Informed Assent for Clinical Trials for Children/Minors


Summary

This template can be used as an informed assent for clinical trials when the subjects are children/minors. It is intended as a general drafting aid and will require modification for the specific clinical trial. This template includes practical guidance, drafting notes, and alternate clauses. Informed consent involves many factors, including: • Providing a potential subject with enough information to allow for an informed decision about the subject's participation in the clinical trial • Facilitating the potential subject's understanding of the information • Providing opportunity for the potential subject to ask questions and to consider whether to participate • Obtaining the potential subject's voluntary agreement to take part in the clinical trial and • Continuing to provide information as the clinical investigation moves forward Children are those persons who have not yet reached the legal age for consent to treatments that are a part of research (45 C.F.R. § 46.402(a)), and this age...