Special Considerations for Enrollment of Wards of the State

Our initial review submission forms ask sites if they plan to enroll wards of the state. Federal regulation 45 CFR § 46.409 outlines special requirements for the involvement of wards in research.  Sites that plan to enroll wards may be required to provide a plan for appointing an advocate for each participant.  Some state and local laws also further restrict enrollment of wards in research. Additional guidance is also available in the FDA guidance document titled “Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors”.