Introduction

Federal regulations require additional safeguards for certain categories of research involving wards of the state. These protections are outlined in Subpart D of 45 CFR 46 (Additional Safeguards for Children Involved in Research).

Definitions

Ward: A ward is a child who is placed in legal custody of the State or other agency, institution, or entity, consistent with applicable Federal, State, or local law.  The term “ward of State” may be used interchangeably with “ward” in this guidance. A court may take responsibility for the legal protection of the individual, and will generally stand in loco parentis to the child. Generally, this entails assuming all lawful authority to make medical and legal decisions on the individual’s behalf.

Guidance

In order for the IRB to determine whether additional safeguards are required for wards of the state in research, the IRB must first determine which approvable category the children’s research falls under. The categories are as follows:

1. Research involving no greater than minimal risk.
2. Research involving interventions or procedures that present greater than minimal risk but offers the prospect of direct benefit or may contribute to the well-being of the individual child.
3. Research involving interventions or procedures that present a minor increase over minimal risk and no prospect of direct benefit to individual children, but likely to yield generalizable knowledge about the child’s disorder or condition.
4. Research not otherwise approvable, but which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. Research in this category must be reviewed and approved by the Secretary of DHHS or the Commissioner of the FDA.

For more information, please refer to the guidance topic, Children, on the IRB website.

Children who are wards of the state may be included in research. No additional regulatory protections apply if the research was approved under categories (1) and (2) above. Because the state will likely stand in loco parentis for the child, obtaining and accurately documenting both parental permission and child assent for the study may pose unique challenges for the investigator.

Obtaining and Documenting Valid Parental Permission and Assent
All investigators conducting studies involving wards of the state should address the following issues related to the consent process and documenting parental permission and assent:

1. Documentation should be obtained from all persons who provide “parental permission” for the ward. This means the guardian is required to provide a signature on the parental permission document. A Waiver of Documentation may be utilized for the ward on a case-by-case basis.
2. The investigator should maintain documentation in their research files of guardian’s official designation by the state as the person who may make medical and legal decisions for the ward.
3. The investigator must provide the IRB with a specific description of how the consent process will be handled for wards of the state. The description should include a contingency for re-consenting participants/their parents in cases where guardianship is returned to the former ward’s biological parent(s) while they are participating in the study, as applicable.
4. Parental Permission cannot be waived for studies subject to FDA regulation.

Additional Protections for Studies that are Greater than Minimal Risk and Offer No Prospect of Direct Benefit to the Participant

The IRB may approve research involving wards approved under category (3) and (4) above only if such research is either a) related to their status as wards; or b) conducted in schools, camps, hospitals, institutions, or similar settings in which most children involved as children are not wards. 

Additionally, the IRB must require 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. 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. 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.

Documents and References

Additional Protections for the Inclusion of Children in Research (FDA): 21 CFR 50

Additional Protections for the Inclusion of Children in Research (OHRP): 45 CFR 46, Subpart D

University of Utah IRB Guidance Topics: Children

Points to Consider