Ethical, Legal and Social Implications (ELSI) Research (R01 Clinical Trial Optional)

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Description

This opportunity invites Research Project Grant (R01) applications to study the ethical, legal, and social implications (ELSI) of human genetics and genomics. Projects may use single or mixed methods, including empirical qualitative and quantitative research, as well as conceptual, legal, and normative analyses. Applied research addressing real-world ELSI issues in genomics is encouraged, and direct engagement with communities and stakeholders is welcomed but not required.

The program aims to address emerging and enduring ELSI questions arising from advances in genomics, such as those related to gene editing, data sharing, commercialization, and the impact of genomics on individuals and society. Multidisciplinary teams and diverse perspectives are strongly encouraged.

A required Plan for Enhancing Diverse Perspectives (PEDP) must be included in all applications.

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Due Dates

• New Applications: June 17, 2025 | October 20, 2025 | February 19, 2026 | June 18, 2026 | October 20, 2026
• Renewal/Resubmission/Revision: July 18, 2025 | November 18, 2025 | March 18, 2026 | July 20, 2026 | November 18, 2026

All applications are due by 5:00 PM local time of the applicant organization.

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Funding Amount

• Budget: No upper limit; budgets must be appropriate to the scope of the project.
• Project Period: Up to 5 years (most projects are expected to be 4 years or less; longer periods must be well justified).
• Note: Projects requesting $500,000 or more in direct costs in any year must contact a Scientific/Research Contact at least 6 weeks before submission.

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Eligibility

Eligible applicants include:

• Public and private institutions of higher education
• Nonprofits (with or without 501(c)(3) status)
• For-profit organizations (including small businesses)
• State, county, city, township, and special district governments
• Native American tribal governments and organizations
• Independent school districts
• Public housing authorities/Indian housing authorities
• Faith-based and community-based organizations
• Regional organizations
• U.S. territories and possessions
• Non-domestic (non-U.S.) entities (foreign organizations) and foreign components

There are no citizenship or residency restrictions for principal investigators.

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Application Process

• Submission: Applications must be submitted electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
• Required Registrations: Applicant organizations must register with SAM, Grants.gov, and eRA Commons. PD/PIs must have an eRA Commons account.
• Application Guide: Follow the NIH How to Apply - Application Guide.
• PEDP Requirement: All applications must include a Plan for Enhancing Diverse Perspectives (PEDP).
• Data Management: All applications must include a Data Management and Sharing Plan.
• Resource Sharing: A Resource Sharing Plan is required for all applications.
• Page Limits: Follow NIH standard page limits.

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Additional Information

• Clinical Trials: Both clinical trial and non-clinical trial applications are accepted.
• Stakeholder Engagement: Direct involvement of key stakeholders and/or communities is encouraged but not required.
• Related Opportunities: For exploratory or pilot projects, consider the ELSI R21 or R03 mechanisms.
• Review Criteria: Applications are evaluated for significance, innovation, approach, investigator(s), and environment, as well as for the quality of the PEDP and data/resource sharing plans.
• Data Sharing: Compliance with NIH Data Management and Sharing Policy and Genomic Data Sharing Policy is required.

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External Links

• NIH Funding Opportunity Announcement (PAR-25-371)
• Grants.gov Opportunity Listing
• NIH How to Apply - Application Guide
• ELSI Research Program Domains & Participating NIH ICOs
• NIH Data Management and Sharing Policy
• NHGRI Data Sharing Expectations

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Contact Information

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