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

The Ethical, Legal and Social Implications (ELSI) Exploratory/Developmental Research Grant (R21 Clinical Trial Optional), issued by the National Institutes of Health (NIH), seeks to fund studies that explore the ELSI associated with human genetic or genomic research. This funding opportunity supports both empirical and conceptual investigations and encourages the use of single or mixed methods. Research proposals should aim to break new ground, extend previous studies, or produce preliminary data for larger-scale investigations. Studies that incorporate applied research addressing real-world ELSI issues in genetics and genomics are also encouraged. The overarching purpose of this opportunity is to support projects that explore ethical, legal, and social dimensions of genomics as these technologies are increasingly integrated into biomedical research and clinical practice. The announcement emphasizes the importance of research that reflects societal, cultural, technological, and scientific developments. Projects may investigate issues related to data sharing, privacy, stakeholder engagement, equity, and governance of genomic data. Proposals are welcome from diverse disciplines including law, bioethics, the social sciences, humanities, genetic science, and public health. Funding is offered through R21 awards, which support exploratory and developmental research. Applications can request up to $275,000 in direct costs over a maximum period of three years, with no more than $200,000 in direct costs allowed in any single year. Budgets should also account for the implementation of data management and resource-sharing plans. While a clinical trial is optional, applications must comply with NIH data sharing policies and are strongly encouraged to utilize the PhenX Toolkit to standardize measures across studies. This opportunity is open to a broad range of U.S. and non-U.S. applicants, including higher education institutions, nonprofits, for-profit organizations, governments, public housing authorities, tribal organizations, and foreign entities. No cost sharing is required. Applicants may submit multiple proposals provided each is scientifically distinct. All applicants must register with several federal systems (e.g., SAM, Grants.gov, eRA Commons) prior to submission. The NIH encourages early submission to address any potential errors or omissions in the application process. Applicants must use one of the NIH-approved submission platforms and follow strict formatting and content guidelines. All applications must include resource sharing and data management plans, and those involving human biospecimens must detail consent processes. Community or stakeholder involvement is permitted and may enhance the application but is not required. Use of the PhenX Toolkit and alignment with NHGRI’s data-sharing expectations are highly recommended. Investigators should also ensure that any community input into data-sharing plans is reflected in the application. Proposals will be reviewed based on significance, innovation, approach, and the expertise of investigators. Applications are judged on scientific merit and feasibility, as well as compliance with NIH standards for human subject research, animal use, and data security. Applications undergo peer review followed by advisory council evaluation. Funding decisions will be based on peer review scores, relevance to NIH goals, and budgetary considerations. Key dates for submission occur in February, June, and October annually through 2026, with earliest start dates falling roughly 10 months after submission.