Part 1. Overview Information

Key Dates

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.

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

Through this limited competition Notice of Funding Opportunity (NOFO), the National Human Genome Research Institute (NHGRI) seeks to broaden the types of knowledge, skills, expertise, experience, and perspectives brought to bear in research addressing the ethical, legal, and social implications (ELSI) of advances in human genetics or genomics. The Building Partnerships and Broadening Perspectives to Advance Ethical, Legal, and Social Implications (ELSI) Research (BBAER) Program will support: 1) transdisciplinary ELSI research addressing timely, complex, and understudied topics associated with advances in human genetics and genomics, 2) the establishment of ELSI research teams that include partnerships with relevant communities affected by and with an interest in the proposed research, 3) research capacity building to develop, conduct, and sustain ELSI research, and 4) workforce development opportunities for early career scholars, research team members, and other BBAER project staff. 

Background

The 2020 NHGRI Strategic Vision notes that genomics has become increasingly woven into the fabric of biomedical research, medical practice, and society and points to the continued importance of research addressing the ethical, legal, and social implications (ELSI) of genetics and genomics.

The increasingly complex and interrelated issues raised by advances in genetics and genomics continue to fuel new questions and challenges for ELSI research. Key tenets from the inception of NHGRI’s ELSI Research Program remain essential today: 1) to anticipate the implications of advances in genomics; 2) to develop and assess policy or societal options for addressing those implications; and 3) to evaluate the impact or effects of options chosen. For decades, ELSI scholars have proposed theories, frameworks, guidelines, programmatic approaches, and policy options to prepare for, mitigate, and address current and future issues in genomics.

As uses for new genomic knowledge, data, and technologies increase in number and complexity, partnerships with a wide range of relevant communities can help inform the implementation of genomics through ELSI research. For purposes of this NOFO, relevant communities are defined as a group or groups of people who are 1) affiliated by geographic proximity, special interest, or similar situations, and 2) affected by and have an interest in topics proposed for research. Representatives from relevant communities are often called upon to serve as human subjects in research but are less frequently engaged as team members in the scientific process. Active and meaningful engagement of relevant communities in the design, conduct, dissemination, and translation of ELSI research can benefit both researchers and the groups represented in their research.

The field of ELSI research can also benefit from the involvement of research organizations that are underrepresented in NHGRI’s ELSI Research Program. Underrepresented organizations are viable sources of new knowledge, skills, expertise, experience, perspectives, and community connections. These research organizations can inspire the use of different disciplines, theories, approaches, methods, and tools that can add rigor, dimension, and value to ELSI research. They also may be part of geographic areas that are not extensively supported by NHGRI’s ELSI Research Program, thereby increasing the likelihood of partnering with new relevant communities, early career scholars, and other researchers into genomics. Supporting the development and strengthening of new partnerships with relevant communities or other organizations can lead to greater innovation and creativity in how we define, assess, and respond to challenges and opportunities in genomics. Greater inclusion may improve assessments of whether the benefits and risks associated with genomic advances are distributed equitably and help illuminate the pathway toward greater equity in genomics.

This limited competition NOFO will support meritorious applications submitted by research organizations that are underrepresented in NHGRI’s ELSI Research Program, to include domestic organizations in the U.S. and its territories that received less than $30 million in total NIH funding per year for each of the past three fiscal years (i.e., FY 2021, FY 2022, and FY 2023).

Program Goals and Requirements

The goals of the BBAER Program are to advance ELSI scholarship, enhance ELSI research teams, build ELSI research capacity, and expand the ELSI workforce. Collectively, these goals will broaden the types of knowledge, skills, expertise, experience, and perspectives brought to bear in ELSI research.

Applications in response to this NOFO must include the following five Elements A, B, C, D and E; and should address each of the corresponding sub-elements (e.g., A1, A2, etc.) in support of BBAER goals.

• Element A: Vision and Strategic Management
  • A1: Vision and Overview
  • A2: Leadership
  • A3: Communication, Collaboration, and Decision-Making
  • A4: Planning, Monitoring, and Evaluation
  • A5: Sustainability
• Element B: Transdisciplinary ELSI Research Projects
  • B1: Research Areas
  • B2: Research Projects
  • B3: Population Descriptors, if applicable
• Element C: Relevant Communities and Team-Based Approach
  • C1: Relevant Communities on Research Teams
  • C2: Team-Based Approach
• Element D: Research Capacity Building
  • D1: Research Capacity Building Needs Assessment
  • D2: Research Capacity Building
• Element E: Workforce Development
  • E1: Workforce Development Participants
  • E2: Workforce Development Activities

An overview diagram of all application elements can be found here. Each Element is described in detail below.

Element A: Vision and Strategic Management

NHGRI envisions the BBAER Program establishing viable, innovative, and productive sites (here forward "BBAER Sites") for conducting transdisciplinary ELSI research, engaging relevant communities in ELSI research, building ELSI research capacity, and developing the ELSI workforce. BBAER Sites should have an overall vision for their participation in the BBAER Program. Given the complexity of the BBAER Program, BBAER Sites will use strategic management to ensure efficient use of resources; successful implementation of proposed activities; effective coordination of all individuals, groups, or organizations involved; and fulfillment of the established vision and goals.

A1: Vision and Overview

Applicants should describe their vision and identify specific goals for their participation in the BBAER Program. Applicants also should highlight the unique capabilities and strengths contributed by the applicant, the relevant communities that will be represented on research teams, the workforce to be involved in developmental activities, and any collaborating organizations; and how their involvement would add value to and support fulfillment of proposed goals. Applicants should understand the research capacity needed to ensure the long-term success of the applicant organization in the field of ELSI research and have a comprehensive approach for building capacity and implementing all program requirements. Applicants should work toward BBAER Site activities and outcomes that will have a scientific or public health impact on the fields of genetics, genomics, or ELSI research. Sustaining some or all of the activities proposed following the end of the federal award project period is expected.

Applicants may, but are not required to, work with collaborators to accelerate BBAER Site goals or to support successful implementation of BBAER Site activities. If collaborators are proposed, then applicants should provide a rationale for the involvement of each collaborator with clearly described contributions, roles, and responsibilities. Applicants should include letters of support from proposed collaborators, if any.

A2: Leadership and Oversight

As part of strategic management, applicants must describe their proposed leadership style, management structure, and process for day-to-day oversight. Each BBAER Element must have a designated leader(s). An individual may have more than one leader role, and co-leaders are allowed. Applicants must include a description of the roles and responsibilities held by each Leader/co-Leader and include an organizational chart/diagram that depicts from where the BBAER Site will be managed; who will lead each Element; and the positions, roles, and relationships among all those involved in BBAER Site activities. Applicants should ensure they have adequate grants administration resources to provide appropriate management and oversight across all phases of the NIH grants process. 

A3: Communication, Collaboration, and Decision-Making

As part of strategic management, applicants should establish an approach and mechanisms for effective communication within and across Elements and consider how transparent communication and psychological safety will be encouraged and supported. They also should establish non-punitive avenues for disclosure of challenges or concerns and a process for ensuring fair and timely response.

Applicants should address how collaboration will be fostered and incentivized. Given the large and complex nature of the BBAER Program, applicants should determine who will be involved in decision-making and how decisions will be made across the organizational structure. Applicants also should consider how differences of opinion will be addressed in decision-making processes and approaches to be used for conflict management.

Awarded BBAER Sites will collaborate with each other and NHGRI in a variety of ways. Types of collaboration may include, but not be limited to 1) participating in regularly scheduled meetings to discuss progress and lessons learned across programmatic elements; 2) participating in BBAER Program-wide evaluation activities; 3) discussing best practices and innovations in community engagement with other NIH funded programs; and 4) networking opportunities. See Section VI. Administrative and National Policy Requirements for additional detail.

A4: Planning, Monitoring, and Evaluation

BBAER Sites will engage in ongoing planning and monitoring to establish specific objectives and activities for implementation over the course of the federal award project period. BBAER Sites will also evaluate their work on the project to identify areas of success and areas needing improvement.

For each Element, applicants should establish clearly defined objectives, activities, timelines, and persons responsible for implementation. Benchmarks (measures of performance related to a desired standard) and milestones (measures of progress over the course of the federal award project period) also should be established and used to monitor project implementation.

Across Elements, applicants should identify a preliminary set of evaluation measures for their project. Applicants may propose various types of evaluation, including but not limited to the following examples: formative evaluation to examine feasibility, appropriateness, or acceptability of an activity or approach); process evaluation to examine whether activities were implemented as intended and resulted in specific outputs; outcome evaluation to examine the degree to which the program is having an effect; and impact evaluation to examine the degree to which project is achieving its ultimate goal. Applicants are not required to, but may, propose more than one type of evaluation.

Applicants may but are not required to establish an advisory committee or board to review progress and offer recommendations for improvement.

NOTE: Applicants that propose an advisory committee or board should not contact potential advisors prior to NIH peer review of the application. Potential advisors should not be named in the application or provide letters of support to reduce the potential for conflicts of interest during review. Instead, applicants should briefly describe the backgrounds, experience, and expertise of proposed members.

A5: Sustainability

BBAER Sites will develop plans for sustaining some or all of the activities proposed following the end of the federal award project period. Applicants should consider what tangible and intangible resources will remain at the end of the federal award project period and develop plans to leverage established capacity for future ELSI research. Applicants also should consider how they will maintain partnerships with relevant communities for future research and potentially establish more formal collaborations.

Element B: Transdisciplinary ELSI Research Projects

BBAER Sites will advance ELSI scholarship by conducting transdisciplinary ELSI research projects addressing timely, complex, and understudied topics. Transdisciplinary ELSI research integrates knowledge and approaches from different disciplines to generate new frameworks, hypotheses, theories, models, or methods that add novelty and nuance to ELSI scholarship. Timely topics are anticipated or interrogated in the field at the time of application or have a clear window of opportunity for exploration at the time of application. Complex topics are issues that necessitate collaborative exploration by multiple disciplines. Understudied topics fill gaps in current knowledge or understanding.

B1: Research Areas

Applicants must select one or more of the following research areas as a focus for the transdisciplinary ELSI research conducted at their BBAER Site:

• Genomics in Context. Addresses the roles, strengths, and limitations of genetics and genomics in understanding and improving human health, behavior, disease, and other variable traits. Genomic research is expanding beyond the realm of rare disease to phenotypes with multifactorial etiologies. When genomics is a causal factor, it is seldom sufficient to fully explain outcomes, particularly in the face of social determinants of health (SDOH). Disproportionate attention to genetic variation in the design of some genomic research studies may reduce the visibility of other contributors to disease and lead to overly deterministic view of the role of genomics.
• Equity and Justice in Genomics. Addresses efforts to define and help achieve equity in genomics for individuals, groups, communities, or populations. Inequities arise from the differential experience of benefit or harm from genomic research participation or genomic discoveries. Disparities across groups in the availability, validity, utility, and accessibility of genomic knowledge, data, and technologies remain a challenge, particularly regarding the use of genomics in health care. Definitions and interpretations of risk, harm, bias, and benefit are critical to the examination of equity and justice across communities. Achieving equity in the advancement of genomics requires attention to both ELSI and scientific issues.
• Genomics and Identity. Addresses how genetics and genomics impact conceptions of individual, group, or population identities; and how conceived identities may impact perceptions people have of, or experiences people have with, genomic information and technologies. Concepts of identity can influence how genomic information is generated, communicated, interpreted, and used. They may evolve over time and shape personal choices and behaviors in a variety of settings. Concepts of identity may include, but are not limited to, race, ethnicity, ancestry, sex, gender, age, religion, ability, occupation, political affiliation, or literacy, along with intersecting identities tied to social or structural injustice.
• Genomic Landscape. Addresses the use and direction of genetics and genomics by a broad range of entities whose mission, scope, and impact go beyond health. Entities may include, but are not limited to, genomic technology and informatics industries, direct-to-consumer companies that offer genetic or genomic services, law enforcement, the judicial system, educational systems, professional or occupational associations, and advocacy organizations. The interplay, involvement, and influence of various entities within genomics may create, exacerbate, prevent, mitigate, or resolve different ELSI issues.

B2: Research Projects

Applicants must describe transdisciplinary ELSI research projects within their selected research area(s) to be implemented by research teams. Proposed projects may vary in duration and topics during the federal award project period. Proposed projects must require two or more academic disciplines or fields of knowledge, and multiple research approaches to fully address research questions of interest. Academic disciplines or fields of knowledge represented on research projects should help ensure various angles or perspectives on a topic can be interrogated.

Research approaches may include but are not limited to empirical quantitative and qualitative methods, as well as conceptual, legal, and normative analyses. Applied research designed to address ELSI issues in genetics and genomics also will be considered responsive. Research projects may develop tools and findings that can be applied across multiple diseases and conditions. Projects focused on a single disease or disorder may be of lower priority for NHGRI unless generalizability or transferability of findings and resources is clearly demonstrated and described.

Applicants are encouraged but not required to identify a unifying theme for the topics addressed by their ELSI research projects. This theme may help define their ELSI research agenda during and beyond the federal award project period.

B3: Population Descriptors

For this NOFO, population descriptors are defined as variables used to describe or distinguish people from each other based on perceived or actual differences. Population descriptors may be used for example, to describe who is participating in a study, what groups are being compared, or to whom particular study findings may apply.

Descriptors measuring the complex concepts of race, ethnicity, genealogical ancestry, and genetic ancestry are commonly employed in biomedical, health services, genomic, and ELSI research. In the United States, there are real and measurable impacts of one’s racial, ethnic or ancestral identity on health, wellness, and life experiences. It may be valid and valuable to use population descriptors in a given analytical context. However, in some cases socially constructed population descriptors like race and ethnicity are used as proxies for human genetic variation in genetic and genomic research, which can lead to conflation between social and biological groups and can cause harm (NASEM Report Using Population Descriptors in Genetics and Genomics Research).

Similarly, sex, gender, gender identity, and sexual orientation are complex, related constructs that are conceptually distinct (NASEM Consensus Report, Measuring Sex, Gender Identity, and Sexual Orientation). They are commonly studied aspects of human identity that impact health, access to health care services, and experiences with discrimination; however, they are often mismeasured and misrepresented in research. Investigators using sex- and gender-related population descriptors in their analyses must understand the distinctions between different measures and choose accordingly.

Overall, the scientific questions to be addressed should guide whether and which population descriptors are used in a given study. Investigators should use established theory, frameworks, or scientific evidence to inform their use of population descriptors. Investigators must consider which population descriptors measure the phenomena of interest, and whether other validated variables (e.g., SDOH) may be more directly associated with those phenomena. The communities or groups involved in a study may have important insights about the most relevant descriptors to use. Investigators can consider collecting data on multiple descriptors of a concept, while also collecting only necessary data in pursuit of well-defined research goals.

To enhance the rigor and replication of proposed research, applicants should be transparent about the use of population descriptors in proposed research projects. Applications should also be transparent about the use of race, ethnicity, or ancestry as proxies for other contributing factors, and acknowledge the challenges and limitations of doing so.

Element C: Relevant Communities and Team-Based Approach

BBAER Sites will enhance ELSI research teams through 1) engagement with relevant communities and 2) the development and implementation of a team-based approach. For purposes of this NOFO, relevant communities are defined as a group or groups of people who are 1) affiliated by geographic proximity, special interest, or similar situations, and 2) affected by and have an interest in a topic(s) proposed for ELSI research.

C1: Relevant Communities on Research Teams

BBAER Sites will engage multiple representatives of relevant communities as community experts on ELSI research teams. Applicants must identify the relevant communities who will be represented on their research teams and discuss why their engagement is important given the proposed ELSI research projects. Engagement may begin with the development of the application submitted in response to this NOFO or the refinement of proposed research questions at the start of the federal award project period.

The number of community experts engaged will be commensurate with the scope and complexity of proposed ELSI research projects. Community experts will be equitable partners on research teams and will be actively and meaningfully engaged across all phases of proposed research projects. As equitable partners, community experts will have opportunities to participate in decisions and contribute to the success of the research team through use of their knowledge, skills, expertise, experience, and perspectives. Community experts should have extensive knowledge about the communities they represent. Prior experience with research projects as a research subject, an advisory board member, a consultant, a community partner, or other role, may be helpful but is not required.

Community experts should be clear about their roles and responsibilities prior to accepting the offer to join a research team. Applicants are encouraged to provide community experts with written descriptions of the roles, responsibilities, and expectations tied to their role as a research team member. If specific community experts are confirmed at the time of submission, then applicants are encouraged to include letters of support in their application that reflect community expert understanding of their roles and responsibilities. In addition, applicants may provide equitable financial compensation to community experts for their work on the research teams.

Applicants must propose activities to ensure community experts are prepared, equipped, and empowered for success in their role(s) over the course of the project. Activities may include, but are not limited to, the provision of education, skills building opportunities, mentorship, peer support, reasonable accommodations, reimbursement for local and non-local travel, reimbursement for conference registration fees, and other reasonable support. Applicants may also propose workforce development activities for other members of research teams to ensure effective collaboration with community experts (see Section I., Element E: Workforce Development).

Applicants may propose other types of engagement or partnerships with relevant communities, but those activities cannot replace the programmatic requirement for multiple community experts to serve as equitable partners on ELSI research teams.

C2: Team-Based Approach

BBAER Sites will establish a team-based approach for implementing proposed ELSI research projects. The knowledge, skills, expertise, experience, and perspectives of team members must be collectively integrated and brought to bear across all phases of proposed research projects. Team-based approaches should include but are not limited to the following features:

• Facilitates bidirectional learning, equitable leadership, and shared power across research team members, including community experts, researchers, and other BBAER project staff.
• Builds and sustains a culture that solicits, respects, and values different types of knowledge.
• Ensures all team members are provided the information and resources necessary to be successful in their role on the project and to work collaboratively.
• Establishes and maintains trust and trustworthiness among team members and fosters psychological safety.
• Identifies and provides opportunities for all team members to benefit (beyond equitable financial compensation) from their membership on the team.

Applicants must describe how they will achieve a team-based approach, which may be already established, adapted from existing models, or newly developed.

Element D: Research Capacity Building

BBAER Sites will conduct a structured needs assessment to identify areas for development, growth, or enhancement; and use findings to develop a research capacity building plan. BBAER Sites should recognize and leverage their current capabilities and strengths when implementing proposed activities and improve their work as research capacity builds. 

Needs assessment activities must include an assessment of the applicant organization and may include assessments of other organizations, collaborators, communities, or groups as appropriate for the BBAER Site. Awarded BBAER Sites will complete needs assessment activities before beginning research capacity building activities; however, other activities under Elements A, B, C, and E may begin prior to needs assessment and be modified based on needs assessment findings or capacity building plans.

Research capacity building activities must occur within the applicant organization. Collaborators may provide capacity building support to applicants, but research capacity building may not occur within a collaborator organization.

D1: Research Capacity Building Needs Assessment

BBAER Sites will conduct a structured needs assessments to examine the applicant organization’s resources, capabilities, strengths, and opportunities. Needs assessments can help identify gaps and inform benchmarks for achieving capacity building goals for developing and sustaining ELSI research.

BBAER Sites will determine the areas of focus for needs assessment, which may include but are not limited to broad areas such as:

• Administration (e.g., process management or process improvement for grants administration, compliance or monitoring, automation, information dissemination),
• Resources (e.g., availability and utilization of resources such as funding, space, equipment),
• Research (e.g., research readiness for development and leadership of ELSI research projects, capacity to conduct human subjects research, grantsmanship),
• Partnerships or collaborations (e.g., need, feasibility, value, or breadth of partnerships within or outside the organization, capacity for engagement with relevant communities), and
• Workforce (e.g., recruitment and retention, team effectiveness, research staff expertise and experience).

Applicants should describe their current research and research training environments and the infrastructure and services that support them. Applicants must submit a detailed and comprehensive plan for conducting a needs assessment that describes the structured approach, resources, and timelines required for implementation. Applicants also should include workforce as part of their needs assessment to inform workforce development activities (see Section I., Element E: Workforce Development). Applicants may but are not required to include preliminary or anecdotal data regarding capacity building needs.

Awarded BBAER Sites are expected to complete their needs assessments activities and submit a summary of findings to NHGRI within 12 months of the start of the federal award project period.

D2: Research Capacity Building

BBAER Sites will develop a capacity building plan to establish, enhance, and sustain ELSI research within the applicant organization based on needs assessment findings. Research capacity building should help reduce barriers to scientific advancement and increase success in receiving independent funding for ELSI research and ELSI research training.

Applicants should consider sustainability when developing their research capacity building plans, including 1) the potential to leverage the research capacity established beyond the federal award project period and 2) the potential for long-term maintenance and evolution of an ELSI research agenda (see Section I., Element A: Vision and Strategic Management).

Applicants must describe their overall approach for building research capacity and are not expected to include a capacity building plan in the application. Applicants may but are not required to use preliminary or anecdotal data to inform their overall approach.

Awarded BBAER Sites are expected to develop a research capacity building plan following completion of the needs assessment and submit the plan to NHGRI within 18 months of the start of the federal award project period.

Element E: Workforce Development

BBAER Sites will propose workforce development opportunities to develop and nurture a strong and multi-faceted cadre of new ELSI researchers.

E1: Workforce Development Participants

Applicants must provide workforce development opportunities to early career scholars. Early career scholars include undergraduates, post-baccalaureates, graduate students, postdoctoral trainees, or junior faculty who are interested in ELSI research. Applicants may focus on one or multiple career stages. Workforce development opportunities may also include members of BBAER research teams (e.g., researcher assistants, community experts) or other BBAER project staff (e.g., administrative staff).

E2: Workforce Development Activities

Applicants must propose workforce development activities designed to increase exposure to ELSI research and provide practical experience partnering with relevant communities in ELSI research. Workforce development activities may also include, but are not limited to, the following:

• Experiential opportunities in transdisciplinary ELSI research projects
• Education or skills development (e.g., seminars, workshops, e-learning courses, practical experience)
• Mentorship and/or peer support
• Career planning and/or development
• Team building

Awarded BBAER Sites should ultimately use needs assessment findings to further inform workforce development opportunities (see Section I., Element D1: Research Capacity Building Needs Assessment).

Attendance of early career scholars at the NHGRI Research Training and Career Development Annual Meeting is strongly encouraged. Attendance of community experts and early career scholars at the Biennial ELSI Congress is strongly encouraged, especially when findings from research projects are available for dissemination.

Data sharing

Recipients must comply with the NIH Data Management and Sharing Policy (NOT-OD-21-013) and NIH Genomic Data Sharing Policy (NOT-OD-14-124). NHGRI supports the broadest appropriate data sharing with timely data release through widely accessible data repositories. Please follow the NIH guidance on Writing a Data Management and Sharing Plan, and ensure the Plan is in alignment with NHGRI’s data sharing expectations, which are summarized at genome.gov/data-sharing.   

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

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible applicants must be a domestic organization located in the United States and its territories that received less than $30 million per year for the past three fiscal years in total NIH funding.

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

• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• U.S. Territory or Possession

Other

• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

This NOFO is a limited competition. Eligible applicants must be a domestic organization located in the United States and its territories that received less than $30 million per year for the past three fiscal years in total NIH funding.

Applicants may choose to work with collaborating organizations that have received more than $30 million per year for the past three fiscal years in total NIH funding.

A single contact organization will receive and administer award.  

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

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

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their 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.

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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

Note: Only PDs/PIs associated with an eligible applicant organization may apply to this limited competition. Eligible applicant organizations must be a domestic organization located in the United States and its territories that received less than $30 million per year for the past three fiscal years in total NIH funding may apply.

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.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

3. Additional Information on Eligibility

Number of Applications

 Eligible applicant organizations must be a domestic organization located in the United States and its territories that received less than $30 million per year for the past three fiscal years in total NIH funding may apply.

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 NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 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 NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Rene Sterling, Ph.D., M.H.A.

National Human Genome Research Institute (NHGRI)
Telephone: 301-435-1275 
Email: [email protected] 

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

Specific Aims

Briefly describe the aims for the entire application across all BBAER Elements. 1 page limit.

Research Strategy

The Research Strategy must consist of the following sections with the indicated page limits:

• Element A: Vision and Strategic Management, up to 6 pages
• Element B: Transdisciplinary ELSI Research Projects, up to 12 pages
• Element C: Relevant Communities and Team-Based Approach, up to 6 pages
• Element D: Research Capacity Building, up to 6 pages
• Element E: Workforce Development, up to 6 pages 

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

Other Attachments

The following attachment must be included to aid in the review of applications. The filename provided for the attachment will be the name used for the bookmark in the application image. Attachments should be uploaded only once. Applicants should reference attachments in the "Research Plan" but not repeat the information provided in the attachment.

1. Organizational Chart (use filename Organizational Chart)

Provide the following charts/diagrams in a single attachment:

• A leadership chart/diagram that depicts 1) from where the BBAER Site will be managed within the applicant organization and 2) who will be Leader/co-Leader for each Element within or outside the applicant organization.
• A site chart/diagram that depicts the positions, roles, and relationships among all those involved in BBAER Site activities within and outside of the applicant organization.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

BBAER UM1 applications submitted in response to this NOFO must be submitted by a single applicant organization with the option of subawards to one or more collaborating organizations. Subawards must be justified and necessary for fulfilling the BBAER Site's vision, goals, and activities. The amount toward subawards may not exceed 40% of direct costs.

Level of Effort

Effective management will require a significant commitment by the PD(s)/PI(s) and the designated Leader(s)/co-Leader(s) of each Element. The total level of effort proposed should be appropriate for the scope and scale of the proposed project.

PD(s)/PI(s) Level of Effort

Applicants should be sure that the level of effort committed by the PD/PI is at least 2.4 calendar months. If multiple PDs/PIs are proposed (i.e., multiple PD/PI model), then the combined level of effort should be at least 2.4 calendar months with at least one PD/PI committing at least 1.2 calendar months. If an individual serves as both a PD/PI and an Element Leader/co-Leader, then the level of effort committed to the PD/PI role cannot be used to meet the expected level of effort for Element Leader/co-Leader.

Element Level of Effort

Applicants should be sure that the level of effort committed to each Element is at least 2.0 calendar months. If a Leader and a co-Leader(s) are proposed for an Element, then the combined level of effort should be at least 2.0 calendar months with the designated Leader committing at least 1.0 calendar month. An individual may serve as a Leader/co-Leader for more than one Element as long as the expected level of effort for each Element is met.

Budget Justifications

A single budget is required. Budget justifications must be delineated by BBAER Program Elements. Subaward budgets should follow the same format. Applicants should demonstrate an understanding of costs and how to track them. Applicants should describe how proposed costs will change over the course of the federal award project period.

Element A: Vision and Strategic Management

Include funds to support all aspects and phases of strategic management of the BBAER Site across all Elements, proposed activities, and individuals involved. Include any funds required to support:

• Planning, monitoring, and evaluation.
• Participation at annual BBAER Program meetings, including up to 5 BBAER Site members, at least one of whom should be a community expert. If additional staff are identified to attend, additional justification is required as part of the Budget Justification.

Element B: Transdisciplinary ELSI Research Projects

Include funds to support all aspects and phases of proposed ELSI research projects, including personnel, recruitment materials, tool development, software licenses, and other research expenses, as appropriate. Include any funds required to support: 

• The management and sharing of scientific data, including but not limited to curating or deidentifying data, developing supporting documentation, local data management, and sharing data through established repositories. NIH provides guidance on allowable costs for data management and sharing here.
• Dissemination of research findings, including any costs associated with the Resource Sharing Plan.
• Participation at national meetings and conferences, including 1) up to 5 research team members, at least one of whom should be a community expert, to attend the biennial ELSI Congress to be held in 2026, 2028, and 2030; and 2) up to 3 early career scholars to attend the NHGRI Research Training and Career Development Annual Meeting. If additional staff are identified to attend, additional justification is required as part of the Budget Justification.

Element C: Relevant Communities and Team-Based Approach

Include funds to support all aspects and phases of engagement with relevant communities and having a team-based approach. Include any funds required to support:

• Equitable compensation to community experts on research teams.
• Activities designed to ensure community experts are prepared, equipped, and empowered to fully participate in BBAER activities and successfully meet BBAER goals.
• Activities designed to build or establish a team-based approach across all research team members.

Element D: Research Capacity Building

Include funds to support all aspects and phases of proposed needs assessment and the development and implementation of a research capacity building plan, including personnel, development and distribution of materials, analysis of needs assessment findings, and capacity building related expenses.

Element E: Workforce Development

Include funds to support all aspects of and phases of workforce development, including costs related to personnel, the recruitment and retention of workforce participants, and the development and implementation of specific workforce development activities.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

The total amount toward subaward budgets may not exceed 40% of direct costs.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Specific Aims

Briefly describe the aims for the entire application across all BBAER Elements.

Research Strategy

Describe the approach to advance BBAER goals for each of the following Elements as directed.

Note: The required attachment detailed in Section IV. Application and Submission Information, 2. SF424 (R&R) Other Project Information: Other Attachments support the narrative information requested below. Applicants should reference or describe the attachments in the Research Strategy but not repeat the information provided in the attachments.

Element A: Vision and Strategic Management

A1: Vision and Overview

Applicants should describe:

• The overall vision and goals for the applicant's participation in the BBAER Program.
• The unique capabilities and strengths contributed by the application organization, proposed relevant communities to be engaged, the workforce to be involved, and any partners; and how they add value to the field of ELSI research.
• The research capacity desired to ensure the BBAER site's long-term success in the field of ELSI research.
• The proposed approach for establishing a BBAER Site, implementing all program requirements, and sustaining ELSI research capacity beyond the federal award project period.
• The expected outcomes and scientific or public health impact of proposed activities in the fields of genetics, genomics, or ELSI research.
• If collaborators are proposed, then include letters of support from proposed collaborators and describe:
  • the contributions, roles, and responsibilities proposed for each collaborator, and
  • how the involvement of each collaborator enhances the applicant's ability to fulfill its vision and goals and adds innovation to proposed activities.

A2: Leadership and Oversight

Applicants should:

• Describe the proposed leadership style and management structure to help fulfill the vision and goals established for the BBAER Site.
• Identify who will provide leadership over each Element and describe their roles and responsibilities.
• Describe how the organizational structure depicted in the leadership chart and site chart provided under "Other Attachments" will support the vision and goals of the BBAER Site.
• Describe the grant administration resources available to support management and oversight of the federal award.

A3: Communication, Collaboration, and Decision-Making

Applicants should describe:

• The approach and mechanisms to be used for effective communication and collaboration within and across Elements, and how collaboration will be fostered and incentivized.
• How decisions will be made across the organizational structure, who will be involved in decision-making processes, and what approaches will be used for conflict management.
• How transparent communication and psychological safety will be encouraged and supported.
• How non-punitive avenues for disclosure of challenges or concerns will be established, including a process for ensuring fair and timely response.

A4: Planning, Monitoring, and Evaluation

Applicants should:

• Describe the overall approach and procedures for day-to-day management and monitoring of the BBAER Site to ensure efficient use of resources and successful implementation of all proposed activities.
• Delineate and describe the objectives, activities, and persons responsible for implementation of proposed activities.
• Establish timelines for implementation of proposed activities.
• Identify benchmarks (measures of performance related to a desired standard) and milestones (measures of progress over the course of the federal award project period) that will be used to monitor project implementation.
• Identify a preliminary set of evaluation measures for the project.
• Describe how proposed evaluation measures will inform work on the project over the course of the federal award project period.
• If proposed, then describe the role and responsibilities of the advisory board committee or board in supporting quality improvement or innovation, and the background, expertise, and experience of proposed members. NOTE: Do not identify proposed members by name to reduce potential for conflicts of interest during NIH peer review of applications.

A5: Sustainability

Applicants should describe:

• The strategies that will be used to ensure a thoughtful approach to sustainability of transdisciplinary ELSI research and/or other BBAER Site activities beyond the federal award project period.
• The tangible and intangible resources anticipated to remain at the end of the federal award project period and plans to leverage established capacity for future ELSI research.
• How current and new partnerships with relevant communities will be developed or maintained for future research.

Element B: Transdisciplinary ELSI Research Projects

B1: Research Areas

Applicants should:

• Identify the research area(s) that will be addressed through transdisciplinary ELSI research, as listed in the NOFO, and why the research area is significant.

B2: Research Projects

Applicants should describe:

• The scope and duration of the ELSI research project(s) that will be implemented during the federal award project period.
• The transdisciplinary nature of proposed research projects, including the academic disciplines, fields of knowledge, and research approaches that will help address research questions of interest and ensure various angles and perspectives on the topic(s) are interrogated.
• How proposed projects are timely, complex, and/or understudied.
• The qualifications, expertise, and experience of researchers who will be involved in proposed projects.
• How the BBAER Site will broaden the types of knowledge, skills, expertise, experience, and perspectives brought to bear in proposed ELSI research projects.
• If projects focus on a single disease or disorder, then describe how the findings and resources are generalizable or transferable to other diseases or conditions.
• If proposed, then describe the unifying theme for ELSI research projects that defines the ELSI research agenda for the BBAER site during and beyond the federal award project period.

B3: Population Descriptors

If ELSI research projects will use population descriptors in analysis, then applicants should:

• Name and define variables most likely to be used. Variables whose use should be named and defined include population descriptors related to race, ethnicity, genealogical ancestry, genetic ancestry, sex, gender, and sexual orientation.
• Provide a rationale for the use of identified variables that is supported by established theory, frameworks, or scientific evidence.
• Describe how use of identified variables relates to anticipated research question(s).
• Describe any assumptions or limitations associated with their use.

Applicants who propose to address or analyze race, ethnicity, genealogical ancestry or genetic ancestry are strongly encouraged to review the 2023 National Academies of Sciences, Engineering, and Medicine (NASEM) report, Using Population Descriptors in Genetics and Genomics Research: A New Framework for an Evolving Field and Recommendations for Transforming the Use of Population Descriptors in Human Genetic and Genomics Research. Those proposing to address or analyze concepts related to sex and gender are strongly encouraged to review the 2022 NASEM report Measuring Sex, Gender Identity, and Sexual Orientation.

Applicants are not required to include in scientific analysis any variable that is required for NIH inclusion enrollment reporting. Do not explain any variables that are collected solely for the purpose of NIH inclusion enrollment reporting that will not be used in data analysis.

NIH encourages applicants to consider the use of variables provided in the PhenX Toolkit which provides recommended standard measures for use in biomedical research. These measures have been selected by domain experts using a consensus process. The Toolkit provides protocols for collecting data, and tools to help investigators incorporate protocols into their studies. Using protocols from the PhenX Toolkit facilitates cross-study analysis, potentially increasing the scientific impact of individual studies. Of note, the SDOH Collections may be important for some ELSI projects to consider. In addition to protocols for core SDOH measures, the collection includes measures at individual and structural levels.

Element C: Relevant Communities and Team-Based Approach

C1: Relevant Communities on Research Teams

Applicants should describe:

• The research team(s) that will be established for the BBAER Site; and if there is more than one research team, then describe the anticipated ELSI research projects or focus established for each team.
• The relevant communities who will be represented on research teams and why partnering with them is important for proposed ELSI research projects.
• When engagement with the community experts who will serve as members on research teams will begin (e.g., during development of the application, at the start of the federal award, etc.) and a rationale for proposed timing.
• The types of activities that will be implemented to ensure community experts are successful in their role over the course of the project.
• How equitable partnerships will be achieved among researchers and community experts.
• The community experts who will join research teams, including their background, experience, expertise, anticipated contribution, and how they will be recruited and onboarded.
• If specific community experts are confirmed at the time of submission, then applicants are encouraged to include letters of support in their application that reflect community expert understanding of their roles and responsibilities.
• If proposed, then describe any other types of community engagement activities (excluding community experts as research team members) and how they will contribute to the BBAER site vision and goals.

C2: Team Based Approach

Applicants should describe:

• How the knowledge, skills, expertise, experience, and perspectives of team members will be collectively integrated and brought to bear across all phases of proposed research projects.
• How a team-based approach that is commensurate with the scope and scale of proposed projects will be achieved, that includes but is not limited to, the following features:
  • Facilitate bidirectional learning, equitable leadership, and shared power across research team members, including community experts, researchers, and other BBAER project staff.
  • Build and sustain a culture that solicits, respects, and values different types of knowledge.
  • Ensure all team members are provided the information and resources necessary to be successful in their role on the project and to work collaboratively.
  • Establish and maintain trust and trustworthiness among team members and fosters psychological safety.
  • Identify and provide opportunities for all team members to benefit (beyond equitable financial compensation) from their membership on the team.

Element D: Research Capacity Building

D1: Research Capacity Building Needs Assessment

Applicants should:

• Describe their current research and research training environments and the infrastructure and services that support them.
• Provide a clearly delineated and comprehensive plan for conducting a structured needs assessment focused on the applicant organization that includes 1) areas of focus and objectives, 2) available sources of data and information (e.g., team members, partners, documents), 3) approach for data collection and analysis, 4) process for identifying gaps and prioritizing needs, 5) people responsible for the needs assessment, and 6) timelines.
• Describe how the needs assessment plan will identify gaps and inform benchmarks for achieving research capacity building goals.
• Describe how the needs assessment plan aligns with the applicant's vision of the research capacity ultimately needed to ensure the long-term success of the applicant organization in the field of ELSI research.

D2: Research Capacity Building

Applicants should:

• Describe the research capacity needed to ensure the applicant organization's long-term success in the field of ELSI research and the overall approach that will be used to build needed capacity during the federal award project period.
• Describe how capacity building will help reduce barriers to scientific advancement and increase the applicant organization's success in receiving independent funding for ELSI research.
• Describe the overall approach and vision for sustaining research capacity beyond the federal award project period, including 1) the potential to leverage the research capacity established beyond the federal award project period and 2) the potential for long maintenance and evolution of an ELSI research agenda.

Element E: Workforce Development

E1: Workforce Development Participants

Applicants should:

• Specify the early career stage(s) that will be of focus for workforce development opportunities (i.e., undergraduates, post-baccalaureates, graduate students, postdoctoral trainees, or junior faculty) and describe how early career scholars who are interested in ELSI research will be recruited.
• If proposed, then identify the other groups who will be part of workforce development opportunities, such as members of BBAER research teams (e.g., community experts) or other BBAER project staff (e.g., administrative staff).
• Provide a rationale for the early career scholars and other groups (if any) that have been selected and how their involvement will help contribute to BBAER Site success.
• Describe the qualifications of researchers who will support development of early career scholars and other groups (if any).

E2: Workforce Development Activities

Applicants should describe:

• The types of workforce development activities that will be offered to early career scholars and any other groups, including whether and how proposed activities will vary across different types of early career scholars and any other groups.
• How needs assessment findings ultimately will be used to enhance workforce development opportunities.
• How proposed activities will help develop and nurture a strong and multi-faceted cadre of new ELSI researchers.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

All applications, regardless of the amount of direct costs requested for any one year, must develop a Resource Sharing Plan consistent with the goals of the proposal.

The Resource Sharing plan should summarize whether and how research findings and products (e.g., publications, meeting reports, software, websites, research tools) will be made available to relevant communities. Applicants should include a proposed timeline for implementing the Resource Sharing Plan, name the platform(s) or mechanism(s) that will be used to make research findings and products publicly accessible, and indicate who will be responsible for implementation. Applicants sharing software are encouraged to use software licenses that allow for unrestricted redistribution and modification of the software. Additionally, NHGRI encourages investigators to consider disseminating research findings and products via publicly accessible platforms such as the Center for ELSI Resources and Analysis.

Other Plan(s): 

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Please follow the NIH guidance on writing a Data Management and Sharing (DMS) Plan here, and ensure the Plan is in alignment with the NHGRI’s data sharing expectations explained below. Additional information can be found at genome.gov/data-sharing.

Per NOT-HG-21-022, NHGRI expects applications awarded under this NOFO to share comprehensive metadata and phenotypic, clinical, and environmental exposure data associated with the study; use standardized data collection protocols and survey instruments for capturing data, as appropriate; and use standardized notation for metadata (e.g. controlled vocabularies or ontologies) to enable the harmonization of datasets for secondary research analyses.

To ensure that maximal scientific benefit is derived from this significant public investment, this funding opportunity aims to advance and accelerate research by supporting rapid sharing of the resulting data with the broad scientific community. All resulting scientific data should be submitted to an established repository as described in the Data Management and Sharing Policy guidance and NHGRI’s guidance on where to submit scientific data.

Where human biological samples will be studied, they are expected to have been obtained using a documented informed consent process that allows for future research use and broad data sharing (NOT-HG-20-011). If new human biospecimens will be collected, or if clinical application is included in the application, the consent process should be described at a high level in the Research Plan and detailed in the Human Subjects Section.

NHGRI strongly encourages studies that propose to derive genomic data from human specimens and cell lines to obtain participant consent either for general research use through controlled access or for unrestricted access. Similarly, consent language should avoid both restrictions on the types of users who may access the data and restrictions that add additional requirements to the access request process. NHGRI acknowledges that this will not always be possible or appropriate. In addition, individual participants who do not consent to future research use or broad sharing of their data (i.e., submission of their data to a publicly accessible data repository) may still participate in the primary study if consistent with study design. Additional guidance on informed consent can be found in the NHGRI Informed Consent Resource.

Applicants are encouraged to get feedback from the communities in which the research will be performed regarding plans for how individual level data resulting from the research projects will be shared with the scientific community for research purposes. Feedback and recommendations for data access, protection of participant and patient privacy and confidentiality, and management of health information should be integrated into the project’s Data Management and Sharing Plan. Note that any project receiving NIH funding that collects or uses identifiable, sensitive information is automatically issued a Certificate of Confidentiality (CoC).

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

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

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - 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 How to Apply - 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 How to Apply - Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

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

See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – 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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

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

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NHGRI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected]. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described 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.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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

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

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.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NHGRI, in accordance with NIH peer review policies and practices, 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 NOFO.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council for Human Genome Research. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Inclusion of organizations or investigators that have not previously received funding from the ELSI Research Program.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.

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 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all 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.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website. 
  • HHS recognizes that NIH 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 NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

 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 (HHS) grant administration regulations at 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 recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

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

• Determining research approaches and study designs, developing and implementing proposed activities under each Element, evaluating site-specific activities, and setting project benchmarks, milestones, and timelines.
• Ensuring that research findings and products (e.g., publications, meeting reports, software, websites, research tools) produced as part of this project are released appropriately according to the Resource Sharing Plan.
• Ensuring that the data produced as part of this project are released appropriately according to the Data Management and Sharing Plan.
• Preparing abstracts, presentations, and publications in a timely manner.
• Adhering to policies regarding sharing of genomic and other types of data, data access, and standardized formats; timely publication; and intellectual property established by the NIH and NHGRI.
• Not disclosing confidential information.
• Interacting with other relevant NHGRI and NIH activities, as needed.
• Completing the required needs assessment activities and summarizing findings which are expected to be submitted to the Project Scientist/Scientific Officer at NHGRI within 12 months of the start of the federal award project period.
• Developing a plan for research capacity building following completion of the needs assessment which is expected to be submitted to the Project Scientist/Scientific Officer at NHGRI within 18 months of the start of the federal award project period.
• The clinical trial(s) supported by this award are subject to the plan detailed in the PHS Human Subjects and Clinical Trials Information in the application submitted to NIH and the NIH policy on Dissemination of NIH-Funded Clinical Trial Information (Public Law 110-85 and NOT-OD-16-149).

Recipients(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current DHHS, PHS, and NIH policies. NIH will have unrestricted access to and use of the data and software, including the right to transfer them to other resource projects for their use, distribution, and integration with other data. NIH expects that the recipient will grant other resources the ability to use and redistribute the data, including integrating the data with other datasets, without restriction, unless otherwise limited by consent requirements. 

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. 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:

• Coordinating activities among and for the recipients related to ELSI research, community engagement, research capacity building, and workforce development, including serving as a liaison to other programs at the NHGRI and other NIH Institutes/Centers/Offices and serving as an information resource for the recipients. The PS/SO will coordinate the efforts of the recipient(s) with other groups conducting similar work, where appropriate.
• Reporting periodically on the progress of the recipients to the NHGRI Director and to the National Advisory Council for Human Genome Research.
• Assisting recipient(s) in the development, if needed, of policies for dealing with situations that require coordinated action.
• Providing advice on the management and technical performance of the award.
• Assisting in promoting the availability of the data and related resources developed in the course of the award to the scientific community.
• Being responsible for the normal scientific and programmatic stewardship of the award, including assessments of how well the recipient has met any milestones required for each year of funding, including the completion of required needs assessment activities and submission of findings, and the finalization of the required research capacity building plan.
• Curtailing, withholding, or reducing support for any recipient that fails to make satisfactory progress toward the work scope that NHGRI approved, has ethical or conflict of interest issues, or fails to comply with the Terms and Conditions of Award.
• Involving NIH or NHGRI staff who may assist the recipient(s) as designated by the PS/SO.
• Where warranted and consistent with authorship and conflict of interest requirements of journals in which participating Recipient(s) decide to publish, co-authoring manuscripts through their role in scientific program management.
• Reserving the right to terminate or curtail the study (or an individual award) and requiring the recipient to submit a close-out plan within two (2) months of the decision to terminate in the event of (a) failure to implement the study protocol, (b) a substantial shortfall in participant recruitment, follow-up, data reporting and dissemination, quality control, or other major breach of the protocol, (c) substantive changes in the agreed-upon protocol with which NHGRI does not concur, (d) reaching a major study objective substantially before schedule with persuasive statistical evidence, or (e) human subjects ethical issues that may dictate a premature termination.

Areas of Joint Responsibility include:

If there are multiple awards under the BBAER Program, ongoing interaction among the participating Recipient(s) and the PS/SO will be required to support participating Recipient(s) and BBAER Program success. This interaction is accomplished by:

• Meeting regularly in a virtual format and annually in-person to share information on progress and lessons learned, best practices for involvement of community experts on research teams and other forms of community engagement, ELSI research study design, opportunities for networking and collaboration, etc.
• Ensuring community experts on research teams participate in all phases of proposed projects throughout the federal award project period.
• Discussing optimal approaches for the development and implementation of proposed activities and identifying experts who could support program innovation or problem solving.
• Establishing a limited set of measures for BBAER Program-wide evaluation across Recipient(s).
• Engaging with other NIH-funded programs doing work in similar areas.
• In addition to the PD(s)/PI(s), key co-investigators, early career scholars (including those who are members of under-represented groups or those from different but related disciplines), community experts, and other members of established research teams are eligible to attend these meetings. NHGRI encourages these co-investigators, early career scholars, community experts, and other members of established research teams to become involved in key working groups, to lead and report on analyses, etc., as appropriate.

The PS/SO will assist and facilitate the group process and not direct it.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. 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 Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. NIH NOFOs 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 2 CFR Part 200.301.

Section VII. Agency Contacts

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

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

Finding Help Online: https://www.era.nih.gov/need-help (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: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Rene Sterling, Ph.D., M.H.A.

National Human Genome Research Institute (NHGRI)
Telephone: 301-435-1275 
Email: [email protected] 

Sarah Wheelan, M.D., Ph.D.

National Human Genome Research Institute (NHGRI)
Telephone: 301-402-8823 
Email: [email protected]  

Devon Bumbray-Quarles

National Human Genome Research Institute (NHGRI)
Telephone: 301-451-7928 
Email: [email protected]

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.

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 2 CFR Part 200.