The "Ethical, Legal and Social Implications (ELSI) Research (R01 Clinical Trial Optional)" funding opportunity, issued by the National Institutes of Health (NIH), invites Research Project Grant (R01) applications to study the ethical, legal, and social implications of human genetic or genomic research. This funding opportunity is a reissue of PAR-23-293 and aligns with NIH’s mission to ensure the responsible use of emerging genomic technologies. It encourages empirical research using qualitative or quantitative methods, as well as conceptual, legal, and normative analyses. Direct engagement with communities and stakeholders is encouraged but not required.

The overarching goal of this funding opportunity is to support research that identifies and addresses ELSI issues in genomics as these technologies evolve and are applied across increasingly diverse populations and contexts. Specific areas of interest include data governance, equity and representation in genomic datasets, informed consent, and the translation of genomic knowledge into clinical and societal applications. Applications from multidisciplinary research teams and a broad range of disciplines—including bioethics, law, humanities, public health, and social sciences—are encouraged to ensure comprehensive analysis of these complex issues.

The opportunity is supported by numerous NIH components including the National Human Genome Research Institute (NHGRI), the National Eye Institute (NEI), and several others, with co-funding possible from offices such as the Office of Behavioral and Social Sciences Research (OBSSR) and the Office of Research on Women’s Health (ORWH). This grant supports projects proposing clinical trials as well as those that do not. Application budgets are not capped but must align with project needs. Projects can span up to five years, though those proposing longer durations must provide strong justification.

Applications must adhere strictly to the NIH's Data Management and Sharing Policy, including detailed Data Management and Resource Sharing Plans. Human subjects and clinical trial protocols, if applicable, must follow NIH guidelines, and additional attention must be paid to community feedback on data sharing strategies. The grant review process evaluates significance, innovation, approach, investigator expertise, and institutional environment. Specific attention is given to research rigor, feasibility, and the importance of stakeholder engagement.

Application deadlines are set three times annually, with upcoming due dates on February 20, June 17, and October 20, 2025. The earliest submission date is January 20, 2025, and the expiration date for the opportunity is November 19, 2026. All submissions must be electronic and comply with detailed NIH guidelines, using platforms such as ASSIST, Grants.gov, or institutional submission systems. Applicants must ensure all necessary registrations (e.g., SAM, eRA Commons, Grants.gov) are completed in advance.