Safety and Feasibility Trials for Rapid-Acting Interventions for Severe Suicide Risk (R01 Clinical Trial Required) | RFA MH 20 345

Opportunity Information: Apply for RFA MH 20 345

The Safety and Feasibility Trials for Rapid-Acting Interventions for Severe Suicide Risk (R01 Clinical Trial Required) funding opportunity (RFA-MH-20-345) is a National Institutes of Health (NIH) grant announcement from the U.S. Department of Health and Human Services, focused on supporting early-stage clinical trials that test rapid-acting interventions intended to reduce severe suicide risk. The emphasis is on pilot and feasibility work rather than large, definitive efficacy trials, meaning the main goal is to determine whether a rapid intervention can be delivered safely and practically to people at very high risk, and whether a larger trial would be realistic and justified. These studies must be conducted as clinical trials, and they are expected to be grounded in real-world, clinically appropriate environments where severe suicide risk is commonly evaluated and managed.

A central feature of this opportunity is that the interventions being tested should have rapid effects on suicide risk, which typically implies approaches designed to produce meaningful risk reduction on a short timescale (for example, hours to days rather than weeks to months). Because the target population involves acute or severe suicide risk, the FOA highlights the importance of specialized healthcare settings that can safely monitor and manage participants. Examples specifically noted include emergency departments and psychiatric inpatient units, as well as other settings capable of meeting Risk Evaluation and Mitigation Strategy (REMS) style requirements where relevant. In practical terms, this points applicants toward environments with strong clinical oversight, the ability to respond quickly to clinical deterioration, and infrastructure for intensive observation, evaluation, and follow-up.

The award mechanism is an R01 grant, which generally supports investigator-initiated research projects but, in this case, is being used for safety and feasibility trials with a clinical trial requirement. The financial scale described includes an award ceiling of $400,000, and the program anticipated making about six awards. The original closing date listed for the opportunity was February 26, 2020, and the opportunity was created on November 25, 2019, which places it in a specific funding cycle and indicates the timing of when applications were originally due.

Eligibility is broad and includes many types of organizations that could credibly carry out clinical research in high-acuity settings. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments and other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding higher education institutions where specified); for-profit organizations other than small businesses; small businesses; and other categories as clarified in the full FOA. This wide eligibility range reflects the reality that suicide prevention research and rapid-intervention trials may be led by academic medical centers, hospital systems, community health organizations, tribal health entities, and other stakeholders with access to high-risk patient populations and the clinical infrastructure needed to conduct trials responsibly.

Overall, this FOA is designed to move promising rapid-acting approaches toward practical clinical use by funding the kind of early trial work that answers essential questions: Can the intervention be administered safely to people in acute crisis? Can it be implemented in settings like EDs or inpatient units without disrupting care? Are recruitment, consent, retention, and follow-up feasible in high-stress clinical contexts? And does the trial generate enough signal and operational learning to justify a larger, more definitive study? The intent is to accelerate progress in suicide prevention by focusing on interventions that could make a difference quickly for individuals facing severe, immediate risk, while prioritizing safety, real-world feasibility, and clinically appropriate oversight.

• The Department of Health and Human Services, National Institutes of Health in the health sector is offering a public funding opportunity titled "Safety and Feasibility Trials for Rapid-Acting Interventions for Severe Suicide Risk (R01 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242.
• This funding opportunity was created on Nov 25, 2019.
• Applicants must submit their applications by Feb 26, 2020. (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 $400,000.00 in funding.
• The number of recipients for this funding is limited to 6 candidate(s).
• 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 (see text field entitled Additional Information on Eligibility for clarification).

Apply for RFA MH 20 345

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: