Re-examination of a Child’s Assent to Participate in Research

A pediatric intensivist from the United Kingdom (UK) critically examined international research guidelines that require children of a certain age to assent to participate in research, and argues that the concept of assent “lacks meaning and should be removed from existing guidelines.” The author reaches this conclusion by first illustrating the lack of clarity in definitions of assent among several international research guidelines. For instance, the American Academy of Pediatrics defines assent as “active agreement by a minor, not qualified to consent, to participate in a research study.” The United States Code of Federal Regulations defines assent as “a child’s affirmative agreement to participate in research… Failure to object, absent affirmative agreement, should not be construed as assent.” The Royal College of Paediatrics and Child Health of the UK …