Limited English Proficiency and Disparities in Clinical Research

Abstract

Patients with Limited English Proficiency (LEP) are a protected class under the Civil Rights Act. However, clinical trials continue to remain largely inaccessible to this population. This article lays out the scientific, legal, and ethical rationales for the inclusion of LEP subjects in clinical research.

Psychometric comparisons of the Pictorial Child Behavior Checklist with the standard version of the instrument.

“…It is estimated that almost half of all American adults lack the literacy skills needed to obtain, process, and understand basic health information (Sarfaty, Turner, & Damotta, 2005). This interferes with their ability to receive appropriate health care (Amerson & Burgins, 2005; Guerra, Krumholz, & Shea, 2005; McBride, 2005) and to participate in health research (Bustillos, 2009; Flores et al, 2002). In families with lower levels of literacy, mental health screening for children has been considered of special importance, because these youngsters, often of minority ethnicity, are at higher risk for psychological problems (Anez, Paris, Bedregal, Davidson, & Grilo, 2005; Duke, Ireland, & Borowsky, 2005; Patel, 2007) Although behavioral and emotional problems are found in children of all socioeconomic status (SES) levels, significant associations between lower SES and higher problem scores have been found in many cultures (Achenbach & Rescorla, 2001; Melchior et al, 2009).…”

Qualitative studies using in‐depth interviews with older people from multiple language groups: methodological systematic review

“…(2007, p. 473) described it as a careful balancing act of ‘maintaining the tension of the weave’ between consideration of language issues and research process. To be financially capable of optimal practice in studies with linguistically diverse participant samples, researchers must give an estimate of costs for language resources in funding proposals (Bustillos 2009) and funding bodies need to recognize that the costs are legitimate and necessary to enable research participation for a previously excluded population (Sin 2004, Bustillos 2009). When the languages spoken by participants are not determined prior to recruitment, estimates of required resources can be made using the language profile of the population of interest.…”

IRB Policies for Obtaining Informed Consent from Non‐English‐Speaking People

“…The authors note that a consent process in a “language understandable to the subject” implies using a language that the subject speaks, 9 and they list key questions about the use of short forms, document translation, and the parameters for enrolling or excluding non‐English‐speaking people 10 . Bustillos examined the evolution of state and federal laws intended to address health services for patients with limited English proficiency and their inclusion in research 11 . Perry evaluated the notion of vulnerability and the consent process through the lens of research that might include non‐English‐speaking refugees 12 .…”