The National Institutes of Health (NIH) has announced the NIH Exploratory/Developmental Research Grant (R21 Clinical Trial Not Allowed), which supports innovative research projects at their early, conceptual stages. These projects aim to address novel ideas, model systems, tools, technologies, and methodologies that can substantially advance biomedical, behavioral, and clinical research. This funding opportunity is not intended for projects that simply extend existing research but instead supports exploratory studies that could lead to breakthroughs or major advances. Projects proposing clinical trials are not eligible for this funding opportunity.

The R21 grant provides funding for short-term research efforts with an emphasis on high-risk, high-reward proposals. Examples of appropriate projects include those testing the feasibility of a new concept, exploring the unique application of an existing methodology, or developing novel tools and models for research. Preliminary data are not required, as the focus is on innovative ideas rather than well-established research paths. Applicants are encouraged to contact the participating Institutes and Centers (ICs) to ensure alignment with specific scientific interests. Applications will be assigned to ICs based on established NIH guidelines.

Eligible applicants include higher education institutions, nonprofits, for-profit organizations, government entities, independent school districts, Native American tribal organizations, and regional organizations. Both domestic and foreign organizations are eligible to apply, including non-domestic components of U.S. entities. Applicants must complete and maintain required registrations in SAM.gov, eRA Commons, and Grants.gov to submit their applications successfully. All PDs/PIs must have an eRA Commons ID, and multiple PD/PI applications are permitted.

The award provides a total budget of $275,000 in direct costs over a two-year project period, with no more than $200,000 allowed in any single year. Projects may not exceed the two-year duration. Applications are subject to standard NIH due dates, with submission cycles occurring in February, June, and October each year. Applicants are encouraged to apply early to resolve any technical issues before the deadline. Late applications will not be accepted unless they meet specific NIH criteria.

Applications will be evaluated based on scientific merit through NIH’s peer review process. Review criteria include the significance and innovation of the research, the rigor and feasibility of the proposed approach, and the qualifications of the investigator(s) and research environment. Projects must demonstrate the potential for substantial impact, introduce innovative concepts, and include a strong scientific foundation. Feasibility will be assessed based on the proposed approach, study design, and potential to generate reproducible results.

Successful applicants will receive a Notice of Award (NoA), and projects will be subject to NIH policies regarding data management, sharing, and resource dissemination. Recipients are required to submit annual progress reports through the Research Performance Progress Report (RPPR) system and adhere to post-award monitoring guidelines. The NIH encourages the use of common data elements (CDEs) to ensure broader usability and integration of data across studies. Contact information for application and scientific inquiries is available through the R21 IC-specific contacts listed in the announcement.

This funding opportunity aligns with NIH's broader mission to foster innovative discoveries, support public health, and promote scientific advancements. It encourages investigators to pursue creative, high-impact research that could lead to significant breakthroughs in biomedical and behavioral sciences. Applicants are advised to carefully follow all application guidelines and seek guidance from program officials to ensure their proposals align with the specific goals and priorities of participating NIH Institutes and Centers.