Word: plunket
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Dates: during 2000-2009
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...later got permission to add more subjects than the original 25 he had applied for. According to the OHRP investigation, 11 of McGee's first 18 subjects didn't meet eligibility criteria. Like most of the key oversight decisions, this one actually came directly from the IRB chair, Daniel Plunket, who often did a one-man "expedited review" without consulting the rest of the board. James Robinson, Plunket's lawyer, insists "there is no evidence" his client "took any action...
Mathias reported substantial protocol violations to Plunket and told Dr. Harold Brooks, dean of the university's College of Medicine in Tulsa, as well. They finally agreed to hire an outside consulting firm to audit the experiment. The finding: deficiencies "so severe that it is beyond the scope of this report to advise corrective actions." This finally persuaded Brooks to put the trial on hold. But according to the investigation, Brooks and Plunket decided not to share the report with the IRB; instead, Plunket filed an annual report that stated, "There are no significant safety issues related to the vaccine...
...Mathias wrote her whistle-blowing letter. On the basis of its investigation, the OHRP shut down all federally funded human research at the university. The university, meanwhile, did its own digging and came to the same conclusions. It disbanded the Tulsa IRB, suspended and later fired McGee, and terminated Plunket and Brooks as well. And on July 7, 2000, it sent a new letter to McGee's subjects. This one admitted that "in fact, the trial was closed because of possible safety concerns...