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.Apply for PAR 20 255
- 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.
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FAQs: Ethical, Legal and Social Implications (ELSI) Exploratory/Developmental Research Grant (R21) (Clinical Trial Optional) - NIH (PAR 20 255)
What is this grant opportunity?
This is the NIH Ethical, Legal and Social Implications (ELSI) Exploratory/Developmental Research Grant (R21) (Clinical Trial Optional). It is a discretionary NIH funding opportunity (Funding Opportunity Number PAR 20 255) that supports early-stage, high-impact research on ethical, legal, and social questions raised by human genome research.
What is the main purpose of the program?
The program is meant to fund exploratory or developmental ELSI projects that are not ready for a large-scale study but have strong potential to move the field forward. This includes projects that break new ground, take prior findings in a meaningfully new direction, or generate preliminary evidence and proof-of-concept results that support a future, larger project.
What does the R21 mechanism mean in this context?
R21 indicates an exploratory/developmental research mechanism. In this opportunity, it signals NIH is looking for feasible, early-stage work that can produce actionable insights and justify follow-on studies, rather than fully built-out, large-scale research programs.
What topics are a central priority for this FOA?
A central priority is research that addresses ELSI issues connected to new or rapidly evolving genomic technologies, or novel ways genomic information is being used. The emphasis is on how changes in genomics (such as sequencing, screening, data sharing, risk prediction, and clinical implementation) create new challenges around consent, privacy, discrimination, equity, trust, and governance.
What kinds of genomic changes or applications does the opportunity highlight?
The description points to fast-moving areas such as sequencing, screening, data sharing, risk prediction, and clinical implementation. The focus is on the ethical, legal, and social implications that arise as these capabilities expand and are deployed in real-world settings.
What kinds of research methods are allowed or encouraged?
Proposals may be single-method or mixed-methods. The opportunity explicitly allows a wide range of rigorous approaches, including qualitative methods (interviews, focus groups, ethnography, deliberative methods), quantitative surveys and experiments, legal or policy analyses, and integrated designs that combine multiple data sources.
Are qualitative studies allowed under this FOA?
Yes. The FOA explicitly notes qualitative designs such as interviews, focus groups, ethnography, and deliberative methods as appropriate approaches.
Are quantitative studies allowed under this FOA?
Yes. Quantitative surveys and experiments are listed as examples of acceptable approaches.
Can a project include legal or policy analysis?
Yes. Legal or policy analyses are explicitly included as acceptable approaches.
What does "Clinical Trial Optional" mean?
It means applicants may propose a project that includes a clinical trial if it fits the ELSI research question, but a clinical trial is not required. The project should remain focused on ELSI questions tied to human genome research rather than shifting into purely biomedical effectiveness research.
Is a clinical trial required to apply?
No. A clinical trial is optional, not required.
If a clinical trial is included, what should the focus be?
If included, the clinical trial should be appropriate for the ELSI question and still centered on ethical, legal, and social implications connected to human genome research, rather than primarily testing biomedical effectiveness.
What are examples of strong ELSI application areas mentioned for this program?
The description highlights projects focused on how genomic information is communicated and understood; how decisions are made by patients and families; how institutions and communities develop 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.
Who is eligible to apply?
Eligibility is broad and includes many U.S.-based applicants as well as certain non-U.S. entities. Eligible applicants listed include various government entities (state, county, city/township, special districts), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, Native American tribal governments (federally recognized) and tribal organizations, public 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.
Are tribal governments and tribal organizations eligible?
Yes. The eligibility list includes federally recognized Native American tribal governments and Native American tribal organizations (other than federally recognized tribal governments). It also highlights Indian/Native American Tribal Governments (other than federally recognized) among additional eligible applicant types.
Are institutions that serve specific populations eligible (for example, HBCUs or HSIs)?
Yes. The FOA explicitly highlights eligible applicant types including Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISI).
Are faith-based or community-based organizations eligible?
Yes. Faith-based or community-based organizations are explicitly highlighted as eligible applicant types.
Are for-profit organizations eligible?
Yes. The eligibility list includes for-profit organizations other than small businesses, and it separately lists small businesses as eligible.
Are non-U.S. (foreign) organizations eligible?
Yes. The FOA highlights non-domestic (non-U.S.) entities (foreign organizations) as eligible applicant types.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are explicitly highlighted as eligible applicant types.
Which activity areas is this opportunity associated with?
The opportunity is categorized under Education, Environment, and Health activity areas.
Which CFDA numbers are associated with this opportunity?
The opportunity is associated with multiple CFDA numbers: 93.113, 93.172, 93.242, 93.399, 93.853, 93.866, and 93.867. This reflects the cross-cutting nature of ELSI work across NIH institutes and programs.
When was this FOA created?
The FOA was created on 2020-07-28.
What is the listed original closing date?
The listed original closing date is 2023-11-17.
Does the provided information include an award ceiling or expected number of awards?
No. The provided source data does not specify an award ceiling or the expected number of awards.
What information is missing that applicants would typically confirm in the full FOA?
Based on the description, applicants would typically consult the full FOA text and NIH guide notices for details such as budget caps, project period limits, and submission cycle details tied to the R21 mechanism, since those are not provided here.
What types of outcomes is NIH likely looking for from funded projects?
The opportunity emphasizes actionable, methodologically sound early findings that clarify real-world ethical, legal, and social stakes of genome research and its applications. Results may inform policy, practice, community engagement, or the design of larger follow-on studies.
What makes a project a good fit, based on the description provided?
A competitive project is likely to identify a pressing, clearly defined ELSI problem linked to current genomic practice, use an approach feasible for an exploratory/developmental R21-scale study, and generate results that can meaningfully inform next steps (policy, practice, engagement, or future larger research).
Can projects focus on equity, discrimination, privacy, or consent in genomics?
Yes. The description explicitly mentions ELSI challenges such as consent, privacy, discrimination, equity, trust, and governance as areas that can arise from emerging genomic technologies and new uses of genomic information.
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| Funding Opportunity |
|---|
| Ethical, Legal and Social Implications (ELSI) (Research R01 Clinical Trial Optional) Apply for PAR 20 254 Funding Number: PAR 20 254 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Ethical, Legal and Social Implications (ELSI) Small Research Grant (R03) Clinical Trial Optional) Apply for PAR 20 257 Funding Number: PAR 20 257 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $50,000 |
| Emergency Awards: RADx-rad Wastewater Detection of SARS-COV-2 (COVID-19) (U01 - Clinical Trials Not Allowed) Apply for RFA OD 20 015 Funding Number: RFA OD 20 015 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $2,000,000 |
| Research to Improve Native American Health (R21 Clinical Trials Optional) Apply for PAR 20 214 Funding Number: PAR 20 214 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $200,000 |
| Intervention Research to Improve Native American Health (R01 Clinical Trial Optional) Apply for PAR 20 238 Funding Number: PAR 20 238 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Superfund Hazardous Substance Research and Training Program (P42 Clinical Trial Optional) Apply for RFA ES 20 014 Funding Number: RFA ES 20 014 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $1,750,000 |
| Ruth L. Kirschstein National Research Service Award (NRSA) Individual Senior Fellowship (Parent F33) Apply for PA 21 047 Funding Number: PA 21 047 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Addressing Health Disparities among Immigrant Populations through Effective Interventions (R01 Clinical Trial Optional) Apply for PAR 21 081 Funding Number: PAR 21 081 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Addressing the Etiology of Health Disparities and Health Advantages Among Immigrant Populations (R01 Clinical trial not allowed) Apply for PAR 21 080 Funding Number: PAR 21 080 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence (U54 Clinical Trial Optional) Apply for PAR 20 316 Funding Number: PAR 20 316 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $1,750,000 |
| HEAL Initiative: HEALthy Brain and Child Development Study (U01 - Clinical Trial Not Allowed) Apply for RFA DA 21 021 Funding Number: RFA DA 21 021 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed) Apply for RFA DA 21 020 Funding Number: RFA DA 21 020 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| HEAL Initiative: HEALthy Brain and Child Development Consortium Administrative Core (U24 - Clinical Trial Not Allowed) Apply for RFA DA 21 022 Funding Number: RFA DA 21 022 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| HEAL Initiative: HEALthy Brain and Child Development Data Coordinating Center (U24) Apply for RFA DA 21 023 Funding Number: RFA DA 21 023 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Hubs of Interdisciplinary Research and Training in Global Environmental and Occupational Health (GEOHealth) Research Training (Collaborative U2R Clinical Trial Optional) Apply for RFA TW 21 002 Funding Number: RFA TW 21 002 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $300,000 |
| Hubs of Interdisciplinary Research and Training in Global Environmental and Occupational Health (GEOHealth) Research (Collaborative U01 Clinical Trial Optional) Apply for RFA TW 21 001 Funding Number: RFA TW 21 001 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| NIH Countermeasures Against Chemical Threats (CounterACT) Early-stage Investigator Research Award (R21 Clinical Trial Not Allowed) Apply for PAR 21 209 Funding Number: PAR 21 209 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Summer Research Education Experience Program (R25 Clinical Trial Not Allowed) Apply for PAR 21 168 Funding Number: PAR 21 168 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $125,000 |
| The Role of Work in Health Disparities in the U.S. (R01 Clinical Trials Optional) Apply for PAR 21 275 Funding Number: PAR 21 275 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) Postdoctoral Career Transition Award to Promote Diversity (K99/R00 - Independent Basic Experimental Studies with Humans Required (BESH)) Apply for PAR 21 273 Funding Number: PAR 21 273 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
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