Section 5.1 of the SOP for Obtaining and Documenting Informed Consent explains when informed consent needs to be obtained.
In accordance with federal regulations 45 CFR 46.116 and 21 CFR 50.20, except as provided elsewhere in the federal regulations, no investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include or have the appearance of including 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.
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