Consent with Subjects Who Do Not Speak English

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

Federal regulations (21 CFR 50.20 and 45 CFR 46.116) state that the information given in the consent process must be:

n language understandable to the subject

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.

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.

The consent process must allow subjects to consider whether or not to participate. Which of the following would be the best way to enhance subject understanding for non-English speakers?

Providing interpreters and time for discussion with advocates during the consent discussion.

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.