Opportunity Information: Apply for PAR 25 369
The Ethical, Legal and Social Implications (ELSI) Exploratory/Developmental Research Grant (R21 Clinical Trial Optional) is a National Institutes of Health (NIH) funding opportunity (PAR-25-369) designed to support early-stage, exploratory projects that examine how advances in human genetics and genomics affect people, institutions, and society. The program is centered on ELSI questions, meaning it funds research that digs into real-world ethical challenges, legal and regulatory issues, and broader social impacts connected to genomic science and the growing use of genetic information in health care, research, public health, and other settings. Because it uses the R21 mechanism, it is intended for developmental work that can test new ideas, launch innovative lines of inquiry, generate preliminary data, or refine frameworks that can later support larger-scale studies.
The NOFO encourages a wide range of research approaches and does not limit applicants to one methodology. Proposals can use single methods or mixed methods, including empirical qualitative work (such as interviews, focus groups, ethnography, or community-engaged methods), quantitative studies (such as surveys, experiments, or analysis of large datasets), or integrative combinations of both. It also explicitly welcomes non-empirical work when appropriate, including conceptual, legal, and normative analyses that clarify what should be done, how policy should be structured, or how competing values like privacy, fairness, autonomy, and public benefit ought to be balanced. A recurring theme is that strong applications will be grounded in the realities of how genomics is actually being developed and used, not only in abstract debate.
A key priority area is research focused on new or emerging genomic technologies and novel uses of genomic information. In practical terms, this means the program is especially interested in projects that anticipate or evaluate the implications of fast-moving developments in genomics, such as increasingly powerful sequencing, expanded genomic screening, AI-driven interpretation, novel data-sharing models, commercial uses of genetic data, new clinical decision-support tools, or population-scale genomics initiatives. The aim is to support studies that can identify risks, gaps, inequities, and governance challenges early, while also clarifying potential benefits and responsible pathways for implementation.
The NOFO also emphasizes involving key stakeholders when that is relevant to the research question. Stakeholder engagement can include patients, research participants, families, clinicians, laboratory professionals, community leaders, advocacy groups, tribal representatives, policymakers, payers, or technology developers. The intent is to ensure the work reflects the lived experiences of people affected by genomic practices and that recommendations are usable in real settings. In ELSI research, stakeholder involvement often strengthens both the ethical credibility and the practical impact of the findings, especially when projects address sensitive topics like consent, secondary use of data, discrimination concerns, community trust, or culturally appropriate governance.
Eligibility is broad and includes many types of organizations and governmental entities. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (outside of higher education); for-profit organizations (other than small businesses); and small businesses. The NOFO also highlights additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations). This wide eligibility reflects NIH interest in drawing ELSI perspectives from many disciplines, sectors, and communities, including groups that are often underrepresented in genomics policy conversations.
The funding instrument is a grant under a discretionary opportunity category, and the activity category is listed broadly across education, environment, health, income security, and social services, which fits ELSI’s cross-cutting nature. The NOFO is associated with multiple NIH CFDA numbers (including 93.113, 93.121, 93.172, 93.173, 93.242, 93.279, 93.310, 93.313, 93.399, 93.853, 93.855, 93.865, 93.867, 93.989), signaling that it aligns with several NIH program areas and institutes that support genomics-related work. The clinical trial designation is “optional,” meaning applicants may propose studies that meet NIH’s definition of a clinical trial, but they are not required to do so; many ELSI projects will be observational, interview-based, survey-based, or policy-focused rather than interventional.
Key administrative details provided in the posting include the opportunity title and number (PAR-25-369), the NIH as the sponsoring agency, and an original closing date of 2026-11-18. The award ceiling and expected number of awards are not specified in the provided data, so prospective applicants would need to consult the full NOFO text for budget structure, project period limits typical of R21s, review criteria, and any institute-specific considerations. Overall, the opportunity is geared toward well-justified, innovative ELSI research that can keep pace with rapid change in genomics and produce insights that inform policy, practice, and ethical governance.Apply for PAR 25 369
- The National Institutes of Health in the education, environment, health, income security and social services sector is offering a public funding opportunity titled "Ethical, Legal and Social Implications (ELSI) Exploratory/Developmental Research Grant (R21 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.121, 93.172, 93.173, 93.242, 93.279, 93.310, 93.313, 93.399, 93.853, 93.855, 93.865, 93.867, 93.989.
- This funding opportunity was created on 2025-01-13.
- Applicants must submit their applications by 2026-11-18. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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FAQs: Ethical, Legal and Social Implications (ELSI) Exploratory/Developmental Research Grant (R21 Clinical Trial Optional) (PAR-25-369)
What is this funding opportunity?
This opportunity is the Ethical, Legal and Social Implications (ELSI) Exploratory/Developmental Research Grant (R21 Clinical Trial Optional), an NIH funding opportunity announcement numbered PAR-25-369. It supports early-stage, exploratory and developmental research focused on the ethical, legal, and social implications of advances in human genetics and genomics.
What is the main purpose of the ELSI R21 program?
The program is designed to fund projects that examine how developments in human genetics and genomics affect people, institutions, and society. It supports work that identifies real-world ethical challenges, legal and regulatory issues, and broader social impacts tied to genomic science and the increasing use of genetic information across health care, research, public health, and other settings.
What kinds of projects are a good fit for an R21 mechanism?
Because this uses the NIH R21 mechanism, it is intended for exploratory and developmental work, such as testing new ideas, launching innovative lines of inquiry, generating preliminary data, or refining frameworks that could support later, larger-scale studies.
What topics does the opportunity focus on?
The focus is on ELSI questions connected to human genetics and genomics. This includes ethical challenges (such as privacy, autonomy, fairness, consent, discrimination concerns, and community trust), legal and regulatory issues (including governance and policy design), and social impacts (including inequities, access, and how institutions and communities are affected by genomic practices).
Does the NOFO prioritize any particular area of genomics?
Yes. A key priority area is research addressing new or emerging genomic technologies and novel uses of genomic information. The program is especially interested in projects that anticipate or evaluate implications of fast-moving developments in genomics and the expanding use of genetic data.
What are examples of “new or emerging genomic technologies” or “novel uses” mentioned in the posting?
Examples described include increasingly powerful sequencing, expanded genomic screening, AI-driven interpretation, novel data-sharing models, commercial uses of genetic data, new clinical decision-support tools, and population-scale genomics initiatives.
Why does the NOFO emphasize studying implications early?
The stated aim is to identify risks, gaps, inequities, and governance challenges early, while also clarifying potential benefits and responsible pathways for implementation as genomic technologies and applications evolve quickly.
What research methods are allowed or encouraged?
The NOFO encourages a wide range of research approaches and does not restrict applicants to a single methodology. Projects may use single methods or mixed methods, including qualitative, quantitative, or integrative designs, depending on what best fits the research question.
What qualitative methods are specifically mentioned?
Examples provided include interviews, focus groups, ethnography, and community-engaged methods.
What quantitative methods are specifically mentioned?
Examples provided include surveys, experiments, and analyses of large datasets.
Are non-empirical projects allowed?
Yes. The NOFO explicitly welcomes non-empirical work when appropriate, including conceptual, legal, and normative analyses. These approaches can help clarify what should be done, how policy should be structured, or how competing values (like privacy, fairness, autonomy, and public benefit) should be balanced.
Does the opportunity favor practical, real-world research over abstract debate?
The posting indicates that strong applications will be grounded in the realities of how genomics is actually being developed and used, not only in abstract discussion.
Is stakeholder engagement required?
The NOFO emphasizes involving key stakeholders when relevant to the research question. Based on the information provided, stakeholder engagement is encouraged and may strengthen a proposal when it fits the project goals, but it is not described as universally required for every project.
Who counts as a “stakeholder” for these projects?
The posting lists potential stakeholders such as patients, research participants, families, clinicians, laboratory professionals, community leaders, advocacy groups, tribal representatives, policymakers, payers, and technology developers.
Why is stakeholder involvement considered important in ELSI research?
Stakeholder engagement is intended to ensure the work reflects the lived experiences of people affected by genomic practices and that resulting recommendations are usable in real settings. It can also strengthen ethical credibility and practical impact, especially for sensitive issues like consent, secondary use of data, discrimination concerns, community trust, and culturally appropriate governance.
What does “Clinical Trial Optional” mean for this R21?
The clinical trial designation is “optional,” meaning applicants may propose studies that meet NIH’s definition of a clinical trial, but they are not required to do so. The posting also notes that many ELSI projects are likely to be observational, interview-based, survey-based, or policy-focused rather than interventional.
Who is eligible to apply?
Eligibility is broad. Eligible applicants include: state, county, city, or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (outside of higher education); for-profit organizations (other than small businesses); and small businesses.
Are specific institution types highlighted as eligible?
Yes. The NOFO highlights additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations).
Can non-U.S. organizations apply?
Yes. The eligibility list explicitly includes non-U.S. entities (foreign organizations).
What agency is sponsoring this opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
What is the opportunity number and title applicants should reference?
The opportunity number is PAR-25-369, and the title is the Ethical, Legal and Social Implications (ELSI) Exploratory/Developmental Research Grant (R21 Clinical Trial Optional).
What is the closing date listed in the posting?
The posting lists an original closing date of 2026-11-18.
Is there an award ceiling listed?
No. The award ceiling is not specified in the provided information. Prospective applicants would need to consult the full NOFO for details on budget structure.
Is the expected number of awards provided?
No. The expected number of awards is not specified in the provided information. The full NOFO would be the place to confirm whether an anticipated award count is stated.
What grant category and activity areas are associated with this opportunity?
The funding instrument is a grant under a discretionary opportunity category. The activity category is described broadly across education, environment, health, income security, and social services, reflecting the cross-cutting nature of ELSI research.
Why are multiple NIH CFDA numbers listed?
The posting indicates the NOFO is associated with multiple NIH CFDA numbers (including 93.113, 93.121, 93.172, 93.173, 93.242, 93.279, 93.310, 93.313, 93.399, 93.853, 93.855, 93.865, 93.867, 93.989). This signals that the opportunity aligns with several NIH program areas and institutes that support genomics-related work.
What kind of impact is this program aiming for?
The opportunity is geared toward innovative ELSI research that can keep pace with rapid change in genomics and produce insights that inform policy, practice, and ethical governance.
Where should applicants look for details not included in the posting summary?
The posting notes that details such as budget structure, project period limits typical of R21s, review criteria, and institute-specific considerations are not included in the provided data. Applicants would need to consult the full NOFO text for those specifics.
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