Ethical, Legal and Social Implications (ELSI) Research (R01 Clinical Trial Optional) | PAR 25 371

Opportunity Information: Apply for PAR 25 371

The National Institutes of Health (NIH) is soliciting R01 research project grant applications under the funding opportunity titled "Ethical, Legal and Social Implications (ELSI) Research (R01 Clinical Trial Optional)" (PAR-25-371). The focus is on research that examines the ethical, legal, and social implications of human genetics and genomics, meaning projects should tackle real-world questions that come up as genetic and genomic knowledge, technologies, and data are generated and used in health care, research, public health, consumer settings, and society more broadly. The opportunity is intentionally broad and supports studies that can clarify problems, document impacts, evaluate policies or practices, and propose or test solutions related to ELSI issues in genetics and genomics.

Applicants can use a wide range of study designs and methods. NIH explicitly welcomes projects that use either a single method or mixed methods, and it notes multiple acceptable approaches: empirical qualitative research (such as interviews, focus groups, ethnography, or deliberative methods), empirical quantitative research (such as surveys, experiments, outcomes analyses, or large-scale data analyses), and non-empirical approaches including conceptual work, legal analysis, and normative or ethical analysis. In other words, proposals do not need to be limited to traditional biomedical research designs; strong applications can be grounded in social science, law, philosophy, ethics, policy research, implementation research, and interdisciplinary frameworks. Where it fits the research question, NIH encourages direct involvement of key stakeholders, which can include patients, research participants, community representatives, clinicians, laboratory professionals, payers, policy makers, advocacy groups, tribal entities, or others affected by or responsible for decisions about genetic and genomic information.

A major application requirement is the Plan for Enhancing Diverse Perspectives (PEDP). This is not optional: applications that do not include a PEDP will not be reviewed. The intent is to ensure that supported projects meaningfully incorporate diverse perspectives into the research process. In practice, a competitive PEDP generally explains who will be included (for example, communities historically underrepresented in genomics, varied professional or disciplinary viewpoints, or stakeholders with different lived experiences), how those perspectives will be integrated into study design and conduct (such as advisory boards, co-design processes, recruitment and retention strategies, governance structures, or dissemination plans), and how the project will avoid tokenism by giving participants or partners real influence on decisions and outputs.

The grant mechanism is an NIH Research Project Grant (R01), and clinical trials are optional, meaning applicants may propose a clinical trial if it is appropriate for the ELSI question, but they are not required to. The opportunity is listed as a discretionary grant and is associated with multiple NIH CFDA numbers (93.113, 93.172, 93.173, 93.242, 93.279, 93.307, 93.310, 93.313, 93.399, 93.853, 93.855, 93.865, 93.867), reflecting that ELSI work can align with missions across NIH institutes and centers. The posting date (creation date) is January 13, 2025, and the listed closing date is November 18, 2026.

Eligibility is broad and includes many types of domestic applicants: 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; public housing authorities/Indian housing authorities; Native American tribal organizations other than federally recognized tribal governments; nonprofits with or without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses. The announcement also highlights additional eligible applicant categories that NIH wants to encourage, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible agencies of the federal government, Indian/Native American tribal governments that are not federally recognized, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities (foreign organizations). This broad eligibility aligns with the program emphasis on diverse perspectives and stakeholder engagement, and it also supports research questions that may be international, cross-cultural, or relevant to specific communities and governance contexts.

Overall, this NOFO is designed for investigators and teams who want to study how genetics and genomics intersect with values, rights, responsibilities, institutions, and social practices. Competitive projects will typically present a clear ELSI problem tied to genetics/genomics, a rigorous and well-justified methodological approach (empirical, conceptual, or mixed), an intentional plan for stakeholder involvement when appropriate, and a strong PEDP that demonstrates how diverse perspectives will shape the research and its real-world relevance.

• 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) Research (R01 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, 93.172, 93.173, 93.242, 93.279, 93.307, 93.310, 93.313, 93.399, 93.853, 93.855, 93.865, 93.867.
• 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.

Apply for PAR 25 371

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: