Office of Responsible Research Practices
The Ohio State University

ORRP News

Updates to the Buck-IRB system

Posted: October 9, 2018

New updates to the Buck-IRB submission system go live on October 10, 2018!

Included in this update are significant revisions to the Risk Assessment page of the continuing review form for IRB-approved human subjects research. The form revisions include  clarifications regarding reporting requirements at the time of continuing review and  more specific selection options to ease form completion. See the list below for the more significant changes to the page:

  • Revised instructions to clarify the IRB’s review of information relating to the risk/benefit assessment, and to define the meaning of unanticipated problems involving risks to subjects or others
  • Added instructions for sponsor-investigators for research involving an Investigational Device Exemption (IDE)
  • Revised/added questions to describe the reporting summary needed at the time of continuing review (unanticipated problems involving risks to subjects or others, serious and/or continuing non-compliance, suspensions, and clinical holds)
  • Added event reporting submission instructions  for any items that should have been previously reported to the IRB, but were not
  • Removed unnecessary questions after the rephrasing of other questions/instructions
  • Added selection options for studies using a Data and Safety Monitoring Board (DSMB) to help researchers clarify when the DSMB has not yet met, is no longer meeting, or when a report is/is not available
  • Restructured the risk/benefit assessment question to only prompt for an updated assessment if there have been changes to the risks/benefits
  • Clarified which supporting documents should be uploaded

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