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.
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Frequently Asked Questions (FAQs)

What is the Investigator-Initiated Genomic Medicine Research (R01 Clinical Trial Optional) opportunity (PAR 18 735)?

It is a National Institutes of Health (NIH) discretionary grant opportunity that supports investigator-driven research projects intended to advance genomic medicine in real-world clinical care. The focus is on how an individual patient's genomic information can be used to guide clinical decisions and how that use affects health outcomes in practice.

What is the main goal of this funding opportunity?

The central goal is to deepen understanding of how patient genomic information can be integrated into clinical workflows and used to make care decisions, and to evaluate the health outcomes that result from using that information in routine care. The emphasis is on moving genomic medicine from promise to practical, measurable impact.

Is this grant focused on basic laboratory discovery or clinical implementation?

Based on the description provided, it is not limited to discovering genetic associations in a lab setting. It is explicitly oriented toward clinical use and implementation: generating, interpreting, communicating, and using genomic results at the point of care, and measuring what happens to patients and health systems when genomic information is used.

What funding mechanism does this opportunity use?

This opportunity uses the NIH R01 mechanism, which generally supports substantial, hypothesis-driven research projects where the investigator defines the research questions, study design, and implementation approach.

Are clinical trials required under this opportunity?

No. The opportunity is labeled "Clinical Trial Optional," meaning applicants may propose studies that include clinical trials or studies that do not include clinical trials, as long as the proposed work advances genomic medicine and its clinical implementation.

What types of research topics fit within the scientific emphasis described?

The description emphasizes research that addresses both understanding and implementation of genomic medicine in clinical care. Examples of topic areas mentioned or implied include 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 using genomic information in practice.

What kinds of barriers or practical issues can applicants address?

The opportunity description highlights practical barriers to uptake and integration of genomic medicine, including clinical decision support needs, provider education, result reporting, patient understanding, consent processes, privacy concerns, and health system integration.

What kinds of outcomes is NIH expecting applicants to evaluate?

The description signals an expectation that projects connect genomic information to measurable impacts. Outcomes mentioned or suggested include changes in diagnosis, treatment selection, disease prevention strategies, medication safety or efficacy (pharmacogenomics), health care utilization, cost, and patient-reported outcomes.

What is the funding activity category for this opportunity?

The funding activity category listed is Health.

What CFDA number is associated with this opportunity?

The CFDA number listed is 93.172.

Is there an award ceiling, and if so, what is it?

Yes. The award ceiling shown is $500,000, indicating an upper bound on the amount that may be awarded under the summarized terms provided.

When was this opportunity created, and what closing date is shown?

The creation date shown is 2018-04-02. The posting lists an original closing date of 2020-07-02.

Who is eligible to apply (in general terms)?

Eligibility is broad and includes many types of domestic applicants. The description lists government entities (state, county, city or township, 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.

Are nonprofit organizations eligible?

Yes. The description states that nonprofit organizations are eligible, including those with 501(c)(3) status and those without 501(c)(3) status (outside of institutions of higher education).

Are for-profit organizations eligible?

Yes. The description includes for-profit organizations other than small businesses, as well as small businesses.

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

Yes. The opportunity explicitly lists non-domestic (non-U.S.) entities (foreign organizations) as eligible, indicating that international institutions may apply when appropriate and consistent with NIH rules.

Which additional categories of applicants are explicitly highlighted as eligible?

The description specifically highlights 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.

What does "investigator-initiated" mean in the context of this opportunity?

It means the research is researcher-driven: investigators propose the questions, hypotheses, study design, and approach, rather than responding to a narrowly prescribed research plan defined by the funder. The purpose is to support projects that investigators believe will push genomic medicine forward in real clinical care.

What does the opportunity emphasize about integrating genomic information into clinical care?

It emphasizes that genomic information should be used in real-world clinical workflows and decisions, and that research should examine not only how to integrate genomic data (for example through reporting, communication, and decision support), but also what happens afterward in terms of outcomes for patients and health systems.

Does this opportunity specifically mention pharmacogenomics?

Yes. Pharmacogenomics is mentioned as an example outcome area, particularly in relation to medication safety or efficacy when genomic information informs prescribing or medication management.

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