Office of Responsible Research Practices
The Ohio State University

ORRP News

Updates to the Buck-IRB system

Posted: June 1, 2018

New updates to the Buck-IRB submission system go live on June 2, 2018

Included in this update are significant revisions to the event reporting submission form for IRB-approved human subjects research. The revisions to the form include enhanced questions to allow investigators and IRB members to make informed and appropriate determinations regarding unanticipated problems and potential noncompliance. See the list below for some of the more significant changes to the form:

  • Categories of protocol deviations added to better clarify the event
  • Investigator determination of whether the event increased risk, was unexpected, and/or was potentially related to research activities is now required
  • The number of participants enrolled must be provided at the time of the event
  • Event timeline details are solicited to inform the IRB of not only when the event occurred, but when the investigator was notified
  • Clarified reporting options to other external/internal entities (such as sponsors and FDA)
  • Corrective action options revised

Login to Buck-IRB at go.osu.edu/Buck-IRB.

For additional information about this Buck-IRB update, please contact Michael Donovan at donovan.6@osu.edu.

Category : Buck IRB / IRB / ORRP