Challenge: Informed Consent Documents
Question Number 1

Where would you find the following statement regarding informed consent?

"No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence."

A
ICH GCP
B
21 CFR
C
Declaration of Helsinki
D
EU Clinical Trials Directive 2001/20/ec

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