December 7, 2025
For Study Team Members
Human Subjects Applications (HUM)
- Minor updates to question and help text on certain device related questions:
- Research Design; 5.1
- Special Considerations; 7-2.1 & 7-3.8
- Devices; 16.2.7, 16.2.8, 16.2.9.1, 16.2.23, 16.2.24, & 16.2.25.1
- A new MIAP worksheet is available to assist PIs in determining the risk of devices when U-M has manufactured a medical device, or has contracted another company to manufacture a medical device, that will not be submitted to the FDA under an IDE. This “U-M Manufactured Device Information Form” is available on the MICHR site and also linked in the 16.2.9.1 and 16.2.25.1 question text.
For IRB Staff
- The IRBs now permit use of the Administrative Approval functionality in the Staff Reviewer Checklist. Specifically, Co-I changes are no longer an exclusion. Therefore, the radio button choice was updated to "Changes to Study Staff (except PIs and Faculty Advisors)".
- Provided the ability for IRB staff to withdraw a CR or AME when in a Pre-submission state.
- Fixed an issue on the Hotlist tab where the My Activities dropdown list, under the Jump To Activity column, was unavailable.
For IRB Staff and MIAP
- Updated the submission's MIAP review tab to include a new table listing all issues related to that HUM, AME, ADV, or CR project.
- Fixed an issue with the MIAP Review triggers:
- The MIAP review requested flag set to "True" should not automatically be carried forward to subsequent amendments. Instead, amendments should be sent to MIAP review only if applicable data in Sections 15 or 16 changed, or if the Update MIAP Review Requirements activity is run.
- When an IND is only held by a company, MIAP review is not required. MIAP was incorrectly receiving applications with this condition when question 15.5, related to involvement of Normal Healthy Subjects, was answered "yes". This has been corrected.