The informed consent document (ICD) is a cornerstone of ethical clinical research, ensuring voluntary participation and protection of subject rights.
21 CFR 50.25(a):Requires the consent form to containall basic elements, including study purpose, risks, benefits, alternatives, confidentiality, compensation, and voluntariness.
ICH E6(R2) 4.8.10:Expands on these requirements, ensuring the ICD contains every mandated element without omission.
Thus, the correct statement is that the ICDmust include all applicable mandated basic elements(D). Options A and B confuse who signs—subjects or legally authorized representatives sign when applicable, not the IRB chair. Option C is incorrect because leaving out elements would violate compliance.
Correct answer:D.
[References:, 21 CFR 50.25(a)., ICH E6(R2), §4.8.10., ]
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