Faculty continues fight against clinical trial review

An external review organization that will examine the University’s clinical research trial process will be on campus this week.

Taylor Nachtigal

While a team of outside reviewers is on campus this week to begin evaluating the University of Minnesota’s clinical research on human subjects, some faculty members are questioning the process.

The panel of experts is coming to the University after a group of 12 professors sent a letter on Sunday to the school’s administrators criticizing the panelists, citing concerns about conflicts of interest and the scope of the review.

The faculty members took issue particularly with the third-party firm managing the review — the Association for the Accreditation of Human Research Protection Programs Inc. — and the three reviewers conducting the investigation.

The firm and the experts, they wrote, have conflicts of interest that won’t let them objectively look at the University’s clinical trial process.

In June, the University signed a nearly $142,000  contract with AAHRPP, following a Faculty Senate resolution from last winter requesting a review of the school’s clinical practices involving human subjects.

The resolution was prompted partially by calls from faculty members for a review of the suicide of Dan Markingson, a participant in a 2004 antipsychotic drug study at the University.

When the University first announced the review team, associate bioethics professor Leigh Turner said AAHRPP shouldn’t oversee the review because it accredited the University’s Human Research Protection Program in 2005, 2007 and 2010.

Karen-Sue Taussig, an associate anthropology professor who signed the letter, said while she is pleased that the University agreed to perform an investigation, she also has issues with the perceived conflicts of interest.

“The big difference that I see is that [AAHRPP] sees conflicts of interest as something that needs to be managed,” she said, “whereas I think conflicts of interest are inherently problematic.”

Turner noted that one of the three experts conducting the review, Jeremy Sugarman, previously worked for Quintiles, which helped manage the drug trial Markingson was involved in.

Despite pushback, the University is moving forward with the review, Vice President for Research Brian Herman said in an email statement on Tuesday, adding that AAHRPP itself is not conducting the review — it’s simply managing the process.

“From the start, our goal has been to ensure a vigorous process that fulfills the Faculty Senate’s resolution to conduct a thorough, professional, independent and transparent review of our human subjects research practices,” he wrote.

The investigation will span back to 2011 and include the University’s Institutional Review Board, but the professors say it should span further to look at serious past allegations relating to past practices, which could include the controversy surrounding Markingson’s death.

“I think [faculty members and administrators] have an obligation,” Turner said. “We can’t just wash our hands [of the Markingson case]. It has become a part of our responsibility.”

Will Durfee, who was the Faculty Consultative Committee Chair when the resolution was passed, said it’s up to the review committee to decide how far back the review will span.

Naomi Scheman, a philosophy professor and co-author of the letter, said even though faculty members want a more extensive examination, those selected shouldn’t perform the review.

“[It doesn’t] make sense to say, ‘Please do this,’ while we’re [also] saying, ‘We’re not sure if we trust you to do this,’” Scheman said.

The team will complete the review over the next couple of months and present its findings to the Faculty Senate in December.