The "Health Equity Innovation Award: Enhance Equity Funding Opportunity (U01) Clinical Trials Not Allowed" is a forecasted initiative by the FDA to support research advancing minority health and health equity. The program focuses on promoting diversity in clinical trials, enhancing the availability of data on diverse populations, and increasing understanding of diverse patient perspectives, preferences, and unmet needs. This aligns with the FDA's commitment to addressing systemic inequities in healthcare and ensuring inclusivity in research and health outcomes.

This funding opportunity seeks innovative approaches to advance equity in clinical trials by increasing participation from underrepresented groups and expanding equitable data collection. Proposals should also aim to amplify the voices of diverse patients, addressing gaps in knowledge and improving the responsiveness of healthcare systems to their needs.

The funding will support four awards, each with a maximum and minimum award amount of $1,000,000. No cost-sharing or matching funds are required. Eligible applicants include a wide range of entities such as state and local governments, public and private higher education institutions, nonprofits with or without 501(c)(3) status, for-profit organizations (excluding small businesses), Native American tribal governments and organizations, public housing authorities, independent school districts, and special district governments.

Applicants should propose projects that demonstrate innovative strategies to achieve health equity objectives, including detailed plans for research, outreach, and implementation. Proposals should highlight measurable outcomes and their potential to inform broader efforts to reduce disparities in healthcare.

While specific application dates are not yet available, the forecasted release date for this opportunity is August 14, 2024, for projects starting in Fiscal Year 2025. Applicants are encouraged to prepare for the official posting by developing research proposals aligned with the outlined objectives.

For further information, contact Terrin Brown at terrin.brown@fda.hhs.gov or call 240-402-7610. Updates and additional details will be provided once the funding opportunity moves from forecast to open.