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Abstract
In this article, we examine Institutional Review Board (IRB) policies, international guidelines, and federal regulations and guidance for dealing with Limited English Proficiency (LEP) research subjects. We show that federal and international guidance concerning this topic is insufficient, and there is considerable variation in IRB policies. While some IRBs have thorough and useful policies, others do not. Many IRBs do not provide researchers and IRB members with answers to several important questions relating to language barriers in research. We recommend that federal agencies, international organizations, IRBs, and researchers take steps to fill in the gaps in guidance and policy to help insure that LEP populations will receive equitable and ethical treatment in research.
Acknowledgment
This research was supported by the Intramural Research Program of the National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). The ideas and opinions expressed in this article to do not represent the views of the NIEHS or NIH.
Notes
21 C.F.R. 50 (2001).
45 C.F.R. 46 (2001).
42 U.S.C. 2000d, Section 601 of Title VI of the Civil Rights Act of 1964
