Monday, March 2, 2015

University of Minnesota administration needs to learn that unethical can be as important as illegal, especially at a university.

But, how much damage will this do to our brand?

In response to a Minnesota Daily piece on the release of the University funded report on clinical trials - but not the Markingson situation - I wrote the following:

The most disappointing thing about this review is the reaction of the administration:“I am particularly gratified—but not surprised—that the panel found no legal or compliance violations, affirming numerous previous reviews and accreditations of our program” President Kaler

There is a significant difference between unethical and illegal. Sadly the same kind of rationalization was used by former AHC vice-president and medical school dean, Frank Cerra, while the conflict of interest scandal was going on. See:"We're not violating a legal statute."link:

This kind of response is not worthy of an institution purporting to be a great university.

Our "brand" certainly has been damaged by this clinical trials fiasco. Claiming to potential participants in research trials that we will do nothing illegal to them is hardly an encouragement to participate.

And for those without the free time to read the report, here are some examples that should serve as examples of why fixing the situation in our clinical trials operation and medical school is so important.

Bill Gleason
UofM grad and former med school faculty

"For example, faculty and staff in Psychiatry repeatedly characterized the climate of work as a 'culture of fear.' They provided stories of intimidation by researchers and fear of retaliation should staff voice opposition to practices that were of concern."

"The review team found little evidence that the University’s IRB engaged in a meaningful process of evaluating research risk."

"Investigators have failed to address issues of vulnerability to coercion or undue influence."

“It was clear to the external review team that the membership of the Medical IRBs did not include sufficient members with the scientific expertise necessary to adequately address the research being reviewed at corresponding meetings.”

“The failure to have either adequate number of IRB members, or adequate expertise, during IRB deliberations raises profound questions about the IRB’s ability to conduct a robust and reliable protocol review.”

“Of the 30 protocols examined for scientific review, five cases were identified where the scientific review was completed by a subordinate faculty member for research in which a department chair was the principal investigator. In these cases, a conflict of interest exists and the risk of bias in the review is significant.”

“Accordingly, the minutes did not completely or accurately appear to represent what occurred during the IRB meetings. “

“The review process, as documented in the minutes, does not reflect a meaningful discussion of the risks and benefits of research protocols and the necessary steps taken to protect human subjects in the face of scientific or ethical concerns. “

If anyone should be stumbling on the Markingson case at the University of Minnesota for the first time, copious posts have been made on this blog regarding this sad situation.

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