Ethical, Legal and Social Implications (ELSI) Research (R01 Clinical Trial Optional) | PAR 23 293

FAQs: Ethical, Legal and Social Implications (ELSI) Research (PAR 23-293) - NIH R01

What is the ELSI Research funding opportunity (PAR 23-293)?

PAR 23-293 is a National Institutes of Health (NIH) discretionary grant funding opportunity that supports Research Project Grant (R01) applications focused on the ethical, legal, and social issues raised by human genetics and genomics.

What is the main goal of this opportunity?

The central aim is to fund rigorous research that helps explain, anticipate, and address how advances in genetic and genomic science affect people, communities, institutions, and society. This includes impacts on rights, responsibilities, access, trust, and real-world decision-making in health care, research, public health, and related settings.

What types of research questions fit within the ELSI scope?

Projects should focus on ethical, legal, and/or social implications of human genetics and genomics. The scope explicitly includes questions about how genomic advances shape systems and decisions, including trust, access, institutional practices, and how responsibilities and rights are understood and applied in real-world contexts.

What grant mechanism does this opportunity use?

This opportunity supports applications for the NIH Research Project Grant (R01) mechanism, which is typically used for substantial, stand-alone research projects intended to produce generalizable knowledge.

Are clinical trials allowed under this announcement?

Yes. Clinical trials are optional under this announcement. Applicants may propose studies that include clinical trial components or studies with no clinical trial components, as long as the work fits the ELSI scope described in the announcement.

What research methods are allowed or encouraged?

A wide range of approaches is allowed, and both single-method and mixed-method designs are explicitly welcomed. The announcement includes empirical qualitative methods (such as interviews, focus groups, ethnography, deliberative forums), empirical quantitative methods (such as surveys, experiments, observational studies, statistical modeling), and non-empirical scholarly approaches (such as conceptual analysis, legal research and analysis, and normative or ethical argumentation).

Can a project be purely conceptual, legal, or normative (non-empirical)?

Yes. The opportunity explicitly allows non-empirical scholarly approaches, including conceptual analysis, legal research and analysis, and normative or ethical argumentation, when those approaches are appropriately matched to the research questions.

Does NIH require mixed methods, or are single-method studies acceptable?

Single-method designs and mixed-method designs are both acceptable. The emphasis is on using methods that are appropriately matched to the question being asked.

What does the NOFO say about stakeholder engagement?

A notable emphasis is placed on engaging key stakeholders when it makes sense for the research question. The expectation is meaningful involvement (not token consultation) that strengthens the relevance, rigor, and usefulness of the research, such as through co-design, community-engaged methods, advisory structures, or participatory approaches.

Who counts as a stakeholder for this program?

Stakeholders may include (as examples listed in the announcement description): patients, research participants, clinicians, genetic counselors, laboratory professionals, community leaders, health system administrators, policymakers, payers, educators, advocacy organizations, tribal representatives, and others directly affected by genetics and genomics.

Is stakeholder engagement required for every project?

The emphasis is on engaging stakeholders when it makes sense for the research question. The description indicates stakeholder engagement is strongly encouraged where appropriate, with an expectation of meaningful involvement when pursued.

What is the Plan for Enhancing Diverse Perspectives (PEDP)?

The PEDP is a required plan that applicants must include. It describes how the project will incorporate and elevate diverse viewpoints through elements such as the project team, methods, stakeholder engagement, study populations (when applicable), and the overall project perspective.

Is the PEDP mandatory, and what happens if it is missing?

Yes. The PEDP is presented as a firm, mandatory application requirement. Applications that do not include a PEDP will not be reviewed.

What kinds of diversity does the PEDP focus on in this opportunity?

Based on the opportunity description, the PEDP focuses on how diverse perspectives will be incorporated and elevated across the team and the research process, including stakeholder engagement and study populations when applicable. The intent is to ensure research processes and teams reflect diverse experiences and expertise, particularly in a field where equity, representation, and historical harms can influence trust and outcomes.

Who is eligible to apply?

Eligibility is broad and includes many organization types. Examples listed include: state, county, city, or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations that are not federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations other than small businesses; small businesses; and other entities.

Are tribal entities and tribal-serving institutions eligible?

Yes. The eligibility description includes federally recognized tribal governments, tribal organizations that are not federally recognized tribal governments, and categories such as Tribally Controlled Colleges and Universities (TCCUs), as well as Indian/Native American Tribal Governments other than federally recognized.

Are non-U.S. (foreign) organizations eligible to apply?

Yes. The eligibility categories explicitly include non-U.S. entities (foreign organizations).

Are U.S. territories or possessions eligible?

Yes. The eligibility list includes U.S. territories or possessions.

Does the opportunity encourage participation from community-based or faith-based organizations?

Yes. The eligibility highlights include faith-based or community-based organizations among the additional eligible applicant categories.

Which federal agency is offering this funding opportunity?

The opportunity is listed under the National Institutes of Health (NIH).

What type of funding instrument is used?

The funding instrument is a grant.

What broad activity areas does the opportunity fall under?

The opportunity falls under broad activity categories that include education, environment, health, income security, and social services.

What are the CFDA numbers associated with this opportunity?

Multiple CFDA numbers are associated: 93.113, 93.172, 93.173, 93.242, 93.279, 93.307, 93.313, 93.399, 93.853, 93.855, 93.865, 93.867.

When was this opportunity created?

The opportunity was created on 2023-10-30.

What is the listed closing date?

The listed closing date is 2026-11-18.

Is there an award ceiling listed for this opportunity?

No. The award ceiling is not specified in the provided information.

Is the expected number of awards listed?

No. The expected number of awards is not specified in the provided information.

What should applicants do if they need more detail on budgets, award sizes, or project periods?

The provided information indicates applicants should consult the full NOFO text and NIH budget guidance for R01s to understand typical award sizes, project periods, and any institute-specific considerations.

What is NIH trying to accomplish through the PEDP requirement in this program?

Based on the description, the PEDP requirement signals that NIH is not only interested in ELSI topics, but also in how research processes and teams incorporate diverse perspectives. This is highlighted as especially important in genetics and genomics contexts where equity, representation, and historical harms can influence trust and outcomes.

What kinds of outcomes or contributions are expected from funded projects?

The opportunity is designed for projects that produce generalizable knowledge about the societal dimensions of genetics and genomics, using methods that fit the problem, incorporating stakeholder input where appropriate, and addressing the non-negotiable PEDP requirement.