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RELEASE: Rep. Bernardy drug trial monitoring proposal included in budget agreement

Sunday, May 22, 2016

ST. PAUL – As work wraps up at the state legislature this weekend, a proposal of Rep. Connie Bernardy (DFL – New Brighton) to require greater monitoring of clinical drug trials at the University of Minnesota was included in the final budget agreement. This came in the wake of a highly critical report by the nonpartisanOffice of the Legislative Auditor which outlined numerous ethical issues and conflicts of interest at the University’s Department of Psychiatry.

“Some of the most vulnerable Minnesotans participate in this program, and some of these activities have led to unfortunate tragedies,” Rep. Bernardy said. “Regrettably, adequate progress has not been made by the U of M regarding the Legislative Auditor’s recommendations, and I’m pleased this budget bill will begin to get us in the right direction.”

Under the bill, $100,000 will be appropriated to the Ombudsman for Mental Health at the U of M to conduct this monitoring. Lack of actually implementing all the needed reform makes it difficult to ensure the University is addressing the identified problems. One of those who blew the whistle was Niki Gjere, a constituent of Rep. Bernardy who has been a U of M Institutional Review Board member.

"Under the leadership of Rep. Connie Bernardy, the legislature has demonstrated their commitment to safety and ethical treatment of vulnerable people in psychiatric clinical drug trials,” Gjere said. “External monitoring has been desperately needed. The Ombudsman's office will now have the power and authority to hold the researchers in the Department of Psychiatry accountable."

“Without people like Ms. Gjere having the courage to speak up, investigations may not have been as effective,” Rep. Bernardy continued. “She had a wonderful op-ed in the Star Tribune earlier this month in support of this measure, and her voice has truly affected change which will help protect Minnesotans.”

The measure, as part of the larger Omnibus Supplemental Budget Bill, is expected to be voted upon later today by the House and Senate. The constitutional deadline for passage of bills by the Legislature is midnight tonight.