is to improve the quality and throughput of atlas generation at key steps of the production pipeline including sample collection, tissue mapping, and data integration and analysis.
• Tissue Mapping Centers- These Centers, initially funded in FY2018, will 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 will be 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 HIVE - This multi-component collaboratory, funded in FY2018, will have responsibility 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- The goal of this initiative, which is expected to start half way through the program pending the availability of funds, 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 and 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 and molecular perturbation 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 non-diseased human 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.

Objectives and Scope of Rapid Technology Implementation (RTI) Projects

The vision for the RTI projects is that they will nimbly integrate new technologies into the HuBMAP so that the Consortium can proactively adapt to the changing landscape and accelerate realization of its goals. This vision will be achieved by supporting projects that work in close collaboration with the existing HuBMAP Consortium to rapidly implement these technologies and optimize for their use.

All technologies are expected to significantly enhance understanding of the spatial distribution of a large number of biomolecules in the intra-, inter- and extra-cellular spaces of non-diseased human tissues. Because HuBMAP supports the analysis of a variety of organs and tissues, it is highly desirable that proposed technologies are adaptable to multiple tissue or data types, expand the expertise and capabilities of the Consortium, and can be readily integrated with existing and emerging projects. Technologies are not required to be completely novel and may include the integration or improvement of commercial off-the-shelf or open source products or code, but they are expected to add significant value and be successfully implemented within three years. Projects are also expected: (1) to have high impact by significantly extending existing capabilities of the Consortium, (2) to use a milestone-driven engineering approach that considers iterative design, testing and evaluation, and (3) to complement and integrate with existing technologies and pipelines used by the HuBMAP Consortium.

Successful projects are expected to: 1) define a realistic strategy and requirements for implementing the technology, 2) quickly optimize, benchmark and validate the technology in the context of the HuBMAP Consortium, 3) plan for training, testing, iteration, and contingencies and 4) realize sustained use of the technology by the Consortium. The ultimate goal is to have the technology ready for incorporation into one of the Tissue Mapping Centers or the HIVE Collaboratory. Pending availability of funds, there might be support for long-term integration through separate initiatives.

Proposed technologies should already have established proof-of-principle for technical feasibility using mammalian tissue and be validated in a lab setting. Typically, this stage of development is characterized by published results in a peer-reviewed journal, adoption of the technology by a third party, or availability of a beta prototype, as well as benchmarking indicative of superior performance. Applicants with technologies that do not have published results demonstrating feasibility using mammalian tissues are encouraged to wait for future HuBMAP Transformative Technology Development (TTD) FOAs (for more information of the distinctions between TTD and RTI projects please see https://commonfund.nih.gov/hubmap/generalfaqs).

Coordination and Collaboration

Successful applicants to this FOA will become members of the larger HuBMAP Consortium composed of investigators who have been funded in response to previous HuBMAP FOAs. The purpose of the Consortium is to enable groups to effectively collaborate with each other to maximize the chances of overall success of the program. In addition to completing the goals outlined in their applications, successful applicants will be expected to work collaboratively with all members of the Consortium to contribute to developing SOPs, data and metadata standards, metrics for data generation, participate in cross-site studies, engage in cross-training, and guide development of data analysis and visualization tools that can be used by the broader scientific community. A Steering Committee (SC) composed of all the funded principal investigators and NIH staff will develop and implement Consortium policies and guide overall direction of the Consortium to meet the goals of the program. This Steering Committee will meet regularly and be complemented by an Executive Committee and a set of working groups. NIH staff will also recruit outside experts (non-awardees) as External Program Consultants (EPCs) to provide advice directly to NIH. All HuBMAP investigators are required to attend the annual HuBMAP investigator meetings, regular teleconferences with Consortium members and NIH Staff for the duration of the funding cycle.

As well as being implemented in HuBMAP, NIH intends that the products of the RTI projects to be broadly available to establish the foundations for a human body map that other programs and the community could build upon; this includes methods, tools, reagents, biospecimens, datasets, and software. Projects will be expected to abide by Consortium policies for rapidly sharing their products within the Consortium and with the external research community.The robustness and reproducibility of experimental results are critical to the success of HuBMAP.In some cases, conducting additional critical experiments will be important for assessing progress. Therefore, NIH Program staff, in consultation with the PD/PI, may modify or add experiments to be conducted during the duration of an award.

Technology Focus

The scope of this FOA encompasses a wide range of technologies that may benefit the HuBMAP Consortium spanning the fields of tissue collection and preservation; high resolution, high content, high-throughput imaging; high sensitivity and high specificity transcriptomics, genomics and proteomics; extracellular environment and matrix composition; analysis, visualization and modelling of multidimension biomolecular data. Potential applicants are strongly advised to consult with the Scientific/Research Contact listed below to discuss the HuBMAP program and priorities, and whether proposed technologies will complement and enhance existing capabilities and address well-defined needs.

Technologies of particular interest include, but are not limited to:

• Tools for reliable multi-site tracking of clinical biospecimens, including the use of unique identifiers, standard data dictionaries for associated metadata, and on-line querying and requests
• High-sensitivity, high-resolution imaging techniques that can rapidly provide spectral data over large areas of tissue
• Quantitative imaging analysis tools, including automated 3D image segmentation, feature extraction, and image annotation
• Large, well-curated, well-annotated datasets of human anatomy and associated tools to assist with building a robust common coordinate framework system of the human body
• Tools for rapid, high-resolution, in situ sequencing and analysis of a wide panel of nucleic acids derived from multiple tissues
• Technologies for quantitative, comprehensive assessment of the extracellular environment of multiple human tissues, including characterization of structural proteins, enzymes, glycoproteins, polysaccharides and biomineralization
• Sensitive and high-specificity assays for identification of different functional states of biomolecules, including post-transcriptional modification, post-translational modification, and proteoforms
• Multi-scale data collection and integration methods from the molecular level to cellular and tissue levels.
• Data visualization methods for intuitive atlas comparison and analysis.

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

• Projects primarily focused on the pursuit of a biochemical mechanism that does not result in a technology that will significantly improve the Consortium's capabilities to spatially map human tissues;
• Projects proposing technologies that significantly overlap with those currently used by the Consortium or that are not compatible with existing assays or analysis techniques used by the Consortium;
• Projects proposing technologies primarily for studying bio-fluids or dissociated cells;
• Projects without published results reliably demonstrating proof-of-principle for the proposed technology using mammalian tissue;
• Projects that do not propose a detailed implementation plan as described below.

Rapid Technology Implementation Project Structure

This FOA invites applications that will optimize, evaluate, and refine technologies that will significantly improve the data generation or analysis capabilities of the HuBMAP Consortium. This FOA uses the UH3 cooperative agreement mechanism to support the rapid implementation of technologies into the HuBMAP Consortium within three years. During this time, projects are expected to benchmark and optimize their technologies in the context of the Consortium and implement it into routine use.

Plug and play of new technologies into an existing consortium is a complex process and requires deep understanding of current processes and willingness of the consortia to change. Successful implementation of a new technology into an existing consortium needs a systematic plan with a shared vision of how the technology will accelerate the consortium reaching its goals. An implementation plan should clearly articulate the evidence that the technology is ready for use by the consortium, how it will accelerate the consortium’s goals, why it will be successfully adopted and what will drive sustained use of the technology. A successful plan will have well-laid out responsibilities, clear go/no-go decision points, flexible scheduling, iterative optimization, training, and stakeholder engagement. Careful attention to be paid to project management along-side technology issues.

A successful technology is one that will let consortium members achieve better results, more quickly or at lower cost. Usability is key because the barrier to adoption of the technology must be low, proficiency must lead to clear efficiencies in data generation or analysis and a pleasant user experience is needed for long-term use. Further, a flexible management plan is critical for guiding and evaluating adoption of a new technology in an existing setting. The implementation science and human factors communities have explored many of the variables that lead to successful adoption or failure of new technologies. Applicants are strongly encouraged to use a coordinated technical, social and organizational approach as part of their implementation plan and to propose quantitative methods to drive the design, implementation and evaluation of the proposed technology.

Because of the short-term nature of these projects, applications should focus on how they can successfully implement their technologies and define clear biannual milestones that are specific, measurable, achievable, realistic and time-bound. Milestones should include details of how success will be measured, go/no-go decision-making points for the project and alternative approaches. Prior to funding an application, NIH program staff will contact the applicant to discuss the proposed milestones and any changes suggested by the review panel or NIH program staff. A final set of milestones will be specified each year in the Notice of Award. Progress towards achievement of the annual milestones and the overall goals will be regularly evaluated by NIH program staff and they may consult as necessary with independent consultants with relevant expertise. If justified, future year milestones may be revised based on data and information obtained during the previous project period. If, based on the progress report, a funded project does not meet the milestones, funding for the project may be discontinued. In addition to milestones, the decision regarding continued funding will also be based on the overall robustness of the entire data package that adequately allows an interpretation of the results (regardless if they have been captured in the milestones), overall progress, program synergy and priorities, competitive landscape, and availability of funds.

Technical Assistance Webinar

Potential 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 Consortium. A technical assistance webinar will be held for potential applicants on January 30, 2019 at 1 pm Eastern time. NIH staff and currently funded investigators will present an overview of the program and will be available to answer questions related to this FOA. Dial-in information for the call as well as a process for matchmaking potential applications with existing awardees will be announced on the HuBMAP website(https://commonfund.nih.gov/HuBMAP).A list of frequently asked questions (FAQs) related to the program is also posted on the website (https://commonfund.nih.gov/HuBMAP/generalfaqs).This information session is open to all prospective applicants, but participation is not a prerequisite to apply.

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

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)

• Eligible Agencies of the Federal Government, including the NIH Intramural Program

• U.S. Territory or Possession

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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

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) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

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  

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  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 NOT-OD-11-101)

1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms 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

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

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:

J. Jerry Li, M.D. Ph.D.

National Cancer Institute (NCI)

Telephone: 240-276-6210

Email: HuBMAP@mail.nih.gov

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

Research Strategy

On the Research Strategy attachment, please use the sub-sections defined below:

Vision and Overview

This section should provide an overview of the project and the vision for how the project will work as part of the HuBMAP Consortium. Do not consider this to be a traditional Specific Aims page for hypothesis-driven research. Briefly state the goals of the project and how the technology addresses the needs and Priorities of the Consortium. Provide a summary of major tasks to be accomplished with milestones and benchmarks, a timeline, and deliverables. In addition, the following elements should be specifically addressed:

• Please clearly indicate which, if any, of the current HuBMAP Priorities are being addressed;
• A vision for how the proposed work integrates into the overall scope and will accelerate the goals of the HuBMAP program;
• A high-level description for how the applicant proposes to work with NIH staff and the HuBMAP Consortium to successfully implement the technology into the data generation or analysis pipelines of the existing awards;
• The comparative advantage to the Consortium of adopting the proposed technology;
• Without duplicating information in the biosketches highlight qualifications, past performance and experience of the key personnel  , particularly working on actively managed, milestone-driven projects;
• Although this RFA does not require cost-sharing, describe details of any cost-sharing, institutional commitment or existing infrastructure or collaborations that the project is building off.

Implementation Strategy

Do not consider this to be a traditional Research Strategy. The objective of this FOA is to identify projects and teams who can successfully integrate new technologies needed by the HuBMAP Consortium. This section should be structured to provide sufficient information to gauge the applicant's likelihood of producing the deliverables and achieving their objectives. This section should cover the following aspects:

• Impact and Significance: Identify the HuBMAP Priority(s) being addressed in this application. Briefly describe the key features of the proposed technology and highlight any conceptual, technical, and/or methodological innovations that increase the significance of the proposed project for HuBMAP. Compare your approach to existing state-of-the-art approaches.
• Preliminary Data: Provide a description of prior work that is of significance to the application. Describe the preliminary data, and associated peer-reviewed publications and demonstrations of efficacy using mammalian tissue.
• Implementation Plan: Describe in detail the specific tasks of relevance and importance to realizing the rapid implementation of the technology as part of the vision for HuBMAP. The plan should demonstrate deep understanding of the technical, organizational and sociological challenges and present a credible plan to achieve the goals.
• Usability Plan: Describe how the technology will be iteratively optimized based on user feedback from the HuBMAP Consortium or the larger community. Describe how needs will be assessed and barriers to adoption will be lowered and how the project will be evaluated.
• Risk Analysis: Provide a description of potential pitfalls and limitations, and approaches to mitigate them.
• Tasks, benchmarks, timeline: For each major task, describe the expected outcomes and deliverables. Include benchmarks for each task that can be used to evaluate interim and final progress towards the deliverables. Benchmarks should include quantifiable criteria for success (i.e. go/no-go) and should aggressively address major risks in the first year of the project. The criteria for success and benchmarks should be based on quantitative estimates, if possible. The timeline must include benchmarks, deliverables, and release of specific infrastructure or other tools to the consortium. A Gantt chart or similar approach is strongly encouraged.
• Investigators: Describe past collaborations between the key personnel, if any. Identify plans for interfacing with the HuBMAP Consortium and explicitly describe which individual(s) are responsible for each deliverable.
• Interactions with HuBMAP Consortium: Describe clearly your plans for assessment, communication, training and evaluation so that the Consortium can successfully and sustainably utilize your technology. These should include technical, sociological and organizational challenges and suggested solutions. Describe plans for participating in program activities, including meetings and working groups.
• Project Management: Describe the leadership and management plan for the project. If the project is to be carried out in more than one department or institution, identify what parts of the project will take place at each organization and justify which senior/key individuals will be responsible for each portion.
• Sustainability Plan: Describe what resources may be needed for sustained use of the technology by the Consortium after the duration of the funded project.

Letters of Support

The following modifications also apply:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Applicants should indicate their willingness to abide by all data deposition consistent with achieving the goals of the program, 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. 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. 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 considered to 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, through the HuBMAP Steering Committee (SC), will develop such policies, methods, and standards 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 Sharing Plan with the applicant.
• • Specific Plan for Public Access: The NIH Common Fund intends to maximize the availability of publications and the sharing of underlying data for HuBMAP Projects. Applicants should describe their proposed process for making resulting publications and to the extent possible, the underlying primary data immediately and broadly available to the public or provide a justification if such sharing is not possible or should be delayed. 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.
  • Specific Plan for 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 HuBMAP Integration, Visualization & Engagement (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://gds.nih.gov/) and should indicate their agreement to abide by it in the data sharing plan.
  • Specific Plan for 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 and as expeditiously used as possible. 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).
  • Specific Plan for Sharing Software: Applicants are asked to propose a plan to manage and disseminate the improvements or customizations of their tools and resources by others. 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, 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 in the event that the original investigators are unwilling or unable to do so.
  • 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. An applicant should take responsibility for creating the original and subsequent "official" versions of a piece of software.

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.

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

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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.

Applications Involving the NIH Intramural Research Program

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 PDs/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.

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.

1. Criteria

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

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 this project make a significant contribution to the overall goals and objectives of the Human BioMolecular Atlas Program?
• Will the proposed technology significantly enhance the capabilities of HuBMAP to map human tissues?
• Will this project address an unmet technology need for the Consortium, and be compatible with existing technologies to create synergy?
• Will the technology and knowledge implemented by this project lead to a better understanding of the relationship between tissue organization and function?

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:

• Do the past performance and proposed duties of the PD/PI or MPIs demonstrate a strong commitment to the success of the project?
• Do the key personnel have the appropriate experience in managing and conducting complex, technology implementation projects involving diverse teams of scientists?
• Do the key personnel have a strong track-record of optimizing and integrating new technology in established projects?
• Is there a clear leadership plan that will enhance the likelihood of success?
• Are there adequate plans for effective interaction and coordination with the Consortium?

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:

• Will the proposed technology complement existing methods/approaches in the HuBMAP Consortium and enhance understanding of tissue organization?
• Is the design of the project innovative, relevant to HuBMAP's goals, and does it accelerate implementation of the technology in a way that would not obviously happen otherwise?
• Does the project have an optimal balance in proposing a state-of-art, cutting-edge technology and approaches that are also proven, validated and reliable so as to meet the vision for the HuBMAP?

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:

• Is there a high potential for this project to achieve its goals within three years? Is the timeline of milestones and deliverables feasible?
• Is the stage of development clearly described and appropriate for this RFA? Does the preliminary data establish feasibility and validity for assaying or analyzing mammalian tissues through peer-reviewed journal, adoption of the technology by a third party, or availability of a beta prototype?
• Are the organizational, technological and sociological approaches proposed, including demonstrated flexibility, likely to lead to a viable and valuable new capability for the Consortium?
• Are the proposed project benchmarks feasible and congruent with the goals outlined for the objectives and scope of this RFA?
• Are the proposed implementation and usability plans, methods, techniques, and procedures for the project sound, feasible, and valid?
• Are anticipated risks and challenges associated with the approach adequately addressed? Are the proposed mitigation plans acceptable?
• Are the proposed design, technical and engagement approaches likely to lead to effective adoption of solutions, tools and products by other similar programs?

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:

• Is there evidence of commitment by the applicant's organization or from other NIH funded projects (if any) to the applicant and the project that will enhance success?
• Are the resources, support personnel, equipment and infrastructure facilities available and in place (or readily obtainable) to rapidly and effectively implement the proposed technology?
• Does the institutional support include contingency plans for changes in personnel?
• Will the project benefit from unique features of the organizational environment, resources, or collaborative arrangements?

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.

Biohazards  

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

Resubmissions  

Not Applicable

Renewals  

Not Applicable

Revisions  

Not Applicable

Applications from Foreign Organizations  

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

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) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

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 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.

• 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.

• Will receive a written critique.

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 applicants are committed to policies as established by the Consortium Steering Committee including with regard to confidentiality, publications, sharing of information and resources, and collaboration.
• Evidence of previous productive, cooperative, and collaborative technology development and implementation taking into consideration the needs of end users.
• Evidence that the project will contribute to the diversity of technical and intellectual approaches and to the overall goals of the HuBMAP program.

3. Anticipated Announcement and Award Dates

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

1. Award Notices

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 grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. 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.

2. Administrative and National Policy Requirements

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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.

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 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this HuBMAP program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below. Awardee will retain custody of and have primary rights to the data and software developed under this award, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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 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.
• 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 to 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 awardees 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 agreement to a confidentiality policy. NIH is solely responsible for appointing the EPCs. The EPCs will meet at least twice a year, once in conjunction with the annual investigators meeting. The 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 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 will be made up HuBMAP awardees, 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.

Rights and 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.
• Providing goals and timely progress reports toward those goals at regular intervals as requested by NIH staff
• Ensuring that data are submitted to the HIVE in a timely fashion, that details of biospecimens are submitted to the Tissue Core, 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
• 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.
• Accepting 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 NIH-approved recommendations from the EPCs.
• Actively and regularly participating in the SC, including attending both in-person and teleconference meetings, and participating in collaborative activities and working groups. At least one in-person SC meeting will be held per year, for which HuBMAP awardees will pay the travel for their attending members.
• 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 Consortium policies -- including those regarding intellectual property, data and software release, publication of HuBMAP Consortium papers, quality control metrics, standardization, metadata requirements, 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 as needed.
• Agreeing to participate in the collaborative activities of the Consortium and agreeing not to disclose confidential information obtained from other members of the Consortium.
• Awardees 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.

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) will provide the standard programmatic oversight and stewardship of the projects, including review of pre-award and award documents/requirements, review of progress reports and budgets, and any other programmatic issues that may arise.
• The PO has the option to recommend to the HuBMAP Program Manager, following consultation with the project staff, ESCs and the NIH WG, the withholding or reduction of support from any project that substantially fails to achieve its goals according to the milestones agreed to at the time of the award. NIH reserves the right to withhold funding or curtail an award in the event of: (a) Substantive changes in the project, or failure to make sufficient progress toward the project milestones, including timely pre-publication deposition of data or reagents in accordance with approved Consortium Policies; or (b) ethical or conflict of interest issues.

• NIH Project Scientists

• One or more NIH Program Staff will serve as Project Scientists (PSs), for each HuBMAP award and, as appropriate, to oversee collaborative projects amongst awardees and/or other Consortium members. The PS will serve as the scientific representative of the NIH to the investigators in accordance with policies and 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 awardee 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.

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 awardees, 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 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.
• 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-awardee 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.

It is anticipated that multiple subcommittees may need to be formed, for example, to address topics such as:

• Data and Reagent Deposition and Sharing
• Quality Control and Validation
• Publications and Outreach

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 awardees 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 agreement to a confidentiality policy. NIH is solely responsible for appointing the EPCs.

The EPCs will meet at least twice a year, once in conjunction with the annual investigators meeting. The 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 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.

Dispute Resolution

3. Reporting

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees 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 $25,000.  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 Appendix XII to 45 CFR Part 75, 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 – Award Term and Conditions for Recipient Integrity and Performance Matters.

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 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

Jerry Li, M.D., Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6210
Email: hubmap@mail.nih.gov

Ross Shonat Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-2786
Email: shonatr@csr.nih.gov

Dawn M. Mitchum, MPH, CRA
National Cancer Institute (NCI)
Telephone: 240-276-5699
Email: dmitchum@mail.nih.gov