consent with subjects who do not speak english

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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

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

The most concerning issue with using a family member to interpret in the consent process is that the family member may not:

Interpret accurately due to language issues, cultural standards, or embarrassment

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.

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


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