Report: Problems continue in U of M research

Published 10:51 am Friday, February 12, 2016

MINNEAPOLIS — Problems continue with psychiatric research practices at the University of Minnesota more than a decade after a schizophrenic patient killed himself while enrolled in a drug trial, a review released Thursday found.

The assessment by a private consultant is the latest following the 2004 death of Dan Markingson.  Among the findings were underqualified staff interacting with clinical research subjects and a psychiatrist enrolling children in clinical trials without first getting written consent from their parents.

The report was being distributed Thursday at the Board of Regents’ audit committee meeting. University officials said in a letter accompanying the review that many of the problems were previously identified and are being addressed.

Email newsletter signup

Findings included a receptionist saying she conducted psychotherapy visits and a psychiatrist enrolling children in clinical trials with only verbal or over-the-phone approvals from parents and getting written consent later.

The report also found instances in the Department of Psychiatry of documents being belatedly fixed or completed so research protocols would be in compliance with ethics rules and pass muster.

“The standard research practices in the Department of Psychiatry demonstrate a profound lack of knowledge about how to conduct clinical research and an intentional lack of adherence to requirements set forth by the U of M IRB (Institutional Review Board) and state and federal regulatory agencies,” the report said.

In the letter accompanying the review, university officials said the school “is committed to correcting all issues identified by the many reviews that have occurred over the past year to ensure the safety of all human research participants, and to be sure that all research is conducted in the most thorough and ethical manner.”

Last year, Minnesota’s legislative auditor reviewed the university’s research practices and found school researchers should report more quickly patients’ serious medical issues during clinical trials. The U.S. Food and Drug Administration earlier investigated the death of Markingson and found no evidence of wrongdoing by the university.