Research Innovations for Scientific Knowledge (RISK) for Musculoskeletal Diseases (R61/R33 Clinical Trial Not Allowed) | RFA AR 19 013

Opportunity Information: Apply for RFA AR 19 013

Research Innovations for Scientific Knowledge (RISK) for Musculoskeletal Diseases (R61/R33 Clinical Trial Not Allowed) is a National Institutes of Health (NIH) funding opportunity from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) designed to back bold, unconventional musculoskeletal research that does not fit comfortably into more traditional NIH grant programs. The central goal is to push the field forward by supporting projects that start from unusual observations, challenge prevailing assumptions, or propose imaginative hypotheses and new conceptual models. In practice, this means NIAMS is explicitly inviting applications that reviewers might otherwise label as too risky, too early-stage, too controversial, or too far outside mainstream thinking, as long as the idea is scientifically grounded and relevant to NIAMS priorities.

The science scope is disease-focused and translational, centered on musculoskeletal diseases and conditions within the NIAMS mission. Supported studies can include work aimed at understanding disease mechanisms (for example, uncovering biological pathways driving tissue degeneration, inflammation, pain, impaired healing, or structural failure in musculoskeletal tissues) and work aimed at developing or testing diagnostics, therapeutic candidates, or preventive interventions. However, the program draws a firm line at human testing: it will support development and preclinical evaluation up to, but not including, first-in-human studies. This is reinforced by the label "Clinical Trial Not Allowed," meaning the FOA is not intended to fund clinical trials, and applicants should avoid proposing trial-like human studies under this mechanism.

The funding mechanism uses the NIH R61/R33 phased innovation structure. The R61 phase is generally intended as an early, milestone-driven stage that allows investigators to establish feasibility, generate critical proof-of-concept data, or de-risk a high-uncertainty idea. If the R61 milestones are met, the project can transition to the R33 phase, which is typically used to expand, validate, and further develop the concept in a more substantial way. This structure is meant to make it easier to support high-risk, high-reward translational projects by tying progression to clear, objective benchmarks rather than requiring a fully mature dataset at the start.

Eligibility is broad across U.S.-based organizations and includes many types of applicants commonly allowed in NIH programs: state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; tribal organizations other than federally recognized tribal governments; nonprofits with or without 501(c)(3) status (outside of higher education); for-profit organizations other than small businesses; small businesses; and other eligible entities. The FOA also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. At the same time, it is restrictive regarding foreign involvement: non-U.S. entities (foreign organizations or foreign institutions) are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed.

Administratively, this is a discretionary grant opportunity in the health category (CFDA 93.846). The funding opportunity number is RFA-AR-19-013, and the opportunity was created on 2018-07-20 with an original closing date of 2020-01-09. The posted information does not specify an award ceiling or the expected number of awards in the provided excerpt, so applicants would typically need to consult the full FOA or NIH Grants.gov posting for budget limits, project period details, and any institute-specific expectations about milestones, allowable costs, or review considerations.

Overall, the program is best suited for teams pursuing musculoskeletal translational ideas that could meaningfully change thinking or practice but currently lack the conventional level of preliminary evidence required for more standard mechanisms. Competitive applications would generally be expected to articulate why the concept is transformative, why it is genuinely high-risk yet testable, how the work fits NIAMS mission areas, and what concrete milestones will demonstrate success in the R61 phase and justify transition to the R33 phase, all while staying clearly on the preclinical or non-trial side of human research.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Research Innovations for Scientific Knowledge (RISK) for Musculoskeletal Diseases (R61/R33 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.846.
• This funding opportunity was created on 2018-07-20.
• Applicants must submit their applications by 2020-01-09. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA AR 19 013

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