CITI - 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

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 a language the subject speaks fluently

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

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.