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Auditor: Reporting of adverse events for U of M's human trials was 'inadequate'

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The state's legislative auditor says reporting by some researchers at the University of Minnesota during the school's controversial psychiatry studies was "inadequate."

The 23-page report by Legislative Auditor Jim Nobles, released Thursday, looked at deaths and other "adverse events" that occurred during clinical studies conducted by the university's psychiatry department from 2004-2014.

They found only one study-related death – Dan Markingson, a diagnosed schizophrenic who took his own life while in the program. His death sparked a full review of the university's human research practices, culminating in stricter rules for the program being approved just last week.

However, when other adverse events occurred, the legislative auditor says the reporting of those incidents to the university's Institutional Review Board "has been inadequate."

The details

There audit looked at 65 studies with enrolled participants during the 10-year period.

A "serious adverse event" can include the following: death, a life-threatening event, a patient being hospitalized or having a hospitalization extended, an incapacitation of some sort that impacts a person's life, or a congenital anomaly or birth defect.

(Note: The report found one death in addition to Markingson, but it occurred before the patient had participated in any treatment. He was diagnosed with cancer after signing the study consent form, and was then withdrawn from further screening.)

When one of those occurs, the review board (referred to as the IRB) has to be notified – but how quickly that must happen, and what qualifies, changed over the years. By current standards, an event would only have to be reported immediately if it met three certain criteria. And the judgment call for whether it did indeed meet those standards was left to the researchers, the study says.

In addition, when adverse events were reported, many didn't include specific details about what happened. That includes not mentioning whether the event was related to the study. The auditor also found 17 percent of the notifications didn't include the date it happened.

Because of the lack of details, it was difficult for the auditor to know how timely certain reporting was.

But of the 73 recorded adverse events that did include a date, 26 percent were reported within 10 days (the general standard). But in 51 percent of the adverse events, it took more than two months for the IRB to be notified. Sometimes it was just a "minor problem" with a patient – but there were also eight hospitalizations which didn't get reported for more than six months.

The legislative auditor's report recommends the IRB require reports of all (or more) adverse events be submitted within five days, and to include detailed reports of what happened to the patient. It should also include a form that allows a researcher to explain their reasoning.

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