Research Involving Children who are Wards of State or any other Agency, Institution, or Entity
- Background Information-Why Does a Child's Status as a Ward Matter?
- What is a 'Ward'?
- What Steps Must a Study Team Take Before Enrolling a Ward in a Research Study?
Background Information-Why Does a Child's Status as a Ward Matter?
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.
What is a Ward?
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.
What Steps Must a Study Team Take Before Enrolling a Ward in a Research Study?
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. For studies in Legacy (paper application system), contact the IRB for this information.
- For studies approved under 45 CFR 46.404 or 45 CFR 46.405:
- 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 approved under 45 CFR 46.406 or 45 CFR 46.407:
- Call the IRB office immediately.
- After hours and on weekends also call the UMHS Operator at (734) 936-4000 and ask for the Pediatric Ethics Committee (PEC) member on-call to be paged to call the appropriate member of the study team. The PEC will select one of its members to serve as an advocate for the ward.
- Conduct an informed consent interview with the guardian in the presence of the advocate.
- Conduct the assent process (if required) with the ward in the presence of the advocate.
- Allow sufficient time for the advocate to discuss the study with the prospective subject, the guardian, and the study team.
- 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 12 of the IRBMED standard template).
- Provide the advocate with a copy of the guidance for advocates. (PDF)
- 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' (MS Word) document. Retain the original for the study files and provide the advocate with a copy.
- 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 this correspondence in the approved study work-space indicating the IRB as a recipient of an email notification
Page Updated: 3/6/2012
