Human Subjects Mechanistic and Minimal Risk Studies (R21 Clinical Trial Optional) | PA 18 500

Opportunity Information: Apply for PA 18 500

The Human Subjects Mechanistic and Minimal Risk Studies funding opportunity (PA-18-500) is an NIH grant program from the National Eye Institute that supports early-stage, exploratory research on the visual system using the R21 mechanism. The main goal is to encourage studies that improve understanding of how human vision works in both health and disease, while keeping the scope appropriate for smaller, shorter, and more targeted projects rather than large, complex clinical trials.

This opportunity allows two broad types of projects. First, it supports human subjects research that does not meet the NIH definition of a clinical trial (as referenced in NIH guidance such as NOT-OD-15-015). Second, it also allows NIH-defined clinical trials, but only when those trials fit into one of two specific categories: mechanistic clinical trials or minimal risk intervention studies. In this context, a mechanistic trial is one designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. A minimal risk study is one in which the expected probability and magnitude of harm or discomfort are no greater than what people typically encounter in everyday life or during routine physical or psychological exams or tests.

A key eligibility boundary is that NIH-defined clinical trials that are neither mechanistic nor minimal risk are not allowed under this FOA. The announcement also makes clear what is out of scope: large-scale clinical trials, gene-transfer trials, stem cell therapy trials, and other studies that are complex, highly resource-intensive, or raise substantial safety concerns are considered inappropriate for this program. Because the clinical trial classification and eligibility rules can be nuanced, applicants are strongly encouraged to contact NEI program staff before submitting, especially if the application involves human subjects, to confirm that the project fits the right funding path.

From an administrative standpoint, this is a discretionary grant in the health category (CFDA 93.867) with an award ceiling listed as $200,000. The original closing date shown in the source data is January 7, 2021, and the FOA record indicates a creation date of December 15, 2017. As an R21, the intent is generally to support innovative, exploratory projects that may generate key preliminary data or proof-of-concept results, rather than fully powered, definitive clinical outcome trials.

Eligibility is broad and includes many types of U.S. organizations such as state, county, city, township, and special district governments; independent school districts; public and state-controlled universities; private universities; federally recognized tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than higher education institutions); for-profit organizations (other than small businesses); and small businesses. The FOA also explicitly highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, certain federal government agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations). Overall, the program is aimed at enabling a wide range of institutions to conduct well-justified, carefully designed human subjects studies that advance vision science while staying within mechanistic and/or minimal-risk boundaries.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Human Subjects Mechanistic and Minimal Risk Studies (R21 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.867.
• This funding opportunity was created on 2017-12-15.
• Applicants must submit their applications by 2021-01-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $200,000.00 in funding.
• 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 PA 18 500

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