Cost of consent document (CD) translation is a potential barrier to consenting limited English-proficient participants (LEPPs) in non-industry–sponsored studies (NISS).

Abstract

6533 Background: Racial/ethnic minority patients (pts) are underrepresented in cancer clinical trials. Challenges specific to LEPPs include the need for translated CDs, which can cause research delays and add cost. While most enrollment barriers are similar between industry sponsored studies (ISS) and NISS, costs of CD translation are typically covered by the sponsor in ISS. NISS often have limited, or no funds allocated for CD translation. Although it is required that LEPPs sign translated CDs, we hypothesized that investigators on NISS would find ways to avoid incurring the cost of CD translation. Methods: All pts who consented to studies at the UCLA Jonsson Comprehensive Cancer Center from 2013-2018 were included. Electronic health record data was reviewed. Adult LEPPs had a primary language other than English and their chart either flagged them as needing an interpreter or the pt used an interpreter in their care 6 months before or after the consent date. For pediatric patients, regardless of the pt’s primary language, LEPPs had a guardian who needed an interpreter within 6 months of the consent date. CD language was documented when available by chart review, but when not, we evaluated all IRB-approved CDs for the corresponding study and assumed that the pt signed appropriately translated CDs if available at the time of consent or within the following month. Chi square tests were used to compare the proportion of LEPPs who consented to NISS vs ISS and the proportion of LEPPs who consented with CDs not in their primary language. All analyses were performed using JMP, Version 16. SAS Institute Inc., Cary, NC, 1989–2021. Results: Although we do not have access to data on to whom consents were offered, of the 12202 consenting events during the study period, the proportion of consenting events for LEPPs was 2.7% in NISS vs 5.4% for ISS (p < 0.01). This difference did not appear to be driven by study type, as results were similar when only consenting events for interventional studies (n = 9886) were considered, with LEPPs representing 2.4% in NISS vs 5.5% in ISS (p < 0.01). Among LEPPs, 67.2% of participants who consented to NISS consented with CDs in a language other than their primary language vs 32.2% in ISS (p < 0.01). LEPPs who consented with language appropriate CDs represented 0.9% of those consenting to NISS vs 3.7% for ISS (p < 0.01). Conclusions: LEPPs consented less frequently to NISS compared to ISS, and when they did consent to NISS, the CDs were usually not translated into the pt’s primary language. We posit that the cost of translating CD discourages investigators from consenting LEPPs to NISS. Approaches that reduce or eliminate translation costs should increase the availability of translated CDs, potentially increasing enrollment of LEPPs to NISS while ensuring that they are fully informed about the purpose, procedures, and risks involved in these trials.