Human subjects research restarts

The OVCR and the UIC Center for Clinical and Translational Sciences (CCTS) have established a COVID-19 Research Recovery Committee to help investigators and deans prioritize IRB-approved studies for reopening.

The OVCR review committee, which meets weekly, is co-chaired by AVCR Jon Klein, associate vice chancellor for research, and CCTS principal investigator Robin Mermelstein and includes faculty from many colleges and representatives from the Faculty Senate Research and Executive Committees.

Online requests for restart and review began June 22 with 71 requests received and reviewed by July 6; 59 requests were received and reviewed by July 13. Forty-eight studies of low and low/moderate risk were approved for restart on July 6; 51 requests were approved for restart on July 13.

Faculty investigators whose protocols are approved for restart have been notified they may resume activities contingent upon: an approved BioRAFT registration; a site or building that has been opened for faculty and staff activities by their dean or director; and appropriate disinfection, signage, physical and temporal spacing of subjects to promote 6-foot physical/social distancing, masks and sanitizer or handwashing capability nearby. 

If the study is to be conducted outside of UI Health clinical care delivery sites, there also must be a plan for screening research subjects for COVID-19 symptoms or exposure; tracking attendance on site by subjects, and ensuring appropriate personal protective equipment and sanitizer are available for subjects.

OVCR is working closely with the Environmental Health and Safety Office (EHSO) to ensure that principal investigators understand the need for and how to track subjects and screen for COVID-19 risk and symptoms, and have adequate protective equipment, sanitation, and training for investigators, staff and research volunteers.  Please contact us if you learn of any issues of which we should be aware, or if you have any experiences or suggestions that would benefit others in their research restart.

Special Note: 
UI Health Incident Command is ending emergency operations for the health system and transitioning to ongoing management of COVID-19 cases and facilities. So, OVCR also will transition the COVID-19 Research Advisory Committee (RAC), effective July 13.  The COVID-19 RAC has reviewed clinical research protocols and advised the chief medical and nursing officers about the scientific importance and implementation feasibility for proposed research addressing COVID-19 treatment or impact within the health care system. Between April-June 2020, the group, led by AVCR Jon Klein, reviewed 16 clinical protocols (including five COVID-19 clinical trials) and more than a dozen registry studies addressing diagnosis, treatment and impact of COVID-19. Special thanks to RAC members Alan Gross, Jesica Herrick and Jerry Krishnan, and also to associate chief nursing officers Tye Hughes-Dillard and Darlene Evans, and chief medical officer Terry VandenHoek and associate chief medical officers Neeta Venepalli and Ari Rubenfeld.