IRB Consent Guidelines: Potential Barriers to Diversity in Research

Area of Science:

• Clinical Research
• Health Equity
• Sociology of Health

Background:

• Ethnic and racially minoritized populations have historically low participation in research studies.
• Existing Institutional Review Board (IRB) guidelines, while necessary for ethical practice, can inadvertently create barriers for these populations.
• Standard consent translation processes may be inefficient and impractical for communities with diverse linguistic backgrounds and varying literacy levels.

Purpose of the Study:

• To explore the challenges of traditional consent processes in research with non-English speaking and marginalized populations.
• To propose and evaluate alternative, more inclusive consent methods.
• To advocate for adjustments in IRB guidelines to reduce barriers and promote diversity in research.

Main Methods:

• The University of Wisconsin's IRB approved an alternative oral consent process for research involving Hmong, Karen, Karenni, and Burmese ethnic groups.
• Translated consent materials were provided in recorded format in each participant's native language.
• Verbal consent was obtained at the study location prior to participation, accommodating participants unable to read their native language.

Main Results:

• Standard written consent processes were found to be difficult and impractical due to low literacy rates in native written languages.
• Access to translators and the consent translation process itself presented significant time and resource constraints.
• The alternative oral consent process, including recorded materials and verbal consent, proved efficient for participants and researchers.

Conclusions:

• Adjusting IRB guidelines related to consent can eliminate time and resource barriers in research.
• Improved efficiency in study design and promotion can result from more inclusive consent methods.
• Emphasis on oral language and adapted consent processes can enhance research diversity among populations with lower written literacy.