Perspective: The Case for Research Justice: Inclusion of Patients With Limited English Proficiency in Clinical Research

Abstract

Persons with limited English proficiency (LEP) constitute a growing portion of the U.S. population, yet they are underrepresented in clinical research. This inherently limits the societal benefits of the research and its generalizability to ethnic populations living in the United States. To illustrate the complexity associated with including LEP participants in clinical research, the authors critically evaluated LEP consent requirements posted on the Web sites of 134 academic health centers in March 2008. They found wide variability with regard to consent policies and striking interinstitutional differences in posted IRB policies and attitudes toward consent of LEP patients in research. The authors argue this variation highlights competing concerns between autonomy and justice. Outcomes-based justice requires inclusion of LEP patients in the research, yet the consent process is often resource-intensive and complex. The authors suggest that more uniform and specific guidance from federal agencies for enrollment of LEP patients in clinical research be established and that this guidance explicitly recalibrate the current balance between autonomy and justice. Investigators and institutional review boards should also develop streamlined best practices to reduce unnecessary effort and expense associated with recruitment of LEP individuals. LEP individuals should have fair access to clinical research in order to fully realize individual and societal benefits of their participation and to ensure the generalizability of scientific discovery.

The ConNECT Framework: a model for advancing behavioral medicine science and practice to foster health equity

“…Another example is that paradoxically, despite high incidence of disability among people with diabetes, individuals with diabetes who have a disability are disproportionately excluded from diabetes research because co-occurrence of disability often disqualifies them from clinical trial participation (Moore, 2012). Persons with limited English proficiency often are similarly excluded from research participation (Glickman et al, 2011). Therefore, the extent to which therapeutic and intervention effectiveness are generalizable to these sizeable, medically vulnerable populations is unclear.…”

A paradigm for understanding trust and mistrust in medical research: The Community VOICES study

“…Nationally, those with LEP are more likely to live in poverty, have poorer health outcomes (Fields 2016), be less educated (Zong and Batalova 2015), and be underrepresented in clinical research. This underrepresentation of significant portions of the population in clinical trials results in research that may not be generalizable to those excluded populations (Glickman et al 2011). …”

“…Sympathetic, culturally appropriate translations by native speakers rather than directly translated words, may avoid confusion due to discrepant meanings and cultural cues (Brown 2014). Systemically, federal guidelines and individual IRBs must reconsider policies that address language barriers, especially in the informed consent process, to facilitate research participation by LEP individuals (Resnik 2006; Glickman 2011; Livaudais-Toman 2014). Fear of deportation amongst undocumented immigrants related to research participation has been identified as a source of mistrust and fear (Brown 2014).…”

Unequal treatment of human research subjects

“…32% stated fluency requirements for the person obtaining consent, while 68% did not. [41] Variations in policies for including subjects with limited English proficiency in research can results in unequal treatment of human participants when they lead to differences in the consent process.…”