Exempt Research with Children as Subjects

Some types of research are considered exempt even when children are subjects. However, some types of research considered exempt when subjects are competent adults are not exempt when children are subjects. Research involving survey or interview procedures is not exempt when children are subjects. Research involving observation of public behavior is exempt only if the researcher does not participate in the activities being observed. Both exempt and not exempt research must be reviewed by Research Compliance Services and/or the CPHS/IRB. In all cases, the assent of the children, and consent of parent(s) or guardian, must be obtained prior to conducting the research.

If a child is a ward of the state or any other agency, institution, or entity, he or she may be a research subject only if the research is 1) related to his or her status as a ward or 2) conducted in a school, camp, hospital, institution or similar setting in which the majority of the children involved as subjects are not wards. An advocate must be appointed for each child who is a ward. This advocate must be a person who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child's participation in the research and who is not associated in any way (except as advocate or member of the CPHS/IRB) with the research, the investigator or the guardian organization. The requirement for an advocate is in addition to the requirement that permission be obtained from any other person acting on behalf of the child as guardian or in loco parentis.