NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)

The National Institutes of Health (NIH) invites applications for the NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required). This funding opportunity supports innovative, early-stage, and high-risk research that has the potential to advance biomedical, behavioral, and clinical science. The program focuses on basic experimental studies involving humans, which prospectively assign human participants to conditions and assess outcomes to understand fundamental phenomena. Applications proposing studies directed toward specific processes or products should instead submit under other Clinical Trial Required or Clinical Trial Optional announcements.

The program seeks to encourage projects that test novel ideas, explore new methods, or develop groundbreaking technologies. Suitable projects could assess the feasibility of a new research area, employ unique methodologies to explore emerging scientific questions, or break new ground in basic science. However, the R21 mechanism is distinct from the R01 mechanism and is not intended to support long-term projects or studies building upon well-established research areas. Proposals must reflect innovation and high potential impact, with an emphasis on conceptual frameworks rather than extensive preliminary data.

The combined budget for direct costs across the two-year project period cannot exceed $275,000, with no more than $200,000 allowed in any single year. The maximum project period is two years. Applications will be assigned to participating NIH Institutes and Centers based on programmatic relevance, and applicants are encouraged to consult the R21 Basic Experimental Studies with Humans Required IC-Specific Scientific Interests and Contact website to identify appropriate program contacts for their research topic.

Eligible applicants include higher education institutions, nonprofits, for-profit organizations, small businesses, local and state governments, Native American tribal organizations, independent school districts, public housing authorities, and foreign institutions. Non-domestic entities and foreign components of U.S. organizations are also eligible. Applicants must complete required registrations with Dun and Bradstreet (DUNS), System for Award Management (SAM), eRA Commons, and Grants.gov prior to submission. Applications must be prepared and submitted electronically using NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system solution.

Proposals will be evaluated through NIH’s peer review process, with reviewers assessing significance, innovation, investigator expertise, approach, and the scientific environment. Additional review considerations include protections for human subjects, inclusion of women, minorities, and individuals across the lifespan, and compliance with NIH’s data management and sharing policies. Applications should clearly describe the proposed study design, justify the use of human participants, outline recruitment plans, and address data management strategies. Award decisions will be based on scientific merit, program priorities, and the availability of funds.

Standard NIH submission deadlines apply, with non-AIDS applications due by 5:00 PM local time on the designated dates. AIDS and AIDS-related applications follow separate deadlines. Applicants are encouraged to submit early to allow sufficient time for corrections to submission errors. Awardees will receive formal Notices of Award and must comply with all NIH terms and policies, including reporting and data sharing requirements. This funding opportunity will expire on January 8, 2025.