Mitra Dutta, Ph.D.
Distinguished Professor and Vice Chancellor for Research
University of Illinois at Chicago
Office of the Vice Chancellor for Research
1737 West Polk Street
Administrative Office Building, Room 310, M/C 672
Chicago, IL 60612-7227
Dear Dr. Dutta:
As you know, the Office for Human Research Protections (OHRP) and the National Institutes of Health conducted an on-site evaluation of the University of Illinois at Chicago (UIC) system for protecting human research subjects from July 8 through July 10, 2014. Thank you for your September 24, 2014 response to our August 14, 2014 letter following the site visit.
Based on the information we received at the site visit, and on your September 24, 2014 report, we make the following determination regarding human subjects research at UIC:
We have determined that the institutional review boards (IRBs) sometimes lacked sufficient information to make the determinations required for approval of research under HHS regulations at 45 CFR 46.111. For example, IRB #1 had the following “Modifications Required” at initial review on May 22, 2014 for study 2014-0439: “Explain the treatment for DSA; include the explanation of the substudy in the initial review application; explain the inclusion/exclusion criteria for the substudy; include how many subjects are expected to participate.” The modifications and clarifications were reviewed in an expedited manner and the study was approved in May 2014. The modifications and clarifications were not reviewed by the convened IRB until September 3, 2014, after OHRP expressed a concern about the IRB lacking sufficient information to approve the study.
We reviewed several studies in which the IRBs requested clarifying information about the study, and the IRB action for these studies was categorized as "Modifications Required." UIC written IRB procedures indicate that such modifications may be required, without the need for further review by the convened IRB, when the convened IRB requires specific changes or information that do not preclude the IRB from making all of the determinations required for approval. In these circumstances, further review by the convened IRB is not necessary. The study noted above did not meet this standard, because the specific changes or information requested precluded the IRB from making all the determinations required for approval.
In addition, several letters to investigators indicate that research is sometimes approved upon initial review by expedited review under category 9, even though that category is only applicable for continuing review of research. For example, study 2009-0743, "Dissemination of Effective Mental Health Services in Foster Care," indicated initial full board review occurred on October 1, 2009, and final approval of the study by expedited review under category 9 occurred eight days later.
Corrective Actions: We acknowledge that UIC is taking the following corrective actions to address the determination:
1) providing education to the Boards explaining the circumstances under which research may be approved by the IRB with conditions (i.e., sufficient information is available to make the determinations at 45 CFR46.111). The education will also clarify that stipulations for approval under these circumstances must be limited to prescriptive changes or requests, and provision of instructions, when appropriate, to the designated reviewer on when the response should be referred to the convened IRB;
2) emphasizing to the IRB Chairs their responsibility to ensure the IRB carefully constructs its review and queries to investigators to accurately represent the IRB’s concerns and the Chairs’ responsibility to determine whether sufficient information is available for making the determinations for approval at 45 CFR 46.111;
3) transitioning from the UIC IRBs current designation representing approval with conditions from “Modifications Required” to “Conditions Required for Approval” beginning January 1, 2015; and
4) conducting random audits of meeting minutes and determination letters in December 2014 and June 2015 for the 3 preceding months for UIC IRBs 1-4 to assess compliance of the IRBs with requirements for granting conditional approval.
We determine that the corrective actions adequately address the determination and concerns. At this time, there should be no need for further involvement by our office in this matter. Please notify us if you identify new information which might alter this determination.
We appreciate your institution’s continued commitment to the protection of human research subjects.
Kristina C. Borror, Ph.D.
Director, Division of Compliance Oversight
1101 Wootton Parkway, Suite 200
Rockville, Maryland 20852
Dr. James H. Fischer, Professor and Director of the Office for Protection of Research Subjects, University of Illinois at Chicago (UIC)
Dr. Patricia West-Thielke, Chairperson, UIC IRB #1
Dr. Susan Labott, Chairperson, UIC IRB #2
Dr. Paul Heckerling, Chairperson, UIC IRB #3
Dr. Kathryn Rugen; Chairperson, UIC IRB #4
Dr. Mani Pavuluri, UIC
Dr. Margaret Hamburg, Commissioner, FDA
Dr. Joanne Less, FDA
Dr. Tom Insel, Director, National Institute of Mental Health, NIH
Dr. Michelle Bulls, Director of OPERA, Office of Extramural Research, NIH
Ms. Sarah Carr, Office of Science Policy, NIH