By Karen Pallarito
NEW YORK, Jul 11 (Reuters Health) - A US federal agency has put a stop to
all government-supported clinical research involving human subjects at the
University of Oklahoma Health Sciences Center in Tulsa, for serious breaches of
patient safety rules.
The Office for Human Research Protections (OHRP) notified university
officials of the suspension in a June 29 letter, citing risks to patients
involved in a melanoma vaccine project.
Dr. Michael A. Carome, chief of the Department of Health and Human Services
(HHS) compliance oversight branch, declined to elaborate on the suspension of
clinical research at Tulsa. But OHRP's letter, signed by Carome, finds that
patients involved in the melanoma project were at risk of exposure to a variety
of bacterial and viral infections because of inadequate procedures for the
manufacturing and safety testing of the experimental vaccine.
The letter also faults the project's principal investigator, Dr. Michael
McGee, for making substantial changes to the project without approval from the
university's institutional review board (IRB), and IRB Chairman Dr. Daniel C.
Plunket for misleading the rest of the IRB board about safety issues related to
the vaccine.
OHRP directed the university to implement numerous corrective actions,
including naming a new board chairperson.
The 17-page letter is addressed to Dr. Joseph J. Ferretti, the university's
senior vice president and provost; Nancy L. Nisbett, director of research
administration in Oklahoma City; and Dr. J. W. Edward Wortham, Jr., director of
the office of research at the university's Tulsa campus.
At deadline, university officials had not returned calls for information
about the vaccine project and how the university intends to respond to the OHRP
charges.
OHRP, a newly created unit of HHS, was formed last month as part of the
federal government's crackdown against patient safety violations in HHS-funded
clinical trials.
