Legislature OKs oversight bill for U drug trials

A bill that would monitor the practices of some U drug studies awaits Gov. Dayton’s response.

Kevin Beckman

After a year of scrutiny and several harsh internal and external reports, drug trials by the University of Minnesota’s Department of Psychiatry are one step away from state oversight.

A bill that would require the state’s Ombudsman for Mental Health and Developmental Disabilities to monitor the department’s drug studies was passed by the Minnesota Legislature late last month and now awaits Gov. Mark Dayton’s signature or veto. 

Though an audit by the Minnesota Office of the Legislative Auditor released last month found the University’s reforms to be on track, some legislators felt that state oversight was necessary to adequately protect psychiatric research participants. 

If signed, the measure would authorize the state to monitor individuals enrolled in the department’s clinical drug trials, as well as gather records related to clinical drug trials and ensure that the psychiatry department’s efforts to protect human subjects comply with federal law and Institutional Review Board mandates. 

“I think that [the office of the ombudsman] will have the trust of patients in a way that University authorities won’t,” said Carl Elliot, a University bioethics professor. “I think the U still has a long way to go. I don’t think that these things are going to by any stretch fix things, but they’re at least small positive steps in the right direction.”

University administrators, including University President Eric Kaler, have said additional oversight is not necessary, but that they understand lawmakers’ concerns. 

“There’s been great progress made in improving the oversight that was already there,” said Dan Gilchrist, communications director for the University’s Office of the Vice President for Research. 

The University pledged dozens of changes last year to how it conducts research on human participants after more than a decade of outcry over research ethics culminated in a handful of reports that revealed numerous flaws with how the school handles research involving human subjects and criticized the University’s responses to questions over its practices. 

Regent Thomas Devine said the Psychiatry Department seems to be already implementing necessary changes, and said the bill brings up concerns over the University’s autonomy from the state. 

“The University has got a level of autonomy to deal with these things,” he said. “The Legislature can ask us to do things and we can decide whether or not we’re going to or not going to do those things, because … we have some flexibility to do what’s best for the institution.” 

But Regent Michael Hsu said he was comfortable with additional oversight until the Psychiatry Department can demonstrate it can properly protect research participants. 

“Right now, we’ve demonstrated that we’re not able to handle this ourselves,” he said. 

Legislative audit

In its most recent look, released at the school’s psychiatric research, the state’s Office of the Legislative Auditor found that the University’s plan to improve its human subject research program is “ambitious and wide-ranging,” though it did conclude that a shift in culture is needed in the department.

The report, released last month, was the office’s third investigation of the department since last March.

The review said concerns in the department raised by previous reports — such as documentation and recruiting vulnerable people into psychiatric drug studies — were all being addressed. 

“Despite all of the problems, all the concerns and criticisms that have been directed at the University and the Department of Psychiatry, we came away from this review encouraged,” said legislative auditor James Nobles. 

Elizabeth Stawicki, director for legal research at the OLA, said the report could only give a small glimpse into a complex issue given the short time frame the office had to prepare the report. 

“Given the short time frame to put this together, we can only give you a sampling of what policies have changed and what might be on the horizon,” Stawicki said. 

University officials said they were happy with the report’s findings. 

“We are pleased with the OLA’s recognition that the University’s plan to reform its human subject research protection program is ambitious, far-reaching, and once implemented, will significantly strengthen protection for human research subjects,” Gilchrist said. 

University IRB member Niki Gjere said that though the report was encouraging, she thinks there is more work to be done. 

“We need to continue to ask the questions and keep the pressure on until the changes are demonstrated,” she said. “So much is still in progress. The culture of fear, intimidation and non-compliance is what got us here.”

Gjere added that it will take a lot of commitment from University administrators and regents to improve the culture.

“I feel pretty comfortable that we have everything in place that we need to do,” Devine said. “It’s an issue of ongoing concern [and] … in essence, we’re doing state of the art work in terms of what our compliance and our follow-up work is.”