August 27, 1999 Contact: Mark Rosati (312) 996-5546 or Bill Burton (312) 996-2269

UIC HUMAN RESEARCH PLACED ON RESTRICTION

Following a three-day site visit by the federal Office for Protection from Research Risks and receipt of a report that found that research participants were inadequately apprised of risks, the University of Illinois at Chicago has been instructed to temporarily halt enrollment of new subjects in all federally supported human research. Ongoing research with previously enrolled participants will continue if it is in a subject's best interest.

The OPRR, which oversees all institutions for compliance with Department of Health and Human Services regulations for protection of human research subjects, required that members of the university's internal research review panel, called an institutional review board or IRB, must receive further training in evaluation of research protocols. Individual research protocols will be allowed to resume after the IRB reexamines and approves them.

OPRR did not suspend UIC's "Multiple Project Assurance," essentially an agreement that allows an institution to perform federally funded human research. Restrictions similar to, or more severe than, those placed on UIC have been levied against about a dozen other institutions since 1997.

The OPRR found that some human subject research projects were conducted at UIC without IRB review, and that in some cases researchers did not obtain "informed consent" from participants. It also found that the university had not provided its IRB with sufficient facilities or support staff and that senior university officials should have seen that these problems were corrected.

Neither OPRR nor the university could find any evidence that any study participants had been harmed. The university had been notified in March that it would be investigated by the OPRR.

"The university's first response was to make sure that no subjects had been harmed," said Eric Gislason, a professor and former head of the chemistry department at UIC who was appointed interim vice-chancellor for research in July.

"People who volunteer to be subjects do so out of concern for others as well as themselves, and without them, much of our research would not be possible," Gislason said. "We bear a heavy responsibility to be certain that these people receive the highest standard of care and that we protect their rights and welfare."

Anticipating the deficiencies pointed out in the OPRR report, Gislason had already begun drafting a Human Subject Protections Corrective Action Plan. UIC will be submitting the plan to the OPRR in September and periodic progress reports thereafter.

The OPRR sends investigators to an institution to perform a review, called a compliance oversight evaluation, in response to indication of noncompliance with HHS regulations. OPRR may be alerted by any of a variety of sources, including the institution itself, which is required to report any breach of policy. Since 1990, OPRR has undertaken more than 125 site visits to various institutions to review their compliance and provide technical assistance with their oversight process.

In its review of UIC, the OPRR examined more than 90 research projects and the minutes of 40 IRB meetings, at which more than 1,000 items were considered. Its report states that UIC's IRB members are "hard-working and display sincere concern for the protection of human subjects," despite "difficult circumstances, which include inadequate resources and training."

Gislason noted that UIC's research programs have grown rapidly, and federal regulators are now applying rules more stringently and comprehensively.

"Our office did not keep up with this growth," he said.

He cited the need for increased staff, bigger computers and more office space to handle the increased demands on the office, and the university has committed to providing those resources. In 1998, UIC had nearly 1,200 human research protocols, twice as many as 10 years ago. UIC's total HHS research funding doubled in just four years, to more than $80 million.

UIC had two IRBs and recently added a third. One is devoted to behavioral projects, including psychological, sociological and survey research. Another is devoted to biomedical research, including drug studies and all clinical interventions. The third board is a hybrid, which is dedicated to projects that span or fall between these broad areas. Each IRB is made up of 15 to 20 individuals with expertise in relevant fields, plus -- as required by OPRR regulations -- at least one non-scientist member of the community.

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