How should parental permission for research involving children be documented?

Permission by parents or guardians shall be documented in accordance with and to the extent required by 46.117 of subpart A of 45 CFR part 46. Essentially, parental permission should be documented in a manner similar to that used to document informed consent. An Institutional Review Board (IRB) may find that waiver of documentation of informed consent is appropriate under the HHS regulations at 46.117.

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