Ethical, Legal and Social Implications (ELSI) Exploratory/Developmental Research Grant (R21) (Clinical Trial Optional) | PAR 20 255

Opportunity Information: Apply for PAR 20 255

The Ethical, Legal and Social Implications (ELSI) Exploratory/Developmental Research Grant (R21) (Clinical Trial Optional) is a National Institutes of Health (NIH) discretionary grant opportunity (Funding Opportunity Number PAR 20 255) that supports early-stage, high-impact research on the ethical, legal, and social questions raised by human genome research. The program is built around the R21 mechanism, which is designed for exploratory or developmental projects that are not yet ready for a large-scale study but have strong potential to move the field forward. In practice, this means NIH is looking for studies that either break new ground, take prior findings in a meaningfully new direction, or generate preliminary evidence and proof-of-concept work that can justify a future, larger project.

A central priority of this FOA is research that tackles ELSI issues connected to new or rapidly evolving genomic technologies or novel ways genomic information is being used. The emphasis on emerging technology reflects how quickly genomics is changing in areas like sequencing, screening, data sharing, risk prediction, and clinical implementation, and how those shifts can create fresh challenges around consent, privacy, discrimination, equity, trust, and governance. Proposals can be designed as single-method studies or mixed-methods studies, which opens the door to a wide range of rigorous approaches, including qualitative designs (such as interviews, focus groups, ethnography, deliberative methods), quantitative surveys and experiments, legal or policy analyses, and integrated designs that combine multiple data sources to produce a more complete picture.

Because it is marked "Clinical Trial Optional," applicants may propose a project that includes a clinical trial if it is appropriate for the ELSI research question, but a clinical trial is not required. The key is that the project remains focused on ELSI research tied to human genome research rather than drifting into purely biomedical effectiveness questions. Many strong applications in this space focus on how genomic information is communicated and understood, how decisions are made by patients and families, how institutions and communities build policies for data access and return of results, and how social structures and legal frameworks shape who benefits from genomics and who may be harmed or left out.

Eligibility is broad and includes many types of U.S.-based applicants as well as certain non-U.S. entities. Eligible applicants listed include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; Native American tribal governments (federally recognized); Native American tribal organizations (other than federally recognized tribal governments); public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other organizations. The FOA also explicitly highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Indian/Native American Tribal Governments (other than federally recognized), faith-based or community-based organizations, eligible federal agencies, regional organizations, non-domestic (non-U.S.) entities (foreign organizations), and U.S. territories or possessions. This wide eligibility reflects NIH interest in building ELSI evidence across diverse settings and communities, including populations that have historically been underrepresented in genomics and in research governance decisions.

From an administrative standpoint, the opportunity is categorized under Education, Environment, and Health activity areas and is associated with multiple CFDA numbers (93.113, 93.172, 93.242, 93.399, 93.853, 93.866, 93.867), reflecting the cross-cutting nature of ELSI work across NIH institutes and programs. The FOA was created on 2020-07-28, and the listed original closing date is 2023-11-17. The provided source data does not specify an award ceiling or the expected number of awards, so applicants would typically consult the full FOA text and NIH guide notices for any budget caps, project period limits, and submission cycle details tied to the R21 mechanism.

Overall, this grant opportunity is aimed at producing actionable, methodologically sound early findings that clarify the real-world ethical, legal, and social stakes of genome research and its applications. Competitive projects are likely to be those that identify a pressing, clearly defined ELSI problem linked to current genomic practice, use an approach that is feasible at the exploratory/developmental scale, and generate results that can inform policy, practice, community engagement, or the design of larger follow-on studies.

• The National Institutes of Health in the education, environment, health 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, 93.172, 93.242, 93.399, 93.853, 93.866, 93.867.
• This funding opportunity was created on 2020-07-28.
• Applicants must submit their applications by 2023-11-17. (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 20 255

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