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MN HF3553

Bill

Status

Introduced

3/23/2016

Primary Sponsor

Cindy Pugh

Click for details

Origin

House of Representatives

89th Legislature 2015-2016

AI 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.

  • Authorizes the ombudsman to gather records related to clinical drug trials from the University of Minnesota Department of Psychiatry and requires the university to notify the ombudsman within 24 hours of any death or serious injury to a trial participant.

  • Prohibits retaliation or adverse action against individuals participating in drug trials or anyone who makes complaints, and protects complainant confidentiality upon request.

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

  • Expands the Medical Review Subcommittee's authority to make preliminary determinations regarding deaths of clinical drug trial participants and to report findings to the Board of Regents of the University of Minnesota.

Legislative Description

Mental health and developmental disabilities ombudsman required to monitor drug trials.

Last Action

Motion to recall and re-refer, motion prevailed Higher Education Policy and Finance

4/1/2016

Committee Referrals

Higher Education Policy and Finance4/1/2016
Health and Human Services Reform3/24/2016
Higher Education Policy and Finance3/23/2016

Full Bill Text

No bill text available