HF3620 Summary

• Requires the ombudsman for mental health and developmental disabilities to monitor treatment of individuals participating in University of Minnesota Department of Psychiatry clinical drug trials and ensure compliance with federal human subjects protections and Institutional Review Board requirements.

• Grants the ombudsman authority to gather records related to clinical drug trials from the University of Minnesota Department of Psychiatry and to receive complaints about actions or inactions of the department related to trial participants.

• Mandates that the lead investigator of a clinical drug trial at the University of Minnesota Department of Psychiatry notify the ombudsman within 24 hours of any death or serious injury to a trial participant.

• Requires the University of Minnesota Board of Regents to reimburse the ombudsman's office for oversight costs incurred in monitoring clinical drug trial participants.

• Expands the Medical Review Subcommittee's duties to make preliminary determinations about deaths of clinical drug trial participants and determine if they warrant investigation and reporting under federal human subjects protection laws.