NEI Collaborative Clinical Vision Project: Resource Center Grant (UG1- Clinical Trial Required) | PAR 18 522

FAQs: NEI Collaborative Clinical Vision Project: Resource Center Grant (UG1 - Clinical Trial Required) (PAR-18-522)

What is this funding opportunity?

This is a National Institutes of Health (NIH) funding opportunity from the National Eye Institute (NEI) titled the "NEI Collaborative Clinical Vision Project: Resource Center Grant (UG1 - Clinical Trial Required)." It supports the specialized infrastructure and centralized services needed to carry out large, complex, and higher-risk clinical trials focused on vision.

What does "UG1 - Clinical Trial Required" mean here?

UG1 is a cooperative agreement mechanism and, for this opportunity, the proposed project must be a clinical trial. The trial must be intended to evaluate an intervention related to vision disorders.

Is a clinical trial mandatory for this application?

Yes. A central feature of this opportunity is that the proposed project must be a clinical trial intended to evaluate an intervention related to vision disorders.

What types of interventions can the clinical trial evaluate?

The clinical trial can evaluate interventions related to screening, diagnosing, preventing, or treating eye and vision conditions. It may also include studies comparing the effectiveness of two or more established interventions.

What kinds of clinical trials does NEI emphasize under this UG1 structure?

NEI emphasizes large-scale, multi-center clinical trials and advanced trials where safety monitoring and clear operational responsibilities are critical. Examples called out include human gene-transfer studies and stem cell therapy studies.

What is the main purpose of the Resource Center Grant?

The Resource Center Grant is meant to provide essential centralized services that enable consistent implementation of the clinical trial across multiple clinical sites. Examples include imaging support, laboratory services, and other specialized centralized capabilities required for the study.

How does the Resource Center fit into the broader NEI "linked award" structure?

This FOA focuses on the Resource Center component of a broader, linked award structure commonly used for major collaborative clinical vision studies. NEI often expects companion applications/awards that function together as one overall project, typically including: (1) a Chairs Grant (leadership/scientific direction), (2) a Coordinating Center (data management, statistical oversight, operations, logistics), and (3) one or more Resource Centers providing specialized centralized services.

Is a Resource Center always required, or can its functions be included elsewhere?

NEI notes that for less organizationally complex projects, some functions (such as data management, statistical analyses, resource-center-like work, or recruitment activities) might be folded into the Chairs Grant application. However, this FOA is explicitly encouraging applications for the standalone Resource Center role when the study demands specialized centralized services.

What makes this a "cooperative agreement," and why does that matter?

This is a UG1 cooperative agreement, meaning NEI expects substantial involvement in the project beyond typical grant stewardship. In practical terms, applications should anticipate active NEI participation in areas such as coordination, oversight, monitoring, and governance expectations.

What management and oversight expectations are highlighted?

The opportunity stresses careful coordination, rigorous oversight, and active monitoring, especially for trials with elevated safety considerations, high resource demands, or multi-site complexity. Applicants should clearly describe organization and management, including concrete delineation of roles and responsibilities among the Chair, Coordinating Center, and Resource Center(s).

What are examples of Resource Center services that may be supported?

Examples referenced include imaging support and laboratory services. The description also points to capabilities such as standardized imaging acquisition and reading, assay processing and biospecimen handling, specialized testing, certification and training, quality assurance, and harmonized protocols to ensure consistency across sites.

Why does NEI want centralized Resource Center services for certain trials?

The goal is to ensure complex vision clinical trials are conducted with consistent methods across sites, strong quality control, and the level of oversight needed to protect participants and produce credible, high-impact results.

What kinds of studies are a strong fit for a Resource Center approach?

This FOA is positioned for large, complex, and higher-risk clinical trials where careful coordination, rigorous oversight, and active monitoring are essential, including multi-center trials and advanced intervention trials (such as gene-transfer or stem cell therapy studies) with heightened safety monitoring needs.

Who is eligible to apply?

Eligibility is broad and includes many types of applicants such as domestic governmental entities (state, county, city/township, special district), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, federally recognized Native American tribal governments, tribal organizations that are not federally recognized governments, public housing authorities/Indian housing authorities, nonprofits with and without 501(c)(3) status (other than higher education institutions), for-profit organizations (other than small businesses), and small businesses.

Are organizations serving historically underrepresented communities mentioned as eligible?

Yes. The FOA highlights eligibility for organizations 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), and Tribally Controlled Colleges and Universities (TCCUs), as well as faith-based or community-based organizations.

Are non-U.S. organizations eligible?

Yes. The FOA explicitly lists non-U.S. entities (foreign organizations) and U.S. territories or possessions among eligible applicants.

Is this opportunity considered discretionary funding, and what is the activity category?

Yes. Administratively, it is listed as discretionary funding. It uses a cooperative agreement funding instrument and is within the health activity category.

What is the CFDA number associated with this opportunity?

The opportunity is associated with CFDA 93.867.

What is the funding opportunity number?

The funding opportunity number is PAR-18-522.

What are the listed key dates in the summary provided?

The summary indicates it was created on 2017-12-20, and the original closing date listed is 2020-11-18.

Does the provided summary list an award ceiling or the expected number of awards?

No. The public summary provided does not specify an award ceiling or an expected number of awards.

If award size and number of awards are not specified here, where would applicants usually look?

Based on the summary, applicants would typically need to consult the full FOA text and any related notices for budget guidance, scope expectations, and information on how many Resource Centers NEI anticipates supporting for a given trial program.

What should a competitive Resource Center application explain about the need for centralized services?

A competitive application would be expected to justify why centralized services are necessary for the proposed multi-center or high-risk trial and how those services will support consistent implementation across sites.

What should applicants describe about integration with the rest of the trial structure?

Applicants should describe how the Resource Center will integrate operationally with study leadership (Chair) and the Coordinating Center, including clear roles and responsibilities and how performance oversight, quality control, and safety monitoring expectations will be met.

What is the overarching goal of this Resource Center funding?

The overarching goal is to enable complex vision clinical trials to run with consistent methods across sites, robust quality control, strong operational accountability, and appropriate oversight to protect participants and support credible results.