The Technology Development Research for Establishing Feasibility and Proof of Concept (R21 Clinical Trial Not Allowed) program by the National Institute of General Medical Sciences (NIGMS) supports exploratory research to evaluate untested concepts for innovative technologies relevant to biomedical research. This program is focused on proof-of-concept studies, targeting technologies that have not yet been demonstrated feasible in the literature or supported by preliminary data. Proposed tools or methods must address significant challenges in the field and have broad applicability.

Projects supported under this program may involve developing laboratory instruments, software, chemical reagents, or biological systems designed as research tools. The proposed technology must present a novel, unproven approach with no prior feasibility data. Applications that include preliminary results or re-purpose existing technologies will be deemed non-responsive and withdrawn without review. The emphasis is on high-risk, high-reward projects that establish foundational proof of concept for subsequent development stages.

The funding opportunity offers up to $275,000 in direct costs over a two-year project period, with no more than $200,000 in any single year. Applicants must justify budgets based on the specific needs of their project. Eligibility extends to a broad range of entities, including higher education institutions, nonprofits, for-profit organizations, and local governments, though foreign organizations are ineligible. Collaborative approaches and diverse team compositions are encouraged to enhance innovation.

Applications must adhere to strict guidelines, including the exclusion of unpublished preliminary data and the inclusion of a required "Letter from PD/PI" confirming compliance with responsiveness criteria. Submission dates are February 16, June 16, and October 16 annually, through January 2028. Proposals must align with NIGMS’s mission to support basic research that advances understanding of biological processes and enables future biomedical applications.

Review criteria focus on the significance, innovation, and approach of the proposed technology, including its potential utility, the novelty of the concept, and the robustness of experimental design. Reviewers will also evaluate the investigator’s expertise, the feasibility of achieving proof of concept, and the proposed project's potential to serve as a foundation for further development through subsequent grant mechanisms.

This program seeks transformative technological innovations that address unmet needs in biomedical research. It provides an opportunity for high-risk exploratory projects to secure foundational support for novel ideas that have the potential to significantly impact the scientific community. Prospective applicants are encouraged to consult with NIGMS program staff to ensure alignment with the program’s goals before submission.