Environmental Health Disparities Centers (P50) Clinical Trial Optional

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Description

The Environmental Health Disparities Centers (P50) program, funded by the NIH, aims to support multidisciplinary research centers focused on environmental health disparities and environmental justice among populations experiencing health disparities within the United States and its territories. The program promotes research capacity building, community-engaged research, and early career investigator development with a disease-agnostic focus.

Centers are expected to conduct innovative research addressing the disproportionate environmental burdens and social determinants of health (SDOH) that contribute to health disparities. The initiative encourages local intervention research with equitable community partnerships and the use of multilevel, multidomain frameworks such as the NIMHD Research Framework and NIEHS Translational Research Framework.

The program explicitly excludes applications focusing solely on climate change without a strong environmental justice and health disparities focus. Indigenous Knowledges and community strengths are emphasized as important components of research.

Required Components

Each center application must include:

• Administrative Core: Provides oversight, coordination, progress monitoring, and compliance with federal policies. Must maintain a public website with updated research summaries.
• Investigator Development Core: Focuses on training early career investigators and building research capacity, including a pilot project program supporting at least three small-scale projects annually.
• Community Engagement and Dissemination Core: Establishes equitable partnerships with affected communities, facilitates bi-directional communication, and disseminates research findings to diverse audiences.
• Research Project(s): One or two projects addressing environmental health disparities; if multiple projects are proposed, one must be an intervention study. Projects may include observational studies, interventions, or clinical trials.

Research Focus Areas

Examples of research topics include:

• Modeling interactions of environmental exposures and SDOH on health outcomes.
• Developing and testing environmental justice interventions, including those incorporating Indigenous Knowledges.
• Addressing upstream SDOH in immigrant and marginalized communities.
• Evaluating impacts of resource extraction, industrial agriculture, and personal care product exposures.
• Investigating environmental exposures’ effects on aging, mental health, and chronic diseases.
• Using GIS and mixed methods to identify and characterize affected communities.

Institute-Specific Interests

• NIA: Environmental factors affecting aging, Alzheimer’s disease, and related dementias.
• NCI: Environmental exposures and cancer disparities, structural racism, and community-engaged cancer control.
• NICHD: Human development, reproductive health, and child health in the context of environmental disparities.
• NINR: Health equity, social determinants, and systems of care across diverse settings.

Due Dates

• Letter of Intent: December 28, 2024
• Application Due Date: January 28, 2025 (5:00 PM local time)
• Scientific Merit Review: June 2025
• Advisory Council Review: August 2025
• Earliest Start Date: September 2025

No late applications will be accepted. Applicants are encouraged to submit early to allow time for corrections.

Funding Amount

• Total anticipated funding: Approximately $9,000,000 to support 4-6 awards.
• Maximum budget: $1,000,000 direct costs per year (excluding consortium indirect costs).
• Project period: Up to 5 years.

Eligibility

Eligible Applicants

• Public and private institutions of higher education, including minority-serving institutions.
• Nonprofits with or without 501(c)(3) status (excluding institutions of higher education).
• For-profit organizations, including small businesses.
• State, county, city, township, and special district governments.
• Federally recognized and other Native American tribal governments and organizations.
• Independent school districts, public housing authorities.
• Faith-based and community-based organizations.
• Regional organizations.

Ineligible

• Foreign (non-U.S.) entities and foreign components of U.S. organizations.

Other Requirements

• Applicants must have all required registrations (SAM, eRA Commons, Grants.gov).
• Program Directors/Principal Investigators must have eRA Commons accounts.
• Multiple applications allowed if scientifically distinct.

Application Process

• Applications must be submitted electronically via Grants.gov using ASSIST or institutional systems.
• Follow the NIH Multi-Project (M) Application Instructions and program-specific guidelines.
• Required components must be included: Overall, Administrative Core, Investigator Development Core, Community Engagement and Dissemination Core, and Research Project(s).
• Page limits: Overall (6 pages), Admin Core (12 pages), Investigator Development Core (6 pages), Community Engagement Core (6 pages), Research Project(s) (12 pages).
• Include a letter of institutional commitment from senior leadership.
• Data Management and Sharing Plan is required.
• Clinical trial optional; if proposed, follow NIH clinical trial policies and include appropriate documentation.
• Prior approval required for pilot projects involving clinical trials or greater than minimal risk.

Review Criteria

Applications will be evaluated on:

• Significance: Importance of the problem, potential to advance environmental health disparities and justice research, community engagement.
• Investigators: Expertise, experience, and ties to affected communities.
• Innovation: Novelty of concepts, approaches, and interventions.
• Approach: Scientific strategy, rigor, feasibility, integration of community partners, and plans for sustainability.
• Environment: Institutional support and resources.
• For clinical trials: study design, ethical considerations, data management, and monitoring.

Additional criteria apply to cores and pilot projects, including training and capacity building effectiveness.

Award Administration

• Notice of Award (NoA) issued upon funding.
• Compliance with federal regulations and NIH policies required.
• Data and safety monitoring required for clinical trials.
• ClinicalTrials.gov registration and results reporting required for applicable trials.
• Annual progress reports and financial statements required.
• Recipients must develop cybersecurity plans if handling sensitive data.
• Prior approval required for changes involving human subjects research.

Additional Information

• Technical assistance webinar held October 22, 2024 (registration required).
• Applicants encouraged to contact NIH scientific/research staff for guidance.
• Applications not meeting eligibility or responsiveness criteria will not be reviewed.
• More information on NIH policies and procedures available on NIH grants website.

External Links

• Environmental Health Disparities Centers (P50) - NIH Guide
• NIMHD Research Framework
• NIEHS Translational Research Framework
• ECHO Program Data - NICHD DASH
• NIEHS Partnerships for Environmental Public Health (PEPH) Resource Center
• NIH Data Management and Sharing Policy
• NIH Stage Model for Behavioral Intervention Development
• NIH Grants Policy Statement

Contact Information