Consent with Subjects Who Do Not Speak English
In certain circumstances, the federal regulations permit researchers to enroll subjects without a written translation by using a "short form" written consent document, in a language the subject understands. Researchers should know that the use of a short form is conditioned upon:
IRB approval of a written summary of information to be presented
Informed consent can be facilitated in a variety of ways. Which of the below is the best way to enhance the understanding of research?
Asking a staff person who speaks the subject's language fluently to explain the concepts in the consent form.
Federal regulations (21 CFR 50.20 and 45 CFR 46.116) state that the information given in the consent process must be:
In language understandable to the subject
Researchers should engage certified interpreters to ensure the subject's comprehension. Even so, communication and comprehension may be difficult. The best strategy for the researcher is to:
Meet with the interpreter prior to meeting with the subject to ensure the interpreter understands the terms and concepts.
When developing a research project that will enroll non-English speakers, researchers should:
Prepare consent documents at an eighth-grade reading level or lower and budget for the cost of translation.
One way to enhance the understanding of research through the consent process for non-English speakers is to train research assistants to use which of the following when explaining the purpose of the research study and study procedures to potential subjects.
Teach-back method
When a researcher is conducting an interpreter-mediated consent discussion with subjects, which of the following is an appropriate action for the interpreter?
The interpreter may explain research-related terms to the subject using culturally relevant examples.
A subject who does not speak English in the U.S. may indicate other areas that must be considered and addressed by researchers. Which of the following is most typically an associated concern?
Cultural Differences
