U clinical trial review postponed

An external review panel requested an extra month to complete its review before reporting results to the Faculty. Senate.

by Taylor Nachtigal

An external review of the University of Minnesota’s clinical trial practices is getting an extension as controversy surrounding the school’s research ethics lingers.

The external review panel requested a one-month extension to complete its work before presenting it to the University’s Faculty Senate.

The senate last year requested a review of the school’s clinical trial practices involving human subjects, following a decade of public criticism after Dan Markingson committed suicide while participating in a University antipsychotic drug study.

The senate was set to review the findings at its meeting last week, but the panel asked for an extra month to finish its work.

The panel is now scheduled to present its results at the end of next month, according to a letter sent to faculty senators by William Durfee, the previous chair of the Faculty and Senate Consultative Committees.

At least one member of the expert panel will attend a meeting of faculty senators to discuss the findings, the letter read.

“The most important thing is to get this thing done right and an extra month doesn’t matter,” Durfee said. “So we were actually quite pleased that they came back with that request and didn’t try to rush things.”

In June, the University signed a nearly $142,000  contract with the Association for the Accreditation of Human Research Protection Programs Inc. to manage the three reviewers selected to examine the clinical trial practices.

But some faculty members have raised concerns over the AAHRPP review, citing concerns about conflicts of interest and the scope of the review, which they said should include the Markingson case.

Bioethics associate professor Leigh Turner told the Minnesota Daily in September that one of the three experts conducting the review, Jeremy Sugarman, previously worked for Quintiles, a health care company that helped manage the drug trial in which Markingson was involved.

And recently, a clinical nurse specialist at the University of Minnesota Medical Center, Fairview, who says she worked at the hospital when Markingson was a drug trial patient, publicly criticized the University’s clinical trial processes.

Niki Gjere, who still works at Fairview, spoke to KMSP-TV late last month about her ethical concerns regarding the recruitment of who she called mentally unstable patients for the study. She said she voiced her concerns at the time, but researchers were not responsive.

“I think there’s some flaws in the system, and I don’t know what people are going to do to fix it,” Gjere said. “I don’t know that the University even thinks that there is anything to fix, and that is what I am worried about, too.”

She said research is highly valued at the University but said doing research shouldn’t come at the cost of patients’ safety.

“The patients need to be able to clearly consent, and they need to have their rights protected,” Gjere said.

The University’s Office of the Vice President for Research did not return multiple requests for an interview by press time.

Along with the University-commissioned review, the state’s legislative auditor’s office is also conducting its own review of the University’s clinical trial processes, following requests from the Legislature and University stakeholders.

Legislative Auditor Jim Nobles said the review, which the office announced early this summer, is still in its beginning phase. He expects it will take several more months to complete.

“The interest of the Legislature and citizens generally is that the University have an absolute fail-safe set of policies and procedures that protect human subjects from any kind of abuse,” he said. “So I think that is the ultimate concern — that all of those policies and procedures not only be in paper, but they be in practice.”