Task force recommendations out


Friday, July 21st 2000, 12:00 am
By: News On 6


TULSA, Okla. (AP) -- A scandal involving a cancer study at the University of Oklahoma's medical school in Tulsa has brought the departure of three top officials and the dismissal of the prime researcher, OU President David Boren said Friday.

The university began termination proceedings Friday against Dr. Michael McGee. Problems with McGee's skin cancer study brought federal suspension last month of five government-sponsored research programs in Tulsa. 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, who chaired the school's research oversight board resigned or retired, Boren said.

"I think we have no choice but to demonstrate we're making afresh start," Boren said. "We simply have to send a very strong signal for the sake of all our research programs." In addition, Boren announced stringent new plans to improve compliance. He said he hopes these new procedures become a handbook for other institutions.

"We're going beyond what the law requires to establish a state-of-art compliance program," he said. The new procedures resulted from a task force established by Boren after the government suspensions.

Last month, safety concerns and problems with the melanoma vaccine study prompted federal regulators to shut down enrollment of five government-sponsored studies on the Tulsa campus.

The university also suspended enrollment in 70 other clinical trials. Regulators gave OU permission last week to reinstate the five federally sponsored studies, pending a review from the Institutional Review Board in Oklahoma City. The skin cancer study remains closed.

The task force report identifies changes that must be undertaken to ensure that the university 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 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. Also, 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, but by Joseph Ferretti, senior vice president and provost of the OU Health Sciences Center. In addition, the task force will recommend developing an educational program to be used for training new employees and updating employees on new research issues.