Word: ohrp
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...years ago, Koski was appointed the first director of the Office for Human Research Protections (OHRP), which was created within the federal Department of Health and Human Services in response to growing governmental concerns about the safety of human research subjects—concerns underscored by the death of a participant in a gene therapy study at the University of Pennsylvania...
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...
...afford to wait for every research institution to react to its own lapses. That's the impetus for a sweeping overhaul of the OHRP, designed by director Greg Koski--with advice from a newly motivated Johns Hopkins--to make the agency more aggressive in protecting human subjects. It's also behind legislation that will soon be moving through both houses of Congress. Representative Diana DeGette of Colorado will introduce a bill this week that is aimed at finally giving humans the same legislative protections that animals receive; the rules will apply to all research on humans, not just federally funded...
Both DeGette and Kennedy endorse the idea of accrediting IRBs. But they are split on whether accreditation should be mandatory. So far, Kennedy is saying yes. DeGette, who has championed patient protection in part because the University of Colorado was severely sanctioned by OHRP in 1999, thinks a voluntary system would, paradoxically, protect patients better. "The whole point of accreditation," says DeGette, "is to encourage research institutions to reach for a higher bar, to go above and beyond the minimum requirements...
...Facing nasty criticism from many of her colleagues at the University of Oklahoma and worried she would not be able to get decent medical treatment in Tulsa, she finally moved to Texas last August. Sometimes she wonders whether she did the right thing by sending that letter to the OHRP, but she is proud of the way the university responded...