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CRC Foundations - Informed Consent questions with answers.
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CRC Foundations - Informed Consent questions with answers.
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CRC Foundations - Informed Consentquestions with answers.
Discuss the impact and applicability of federal regulations, international guidelines, and state law on
informed consent documents and process. ANS -
Define the roles and responsibilities of the Institutional Review Board (IRB), principal investigator (PI),
and CRC in the informed consent process. ANS -
Explain the difference between the informed consent form and the process. ANS -
Identify required and additional elements of the informed consent document. ANS -
Describe situations that require subject re-consent. ANS -
Identify resources to consult when creating a consent form document. ANS -
Describe types of consent waivers and when waivers may apply in a study. ANS -
List ways researchers can assess subject understanding. ANS -
Explain consent form documentation requirements ANS -
Define therapeutic misconception and describe ways to mitigate it. ANS -
In the U.S., consent form and process must comply with:
A) ICH E6 and state laws
, B) HHS and FDA regulations, and state laws, as applicable to the study
C) ICH E6
D) HHS and FDA regulations, as applicable to the study ANS - HHS and FDA regulations, and state laws,
as applicable to the study
The correct response is that in the U.S., ICH E6 is considered a guideline. However, studies must comply
with HHS and FDA regulations as well as state laws, as applicable to the study.
Therapeutic misconception can be avoided by:
A) Increasing length of consent form
B) Avoiding use of consent templates or checklists
C) Verifying comprehension before signature is obtained
D) Limiting the consent process to consent forms, and not using videos or pamphlets ANS - Verifying
comprehension before signature is obtained
The correct response is that according to the AAMC (2007), employing supplemental materials such as
videos or pamphlets, decreasing the length of consent forms, using consent templates or checklists, and
verifying comprehension before signature is obtained can all reduce therapeutic misconception.
Which of the following is an incorrect statement regarding the obligations of the person obtaining
consent?
A) Guarantee that the subject has read the consent form
B) Avoid undue influence during the consent process
C) Present the consent form in a language the subject understands
D) Ensure the potential subject has ample time to read the consent form ANS - Guarantee that the
subject has read the consent form
The correct response is that the person obtaining consent is not obligated to guarantee that the subject
read the consent form. The consent form must be presented in a language the subject understands and
the consent process must not involve undue influence or coercion. Though the subject must be given
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