UIC RESUMES HUMAN SUBJECT RESEARCH

The University of Illinois at Chicago is resuming human subject research after the university's internal review panels approved the first 25 proposals and the university received a favorable response from the federal government to its corrective action plan for research oversight.

UIC research involving humans was suspended Aug. 27 after regulators from the federal Office for Protection from Research Risks found violations in obtaining informed consent, along with inadequate training and staffing for the university's institutional review boards, or IRBs, which oversee research and protect subjects from risk. Neither the university nor the government investigators found that any participants had been harmed.

In response to the restrictions, UIC added staff for the campus review boards, provided training and allocated more time and space for the boards to review projects. A letter received Friday from OPRR noted that UIC had made "impressive strides" in educating its review board members on the principles and regulatory requirements for research oversight.

"Our goal was to create a review system that is not just compliant, but exemplary," said Elizabeth Hoffman, provost and vice chancellor for academic affairs. "We are pledged to afford research participants every possible protection."

The boards must re-evaluate every research project on campus involving human subjects -- nearly 2,000 projects in all, representing about 30 percent of all research on campus. Campus officials expect that each board member will spend 100 hours a month reading and reviewing protocol application forms, 10 times the amount of time normally required, from now through the end of the academic year next spring.

"It represents a heroic effort," says Eric Gislason, interim vice chancellor for research. "We have three years' worth of projects on the books that need to be re-reviewed, plus new ones that are coming into the system. We will get this done as quickly as we can, with all due diligence."

The boards began deliberations the week of Oct. 4 with 50 "exempt" projects that were primarily surveys and social sciences studies. The IRBs will next consider 50 higher-priority "expedited" projects that have more effect on their human subjects.

Protocols that require review were assigned a priority number by each college. Campus officials hope to have a substantial majority of high priority projects restored by Jan. 1.

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