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CONTACT: STEVE PARROTT
100 Jessup Hall
Iowa City IA 52242
(319) 335-0552; fax (319) 335-0558
email: steven-parrott@uiowa.edu

Release: July 23, 2001

University of Iowa responds to Des Moines Register article

Following is a statement from David Skorton, UI Vice President for Research, regarding a front-page headline ("U of I faces probe over research") accompanying a July 22 article in the Des Moines Sunday Register:

"We do not believe it is accurate to say that the University of Iowa is facing a probe over our human research activities. From June through December of 1999, we had continuing dialogue with two federal agencies about administrative and record-keeping rules as a result of a regular, periodic inspection by the Food and Drug Administration (FDA) in 1998. Until last Friday, we had assumed that both agencies were satisfied with all documentation we had provided them. Instead, we learned that no official "closure letter" had been written by the Office of Human Research Protections (OHRP) because of a large backlog in the federal agency, and therefore the case was not officially closed by that agency as it has been by the FDA. But as far as we can ascertain, closure is imminent and there is no action pending in Washington, D.C. against the University of Iowa. Furthermore, we conveyed this message and explained the rather complicated circumstances in full to the Des Moines Register last Friday.

"Colleen Krantz's article itself, if read in its entirety, presents a balanced and mostly accurate picture. But it is not just the words in a story that convey a newspaper’s message. The story’s headline and placement telegraph the newspaper’s sense of the story’s importance. We are deeply concerned that the Register’s headline — "U of I faces probe over research" — and its placement as Sunday’s front-page lead article imply that this story is ‘breaking news’ of a grave and serious nature. That simply is not true, and we wish to assure the citizens of Iowa and all enrolled in our clinical trials here that that is not the case. We believe that the only federal action actually pending is correspondence to us from the Office of Human Research Protections indicating closure.

"It is in everyone’s best interest that research be conducted in accordance with the highest ethical standards, and we also appreciate the need for following administrative procedures. We believe that the University of Iowa operates an excellent system and is accomplishing both of these goals."