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Grant Analysis

Purpose & Target

This grant, the 'NEI Collaborative Clinical Vision Research Project: Coordinating Center Grant (UG1 Clinical Trial Required)', aims to support organizations establishing a Coordinating Center for investigator-initiated large-scale clinical trials focused on vision disorders.
The target recipients are organizations that can provide scientific and technical leadership for trial statistical and data management activities, and oversee other investigators conducting the study.
This is a SECTOR-SPECIFIC grant, specifically targeting clinical research in vision.
Geographic scope is broadly defined, welcoming applications from U.S. and foreign institutions.
Key filtering criteria include the requirement for the proposed project to be a clinical trial, involve complex or high-risk studies, and focus on interventions for vision disorders.
This is a recurring grant opportunity, indicated by its reissuance (Reissue of PAR-21-042) and multiple submission cycles.

Financial Structure

Budget Range and Limitations: Application budgets are not limited but must reflect the actual needs of the proposed project.
Grant Duration: The maximum project period is five years.
Eligible Costs: Not explicitly detailed, but implied to cover costs associated with conducting large-scale clinical trials, including statistical and data management, oversight, and potentially laboratory work for study product (manufacture, repackaging, distribution, quality assurance, participant safety).
Ineligible Costs: Not explicitly detailed, but certain activities are non-responsive (e.g., preclinical studies, basic experimental studies with humans).
Matching Fund Requirements: No cost sharing is required.
Indirect Cost Policies: Not specified, but standard NIH indirect cost policies would apply.
Financial Reporting: Recipients are required to submit an annual Research Performance Progress Report (RPPR) and financial statements as required by the NIH Grants Policy Statement. A final RPPR, invention statement, and expenditure data are required for closeout.

Eligibility Requirements

Organizational Eligibility

Eligible Organization Types: Higher Education Institutions (Public/State Controlled, Private), Nonprofits (with or without 501(c)(3) IRS Status), For-Profit Organizations (Small Businesses, Other For-Profit Organizations), Local Governments (State, County, City or Township, Special District, Indian/Native American Tribal Governments), Federal Government (Eligible Agencies, U.S. Territory or Possession), and Other (Independent School Districts, Public Housing Authorities/Indian Housing Authorities, Native American Tribal Organizations, Faith-based or Community-based Organizations, Regional Organizations, Non-domestic (non-U.S.) Entities/Foreign Institutions).
Required Registrations: Applicants must complete and maintain active registrations with:
System for Award Management (SAM), renewed at least annually. Foreign organizations need a NATO Commercial and Government Entity (NCAGE) Code to register in SAM.
Unique Entity Identifier (UEI) obtained through SAM.gov.
eRA Commons, requiring at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
Grants.gov (requires active SAM registration).
Geographic Location: Open to U.S. entities and Non-domestic (non-U.S.) Entities (Foreign Institutions) and non-domestic components of U.S. organizations. Foreign components are allowed.

Project Specific Requirements

Clinical Trial Requirement: Only applications proposing NIH-defined clinical trial(s) are accepted.
Scope of Project: Must evaluate interventions for screening, diagnosing, preventing, or treating vision disorders, or compare effectiveness of two or more established interventions.
Complexity: Projects must be complex or involve high resource- or safety-risk.

Exclusion Criteria

Applications proposing activities not directly intended to evaluate screening, diagnostic, preventative, or therapeutic interventions, or compare effectiveness of established interventions.
Applications that are not complex or of high resource- or safety-risk.
Preclinical, developmental, or preparatory studies for gene transfer and stem cell therapy.
NIH-defined clinical trial applications proposing basic experimental studies with humans (BESH) and/or minimal risk studies.

Application Process

Application Forms: The application forms package must be accessed through NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system (S2S) solution.
Submission Method: Applications must be submitted electronically through Grants.gov and tracked in eRA Commons. Paper applications are not accepted.
Pre-submission Requirement: Applicants requesting $500,000 or more in direct costs in any single year (excluding consortium F&A) must contact a Scientific/Research Contact at least 6 weeks prior to submission.

Submission Deadlines

Applications are accepted on multiple recurring deadlines throughout the year. The latest application due date for the specified cycles is January 25, 2026, by 5:00 PM local time of the applicant organization.
Early submission is encouraged to allow for corrections. Applications submitted after the deadline will be considered late.
If a submission date falls on a weekend or Federal holiday, the deadline is automatically extended to the next business day.

Required Documentation and Materials

Standard Forms: Applicants must follow instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, including SF424(R&R) Cover, Project/Performance Site Locations, Senior/Key Person Profile, R&R Budget, R&R Subaward Budget, PHS 398 Cover Page Supplement, PHS 398 Research Plan, PHS Human Subjects and Clinical Trials Information, and PHS Assignment Request Form.
Required Attachments (Specific to this NOFO):
Statistical Analysis Plan (SAP): Must describe study outcome measures, estimates of treatment effect, power, sample size justification, methods for primary outcome analysis, and plans for interim/final analyses. File name: 'Statistical Analysis Plan.pdf'.
Data Handling, Quality Assurance, and Monitoring Plans: Details on data collection/management, quality assurance, monitoring processes (data entry, storage, security, personnel training, on-site/off-site monitoring, participant safety monitoring, data confidentiality, privacy). File name: 'DataHandling.pdf'. This is distinct from the NIH Data Management and Sharing (DMS) Plan.
Clinical Center Information: Describes Coordinating Center's plans for identifying, engaging, and overseeing investigators, including participant availability, recruitment/retention plans, facilities, team qualifications, and collaboration with other centers. File name: 'ClinicalCenter.pdf'.
Clinical Center Table (if applicable): For entities issuing clinical enrollment center subcontracts, a list of institutions and PIs with Federal Wide Assurance (FWA) numbers. File name: 'ClinicalCenterTable.pdf'.
Research Plan Components:
Specific Aims: Overview of study, Coordinating Center's roles, data management/statistical considerations, leadership, and administration.
Research Strategy: Discussion of trial coordination/administration, data management, biostatistical support, and results dissemination.
Resource Sharing Plan: Plans for supporting timely publication and dissemination of study findings.
Other Plan(s): Data Management and Sharing Plan (DMS Plan) for scientific data generation.
Appendix: Limited materials allowed (blank questionnaires, surveys only; no publications).
Letters of Support: Required from institutions with a key role in the study.

Post-Award Requirements

Reporting: Annual Research Performance Progress Report (RPPR), financial statements, and a final RPPR for closeout. Compliance with NIH policies and DMS Plan is reported in RPPR.
ClinicalTrials.gov Registration and Reporting: Required for applicable clinical trials.
IRB/IEC Approval: Protocols must be reviewed by the institution's IRB or Independent Ethics Committee.
Data and Safety Monitoring: Compliance with NIH policy for oversight and monitoring of human biomedical/behavioral intervention studies.
IND/IDE Requirements: Compliance for projects involving investigational therapeutics, vaccines, or medical interventions.

Evaluation Criteria

Scored Review Criteria

Overall Impact: Assesses the likelihood of the project to significantly influence the research field.
Significance:
Addresses an important problem or barrier in the field.
Rationale for clinical trial is well-supported by preliminary data or literature.
Necessity of the clinical trial for advancing scientific understanding or changing clinical practice.
Specific to this NOFO: Likelihood of the Coordinating Center to provide scientific/technical leadership for statistical and data management, and appropriate scope of proposed activities.
Investigator(s):
Expertise, experience, and ability of PD(s)/PI(s), collaborators, and key personnel to organize, manage, and implement the clinical trial.
Appropriate expertise in study coordination, data management, and statistics.
For multicenter trials, suitability of organizational structure and identification of potential center investigators/staffing.
Innovation:
Challenges current paradigms with novel concepts, approaches, methodologies, instrumentation, or interventions.
Design/research plan includes innovative elements enhancing sensitivity or potential to advance knowledge.
Approach:
Overall strategy, methodology, and analyses are well-reasoned and appropriate.
Plans to address weaknesses in prior research and ensure robust, unbiased approaches.
Presentation of potential problems, alternative strategies, and benchmarks.
Plans for addressing relevant biological variables (e.g., sex) in human/animal subjects.
Study Design: Justified and appropriate design to address outcome variables, adequate power/sample size, ethical considerations, recruitment/retention plans, and adherence monitoring.
Data Management and Statistical Analysis: Appropriate plans for data management, quality control, and statistical approach, including Statistical Analysis Plan (SAP) and Data Handling, Quality Assurance, and Monitoring Plan.
Environment:
Scientific environment, institutional support, equipment, and physical resources are adequate and contribute to success.
Appropriateness of administrative, data coordinating, enrollment, and laboratory/testing centers.
Capability to conduct trial at proposed sites, and plans for adding/dropping enrollment centers.

Additional Review Criteria (Not Scored)

Study Timeline: Detailed, feasible, and justified timeline including start-up, enrollment, and follow-up. Incorporates efficiencies and addresses potential challenges.
Protections for Human Subjects: Justification for involvement, adequacy of protection against risks, potential benefits, importance of knowledge, and data/safety monitoring.
Inclusion of Women, Racial and Ethnic Minorities, and Individuals Across the Lifespan: Justification for inclusion/exclusion plans based on scientific goals.
Vertebrate Animals (if applicable): Justification for use, minimization of discomfort, and euthanasia methods.
Biohazards (if applicable): Adequacy of proposed protection against potential hazards.
Resubmissions: Evaluation of responses to previous comments and evident changes.
Renewals: Consideration of progress made in the last funding period.
Revisions: Appropriateness of proposed expansion of scope.
Applications from Foreign Organizations: Assessment of special opportunities for furthering research through unique talent, resources, populations, or environmental conditions not readily available in the U.S. or augmenting U.S. resources.
Select Agent Research (if applicable): Information on select agents, registration, monitoring, biosafety, and security.
Resource Sharing Plans: Reasonableness of sharing plans or rationale for not sharing.
Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring validity of resources.
Budget and Period of Support: Justification and reasonableness of budget and requested support period.

Compliance & Special Requirements

Regulatory Compliance

General Compliance: All NIH awards are subject to the NIH Grants Policy Statement, including federal-wide research terms and conditions, prohibition on certain telecommunications equipment, and acknowledgment of federal funding.
Civil Rights Compliance: Recipients of Federal financial assistance from HHS must comply with federal civil rights laws prohibiting discrimination based on race, color, national origin, age, sex, and disability. This includes providing access for limited English proficient individuals and effective communication for persons with disabilities.
Labor Standards: HHS funded health and education programs must be administered in an environment free of sexual harassment.
Conscience Protection: Compliance with federal religious nondiscrimination laws and conscience protection laws.
FAPIIS (Federal Awardee Performance and Integrity Information System): NIH awards are subject to FAPIIS requirements, allowing review of an applicant's integrity and performance record.
Transparency Act: Recipients of Federal grants report information about first-tier subawards over $25,000 to FSRS (Federal Subaward Reporting System).

Data and IP

Data Management and Sharing Policy (DMS Policy): All applicants generating scientific data must comply with the NIH DMS Policy. An approved DMS Plan must be implemented, and progress reported annually. NEI generally does not endorse specific repositories.
Intellectual Property: Recipient institutions retain custody and primary rights to data and software developed under the award, subject to Government rights of access.