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E. Informed Consent Elements of Disclosure
Pages 92-94

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From page 92...
... , 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 will minimize the possibility of coercion or undue influence.
From page 93...
... (d) An TRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the TRB finds and documents that: (~)
From page 94...
... (e) The idled consent re~ircme~s in this policy are Dot lme~ed to preempt am applicable federal, state, or local laws which rewire additional ideation to be disclosed in order far indeed consent to be legaHy c~clive


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