Advancing Genomic Medicine Research (R21 Clinical Trial Optional) | RFA HG 23 033

Frequently Asked Questions (FAQs)

What is the Advancing Genomic Medicine Research (R21 Clinical Trial Optional) funding opportunity?

It is a National Institutes of Health (NIH) funding opportunity being developed by the National Human Genome Research Institute (NHGRI). Its purpose is to support early-stage, innovative research that improves real-world understanding of when, where, and how genomic information and genomic technologies should be used and shared in clinical care.

What is the main goal of this program?

The overall aim is to generate practical, actionable evidence that helps healthcare systems responsibly and effectively integrate genomic medicine into clinical care. The emphasis is on implementation: understanding what works, for whom, under what conditions, and how to make genomic medicine effective, equitable, and scalable in real healthcare settings.

Is this opportunity focused on laboratory discovery or clinical implementation?

This opportunity is explicitly focused on implementation questions in healthcare settings rather than only advancing laboratory discovery. Projects are expected to address how genomic tools and results are integrated into care delivery and how they are used and shared in practice.

What does the NIH R21 mechanism mean for applicants?

The NIH R21 mechanism is designed for exploratory and developmental research. In practice, that means NHGRI is looking for creative, potentially high-impact ideas that can generate strong preliminary data, test new strategies, or explore new models for integrating genomic tools into clinical care.

What does "Clinical Trial Optional" mean?

"Clinical Trial Optional" means an applicant may propose a clinical trial if it fits the scientific goals of the project, but a clinical trial is not required. Applications may include a trial or may focus on other study designs aligned with implementation research.

What types of projects are encouraged under this FOA?

Projects can range from implementation research and pragmatic evaluations to systems-level or community-engaged studies. The FOA highlights topics such as barriers and facilitators to use, clinical workflows, decision support, patient communication, data sharing practices, and outcomes related to the use of genomic information in clinical environments.

What kinds of research questions does this FOA prioritize?

The FOA prioritizes practical implementation questions, including how genomic results are returned and used, how genomic information is shared across care teams and systems, and what conditions make genomic medicine effective, equitable, and scalable in real-world healthcare settings.

How important is health equity to this opportunity?

Health equity is a central emphasis. The opportunity specifically seeks to ensure genomic medicine works for everyone, including groups and communities that experience health disparities. Competitive projects will likely be those that directly address equity challenges in access, trust and engagement, infrastructure, representation in genomic resources, and downstream follow-up care.

Which populations are specifically mentioned as experiencing health disparities?

The description includes examples such as racial and ethnic minority populations, people with lower socioeconomic status, underserved rural communities, and sexual and gender minority groups.

Does the FOA encourage community-engaged approaches?

Yes. The opportunity description notes that projects may include community-engaged studies, particularly where they help examine barriers, facilitators, trust, engagement, communication, and equitable implementation of genomic medicine in clinical settings.

Who is the funding agency and which NIH institute is leading this opportunity?

The funding agency is the NIH, and the institute developing the opportunity is the National Human Genome Research Institute (NHGRI).

What is the Funding Opportunity Number?

The Funding Opportunity Number is RFA-HG-23-033.

What is the application closing date listed in the notice?

The original closing date provided is 2025-02-11.

What is the award ceiling for this opportunity?

The award ceiling is listed as $250,000.

What CFDA numbers are associated with this opportunity?

The opportunity is listed under CFDA numbers 93.172 and 93.393.

How is this opportunity categorized?

It is categorized under Education and Health.

What organizations are eligible to apply?

Eligibility is broad and includes many types of U.S.-based organizations and government entities. Eligible applicants include state, county, city, township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized governments; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses.

Are minority-serving institutions mentioned as eligible applicants?

Yes. The notice highlights additional eligible applicant types including Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs).

Can faith-based or community-based organizations apply?

Yes. The notice indicates that faith-based or community-based organizations may apply if they meet eligibility requirements.

Are federal agencies eligible to apply?

Yes. The notice states that eligible federal agencies may apply.

Are U.S. territories or possessions included in eligibility?

Yes. The notice indicates that regional organizations and U.S. territories or possessions are included.

Are foreign (non-U.S.) organizations eligible to apply as the primary applicant?

No. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply as the primary applicant.

Can a non-domestic component of a U.S. organization apply?

No. Non-domestic components of U.S. organizations are also not eligible to apply.

Are any types of international collaboration allowed?

Yes. The notice states that "foreign components" are allowed as defined in the NIH Grants Policy Statement. This means a U.S. applicant may include certain foreign collaborations or activities if they meet NIH requirements and are justified, even though a foreign institution cannot be the primary applicant.

How does this FOA describe the kind of impact it wants to see?

The program is geared toward generating actionable knowledge that helps healthcare systems integrate genomic medicine responsibly and effectively. It aims to move the field toward practical, evidence-based approaches for implementation, with particular attention to improving real-world use for communities that have historically been left out or underserved.

What does it mean that the FOA concept was approved by the National Advisory Council on Human Genome Research?

The notice indicates that the FOA concept was approved by the National Advisory Council on Human Genome Research, suggesting the program reflects broader NHGRI priorities and community input about where genomic medicine implementation research needs to go next.