Process Improvements

UCI Human Research Protections (HRP) and the Institutional Review Board (IRB) are always looking for ways to reduce administrative burden on researchers, IRB Members and IRB Staff. We are pleased to announce the first of several changes in our procedures that should help reduce burden.

Reminder of Recent Changes…

  • Research Protections Roadmap – a simple, quick tool to assist investigators in navigating UCI’s regulatory and institutional requirements.
  • Removing the expiration date from IRB-approved documents – to reduce renewal processing and the number of versions to be maintained over the life of a study. Removing the expiration date from the consent also reduces the likelihood that researchers will obtain consent using an expired consent form. For active studies, the most recent version of the IRB-approved documents are always available on the IRB Document Depot.

New Updates…

  • Registration of new exempt research will now be extended to five years from three years.
  • The Biomedical/Clinical and the Social/Behavioral/Educational IRB Protocol Narratives for Expedited/Full Committee Research have been updated and streamlined. Use of these revised narratives will be required for new submissions effective October 15th.
  • For cancer-related protocols, Protocol Review and Monitoring Committee (PRMC) review is now concurrent to IRB review, except for Investigator-Authored (IA) research. For IA cancer-related research, PRMC approval is still required prior to IRB review. For more information contact the PRMC at CancerCenter_Committees@Health.uci.edu” >CancerCenter_Committees@Health.uci.edu.
  • Western IRB, Copernicus Group IRB, Aspire IRB, Midlands IRB and New England IRB are all part of the WIRB-Copernicus Group (WCG). For industry-authored clinical trials, where the sponsor has chosen one of these IRBs as the IRB of Record, UCI Investigators, with documented permission from the sponsor, may use Western IRB (WIRB) for IRB review of qualified trials. Prior UCI IRB administrative registration is required.

Future Changes…

  • Streamlined UCI IRB procedures when UCI is the “relying” IRB
  • Updated Unanticipated Problems Reporting Process
  • Expansion of optional CITI training including new GCP Modules and Clinical Coordinator Modules
  • Additional IRB Reliance Opportunities

For questions or to provide suggestions, please contact:
Karen Allen
Director, Research Protections
949-824-1558 or karen.allen@uci.edu” >karen.allen@uci.edu

 

 

James W. Hicks, Ph.D.
Interim Vice Chancellor for Research
Professor of Ecology & Evolutionary Biology