June 29, 2020
Human Subjects Application
- Updated HUM questions on Exempt 2 and Exempt 3 to clarfiy requirements when collecting identifiable, sensitive data.
- Updated wording of HUM question 1.1.3 - Does this application include the study of COVID-19, to provide examples when the question should be answered "No".
- The Study Team Accept Role workspace messages have been updated to include name(s) of the members who need to accept their role.
- The Study Team Appointment Selection workspace messages have been updated to include name(s) of members who still require an appointment be selected.
- Resolved a smartform routing issue that occurred when removing the Waiver of Informed Consent.
AE/ORIO
Resolved an issue on AE/ORIOs not storing a selection in section, 1-4. Previous ORIOs.
COI Ancillary Committee
A new Advance for IRB Review activity is available for COI Ancillary Committee members to advance a submission to IRB for review, prior to completing COI review. For additional information, see Ancillary Advance for IRB Review Information for Ancillary Committees.
IRB Staff & Reviewers
- The separate Flint IRB-HSBS panel is deactivated as of July 1. It will no longer be a selection under Select a Committee.
- Added new Reviewer Checklist Item for Exempt 2 and Exempt 3 to clarify requirements when collecting identifiable, sensitive data.
- A new Advance for IRB Review activity is available for COI Ancillary Committee members to advance a submission to IRB for review, prior to completing COI review. For additional information, see Ancillary Advance for IRB Review Information for IRB Staff.