Abstract

Excerpted From: Sarah C. Reckess, English Only: The Increasing Problem of National Origin Discrimination in Federally Funded Clinical Research, 36 Health Matrix: Journal of Law-Medicine 393 (2026) (226 Footnotes) (Full Document)

The Civil Rights Act of 1964 is a landmark civil rights legislation that requires federal agencies and federally funded contractors to provide equal access to all residents in the United States. Under Title VI of the Civil Rights Act, federal agencies cannot provide federal financial assistance to grant recipients who intentionally exclude people from receiving services or participating in federal programs due to their race, color or national origin. Title VI applies to the Health and Human Services Administration and all federally funded healthcare recipients, including medical research sites. Many federal agencies, including the National Institute of Health (“NIH”), the National Science Foundation, and the Department of Defense fund medical research with human subjects. Institutions that receive federal dollars must serve all Americans, or they are excluded from receiving federal funds.

Medical researchers and institutions receiving federal funds run afoul of the Civil Rights Act when they exclude research participants with limited English fluency from clinical research trials because federally-funded healthcare entities are required to provide meaningful access to Limited English Proficiency (“LEP”) populations. Title VI of the Civil Rights Act prohibits exclusion or discrimination based on a person’s national origin, which includes non-English speakers or LEP populations. Yet, exclusions of LEP populations in medical research have increased as LEP populations in the United States have increased. Federal agencies should not allocate federal dollars to clinical research trials that actively discriminate against LEP populations, effectively ignoring the most significant piece of civil rights legislation passed in the 20th century.

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Everyone who designs, implements, reviews, or funds clinical trials that include human subjects is responsible for following the federal laws and guidelines that prohibit national origin discrimination. Additionally, it is imperative to recognize the negative impacts of excluding LEP populations from clinical research. English-only exclusions undermine trust in science and reinforce healthcare inequities, which limit access to new treatments and medical technologies leading to people living longer and healthier lives. The available mechanisms to challenge exclusion criteria are minimal and require individual complaints from those LEP participants who are excluded. The result is a documented increase in exclusion criteria over the past 25 years that prevents LEP populations from participating in federally funded clinical trials. LEP exclusion from federally funded medical research will continue until IRBs, peer reviewers and federal agencies identify these exclusions as national origin discrimination and take steps to address exclusion criteria. Research scientists must recognize these exclusions as ethically unacceptable and unlawful. Providing meaningful access to clinical research is imperative in a country as multi-lingual as the United States, because all Americans have the right to participate in taxpayer-funded medical research. Research that reflects the American public legitimizes clinical studies and increases trust in science.

IRBs should carefully review study protocols, including the study recruitment plan often required in research protocols, and ask thoughtful questions about whether these recruitment plans will actually increase LEP population access to the clinical trial. Peer reviewers reviewing research protocols must think critically about where research is occurring and who is being excluded from the potential participant lists. Criteria that exclude LEP populations or require ““English fluency” should be questioned and required to provide scientific justification. Lastly, federal agencies that work with peer reviewers must identify language exclusion policies for what they are: national origin discrimination. These federal agencies should refuse to allocate funding unless English-only exclusions are removed and the study design truly reflects the population it claims to serve.

Title VI is a federal mandate prohibiting research sites from engaging in national origin discrimination, and clinical trials can meet that mandate with an open mind and an understanding that their research is only as good as the breadth of human subjects they enroll. LEP communities should be able to participate in the programs they fund through their taxes, and this includes participation in clinical research trials that seek to improve public health and find solutions to our medical mysteries.

Assistant Professor, Center for Bioethics and Humanities, State University of New York Upstate Medical University.