How can consent be obtained from children or from persons with an impaired ability to understand a consent form?
The key requirement is to use language that will be understandable to the person and to take sufficient time to be sure that the person understands the nature of the research and any risks before requesting agreement from the person to participate in the research. See the example of an assent form for a child in Appendix C-2 (on page 23) of Policies and Procedures. For other situations with vulnerable populations, consult Subparts B, C, and D of the Federal Policy at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.
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