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Grant Details

https://www.grants.gov/search-results-detail/348386

Grant Analysis

Purpose & Target

The core objective of this grant is to support investigator-initiated, complex, high-resource, or high-safety-risk clinical trials that evaluate interventions for screening, diagnosing, preventing, or treating vision disorders, or compare the effectiveness of established interventions. This specific Notice of Funding Opportunity (NOFO) focuses on the Chair's Grant, which outlines the scientific rationale, study aims, and overall significance of the research project. - Target recipients: Higher Education Institutions, Nonprofits, For-Profit Organizations (including Small Businesses), Local Governments, Federal Government agencies, and other organizational types including foreign entities. - Size: Open to organizations of various sizes, from small businesses to larger for-profit entities and government agencies. - Sector: SECTOR-SPECIFIC (Healthcare, specifically Vision Research/Ophthalmology). - Geographic scope: United States and Non-U.S. (Foreign Institutions) are eligible. - Key filtering criteria: Must propose an NIH-defined clinical trial focused on vision disorders, and the trial must be complex or involve high resource or safety risks. - Grant frequency: Reissue of a previous opportunity (PAR-21-041), indicating it is a recurring program. - Program context: This Chair's Grant is typically one component of a larger, multi-entity study funded through NEI's UG1 cooperative agreement awards, often involving companion Coordinating Center and Resource Center grants.

Financial Structure

  • Application budgets are not limited but must reflect the actual needs of the proposed project.
  • The maximum project period for an award is five years.
  • No cost sharing is required for this NOFO.
  • Pre-award costs are allowable as described in the NIH Grants Policy Statement.
  • 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 submitting the application.
  • Currency: USD.

Eligibility Requirements

Organizational Types
  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education
  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)
  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession
  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)
Project Type
  • Must propose a clinical trial as defined by NIH.
  • The proposed study must be intended to evaluate interventions aimed at screening, diagnosing, preventing, or treating vision disorders, or to compare the effectiveness of two or more established interventions.
  • The proposed clinical trial must be complex or of high resource- or safety-risk.
Required Registrations (for applicant organizations)
  • System for Award Management (SAM) with an active registration, requiring annual renewal. Foreign organizations need a NATO Commercial and Government Entity (NCAGE) Code to register in SAM.
  • Unique Entity Identifier (UEI) obtained through the SAM.gov registration process.
  • eRA Commons account, requiring at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account.
  • Grants.gov registration, which requires an active SAM registration.
Eligible Individuals (Program Director/Principal Investigator)
  • Any individual with the skills, knowledge, and resources necessary to carry out the proposed research.
  • Must have an eRA Commons account affiliated with the applicant organization.
  • For multiple PD/PIs, applications must adhere to the Multiple Program Director/Principal Investigator Policy.
Exclusion Criteria
  • Applications for clinical experiments not directly evaluating screening, diagnostic, preventative, or therapeutic interventions, or comparing effectiveness of established interventions.
  • Applications for clinical trials 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 Limits
  • Applicant organizations may submit more than one application, provided each is scientifically distinct.
  • NIH will not accept duplicate or highly overlapping applications under review at the same time.

Application Process

Application Deadlines
  • Multiple application due dates are available; the latest listed application due date is January 25, 2026, by 5:00 PM local time of the applicant organization.
  • Applicants are encouraged to submit early to allow time for error corrections.
  • If a submission date falls on a weekend or Federal holiday, the deadline is automatically extended to the next business day.
  • The expiration date for this NOFO is May 26, 2026.
Submission Process and Platform
  • Applications must be submitted electronically through Grants.gov.
  • The application forms package can be accessed via the NIH ASSIST system, an institutional system-to-system (S2S) solution, or Grants.gov Workspace.
  • Applicants must track the status of their application in the eRA Commons.
  • Errors identified during submission must be corrected, and a changed/corrected application resubmitted by the due date.
Required Documentation and Materials
  • Applicants must strictly follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide and any program-specific instructions detailed in this NOFO.
  • All page limitations must be adhered to.
  • Required Attachments (if applicable):
    • Clinical Protocol: A full clinical protocol, using the FDA and NIH template (Filename: ClinicalProtocol.pdf).
    • Milestone Plan: Detailed project performance and timeline objectives, including completion of start-up activities, enrollment percentages, data collection, analyses, manuscript publication, and data sharing (Filename: MilestonePlan.pdf).
    • Overall Study Organization, Administration, and Procedures: Details on collaborative arrangements, roles, communication lines, and administrative arrangements for regulatory submissions and safety monitoring (Filename: StudyOrganization.pdf).
    • Manual of Procedures (MOP): Comprehensive manual including visit schedules, examination procedures, expected adverse events, and data management details (Filename: MOP.pdf).
    • Interventional Agent(s) or Device(s) Availability (if applicable): Documentation and plans for acquisition and distribution.
    • Statistical Analysis Plan (SAP) (optional): Required only if the Chair UG1 application is not accompanied by a companion Coordinating Center UG1 application. Must detail outcome measures, power, and sample size (Filename: Statistical Analysis Plan.pdf).
    • Clinical Center Table (if applicable): A list of institutions and PIs involved in participant enrollment if the applicant issues subcontracts.
  • Other Key Application Sections:
    • Standard SF424(R&R) forms (Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile, R&R Budget, R&R Subaward Budget).
    • PHS 398 Cover Page Supplement.
    • PHS 398 Research Plan: Including Specific Aims, Research Strategy (covering scientific background, leadership qualifications, coordination, integrity, dissemination), and Letters of Support from key institutions.
    • Resource Sharing Plan: As per SF424 (R&R) Application Guide, with an added focus on timely publication and dissemination.
    • Other Plan(s): A Data Management and Sharing Plan is required for all applications (effective for due dates on or after January 25, 2023).
    • Appendix: Only limited materials allowed (e.g., blank questionnaires/surveys).
    • PHS Human Subjects and Clinical Trials Information: Required if human subjects research is involved.
    • PHS Assignment Request Form.
Pre-Application Requirements
  • For applications requesting $500,000 or more in direct costs in any single year, applicants must contact a Scientific/Research Contact at least 6 weeks prior to submission.
  • Required registrations (SAM, UEI, eRA Commons, Grants.gov) should be initiated at least 6 weeks prior to the submission date to ensure completion.
Post-Submission Materials
  • Applicants can submit a 1-2 page status update document up to 30 days prior to the review meeting (e.g., updates on recruited sites, key personnel, drug/device access, regulatory/IRB approvals).
Project Implementation Timeline & Reporting
  • The maximum project period is five years.
  • An annual Research Performance Progress Report (RPPR) is required.
  • A final RPPR, invention statement, and expenditure data are required for award closeout.
  • Regular reporting on compliance with NIH policies, including ClinicalTrials.gov registration and results submission, relevant personnel trainings, data sharing, and public access.
  • Progress tracking against specified study timelines and milestones (e.g., regulatory approvals, first participant enrollment, ClinicalTrials.gov registration, enrollment completion, follow-up completion, data sharing initiation).
  • Timely implementation of Data and Safety Monitoring Committee (DSMC) recommendations.
  • Prompt notification (within 24 hours) to the NEI program director regarding any FDA regulatory actions or DSMC recommendations to substantively modify or stop the study.
Post-Award Requirements & Compliance
  • Compliance with all terms and conditions outlined in the NIH Grants Policy Statement.
  • Registration and submission of results for applicable clinical trials on ClinicalTrials.gov.
  • Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval required for all protocols, with major changes reported to NIH.
  • Adherence to Data and Safety Monitoring requirements for human biomedical and behavioral intervention studies.
  • Compliance with Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements for clinical research involving investigational therapeutics or devices.
  • Compliance with federal civil rights laws (e.g., anti-discrimination), federal conscience laws, and ensuring meaningful access for limited English proficient individuals and persons with disabilities.

Evaluation Criteria

Overall Impact
  • Reviewers assess the likelihood for the project to exert a sustained, powerful influence on the research field(s).
Scored Review Criteria
  • Significance: Evaluates if the project addresses an important problem, its potential to advance scientific knowledge/clinical practice, and the rigor of prior supporting research. Assesses if the trial is necessary for testing intervention safety/efficacy or advancing scientific understanding.
  • Investigator(s): Examines the suitability, expertise, and experience of the PD(s)/PI(s), collaborators, and other researchers. For collaborative projects, it assesses complementary expertise and appropriate leadership/organizational structure.
  • Innovation: Determines if the application challenges current paradigms through novel concepts, approaches, methodologies, instrumentation, or interventions, or proposes significant refinements/improvements.
  • Approach: Assesses the soundness of the overall strategy, methodology, and analyses. Includes plans to address rigor, ensure unbiased approach, manage risks, and address biological variables (e.g., sex). For human subjects/clinical research, plans for protection and inclusion/exclusion justification are evaluated.
    • Study Design: Evaluates the justification and appropriateness of the study design for clear outcomes, scientific premise, power, and efficiency. Assesses appropriateness of study populations, intervention arms, duration, ethical considerations, recruitment/retention plans, and standardization/quality assurance.
    • Data Management and Statistical Analysis: Reviews appropriateness of planned analyses and statistical approaches, adequacy of data management/quality control procedures, and plans for data analysis completion.
  • Environment: Assesses the scientific environment, institutional support, equipment, and physical resources. Considers if the project benefits from unique features or collaborative arrangements. Evaluates the appropriateness and capability of proposed centers/sites.
Additional Review Criteria (not separately scored, but considered)
  • Study Timeline: Detailed, feasible, and justified timeline, including start-up, enrollment rates, follow-up, efficiencies, and solutions for potential challenges.
  • Protections for Human Subjects: Justification for involvement, proposed protections against risks, potential benefits, importance of knowledge, and data/safety monitoring plans for clinical trials.
  • Inclusion of Women, Racial and Ethnic Minorities, and Individuals Across the Lifespan: Evaluation of proposed plans for inclusion/exclusion based on scientific goals and research strategy.
  • Vertebrate Animals: Justification for use, appropriateness of species, interventions to minimize discomfort, and justification for euthanasia methods.
  • Biohazards: Assessment of potential hazards and proposed protection measures.
  • Resubmissions: Evaluation of responses to previous scientific review comments and changes made to the project.
  • Renewals: Progress made in the last funding period.
  • Revisions: Appropriateness of proposed expansion of scope.
Additional Review Considerations (not scored, but comments provided)
  • Applications from Foreign Organizations: Special opportunities for research advancement through unique talent, resources, populations, or environmental conditions in other countries.
  • Select Agent Research: Information regarding select agents, registration status, monitoring procedures, and biosafety/security plans.
  • Resource Sharing Plans: Reasonableness of the plan or rationale for not sharing resources.
  • 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 the proposed budget and project duration in relation to the research.

Compliance & Special Requirements

Regulatory Compliance
  • Adherence to U.S. Federal Regulations 42 CFR Part 52, 45 CFR Part 75, and 2 CFR Part 200.
  • Compliance with all terms, conditions, and cost principles described in the NIH Grants Policy Statement.
  • Adherence to Federalwide Research Terms and Conditions and prohibition on certain telecommunications and video surveillance services/equipment.
  • Acknowledgment of Federal Funding is required.
  • Completion of HHS Assurance of Compliance form (HHS 690) regarding federal civil rights laws (prohibiting discrimination based on race, color, national origin, age, sex, disability) and federal conscience laws.
  • Requirements to ensure meaningful access for persons with limited English proficiency and effective communication with persons with disabilities.
  • Compliance with federal religious nondiscrimination laws and conscience protection laws.
  • ClinicalTrials.gov registration and results reporting for applicable clinical trials.
  • Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval for all protocols.
  • Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements for clinical research involving investigational agents/devices.
  • Reporting to the Federal Awardee Performance and Integrity Information System (FAPIIS) for awards exceeding $10,000,000.
Data and Security
  • A Data Management and Sharing Plan is required for all applications (effective for due dates on or after January 25, 2023).
  • Approved DMS Plans must be implemented; failure to adhere may result in enforcement actions.
  • NEI encourages selecting the most appropriate data repository for the data type.
  • Emphasis on quality control and proper data management procedures within the study design.
Ethical Standards & Human Subjects
  • Strict adherence to ethical standards for human subjects research is paramount.
  • Plans for the protection of human subjects from research risks are critically evaluated.
  • Justification for the inclusion or exclusion of individuals based on sex, race, ethnicity, and age must be scientifically sound.
  • An appropriate informed consent or assent process must be in place.
  • Data and Safety Monitoring is required for clinical trials to ensure participant safety and data integrity.
Intellectual Property
  • The recipient institution retains custody of and primary rights to data and software developed under the award, subject to Government access rights consistent with HHS, PHS, and NIH policies.
Unique Aspects and Considerations
  • This grant is awarded as a Cooperative Agreement, signifying substantial Federal scientific or programmatic involvement from NIH/NEI in the project activities, beyond standard oversight.
  • The Chair's Grant is typically part of a larger, multi-component study structure, often involving separate companion grants for a Coordinating Center and Resource Centers. Applicants for the Chair's grant should understand their role within this broader collaborative framework.
  • The focus is on investigator-initiated, complex, or high-resource/safety-risk clinical trials within vision research, which means lower-risk or purely preclinical/basic studies are not suitable.
  • Strict adherence to detailed application instructions and forms is enforced; non-compliant applications may be withdrawn without review.
  • A specific Dispute Resolution procedure is available for scientific or programmatic disagreements that may arise between award recipients and NIH.
  • NEI reserves the right to curtail, withhold, or terminate support due to inadequate progress, breaches of protocol, major changes to the agreed-upon protocol, early achievement of endpoints, data sharing failures, or human subject ethical issues.
Cross-Cutting Themes
  • Explicit evaluation of inclusion plans for women, racial and ethnic minorities, and individuals across the lifespan.
  • Strong emphasis on maintaining scientific integrity, protocol fidelity, data quality, and timely public dissemination of research results.
Industry-Specific Compliance
  • Compliance with FDA (Food and Drug Administration) regulations, including Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements, and prompt reporting of FDA regulatory actions.
  • Mandatory registration and results reporting on ClinicalTrials.gov for applicable clinical trials.

Grant Details

healthcare medical research clinical trials ophthalmology vision science public health diagnostics therapeutics interventions research funding cooperative agreement usa international global vision eye health disease prevention diagnosis treatment comparative effectiveness large-scale studies investigator-initiated multicenter trials data management human subjects health disparities equity inclusion ethical research NIH NEI universities nonprofits for-profits small business government ngos development clinical validation efficacy testing intervention studies
NEI Collaborative Clinical Vision Research: Chair's Grant (UG1-Clinical Trial Required)
PAR-23-209
National Institutes of Health (NIH)
UNIVERSITY NGO SME ENTERPRISE PUBLIC OTHER
US AF AL DZ AS AD AO AI AQ AG AR AU AT BY BE BA BR BG CA CN HR CY CZ DK EG EE FI FR GE DE GI GR HU IS IN IE IL IT JP LV LI LT LU MK MY MT MX MD ME NL NZ NO PL PT QA RO SA RS SC SG SK SI KR ES SE CH TW TR UA AE UK VA VG VI
HEALTHCARE
DEVELOPMENT MATURE
OTHER
SDG3
FUNDING MENTORSHIP RESEARCH_DEVELOPMENT CAPACITY_BUILDING
None
None
None
USD
None
Jan. 25, 2026, 10 p.m.
May 2026 - July 2026