U01FD007982

Racial and Ethnic Minority Acceleration for Health Equity Consortium U01 - Project Summary/Abstract

This proposal responds to FDA's OMHHE desire to accelerate efforts to address racial and ethnic minority and health equity through its REACH Consortium. This two-phase "Health Equity Acceleration" U01 application is submitted to participate in the FDA OMHHE Health Equity Innovation Award for "Racial & Ethnic Minority Acceleration Consortium for Health Equity (REACH) (U01)" focused on advancing "minority health and health equity focused research, outreach, and communications as well as support training and mentoring of diverse HBCU advanced students, fellows, and researchers."

The proposed program and projects benefit from established partnerships and recognized leadership between the Patients Program at the University of Maryland Baltimore, the Pastor of Mt. Lebanon Baptist Church (Pastor Lance MLBC), a rural health equity expert (Dr. Datcher), and two historically black colleges/universities (HBCUs): Coppin State University (CSU) Helene Fuld School of Nursing (Dean Tilghman), and Xavier University of Louisiana (XULA) College of Pharmacy (Dean Kennedy).

Two pilot projects/programs submitted in this application encompass two RFA "pillars' of "Equity of Voices" and Equity in Clinical Trials" which will be developed under Phase 1:

A) A pilot curriculum and potential FDA OMHHE rotations on "Regulatory Issues and Health Equity" for advanced students and faculty in HBCUs in pharmacy and nursing; and

B) A pilot research project which moves beyond clinical trial barrier identification to development of strategies to address barriers to clinical trial diversity, in order to increase trustworthiness, transparency in sponsors and researchers, and increase willingness to participate in trials.

In Phase 1, planning, administrative procedures and logistics will be developed and in Phase 2, the pilot project and program will be implemented.

Specific aims for the two-phase proposal:

Aim 1 Administrative Core: Establish the Administrative Core (AC) to co-institute policies and procedures with the Community and Health Professional Advisory Board (CHPAB) in order to cultivate effective interactions with the FDA OMHHE and its REACH Consortium.

Aim 2 (Equity of Voices): Co-develop, with guidance of the CHPAB and input from the FDA OMHHE, a curriculum on "Regulatory Science and Health Equity," and potential rotations at FDA OMHHE for HBCU fellows, postdoctoral researchers, and graduate students.

Aim 3 (Equity in Clinical Trials): Conduct pilot research designed to delineate strategies for overcoming identified barriers to clinical trials participation for African Americans, in order to increase equity in participation of underrepresented minority racial and ethnic groups in clinical trials.

University Of Maryland, Baltimore

TO ASSIST INSTITUTIONS AND ORGANIZATIONS, TO ESTABLISH, EXPAND, AND IMPROVE RESEARCH, DEMONSTRATION, EDUCATION AND INFORMATION DISSEMINATION ACTIVITIES, ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS), BIOLOGICS, BLOOD AND BLOOD PRODUCTS, THERAPEUTICS, VACCINES AND ALLERGENIC PROJECTS, DRUG HAZARDS, HUMAN AND VETERINARY DRUGS, CLINICAL TRIALS ON DRUGS AND DEVICES FOR ORPHAN PRODUCTS DEVELOPMENT, NUTRITION, SANITATION AND MICROBIOLOGICAL HAZARDS, MEDICAL DEVICES AND DIAGNOSTIC PRODUCTS, RADIATION EMITTING DEVICES AND MATERIALS, FOOD SAFETY AND FOOD ADDITIVES. THESE PROGRAMS ARE SUPPORTED DIRECTLY OR INDIRECTLY BY THE FOLLOWING CENTERS AND OFFICES: CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER), CENTER FOR DRUG EVALUATION AND RESEARCH (CDER), CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH), CENTER FOR VETERINARY MEDICINE (CVM), CENTER FOR FOOD SAFETY AND APPLIED NUTRITION (CFSAN), NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH (NCTR), THE OFFICE OF ORPHAN PRODUCTS DEVELOPMENT (OPD), THE CENTER FOR TOBACCO PRODUCTS (CTP), AND OFFICE OF REGULATORY AFFAIRS (ORA), AND THE OFFICE OF THE COMMISSIONER (OC). SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAMS: TO STIMULATE TECHNOLOGICAL INNOVATION, TO ENCOURAGE THE ROLE OF SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION BY MINORITY AND DISADVANTAGED PERSONS IN TECHNOLOGICAL INNOVATION. FUNDING SUPPORT FOR SCIENTIFIC CONFERENCES THAT ARE RELEVANT TO THE FDA SCIENTIFIC MISSION AND PUBLIC HEALTH ARE ALSO AVAILABLE.

93.103 - Food and Drug Administration Research

FDA Office of Acquisition and Grant Services (OAGS) [HHS - FDA]

FDA Office of the Commissioner [HHS - FDA]

Baltimore, Maryland 21201 United States

Single Zip Code

FDA OMHHE Racial & Ethnic minority Acceleration Consortium for Health Equity (REACH) (RFA-FD-23-010)

Amendment Since initial award the End Date has been extended from 05/31/25 to 05/31/28 and the total obligations have increased 315% from $500,000 to $2,074,999.