Funder: National Institutes of Health (NIH)
Due Dates: Expired (Last due date: January 8, 2025)
Funding Amounts: Up to $275,000 total direct costs over 2 years, with no more than $200,000 in any single year
Summary: Supports early-stage, high-risk basic experimental research involving human participants to explore fundamental biomedical or behavioral phenomena without specific application towards products or processes.
Key Information: This FOA requires proposed studies to be basic science clinical trials involving humans and excludes studies with specific applications toward processes or products; it has been reissued as PA-25-307 effective January 8, 2025.
Description
The NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required) supports innovative, early-stage research projects that involve basic experimental studies with human participants. This funding opportunity is designed to foster novel scientific ideas, model systems, tools, agents, methodologies, or applications that could lead to breakthroughs in biomedical, behavioral, or clinical research.
This FOA specifically targets basic science clinical trials where human participants are prospectively assigned to experimental conditions to understand fundamental aspects of phenomena without a direct focus on developing specific products or processes. Studies with specific applications toward health-related products, procedures, or services should apply under other NIH clinical trial FOAs.
The program encourages exploratory and developmental projects distinct from traditional R01 grants, emphasizing novelty and potential for significant impact rather than extensive preliminary data. It is suitable for projects that may involve considerable risk but have the potential to substantially advance knowledge or methodologies.
Applicants must ensure their proposed research aligns with the scientific missions of one or more participating NIH Institutes and Centers (ICs). The FOA is not suitable for long-term projects or those aimed at incremental advances in well-established fields.
Due Dates
- This funding opportunity expired on January 8, 2025.
- Prior standard application due dates applied, with the first due date on June 16, 2020.
- AIDS-related applications had standard due dates starting September 7, 2020.
- The FOA has been reissued as PA-25-307 effective January 8, 2025.
Funding Amount
- Maximum combined direct costs: $275,000 over a 2-year project period.
- No more than $200,000 may be requested in any single year.
- Number of awards depends on NIH appropriations and meritorious applications.
Eligibility
Eligible Applicants
- Higher Education Institutions (public/state controlled and private)
- Nonprofits (with or without 501(c)(3) status, excluding institutions of higher education)
- For-profit organizations including small businesses
- Local governments (state, county, city/township, special districts)
- Federally recognized and other Native American tribal governments and organizations
- Federal agencies and U.S. territories or possessions
- Independent school districts, public housing authorities
- Foreign institutions and foreign components of U.S. organizations are eligible
Eligible Individuals
- Any individual with the skills, knowledge, and resources to carry out the proposed research.
- Early Stage Investigators and individuals from underrepresented groups are encouraged to apply.
Registrations Required
- Dun and Bradstreet Universal Numbering System (DUNS)
- System for Award Management (SAM)
- eRA Commons account for PD(s)/PI(s)
- Grants.gov registration
Cost Sharing
Application Process
- Applications must be submitted electronically via Grants.gov and tracked through eRA Commons.
- Follow the SF424 (R&R) Application Guide and program-specific instructions.
- Applications must include a Data Management and Sharing Plan.
- Only new, resubmission, and revision applications are allowed.
- Applications must propose a clinical trial that meets NIH’s definition of basic research clinical trials involving humans.
- Preliminary data are not required but may be included.
- Applications must comply with NIH policies on human subjects, clinical trials, and data sharing.
- Limited appendix materials allowed.
- Applications will be reviewed for completeness and compliance before peer review.
Review Criteria
- Significance: Importance of the problem and potential impact on the field.
- Investigator(s): Qualifications and expertise of the research team.
- Innovation: Novelty and potential to shift current paradigms.
- Approach: Soundness of strategy, methodology, and analysis.
- Environment: Institutional support and resources.
- Additional considerations include study timeline, protections for human subjects, inclusion of diverse populations, and data management.
Additional Information
- This FOA is for basic experimental studies involving humans that are clinical trials but do not have specific applications toward products or processes.
- Studies with specific applications (e.g., FDA Phase 0 or 1, mechanistic clinical trials) should apply under Clinical Trials Required or Optional FOAs.
- Observational studies should apply under Clinical Trials Not Allowed FOAs.
- Applicants are encouraged to contact NIH scientific/research staff to discuss the appropriate funding mechanism.
- Awards are subject to NIH Grants Policy Statement terms and federal civil rights laws.
- Data and safety monitoring is required for all NIH-supported clinical trials.
- The FOA has been reissued as PA-25-307 effective January 8, 2025.
External Links
Contact Information
This funding opportunity is no longer active but has been reissued under a new announcement (PA-25-307). Researchers interested in early-stage basic experimental studies involving humans should refer to the updated FOA for current submission opportunities.