§46.117. Documentation of informed consent. — Inbound Citations
45 C.F.R. § 46.117
Statutory Authority
Cited by 5 regulations in release Current.
Citations to 45 U.S.C. § 46.117 as a whole
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(ii) Documentation of informed consent or waiver of documentation of consent was obtained in accordance with § 46.117;
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(c) An IRB shall require documentation of informed consent or may waive documentation in accordance with § 46.117.
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(5) Informed consent will be appropriately documented or appropriately waived in accordance with § 46.117.
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(d) Permission by parents or guardians shall be documented in accordance with and to the extent required by § 46.117 of the pre-2018 Requirements or the 2018 Requirements, as applicable.