NINDS Efficacy and Exploratory Clinical Trials (UG3/UH3 - Clinical Trial Required)

HHS-NIH11 PAR-27-065
Posted: Aug 31, 2026 12:00:00 AM EDT
Closes: 03/09/2029

Description

This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). These trials must address questions within the mission and research interests of the NINDS and may include studies of small molecules, biologics, devices as well as surgical, behavioral, diet-based, or rehabilitation therapies. Studies addressing neurological diseases and care across the lifespan are highly encouraged. This notice invites both early- and middle-phase exploratory clinical trials as well as later phase confirmatory Phase 3 or comparative effectiveness clinical trials.

Synopsis

This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). These trials must address questions within the mission and research interests of the NINDS and may include studies of small molecules, biologics, devices as well as surgical, behavioral, diet-based, or rehabilitation therapies. Studies addressing neurological diseases and care across the lifespan are highly encouraged. This notice invites both early- and middle-phase exploratory clinical trials as well as later phase confirmatory Phase 3 or comparative effectiveness clinical trials.

Eligibility

Eligible Applicants:
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities Special district governments For profit organizations other than small businesses Independent school districts Private institutions of higher education County governments Small businesses State governments Public and State controlled institutions of higher education Others (see text field entitled "Additional Information on Eligibility" for clarification)
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16.8 Collaborative International Research Awards.Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Funding Activity Categories

Health

CFDA Numbers

  • 93.853 - Extramural Research Programs in the Neurosciences and Neurological Disorders

Contact Information

Agency: National Institutes of Health
Contact: National Institutes of Health
Phone: 301-402-2541
Exploratory_Efficacy_Trials@ninds.nih.gov
Exploratory_Efficacy_Trials@ninds.nih.gov

Additional Information

Document Type: synopsis
Opportunity Category: Discretionary
Version: 1
Last Updated: Aug 31, 2026 10:35:01 AM EDT

Related Opportunities