How do I consent children, and when is a child assent form necessary?
When children or minors are involved in research, the regulations require the assent of the child or minor and the permission of the parent(s) in place of the consent of the subjects. Given that children have not reached their full intellectual and emotional capacities and are legally unable to give valid consent, involving children in research requires the permission of their parents or legally authorized representatives. The HSC must ensure that adequate provisions are made for soliciting the assent of the children when in the judgment of the HSC the children are capable of providing assent. While children may be legally incapable of giving informed consent, they nevertheless may possess the ability to assent to or dissent from participation. Out of respect for children as developing persons, children should be asked whether or not they wish to participate in the research, particularly if the research: (1) does not involve interventions likely to be of benefit to the subjects and (2)
When children or minors are involved in research, the regulations require the assent of the child or minor and the permission of the parent(s) in place of the consent of the subjects. Given that children have not reached their full intellectual and emotional capacities and are legally unable to give valid consent, involving children in research requires the permission of their parents or legally authorized representatives. The HSC2 must ensure that adequate provisions are made for soliciting the assent of the children when in the judgment of the HSC2 the children are capable of providing assent. While children may be legally incapable of giving informed consent, they nevertheless may possess the ability to assent to or dissent from participation. Out of respect for children as developing persons, children should be asked whether or not they wish to participate in the research, particularly if the research: (1) does not involve interventions likely to be of benefit to the subjects and (
