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Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01 Clinical Trial Not Allowed)




November 6, 2023



November 2, 2026



Award Floor:



Match Required?





Entity Types:

State governments, County governments, City or township governments, Special district governments, Independent school districts, Public & State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities, Native American tribal organizations, Nonprofits (with 501(c)(3) status), Nonprofits (without 501(c)(3) status)

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.




Source Type:


This NOFO is one part of the NIAMS Clinical Research program, which includes the NIAMS Exploratory Clinical Trial Grants (R61). The overall goals of the NIAMS Clinical Research program are to support well-designed, high impact studies that lead to advances in the prevention or reduction of symptoms and improve outcomes and function in patients with rheumatic, musculoskeletal, or skin conditions or diseases. This NOFO will only support Clinical Observational (CO) studies, defined as a clinical study in which the investigator does not intervene to alter the care or treatment that people receive, but only observes and collects different outcomes and analyzes data. These studies often assess specific health characteristics of the enrolled participants by collecting biospecimens (e.g., for biomarker or genomic analyses), obtaining photographic, radiographic or other images, and/or collecting medical history or exposure data from research subjects. Applications that leverage telehealth methods, digital outcomes, or wearable devices are encouraged. Studies other than observational studies submitted to this NOFO will not be supported. Applications can include studies to obtain information about disease symptoms, stages, and timing of disease progression; comorbid conditions; availability of potential clinical study participants; and outcomes that are important to patients. These CO studies can also facilitate efforts to validate objective biomarkers or subjective outcome measures for use in a future clinical study. Applicants to this NOFO are encouraged to propose studies that address significant obstacles or questions in the design of a clinical study, such as determining the appropriate primary or secondary outcome measures or identifying the stages of disease during which patients are most likely to respond to an intervention. Applicants are also highly encouraged to consider use of the best available methods for design, assessment, and analysis in observational studies. Although these studies are intended to inform the planning and execution of future clinical research studies, the resulting data may also have a direct impact on clinical care.

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