Word: ohrp
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...been suspended out of a growing concern among McGee's supervisors that it may have been doing more harm than good. So after agonizing for days about what to do, she wrote a long, detailed letter to what is now called the federal Office for Human Research Protections (OHRP), describing McGee's multiple lapses. Her letter reported that McGee had, among other things, stored the vaccine improperly, exposing it to potential contamination; failed to maintain adequate records and track its consistency from batch to batch; mislabeled vials of the stuff; and, worst of all, kept most of the data...
...clinical trials really are. Still others are convinced that financial conflicts of interest--drug companies sponsoring trials and paying doctors--are the root of all evil. Bills are being introduced in both houses of Congress in the next few weeks that are designed to better protect research subjects, and OHRP, the main research regulatory agency, is rewriting its rules. What's clear to nearly everyone, though, is that without uniform, federally mandated regulations, the situation will only get worse...
Until last year, in fact, when the agency's budget tripled, OHRP had just two full-time investigators to monitor more than 4,000 federally funded research institutions. Since 1980, the agency has audited, on average, just four sites a year. The FDA is somewhat more vigilant, making site visits to about 200 of the approximately 1,900 IRBs that oversee research on FDA-regulated products...
...board met just once a month, typically for an hour, and then went out to dinner. Among other things, the board approved McGee's consent form, which contained 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...
...OHRP began its investigation of the China studies in response to a complaint filed in 1999 by Gwendolyn Zahner, a former assistant professor at HSPH. These questionable research practices were later the subject of a series of investigative articles by the Washington Post...