Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Human Genome Research Institute (NHGRI)

Funding Opportunity Title
The NHGRI Genomic Data Science Analysis, Visualization, and Informatics Lab-space Clinical Resource (ACR) (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
New
Related Notices

September 28, 2022 - Notice of Pre-Application Webinar for the NHGRI Genomic Data Science Analysis, Visualization, and Informatics Lab-space Clinical Resource (ACR) (U24 Clinical Trial Not Allowed) (RFA-HG-22-021). See Notice NOT-HG-23-003

NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022

Funding Opportunity Announcement (FOA) Number
RFA-HG-22-021
Companion Funding Opportunity
RFA-HG-22-020 , U24 Resource-Related Research Project (Cooperative Agreements)
Assistance Listing Number(s)
93.172
Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to support the development, implementation, and maintenance of the AnVIL Clinical Resource (ACR), a suite of genomic-based clinical tools and services built into the NHGRI Data Science Analysis, Visualization, and Informatics Lab-Space (AnVIL) to foster clinical genomic research. AnVIL is a scalable and interoperable resource for the basic and clinical genomic research communities that leverages a cloud-based infrastructure to democratize data access, sharing, and computing across large genomic and genomic-related datasets.

Key Dates

Posted Date
September 16, 2022
Open Date (Earliest Submission Date)
November 02, 2022
Letter of Intent Due Date(s)

October 19, 2022

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
December 02, 2022 Not Applicable Not Applicable March 2023 May 2023 July 2023

All applications are due by 5:00 PM local time of applicant organization. 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date
December 03, 2022
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

Background and Objectives

The NHGRI Genomic Data Science Analysis, Visualization, and Informatics Lab-space (AnVIL) is a scalable and interoperable resource for the basic and clinical genomic research communities that leverages a cloud-based infrastructure to democratize data access, sharing, and computing across large genomic and genomic-related datasets. The AnVIL platform facilitates integration and computing on and across large datasets generated by NHGRI programs, initiatives funded by the National Institutes of Health (NIH), and other agencies supporting human genomic research. The key components of the AnVIL Program include:

  1. Infrastructure and cost controls
  2. Cloud platform interoperability
  3. Data onboarding
  4. Tool identification, onboarding, and deployment
  5. Community building and user support
  6. System and data security
  7. Leveraging technological opportunities
  8. Governance and project management

As an NIH-Designated Data Repository, the NHGRI AnVIL platform is authorized to share controlled-access datasets with the research community. This authorization complies with the NIH Genomic Data Sharing (GDS) Policy for controlled-access genomic datasets, including associated metadata and phenotypic data. In addition, the AnVIL Program has successfully ingested over 4.5 petabytes of data, integrated genomic data analysis tools and resources such as Bioconductor, Galaxy, PharmCAT, seqr, and Dockstore to serve both the basic and clinical genomic research communities, developed outreach and educational tools, and successfully piloted the Data Use Ontology System to understand the use of a semi-automated data access management service to manage compliant sharing of controlled-access data.

In February 2021, the NHGRI hosted a workshop titled “Genomic Medicine XIII: Developing a Clinical Genomic Informatics Research Agenda” to develop a research strategy on the use of genomic-based clinical informatics resources to improve the detection, treatment, and reporting of genetic disorders in a clinical setting. In addition, in October 2021, NHGRI hosted another workshop titled “Future Directions of the NHGRI Analysis, Visualization, and Informatics Lab-space (AnVIL)” to identify gaps, challenges, and future opportunities related to NHGRI's investments in the AnVIL Program. Outcomes from these workshops highlighted support for the AnVIL’s existing infrastructure and services and identified opportunities to expand the AnVIL team’s activities to better support both the basic and the clinical genomic research communities. Specifically, these activities include increasing the availability of analysis tools and workflows, increasing outreach and educational offerings, addressing challenges related to using cloud-based services, improving interoperability with other cloud-based data resources, and increasing support for the clinical research community.

Over the next five years, AnVIL should transition from being primarily a data submission and sharing platform to serving as a multi-functional discovery platform to perform basic and clinical genomic research. AnVIL should also further develop as a resource for genomic data science education. In addition, the AnVIL Program should build on current successes (e.g., advancing data sharing, platform development, and outreach) while also evaluating and leveraging new scientific and technical advances to improve its services.

Two Funding Opportunity Announcements (FOAs) have been released to achieve NHGRI's vision for the renewal of the AnVIL Program: RFA-HG-22-020, “The NHGRI Genomic Data Science Analysis, Visualization, and Informatics Lab-space (AnVIL) (U24 Clinical Trial Not Allowed)”, and RFA-HG-22-021, “The NHGRI Genomic Data Science Analysis, Visualization, and Informatics Lab-space Clinical Resource (ACR) (U24 Clinical Trial Not Allowed).” RFA-HG-22-020 is a limited competition FOA that focuses on the continued development, maintenance, and user support of the AnVIL Program. RFA-HG-22-021 is an open competition FOA that focuses on integrating clinical genomic research components into the AnVIL Program. The AnVIL Program encompasses all efforts under both RFAs, while the AnVIL team is defined as the combined group of all awardees under both FOAs. All members of the AnVIL team are expected to work together closely to achieve the goals of the AnVIL Program.

This FOA, RFA-HG-22-021, specifically describes how the AnVIL Program aims to support the clinical genomic research community and the ACR team will provide subject matter expertise in the necessary guidelines and technical standards that are necessary for clinical genomic research.

Specifically, the ACR is expected to allow AnVIL users to manage, explore, visualize, analyze, report, and disseminate genomic-based clinical research data via the AnVIL platform. In addition, the ACR team should identify multiple heterogeneous research participant level clinical, imaging, and social determinants of health (SDOH) datasets for clinical genomic research use and assist in integrating them into the AnVIL platform. The ACR team should provide subject matter expertise in the necessary guidelines and technical standards required to facilitate the realization of the AnVIL platform being part of a federated data ecosystem for clinical genomic research.

The ACR team should also focus on developing and supporting a community of users to leverage the AnVIL platform to perform clinical genomic research. The resources and services provided by the ACR should be scalable, modular, and are expected to be integrated into the AnVIL Program. The specific objectives and requirements of this FOA are the following:

1. Infrastructure and cost controls

Awardees under RFA-HG-22-020 will bear primary responsibility for the infrastructure and cost controls of the AnVIL platform. The ACR team should work closely with the rest of the AnVIL team to ensure that the platform's infrastructure and cost controls adequately serve the needs of the clinical genomic research community.

2. Cloud platform interoperability

The ACR team will focus on AnVIL's participation in a NIH federated data ecosystem in support of clinical research and, as member of the AnVIL team, it is expected to work with representatives from other NIH funded cloud-based resources, such as the partners of the NIH Cloud Platform Interoperability (NCPI) efforts, clinical laboratory management systems, and hospitals to exchange data, generate reports, to facilitate analyses and research on the AnVIL platform.

3. Data onboarding

The ACR team will work with the clinical genomic research community to identify valuable datasets for inclusion in AnVIL. The ACR team should focus on the inclusion of datasets from populations of diverse ancestry and, in parallel, include the necessary tools to analyze them within the AnVIL platform. Data harmonization is another integral part of the AnVIL data onboarding process. The ACR team will work with the rest of the AnVIL team in ensuring the data harmonization and quality control of data efforts of the AnVIL Program address the needs of the clinical research community.

4. Tool identification, onboarding, and deployment

The ACR team will focus on the identification, deployment and implementation of clinical software, tools, workflows, and processes for returning clinical genomic-based results for research purposes to clinical researchers. The ACR is expected to include in the AnVIL platform tools and other resources that provide users the ability to develop and utilize methods to incorporate, combine, and search clinical information with genomics and other heterogeneous datasets within the AnVIL platform, using known and emerging standards that is useful to the clinical genomic research community. In collaboration with members of the clinical genomic research community, the ACR team should identify, adopt and integrate software, tools, and workflows within the AnVIL platform for users to visualize and analyze relationships between genomic, imaging, clinical, molecular, and SDOH data derived from clinical settings, to develop, for example, computational predictive models, facilitate variant interpretation, and improve the reproducibility of findings for clinical translation purposes.

The ACR team will work with the rest of the AnVIL team to develop and implement resources within the AnVIL platform that leverage community standards, such as those established by the Health Level Seven's Fast Healthcare Interoperability Resources (FHIR) and Global Alliance for Genomics and Health (GA4GH). The ACR will also provide users the ability to develop and implement innovative methods for conducting analyses and securely generating and disseminating surveys and reports to advance clinical genomic research within the AnVIL platform. Also, the ACR will provide a foundation within the AnVIL platform for users to design and implement pilots that focus on discovering innovative ways cloud-based resources can be leveraged to develop, for research purposes, digital health applications that monitor, manage, and support genomic based health conditions. It is expected that all software, tools, and workflows developed with funding from this FOA will be open source, cloud agnostic, and also integrated into the AnVIL platform..

5. Community building and user support

The ACR team will focus on community building and user support for the use of the AnVIL platform for clinical genomic research. The AnVIL Program has already established a collection of educational assets to assist the genomic research community in using cloud-based resources. In particular, the AnVIL Program is focused on enabling users from the basic and clinical genomic research communities to leverage cloud-based resources to conduct genomic based research.

According to the Notice of NIH’s Interest in Diversity (NOT-OD-20-031), “diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform teams having a homogeneous background.” This theme was further developed in the 2020 NHGRI strategic vision, which emphasizes that “the promise of genomics cannot be fully achieved without attracting, developing, and retaining a diverse workforce, which includes individuals from groups that are currently underrepresented in the genomics enterprise.”The AnVIL team has been actively involved in the Genomic Data Science Community Network (GDSCN), the Research Centers in Minority Institutions’ Virtual Applied Data Science Training Institute (VADSTI) to better enable genomic data science researchers to use cloud based resources. The AnVIL team will continue to be committed to supporting students, researchers, institutions, and consortiawith a broad set of perspectives, backgrounds, and academic disciplines in using cloud-based resources for genomic based analysis. The ACR team will need to expand those assets to serve the clinical genomic research community. These efforts include, but are not limited to, conducting focus group sessions, providing educational sessions to serve specific groups, soliciting, and addressing users’ feedback about ACR related AnVIL’s interfaces and datasets, improving the quality of AnVIL services, and inform the development of priorities.

6. System and data security

The ACR team will focus on data access and data security tailored for using the AnVIL platform for clinical genomic research. The ACR onboarded datasets, the deployed tools, and any other resource generated by the ACR are expected to comply with the data access and security requirements of AnVIL. Awardees under this FOA are expected to work closely with awardees under RFA-HG-22-020 to make the AnVIL platform a Health Insurance Portability and Accountability (HIPAA) compliant resource. Also, as part of the AnVIL Program to serve the clinical genomic research community, the ACR team will investigate ways to make the AnVIL platform compliant with Good Clinical Practice for hosting and storing records and reports. Because the AnVIL platform will need to host data for clinical research use, the ACR team, along with the rest of the AnVIL team, will ensure that data identified for clinical research will be stored within the geographical borders of the continental United States of America.

7. Leveraging technological opportunities

Over the project period of the ACR award, new scientific and technological advances for supporting genomic data sharing, access, and computing in a federated data ecosystem may emerge. The ACR team should aim to identify, evaluate, and incorporate new clinical genomic research focused approaches and information technologies that improve the quality of the services provided to the clinical genomic research community. Examples include, but are not limited to, the optimization of analysis tools and workflows for clinical genomic research, the adoption of new data compression methods to reduce storage costs for imaging data, and tools to improve data security and protection of research participant data.

8. Governance and project management

Awardees under this FOA should work in close collaboration with the awardees under the companion RFA-HG-22-020 for the governance and project management of the AnVIL Program. The project management structure should ensure the efficient planning, initiation, implementation, and timely completion of all activities and day-to-day oversight of the activities. Metrics to assess the utilization of the resource and its impact on the genomic research community should also be developed. In addition, specific timelines and milestones should be developed and updated as needed, in collaboration with the other AnVIL Program awardees, NHGRI staff and the AnVIL Steering Committee, and the External Consultant Committee (see below). In addition, the project management should involve frequent interactions and communications with NHGRI staff, including hosting site visits and preparing additional reports as requested by NHGRI staff. Finally, the project management structure should ensure efficient engagement with NIH-funded consortia that are using the AnVIL platform for their data and analysis needs.

AnVIL Steering Committee (ASC)

The ASC will constitute the main governing entity of the AnVIL Program. The ASC includes key personnel from all AnVIL awardee institutions (both RFA-HG-22-020 and RFA-HG-22-021) including PDs/PIs and project managers and the NHGRI AnVIL Program staff. The ASC will provide guidance regarding uniform data use procedures and policies across the program and ensure robust participant protection practices for data access and management that adhere to NIH policies and best practices. In addition, the ASC will develop criteria and assist in prioritizing datasets, software, tools, and workflows to be hosted and made accessible to the broad clinical and scientific genomic research communities via the AnVIL platform. It is anticipated that the ASC will meet once a week. Major decisions involving the AnVIL Program will be determined by consensus or as needed, by majority vote of the ASC. Each primary awardee site will have one vote, regardless of the number of participants from those sites that are part of the ASC. NIH staff that are part of the ASC will collectively have only one vote. If a vote ends in a tie, then one of the members of the External Consultant Committee will be temporally added as an impartial member of the ASC who will review the arguments and make a recommendation to resolve the dispute

External Consultant Committee (ECC)

The ECC assesses the AnVIL Program’s operations, scientific progress, guidelines to streamline data access, oversight of ethics concerns and participant protection practices, adoption of new technology solutions, cost-effective use of cloud resources, and interoperability with other data resources in consultation with NHGRI staff. The ECC members should have expertise in a broad range of topics relevant to genomic medicine and genomic research including genomic technologies, computational genomics, data science, cloud computing, data management, data sharing concerns (such as participant protection issues), and Ethical Legal Social Implication issues. Applications should not include proposed ECC members or recruit members to serve on the ECC prior to the peer review of the application.

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.

Funds Available and Anticipated Number of Awards

NHGRI intends to commit a total of $1,500,000 per year in FY 2023 through FY 2027 to fund 1 award.

Award Budget
Application budgets are not limited but 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 5 years.

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

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
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)

Applications from institutions that are the primary awardees from RFA-HG-17-011, “The NHGRI Genomic Data Science Analysis, Visualization, and Informatics Lab-space (AnVIL) (U24)” are not eligible to be the primary institution submitting an application in response to this funding opportunity announcement.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are 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.

  • System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; 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 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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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:

Ken Wiley, Jr., Ph.D.
Email: anvil@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

For this specific FOA, the Research Strategy section is limited to 30 pages.

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.

SF424(R&R) Senior/Key Person Profile

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

Without duplicating information contained in the biosketches, describe the investigator's experience in successfully coordinating and collaborating with efforts of comparable size and complexity. Describe the investigator’s scientific expertise in clinical genomic research, data science, and data management. Also describe the investigator’s expertise in leading efforts in making data accessible to the research community, outreach to the broad scientific community, and managing consortium logistics.

R&R Budget

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

ACR budgets should include the costs for participation in AnVIL program activities, including regular meetings of a number of existing AnVIL working groups.

Since effective management of this resource requires a significant commitment by Program Director(s)/Principal Investigator(s), they should devote sufficient time to serve their proposed roles.

Budgets should include costs required for active participation and hosting of virtual and in-person meetings of the AnVIL Program.

  1. ECC meetings.
    Frequency: twice a year, one in-person meeting and one virtual meeting.
    Hosting: budget to host 1 in-person meeting over the 5-year project period. Travel costs for 10 ECC members should be included in the hosting costs.
  2. AnVIL Team meetings.
    Frequency: once a year, in-person.
    Hosting: budget to host 1 in-person meeting over the 5-year project period.
  3. Community workshops.
    Frequency: every other year, in-person.
    Hosting: budget to host 1 in-person meeting over the 5-year project period.

Awardees under this RFA and the companion RFA-HG-22-020 will rotate the hosting responsibilities for these meetings over the 5-year project period.

In addition, budgets should include costs for developing and organizing focus groups to assist the AnVIL team in identifying ways the AnVIL Program can serve the aforementioned community.

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 are reminded that over the AnVIL Program renewal period, AnVIL should transition from being primarily a data submission and sharing platform to serving as a multi-functional discovery platform to perform basic and clinical genomic research and a resource for genomic data science education.

The Background and Objectives in Section I above includes eight key components which should be read carefully, and for each capability applicants should provide the following:

  • A detailed plan for how the applicant proposes to meet the component’s objectives, both independently and in collaboration with the other awardees of the AnVIL Program, including those under this RFA and the companion RFA-HG-22-020
  • Benchmarks for success
  • Proposed timelines and milestones for the whole project period
  • A description of anticipated key issues and challenges

Applicants are encouraged to include in their application additional topics or features that may improve the quality and effectiveness of the services provided by the ACR to the AnVIL Program.

Additional information applicants should provide for some specific components is described below.

Infrastructure and cost controls

Applicants should describe how they will work with the clinical genomic research community to identify and prioritize changes to the AnVIL platform needed for that community to make full use of the platform. Applicants should also describe how they will effectively communicate these needs with the rest of the AnVIL team and work collectively to either implement the changes themselves or work with other elements of the AnVIL team to implement them.

Cloud platform interoperability

Applicants should describe how they will ensure AnVIL's participation in a NIH federated data ecosystem supports clinical research.

Data onboarding

Applicants should propose an initial set of either unrestricted or controlled access datasets to be hosted and made available for users to perform clinical genomic research via the AnVIL platform. Datasets should be from populations with diverse ancestry. Applicants should provide a description of the suggested dataset’s formats, data types, quality and data usage limitation, estimated cloud costs and any other relevant information that explains the importance of these datasets for clinical genomic research. Applicants should also describe how they will work in an ongoing manner with the clinical genomic research community to identify and prioritize datasets of value to that community for inclusion into AnVIL.

Tool identification, onboarding, and deployment

Applicants should describe the technologies they will use and measures they will take to enable deployment of genomic-based clinical software, tools, and workflows within the existing AnVIL platform. This should also include proposals for how the ACR team will develop and integrate the infrastructure within the AnVIL platform to support the development of a service that provide reports and surveys for clinical genomic researchers. In addition, applicants should describe their plans for use cases that can be developed into pilots that use standards and APIs in a manner that addresses the needs of clinical genomic research users’ ability to access and utilize the AnVIL platform.

Community building and user support

Applicants should propose how they will build upon the existing AnVIL Program’s outreach and user education services to enable AnVIL users to visualize and analyze clinical genomic and related data. In addition, applicants should also propose, and show expertise regarding, how they will build trust relationships and handle stakeholder engagement efforts with representatives from clinical sites, laboratories, and hospitals to assist in their efforts to develop use cases for using ACR for clinical genomic research. Applicants should also include in their proposals how they plan to integrate their outreach and educational efforts with the existing AnVIL Program’s resources and provide appropriate program management support for these activities.

System and data security

Applicants should describe how they plan to comply with existing AnVIL data access and security requirements, and how they will implement standard clinical security perimeters to allow clinical research groups to access data and reports within the AnVIL platform. Applicants should describe any security certifications they believe to be necessary to ensure the AnVIL platform is a HIPAA compliant resource and describe how they will achieve and maintain HIPAA compliance over the award period. Applicants should also describe how they plan to make their software, tools, and workflows compliant with Good Clinical Practice guidelines for storing and accessing data.

Leveraging technological opportunities

Applicants should describe how they will identify new technological opportunities, evaluate their value to the AnVIL platform and the clinical genomic research community, and decide whether to implement them.

Governance and project management

Applicants should clearly describe the organizational structure and division of responsibilities for the whole project. The plan should also describe how the PD(s)/PI(s) will manage the proposed resource, coordinate the day-to-day activities of the ACR with the other AnVIL awardees and NIH staff and support achievement of the proposed goals and milestones, plans for conflicts resolutions, as well as the provisioning of data for research use.

Metrics to assess the utilization of the resource and its impact on the clinical genomic research community should be described.

Applicants should describe how they plan to interact with the ASC and the ECC. Applicants should also describe previous experience with similar committees and include examples regarding how recommendations from such groups were incorporated into a project and how this contributed to a project’s outcome. Applications should not include proposed ECC members or recruit members to serve on the ECC prior to the peer review of the application.
 

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:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
  • NHGRI expects all educational or outreach materials, software, workflows, and tools developed from this Program to be made available as soon as they are ready under an open-source license which will permit the public to use the materials without substantive restrictions. Awardees are expected to comply with the NIH Genomic Data Sharing Policy.

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.

Foreign Institutions

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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the 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 NHGRI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NHGRIReferral Office by email at bettie_graham@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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.

For this particular announcement, note the following: Applicants are expected to describe how they propose to meet each component’s objectives, both independently and in collaboration with other awardees of the AnVIL Program, including those under this RFA and the companion RFA-HG-22-020.

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.

 

Is the scope of activities proposed for the ACR appropriate to meet the needs of the clinical genomic research community?

Does the project address important problems or critical barriers in the AnVIL Program being able to serve the clinical genomic research community?

Will successful completion of the aims improve the concepts, methods, technologies, and services of the AnVIL Program? 

 

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?

Do the investigators have appropriate experience working with clinical genomic research data and consortia, developing methods, harmonizing phenotypes, integrating disparate datasets, and analyzing clinical genomic data?

Have the investigators demonstrated experience in managing data science and research projects involving clinical genomic information?

Do the investigators demonstrate significant experience in developing relationships with clinical laboratories and clinical research groups to conduct clinical genomic research initiatives?

Do the proposed personnel include expertise in human subject research?

Do the investigators have a diverse team with multifaceted backgrounds that are able to leverage cloud-based resources to conduct clinical genomic based research?

Do the investigators have experience in developing software, tools, and workflows that serve the clinical-genomic research community?

If the proposed resource is multi-PD/PI, do the investigators have complementary expertise and skills and a track record of working collaboratively?

Do the applicants have experience overseeing subawards, if needed?

 

Are the concepts, approaches or methodologies, instrumentation, novel to clinical genomic research in a broad sense?

 

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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?

Will the strategy establish feasibility and will particularly risky aspects be managed?

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

Is there an appropriate work-flow plan and includes well-established timelines and milestones?

Does the proposed resource meet the goal to assist the clinical genomic research community's transition to a collaborative environment by providing data, services, software, tools, and workflows that foster clinical genomic research?

Are the proposed data, software, tools, and workflows cloud agnostic?

Are the plans for ensuring and maintaining data access, data security, including audits of the data security processes adequate?

Are the proposed plans for providing outreach and education and soliciting user feedback from the clinical genomic research community adequate?

Is the plan for collaborative activities and interoperability approaches to use in a federated data ecosystem adequate?

Are the plans for collaborating with the AnVIL Program members adequate?

Are the procedures for data harmonization and quality control of data adequate for clinical genomic research sites or laboratories, as applicable?

Are the plans for collaborating with the AnVIL Program members adequate?

Are their leadership approach, governance, and organizational structure appropriate for the project?

Is the leadership approach, governance, organizational structure, and plans for conflict resolution appropriate for the resource?

 

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?

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.

   

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

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

 

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

 

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

 

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

 

Not Applicable.

 

Not Applicable.

 

Not Applicable.

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.

 

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

 

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

 

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

 

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

 

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NHGRI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council for Human Genome Research. 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.
  • Ability of the applicant to work effectively with the other members of the AnVIL Program.

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: Generaland 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.

Should the applicant organization successfully compete for an award, 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 (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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 https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/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 and 2 CFR 200, and other DHHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an “assistance” mechanism (rather than an “acquisition” mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

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

  • Determining technical and operational approaches to support the ACR and setting project milestones and timelines.
  • Ensuring that the data, software, resources, materials, etc. produced as part of this project are released appropriately according to the Resource Sharing Plan.
  • Ensuring staff supported under this award will not disclose confidential information and will adhere to the “AnVIL Staff Code of Conduct” included below.
  • Interacting with other relevant NHGRI and NIH activities, as needed, to promote interoperability among similar or related NIH projects.
  • Working collaboratively with all AnVIL recipients in support of the project’s governance structure.
  • Being active ASC members and establishing AnVIL workgroups that support clinical genomic research.
  • Providing effective leadership and management.
  • Accommodating necessary changes to improve the efficiency of operations and services.
  • Providing interim reports or information requested by NHGRI staff.
  • Providing logistical and administrative support for the External Consultant Committee (ECC) meetings, the NIH Cloud Platform Interoperability effort, ASC meetings, and AnVIL workgroups.
  • Addressing and implementing the guidance and recommendations of the ASC, the ECC, and NHGRI.
  • Serving as active members of the ASC, NCPI, and participating/leading working groups that focus on topics or activities that affect the value, quality, and efficiency of the operations and services provided by the AnVIL Program.
  • Assisting in the development of policies that require coordinated action.
  • Maintaining security certifications of the AnVIL platform and facilitating data security audits and certification by third parties.
  • Maintaining necessary regulatory and policy compliance related to data access and data security for both unrestricted and controlled access data, including NIH-designated best practices for genomic data sharing.
  • Adhering to policies regarding data access, publication, and intellectual property established by NIH and the ASC.
  • Working productively with program staff from other NIH institutes as needed.
  • Agreeing to accept close coordination, cooperation, and participation of NHGRI staff in those aspects of scientific and technical management of the service as described under “NIH Program Staff Responsibilities.”
  • Agreeing to be subject to Government rights of access consistent with current DHHS, PHS, and NIH policies
  • Notifying NHGRI staff within 24 hours of being made aware of a data management incident under the genomic data sharing policy, a security breach, a data loss, or a system wide loss of data access.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The Project Scientist/Scientific Officer (PS/SO) at NHGRI also holds the dual role of Program Director (PD). The Program Director will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice, coordination, and also will be responsible for the normal scientific and programmatic stewardship of the award. The role of the Program Director will be to facilitate and not to direct the activities. The Program Director will be named in the Notice of Grant Award, and will, along with other NIH staff, be represented as a single collective voting member of the AnVIL Steering Committee (ASC) and External Consultant Committee (ECC). The Program Director will have the following substantial involvement:

  • Serving as a liaison and helping to coordinate activities among and for the recipients, including acting as a liaison to the NHGRI and as an information resource for the recipients about NHGRI and NIH priorities. The Program Director will also coordinate the efforts of the grantee(s) with other groups conducting similar studies.
  • Assisting recipient(s) in the development, if needed, of policies for dealing with situations that require coordinated action.
  • Providing advice on the management and technical performance of the award.
  • Assisting in promoting the availability of the data and related resources developed in the course of the award to the scientific community.
  • Being responsible for the normal scientific and programmatic stewardship of the award, including assessments of how well the awardee has met any milestones required for each year of funding.
  • Curtailing, withholding, or reducing support for any recipient that fails to make satisfactory progress toward the work scope that NHGRI approved, has ethical or conflict of interest issues, or fails to comply with the Terms and Conditions of Award.
  • Involving NIH or NHGRI staff who may assist the recipient(s) as designated by the Program Director.
  • Where warranted and consistent with authorship and conflict of interest requirements of journals in which the Consortium/Network decides to publish, co-authoring manuscripts through their role in scientific program management.
  • Other NHGRI staff may assist the recipient(s) as designated by the Program Official


Data/software ownership and transition to another grantee:

AnVIL 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.

Ownership of the data and software hosted, uploaded, or generated on AnVIL’s platform remains with the data and software providers. The recipients have no possessor rights of the data, software, and workflows provided or generated by AnVIL platform users, who will retain ownership and control of their resources.

A fundamental objective of this cooperative agreement is to ensure that the valuable data, software, and workflow resources provided by the AnVIL Program remain available without interruption to the research community if the recipient withdraws or otherwise can no longer manage the resource or if the award is terminated by the NIH. At the end of the award, or if a new recipient has been selected prior to the end of the award, the recipient will work with NHGRI staff and the new award recipient to transition the data and software to the new service, or to the Government.

Open Source Technology:

Capabilities, software, tools, and workflows built as part of the AnVIL Clinical Resource must be delivered under an open-source model and integrated into the existing AnVIL platform. Organizations may propose to use proprietary software, tools, and workflows so long as the requirements for data transparency and interoperability with the AnVIL platform are maintained.

Areas of Joint Responsibility include:

Due to the complexity of the infrastructure and services provided by the AnVIL Program, a close collaboration among PIs/PDs of this RFA, the companion RFA-HG-22-020, and NHGRI staff is required to manage, assess, and implement the Program. This is accomplished by:

  • Meeting weekly by conference call or in person to share information on data resources, methodologies, analytical tools, data analyses, preliminary results, etc.
  • Establishing best practices for data integration and collaborative analyses as appropriate.
  • Generating responses to ECC recommendations.
  • Naming ASC members.
  • Promoting the availability of the data and related resources developed in the course of this service to both the clinical and genomic research communities at large.
  • Developing joint timelines and milestones.

Publications:

The PIs/PDs are encouraged to generate publications regarding the AnVIL Program’s infrastructure and services.

For AnVIL-associated datasets that have not been publicly released, the PIs/PDs will need approval in writing from the data owners before using the data.

For controlled-access datasets hosted by the AnVIL Program, the PIs/PDs will need to go through the proper controlled access authorization process.

AnVIL Staff Code of Conduct:

The AnVIL Staff Code of Conduct sets forth expectations for the responsible management and use of controlled-access data in National Institutes of Health (NIH)-supported repositories. Failure to abide by any term within this Code of Conduct is expected to be resolved between the NIH and the recipient institution which can lead to disciplinary action that may include, but not limited to, termination of the staff from involvement in the data repository’s development and any other access to data in NIH-supported repositories. AnVIL staff is defined as the role of a person or group of persons directed by NIH to develop and test platforms, pipelines, analysis tools, and user interfaces that store, manage, and interact with data from NIH-supported repositories via an NIH funding mechanism. Staff with access to controlled-access data in NIH-supported repositories for development purposes agree to:

  1. Use datasets for the sole purposes of developing, testing and implementing the environment and building the infrastructure during both development and production phases of deployment (these functions include software development to enable researchers to access and analyze data);
  2. Not perform hypothesis driven research in their AnVIL staff capacity;
  3. Make no attempt to identify or contact individual participants or groups from whom data were collected, or generate information that could allow participants’ identities to be readily ascertained;
  4. Maintain the confidentiality of the data and not distribute data to any entity or individual without appropriate approvals from the NIH;
  5. Implement administrative and technical safeguards to prevent unauthorized access to the data and adhere to the NIH Security Best Practices for Controlled-Access Data Subject to the NIH Genomic Data Sharing Policy and any other relevant federal (e.g., FISMA) and institutional security requirements;
  6. Ensure that only authenticated and authorized users can gain access to data files, as appropriate;
  7. Report any inadvertent data release, breach of data security, or other data management incidents in accordance with any agreements and/or Institute or Center requirements.

No ownership rights of the datasets (including derived or derivative data) are granted to staff or their affiliates.

Staff who want to perform research are required to seek separate approval by the relevant NIH Data Access Committee via a Data Access Request. Finally, the NHGRI reserves the right to modify the AnVIL Staff Code of Conduct modified as needed.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NHGRI may be addressed by convening a Dispute Resolution Panel. It will be composed of three members: a designee of the ASC chosen without NIH staff voting, one NIH designee, and an ECC member with relevant expertise who is chosen by the ASC. 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)

Ken Wiley, Jr., Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-5540
Email: anvil@mail.nih.gov

Chris Wellington
National Human Genome Research Institute (NHGRI)Telephone: 301-48-3496
Email: anvil@mail.nih.gov

Peer Review Contact(s)

Rudy Pozzatti, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-8739
Email: pozzattr@exchange.nih.gov

Financial/Grants Management Contact(s)

Lisa Oken
National Human Genome Research Institute (NHGRI)
Telephone: 301-594-5250
Email: lisa.oken@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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