The eResearch system contains many IRB submissions that have not been completed. Any submission that has been with the study team for more than 6 months without responding to changes required by the IRB is considered to be “abandoned”. This applies to all submission types: new applications (HUMs), amendments (AME), scheduled continuing reviews (SCRs), and adverse events/ORIO reports (ADVs). In preparation for the future transition to new IRB application software, the IRB-HSBS is addressing these abandoned, unapproved submissions now. IRBMED undertook a similar process earlier this year.

• Beginning September 14, 2020, new study applications or amendments returned prior to 2019 that have had no study team action will be administratively withdrawn by the IRB-HSBS staff without prior notice to individual study teams. The IRB-HSBS staff will post a correspondence to the application when this action is complete. After an application is withdrawn, it is archived and can no longer be re-submitted; however, study teams are still able to access information in the IRB application.
• For new study applications or amendments returned between January 1, 2019 and September 30, 2019 that have had no study team action, the IRB staff will contact each study team via eResearch for a status update. If there is no response from the study team by the timeframe specified in the correspondence, the IRB-HSBS staff will administratively withdraw these submissions. After an application is withdrawn, it is archived and can no longer be re-submitted; however, study teams are still able to access information in the IRB application.
• For all continuing reviews or AE/ORIO submissions, the IRB staff will contact the study team via eResearch for a status update.

Study team members are encouraged to check the current status of submissions under the “Require Action by Study Team” listing on the home page of their eResearch workspace.