Pre-Application: Research Innovation for Scientific Knowledge (RISK) for Musculoskeletal Diseases (X02 Clinical Trial Not Allowed) | PAR 18 865

Opportunity Information: Apply for PAR 18 865

The Pre-Application: Research Innovation for Scientific Knowledge (RISK) for Musculoskeletal Diseases (X02 Clinical Trial Not Allowed) opportunity (PAR 18-865) is a National Institutes of Health (NIH) funding announcement from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). It is built to pull in bold, unconventional ideas in musculoskeletal research that do not fit comfortably within more traditional NIH grant mechanisms. The core theme is scientific risk: NIAMS is explicitly looking for projects that start from unusual observations, challenge mainstream assumptions, test imaginative hypotheses, and explore creative concepts that could open up entirely new ways of understanding or treating musculoskeletal diseases, even if the approach seems premature, controversial, or not yet fully validated by the field.

The research scope is disease-focused and translational, meaning the work should connect clearly to diseases or conditions within the NIAMS mission and aim to move knowledge toward practical biomedical impact. The announcement invites studies that dig into underlying disease mechanisms, as well as projects that develop or test diagnostics, therapeutic candidates, or preventive interventions. A key boundary is that the work can progress up to, but not including, first-in-human studies. In other words, the opportunity supports preclinical or translational groundwork and development, but it is not meant to fund clinical testing in humans at the initial stage.

Clinical trials are not allowed under this specific announcement. The language emphasizes that the associated RISK R61/R33 funding announcements are not intended to support clinical trials, and this pre-application mechanism is likewise designated “Clinical Trial Not Allowed.” Applicants need to keep the proposed activities firmly outside the clinical trial category and within non-human, preclinical, or other non-clinical translational research domains as appropriate.

In terms of who can apply, eligibility is broad across U.S.-based organizations and includes many types of public and private entities. Eligible applicants listed include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized governments; public housing authorities and Indian housing authorities; nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status (in both cases, other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other eligible entities. The announcement also calls out 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 government agencies, regional organizations, Indian/Native American tribal governments other than federally recognized, and U.S. territories or possessions.

Foreign participation is tightly restricted. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply. Non-domestic components of U.S. organizations are not eligible to apply, and foreign components (as defined by the NIH Grants Policy Statement) are not allowed. Practically, that means the applicant organization must be U.S.-based and the proposed work must not rely on a foreign component structure that NIH would classify as disallowed under this announcement.

Administratively, this is a discretionary grant opportunity in the health funding category (CFDA 93.846) managed by NIH/NIAMS. The source data provided shows an original closing date of 2018-08-10 and a creation date of 2018-07-20. The award ceiling and expected number of awards were not specified in the provided excerpt, so applicants would normally need to consult the full funding announcement and related NIH documentation for budget structure, review criteria, and any phase-based milestones that may apply to the broader RISK program design. Overall, the opportunity is best suited for investigators with high-upside musculoskeletal disease ideas that need targeted support specifically because the concepts are outside the current mainstream, early-stage, or inherently uncertain, while still being grounded in a plausible path toward translational impact.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Pre-Application: Research Innovation for Scientific Knowledge (RISK) for Musculoskeletal Diseases (X02 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 2018-08-10. (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 PAR 18 865

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