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Grant Analysis

Purpose & Target

This grant, The Role of Work in Health Disparities in the U.S. (R01 Clinical Trials Optional), aims to support innovative population-based research. Its core objective is to identify and characterize how work and occupation influence health outcomes and status, particularly among populations experiencing health and/or healthcare disparities. The grant is SECTOR-SPECIFIC, focusing on public health, social sciences, and healthcare research. It targets organizations conducting research within the U.S. and its territories (including Puerto Rico and the Trust Territory of the Pacific Islands). This is a recurring grant opportunity with multiple application cycles until early 2028, indicating an ongoing program context within the NIH's broader mission to reduce health disparities.

Financial Structure

Budget Range and Limitations

Budget is not explicitly limited, but proposed budgets must reflect the actual needs of the project.
For requests of $500,000 or more in direct costs in any single year (excluding consortium F&A), applicants must contact a Scientific/Research Contact at least six weeks before submitting the application.

Project Period

The maximum project period is 5 years; the scope of the proposed project should determine the requested duration.

Matching Funds/Cost Sharing

No cost sharing is required for this funding opportunity.

General Financial Policies

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Eligibility Requirements

This funding opportunity is open to a wide range of U.S.-based organizations:

Higher Education Institutions: Both public/state controlled and private universities.
Nonprofits: Includes organizations with and without 501(c)(3) IRS status.
For-Profit Organizations: Both small businesses and other for-profit entities are eligible.
Government Entities: State, county, city or township, and special district governments, as well as federally recognized and other Indian/Native American Tribal Governments, and eligible agencies of the Federal Government.
Other Organizations: 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, and Regional Organizations.

Geographic and Structural Requirements

No Foreign Entities: Non-domestic (non-U.S.) organizations are not eligible, nor are non-domestic components of U.S. organizations.
No Foreign Components: Projects requesting foreign components (as defined by NIH) are not allowed.
U.S. Research Focus: Projects must focus on NIH-designated populations experiencing health disparities in the U.S. and research must be conducted within the U.S., its territories, Puerto Rico, or the Trust Territory of the Pacific Islands.

Registration Requirements Applicant organizations must complete and maintain active registrations prior to submission: * System for Award Management (SAM): Requires annual renewal. Includes assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations. * Unique Entity Identifier (UEI): Issued through SAM.gov registration, must be consistent across all registrations and the application. * eRA Commons: Organizations must register and identify at least one Signing Official (SO) and one Program Director/Principal Investigator (PD/PI) account. * Grants.gov: Requires an active SAM registration. Principal Investigator Requirements

Any individual with the necessary skills, knowledge, and resources can serve as a Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)).
All PD(s)/PI(s) must have an eRA Commons account and affiliate it with the applicant organization.

Application Limits

Organizations may submit more than one application, provided each is scientifically distinct.
Duplicate or highly overlapping applications under review at the same time will not be accepted.

Cost Sharing

No cost sharing is required for this funding opportunity.

Application Process

Application Submission Methods Applications must be submitted electronically through one of the following methods: * NIH ASSIST system: For preparing, submitting, and tracking applications online. * Institutional System-to-System (S2S) solution: Applicants should check with their institutional officials for availability. * Grants.gov Workspace: For preparing and submitting applications, with tracking via eRA Commons. Key Application Due Dates This is a recurring funding opportunity with multiple application due dates annually until January 2028. The latest application due date specified is October 05, 2027, by 5:00 PM local time of the applicant organization. * Earliest Submission Date: January 05, 2025 * Letter of Intent Due Date: Not Applicable * Expiration Date of FOA: January 08, 2028 Applicants are strongly encouraged to submit applications early to allow time for correcting any errors found during the submission process. Application Content and Forms Applicants must follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide and any program-specific instructions outlined in this funding opportunity. Key forms include: * SF424(R&R) Cover, Project/Performance Site Locations, Other Project Information, Senior/Key Person Profile. * R&R or Modular Budget, R&R Subaward Budget. * PHS 398 Cover Page Supplement, Research Plan. * PHS Human Subjects and Clinical Trials Information (if applicable). * PHS Assignment Request Form. Important Submission Details

Electronic Submission Only: Paper applications will not be accepted.
Required Registrations: All organizational registrations (SAM, UEI, eRA Commons, Grants.gov) must be completed before the application due date. PD(s)/PI(s) must also have an eRA Commons ID.
Page Limitations: All page limitations described in the How to Apply - Application Guide and the Table of Page Limits must be followed.
Data Management and Sharing Plan: Required for all applicants planning research that generates scientific data, regardless of the direct costs requested.
Appendix Materials: Only limited appendix materials are allowed (e.g., blank questionnaires or surveys). No publications or other materials are permitted.

Evaluation Criteria

Applications are evaluated for scientific and technical merit through the NIH peer review system. The assessment focuses on the project's likelihood to exert a sustained, powerful influence on the research field(s). Scored Review Criteria Reviewers will provide an overall impact score considering these three primary factors, with Factor 1 and 2 also receiving separate scores: * Factor 1. Importance of the Research (Significance and Innovation): Evaluates the project's potential to advance scientific knowledge and its novelty. * Factor 2. Rigor and Feasibility (Approach): Assesses the soundness of the proposed methodology and its practical execution. * Factor 3. Expertise and Resources (Investigator(s) and Environment): Reviews the qualifications of the research team and the suitability of the research environment. Additional Review Criteria These items are considered but not individually scored; they contribute to the overall impact score: * Protections for Human Subjects: Ensuring ethical treatment and safety of human participants. * Vertebrate Animals: If applicable, justification for animal use, minimization of discomfort, and euthanasia methods. * Biohazards: Evaluation of specific hazardous materials or procedures and proposed protection measures. * Resubmissions: Evaluation of the full application as presented. * Renewals: Evaluation of progress made in the previous funding period. * Revisions: Evaluation of the appropriateness of any proposed expansion of the project's scope. Additional Review Considerations These are considered but not scored, and do not factor into the overall impact score directly: * Authentication of Key Biological and/or Chemical Resources: Plans to ensure validity of resources. * Budget and Period of Support: Assessment of whether the budget and requested project duration are justified and reasonable. Funding Decisions In addition to scientific and technical merit from peer review, funding decisions also consider: * Availability of funds. * Relevance of the proposed project to program priorities.

Compliance & Special Requirements

Regulatory and Policy Compliance Award recipients must comply with extensive federal regulations and policies, including: * 2 CFR Part 200: Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. * NIH Grants Policy Statement: Applies to all applications and awards. * Nondiscrimination Laws: Recipients must follow all applicable nondiscrimination laws and submit an Assurance of Compliance (HHS-690). * Federal Statutes and Regulations: All relevant to federal financial assistance, including those highlighted in the NIH Grants Policy Statement Section 4 (Public Policy Requirements). Research-Specific Requirements

Human Subjects Research: If involving human subjects, research must comply with PHS Human Subjects and Clinical Trials Information guidelines and require Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approval.
Clinical Trials: If the project includes clinical trials, the responsible party must register and submit results information on ClinicalTrials.gov.
Data and Safety Monitoring: Required for all NIH-conducted or -supported human biomedical and behavioral intervention studies.
Investigational New Drug (IND) or Investigational Device Exemption (IDE): Required for clinical research involving investigational therapeutics, vaccines, or devices.

Data and IT Standards

Health IT: If award funding involves implementing, acquiring, or upgrading health IT, recipients must use IT that meets standards in 45 CFR part 170, Subpart B, and/or certified under the ONC Health IT Certification Program if applicable.
Cybersecurity: If recipients, subrecipients, or third parties have ongoing access to HHS information or operational technology systems, or handle PII/PHI obtained from HHS, they must develop plans and procedures modeled after the NIST Cybersecurity framework.
Data Management and Sharing: Recipients are required to adhere to the 2023 NIH Policy for Data Management and Sharing once their plan is approved.

Reporting and Post-Award Obligations

Annual Reporting: Recipients must submit the Research Performance Progress Report (RPPR) annually and financial statements.
Closeout Reporting: A final RPPR, invention statement, and expenditure data are required for award closeout.
Mandatory Disclosure: Recipients must disclose any information related to violations of federal criminal law involving fraud, bribery, or gratuity potentially affecting the federal award.

Grant Details