Research Involving Children Who Are Wards of State or Any Other Agency, Institution, or Entity

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 that poses greater than minimal risk and does not present a prospect of direct benefit (45 CFR 46.406 and .407; and 21 CFR 50.53 and 54).

Specifically (45 CFR 46.409(a); 21 CFR 50.56(a)), children who are wards of the state or any other agency, institution, or entity can be included 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, only if such research is

1. Related to their status as wards; or
2. Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards.

The regulations further require (45 CFR 46.409(b); 21 CFR 50.56(b)) appointment of an advocate for each child who is a ward. The advocate will serve in addition to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as advocate for more than one child. 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 also 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 organization.

A ‘ward’ is a child who is has been placed under the care or protection of a guardian, court, or an agency that is legally responsible for the child. Foster children are wards; their care may be in the hands of a foster parent or a governmental agency such as Children’s Social Services. Children who live in an orphanage or penal institution may be wards. If needed, contact the Health System Legal Office at (734) 764-2178 for assistance in making the determination.

1. During the informed consent process determine if a child is a ward. When using the standard IRBMED template, this can be done by noting the bolded italic text under the parent’s signature line that states, “If this consent is for a child who is a ward of the state (for example a foster child), please tell the study team immediately.“
2. If the child is a ward, refer to the study records to see which of the children’s regulations(s) the study has been approved under. This information is in section 33 of eResearch.

Follow procedures below, depending on which regulations apply to your study:

For studies that involve no more than minimal risk (45 CFR 46.404 and/or 21 CFR 50.51); or that involve greater than minimal risk but present the prospect of direct benefit to the individual subjects (45 CFR 46 .405 and/or 21 CFR 50.52):

→ Request a copy of the guardianship papers to see if the guardian has legal authority to consent to the child’s participation in research. If needed, contact the Health System Legal Office at (734) 764-2178 for assistance.

For studies that pose greater than minimal risk and do not present a prospect of direct benefit (45 CFR 46.406 and .407; and 21 CFR 50.53 and 54):

1. Call the IRB office immediately at (734) 763-4768; after hours see the Emergencies/On-Call information on the website.
2. Call the UMHS Operator at (734) 936-4000 and ask for the Pediatric Ethics Committee (PEC) member on-call to be paged. The PEC can call the study team and select one of its members to serve as an advocate for the ward.
   • Provide the advocate with a copy of the guidance for advocates.
3. Conduct an informed consent interview with the guardian in the presence of the advocate.
4.  Conduct the assent process (if required) with the ward in the presence of the advocate.
5. Allow sufficient time for the advocate to discuss the study with the prospective subject, the guardian, and the study team.
6. If the guardian, advocate, and (in studies for which assent is required) the prospective subject agree that the child may participate in the research, have the consent/assent documents signed.
   • The guardian should sign the informed consent document (section 13 of the IRBMED standard template).
   • Ask the advocate to sign and date the informed consent document on the signature page, where room permits. Also print the advocate’s name.
   • Have the advocate complete and sign the Guidelines and Checklist for Advocates document. Retain the original for the study files and provide the advocate with a copy.
7. Send the IRB a correspondence that provides the name of the advocate and a brief description of the process that took place and includes a copy of the completed ‘Guidelines and Checklist for Advocates’ document.
   • eResearch studies – Post Correspondence in the approved study work-space indicating the IRB as a recipient of an email notification