Page 1: Q. 1.5 USC IRB names have been updated to be there USC Biomedical IRB and the USC Social Behavioral IRB. Guidance for determining which IRB to submit to is available on the question
Page 1: Covid-19 question added to indicate priority for review
Page 4: Funding question revised
Page 6: Questions to determine whether there are other sites have been altered to better distinguish the information required on page 6c
Page 6c: new question if USC/CHLA is the coordinating center - most other other questions have been removed.
Page 22d: For CHLA, hide Question 22d.3
Page 50: Functionality was added to facilitate department/division routing based on answers from Additional Required Approvals section from this page
Page D01: Both D1.6. and D1.6.1 questions have been deprecated on the Ceded Review application as the auto not-engaged functionality has been removed
New Reportable Events Form and process for CHLA
New Study Reactivation Review process for CHLA
New Not Human Subjects Review activity available for the IRB for studies in IRB review. The IRB can designate a project as NHSR and send a determination letter.
Edit Study Personnel: relaxed requirements for USC based on new policy: Co-Investigators can be added or removed from this activity.
Co-Investigators can now sign off while the study is approved to facilitate adding co-Is with the edit study personnel activity
Individual Investigator agreements are now person based rather than study based. Individuals who signed paper versions can have their agreement uploaded into their profiles.
New mechanism for COIs to show up on the next IRB agenda after getting added via an amendment
CHLA: show ancillary committee review status on workspace (HIROC and RSC)
New reports for CHLA
Emergency Use applications initial submission emails will include CHLA IRB staff (no longer limited to Chairs)
Auto-acknowledged letter template revised for CHLA
Auto Not-Engaged functionality for Ceded Review studies was removed
Various miscellaneous bug fixes and enhancements
IACUC Changes
Form Changes
Species are now more specific with additional species available to be added to protocols in Section 3
Animal Numbers in Species 1.3. and 1.4. have been updated to be total animal numbers for 3 years instead of for each year. Also, there is no longer a need to separate out USC breeding colonies and outside vendor numbers in Species 1.4.
Staff Changes
Workflow update for NCR - Staff can now "Send Letter to PI" after Corrective Action Plan is submitted by PI.
"Send Message to Investigator" now have ability to specify additional recipients outside of the system.
Various miscellaneous bug fixes and enhancements
IBC Changes
Form Changes
Section 15.3. Related IACUC Protocols now contain Amendment/Renewal information so amendments and renewals do not need to be added. Only the main protocol needs to be added to this section.
