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Abstract

Title VI of the U.S. Civil Rights Act prohibits institutions receiving federal financial assistance from discriminating based on race, color, or national origin. The term “national origin” includes people with limited English proficiency (“LEP”). The number of LEP residents has increased in the United States to over 10% of the residents in the most populous states (Texas, California, New York, Florida, and Nevada). Executive Order 13166, issued in 2000, requires all federal agencies to comply with Title VI by establishing guidelines that remove language barriers to federal programs, services, benefits, and activities. Additionally, it allows federal agencies to withhold funding from federal contractors who engage in national origin discrimination. Clinical researchers engage in national origin discrimination when they exclude LEP clinical trial participants without scientific justification. Since the issuance of Executive Order 13166, English proficiency requirements for clinical trial enrollment has worsened rather than improved. Federal agencies that support medical research should decline to fund clinical trials that discriminate against LEP populations with “English-only” exclusions. These exclusions undermine public trust in science, discriminate against the LEP taxpayers who pay for these studies, and increase healthcare inequity by restricting a significant number of potential enrollees from clinical trials.

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