Medical interpretation expert co-authors CITI Program module on obtaining consent from non-English-speaking study populations

September 08, 2016

A UMass Medical School expert on medical interpretation and cultural competency has co-authored an advanced Collaborative Institutional Training Initiative (CITI Program) module to instruct researchers on strategies to obtain informed consent from potential study participants who do not speak English well. 

“We need to go the extra mile when someone doesn’t speak and/or understand English or is of a different culture,” said Lisa Morris, MSTD, director of Cross Cultural Initiatives at the Massachusetts Area Health Education Center (MassAHEC) Network, a unit within UMass Medical School’s Commonwealth Medicine division.

The CITI Program is a training program researchers across the U.S. and around the world take to prepare for the Institutional Review Board (IRB).  The module focuses on the role language plays in developing consent processes and obtaining informed consent from study populations who do not speak English sufficiently to understand the research project. It was designed to be taken after researchers complete basic informed consent training.

The module includes federal regulations and guidelines on recruitment and consent for study participants who do not speak English; the role of interpreters in obtaining consent; the challenges facing researchers who are not fluent in the potential participant’s language; and strategies to enhance understanding for participants who do not speak English well.

Researchers working with study populations that do not speak English should confirm that participants understand the information by asking them to repeat it back to the research staff, Morris said.

Clinical and biomedical research may include information that is complex, the authors said. The information should be communicated through an interpreter with training in and understanding of medical and research terminology.

“When research staff work with an interpreter, it’s important to make sure the interpreter understands,” Morris said. “Interpreters know the language, but they may not know the complexities of what’s being communicated specific to the proposed project.”

“Technical terms and jargon involved in informed consent and research may be new to the interpreter. Researchers may need to educate the interpreter before going forward with an actual interpretation,” Morris said.

Individuals who do not speak English in the U.S. also may have cultural differences that must be considered, the authors said. Someone from a culture in which deference to authority is ingrained, for example, may agree to participate in a study just because the doctor suggested it, Morris said.

Another consideration is the complexity of the consent form. If it is too complicated, it may be too complex for the study participant to understand, Morris said. Researchers should ensure the instructions about the research project are at an appropriate reading level.

Morris began working on the module in 2015 with Gary L. Chadwick, PharmD, MPH, CIP, professor emeritus in the Department of Medical Humanities and Bioethics at the University of Rochester and senior consultant at the HRP Consulting Group. The module was approved in April 2016 and published in June.

Morris received a Special Award Certificate for her work on the module from Commonwealth Medicine.

Morris has extensive experience in medical interpreting. She collaborated with MassHealth, Massachusetts’ Medicaid program, and the Massachusetts Commission for the Deaf and Hard of Hearing on a 16-hour program to teach American Sign Language interpreters with little to no medical training to work with medical terminology, clinical procedures and ethical issues in health care settings.

MassAHEC has run a statewide program to train spoken language medical interpreters in partnership with MassHealth for the past 17 years; the course has served as a model for national medical interpreter certification requirements. MassAHEC and MassHealth also sponsor an annual one-day conference, Paving the Way to Health Care Access, for medical interpreters and the health care teams who work with them.

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