Investigator-Initiated Research on Genetic Counseling Processes and Practices (R01, Clinical Trial Optional) | RFA HG 20 048

Opportunity Information: Apply for RFA HG 20 048

The Investigator-Initiated Research on Genetic Counseling Processes and Practices (R01, Clinical Trial Optional) funding opportunity (RFA HG 20 048) is a National Institutes of Health (NIH) discretionary grant program designed to advance how genetic counseling is delivered and integrated into modern genomic medicine. The central goal is to support investigator-driven research that evaluates, improves, and rethinks genetic counseling processes in real-world healthcare settings, with a clear emphasis on practical solutions that can work under the constraints most systems face today, including limited workforce capacity, uneven access to services, and growing demand for genomic testing and interpretation.

A key motivation behind the opportunity is that genetic counseling resources are not keeping pace with the rapid expansion of genomic medicine. Many patients and families cannot reliably access in-person genetic counseling, and availability varies widely across U.S. health systems depending on geography, institutional capacity, and local workforce supply. This initiative targets research that can help optimize counseling models so that care remains high-quality while becoming more scalable and efficient. Projects supported under this announcement are expected to test and refine new approaches to service delivery, evaluate what works across diverse settings, and generate evidence that can guide broader adoption.

The scope of work includes assessing current genetic counseling practices, innovating new counseling workflows or communication strategies, scaling promising models to reach larger or more diverse populations, and studying implementation in clinical environments. Strong alignment includes research that tackles how genomic information is communicated effectively and efficiently to multiple audiences, including clinicians, patients, and families. That could involve investigating how results are explained, how risk and uncertainty are conveyed, how counseling supports shared decision-making, and how downstream clinical actions are coordinated. Because the announcement is listed as “Clinical Trial Optional,” applicants have flexibility to propose either clinical trial designs (if appropriate to the research question) or non-trial studies such as pragmatic evaluations, implementation research, mixed-methods studies, or comparative effectiveness work focused on counseling processes and outcomes.

This is an R01 mechanism, meaning it is intended for substantial, hypothesis-driven or well-justified research programs led by investigators, typically with enough scale to produce generalizable findings. The listed award ceiling is $500,000 (as provided in the source data). The opportunity was created on July 30, 2020, and the original closing date was July 8, 2021, indicating it was a time-bound solicitation within that period. The associated CFDA numbers are 93.172 and 93.393, reflecting the federal assistance catalog entries tied to NIH genomic and related research programs.

Eligibility is broad and includes many types of organizations capable of conducting rigorous health and implementation research. Eligible applicants include state, county, city or 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; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3), excluding institutions of higher education where applicable); for-profit organizations (other than small businesses); and small businesses. The announcement also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); faith-based or community-based organizations; eligible federal agencies; regional organizations; U.S. territories or possessions; Indian/Native American tribal governments that are not federally recognized; and non-domestic (non-U.S.) entities (foreign organizations). This breadth signals an intent to encourage participation from institutions serving diverse communities and to support research that can address disparities in access to genetic counseling services.

Overall, the opportunity is aimed at building an evidence base for next-generation genetic counseling models that can meet rising demand in genomic medicine without sacrificing quality, clarity, or patient-centered care. It emphasizes practical innovation and implementation, with the expectation that funded projects will generate findings that help health systems deliver genetic counseling more equitably, efficiently, and effectively across different clinical contexts and populations.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Investigator-Initiated Research on Genetic Counseling Processes and Practices (R01, Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.172, 93.393.
• This funding opportunity was created on 2020-07-30.
• Applicants must submit their applications by 2021-07-08. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA HG 20 048

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