Pre-Application: Research Innovation for Scientific Knowledge (RISK) for Skin and Rheumatic Diseases (X02 Clinical Trial Not Allowed) | PAR 18 866

Opportunity Information: Apply for PAR 18 866

The grant opportunity titled "Pre-Application: Research Innovation for Scientific Knowledge (RISK) for Skin and Rheumatic Diseases (X02 Clinical Trial Not Allowed)" is an NIH (NIAMS) funding announcement designed to surface bold, unconventional ideas in skin and rheumatic disease research that often struggle to compete in traditional NIH mechanisms. The central theme is high-risk, high-reward science that challenges prevailing assumptions or standard practice. NIAMS is explicitly looking for proposals built around unusual observations, imaginative hypotheses, creative concepts, or new paradigms that could reshape understanding in areas within the NIAMS mission, even if the ideas seem premature, controversial, or not yet fully supported by extensive preliminary data. The intent is to encourage investigators to take scientific chances where the payoff could be substantial, rather than rewarding only incremental advances.

The scientific scope is disease-focused and translational, meaning applicants are expected to connect their work to specific skin or rheumatic diseases or conditions relevant to NIAMS. The announcement invites studies that dig into underlying mechanisms of disease, including biological pathways and processes that drive onset, progression, or severity. In addition, it welcomes projects aimed at developing or testing diagnostics, therapeutic agents, or preventive interventions, with an important boundary: work may progress up to, but not including, first-in-human studies. This places the emphasis on preclinical and translational research stages such as target validation, proof-of-concept experiments, biomarker development, assay development, prototype diagnostic testing, and preclinical evaluation of candidate therapeutics or prevention strategies. At the same time, the announcement clearly states that the RISK R61/R33 program is not intended to support clinical trials, and the specific listing here is marked "Clinical Trial Not Allowed," reinforcing that human interventional clinical trial activity is outside the allowed scope.

Administratively, this is a discretionary grant opportunity from the National Institutes of Health under CFDA 93.846, categorized under health-related funding activities. The opportunity number is PAR 18 866, and it is presented as a pre-application mechanism (X02). The posted original closing date was 2018-08-10, and the record does not list an award ceiling or expected number of awards in the provided data. Because it is a pre-application, the general expectation is that applicants submit an initial concept or preliminary package for consideration before being invited or guided toward a subsequent full application stage, helping NIAMS identify the most compelling high-risk ideas early and reducing the burden of preparing a full application that may not be aligned with program goals.

Eligibility is broad across U.S.-based organizations and governmental entities. Eligible applicants include state, county, city or township governments, special district governments, independent school districts, and federally recognized tribal governments. Higher education institutions are eligible, including public/state-controlled and private institutions of higher education. A wide range of nonprofit entities may apply, both those with and without 501(c)(3) IRS status (when not applying as institutions of higher education). For-profit organizations (other than small businesses) and small businesses are also listed as eligible, along with certain other categories such as public housing authorities/Indian housing authorities and tribal organizations that are not federally recognized tribal governments. The announcement also highlights inclusion of mission-relevant institution types and community-linked organizations, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, 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.

Foreign participation is restricted in a straightforward way: non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply, and foreign components as defined in the NIH Grants Policy Statement are not allowed. In practical terms, that means the applicant organization must be U.S.-based and the proposed work cannot include a foreign component as NIH defines it, which limits the ability to place substantive project elements or performance sites outside the United States under this funding opportunity.

Overall, this opportunity is best suited for teams proposing ambitious, mechanism-driven or translationally oriented research in skin and rheumatic diseases where the core idea is genuinely novel and carries real uncertainty, but is still anchored to a clear disease relevance and a credible path toward generating decisive evidence. It is not meant for clinical trial execution, and it is not meant for conventional, incremental projects; it is meant for researchers prepared to test a daring idea with the potential to open new directions for diagnosis, prevention, or treatment prior to any first-in-human step.

• 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 Skin and Rheumatic 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 2018-07-23.
• 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 18 866

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