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.
