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. This Notice of Funding Opportunity (NOFO) solicits UM1 applications from domestic organizations located in the United States and its territories that received less than $30 million per year in total NIH funding for the past three fiscal years. These organizations are underrepresented among those receiving NHGRI funding for ELSI research. The Building Partnerships and Broadening Perspectives to Advance Ethical, Legal, and Social Implications (ELSI) Research (BPAER) Program will support: 1) transdisciplinary ELSI research addressing timely, complex, and understudied topics, 2) the establishment of research teams that include representatives from relevant communities who are affected by and have 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 research project staff.
Transdisciplinary ELSI research projects require involvement from two or more fields of knowledge and use of multiple research approaches. Relevant communities must be actively and meaningfully involved on ELSI research teams across all phases of proposed research projects. Research capacity building plans must be informed by a needs assessment. Given the complex structure, a strategic management plan, evaluation plan, and sustainability plan are required to ensure successful completion of the program.

RFA-HG-24-026: Limited Competition: Building Partnerships and Broadening Perspectives to Advance Ethical, Legal, and Social Implications (ELSI) Research (BBAER) Program (UM1), Clinical Trial Optional

March 31, 2025

This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s) National Institutes of Health (NIH)

Components of Participating Organizations National Human Genome Research Institute (NHGRI)

Funding Opportunity Title Limited Competition: Building Partnerships and Broadening Perspectives to Advance Ethical, Legal, and Social Implications (ELSI) Research (BBAER) Program (UM1), Clinical Trial Optional

Activity Code UM1

Announcement Type New

Related Notices

• March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission.
• July 25, 2024 - Notice of Pre-Application Webinar for RFA-HG-24-026, Limited Competition: Building Partnerships and Broadening Perspectives to Advance Ethical, Legal, and Social Implications (ELSI) Research (BBAER) Program (UM1, Clinical Trial Optional). See Notice NOT-HG-24-038
• April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084.
• August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198.
• August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy. See Notice NOT-OD-22-189.

Funding Opportunity Number (FON) RFA-HG-24-026

Companion Funding Opportunity None

Number of Applications See Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) 93.172

Funding Opportunity Purpose 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.

This Notice of Funding Opportunity (NOFO) is for a limited competition that solicits UM1 applications from domestic organizations located in the United States and its territories that received less than $30 million per year in total NIH funding for the past three fiscal years. These organizations are underrepresented among those receiving NHGRI funding for ELSI research.

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.

Expiration Date August 03, 2026

Due Dates for E.O. 12372 Not Applicable

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

• Use the NIH ASSIST system to prepare, submit and track your application online.
• 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.
• 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, 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 well distributed and help illuminate the pathway toward greater benefits for all 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.
• Genomics for All. Addresses efforts to define and help achieve access in genomics for a broad range of individuals, groups, communities, or populations. Health disparities 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 mitigating disparities across communities.
• 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, age, religion, ability, occupation, political affiliation, or literacy, along with intersecting identities.
• 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, for example, 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.

These descriptors 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.

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 effective partners on research teams and will be actively and meaningfully engaged across all phases of proposed research projects. As true 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 appropriate 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 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, effective 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 suitable 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)
• 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

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

Application Types Allowed

• New
• Resubmission
• Revision

The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial? Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial? See NIH guidance.

Funds Available and Anticipated Number of Awards NHGRI intends to commit approximately $4,800,000 in FY 2025 to fund up to 4 awards.

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

• Application budgets are limited to $650,000 direct costs per year.
• The budget for subawards is limited to 40% of direct costs of the application.

Application budgets need to reflect the actual needs of the proposed project. All increases in budget must be thoroughly justified and no escalation in costs will be provided.

Award Project Period The maximum project period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations 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
• 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.

Foreign Organizations 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.

Required Registrations

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.

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

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

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.

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

Instructions for Application Submission 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:
    • Appropriate 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, and sex.
        • 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.

        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 effective 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, effective 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 appropriate 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.

Mandatory Disclosure 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 disclosure@oig.hhs.gov.

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.

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

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

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

  In addition, for applications involving clinical trials: Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

  Specific to this NOFO:

  • Does the applicant propose a compelling vision and corresponding goals for their participation in the BBAER Program?
  • Does the application propose timely, complex, and/or understudied research topics that align with one or more of the four research areas proposed in the NOFO and describe why the research area(s) is significant?
  • Is successful implementation of the proposed approach for building ELSI research capacity likely to support the applicant organization’s long-term success in the field of ELSI research, including 1) its potential to leverage the research capacity established beyond the federal award project period and 2) its potential for long-term maintenance and evolution of an ELSI research agenda?
  • Is successful implementation of proposed workforce development activities likely to 1) enhance the career trajectory for the early career scholars to be recruited and 2) support the development and nurturing of a strong and multi-faceted cadre of new ELSI researchers?

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

  In addition, for applications involving clinical trials: With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

  Specific to this NOFO:

  • Does the application identify who will provide leadership over each Element and describe their roles and responsibilities? Does the applicant propose an adequate level of effort for designated leaders of each Element?
  • Does the leadership team possess the knowledge, skills, expertise, experience, and perspectives necessary for success in implementing the proposed activities?
  • Are the knowledge, skills, expertise, experience, and perspectives of research team members appropriate for the proposed ELSI research projects?
  • Are the backgrounds, expertise, and experience of proposed or anticipated community experts appropriate for their assigned teams and projects?
  • Do the research team members involved in workforce development activities have demonstrated experience and appropriate qualifications to support the mentoring and development of proposed early career scholars?
  • If collaborating organizations are proposed, then to what extent do the proposed partners enhance the applicant's ability to fulfill the proposed vision and goals?

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

  In addition, for applications involving clinical trials: Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

  Specific to this NOFO:

  • Does the applicant describe innovative strategies or approaches for achieving effective partnerships among researchers and community experts?
  • Does the applicant propose a team-based approach that is commensurate with the scope and scale of proposed projects and is innovative or novel?
  • Does the applicant propose novel or innovative strategies to ensure a thoughtful approach to sustainability of transdisciplinary ELSI research and/or other BBAER Site activities beyond the federal award project period?

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

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

  In addition, for applications involving clinical trials: Does the application adequately address the following, if applicable:

  • Study Design: Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, sex, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
  • Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex and race/ethnicity?
  • Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
  • Data Management and Statistical Analysis: Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

  Specific to this NOFO:

  • Does the applicant describe academic disciplines, fields of knowledge, and research approaches that are appropriate for the proposed research projects and ensure that various angles and perspectives are interrogated?
  • Does the applicant have an effective plan for engaging community experts on research teams and describe why partnering with them is important for proposed research projects?
  • Does the applicant propose an effective approach for ensuring the knowledge, skills, expertise, experience, and perspectives of team members are collectively integrated and brought to bear across all phases of proposed research projects?
  • If research projects use population descriptors related to race, ethnicity, genealogical ancestry, genetic ancestry, or sex in the analyses, does the application name and define those variables, provide an adequate rationale for their use, and note any associated limitations?
  • Does the applicant provide a clear and comprehensive needs assessment plan that aligns with the applicant's vision of the research capacity ultimately needed to ensure its long-term success in the field of ELSI research?
  • Does the application describe a thoughtful approach(es) and adequate mechanism(s) for effective communication, collaboration, decision-making, and conflict management within and across programmatic elements?
  • Does the application clearly 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?
  • Are the timelines, benchmarks, and milestones proposed clearly described, feasible, and appropriate for proposed activities?
  • Does the application identify and define a preliminary set of measures that would be useful for BBAER Site evaluation over the course of the federal award project period, including identifying areas of success and areas for improvement?
  • Does the application propose a well-developed and thoughtful approach to sustainability of transdisciplinary ELSI research and/or other BBAER Site activities beyond the federal award project period?

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

  In addition, for applications involving clinical trials:

  • If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
  • Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
  • If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
  • If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

  Specific to this NOFO:

  • Does the applicant describe unique capabilities, strengths, and value added by the applicant organization, proposed relevant communities to be engaged, the workforce to be involved, and any partners?
  • Does the application propose a plan for encouraging and supporting transparent communication and psychological safety?
  • Does the application propose non-punitive avenues for disclosure of challenges or concerns, including a process for ensuring fair and timely response?
  • Does the applicant have adequate grants administration resources to manage the award?

Additional Review Considerations 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.

• Study Timeline Specific to applications involving clinical trials: Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

• Protections for Human Subjects For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials. For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

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

• Vertebrate Animals The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

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

• Resubmissions For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

• Renewals Not Applicable

• Revisions For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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

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

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

• Resource Sharing Plans Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

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

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

2. Review and Selection Process Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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.

Cooperative Agreement Terms and Conditions of Award The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (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, 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.

Application Submission Contacts

• eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
  • Finding Help Online: 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: grantsinfo@od.nih.gov (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: support@grants.gov

Scientific/Research Contact(s)

• Rene Sterling, Ph.D., M.H.A. National Human Genome Research Institute (NHGRI) Telephone: 301-435-1275 Email: rene.sterling@nih.gov

Peer Review Contact(s)

• Sarah Wheelan, M.D., Ph.D. National Human Genome Research Institute (NHGRI) Telephone: 301-402-8823 Email: sarah.wheelan@nih.gov

Financial/Grants Management Contact(s)

• Devon Bumbray-Quarles National Human Genome Research Institute (NHGRI) Telephone: 301-451-7928 Email: devon.bumbray-quarles@nih.gov

Section VIII. Other Information

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

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

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