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NIH
Posted

PAR-25-369

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

Summary

AI-generated

PAR-25-369: ELSI Exploratory/Developmental Research Grant (R21)

Research Focus

This program funds exploratory and developmental research examining the ethical, legal, and social implications (ELSI) of advances in human genetic and genomic research. The National Human Genome Research Institute (NHGRI) and 12 partner NIH institutes recognize that as genomic technologies—including gene editing, gene therapy, polygenic risk scores, and direct-to-consumer testing—expand into diverse populations and healthcare settings, novel ELSI questions emerge. The program seeks research that identifies and addresses real-world challenges: validity and transferability of genomic innovations across populations underrepresented in genomic discovery; governance and stewardship of genomic data increasingly merged with electronic health records, mobile health devices, and environmental data; equitable representation in genomic datasets to prevent bias in artificial intelligence and machine learning applications; and prevention of genetic determinism in public understanding of complex traits like hypertension, diabetes, and depression.

Research approaches may combine qualitative and quantitative empirical methods with conceptual, legal, and normative analyses. Applied research addressing ELSI issues in genomics practice is encouraged. Direct engagement with communities and stakeholders is supported but not required. Investigators from bioethics, humanities, behavioral and social sciences, law, genetic counseling, clinical medicine, health services research, public health, and data science are invited; multidisciplinary teams are particularly encouraged.

At-a-Glance

  • Who can apply: Investigators from diverse academic disciplines; multidisciplinary teams encouraged. Institutions must align with participating NIH institute missions.
  • Funding & project length: Up to $225,000 total direct costs per year for 2–3 years (exploratory/developmental scope).
  • Award mechanism: R21 Exploratory/Developmental Research Grant (clinical trials optional).
  • Key dates: Applications due February 20, June 18, October 20, 2025 and continuing; earliest start July 2025; program expires November 19, 2026.
  • Best fit for: Pilot studies, feasibility work, or preliminary data generation in genomics ELSI; secondary data analyses; conceptual or legal analyses; studies of genomic data governance, equity in genomic research, or implementation of genomic medicine across diverse populations.

Key Facts

Deadline

Wed, November 18, 2026

Posted

Mon, January 13, 2025

Award / Year (direct costs)

$275,000

Max Total

$550,000

Max Duration

3 years

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Detailed
Grants.gov
Agency

Keywords

ethical implications of genomics
genomic data sharing
polygenic risk scores
gene editing
gene therapy
genomic medicine
health disparities in genomics
artificial intelligence in genomic analysis
direct-to-consumer genetic testing
community engagement in research
bioethics
data governance
genetic counseling
health communications
qualitative research methods
quantitative research methods
implementation science
genomic data privacy

Research Areas

ANZSRC FoR
Biological Sciences31
Bioinformatics & Computational Biology3102Genetics3105
Biomedical & Clinical Sciences32
Immunology3204
Education39
Health Sciences42
Health Services & Systems4203Public Health4206
Human Society44
Anthropology4401Political Science4408Sociology4410
Information & Computing46
Data Management & Data Science4605Machine Learning4611
Language & Communication47
Communication & Media Studies4701Linguistics4704
Law & Legal Studies48
Environmental & Resources Law4802International & Comparative Law4803Law in Context4804
Philosophy & Religious Studies50
Applied Ethics5001Philosophy5003
Psychology52
Biological Psychology5202Social & Personality Psychology5205

Gotchas (4)

Soft Block
submissiontimeline project start end

R21 mechanism is limited to 2-3 year projects; applications proposing longer timelines may be considered non-responsive

AI

85%

Source Text

Applications to this NOFO should propose exploratory or developmental studies that can be accomplished in two to three years.

Soft Block
planningprogram scope topic

Multiple participating ICOs with potentially different research priorities; applicants must align with specific IC's research interests or risk non-responsiveness

AI

90%

Source Text

Participating NIH Institutes, Centers, and Offices (ICOs) listed at the top of this announcement have specified research areas of interest on the ELSI Participating NIH ICOs webpage. Prospective applicants are strongly encouraged to review these resources and contact the scientific/research contacts listed in Section VII of this NOFO prior to initiating plans for application submission.

Soft Block
writingsubmission pre submission

The NOFO references the 'ELSI Participating NIH ICOs webpage' for research areas of interest specific to each IC, but this webpage is not provided in the NOFO text. Applicants must locate this externa

AI

85%

Source Text

Participating NIH Institutes, Centers, and Offices (ICOs) listed at the top of this announcement have specified research areas of interest on the ELSI Participating NIH ICOs webpage. Prospective applicants are strongly encouraged to review these resources and contact the scientific/research contacts listed in Section VII of this NOFO prior to initiating plans for application submission.

Soft Block
eligibilityeligibility mechanism or sponsor

Applications must align with the mission of the specific participating IC(s) to which they are assigned, and only certain NIH offices may co-fund based on IC assignment. This creates a potential gotch

AI

85%

Source Text

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers. [Lists OBSSR and ORWH as potential co-funders]

AI-generated content — verify with the issuing agency’s official FOA/NOFO. Not endorsed by HHS.

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