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
Educational Hub for Enhancing Diversity in Computational Genomics and Data Science (U24 Clinical Trials Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
New
Related Notices

None

Funding Opportunity Announcement (FOA) Number
RFA-HG-22-002
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.172
Funding Opportunity Purpose

The overarching purpose of this initiative is to leverage the NHGRI-funded Genomic Data Science Analysis, Visualization and Informatics Lab-space (AnVIL) and other NIH cloud-based platforms, to enhance the diversity of individuals who have access to educational and research opportunities in computational genomics and data science (CGDS), including those from underrepresented groups. This initiative will focus on opportunities at the undergraduate and master’s degree level. The intent of this specific funding opportunity is to create a CGDS educational hub which will support activities to increase awareness of CGDS and cloud computing concepts, and address barriers to effective CGDS education. The Hub will coordinate with NIH cloud computing platforms to organize workshops, collect stakeholder input, disseminate materials, evaluate educational opportunities and provide logistical support.

Key Dates

Posted Date
May 10, 2022
Open Date (Earliest Submission Date)
May 27, 2022
Letter of Intent Due Date(s)

June 27, 2022

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
July 27, 2022 Not Applicable Not Applicable November 2022 January 2023 April 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
July 28, 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

The National Institutes of Health (NIH) recognizes that scientists and students from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems (see NOT-OD-20-031 ). Benefits of a diverse scientific workforce include fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust. Yet many institutions that enroll significant numbers of students from groups underrepresented in science are under-resourced and their faculty are supported by fewer NIH research grants. There is a pressing need to enhance educational and research capacity and opportunities for student research projects in biomedical science at such institutions.

Accordingly, the NIH continues to encourage institutions to diversify their student and faculty populations and to enhance the participation of individuals from diverse groups, including racial and ethnic groups nationally underrepresented in biomedical, clinical, behavioral, and social sciences research, those from disadvantaged backgrounds, and individuals with disabilities (see NOT-OD-20-031). Although the NIH currently provides multiple opportunities to develop research careers and improve participation for individuals from groups with lower representation in the biomedical and behavioral sciences, reports from the National Science Foundation (NSF) and others, provide strong evidence that diversity remains an ongoing challenge that must be addressed at every level of the educational pipeline.

As a leading authority in the field of genomics, NHGRI’s Strategic Vision is to be at the ‘Forefront of Genomics’ by accelerating scientific and medical breakthroughs that improve human health and well-being. We do this by driving cutting-edge research, developing new technologies, and studying the impact of genomics on society. This requires expertise in the foundational sciences relevant to genomics - biomedical, physical, mathematical, and computer and engineering sciences, biostatistics, epidemiology, bioinformatics, bioethics, social and behavioral sciences, law, and the humanities. Thus, research education in these areas will allow those who participate in NHGRI-supported research activities to be well positioned to contribute to biomedical research in the future. The Strategic Vision also highlights championing a diverse workforce as one of the guiding principles and values for genomics. As detailed in NHGRI’s 2021 “Building a Diverse Genomics Workforce: An NHGRI Action Agenda”, a major implementation goal for achieving that vision is to develop and support educational programs and networks that connect undergraduate and graduate education to careers in genomics. This includes ensuring that institutions that have a mission to serve groups that are currently underrepresented in the genomics enterprise are aware of and tightly connected to these networks.

Concurrently, the Strategic Vision highlights the importance of computational genomics and data science (CGDS) in sustaining and improving a robust foundation for genomics. CGDS is the cross-cutting area where statistics and computer science are used to understand, analyze, and interpret information from genome sequences. Genomics is inherently a “big data” field, and appropriate skills in data science and data stewardship are now prerequisites for becoming a genomics researcher. Therefore, the next generation of genomic scientists needs to be sufficiently trained in data science. However, not all undergraduate and master’s level students who are interested in genomics have access to the infrastructure and specialized education needed to obtain those skills.

In recent years, cloud computing technology has revolutionized CGDS, by democratizing access to genomics data sets, tools, and computing resources, and by enabling efficient genomic data sharing and collaboration. In contrast to traditional, locally provisioned, “on-premises” computing, cloud computing provides access to on-demand, scalable computing and storage resources with a variety of payment models, most of which scale with usage. Most cloud service providers also offer software services such as database management systems and/or machine learning toolboxes, etc. Cloud platforms also provide an opportunity to collocate data and computing resources in the same cloud for high-speed connection between the data and the computers.

Both NIH-supported and non-NIH supported researchers can access large scale genomics datasets through cloud-based platforms such as the NHGRI AnVIL, NHLBI BioData Catalyst, the All of Us Research Hub and the NCI Cancer Research Data Commons. NIH’s Office of Data Science Strategy (ODSS), as part of its mission to implement the NIH Strategic Plan for Data Science, has been a key leader of NIH’s cloud computing implementation through the NIH Science and Technology Research Infrastructure for Discovery, Experimentation, and Sustainability (STRIDES) program.

Purpose and Objectives

The overarching goal of this FOA is to increase availability and access to educational and research opportunities in cloud-based CGDS for undergraduate and masters’ degree students enrolled in institutions currently under-represented in CGDS. For this initiative, such institutions are hereafter termed “Target Institutions”, and are defined as those that have a mission to serve groups that are currently underrepresented in computational genomics and data science. Examples of Target Institutions include, but are not limited to, Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions (HSIs), Tribal Colleges and Universities (TCUs) and women’s colleges. By focusing on early career stages (undergraduate and master’s degree), this funding opportunity will enable students at such institutions to obtain a more robust foundation in CGDS and facilitate the development of a diverse data science and genomics workforce. Students and faculty intended to be engaged through this initiative include not only those who are part of biology or computer science departments, but other associated STEM disciplines as well (e.g., mathematics, statistics/biostatistics, and bioengineering.

The intent of the current FOA is to create a CGDS educational hub (hereafter referred to as “the Hub”) which will support activities to increase awareness of CGDS and cloud computing services provided by the NHGRI-funded AnVIL and other NIH cloud-based platforms among such groups, and address barriers to effective CGDS education. A companion FOA will be released in FY24 to support the development of cloud-based CGDS instructional materials by faculty at Target Institutions.

This goal will be achieved through four complementary activities conducted by the Hub:

  1. Creating a community of target institutions interested in CGDS education and cloud computing. The scope of this goal includes identifying challenges currently faced by these institutions in these topics, developing strategies to address these challenges, and testing and evaluating these strategies.
  2. Facilitating CGDS and cloud computing educational initiatives at Target Institutions. The scope of this goal includes organizing workshops and hands-on learning sessions in CGDS topics for students and faculty at Target Institutions, including train-the-trainer content for faculty members at Target Institutions to facilitate CGDS teaching by their institutional colleagues
  3. Integrating and disseminating CGDS educational resources through a cloud-hosted platform. The scope of this goal includes assisting faculty of participating institutions of the companion FOA with developing CGDS educational materials, adapting these materials for hosting on the cloud and disseminating these materials through a cloud-hosted portal created by the Hub
  4. Providing logistical support and coordinating with participating NIH cloud computing platforms and partner Target Institutions that will be funded through the companion FOA to further the educational, diversity, and workforce development goals of this FOA.

As a complement to classroom and cloud-based CGDS instructional content, the Hub should also support opportunities for students at Target Institutions to conduct hands-on genomic research projects . Specifically, in the fourth and fifth years of the five-year project period for this FOA (FY26 and FY27), the Hub will also be expected to administer a competitive opportunity for faculty at Target Institutions to receive support for hands-on student research projects in CGDS.

Resource Sharing

NHGRI expects that all educational or outreach materials, including curricula and syllabi, developed by the Hub will be made available as soon as they are ready under a CC BY 4 Creative Commons license, which will permit the public to use the materials without substantive restrictions (https://creativecommons.org/licenses/by/4.0/). NHGRI also expects that the availability of these materials to the broader CGDS education community will be communicated broadly and actively.

Licensing for software developed through this FOA will be expected to follow the least restrictive option from among existing licensing standards. The materials should be provided in easily shareable formats that are widely available at no cost. The non-Federal entity may copyright any work that is subject to copyright and was developed, or for which ownership was acquired, under a Federal award. The HHS awarding agency reserves a royalty-free, nonexclusive and irrevocable right to reproduce, publish, or otherwise use the work for Federal purposes, and to authorize others to do so.

All resources and tools developed by the Hub will be designed as non-proprietary and open source employing user interfaces that will allow the upload and download of resources. In addition, all resources and tools should be portable and easily transferred to other institutions as needed.

Annual Programmatic Meetings

The Hub will be expected to organize annual in-person/virtual hybrid meetings for members of the Hub, representatives of participating NIH cloud platforms and NIH program staff, and faculty at Target Institutions engaged in the Hub’s activities, including those supported by the companion FOA. These meetings will focus on sharing best practices and lessons learned among the sites, and on how to disseminate the curricula and teaching aids developed through this initiative with institutions beyond the immediate awardees. Additionally, at these annual meetings, the Hub will report progress, seek new research directions and ideas, and update NHGRI on issues of need.

Project Management

The leadership and management structure of the Hub should be commensurate to the complexity of the project. The project management structure should ensure the efficient planning, initiation, implementation, and timely completion of all activities as well as day-to-day oversight of the activities. Specific timelines and milestones should be developed and updated as needed, in collaboration with program staff from NHGRI and NIH partner Institutes, Centers and Offices (ICOs) for this FOA and the External Consultants Committee (see below). Metrics to assess the utilization of the resource and its impact on CGDS education in Target Institutions should also be developed. 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.

Scientific Experts Group (SEG):

The PD/PI should develop plans for a Scientific Experts Group (SEG) to consult on the progress and priorities of the Hub. The SEG should encourage continuous improvements as methods, data, and needs change with time. A strong emphasis on operating in a cost-effective manner should be established. Applicants should describe how they would appoint and use the SEG, and how they plan to organize SEG meetings. Applicants should describe previous experiences with consultatory panels, how advice was incorporated into a project, and how the advice contributed to a project’s outcome. The SEG members should have expertise in a broad range of topics that are relevant to scientific workforce development, workforce diversity, CGDS education and research and ethical, legal, and social implications (ELSI) research.The SEG will meet, at a minimum, semi-annually (one conference call and one in-person meeting per year). Following each meeting, the SEG will submit their input to the PD/PI and NHGRI.

New applications should not name proposed SEG members or recruit members to serve on the SEG prior to the peer review of the application. However, they should describe the expertise to be included on the SEG.

Informational Webinar

NIH staff intend to hold a pre-application Informational Webinar for all interested prospective applicants to this funding opportunity. Webinar date and other details will be posted on https://www.genome.gov/event-calendar. NHGRI staff will be available to answer questions related to this FOA. Additional resources, including Frequently Asked Questions, will be posted on the website. Investigators planning to submit an application in response to this FOA are encouraged to contact and discuss their proposed research aims with the scientific contact listed in Section VII in advance of the application receipt date.

Responsiveness Criteria:

Applications nonresponsive to the goals and objectives of this FOA will not be reviewed, e.g.:

  • Applications that address educational opportunities for data science without a genomics component,
  • Applications that address educational opportunities for genomics, but without a data science component
  • Applications that do not involve the use of cloud computing resources as an educational tool

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 and partner components intend to commit a maximum of $1.5 million per year in total costs between FY23-FY25 to fund one Hub award, with an additional $300K Total costs per year for FY26 and FY27 for hands-on student research projects.

Award Budget

Application budgets may not exceed $1.5 million total costs per year for FY23-FY25, may not exceed $1.8 million total costs per year for FY26 and FY27, and must reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum period is five 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
Foreign Institutions

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are not 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. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, 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.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) 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 underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. See, Notice of NIH’s Interest in Diversity, NOT-OD-20-031. 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 by 11:59 PM, EST on June 27, 2022 to:

Shurjo K. Sen, Ph.D.
Telephone: 301-827-7028
Email: sensh@mail.nih.gov

Page Limitations

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

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

The PD(s)/PI(s) should have appropriate experience and training in genomics, data science, community engagement with minority-serving institutions, educational content devekopment and cloud computing to be succesful leaders of the Hub. Early Stage Investigators or those in the early stages of independent careers listed as Senior Key Persons will be expected to have appropriate experience and training. Established investigators will be expected to have demonstrated an ongoing record of accomplishments that have advanced the above fields. If the project is collaborative or multi-PD/PI, the investigators should have complementary and integrated expertise.

Specifically, the PD(s)/PI(s) should have a track record in (a) culturally aware career development and mentoring (b) curriculum and/or educational materials/activities development, assessment, and dissemination (c) incorporation of ethical considerations in skills and workforce development activities, leading to an ongoing record of accomplishments in CGDS education. They should have a track record of successfully engaging Target Institutions for undergraduate and master’s degree level educational initiatives, and significant experience with coordinating collaborative educational initiatives, including experience overseeing selection and management of subawards.

R&R Budget

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

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

  • Costs for the procurement of cloud services should be clearly identified and detailed justification should be provided.
  • A 1.2 Calendar Month minimum level of effort from the PI is required. For Multiple PD/PI applications, the aggregate PI minimum level of effort must be 1.2 Calendar Months.
  • A 6 Calendar Month minimum level of effort is required for the primary project manager for the Hub
  • Meeting and travel costs should be specified, including (a) budget to host the Annual Meeting referred to above; (b) budget to host and organize SEG meetings; (c) budget for travel to visit Target Institutions and collaborating cloud platforms, capped at ten trips per award year for no more than two personnel per trip and; (d) budget for faculty and student travel to in-person events hosted at the Hub location
  • In the fourth and fifth years of the five-year project period for this FOA (FY26 and FY27), the Hub budget should include $300K total costs to support for hands-on research projects in CGDS directed by participating faculty at Target Institutions awarded as competitive opportunity funds administered through the Hub
  • Additional costs anticipated for activities of the Hub in the areas of resource dissemination, support for portal/web site creation and tools for training material generation

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:In the Research Strategy, applicants should propose plans, approaches, and potential alternative strategies for carrying out the activities of the Hub as described in the Purpose and Objectives section above. The Research Strategy should consist of the following sections. Details about what should be discussed in each section are described below.

1. Overview of the Hub

  • Provide an overview (maximum 2 pages) of how the Hub will be structured to facilitate the objectives described in the Purpose and Objectives section above
  • Highlight the significance and innovation of the proposed plan.
  • Highlight ways in which the Hub will address the needs of the community to have access to adequate resources for teaching CGDS using cloud computing as an educational tool
  • Describe how the scope of activities proposed for the Hub are appropriate to meet those needs
  • Describe how successful completion of the Hub's aims will bring unique advantages or capabilities to the CGDS education community
  • Describe how efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the Hub
  • This section should include a description of previous experience in teaching data science and genomics to a diverse audience at the undergraduate and/or master’s degree level and in using cloud computing resources for research and educational purposes
  • Note in this section any additional applicant competencies that are not detailed in the FOA but are considered relevant for the operation of the Hub and describe potential approaches.

2. Plans and Approaches to Create a Community of Target Institutions Interested in CGDS Education and Cloud Computing, and Identify Challenges Currently Faced by These Institutions

  • Describe plans for outreach to Target Institutions and engaging with biology, computer science, mathematics, and statistics faculty (or any faculty who may have CGDS-relevant interests) at these Institutions
  • Describe plans for sharing the educational value proposition of the Hub with faculty at Target Institutions
  • Describe strategies for identifying challenges faced by faculty at Target Institutions in teaching cloud computing and CGDS concepts
  • Describe strategies for engaging and building trust with faculty at Target Institutions
  • Describe strategies for working with appropriate stakeholders and collaborators to develop and test solutions to address these challenges
  • Describe how the balance of the proposed activities is responsive to the needs and opportunities of Target Institutions
  • Describe plans to engage the AnVIL platform or other NIH cloud-based platforms in support of the CGDS and cloud computing curriculum development efforts.
  • Describe novel technical approaches and administrative solutions to support the needs of CGDS education at Target Institutions
  • Describe plans for leveraging cloud computing as an educational tool
  • Applicants are encouraged to propose and justify any other activities relevant to facilitating collaborations and coordinating scientifically focused discussion groups.

3. Plans and Approaches to Facilitate CGDS and Cloud Computing Educational Initiatives at Target Institutions

The scope of the Hub does not include a mandate to independently create classroom lectures or online labs in CGDS. Those activities are envisioned as a partnership between the Hub and the Target Institutions. The primary roles of the Hub are intended to be focused either at the foundational stage of increasing awareness of and familiarity with CGDS and cloud computing concepts, assisting and facilitating faculty at Target Institutions to create educational material in these areas, and finally to adapt such content to be stored, taught and shared using NIH-funded cloud platforms. In this context, applicants should:

  • Describe plans for hosting and/or organizing well-structured workshops and hands-on learning sessions on cloud computing and CGDS concepts for students and faculty at Target Institutions (including both virtual, in-person and hybrid participation strategies)
  • Describe the overall approach to assist and collaborate with faculty at Target Institutions to support their efforts (funded through the companion FOA) in the development of CGDS and cloud computing curricula
  • Describe planned activities and approaches for faculty who currently teach biology classes without a genomics or data science component at Target Institutions to incorporate these aspects into their courses
  • Describe planned activities and approaches for faculty who teach computer science, mathematics, statistics, or data science courses without a genomics component to incorporate genomics concepts into their courses
  • Describe plans for train-the-trainer workshops where faculty from Target Institutions will receive instruction in enabling their colleagues who are interested in CGDS and cloud computing to teach these topics
  • Describe plans to collect, update, maintain, and publicly release the data and tools developed, including a strategy to ensure that curation is accurate and that error propagation is minimized
  • Describe plans for researchers to access the resource data or materials, including plans to make available the entire resource and data schema

  • Describe plans to implement Findable, Accessible, Interoperable and Reusable (FAIR) guidelines for Hub activities

  • Describe strategies for collecting, housing and evaluating necessary data for evaluating assessing the effectiveness of solutions implemented by the Hub. This should include an outline of the plans to secure data for measures that may include personally identifiable (PII) or privileged information, including how data will be secured (e.g. what firewalls exist, how information will be protected from hacking), and where it will be housed.

The Hub is not intended to support development of educational content that focuses on genomics or genetics without including a strong computational or analytical focus. Support may be provided for including basic genomics concepts in courses that are otherwise intended to teach CGDS topics.

4. Plans and Approaches to Create a Cloud-Hosted Platform for CGDS Educational Resources

Applicants should:

  • Outline their overall strategies for facilitating the use of cloud-based infrastructure and platforms as an educational tool
  • Address ways in which new users of cloud computing amongst students and faculty at Target Institutions will be provided reasonable levels of assistance when needed for activities administered through the Hub.
  • Address how both individual users as well as institutions will be able to share and access educational resources and content created either by the Hub or by faculty at participating Target Institutions
  • Address strategies to promote interoperability among different cloud platforms for use as educational tools adequate (e.g., how educational content originally developed for an NIH cloud using Google’s GCP platform would be made interoperable with another NIH-supported cloud using Amazon’s AWS platform)
  • Describe strategies for creating a web portal representing the Hub that bridges educational activity of the Hub with the NHGRI AnVIL and other partnering NIH cloud platforms
  • Include a detailed plan on how the structure of the above portal, its specific elements and content, the backend infrastructure (e.g., the database schema, the software interfaces, the associated documentation, etc.) and any related data analysis tools, including both executables and source code, will be rendered easily transferable to third parties or other institutions at the completion of the grant period.
  • Propose an initial set of deidentified, datasets (consent codes NRES, GRU or equivalent) that will be hosted on a cloud environment and made available to the CGDS education community for use in student activities. A description should be provided of their formats, data types, data usage limitation, estimated cloud storage costs and any other relevant information that explains the importance of these datasets for CGDS education, with a particular emphasis on ensuring that the chosen datasets reflect the diversity of the students and faculty expected to be engaged by the Hub during the award period.
  • Propose a billing model for using NIH-funded cloud platforms as educational tools (including cost control strategies) and describe how it would be implemented technically. NIH-supported researchers can access cloud computing platforms through the NIH Science and Technology Research Infrastructure for Discovery, Experimentation, and Sustainability (STRIDES) Initiative.
  • Describe plans for ensuring and maintaining data access, data security, including audits of the data security processes
  • Describe proposed plans for cloud computing user authentication and authorization

5. Strategies for Administering Opportunity Funds for Student Research Projects at Target Institutions

Applicants should:

  • Propose and describe a management plan for an Opportunity Funds program in FY26 and FY27 for a subset of faculty at Target Institutions to develop independent research projects in experimental or computational genomics that will be used as the substrate for subsequent hands-on experience in cloud-based CGDS analysis
  • Include a description of the administrative structure, process for solicitation, review, and selection of projects, recommendation process for NHGRI review and approval, procedures for funds disbursement, and plans for monitoring and reporting progress.
  • Describe plans for interacting with the institutions of awardees and for regularly reporting on awardee progress, expenditures, and management of the Opportunity Funds program.
  • As needed, propose and justify any other activities relevant to management of the Opportunity Funds that are not detailed in this section

6. Timeline

  • Provide a detailed timeline (e.g., Gantt chart) of activities and milestones to track progress towards the Hub’s objectives. This should be organized by quarter years.

Leadership and project management plan: Applicants should clearly describe the division of responsibilities for the whole project. The plan should also describe how the PD(s)/PI(s) will manage the proposed Hub, coordinate the day-to-day activities and support achievement of the proposed goals and milestones, and plans for conflicts resolutions both internally at the Hub as well as with external collaborators at Target Institutions.

Plan for Instruction in the Responsible Conduct of Research: All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction – instruction must occur during each career stage and at least once every four years. See also NOT-OD-10-019. The plan should be appropriate and reasonable for the nature and duration of the proposed program.

Applications lacking a plan for instruction in Responsible Conduct of Research will not be reviewed.

Evaluation Plan: Applications must include a plan for evaluating the activities supported by the award. The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of faculty and students at Target Institutions engaged by the Hub in CGDS educational activities), as well as measures to gauge the short or long-term success of the award in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements.

Applications lacking an Evaluation Plan will not be reviewed.

Dissemination Plan: A specific plan must be provided to disseminate nationally any findings resulting from or materials developed under the auspices of the Hub, e.g., sharing course curricula and related materials via web postings, presentations at scientific meetings, workshops

.

Other elements: Applicants are encouraged to include in the application additional topics or features that may improve the quality and effectiveness of the services provided by the Hub resource.

Letters of Support: Applicants should include letters of support from any person or group that is providing the proposed project with resources, such as materials, data, or software. Applicants should include letters only from those offering specific resources and collaborations, rather than many letters of general support, to avoid unnecessarily limiting the pool of non-conflicted reviewers.

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 resources and tools developed by the Hub will be portable and easily transferred if needed.

All applications, regardless of the amount of direct costs requested for any one year, must address a plan for sharing educational tools and other resources produced by the Hub. The plans may include policies for access and sharing; including provisions for appropriate protection of privacy, confidentiality, security, intellectual property, or other rights or requirements.

For Educational Tools: In the body of the text, the section should begin with a heading indicating "Tool Sharing Plan". Tool Sharing Plans should provide details for the tool components or modules, tool parameters and associated datasets. The plan should include the minimum requirements for tool documentation, tool building, tool validation and tool reproducibility. Applicants are also expected to include plans to link proposed tools with other relevant tools. Any software associated with proposed tools are expected to also be addressed in the Software Sharing Plan (below).

For Software: In the body of the text, the section should begin with a heading indicating "Software Sharing Plan". There is no prescribed single license for software produced through grants responding to this announcement. However,

  • The software should be freely available to biomedical, biological, behavioral, environmental, and clinical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
  • The terms of software availability should permit the 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 reproduce the analytical tool and continue development in the event that the original investigators are unwilling or unable to do so.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

Plan for Enhancing Diverse Perspectives (PEDP)

Application to this FOA requires a Plan for Enhancing Diverse Perspectives (PEDP). Applications submitted without a PEDP will be considered incomplete and will be withdrawn prior to peer review. A PEDP is a summary of strategies to advance the scientific and technical merit of the proposed project through inclusivity. Broadly, diverse perspectives refer to the people who do the research, the places where research is done, as well as the people who participate in the research as part of the study population. The PEDP is submitted as a 2-page “Other Attachment”. Within the two pages, applicants should include a timeline and milestones for relevant components that will be considered as part of the review. Within the Research Strategy, applicants should align their description with the PEDP strategies and milestones and are encouraged to refer to information included in the PEDP attachment. In the 2-page PEDP summary, applicants are expected to show how enhancing diverse perspectives is supported throughout the application and how this strengthens the scientific and technical merit of the project (in terms of significance, investigator(s), innovation, approach, and environment), as appropriate. It is anticipated thatevery PEDP will be unique and will depend on the content and structure of the scientific aims, the required expertise, the environment, and the performance site(s).

Examples of items that advancing diverse perspectives in research and may be part of the PEDP can include, but are not limited to:

  • Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
  • Description of any planned institutional partnerships that may enhance geographic and regional diversity.
  • Plan to enhance recruiting of women and individuals from groups traditionally underrepresented in the biomedical, behavioral, and clinical research workforce.
  • Proposed monitoring activities to identify and measure PEDP progress benchmarks.
  • Publication plans that describe equitable processes to determine inclusive authorship and authorship order and ensure proper attribution.
  • Opportunities to promote visibility of junior faculty, post-docs, trainees, etc. by serving as first authors and/or presenting at National/International scientific meetings.
  • Outreach to and recruitment of trainees from traditionally underrepresented groups and investigators at regional and national scientific meetings (e.g., Society for the Advancement of Chicanos/Hispanics and Native Americans in Science
    (SACNAS), American Indian Science and Engineering Society (AISES), Annual Biomedical Research Conference for Minority Students (ABRCMS), American Institute of Chemical Engineers
    (AIChE), Institute of Electrical and Electronics Engineers (IEEE),  etc.).
  • Partnerships with advocacy groups or professional societies to help recruit study participants for clinical research and/or to aid with dissemination of research results.
  • Outreach activities to various public stakeholders (e.g., educators, data scientists, etc.) to improve engagement and understanding of CGDS education and research.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof 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 (DUNS number or UEI as required) provided 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.

In order to expedite review, applicants are requested to notify the NHGRI Referral Office by email at grahamb@odder.nhgri.nih.gov when the application has been submitted. Please include the FOA number and title, PD(s)/PI(s) name(s), and title of the application.

Requests of $500,000 or more for direct costs in any year

Not applicable.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

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

Overall Impact

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.

 

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: Is the proposed resource valuable for the broad genomics research community?

Does the proposed resource address the needs of the community to have access to adequate resources for teaching CGDS using cloud computing as an educational tool? Is the scope of activities proposed for the resource appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the CGDS education community?

To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the Hub?

 

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 investigators have a track record in (a) culturally aware career development and mentoring (b) curriculum and/or educational materials/activities development, assessment, and dissemination (c) incorporation of ethical considerations in skills and workforce development activities? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in CGDS education? Do the investigators have a track record of successfully engaging Target Institutions for undergraduate and master’s degree level educational initiatives? Do the investigators demonstrate significant experience with coordinating collaborative educational initiatives? Does the proposed personnel include expertise in human subjects research?

Does the applicant have experience overseeing selection and management of subawards, if needed?

 

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:

Does this application propose novel technical approaches and administrative solutions to support the needs of CGDS education at Target Institutions? Are the concepts and strategies novel and applicable in a broad sense? Are the plans for leveraging cloud computing as an educational tool innovative and adequate? Does the application propose innovative strategies for engaging and building trust with faculty at Target Institutions?

 

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA:

Are the methods to produce the resource efficient and cost-effective? If the size of the resource is likely to increase over time, will the proposed methods work at increased scale to allow the applicants to meet the goals in an efficient and cost-effective way?

Are the approaches for identifying challenges faced by Target Institutions in teaching cloud computing and CGDS concepts adequate? Are the proposed solutions for working with appropriate stakeholders and collaborators to develop and test strategies to address these challenges adequate? Is an well-designed evaluation plan included for testing the effectiveness of these strategies? Does the applicant propose a plan for organizing well-structured workshops and hands-on learning sessions on cloud computing and CGDS concepts for students and faculty at Target Institutions and recruiting participants to these events? Are the proposed cloud cost control and tracking methods adequate? Is the proposed user billing model appropriate?

Does the application include strategies for assisting faculty at Target Institutions in developing CGDS instructional content that leverages the computing resources and datasets available through the NHGRI AnVIL and other NIH cloud platforms? Does the applicant include strategies for disseminating these curricula and associated materials to the broader educational community? Does the application include train-the-trainer content for faculty members at Target Institutions to teach cloud-based CGDS courses?

Does the proposed cloud-based infrastructure and software platform meet the goal to facilitate CGDS education at Target Institutions? Is the proposed approach for ingesting third-party educational content and adapting it for use and sharing through cloud environments adequate? Are plans for addressing interoperability among different cloud platforms that may be used by the Hub adequate?

Are the proposed plans for providing educational outreach and soliciting users’ feedback from the research community adequate?

Are the plans for collaborative activities and interoperability approaches among different cloud platforms for use as educational tools adequate?

Are the proposed initial datasets to be hosted and made available by the resource of broad utility to the genomic research community and of appropriate size and quality for developing educational content?

Are the plans for ensuring and maintaining data access, data security, including audits of the data security processes, adequate? Are the proposed plans for user authentication and authorization appropriate?

Should funding for this Hub come to an end, is a plan for the transfer of Hub resources (i.e., online portal, databases, software and other code) to NHGRI or another entity clearly described, reasonable and appropriate?

How adequate is the proposed Resource Sharing Plan? Are well-developed proposals for sharing educational tools and software developed by the Hub included?

Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?

Are the planned efforts for the PD/PI appropriate and sufficient for the work proposed? For MPI applications, is the aggregate effort for the MPIs appropriate and sufficient for the work proposed

How adequate is the proposed governance structure, including its timelines and milestones? Is the leadership structure appropriate for this resource project, including the level of effort of key personnel? Is the project schedule reasonable and well thought out? Is the plan for interacting and soliciting input from the SEG appropriate

 

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:

Will the range of departments and/or institutions involved enhance the diversification of the team in terms of the backgrounds, and expertise and skills of the researchers?

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

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

 

How is the balance of the proposed activities responsive to the needs and opportunities of the potential user communities?

 

 

How adequate are the plans to collect, update, maintain, and publicly release the data and tools developed? How adequate are the plans to ensure that curation is accurate and that error propagation is minimized?

 

How adequate are the plans for researchers to access the resource data or materials, including plans to make available the entire resource and data schema? How well does the resource plan implement the Findable, Accessible, Interoperable and Reusable (FAIR) guidelines?

 

 

How adequate are the plans for providing educational programs to the research community on how to use the resource, if appropriate? Are the proposed metrics to assess the utilization of the Hub and its impact on the genomic research community adequate?

 

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

 

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

2. Review and Selection Process

2. Review and Selection Process 

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), 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 on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this 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.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

2. Administrative and National Policy Requirements

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

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

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, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

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

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

  • Meeting the goals and objectives, as well as timelines and milestones.
  • Providing effective leadership and management.
  • Accommodating any necessary changes to improve the efficiency of the Hub operations and services and decrease costs.
  • Providing interim reports or information requested by NHGRI staff.
  • Providing logistical and administrative support for meetings of the Scientific Experts Group (SEG) and of any governance committee instituted to oversee and guide the Hub operations.
  • Addressing and implementing the guidance and recommendations of the SEG.
  • Serving as active members 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 Hub.
  • Assisting in the development of policies for dealing with situations that require coordinated action.
  • Maintaining data integrity and facilitating data security audits and certification by third parties.
  • Adopting new solutions and technologies to ensure data security and data privacy.
  • Data and software transition. 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.
  • Ensuring that educational resources and data administered by the Hub will be stored within the geographical borders of the continental United States of America.
  • Maintaining necessary regulatory and policy compliances related to data access and data security for both unrestricted and controlled access data, including any NIH-designated best practices for genomic data sharing.
  • Ensuring that the educational content and data sets created by or submitted to the Hub and resources developed as part of this service are made publicly available according to NHGRI and the NIH policies.
  • Agreeing and accepting 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

Data/software ownership and transition to another grantee:

The Hub will host genomic data and educational content generated by either itself, by faculty at Target Institutions, or by the NHGRI AnVIL or other NIH cloud platforms, and the Hub recipient is responsible for the proper stewardship and security of all data. A fundamental objective of this cooperative agreement is to ensure that the valuable data and software resources provided by the Hub remain available without interruption to the research community if recipient withdraws or otherwise can no longer manage the resource or the award is terminated by the NIH.

Consistent with 45 C.F.R. 75.322, the recipient will own the data generated and software developed by the recipient, and it will be able to continue to use these data and software upon expiration or termination of the award. NIH will have unrestricted cost-free access and use of the data and software generated by the recipient, including the right to transfer said data and/or software to other NIH-funded and/or managed resource projects, at the NIH's sole reasonable discretion upon termination or expiration of this cooperative agreement.

Ownership of the data, educational content and software hosted by the Hub remain with the data and software providers. The Hub has no possessor rights of the data and software provided or generated by its users, who will retain ownership and control of their own resources.

Open Source Technology: Capabilities and software built as part of the Hub must be delivered under an open source model. Organizations may propose to use proprietary platforms, so long as the requirements for data transparency and interoperability are maintained.

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 is a dual role held by a NHGRI Program Director (PD). In the Project Scientist role, the Program Director will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination. In the Scientific Officer role, the Program Director will be responsible for the normal scientific and programmatic stewardship of the award and manages concerns about bias as it affects the project. The role of NHGRI PS/SO will be to facilitate and not to direct the activities. The PS/SO will be named in the Notice of Award.

The PS/SO will have the following substantial involvement:

  • Participating with the Hub’s SEG in the group process of setting scientific, administrative and technical priorities, deciding optimal approaches and protocol designs, and contributing to the adjustment to protocols or approaches as warranted.
  • Serving as a liaison, helping to coordinate activities among and for the recipient(s), including acting as a liaison to the NIH, and as an information resource for the recipient(s) about scientific, administrative, and technical activities.
  • Facilitate the dissemination of experiences and approaches among recipients of the program as well as other NIH-supported networks.
  • Help reprogram efforts within the peer-reviewed scope of work, including options to modify program goals and milestones when programs are not making headway relative to timelines for achieving the objectives of the FOA.
  • Assist in coordinating the efforts of the resource with other groups conducting similar efforts at the NIH.
  • Assisting in promoting the availability of the data and related resources developed in the course of the award to the scientific community.
  • Periodically reporting on the progress of the program to NHGRI Division Directors, the NHGRI Director, and to the National Advisory Council for Human Genome Research.
  • Serving as a liaison between the Hub SEG and other federal agencies.
  • Providing advice in the management and technical performance of the award.
  • Participating in data analyses, interpretations where warranted.
  • Being responsible for the normal scientific and programmatic stewardship of the award, including assessments of how well the recipient has met any milestones required for each year of funding.
  • Where warranted and consistent with authorship and conflict of interest requirements of journals in which the Hub decides to publish, co-authoring manuscripts through their role in scientific program management.
  • The PS/SO may withhold or reduce support from any recipient that fails to achieve its goals or comply with the Terms and Conditions of Award.
  • Other NHGRI staff may assist the recipient(s) as designated by the PS/SO.

Areas of Joint Responsibility include:

Due to the complexity regarding the infrastructure and services provided by the Hub, a close, and collaborative, interaction among PIs/PDs, and staff at NIH will be required. An example of such interaction is promoting the availability of the data and related resources developed in the course of this service to the scientific community at large. Another area of joint responsibility is that the NIH staff and the PIs/PDs will work with and provide information to the SEG. Other areas of joint responsibility include:

    Meeting virtually every quarter calendar year 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.
  • Setting research priorities, deciding optimal research approaches and protocol designs, and contributing to the adjustment of research protocols or approaches as warranted.
  • Generating responses to SEG recommendations.

Publications:

The PIs/PDs are encouraged to generate publications regarding the Hub infrastructure and services.

For datasets used by the Hub that have not been publicly released, the PIs/PDs will need to get approval in writing from the data owners before using the data.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened, including a designee of the Hub SEG, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of NIH and Hub SEG cannot reach an agreement on the third member, the third member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

Programs that involve participants should report on education in the responsible conduct of research and complete a Trainee Diversity Report, in accordance with the RPPR Instruction Guide.

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)

Shurjo K. Sen, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-827-7028
Email: sensh@mail.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Natalie Linear

National Human Genome Research Institute (NHGRI)
Telephone: 301-827-0611
Email: natallie.linear@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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