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Grant Analysis

Purpose & Target

The core objective of this grant is to support secondary data analysis of existing human vision-related clinical, epidemiologic, and healthcare data. The goal is to investigate new scientific ideas, models, systems, tools, or methods that have the potential for significant impact in areas relevant to the National Eye Institute's (NEI) mission. The grant explicitly supports research that can deepen the understanding of vision health problems, address leading causes of blindness, and enhance the quality of life for individuals with impaired vision. This is a SECTOR-SPECIFIC grant, focused exclusively on vision research. It targets a broad range of organizations, including higher education institutions, nonprofits, for-profit organizations (including small businesses), and various government entities, both domestic and foreign, with no explicit size limitations beyond their categorization. The geographic scope is global, as foreign organizations are eligible to apply. Key filtering criteria for initial screening include: projects must propose secondary data analysis of human vision-related data only, cannot involve the collection of new data, cannot analyze animal data, and cannot be used to support ongoing data analysis or data set maintenance. The existing data must already be in an analyzable format. This funding opportunity is a reissue of PAR-22-141, indicating it is a recurring program, specifically an R21 Exploratory/Developmental Research Grant under the NIH/NEI.

Financial Structure

Award Budget

The National Eye Institute (NEI) permits direct costs up to $275,000 USD for the entire two-year project period.
No more than $200,000 USD in direct costs may be requested in any single year.
Applicable F&A (Facilities and Administrative, or indirect) costs are permitted, especially for consortia.

Eligible and Ineligible Costs

Eligible Costs: Direct costs associated with secondary data analysis, statistical methodology development, and related research activities are generally eligible. Applicable F&A costs are also covered. Pre-award costs are allowable as described in the NIH Grants Policy Statement.
Ineligible Costs: Costs related to activities outside the grant's scope are ineligible, including those for collecting new data, analyzing non-human/animal data, or maintaining existing datasets.

Matching Fund and Co-financing Requirements

This funding opportunity does not require cost sharing or matching funds, as defined in the NIH Grants Policy Statement.

Payment Schedule and Mechanisms

The specific payment schedule is not detailed within the provided document, but it is described as a 'Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity'. Funds are typically requested from a designated HHS payment system or office.

Financial Reporting and Audit Requirements

Recipients are required to submit an annual Research Performance Progress Report (RPPR) and financial statements as required by the NIH Grants Policy Statement.
For closeout of an award, a final RPPR, an invention statement, and the expenditure data portion of the Federal Financial Report (FFR) are required.
Audit requirements implicitly follow the rules at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.

Eligibility Requirements

Eligible Organizations This grant is open to a very broad range of organizations: - Higher Education Institutions: Public/State Controlled Institutions of Higher Education and Private Institutions of Higher Education. - Nonprofits: Both 501(c)(3) IRS Status (Other than Institutions of Higher Education) and Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education). - For-Profit Organizations: Includes Small Businesses and For-Profit Organizations (Other than Small Businesses). - Local Governments: State, County, City or Township Governments, Special District Governments, and both Federally Recognized and Other Indian/Native American Tribal Governments. - Federal Governments: Eligible Agencies of the Federal Government and U.S. Territory or Possession. - Other: 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, and Non-domestic (non-U.S.) Entities (Foreign Organizations). Geographic Eligibility All domestic (U.S.) and non-domestic (non-U.S. Entities, or foreign organizations) are eligible to apply. Non-domestic components of U.S. organizations are also eligible. Project Scope Restrictions (Exclusion Criteria) Applications will be considered non-responsive and will not be reviewed if they: - Propose to collect or generate new data (e.g., grading images, running lab assays). - Propose to analyze data obtained from non-human samples or animal studies. - Propose to carry out or complete currently ongoing data analysis or to maintain and distribute data sets. - Propose analyses of data sets that are not currently available in analyzable format. - Propose clinical trials (this NOFO is 'Clinical Trial Not Allowed'). Required Registrations All applicant organizations must complete and maintain the following active registrations prior to application submission. These processes can take 6 weeks or more: - System for Award Management (SAM): Requires annual renewal. Includes the assignment of a Unique Entity Identifier (UEI). Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code to register in SAM. - eRA Commons: Organizations must register and identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account. If a PD/PI is also an SO, they must have two distinct accounts. Obtaining an eRA Commons account can take up to 2 weeks. - Grants.gov: Requires an active SAM registration to complete. Eligible Individuals (Program Director/Principal Investigator) Any individual with the necessary skills, knowledge, and resources to conduct the proposed research is invited to apply. All PD(s)/PI(s) must have an eRA Commons account, affiliated with the applicant organization.

Application Process

Application Submission Process Applications must be submitted electronically through one of the following methods: - NIH ASSIST system: Used to prepare, submit, and track your application online. - Institutional system-to-system (S2S) solution: Your organization's internal system can be used to prepare and submit to Grants.gov and eRA Commons. - Grants.gov Workspace: Used to prepare and submit your application. After submission via Grants.gov, applicants must track the status of their application in the eRA Commons. It is critical to adhere to the instructions in the Research (R) Instructions in the 'How to Apply - Application Guide', as well as any program-specific instructions in this NOFO. Application Deadlines and Timeline Applicants are encouraged to submit applications early to allow time for corrections. All applications are due by 5:00 PM local time of the applicant organization.

Latest Application Due Date for New Applications: October 16, 2027
Latest Application Due Date for Renewal/Resubmission/Revision (as allowed, including AIDS-related): November 16, 2027 (This is the latest date given in the provided schedule, though non-AIDS applications may align with the New Application deadline.)
Funding Opportunity (NOFO) Expiration Date: October 17, 2027

Project Period

The total project period for an awarded application may not exceed two years.

Required Documentation and Materials Applicants must use the SF424(R&R) and PHS 398 forms, following the 'How to Apply - Application Guide' instructions, with specific additions: - Research Strategy: Must clearly explain how proposed secondary analyses provide important insight into vision health, detail existing data utilization, demonstrate data quality and analyzability, include plans to control for biases/deficiencies, and, if applicable, show how new methodologies improve future analyses. - Resource Sharing Plan: Individuals must comply with instructions for Resource Sharing Plans. - Data Management and Sharing Plan: Required for all applications, regardless of the direct costs requested, for research generating scientific data. - Appendix: Only limited Appendix materials are allowed, specifically blank questionnaires or blank surveys. No publications or other materials. - Human Subjects and Clinical Trials Information: If human subjects are involved, include study records via the 'PHS Human Subjects and Clinical Trials Information form' or 'Delayed Onset Study record'. Reporting Obligations

Annual Reporting: Recipients must submit the Research Performance Progress Report (RPPR) annually and financial statements.
Closeout Reporting: A final RPPR, an invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout.
Manuscript Milestones: Projects are expected to make substantial progress towards submitting at least one vision-related manuscript to a peer-reviewed journal within the first year. A total of two manuscript submissions are required: one submitted prior to the Research Performance Progress Report (RPPR) and one prior to the Final Progress Report.

Application Assistance Availability

eRA Service Desk: For system questions (ASSIST, eRA Commons, errors, submission issues). Toll-free: 1-866-504-9552, Phone: 301-402-7469. Also via web ticket.
General Grants Information: For application instructions, processes, and NIH resources (Email: [email protected], Phone: 301-480-7075).
Grants.gov Customer Support: For Grants.gov registration and Workspace (Phone: 800-518-4726, Email: [email protected]).
Specific Contacts: The NOFO provides direct contact information for Scientific/Research, Peer Review, and Financial/Grants Management inquiries at the National Eye Institute.

Evaluation Criteria

Applications submitted to the NIH are evaluated for scientific and technical merit through a peer review system, which culminates in an 'Overall Impact' score. This score reflects the likelihood of the project to exert a sustained, powerful influence on the research field(s) involved. Scored Review Criteria Reviewers will assess the following three factors, each receiving a separate score, which directly contribute to the 'Overall Impact' score:

Factor 1. Importance of the Research (Significance and Innovation): Reviewers evaluate whether the proposed secondary analyses provide important insight into vision health problems. This factor assesses the project's potential to significantly advance the field, whether through novel approaches, addressing critical gaps, or developing innovative methodologies.
Factor 2. Rigor and Feasibility (Approach): This criterion focuses on the scientific and technical soundness of the proposed plan. Key considerations include:
- Clarity on how proposed secondary analyses provide important insights into vision health problems.
- Detailed description of existing data (data sets or databases) and how they will be utilized to address specific aims and NEI's mission.
- Demonstration that the data are of sufficient quality for the study's aims and currently exist in an analyzable format.
- Inclusion of plans to control or account for potential biases and deficiencies in data (e.g., missing data, inconsistencies, misclassification, selection bias, confounding).
- For proposed new methodologies, evidence must be provided that the new approaches are needed and how they will improve future analyses of vision-related research data.
Factor 3. Expertise and Resources (Investigator(s) and Environment): This evaluates the capabilities of the research team and the suitability of the research setting:
- Investigator(s): Assessment of the investigator's background, training, and expertise relevant to the proposed work. For applications with multiple Principal Investigators (MPIs), the quality of the leadership plan for coordination and collaboration is assessed.
- Environment: Evaluation of whether the institutional resources and overall research environment are appropriate and supportive for the successful execution of the proposed work.

Additional Review Criteria These items are considered by reviewers while determining scientific and technical merit and contributing to the 'Overall Impact' score, but they do not receive separate criterion scores:

Protections for Human Subjects: Evaluation of justification for involvement of human subjects and the proposed protections against research risks (e.g., risk to subjects, adequacy of protection, potential benefits, importance of knowledge, data and safety monitoring).
Vertebrate Animals: If applicable, evaluation of procedures involving animals, justification for their use, measures to minimize discomfort, and justification for euthanasia methods.
Biohazards: Assessment of hazardous materials or procedures and proposed adequate protections.
Resubmissions/Renewals/Revisions: Specific evaluation of progress or appropriateness of proposed scope changes, as applicable.

Additional Review Considerations These items are considered by reviewers but do not receive scores and do not factor into the 'Overall Impact' score:

Authentication of Key Biological and/or Chemical Resources: Evaluation of brief plans for identifying and ensuring the validity of these resources.
Budget and Period of Support: Assessment of whether the budget and requested period are fully justified and reasonable in relation to the proposed research.

Compliance & Special Requirements

Regulatory Compliance

Awards are subject to the terms and conditions outlined in the NIH Grants Policy Statement and federal regulations, particularly 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards) and 42 CFR Part 52.
Recipients must comply with all applicable nondiscrimination laws, agreeing to this upon SAM.gov registration and submitting an Assurance of Compliance (HHS-690).
Mandatory Disclosure: Recipients must disclose any violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award, as per 2 CFR 200.113.
Health IT Standards: Where funding involves implementing, acquiring, or upgrading health IT, recipients must use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, and, for eligible clinicians/hospitals, health IT certified under the ONC Health IT Certification Program.
Cybersecurity Compliance: Pursuant to the Cybersecurity Act of 2015, recipients with ongoing access to HHS information or operational technology systems, or handling PII/PHI, must develop plans and procedures modeled after the NIST Cybersecurity framework to protect HHS systems and data.

Ethical Standards

For research involving human subjects, recipient institutions must ensure that protocols are reviewed and approved by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).

Data Management and Sharing

A Data Management and Sharing Plan is mandatory for all applications proposing research that generates scientific data, regardless of the direct costs requested. This is consistent with the 2023 NIH Policy for Data Management and Sharing.
The NEI encourages applicants to use common formats and metadata standards for ocular imaging (NOT-EY-24-006).
Integration of FHIR (Fast Healthcare Interoperability Resources), OMOP (common data models), FAIR (Findability, Accessibility, Interoperability, Reuse) principles for healthcare data, and DICOM (Digital Imaging and Communications in Medicine) standards for imaging data is encouraged to facilitate electronic health information exchange.

Risk Management

Applications must include explicit plans to control or account for potential biases and deficiencies in the existing data being analyzed. This includes addressing issues such as missing, inconsistent, or implausible data; misclassification and information bias; selection bias; and potential confounding.

Unique Aspects and Challenges

Strict Scope Limitation: A critical and unique aspect of this grant is its exclusive focus on secondary data analysis of existing human vision-related data. Any proposal involving new data collection, animal studies, or maintenance of existing datasets will be deemed non-responsive and will not be reviewed. This requires applicants to have access to high-quality, already analyzable datasets.
Publication Milestones: A clear and demanding requirement is the expectation to submit at least one vision-related manuscript to a peer-reviewed journal within the first year of the project, and a total of two by the project's end (one before the RPPR, one before the Final Progress Report).
Data Quality Burden: Applicants must demonstrate that their chosen existing data are 'of sufficient quality' and 'currently exist in analyzable format' to address their specific aims.

Strategic Opportunities

This grant offers a cost-effective opportunity to leverage the 'wealth of data' already generated by extensive NEI-supported clinical trials and epidemiologic research, as well as other clinical and health care database resources (e.g., EHR, administrative claims data, surveys).
It actively encourages the development of new statistical methodologies and computational modeling for vision health data, providing an avenue for methodological innovation.
The focus on standardized data formats (FHIR, OMOP, FAIR, DICOM) presents an opportunity to contribute to significant advancements in data interoperability and the development of extensive training sets for AI-driven research in vision.

Cross-Cutting Considerations

Strong emphasis on ethical conduct in human subjects research and robust data management/sharing practices.
Promotes the use of advanced data analysis techniques and adherence to modern data standards, aligning with broader trends in scientific research.

Grant Details