NEI Collaborative Clinical Vision Project: Resource Center Grant (UG1- Clinical Trial Required) | PAR 21 043

FAQs: NEI Collaborative Clinical Vision Project - Resource Center Grant (UG1 - Clinical Trial Required) (PAR-21-043)

What is this funding opportunity?

This is a National Eye Institute (NEI), National Institutes of Health (NIH) Funding Opportunity Announcement (FOA) PAR-21-043 for the "NEI Collaborative Clinical Vision Project: Resource Center Grant (UG1 - Clinical Trial Required)." It supports a Resource Center that provides centralized, trial-integrated services for major vision-related clinical trials and other demanding clinical studies.

Which NIH Institute is offering this and what is it focused on?

The opportunity is offered by NEI, a part of NIH, and it is focused on clinical trials and complex clinical studies in vision science, particularly those that require strong organization, careful monitoring, and robust patient safety protections.

What award mechanism is used for this opportunity?

The FOA uses the UG1 cooperative agreement mechanism. A cooperative agreement is intended for large, complex, and higher-risk clinical research where NIH staff have substantial involvement in project oversight and coordination.

What does "Clinical Trial Required" mean here?

The proposed work must be a clinical trial (or part of a clinical trial enterprise) intended to evaluate interventions related to vision disorders. This includes interventions aimed at screening, diagnosing, preventing, or treating eye and vision conditions, and may include studies comparing the effectiveness of two or more established interventions.

What types of clinical trials or studies are emphasized?

The FOA highlights investigator-initiated clinical trials and demanding clinical studies in vision science, including large-scale multi-center trials, human gene-transfer trials, stem cell therapy trials, and similarly complex studies.

What is the main purpose of the Resource Center grant?

The Resource Center grant is intended to provide required shared, centralized services that are essential to executing a multi-center or otherwise complex/high-risk clinical trial properly. The goal is to ensure consistency across sites, strong quality control, participant safety protections, and interpretable results.

How is a Resource Center different from a typical core facility?

In this FOA, a Resource Center is described as a backbone unit for a major vision clinical trial. It is not simply a supporting lab or imaging core; it is expected to be organized and integrated into the trial, with appropriate staffing, standard operating procedures (SOPs), quality management, and coordination capacity to produce consistent, auditable, high-quality outputs across participating clinical sites.

What are examples of services a Resource Center might provide?

Examples implied by the FOA include imaging support (such as standardized acquisition, grading, and quality assurance), laboratory services (such as centralized specimen processing, biomarker assays, or specialized testing), and other essential centralized resources that must be consistent across sites.

Why does the FOA emphasize standardization and centralization?

Because the supported trials can be large and multifaceted, centralization and standardization help ensure data quality, protect participant safety, and improve the interpretability and reliability of results across multiple clinical sites and procedures.

What kinds of oversight and monitoring are expected?

The FOA emphasizes clearly defined study organization and roles across the overall trial structure, active performance oversight, and safety monitoring appropriate to the level of risk and complexity. Under the UG1 cooperative agreement, NIH staff are expected to have substantial involvement in oversight and coordination.

Is this FOA for the entire clinical trial or only part of it?

This FOA is specifically oriented toward the Resource Center component of an NEI UG1-supported clinical trial program. It supports the centralized services needed by the broader trial effort rather than serving as a standalone clinical trial award in isolation.

How does NEI typically structure funding for these large collaborative trials?

NEI describes a model where the overall effort may be funded as a set of linked companion awards. These can include: (1) a Chair's Grant to provide scientific leadership, (2) a Coordinating Center to manage operations such as data systems and trial logistics, and (3) one or more Resource Centers when specialized centralized services are needed.

Will every project need separate companion awards for Chair, Coordinating Center, and Resource Center functions?

No. The FOA notes that not every project will need separate companion awards for all functions. For less organizationally complex studies, some functions that might otherwise be handled by a separate Coordinating Center or Resource Center could be included within a Chair's Grant application.

When is a dedicated Resource Center especially important?

This Resource Center FOA is geared toward situations where a dedicated, centralized service unit is necessary to execute the trial properly, especially when the trial spans multiple sites or involves advanced procedures that require standardization and oversight.

Who is eligible to apply?

Eligibility is broad and includes many types of institutions and organizations. The FOA lists eligible applicants such as state/county/city/township and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses) and small businesses; and other entities.

Are specialized institution types and community-based organizations included in eligibility?

Yes. The FOA highlights additional eligible applicant types including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

Are non-U.S. (foreign) organizations eligible?

Yes. The FOA indicates that non-U.S. (foreign) organizations are eligible, signaling openness to specialized expertise or infrastructure outside the United States, provided the applicant can meet NIH requirements and effectively support the clinical trial.

What is the assistance listing (CFDA) number associated with this opportunity?

The opportunity is associated with CFDA/Assistance Listing number 93.867.

What is the activity category?

The FOA is described as a discretionary funding opportunity under the health activity category.

What is the instrument type?

The instrument type is a cooperative agreement, reflecting an expectation of close work with NEI/NIH staff on governance, milestone-based progress, and oversight.

When was this opportunity created and what closing date is shown in the provided information?

The opportunity was created on 2020-11-18, and the original closing date listed in the provided source data is 2023-05-07.

Does the provided information include an award ceiling or expected number of awards?

No. The excerpt provided does not specify an award ceiling or the expected number of awards. Applicants would typically need to consult the full FOA and NIH guidance for budget expectations, project period norms, and anticipated funding levels.

What kinds of interventions can be evaluated under the required clinical trial?

The clinical trial is intended to evaluate interventions related to vision disorders. This includes interventions for screening, diagnosis, prevention, or treatment of eye and vision conditions, and it can also include comparisons of the effectiveness of two or more established interventions.

What is the overall intent of supporting a Resource Center for these trials?

The intent is to ensure that high-stakes vision clinical studies, particularly those involving advanced therapies or elevated safety considerations, have centralized technical capabilities and an oversight structure that helps protect participants and produces reliable, actionable results.