Atom | NIH Exploratory/Developmental Research Project Grant (Parent R21 Clinical Trial Required)

Funder: National Institutes of Health

Funding Amounts: Up to $275,000 direct costs over 2 years; no more than $200,000 in any single year; project period max 2 years.

Summary: Supports early-stage, high-risk clinical trial research with potential for breakthroughs in biomedical, behavioral, or clinical fields.

Key Information: At least one clinical trial is required; some NIH Institutes only accept mechanistic trials—check IC-specific guidance before applying.

Description

This opportunity supports exploratory and developmental research projects at the early and conceptual stages, specifically requiring at least one clinical trial. The program is designed to foster innovative, high-risk studies that may lead to significant advances or the development of novel techniques, agents, methodologies, models, or applications in biomedical, behavioral, or clinical research. Projects should be distinct from traditional R01 research, focusing on new directions, feasibility assessments, or novel uses of existing methods.

The proposed research must align with the programmatic interests of at least one participating NIH Institute or Center (IC). Not all ICs participate, and some only accept mechanistic clinical trials under this announcement. Applicants are strongly encouraged to review IC-specific interests and contact relevant NIH staff before applying.

Due Dates

Standard NIH R21 due dates apply:
- June 16, 2025 (New applications)
- July 16, 2025 (Renewal/Resubmission/Revision)
- September 7, 2025 (AIDS-related applications)
- October 16, 2025 (New)
- November 16, 2025 (Renewal/Resubmission/Revision)
- January 7, 2026 (AIDS)
- Additional cycles continue through January 2028

All applications are due by 5:00 PM local time of the applicant organization. See the NIH standard due dates for the full schedule.

Funding Amount

Direct costs: Up to $275,000 total for the 2-year project period
Annual limit: No more than $200,000 in direct costs in any single year
Project period: Maximum of 2 years
Number of awards: Contingent on NIH appropriations and the number of meritorious applications

Eligibility

Eligible applicants include:

Public and private institutions of higher education
Nonprofits (with or without 501(c)(3) status)
For-profit organizations (including small businesses)
State, county, city, township, and special district governments
Native American tribal governments and organizations
Independent school districts
Public housing authorities/Indian housing authorities
Faith-based and community-based organizations
Regional organizations
U.S. federal agencies and U.S. territories/possessions
Non-domestic (non-U.S.) entities and foreign components of U.S. organizations

Individuals: Any investigator with the skills, knowledge, and resources to carry out the proposed research may apply. Multiple applications from the same organization are allowed if scientifically distinct.

Application Process

Submission: Applications must be submitted electronically via Grants.gov using ASSIST, Grants.gov Workspace, or an institutional system-to-system solution.
Required registrations: Applicant organizations must register with SAM, eRA Commons, and Grants.gov. Registration can take 6+ weeks.
PI requirements: All PD(s)/PI(s) must have an eRA Commons account.
Application instructions: Follow the NIH How to Apply - Application Guide and the specific instructions in the funding announcement.
Clinical trial requirement: All applications must propose at least one clinical trial as defined by NIH.
Page limits: Standard NIH R21 page limits apply.
Data Management and Sharing Plan: Required for all applications.

Additional Information

Mechanistic trials: Some NIH ICs only accept mechanistic clinical trials under this announcement. Mechanistic studies are designed to understand biological or behavioral processes, disease pathophysiology, or mechanisms of action.
IC participation: Not all NIH ICs participate in this parent announcement. Check the R21 IC-Specific Scientific Interests and Contact page for details.
No cost sharing required.
Foreign organizations: Eligible to apply.
Multiple applications: Allowed if scientifically distinct.
Review criteria: Emphasize innovation, significance, rigor, feasibility, and investigator expertise. Preliminary data are not required.

External Links

Contact Information

Purpose	Contact	Details
General Grants Info	Email	GrantsInfo@nih.gov
General Grants Info	Phone	301-480-7075
Application Submission (eRA)	Online	eRA Service Desk
Application Submission (eRA)	Phone	301-402-7469 or 866-504-9552
Grants.gov Support	Email	support@grants.gov
Grants.gov Support	Phone	800-518-4726
Scientific/Research Contacts	Web	R21 IC-Specific Contacts

For additional contacts, see Section VII. Agency Contacts in the full announcement.