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

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Abstract

Persons with limited English proficiency (LEP) constitute a growing portion of the U.S. population, yet they are underrepresented in clinical ÌÇÐÄ´«Ã½. This inherently limits the societal benefits of the ÌÇÐÄ´«Ã½ and its generalizability to ethnic populations living in the United States. To illustrate the complexity associated with including LEP participants in clinical ÌÇÐÄ´«Ã½, 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 ÌÇÐÄ´«Ã½. The authors argue this variation highlights competing concerns between autonomy and justice. Outcomes-based justice requires inclusion of LEP patients in the ÌÇÐÄ´«Ã½, 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 ÌÇÐÄ´«Ã½ 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 ÌÇÐÄ´«Ã½ in order to fully realize individual and societal benefits of their participation and to ensure the generalizability of scientific discovery.

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