Monday, May 11, 2015

For the Record: Fear and Loathing at Fairview over U Psychiatry Research #Markingson

How does one "trust but verify" when there is
an admitted  culture of  "profound distrust?"

From MPR news:

Report: Deep distrust at Fairview over U psychiatry research

Alex Friedrich ·
An internal investigation at the University of Minnesota found that some Fairview Health Services personnel have a "profound" distrust of some U of M psychiatric researchers working there.

The report is the third this year to reveal dysfunctions in the university's psychiatry department. Critics suspect many of those problems were linked to the death of a mentally ill research subject during a drug trial in 2004.

The report, released late last week, adds context to findings in an external review from February that said the university's psychiatry department suffers from a "culture of fear" that hindered efforts to improve the protection of vulnerable research patients.

• Earlier: Legislative auditor blasts U over ethics, conflicts in drug trial patient's suicide

Although the internal report found no evidence that researchers had violated university policies regarding the protection of research subjects, it said some Fairview employees felt that policies ensuring proper consent and recruitment of patients were weak.

Conflicting attitudes about how to treat patients has created significant tension between Fairview and U of M personnel, the report said, and leaders of both organizations have done nothing to stop it.

"UMN and Fairview leadership appears insensitive to the cultural tensions and the causes of it," the report said. Management "appears to be exacerbating the tension by not understanding and/or addressing the issues at hand, real or perceived."

Epidemiology professor Michael Oakes, chairman of the panel that oversees research at the university, acknowledged the culture is dysfunctional, and that some people are afraid to speak out.

"There is clearly a cultural rift there — with distrust," he said. "It's not universal ... but it's there, and it makes people anxious."

Dr. Brooks Jackson, dean of the university's medical school, said he is "pleased" that the inquiry found no regulatory violations, but acknowledged that the culture must change.

Leaders of the university and Fairview "are both concerned," he said. "We are all working daily to come up with an action plan ... to address this issue."

Jackson said he is working on several measures to improve trust, including more education, a thorough assessment of the work climate and an oversight committee.

"When people work together on a project," he said, "that starts to break down the mistrust."

Oakes and a team of investigators were charged with looking into concerns over potentially serious or ongoing violations of on schizophrenia and bipolar disorder. The names of the studies and the researchers involved were redacted in the report.

The team interviewed more than 40 physicians, nurses, social workers and other employees of the University of Minnesota and Fairview. It found no violations, and concluded that patients "were not at undue risk."

But it said Fairview staff and some university researchers worried about a handful of their fellow researchers and some of their staff. They said they did not trust those colleagues to properly obtain the consent of patients, and that those colleagues "did not fully appreciate the vulnerable state of many patients."

The report said some researchers also did not consult enough with hospital caregivers, who the report said are in a good position to judge the ability of a patient or family member to give informed consent.

"Several interviewees expressed concern about the lack of transparency, consultation and scientific motivation for psychiatric studies run by some [researchers]," the report said.
Legislative Auditor Jim Nobles called the report "disturbing."

Fairview personnel "are the people who are there [in the hospital] day in and day out observing what's going on in the care of these vulnerable people. And they're expressing this kind of concern," he said.

Fairview spokesperson Jennifer Amundson said in a written statement, "A lack of trust in the workplace is unacceptable, and we are taking action based on the findings that were just released. Our plans will include specific actions to establish an environment of inclusion, shared values, trust, transparency and integrity for psychiatric clinical care and research."
In April, Nobles said the university had failed to adequately protect Dan Markingson, a patient enrolled in a psychiatric drug trial, and that U of M leaders had ignored "serious ethical issues" in the case. It found real and potential conflicts of interest in the case, and said Markingson enrolled in the trial under potentially coercive conditions.

• Related: U's handling of drug study suicide earns an 'F' among peers

University leaders are expected to roll out a plan by May 15 to carry out dozens of reforms suggested in February's external review, which was conducted by the Association for the Accreditation of Human Research Protection Programs.

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