Consent with Subjects Who Do Not Speak English
Quiz Results
You correctly answered 5 of 5 quiz questions.
Question 1
Question 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?
Your Answer Cultural differences
Result Correct
Comment Not speaking English in the U.S. typically indicates cultural differences
(such as, deference to authority), which must be considered and addressed.
Ignorance, lack of formal education, and incapacity are not directly
associated with an inability to speak a second language.
Question 2
Question Informed consent can be facilitated in a variety of ways. Which of
the below is the best way to enhance the understanding of research?
Your Answer: Asking a staff person who speaks the subject’s language fluently to explain
the concepts in the consent form.
Result Correct
,Comment Asking a staff person who speaks the subject’s language fluently to
explain the form is the best option presented above to enhance subject
understanding. Reading the consent to a subject, testing, and
improving the readability and design of the consent form does not
necessarily enhance understanding; a two-way conversation is needed.
Question 3
Question When a researcher is conducting an interpreter-mediated consent
discussion with subjects, which of the following is an appropriate action for
the interpreter?
Your Answer The interpreter may explain research-related terms to the subject using
culturally relevant examples.
Result Correct
Comment The interpreter may explain research-related terms to the subject using
culturally relevant examples; for example, explaining randomization as the
tossing of prayer stones rather than pulling numbers from a hat. An
interpreter is not allowed to share his or her opinion with the subject
regarding concerns they may have related to the researcher’s study plan
according to the National Standards of Practice. The interpreter must
remain transparent at all times, only interpreting what has been said by
researcher and subject.
Question 4
Question 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:
Your Answer IRB approval of a written summary of information to be presented
Result Correct
Comment 21 CFR 50.27(b)(2) (Protection of Human Subjects 2015) and 45 CFR
46.117(b)(2) (Protection of Human Subjects 2017) state that “the consent
form may be…: A short form written consent document stating that the
elements of informed consent … have been presented orally to the subject or
the subject's legally authorized representative.” When this method is used,
there shall be a witness to the oral presentation. In addition, the IRB shall
, approve a written summary of what is to be said to the subject or the
representative. An information sheet may be close to what the regulations
require, but there is no requirement for a specific reading level. While a
witness is required when using a short form, a LAR is not. There is no
requirement for researcher fluency.
Question 5
Question Federal regulations (21 CFR 50.20 and 45 CFR 46.116) state that
the information given in the consent process must be:
Your Answer In language understandable to the subject
Result Correct
Comment Federal regulations state that information given in the consent process
must be in language understandable to the subject. While this generally
would be a language the subject speaks, this is not specifically required by
the regulations and there is no requirement for fluency. 21 CFR 50.20 and
45 CFR 46.116 address the consent process, not the consent form – the
written form might only be a statement that the information has been
provided. There is no federal requirement for back-translation, although
most IRBs require some type of verification that translations are accurate.
Consent with Subjects Who Do Not Speak English
Quiz Results
You correctly answered 5 of 5 quiz questions.
, Question 1
Question When a researcher is conducting an interpreter-mediated consent
discussion with subjects, which of the following is an appropriate action for
the interpreter?
Your Answer The interpreter may explain research-related terms to the subject using
culturally relevant examples.
Result Correct
Comment The interpreter may explain research-related terms to the subject using
culturally relevant examples; for example, explaining randomization as the
tossing of prayer stones rather than pulling numbers from a hat. An
interpreter is not allowed to share his or her opinion with the subject
regarding concerns they may have related to the researcher’s study plan
according to the National Standards of Practice. The interpreter must
remain transparent at all times, only interpreting what has been said by
researcher and subject.
Question 2
Question 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.
Your Answer Teach-back method
Result Correct
Comment Training research assistants to ensure their understanding of possible
language barriers, and explaining the purpose of the research study to
potential subjects when obtaining consent as well as the use of teach-back
methods are recommended tools to inform about consent and authorization,
and to verify comprehension.
Question 3
Question 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:
Quiz Results
You correctly answered 5 of 5 quiz questions.
Question 1
Question 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?
Your Answer Cultural differences
Result Correct
Comment Not speaking English in the U.S. typically indicates cultural differences
(such as, deference to authority), which must be considered and addressed.
Ignorance, lack of formal education, and incapacity are not directly
associated with an inability to speak a second language.
Question 2
Question Informed consent can be facilitated in a variety of ways. Which of
the below is the best way to enhance the understanding of research?
Your Answer: Asking a staff person who speaks the subject’s language fluently to explain
the concepts in the consent form.
Result Correct
,Comment Asking a staff person who speaks the subject’s language fluently to
explain the form is the best option presented above to enhance subject
understanding. Reading the consent to a subject, testing, and
improving the readability and design of the consent form does not
necessarily enhance understanding; a two-way conversation is needed.
Question 3
Question When a researcher is conducting an interpreter-mediated consent
discussion with subjects, which of the following is an appropriate action for
the interpreter?
Your Answer The interpreter may explain research-related terms to the subject using
culturally relevant examples.
Result Correct
Comment The interpreter may explain research-related terms to the subject using
culturally relevant examples; for example, explaining randomization as the
tossing of prayer stones rather than pulling numbers from a hat. An
interpreter is not allowed to share his or her opinion with the subject
regarding concerns they may have related to the researcher’s study plan
according to the National Standards of Practice. The interpreter must
remain transparent at all times, only interpreting what has been said by
researcher and subject.
Question 4
Question 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:
Your Answer IRB approval of a written summary of information to be presented
Result Correct
Comment 21 CFR 50.27(b)(2) (Protection of Human Subjects 2015) and 45 CFR
46.117(b)(2) (Protection of Human Subjects 2017) state that “the consent
form may be…: A short form written consent document stating that the
elements of informed consent … have been presented orally to the subject or
the subject's legally authorized representative.” When this method is used,
there shall be a witness to the oral presentation. In addition, the IRB shall
, approve a written summary of what is to be said to the subject or the
representative. An information sheet may be close to what the regulations
require, but there is no requirement for a specific reading level. While a
witness is required when using a short form, a LAR is not. There is no
requirement for researcher fluency.
Question 5
Question Federal regulations (21 CFR 50.20 and 45 CFR 46.116) state that
the information given in the consent process must be:
Your Answer In language understandable to the subject
Result Correct
Comment Federal regulations state that information given in the consent process
must be in language understandable to the subject. While this generally
would be a language the subject speaks, this is not specifically required by
the regulations and there is no requirement for fluency. 21 CFR 50.20 and
45 CFR 46.116 address the consent process, not the consent form – the
written form might only be a statement that the information has been
provided. There is no federal requirement for back-translation, although
most IRBs require some type of verification that translations are accurate.
Consent with Subjects Who Do Not Speak English
Quiz Results
You correctly answered 5 of 5 quiz questions.
, Question 1
Question When a researcher is conducting an interpreter-mediated consent
discussion with subjects, which of the following is an appropriate action for
the interpreter?
Your Answer The interpreter may explain research-related terms to the subject using
culturally relevant examples.
Result Correct
Comment The interpreter may explain research-related terms to the subject using
culturally relevant examples; for example, explaining randomization as the
tossing of prayer stones rather than pulling numbers from a hat. An
interpreter is not allowed to share his or her opinion with the subject
regarding concerns they may have related to the researcher’s study plan
according to the National Standards of Practice. The interpreter must
remain transparent at all times, only interpreting what has been said by
researcher and subject.
Question 2
Question 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.
Your Answer Teach-back method
Result Correct
Comment Training research assistants to ensure their understanding of possible
language barriers, and explaining the purpose of the research study to
potential subjects when obtaining consent as well as the use of teach-back
methods are recommended tools to inform about consent and authorization,
and to verify comprehension.
Question 3
Question 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:
