There are both state and federal laws that regulate what is allowed and what must be done when a ward participates in a research study.
Legal guardianship in Michigan ranges in the level of authority granted to a guardian. If a child who is a prospective subject in a research study is determined to be a ward, the study team must request to see a copy of the guardianship papers to assure the guardian has legal authority to consent to the child's participation in research.
Federal regulations 45 CFR §46.409 and 21 CFR §50.56 require additional protections when children who are wards of the state or any other entity are enrolled in research approved under 45 CFR §46.406 and/or 21CFR §50.53, or under 45 CFR §46.407 and/or 21 CFR §50.54.
Specifically, the regulations require appointment of an advocate for each child who is a ward. The advocate must be an individual who has the background and experience to act in, and agrees to act in, the best interest of the child for the duration of the child's participation in the research and the advocate must not be associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.