Consent document translation expense hinders inclusive clinical trial enrolment

Maria A. Velez, Beth A. Glenn, Maria Garcia-Jimenez, Amy L. Cummings, Aaron Lisberg, Andrea Nañez, Yazeed Radwan, Jackson P. Lind-Lebuffe, Paige M. Brodrick, Debory Y. Li, Maria J. Fernandez-Turizo, Arjan Gower, Maggie Lindenbaum, Manavi Hegde, Jenny Brook, Tristan Grogan, David Elashoff, Michael A. Teitell and Edward B. Garon ()
Additional contact information
Maria A. Velez: University of California, Los Angeles
Beth A. Glenn: Jonsson Comprehensive Cancer Center, University of California, Los Angeles
Maria Garcia-Jimenez: University of California, Los Angeles
Amy L. Cummings: University of California, Los Angeles
Aaron Lisberg: University of California, Los Angeles
Andrea Nañez: University of California, Los Angeles
Yazeed Radwan: University of California, Los Angeles
Jackson P. Lind-Lebuffe: University of California, Los Angeles
Paige M. Brodrick: University of California, Los Angeles
Debory Y. Li: University of California, Los Angeles
Maria J. Fernandez-Turizo: Beth Israel Deaconess Medical Center
Arjan Gower: University of California, Los Angeles
Maggie Lindenbaum: Jonsson Comprehensive Cancer Center, University of California, Los Angeles
Manavi Hegde: Jonsson Comprehensive Cancer Center, University of California, Los Angeles
Jenny Brook: University of California, Los Angeles
Tristan Grogan: University of California, Los Angeles
David Elashoff: Jonsson Comprehensive Cancer Center, University of California, Los Angeles
Michael A. Teitell: Jonsson Comprehensive Cancer Center, University of California, Los Angeles
Edward B. Garon: University of California, Los Angeles

Nature, 2023, vol. 620, issue 7975, 855-862

Abstract: Abstract Patients from historically under-represented racial and ethnic groups are enrolled in cancer clinical trials at disproportionately low rates in the USA1–3. As these patients often have limited English proficiency4–7, we hypothesized that one barrier to their inclusion is the cost to investigators of translating consent documents. To test this hypothesis, we evaluated more than 12,000 consent events at a large cancer centre and assessed whether patients requiring translated consent documents would sign consent documents less frequently in studies lacking industry sponsorship (for which the principal investigator pays the translation costs) than for industry-sponsored studies (for which the translation costs are covered by the sponsor). Here we show that the proportion of consent events for patients with limited English proficiency in studies not sponsored by industry was approximately half of that seen in industry-sponsored studies. We also show that among those signing consent documents, the proportion of consent documents translated into the patient’s primary language in studies without industry sponsorship was approximately half of that seen in industry-sponsored studies. The results suggest that the cost of consent document translation in trials not sponsored by industry could be a potentially modifiable barrier to the inclusion of patients with limited English proficiency.

Date: 2023
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DOI: 10.1038/s41586-023-06382-0

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