What is the role of an advocate in research involving children?
The advocate must be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child throughout the duration of the child’s participation in the research. This includes ensuring that to the extent possible, the child understands what will be required of him or her during the research, and that if capable, the child provides his or her assent to participate. Acting in the best interests of the child could include evaluating the ongoing impact of the research study on the child. The advocate should represent the individual child subject’s interests throughout the child’s participation in the research. This added protection is intended to ensure that the ward, who is particularly vulnerable, is not exploited, coerced, or subjected to undue influence or harm in the course of the research. HHS regulations further require that the advocate not be associated in any way (except in the role of advocate or member of the Institutional Review Bo
