In the United States, one reason for low clinical study enrollment among patients from underrepresented racial and ethnic groups, often people with limited English proficiency (LEP), is the cost of consent document translation for clinical research investigators.
That is what over a dozen researchers from the University of California at Los Angeles (UCLA) concluded after collaborating on an investigation. Their findings were published on August 2, 2023, in the Nature journal.
The researchers evaluated over 12,000 consent events in a retrospective study using data obtained over a close to six year-period (January 2013 to December 2018) at UCLA’s Jonnson Comprehensive Cancer Center.
A consent event is the process of providing potential clinical study participants with information about the study, including any known procedures, risks, and benefits. Based on this information, patients can provide or deny consent to participate.
The 12,082 consent events evaluated represented 9,213 patients, as some participated in more than one clinical study. To assess possible differences based on criteria that included levels of English proficiency, race and ethnicity, and age, the researchers also compared non-sponsored trials, i.e., those funded with grants from the government or charitable funds, to sponsored trials, i.e., those funded by private corporations.
Out of the consent event sample, the vast majority of patients listed English as their primary language, with a population of just 742 representing people with varying levels of English proficiency and multiple ethnicities. LEP patients signed 481 consent documents, with a total of 17 interpreter interventions. The most common languages other than English listed were Spanish and Chinese.
Translation Cost a Factor
According to the study, which includes very detailed statistical analyses, the word count in consent documents ranged from 598 to 20,382. The median word count was 7,491.5, for which the cost is an estimated USD 1,498. Out of 758 clinical studies where patients signed consent documents, 261 had institutional review board (IRB) approved translations (just over a third).
More significantly, the researchers remarked, only a combined 18 sponsored and non-sponsored studies had translated consent documents at study opening. They also found that “the proportion of consent events for patients with LEP in studies not sponsored by industry was approximately half of that seen in industry-sponsored studies.”
The researchers stated that about 70% of randomized cancer clinical studies are sponsored by a company, with the remaining studies usually financed with grants. They further explained that grants generally offer a limited budget per patient and many investigators find it difficult to obtain funding for consent translation.
The US Department of Health and Human Services requires consent information to be made available “in a language understandable to the subject” of a clinical study, but the requirement falls short of being a mandate by saying that it “encourages the use of this procedure whenever possible.”
Although the US Food and Drug Administration (FDA) makes a recommendation for IRBs to ensure that consent documents are translated and certified, this has been described by principal study investigators as a costly process, according to the UCLA researchers.
Increasing Inclusive Participation
The researchers explained that in 43.8% of the consent events for sponsored studies evaluated the patient had signed a document in a language other than their primary language. In non-sponsored studies, less than 1% of patients signed consent documents in their primary language.
In view of their findings, the researchers expressed concern about the quality of information LEP patients are receiving, noting that The National Institutes of Health (NIH) Policy and Guidelines on the Inclusion of Women and Minorities indicates that “inclusion of participants with limited English proficiency in clinical research should not hinder their participation.”
Drawing a link between the availability of translated materials and potential higher participation from underrepresented groups, the researchers concluded that “an approach that increases the participation of patients with a primary language other than English in non-industry sponsored studies to the level seen in industry-sponsored studies would be expected to lead to a modest increase in the representation of patients from ethnic or racial groups other than non-Hispanic white.”
Study authors from UCLA: Edward B. Garon; Maria A. Velez, MD; Beth A. Glenn, PhD; Maria Garcia-Jimenez, MD; Amy L. Cummings, MD, PhD; Aaron Lisberg, MD; Andrea Nañez, MD; Yazeed Radwan, BS; Jackson P. Lind-Lebuffe, BS; Paige M. Brodrick, BS; Debory Y. Li, MS; Arjan Gower, MD; Maggie Lindenbaum, BS; Manavi Hegde, MS; Jenny Brook, MS; Tristan Grogan, MS; David Elashoff, PhD; Michael A. Teitell, MD, PhD. Maria J. Fernandez-Turizo, MD, from Beth Israel Deaconess Medical Center also contributed.
All data collected in the study is publicly available at https://doi.org/10.5281/zenodo.7992491.