Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01 Clinical Trial Not Allowed)
Can you apply?
This grant is for researchers conducting observational studies in musculoskeletal, rheumatic, and skin diseases. NIH R01 grants support independent research projects led by established investigators. Applicants typically must have a PhD, MD, or equivalent research credential and institutional affiliation. Clinical trials are not allowed; only observational study designs qualify. U.S. institutions, including universities, medical schools, and nonprofit research organizations, are eligible to apply.
Program description
This Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01 Clinical Trial Not Allowed) PAR, was re-issued as a result of the Simplifying Review of Research Project Grant Applications [link: https://grants.nih.gov/policy-and-compliance/policy-topics/peer-review/simplifying-review].
The Simplified Review changes in Section V are the only changes that have been made. All other aspects of this funding opportunity remain the same.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- Colleges (all higher ed)
- Community Health Center
- County Government
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
How to apply
Application links
Required documents
- SF-424 (R&R) Federal Application Form
- Project Narrative (research plan)
- Detailed Budget and Budget Justification
- Biographical Sketches of all key personnel
- Institutional Support Letter
- Preliminary Data or Supporting Evidence
- Data Management and Sharing Plan
- Protection of Human Subjects documentation (IRB approval or exemption letter)
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.846 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$63,962,483
-
$60,038,896
-
$34,166,872
-
$27,648,731
-
$27,051,746
-
$21,654,386
-
$20,288,994
-
$20,225,012
-
$16,326,540
-
$15,274,546
Top States by Funding
- CA 13 awards $123.5M
- MA 15 awards $123.0M
- NY 12 awards $106.8M
- NC 4 awards $102.5M
- PA 11 awards $101.4M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.846). How funding has trended year over year.
| 2018 | $476,478,975 | |
| 2019 | $490,084,446 | |
| 2020 | $505,547,334 | |
| 2021 | $509,241,630 | |
| 2022 | $499,786,367 | |
| 2023 | $548,439,000 | |
| 2024 est. | $545,593,000 | |
| 2025 est. | $541,712,000 |
FAQ
Who can apply for this NIH R01 grant?
Researchers with PhD, MD, or equivalent credentials at eligible U.S. institutions. You must demonstrate research independence and institutional support.
Are clinical trials allowed?
No. This program explicitly excludes clinical trial designs. Only observational studies qualify.
What study types are funded?
Observational research in musculoskeletal, rheumatic, and skin diseases. Cohort studies, case-control, cross-sectional, and registry-based studies are typical examples.
What is the typical funding range?
NIH R01 grants typically range from $250,000 to $500,000 annually, but amounts vary by field and project scope.
When is the next deadline?
The deadline is November 2, 2026. Plan to submit at least 2-3 months before for internal review.
💡 Tips for applicants
- Build a strong preliminary data section. Reviewers expect published or near-publishable results supporting feasibility.
- Clearly explain why your question requires observational design. Justify why a clinical trial cannot answer your research question.
- Include a detailed statistical analysis plan. NIH reviewers scrutinize observational study methods closely.
- Highlight your team's expertise in epidemiology, biostatistics, and disease-specific knowledge relevant to your topic.
- Use the NIH Early Stage Investigator designation if eligible; it can strengthen competitiveness for newer researchers.
⚠️ Common mistakes
Proposing a design that resembles a clinical trial or intervention study. Weak preliminary data or insufficient evidence of feasibility. Vague statistical analysis plans without detailed covariate adjustment strategies.
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