October 28, 2019
Human Subjects Applications
- The application for external sites participating in a Multi-site Study where U-M is the Single IRB of Record was updated to include Continuing Review (CR), Incident (AE/ORIO), and Termination reporting. See Participating Sites documentation and 4.4.5 release notes for more information.
- Study applications and approval letters were updated to reflect consolidation of IRB Flint into IRB-HSBS Flint. Any active or in-progress applications that were under IRB Flint now fall under the review of IRB HSBS Flint.
- An issue where an amendment’s related UFAs were removed at approval has been resolved.
- The text of question 16.1 and answer choices were reworded to better inform when studies need review by the Michigan Medicine Clinical Engineering Unit.
- Text of question 21-1.3.2 has been revised to more accurately reflect RDRC/SHUR annual reporting requirements.
For IRB Staff
- An expiration date error that occurred when an IRB member tried to approve an amendment for a No CR Required study has been resolved.
- The Staff Owners on a parent study will not be updated when an amendment is approved. This allows for changes to Staff Owners on amendments without impacting the parent study.
- When U-M is a performance site in a Multi-site Study, the reviewer checklist choices on a Continuing Review have been updated to more appropriately describe the determination.