U of M Board of Regents to provide strict oversight of improvements to human subjects research program

March 27, 2015

The University of Minnesota’s Board of Regents today pledged to provide an open and collaborative action planning process and oversight and monitoring of the University’s efforts to strengthen human subjects research practices. Regents also passed a resolution that endorsed the administration’s immediate and longer-term actions, commits to faculty and community engagement and reaffirms the U’s research mission.

“Recent independent reports have made it clear that we must improve our current practices,” said Board of Regents Chair Richard Beeson. “The Board will be playing an active role in forming the University’s action plan and we will provide robust oversight to the implementation of those plans. We will be transparent and accountable as the University takes steps to become a national model for ethical human subjects research.”

Two recent independent external reviews of the University’s human subjects research protection practices — including an independent external review and a March 19, 2015, report by the Legislative Auditor — outline recommendations for improvement.

Beeson has designated Regent Patricia Simmons, M.D., to serve as the Board’s liaison with the administration in crafting and implementing action plans. Simmons has three decades of medical experience and recently retired from Mayo Clinic.

“We heard the Legislative Auditor and external panel loud and clear, and we will work tirelessly to strengthen public trust and confidence in our work,” said Kaler. “We will do this through action and transparency, engaging with University faculty and holding ourselves accountable. We invite the Legislative Auditor and public to verify our implementation in the coming months.”

Some of the external review recommendations are already being implemented. Other actions include:

  • Suspend enrollment in all current (17) Department of Psychiatry interventional drug studies – all active or awaiting approval – until they are reviewed by an external and independent Institutional Review Board (IRB);
  • Develop a plan of action by May 15 to review and implement recommendations from the external review panel report;
  • Examine other clinical studies that target vulnerable populations, using an independent Institutional Review Board and the U’s post-approval monitoring process;
  • Appoint a Community Oversight Board of external experts in human subjects research and research ethics to ensure we are using best practices.

The U has begun to secure an external and independent IRB to assure that ongoing activities in the suspended trials are consistent with recommendations made by the external review panel. The Office of the Vice President for Research will hire the independent, external IRB as soon as possible and expects the review process to last two to four weeks. The independent, external IRB will review protocol followed for each study, including whether patients provided proper consent to participate.

Vice President for Research Brian Herman said that pausing enrollment will ensure that all patients are being cared for in the most ethical way. He expects the suspended recruitment will be short term.

“Conducting clinical research is critical to finding treatments and cures to improve human health, save lives and provide hope to Minnesotans and their families,” said Herman. “We must engage in cutting-edge clinical research of the highest quality. We have an obligation to deliver the best science while also providing the most ethical care to our patients.”

An efficient and effective University
Kaler’s Operational Excellence initiative — a long-term commitment to work smarter, reduce costs, enhance services and increase revenues — is showing results across the University.

On April 10, the University will implement The Upgrade, which will update outdated and inefficient student, financial and human resource systems. This will allow the U to better serve its nearly 100,000 students, faculty and staff members at its five campuses.

In an update to the Board, the following examples of Operational Excellence progress were discussed:

  • Administrative Cost Savings. Reallocated $39 million in administrative costs in the last two years, more than 43 percent toward Kaler’s 6-year commitment of $90 million. 124 positions were eliminated in FY2014. An additional $15 million in savings is planned for FY2016.
  • Information Technology. Software changes, renegotiated contracts, alignment of 52 of 73 IT Help Desks and improving academic technology have increased service and reduced costs.
  • Human Resources. Recommendations from the 2013 Huron report, including better service delivery, have been addressed. Major changes in the Human Resource Management System, part of The Upgrade, will simplify benefits plans and processes, implement online time and labor and absence management, and streamline payroll and payroll accounting processes.
  • Finance and Procurement. Implemented electronic procurement system and new tools to manage large vendor contracts, and expanded use of electronic vendor payments and cash management for students. Ongoing plans include risk-based purchasing thresholds, an improved system to pay research subjects and better options and services for those traveling on University business.
  • Student Systems. More efficient forms handling, especially for graduate students, has significantly reduced staff time and expenses. With new software, OneStop Student Services was able to retire four systems and integrate with three products handling more than 187,000 cases.

The Board also:

  • reviewed progress on the Twin Cities campus Strategic Plan. Through the current budgeting process, colleges and other units are identifying strategic priorities that align with the plan and activities that don't serve strategic priorities. Team-taught “Grand Challenge courses” are being developed for undergraduates to take beginning this fall. Topics will include: global health, food, and political reconciliation, among others. Work is also under way to identify Grand Challenge research priorities. Methods that can be used to measure success of the plan in advancing the University's excellence and impact are also under development.
  • discussed long-range planning on the Twin Cities campus. Providing an exceptional place-based experience is a competitive advantage for the U’s Twin Cities campus. This is at the core of the 2009 Campus Master Plan, which guides decision-making today based on assumptions in areas such as student populations, facility expansion and research. University leaders today discussed 10 questions that must be considered when determining future planning and development.
  • recognized eight McKnight Land-Grant Professors. These junior level faculty members are selected for their potential to contribute significantly to their fields.

Prior to today’s meeting, new Regents Thomas Anderson, Michael Hsu and Darrin Rosha took an oath of office, given by Minnesota Justice G. Barry Anderson. Regents Beeson and Simmons, both re-elected, also took the oath.

There were no committee meetings this month. Instead, the Board visited the College of Education and Human Development (CEHD) where they learned about current research and issues affecting education. They also experienced new classroom technologies that impact how students learn.

See President Kaler's report to the Board.

The Board will meet again on May 7-8. For more, go to regents.umn.edu.

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