U.S. Department of Health & Human Services
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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.
Last Reviewed: 01/20/2011
Related Questions:
- Do both parents need to provide permission for their child to participate in research?
- What is child assent, and how do the requirements vary with the age of the research subjects?
- When does child assent have to be obtained for research and can it be waived?
- How should child assent for research participation be documented?
- Do parental permission and child assent for research involving children have to occur at the same time or in any particular order?
