CONTACT: STEVE PARROTT
100 Jessup Hall
Iowa City IA 52242
(319) 335-0552; fax (319) 335-0558
Release: July 23, 2001
UI releases details of 1999 letter from Food and Drug Administration
IOWA CITY, Iowa In addition to releasing a statement questioning
the accuracy of a headline in a July 22 article in the Des Moines Sunday Register,
University of Iowa officials today released information about the Food and
Drug Administration (FDA) letter that was the basis for the Registers
The Registers story was apparently precipitated, in part, by a letter
to the university that has been posted on the FDAs web site since 1999.
Posting such letters is a standard part of the FDAs Freedom of Information
process. The site, however, does not post subsequent correspondence demonstrating
the dialogue between the university and the agency and resolution of the FDAs
The FDAs letter, dated June 18, 1999, refers to a regular investigation
that took place between Feb. 2 and June 23, 1998. The letter says, in part:
"We apologize for the delay in providing you with an official notice
of the results of the inspection. Even at this late date, the significance
of the following violations are of particular importance because many of them
have been observed during past inspections where corrections were promised
by your institution but not implemented."
That language alarmed university officials, who said it directly contradicted
what they had been told by an FDA inspector during an on-campus meeting in
May of 1998.
In a letter of response to the FDA dated July 27, 1999, UI Vice President
for Research David Skorton wrote: "We are surprised by that statement
because the University of Iowa has expended considerable effort to address
all prior FDA concerns that were detailed in your June 18 letter. And, in
interview minutes dated May 1, 1998, provided by the FDA to the university,
Mr. Iwen [FDA investigator John A. Iwen] stated, The items listed in
the pervious inspection either appear to have been corrected or were not noted
during this inspection."
Some of the violations concerned minutes of meetings for the universitys
Institutional Review Board, which must approve all research involving human
subjects. In some cases, the minutes did not record votes of everyone at the
meeting. The university was able to respond by providing evidence that some
members who were present at the meeting chose not to vote on specific projects,
as is their right.
Another violation concerned the identification of committee members with
the same last name. The FDA citation noted that the minutes should have included
the first initial of the person in attendance. The university has subsequently
followed that recommended procedure.
The FDAs letter also raised a concern that the universitys Institutional
Review Board used an expedited process to add a statement into a consent form
for human research participants. The addition noted that patients should be
aware that the FDA could copy and inspect research records.
In its response, the university noted that FDA guidelines allow for such
expedited modifications. In addition, the university explained that the change
was implemented before the beginning of the research program cited in the
letter from the FDA. All research participants involved in that study signed
a consent form that contained the required language, the university noted.
The FDA accepted information provided by the university, and the matter
was closed in November of 1999.