Legislators have passed a bill granting oversight of psychiatric drug research at the University of Minnesota in Minneapolis (UM) to an independent state ombudsman’s office. The law awaited approval or veto by the governor as this issue went to press.

The action culminates a seemingly endless series of reports and investigations into UM research after the 2004 suicide of a man enrolled in a psychiatric drug trial. (See the June 2016 issue of IRB Advisor for more information.)

While the university and some members of the Board of Regents have said the oversight is not needed given the many reforms put in place, others hailed state monitoring of clinical drug trials as a much-needed step to ensure the psychiatry department protects human subjects and complies with all IRB requirements. The university has been subjected to withering criticism of its psychiatric research program in various reports, but a recent update by the state auditor1 found positive improvements in the IRB that could sway the governor’s decision. The auditor’s finding included the following:

“The University has implemented and will continue to implement a wide range of changes to strengthen the oversight capacity of its IRB. In addition, the University is in the process of establishing a new Research Compliance Office to investigate certain allegations about research projects, a function previously performed by the IRB.

We think the following four changes are particularly significant:

Expansion of the IRB’s Membership and Structure:

The University is in the process of revamping its IRB approval process to increase the number of IRB members, panels, and expertise. One of the problems with the current IRB system was that it has been understaffed. According to University officials we interviewed, it was difficult to get people to participate because IRB members were overworked, unpaid, and received no recognition from their department or the medical school for serving on an IRB.

Instead of having four medical panels focused on a particular topic, there will be eight panels with a variety of experts on each of them. If some projects require special expertise and none of the panels have appropriate experts, the University will supplement the panels with a roster of consultants or people within or outside the University who can serve as objective reviewers. Serving on an IRB will also be recognized as a service to the University and members will be paid.

Creation of a Research Compliance Office:

In 2015, the University Vice President for Research created the Research Compliance Office (RCO) to consolidate the University’s oversight of research compliance with pertinent regulations. Previously, such oversight occurred in various parts of the University, depending on where funds for the research came from, or whether the research involved humans, animals, biosafety, or other areas of focus. The RCO has also assumed responsibility for some investigations — known as ‘for-cause’ investigations — that the IRB previously conducted. ‘For-cause’ investigations examine concerns about research compliance in response to a specific allegation. These investigations are not part of routine monitoring of compliance with regulations; they may reflect cases in which researchers have not adequately addressed compliance problems or in which University officials want more information on a particular problem. In addition, the RCO will track the ongoing compliance of research projects with regulations and develop accountability measures for approved projects. The University expects to approve policies and procedures for this office in July 2016.

Use of an External IRB:

Since we issued our reports last year, the University has outsourced the oversight of 12 psychiatry studies involving human subjects. Previously, the University’s IRB reviewed the research protocols for these studies and provided ongoing oversight. In 2015, the University entered into an agreement with a private IRB. For studies selected by the University, this IRB (Quorum) has independently examined the research protocols. In 2015, Quorum recommended that one study the University’s IRB had already approved be discontinued, due to what it considered an inadequate study protocol submitted by the principal investigator.

Electronic IRB Tracking of Research Studies:

The University is investing approximately $5 million in a new system to make its entire IRB submission, approval, and review process electronic. Part of the expense is to acquire software packages … for researchers and IRB staff and members to communicate, submit, and review documents. The University expects the new system to streamline the current process which University officials characterize as extremely inefficient and ill-suited for the volume and complexity of research the Human Research Protection Program oversees.

The program receives approximately 10,000 unique submissions annually. According to an official in the program, under the current system, ‘[S]ubmissions are emailed to our office. Each email and all attachments must be downloaded to PDFs and details about the submission must be added by staff into our database (a system implemented in 2005). Each submission and all subsequent communication must also be added to our document routing system and the online file sharing site reviewers use to access materials. Our database feeds minimal information to a system transparent to researchers. They are able to check basic status information but little else. They may be able to see that a submission is under review, but they are unable to view the documents or communication related to that review.’

IRB staff and reviewers will start using some elements of the software in July 2016. But some elements that researchers will use, such as standard operating procedures, templates, worksheets, and an investigator manual, will not be available until the end of the year.”

REFERENCE

  1. Office of the Legislative Auditor. Protections for Human Subjects in Research Studies at the University of Minnesota Department of Psychiatry: A Preliminary Assessment of Reforms. May 16, 2016: http://bit.ly/1YbaxHe.