Institutional Review Board (IRB) Evaluation of Policies Affecting Minority Inclusion in Clinical Research

Abstract

Institutional Review Board Evaluation of Policies Affecting Minority Inclusion. PURPOSE: In a 2021 post COVID-19 pandemic recommendation, federal agencies questioned: “What is the role of the IRB in ensuring that research conducted in this setting appropriately protects the rights and welfare of research participants?” Academic Institutional Review Boards (IRBs) in minority rich communities may be a conduit for better understanding barriers and solutions to increase racial minority representation in clinical research. This study explored the perspectives of multi-institutional IRB leaders on current practices and proposed policies that affect inclusion of underserved populations. METHODS: A qualitative, noninterventional, exploratory research study was conducted through individual, 30-minute, semi-structured interviews that were recorded, transcribed, de-identified and analyzed to identify common themes and actionable solutions for enhanced support of underserved populations. RESULTS: Fourteen subjects across 11 eligible institutions in eight states participated in study interviews. Of the 14 leaders, ten were IRB Directors with one to 14 years of experience, three were IRB members with nine to 11 years of experience and one was an IRB Chair with 12 years of experience. Eleven participants were White, two were Black and one was Hispanic. Emerging themes were analyzed across institutional cohorts to assess differences in experiences by racial community settings. Findings indicate a strong association between Black institutions and community engagement, that Asians may be protected by resources and local policy, and Hispanic institutions have higher association with more IRB practices potentially to address language considerations. CONCLUSION: Lacking institutional commitment and access to sufficient resources, Hispanic institutions are further affected by increased IRB practice needs support inclusion of non-English community members.