U research faces deep review after scrutiny

Clinical research practices are set for two long-awaited studies, one of which dates back to 2004.

by Anne Millerbernd

The University of Minnesota will undergo two external reviews evaluating its past and current clinical research practices after having been a yearslong source of scrutiny.

Minnesota legislative auditor Jim Nobles said Tuesday that his office will perform its own review of the University’s clinical drug trials spanning the past 10 years. And earlier this month, the University announced that it had hired a third-party accrediting body to manage a review of its practices involving clinical research on human subjects dating back to 2011.

The legislative auditor’s office will look at drug trials stretching back to 2004, the same year psychiatric clinical trial participant Dan Markingson committed suicide, which helped spark a decade of controversy and calls for further review of University research practices.

Nobles said he’s not certain whether the investigation will take an in-depth look specifically at Markingson’s case, but Mike Howard, a friend of Markingson’s mother, Mary Weiss, said he’s pleased with Nobles’ initiative.

“If there’s one office that certainly has the integrity to look into things, it would certainly be Jim Nobles’ office,” Howard said.

Nobles said he has begun drafting a letter to University President Eric Kaler requesting data and will move forward from that, likely putting together a committee to do the review. He said the process is still in its early stages.

Associate bioethics professor Leigh Turner said he and other faculty and staff members have called for reviews from government offices like the attorney general’s, but he didn’t expect the legislative auditor to be the one reviewing the clinical practices.

Still, Nobles said this investigation is within the scope of his office, and the review will not focus simply on the University’s finances.

“We go way beyond doing just financial work,” he said. “We have a long record of doing [these] kinds of evaluations.”

Kaler and other University officials met with former Gov. Arne Carlson on Monday to discuss research involving human subjects, University spokesperson Chuck Tombarge said. Turner, who’s been outspoken about the Markingson case, said Carlson initially asked him to be in the meeting but said Kaler nixed that invitation.

Still, Turner said he thinks this investigation will prove more credible than the one the University hired the third party to manage.

“This looks much closer to the notion of an outside body conducting a genuine investigation,” he said, “and so I think that’s a really significant development.”

Review plans cause contention

In light of Nobles’ investigation, the third-party review will continue as planned, Tombarge said. For that, the University hired the Association for the Accreditation of Human Research Protection Programs to manage a review of its clinical research practices, particularly on human subjects with limited ability to consent, dating from 2011. Four independent experts will perform the review, according to a May 19 proposal to manage the review from AAHRPP.

The review should last six months and its proposed budget is $141,900, the proposal said.

However, some are skeptical of the objectivity involved in the investigation. AAHRPP accredited the University’s Human Research Protection Program in 2005, 2007 and 2010 — a fact Turner said shouldn’t be ignored.

“Because AAHRPP is already doing accreditation of the research protection program,” Turner said, “it’s probably better for some other body [to do this].”

But Vice President for Research Brian Herman said because AAHRPP as a whole has no part in the investigation, findings or recommendations, there is no conflict of interest. AAHRPP’s role is to do things like pay experts running the review, manage documents and help organize interviews, he said.

Another source of concern has been Jeremy Sugarman, one of the selected reviewers. Sugarman has consulted for Quintiles, which helped manage the drug trial in which Markingson was involved, called the Comparison of Atypicals in First Episode of Psychosis.

Herman said the University didn’t catch the conflict of interest initially, but it has since been recognized and Sugarman has agreed to remove himself if his participation creates a conflict of interest.

Howard said though he’s glad the University is ensuring its current practices are in line with national standards through the third-party review, he wasn’t satisfied that the review won’t include controversial cases before 2011.

“These [cases] didn’t happen last year — some of them happened three or four years ago,” he said, “and those are the ones the ‘U’ [is] afraid of.”

The AAHRPP review was prompted by calls from faculty and staff members asking for a review of the University’s clinical practices on human subjects, particularly in relation to Markingson’s death, Faculty Senate Consultative Committee Chair William Durfee said.

The Faculty Senate reached a middle ground, he said, by pursuing an investigation that would ensure current practices are meeting or exceeding national standards.

Turner said the University could benefit from the legislative auditor’s review, as it will bring closure to a decade-old controversy.

“It has potential to just simply be good news for the University,” Turner said. “This is a story that’s kind of gone on in an unresolved way for a very long time, and [by] having a legitimate, independent investigation, [it] will hopefully be done in a definitive way.”