Emory Research Administration News

eIRB Upgrade News Update (as of 11/15/2019)

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by

Ashley Myers
in

To view the most recent updates as of 12/23/19, please visit the latest article here.

eIRB Upgrade Latest Information

  • User Testing ended this week! Thanks to all who volunteered!
  • **IMPORTANT** Upcoming Hiatus on Continuing Reviews** – see below
  • Be Prepared: Strategic Slowdown in Submissions – see below
  • New Protocol Templates Required for Upgraded System – see below

 **IMPORTANT** Upcoming Hiatus on Continuing Reviews** 

We need to stop processing continuing reviews during the migration slowdown period (see below).  We requested teams to submit their continuing review applications by 11/15/2019 if expiring between 1/1/2020 and 2/21/2020.  Are you affected?? Review this list of expiring studies by PI.

If you missed the deadline, know that we will do our best to approve your submission but we cannot guarantee approval before the upgrade.  Submit right away! If your study approval lapses, you will have to submit your CR in the new system AND stop all research until receiving reapproval.

Be Prepared: Strategic Slowdown in Submissions 

  • Why? To enable efficient data migration. Only fully approved studies (with no open amendments/renewals) can be migrated.
  • When? January 7 through “go-live” around January 31
    • See above for continuing review deadlines
  • What?
    • New Studies: Limited to interventional studies with these criteria:
      • Competitive enrollment or contractual obligation for quick start-up (e.g. NCI grant)
      • IRB is limiting factor in start-up (i.e. do not submit if contract, etc. will not be ready)
      • Others: hold until new system go-live (consult IRB leadership if special concerns)
      • Any studies submitted: need to wrap up within 90 days of go-live, else must resubmit in new system
    • Amendments: only if updating protocol, IB, consents, or other study documents when immediate change is required by Sponsor or affects safety/welfare of subjects. Amendments for non-urgent changes should be held until go-live
    • Reportable events: Submit as usual in the current eIRB system
    • WIRB and other External IRB-Reviewed Studies: we will have another workflow available outside eIRB

Contact the IRB if you have any questions.