Inclusion of non-English-speaking patients in research: A single institution experience

Abstract

Background: Considering the recent increase in medical care provided to patients from foreign countries and the diversity of languages spoken by families living within the United States, it is important to determine whether non-English-speaking patients have access to participate in clinical research from which they may benefit.

Aims: We aimed to determine the number of non-English-speaking patients presenting to Boston Children's Hospital for medical care between 2011 and 2016, the number of clinical research protocols active within the Department of Anesthesiology, Critical Care and Pain Medicine approved to enroll non-English-speaking patients, as well as the number of both non-English- and English-speaking patients approached and enrolled in these studies. Furthermore, we attempted to determine barriers that may have prevented non-English-speaking patients from inclusion in clinical research.

Methods: We conducted a retrospective review of various data sources during a 5-year period. Data included the number of non-English-speaking patients presenting to Boston Children's Hospital for care as well as the number of English- and non-English-speaking patients approached for studies at the Department of Anesthesiology each year. Additionally, we reviewed data from the IRB which included the justification that research teams provided when opting to exclude non-English-speaking participants. In addition, we attempted to determine the barriers that may have prevented these patients from inclusion in research protocols.

Results: We found that the number of non-English-speaking patients presenting to Boston Children's Hospital increased over time. However, the number of studies approved to enroll non-English-speaking patients within the Department of Anesthesiology and the rate of enrollment of these patients did not increase at the same rate.

Conclusion: In order to increase the number of non-English-speaking patients approached to participate in research, we must improve cultural awareness and provide investigators with resources for interpreter and translation services.

Keywords: cultural competency; cultural diversity; informed consent; language; research; research personnel.