Investigator-Initiated Genomic Medicine Research (R01 Clinical Trial Optional) | PAR 18 735

Opportunity Information: Apply for PAR 18 735

The Investigator-Initiated Genomic Medicine Research (R01 Clinical Trial Optional) funding opportunity (PAR 18 735) is a National Institutes of Health (NIH) discretionary grant program designed to support researcher-driven projects that push genomic medicine forward in real-world clinical care. The core purpose is to deepen what is known about how an individual patient's genomic information can be used to guide clinical decisions and, importantly, to evaluate the health outcomes that result from using that information in practice. In other words, it is not just about discovering genetic associations in the lab; it is also about understanding how genomic data can be integrated into clinical workflows and whether that integration improves patient care, outcomes, or health system performance.

This opportunity uses the R01 mechanism, which generally supports substantial, hypothesis-driven research projects led by investigators who define the research questions, study design, and implementation approach. The notice indicates that clinical trials are optional, meaning applicants may propose studies that include clinical trials, as well as studies that do not, as long as the work directly contributes to advancing genomic medicine and its clinical implementation. The funding activity category is Health, and the CFDA number listed is 93.172. The award ceiling shown is $500,000, indicating an upper bound on the amount that may be awarded under the terms summarized here. The posting lists an original closing date of 2020-07-02 and a creation date of 2018-04-02, which helps place the timeline of the solicitation as originally announced.

The scientific emphasis is on both understanding and implementation. That typically includes research on how genomic results are generated, interpreted, communicated, and used at the point of care; how providers and patients act on genomic information; and what clinical, behavioral, or health-economic outcomes follow from that use. Projects under this umbrella often address practical barriers to uptake (such as clinical decision support needs, provider education, result reporting, patient understanding, consent processes, privacy concerns, and health system integration) and may evaluate the effectiveness of implementation strategies in diverse clinical settings. Because the opportunity statement explicitly calls out "health outcomes of that clinical use," it signals an expectation that applications will connect genomic information to measurable impacts, such as changes in diagnosis, treatment selection, disease prevention strategies, medication safety or efficacy (pharmacogenomics), utilization, cost, or patient-reported outcomes.

Eligibility is broad and includes many types of domestic applicants: state, county, and 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 Native American tribal governments; public housing authorities/Indian housing authorities; and Native American tribal organizations other than federally recognized tribal governments. It also welcomes nonprofit organizations (both those with 501(c)(3) status and those without, outside of institutions of higher education), for-profit organizations other than small businesses, and small businesses, as well as an "Other" category that further widens who can apply depending on NIH policy and the specific program rules.

In addition to the standard applicant types, the opportunity explicitly highlights additional eligible applicants that NIH wants to ensure are included. These include Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American 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 agencies of the federal government; regional organizations; Indian/Native American tribal governments that are not federally recognized; and U.S. territories or possessions. Notably, non-domestic (non-U.S.) entities (foreign organizations) are also listed as eligible, which signals that international institutions may apply when appropriate, consistent with NIH rules for foreign applications and the project scope.

Overall, this grant opportunity is aimed at moving genomic medicine from promise to practice by funding rigorous, investigator-initiated studies that clarify how genomic data should be used in clinical care, how to implement that use effectively, and what real health outcomes result when genomic information informs decisions for individual patients.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Investigator-Initiated Genomic Medicine Research (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.
• This funding opportunity was created on 2018-04-02.
• Applicants must submit their applications by 2020-07-02. (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 PAR 18 735

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