OU President Announces Personnel And Policy Changes

The President of the University of Oklahoma, former U.S. Senator David Boren, this afternoon announced that four OU officials are being replaced as a result of human subjects compliance problems at the Tulsa campus. Harold Brooks, dean of the college of medicine in Tulsa; Edward Wortham Jr., director of the Office of Research at the Health Science Center, and Daniel Plunket, chairman of the school's research oversight board, have resigned or retired. In addition, OU has begun termination proceedings against Dr. Michael McGee, former vice chair of the OU-Tulsa surgery department and PI in the clinical trial that was the focus of OHRP's recent enforcement action. In addition, Dr. Boren announced a number of administrative and procedural changes concerning research compliance that will affect all of the OU campuses. An article on Dr. Boren's address to the media on his actions from the "Tulsa World" newspaper web page follows.

Tony Mazzaschi AAMC

Kelly Kerr/Tulsa World

Four University of Oklahoma officials have been forced out because of troubles surrounding research at the school's Tulsa campus, OU President David Boren said Friday.

The university began termination proceedings Friday against Dr. Michael McGee.

Harold Brooks, dean of the college of medicine in Tulsa; Edward Wortham Jr., director of the Office of Research at the Health Science Center, and Daniel Plunket, chairman of the school's research oversight board resigned or retired, Boren said.

The problems stem from a melanoma vaccine study under McGee's supervision.

""I think we have no choice but to demonstrate we're making a fresh start," Boren said. "We simply have to send a very strong signal for the sake of all our research programs."

The announcement came in conjunction with several recommendations from an OU task force appointed by Boren.

Future clinical research projects conducted through OU will have to undergo several layers of checks to ensure that all regulations are being followed.

Also, OU employees will be required to sign a statement under oath saying they will report any research compliance concerns they have.

The task force report identifies system-wide changes that must be undertaken to ensure that OU becomes a leader in research compliance.

These recommended changes are in addition to corrective actions the university outlined in a July 10 letter to the Office for Human Research Protections, which is part of the U.S. Department of Health and Human Services.

Primarily, the task force is recommending the creation of a new central research compliance office with a director who will help make sure the university is complying with research regulations, sources said. That director will report to the university's attorneys and internal auditor.

That office also will have a 24-hour hot line for anonymous callers to report any violations. All new employees must attend an orientation on compliance.

Moreover, university employees will have an obligation to report any concerns they have regarding noncompliance issues. Failure to report wrongdoing will result in an employee's dismissal.

Also in the future, Tulsa's research projects will be approved not only by the university's Institutional Review Board -- the research oversight committee -- but by Joseph Ferretti, senior vice president and provost of the OU Health Sciences Center, sources said.

The problem before was that no mechanism for spot checks existed. Now, each research project will have its own compliance officer -- a staff or faculty member -- who will be responsible for helping monitor the research project in addition to the IRB chairman and department chairman. In addition, the university's Internal Audit Department will make unannounced spot checks of human research projects.