Released April 11, 2016
The following changes apply to the Human Subjects Application (HUM):
New Mobile Medical Device questions have been added to sections 7-2 and 7-3.
PDQ Submissions is no longer a selectable option in question 1-2.5.1.
A broken link in question F5 has been fixed.
For studies where IRB-HSBS, Dearborn or Flint is selected in question 1.9 and question 14.5 is answered “No,” an error incorrectly causing section 14-1 to display has been fixed.
An error preventing some users from submitting a new application has been fixed.
In cases where a PI is changed on an amendment, and the new PI did not previously have edit rights on the study, an error preventing the new PI from submitting the amendment has been fixed.
An error preventing studies placed on Full/Partial Hold or Suspension from receiving Renewal reminders and displaying on the Approaching Expiration list on PI/Study Team Inbox has been fixed.
The following changes apply to the IBC Application and workspace:
For clarification purposes, several textual updates have been made to IBC Application questions.
Several wording changes have been made to the IBC Expiration Reminder message and the 30, 60 and 90 Day IBC Renewal Reminder messages.
The following message now displays at the top of Legacy IRB Registration workspaces:Note: This IBC Registration approval is valid for the work it contains until the stated expiration date. If your recombinant DNA work has changed from what is represented in this IBC Registration (e.g., use of transgenic animals, or administration of rDNA to animals) or if this IBC Registration requires renewal, you need to initiate a new IBC Application. For more information, see http://research-compliance.umich.edu/ibc-oversight-expansion.
The following changes apply to Core Staff:
A Staff Can Review Contingencies column has been added to the All IRB Reviews list on the IRB tab of submissions being reviewed by the IRB. A Yes indicates that Core Staff can review contingencies. If the column is blank, Core Staff cannot review contingencies.
A Manage Action Items activity link now displays at the top of the Staff Review Checklist.
The following change applies to all IRB Committees, IRB Staff and Ancillary Committees:
The subject line on all internal correspondence activities is now editable.
The following change applies to IRBMED:
For amendments where changes are made to the list of supporting documents in application question 44.2, these changes will now automatically be reflected on the IRBMED Approval Letter.
The following change applies to IRB-HSBS:
An error causing child submissions to incorrectly display on the IRB Committee Member Inbox tab has been fixed.
The following changes apply to MIAP:
For studies not previously reviewed by MIAP, where the conditions for MIAP review are met, the first (or next) amendment will now be routed for MIAP review regardless of whether or not changes are made to sections 15. Drugs, Biologics, Etc. and/or 16. Devices.
An error causing IRB Contingencies to be created even when MIAP Review was not required has been fixed.
An error causing the Update MIAP Requirements activity record to incorrectly display on the Main tab of the application workspace has been fixed.
When asked to re-review an application prior to approval after having previously marked the application as “exempt from further review,” an error preventing MIAP from completing their review has been fixed.
The IND/IDE Filing Date (Investigational New Drug/Investigational Device Exemption) entered in section 15. Drug, Biologics, Etc. or section 16. Devices is now only required if the IND/IDE is held by a U-M Investigator.
The following change applies to CRAO:
Any changes made to application section 5. Research Design (and any sub-sections therewithin) via an amendment now triggers CRAO re-review of the amendment.
The following chage applies to MCRU:
Correspondence records for the For Reviewers and MCRU Office activity that display on the MCRU tab in the application workspace are now only visible to MCRU Staff and MCRU Reviewers.