Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01 Clinical Trial Not Allowed)
National Institutes of Health (NIH)
Direct costs limited to $475,000 over a maximum project period of four years.
No more than $250,000 in any single year.
To encourage Research Project Grant (R01) applications for clinical observational studies.
To obtain data necessary for designing clinical studies for musculoskeletal, rheumatic, or skin diseases.
Researchers in the fields of musculoskeletal, rheumatic, and skin diseases.
Patients affected by these diseases.
Eligible organization types include higher education institutions, nonprofits, for-profit organizations, local and state governments, and tribal governments.
Non-domestic (non-U.S.) entities are not eligible to apply.
Organizations must be based in the U.S. or its territories.
Non-domestic components of U.S. organizations are not eligible.
Only observational studies will be supported.
Studies must address significant obstacles or questions in clinical project design.
Direct costs limited to $475,000 over four years.
No cost-sharing is required.
Applications are due by 5:00 PM local time on specified due dates.
The maximum project period is four years.
The NIH will not accept duplicate or highly overlapping applications under review at the same time.
Applications must follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide.
Applications will be evaluated based on scientific and technical merit.
Applications will undergo a peer review process.
Applications deemed to have the highest scientific and technical merit will be prioritized.
Applications must include a Data Management and Sharing Plan.
Non-responsive applications will be returned without review.
Applications that leverage telehealth methods or digital outcomes are encouraged.
High impact applications will integrate necessary components for significant clinical studies.
Demonstrating the significance of the proposed research.
Submitting applications that do not comply with the application instructions.
Consider the current state of clinical research in the relevant disease.
Highlight the innovative aspects of the proposed observational study.