INFORMING THE CHILD AND ASSENT
Information about the study must be provided to children in language appropriate for their age
- active written “assent” should be obtained from children of appropriate intellectual age (often 7 years of age, but defined by the local IRB)
- such “assent” includes the child’s right to refuse to participate or withdraw from the study at any time
- may be over-ridden by parental consent in therapeutic trials where the child’s welfare is endangered by not participating