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.Apply for PA 18 500
- 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.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Frequently Asked Questions (FAQs): Human Subjects Mechanistic and Minimal Risk Studies (PA-18-500)
What is the PA-18-500 funding opportunity?
PA-18-500, titled "Human Subjects Mechanistic and Minimal Risk Studies," is an NIH funding opportunity from the National Eye Institute (NEI). It supports early-stage, exploratory research on the visual system using the R21 grant mechanism, with an emphasis on well-justified, targeted studies in humans that advance understanding of vision in health and disease.
Which NIH institute is offering this grant?
This opportunity is offered by the National Eye Institute (NEI), a component of the National Institutes of Health (NIH).
What type of grant mechanism is used?
The program uses the R21 mechanism, which is generally intended for innovative, exploratory projects that may produce preliminary data or proof-of-concept findings rather than large, definitive clinical outcome trials.
What is the main purpose of this R21 opportunity?
The primary goal is to encourage studies that improve understanding of how human vision works in both health and disease, while keeping projects smaller in scope, shorter in duration, and more targeted than large or complex clinical trials.
What kinds of human studies are supported under this opportunity?
Two broad project types are supported: (1) human subjects research that does not meet the NIH definition of a clinical trial, and (2) NIH-defined clinical trials only if they fit within specific allowable categories (mechanistic clinical trials or minimal risk intervention studies).
Does this FOA allow NIH-defined clinical trials?
Yes, but only a subset. NIH-defined clinical trials are permitted only when they qualify as either a mechanistic clinical trial or a minimal risk intervention study as described in the opportunity information.
What is considered a mechanistic clinical trial in this program?
In this context, a mechanistic clinical trial is designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention, rather than primarily to test clinical efficacy outcomes in a large, definitive way.
What is considered a minimal risk intervention study?
A minimal risk study is one in which the expected probability and magnitude of harm or discomfort are no greater than what people ordinarily encounter in daily life or during routine physical or psychological examinations or tests.
Are NIH-defined clinical trials that are not mechanistic or minimal risk allowed?
No. A key eligibility boundary stated in the opportunity is that NIH-defined clinical trials that are neither mechanistic nor minimal risk are not allowed under this FOA.
What types of projects are explicitly out of scope for PA-18-500?
The opportunity indicates that large-scale clinical trials, gene-transfer trials, stem cell therapy trials, and other studies that are complex, highly resource-intensive, or that raise substantial safety concerns are considered inappropriate for this program.
Is this program intended to fund large, complex clinical outcome trials?
No. The R21 scope described here is oriented toward exploratory, early-stage work rather than fully powered, definitive clinical outcome trials or large, complex clinical trial efforts.
Why does the FOA encourage contacting NEI program staff before submitting?
Because clinical trial classification and eligibility can be nuanced, applicants are strongly encouraged to contact NEI program staff before submission, particularly for applications involving human subjects, to confirm that the project fits the appropriate funding path and is within scope.
What is the CFDA number and category for this grant?
The opportunity is listed as a discretionary grant in the health category under CFDA 93.867.
What is the listed award ceiling?
The award ceiling listed in the provided information is $200,000.
What is the closing date shown in the source information?
The original closing date shown is January 7, 2021.
When was the FOA record created according to the provided information?
The FOA record indicates a creation date of December 15, 2017.
Who is eligible to apply?
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.
Are minority-serving and mission-focused institutions eligible?
Yes. The FOA explicitly highlights eligibility for institutions and organizations including 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), and faith-based or community-based organizations.
Are federal agencies, regional organizations, and U.S. territories eligible?
Yes. The eligibility list explicitly includes certain federal government agencies, regional organizations, and U.S. territories or possessions.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. The FOA explicitly includes non-U.S. entities (foreign organizations) among eligible applicants.
Does this opportunity focus only on eye diseases, or also normal vision?
Based on the provided description, the program aims to improve understanding of how human vision works in both health and disease, so it can support studies relevant to normal visual function as well as vision-related disease processes, as long as the work fits the mechanistic and/or minimal-risk boundaries described.
What is the key compliance issue applicants should watch for?
The most important boundary described is whether a proposed human study is an NIH-defined clinical trial, and if so, whether it is specifically a mechanistic clinical trial or a minimal risk intervention study. Clinical trials outside those categories are not allowed under this FOA.
Browse more opportunities from the same category: Health
Next opportunity: NEI Academic Research Enhancement Award for Mechanistic and Minimal Risk Human Subjects' Research (R15 Clinical Trial Optional)
Previous opportunity: 2017 RSVP Expansion Notice of Funding Opportunity
Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for PA 18 500
Applicants also applied for:
Applicants who have applied for this opportunity (PA 18 500) also looked into and applied for these:
| Funding Opportunity |
|---|
| Discovery and Biological Signatures of Diet Derived Microbial Metabolites (R01 Clinical Trial Optional) Apply for RFA AT 18 003 Funding Number: RFA AT 18 003 Agency: National Institutes of Health Category: Health Funding Amount: $250,000 |
| Alzheimer's Clinical Trials Consortium (ACTC) Clinical Trials (R01 Clinical Trial Required) Apply for PAR 18 513 Funding Number: PAR 18 513 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Health-professional Education Partnership Initiative (HEPI) (R25 Clinical Trial Not Allowed) Apply for RFA TW 17 001 Funding Number: RFA TW 17 001 Agency: National Institutes of Health Category: Health Funding Amount: $600,000 |
| Effects of In Utero Alcohol Exposure on Adult Health and Disease (R01 - Clinical Trial Optional) Apply for PA 18 507 Funding Number: PA 18 507 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Consequences of amyloid protein polymorphisms in Alzheimer's disease (R01 - Clinical Trial Not Allowed) Apply for RFA AG 18 025 Funding Number: RFA AG 18 025 Agency: National Institutes of Health Category: Health Funding Amount: $500,000 |
| NEI Collaborative Clinical Vision Project: Resource Center Grant (UG1- Clinical Trial Required) Apply for PAR 18 522 Funding Number: PAR 18 522 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Effects of In Utero Alcohol Exposure on Adult Health and Disease (R21 - Clinical Trial Optional) Apply for PA 18 508 Funding Number: PA 18 508 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| CREATE Bio Development Track: Preclinical and Early-Phase Clinical Development for Biologics (U44 SBIR- Clinical Trial Optional) Apply for PAR 18 543 Funding Number: PAR 18 543 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Clinical Trial Readiness for Rare Neurological and Neuromuscular Diseases (U01) Apply for PAR 18 534 Funding Number: PAR 18 534 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Human Cell Biology of Alzheimer's Disease Genetic Variants (R01 - Clinical Trial Not Allowed) Apply for PAR 18 516 Funding Number: PAR 18 516 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NEI Collaborative Clinical Vision Research Project: Coordinating Center Grant (UG1 Clinical Trial Required) Apply for PAR 18 521 Funding Number: PAR 18 521 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Radiological/Nuclear Medical Countermeasure Product Development Program (SBIR) (R43/R44 Clinical Trial Not Allowed) Apply for PA 18 525 Funding Number: PA 18 525 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NEI Collaborative Clinical Vision Research : Chair's Grant (UG1-Clinical Trial Required) Apply for PAR 18 523 Funding Number: PAR 18 523 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Sensory and motor system changes as predictors of preclinical Alzheimers disease (R01 - Clinical Trial Not Allowed) Apply for PAR 18 519 Funding Number: PAR 18 519 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NINDS CREATE Bio Development Track: Preclinical Development for Biotechnology Products and Biologics (U01 - Clinical Trial Optional) Apply for PAR 18 542 Funding Number: PAR 18 542 Agency: National Institutes of Health Category: Health Funding Amount: $1,500,000 |
| NeuroNEXT Clinical Trials (U01 - Clinical Trial Optional) Apply for PAR 18 528 Funding Number: PAR 18 528 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NIDCD Research Grants for Translating Basic Research into Clinical Tools (R01- Clinical Trials Optional) Apply for PAR 18 533 Funding Number: PAR 18 533 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Understanding the Effects of ApoE2 on the Interaction between Aging and Alzheimers Disease (R01 - Clinical Trial Not Allowed) Apply for RFA AG 18 022 Funding Number: RFA AG 18 022 Agency: National Institutes of Health Category: Health Funding Amount: $500,000 |
| Institutional Training Programs to Advance Translational Research on Alzheimer's Disease and AD Related Dementias (T32 - Clinical Trial Not Allowed) Apply for PAR 18 524 Funding Number: PAR 18 524 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NIDCR Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3) - Clinical Trial Required Apply for PAR 18 547 Funding Number: PAR 18 547 Agency: National Institutes of Health Category: Health Funding Amount: $400,000 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Inside Our Applicants Portal
Access Applicants Portal
- Grants Repository - Access current and historic funding opportunities with ease. Thousands of funding opportunities are published every week. We can help you sort through the database and find the eligible ones to apply for.
- Applicant Video Guides - The grant application process can be challenging to follow. We can help you with intuitive video guides to speed up the process and eliminate errors in submissions.
- Grant Proposal Wizard - We have developed a network of private funding organizations and investors across the United States. We can reach out and submit your proposal to these contacts to maximize your chances of getting the funding you need.
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Learn More
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "PA 18 500", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.