Research Project Grant (Parent R01 Clinical Trial Required)
Can you apply?
This grant is for health and biomedical research organizations conducting clinical trials. Eligible applicants include academic institutions, research hospitals, nonprofits, small businesses, and federal agencies with research capacity. Applicants must propose original research aligned with NIH priorities and demonstrate institutional support through letters of commitment. The research must involve human subjects and meet all federal regulations for clinical trials.
Awards typically support project costs including personnel, equipment, and patient care costs. The grant requires a detailed research protocol, statistical plan, and human subjects protections documentation. Institutions must have appropriate IRB approval and demonstrate scientific merit through peer review.
This grant is for health and biomedical research organizations conducting clinical trials. Eligible applicants include academic institutions, research hospitals, nonprofits, small businesses, and federal agencies with research capacity. Applicants must propose original research aligned with NIH priorities and demonstrate institutional support through letters of commitment. The research must involve human subjects and meet all federal regulations for clinical trials.
Awards typically support project costs including personnel, equipment, and patient care costs. The grant requires a detailed research protocol, statistical plan, and human subjects protections documentation. Institutions must have appropriate IRB approval and demonstrate scientific merit through peer review.
Program description
The NIH Research Project Grant supports a discrete, specified, circumscribed project in areas representing the specific interests and competencies of the investigator(s). This Parent Notice of Funding Opportunity Announcement requires that at lease 1 clinical trial be proposed. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- Colleges (all higher ed)
- Community Health Center
- County Government
- Hospital
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Details
This grant is for health and biomedical research organizations conducting clinical trials. Eligible applicants include academic institutions, research hospitals, nonprofits, small businesses, and federal agencies with research capacity. Applicants must propose original research aligned with NIH priorities and demonstrate institutional support through letters of commitment. The research must involve human subjects and meet all federal regulations for clinical trials.
Awards typically support project costs including personnel, equipment, and patient care costs. The grant requires a detailed research protocol, statistical plan, and human subjects protections documentation. Institutions must have appropriate IRB approval and demonstrate scientific merit through peer review.
How to apply
Application links
Required documents
- NIH R01 Application (SF-424 R&R)
- Project Narrative (Research Strategy, up to 15 pages)
- Specific Aims (1 page)
- Research Design and Methods
- Budget and Budget Narrative (modular or detailed)
- Biosketch for all key personnel (4 pages each)
- Institutional Letter of Support
- IRB Approval or Certification of Human Subjects Protocol
- Letters of Commitment from collaborating institutions
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.233 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$16,277,433
-
$13,970,558
-
$12,669,690
-
$8,456,005
-
$7,924,752
-
$7,333,951
-
$7,218,079
-
$6,880,168
-
$6,771,213
-
$6,674,878
Top States by Funding
- MA 17 awards $92.5M
- PA 11 awards $50.5M
- IL 10 awards $44.8M
- CA 11 awards $36.0M
- MD 7 awards $30.3M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.233). How funding has trended year over year.
| 2024 | $104,734,238 | |
| 2025 | $116,468,492 |
FAQ
Who is eligible to apply for this Parent R01?
Research institutions, universities, hospitals, nonprofits, and small businesses with research infrastructure. Federal agencies can also apply if they meet NIH guidelines.
What happens if my application doesn't include a clinical trial component?
This specific grant requires a clinical trial. Proposals without human subjects research in a clinical setting will be considered non-responsive.
How competitive is this funding?
NIH R01 grants are highly competitive. Success rates typically range from 10-20%, with strong emphasis on preliminary data and research team qualifications.
What is the typical funding range?
R01 awards vary widely by field and scope. NIH publishes annual success rates and funding amounts in agency announcements. Check the specific program announcement for details.
When should I start preparing my application?
Begin 3-4 months before the deadline. This allows time for internal review, IRB submissions, and institutional approval processes.
💡 Tips for applicants
- Start early. Clinical trial research requires IRB approval, which takes considerable time before submission.
- Build a strong preliminary data section. Reviewers prioritize applications with published results demonstrating feasibility.
- Clearly define your clinical trial endpoints. Specify primary and secondary outcomes with justification for each measurement.
- Address scientific rigor upfront. Include power calculations, blinding strategies, and plans for missing data.
- Engage your institution early. Secure commitments from department leadership and research administration before drafting.
⚠️ Common mistakes
Weak preliminary data or insufficient evidence of clinical trial feasibility. Underestimating the complexity of patient recruitment and retention strategies. Poor alignment with current NIH strategic priorities despite strong science.
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