Communicating informed consent with LEP participants during clinical trials: A case study

Healthcare systems are under pressure to eliminate disparities of care. Communication methods used with Limited English Proficiency (LEP) patients was presented in the literature as an essential component to deliver quality and equal care. Several strategies have been implemented to assess and target the communication methods between patients and health care teams. The challenge for health systems workers is to address communication barriers to eliminate disparities of care and medical errors. The purpose of the present qualitative case study was to explore if communication barriers affect the understanding of LEP research participants while participating in the informed consent process during clinical trials. Communication barriers during the informed consent process may affect clinical trial outcomes. In the study, the use of a triangulation data gathering method was associated with a qualitative case study. Data regarding barriers of communication during the informed consent process were gathered by performing semistructured interviews. The study population included six principal investigators, five interpreters, and nine LEP research participants. Data analysis involved reviewing the emerging themes from participants’ responses. Results indicated four major themes supporting communication challenges. The themes included authority figure, cultural sensitivity, communication barriers, and education. The study suggested the need for further research regarding communication barriers during the clinical trials process