Chicken Soup for the Busy Coordinator February 2009

Tip of the Month Scenario: I am designing a consent form for a study which involves children as clinical trial participants. Do the regulations require the informed consent document to contain a space for assent by children? How do I obtain assent from the children?

Answer No. Ethics Committees generally require investigators to obtain the permission of one or both of the parents or guardian (as appropriate) and the assent of children who possess the intellectual and emotional ability to comprehend the concepts involved. Assent may be obtained through various methods 1) verification by a third party who signs on the consent form (especially for younger children) 2) signing the consent form for older children

References SGGCP CFR 50 Protection of Human Subjects Subpart D - Additional Safeguards for Children in Clinical Investigations. 45 CFR 46 Subpart D - Additional Safeguards for Children in Clinical Investigations. ICH Guideline for Good Clinical Practice

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