"If the study involves children or persons with impaired
decision-making capacity, how will the assent of each person be
obtained?" Gene transfer studies may enroll children or
cognitively impaired persons if the investigator can provide
justification for their participation in the study. In such
instances, investigators must obtain permission from the legally
authorized representative of the child or cognitively impaired
person. Investigators must also obtain the assent of the
potential participant when appropriate. Permission from Legally
Authorized Representatives: For potential participants who
cannot give consent, investigators must obtain permission from a
legally authorized representative of the potential participant.
For children, this is usually the parent. For adults, it may be
someone designated as health care proxy. The permission process
should include instruction to the parents and/or legally
authorized representatives regarding the difference between
permission for treatment and permission for