Word: irbe
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...back-alley clinic or a storefront in Tijuana. In fact, the study was conducted at the St. John Medical Center in Tulsa, Okla., and co-sponsored by the respected University of Oklahoma Health Sciences Center. It had been approved by the university's institutional review board, or IRB, a body set up to ensure that such trials meet federal standards for experimental design--including the obligation to inform participants of any safety issues. And it had been given the green light by the FDA itself...
Meanwhile, IRBs, which are supposed to be the first line of defense against unethical or badly designed studies, are often overwhelmed by the job. At some large research universities, a single IRB must supervise more than 1,000 clinical trials at once. Indeed, a 1996 report by the General Accounting Office found that some IRBs spend only one to two minutes of review per study. Board members can't possibly be experts in every field; most are in-house researchers whose own studies are likely to come up for review someday. Says George Annas, a critic of current U.S. laws...
...numerous errors. McGee 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...
...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." That gave cover to McGee's letter lying to patients about why the trial was being halted...
That's when 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...