Joint NINDS/NIMH Exploratory Neuroscience Research Grant (R21 Clinical Trial Optional)

The Department of Health and Human Services, through the National Institutes of Health (NIH), has reissued the Joint NINDS/NIMH Exploratory Neuroscience Research Grant (R21), under announcement number PA-21-219. This program is administered by the National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute of Mental Health (NIMH). Its goal is to support early-stage and high-risk exploratory research projects within the missions of both NINDS and NIMH, providing opportunities for projects that could lead to groundbreaking discoveries in neuroscience. This grant is designed for novel research that may lack extensive preliminary data but has the potential for significant contributions to the field. Applications may include basic experimental studies with humans (BESH) or mechanistic clinical trials, which investigate how an intervention works, without assessing its safety or efficacy.

The R21 funding mechanism is specifically tailored for exploratory and developmental research. These grants will support projects in the conceptual stage, often involving innovative ideas that require initial feasibility studies. The maximum project period is two years, with a budget limited to $275,000 in direct costs over the grant period, and no more than $200,000 can be requested in any single year. The program does not require cost-sharing, and eligible applicants include higher education institutions (including HBCUs, Hispanic-serving institutions, and Tribally Controlled Colleges and Universities), non-profit organizations, small businesses, for-profit organizations, and certain government entities. Foreign institutions and non-domestic entities may also apply.

Given the exploratory nature of this funding, the program encourages the development of new techniques, methodologies, and models relevant to neuroscience. The program welcomes projects that assess the feasibility of novel areas of investigation, such as the application of existing methodologies in new contexts, or the development of entirely new approaches. The initiative is particularly well-suited to projects that involve high levels of uncertainty but could potentially lead to major advances in understanding neurological or mental health disorders.

Applications proposing clinical trials must adhere to specific guidelines. Only mechanistic trials and basic experimental studies with humans (BESH) will be supported, while trials assessing safety, efficacy, or effectiveness are excluded from this opportunity. Investigators interested in conducting other types of clinical trials are directed to alternative NIH funding mechanisms, such as PAR-18-420 for exploratory clinical trials. Applicants are strongly encouraged to contact NIH program staff for guidance on submitting proposals that involve human subjects to ensure alignment with the correct funding opportunity.

Key dates for submission follow the NIH’s standard schedule, with application deadlines spaced throughout the year. The next deadlines include October 16, 2023, February 16, 2024, and subsequent cycles through 2025. Submissions must be made electronically via the NIH ASSIST system, Grants.gov, or other institutional systems-to-systems solutions. Early submission is encouraged to allow time for resolving errors before the final deadline. Applicants must also complete several registrations, including with SAM, DUNS, and eRA Commons, well in advance of the submission due date.

Applications will be reviewed based on scientific merit, innovation, significance, approach, investigator qualifications, and environment. Reviewers will assess the project's potential to contribute to significant advances in neuroscience and whether the risks involved are justified by the potential rewards. Priority will be given to projects that promise to introduce new perspectives, challenge existing paradigms, or address critical gaps in current knowledge.

For further assistance or inquiries, applicants can contact NIH program officials from either NINDS or NIMH, as detailed in the funding announcement. The final deadline for applications under this opportunity is January 8, 2025.