Pre-Application: Research Innovation for Scientific Knowledge (RISK) for Skin and Rheumatic Diseases (X02 Clinical Trial Not Allowed) | PAR 18 899

Opportunity Information: Apply for PAR 18 899

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), part of the National Institutes of Health (NIH), offered this grant opportunity as a pre-application pathway called the Research Innovation for Scientific Knowledge (RISK) for Skin and Rheumatic Diseases. The core idea is to create space for high-risk, high-reward research that sits outside mainstream thinking in the skin and rheumatic disease fields. NIAMS is explicitly looking for proposals that start from unusual observations, challenge prevailing assumptions, and test bold or unconventional hypotheses that might be seen as too early, too speculative, or too controversial for more traditional NIH funding mechanisms. The opportunity is framed as a way to seed ideas that could reshape how these diseases are understood or approached, especially when the work is exploratory but still grounded in a plausible scientific rationale.

This specific mechanism is an X02 pre-application (Funding Opportunity Number PAR 18 899). It is described as a strongly encouraged first step, rather than a strict requirement, for the companion full application program using the R61/R33 mechanism (referenced as RFA-AR-19-012). In practice, the X02 functions like a screening and feedback gate: investigators submit a concise pre-application, and NIAMS identifies the projects that best fit the RISK program goals. Applicants whose X02 submissions are judged to be both highly innovative and closely aligned with NIAMS priorities are then notified that they have the opportunity to submit a full R61/R33 application under the companion announcement. The point of this structure is to focus full applications on ideas NIAMS sees as truly transformative and mission-relevant, reducing wasted effort on long applications that do not match the program intent.

Scientifically, the program emphasizes disease-focused translational studies within the NIAMS mission area, specifically for skin and rheumatic diseases under this X02. NIAMS signals interest in projects that either (1) deepen mechanistic understanding of diseases or conditions relevant to its mission, or (2) develop and/or test diagnostics, therapeutic agents, or preventive interventions, but only up to the stage before first-in-human work. That boundary is important: this program is not intended to support clinical trials, and it does not support first-in-human studies. The announcement repeatedly clarifies that both the RISK X02 and the companion R61/R33 are "clinical trial not allowed," meaning applicants need to keep the work in preclinical, mechanistic, or non-trial translational territory rather than interventional studies in people.

In terms of who can apply, eligibility is broad across typical U.S.-based research and public organizations. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; for-profit organizations other than small businesses; small businesses; and federally recognized Native American tribal governments as well as tribal organizations that are not federally recognized. The announcement also highlights categories of institutions and organizations often called out in federal funding for inclusivity and reach, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), and faith-based or community-based organizations, among others.

At the same time, the FOA places strict limits on foreign involvement. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply. Non-domestic components of U.S. organizations are also not eligible. In addition, foreign components, as defined by the NIH Grants Policy Statement, are not allowed, which effectively prevents structuring the research so that a substantial scientific element is carried out outside the United States under a foreign component arrangement.

From an administrative standpoint, the opportunity is categorized as a discretionary grant in the health area (CFDA number 93.846) under NIH. The original closing date listed for this pre-application was July 3, 2019, and the funding record notes no stated award ceiling and does not specify the expected number of awards in the provided source details. The most important practical takeaway is that this is not a stand-alone clinical research grant but a front-end step in a larger RISK funding pipeline, intended to identify the most compelling, unconventional, and mission-aligned ideas in skin and rheumatic disease research and channel them toward the companion R61/R33 application process.

• 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 2018-08-10.
• Applicants must submit their applications by 2019-07-03. (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 18 899

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: