Office of Responsible Research Practices
The Ohio State University

ORRP News

Updates to the Buck-IRB system

Posted: January 21, 2019

New updates to the Buck-IRB submission system went live on January 20, 2019.

This update involves the Exempt, Continuing Review, Annual Status Report, and Final Study Report applications. The application revisions incorporate the Common Rule changes (http://orrp.osu.edu/irb/common-rule-revisions/) that take effect on January 21, 2019.

Exempt Application Updates:

  • The “Screening Questions” and “Exempt Categories” pages were substantially revised to accommodate new and revised exempt categories.
  • Exempt categories 2, 3, and 4 now require selection of a sub-category.
  • Minor revisions were made to the “Research Methods & Activities,” “Participant Population,” “Informed Consent Process,” and “Confidentiality of Data” pages to accommodate new and revised exempt categories.
  • New actions and correspondence were added to accommodate the new “limited IRB review” for certain exempt categories.

Study Management Updates:

  • Risk level will now be displayed in “Study Workspace.”
  • Buck-IRB will display either a “Start Continuing Review” or a “Start Annual Status Report” option 90 days before study expiration.
    • FDA-regulated studies will NOT qualify for an Annual Status Report (ASR).
    • Federally funded studies with initial approval prior to January 21, 2019, will NOT qualify for an ASR.
    • Greater than minimal risk studies will start in the continuing review (CR application), but may eventually be able to transition to an ASR.
  • IRB submission form HTML files found on the “Print/View Study” tab of the left-hand navigation menu will display either a “pre-2018 Rule” or “Final Rule” label at the top of the document, depending on if the initial IRB approval was prior to January 21, 2019, or after.

Continuing Review & Annual Status Report Application Updates:

  • Certain responses on the “Research Status” page in the CR and ASR applications will transition qualifying studies from one application to another (i.e., CR to ASR, CR to Final Study Report (FSR), or ASR to FSR).
  • The “Research Status” page was moved up in the CR application so that unnecessary parts of the form would not be completed should the system transition it to an ASR or a FSR.
  • Both CR and ASR applications will now automatically populate descriptions of amendments approved since the last review on the “Research Progress” page.

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