Page 1: Question 1.5 now has a notice detailing which IRB study team members should be requesting review from. Informs them of the consequence of incorrect designation.
Page 2: Section 2.1 - the auto-populate feature attached to the questions regarding informed consent, participant intervention, and identifiable data was removed; going forward, the study team will be required to answer each question independently.
Page 9: (USC) New Questions relating to in person research that is conducted in the field (9.1.2 with 9.1.2.x questions)
Page 39: (CHLA) Potential COI question is required to answer and if “Yes” is indicated, an unexpired disclosure must be linked from diSClose (submission will be prevented otherwise).
COI Annual Disclosure Status now appears in Page 39, updated in real-time from diSClose
Page 39: (CHLA) The new multi-document upload field to store reviewed CMPs will now display on this page. The old single-document upload field is now deprecated in the system, but will still appear if it contains previously uploaded CMPs.
Continuing Review application (Page 1): Two new attestations were added so that investigators can confirm that all research activities will stop once the study expires. If the continuing review is submitted prior to expiration, the investigator must attest that all research activities will stop if the protocol expires and will not resume until re-approval is granted by the IRB. If a continuing is submitted after the study expires, they must attest that all research activities have stopped as of the date of expiration and will be required to include a corrective action plan.
(USC) New Ancillary review for EH&S to review the plan for in person research in the field if that research cannot follow the guidelines as written
Bug Fixes
Page 13: Older versions of documents no longer are removed upon upload.
Misc Functionality
CHLA Approval Letter formatting revised and updated. Footers added.
IRB monikers have been modified on correspondences (UPIRB to SBIRB and HSIRB to BioIRB – to better suit roles of review boards).
Continuing Reviews that indicate study closure and Contract/Grant applications no longer require COVID PI Level Approval Plans nor Attestations.
Email notices for COI reviewers have been reworked to be role based instead of baed on individuals
Conflict of Interest Review activity: The single document upload field for CMPs was replaced with a multi-document upload field. Small editorial changes were made to the questions on this activity form. In order to improve accessibility, the CMPs will now appear in the history log. If the study still requires further review by the conflict of interest committee, an updated status of the review will display in the history log.
Various miscellaneous bug fixes and enhancements
IACUC Changes
Form Changes
New Species added: Turquoise Killifish; Tokay Gecko; Mongolian Gerbil; Green Iguana; Western Whiptail Lizard; Verill's Two-Spot Octopus
Species Antibody Production Section 5.3.1. - 5.3.5 will only appear and be required if 5.3 was answered "Yes"
Staff
Controlled Substances Reviewer role was added to the system; staff can now notify CS reviewers to review when protocols are assigned to a meeting
Various miscellaneous bug fixes and enhancements
IBC Changes
CHLA: Exposure Control Plan was moved from section 15.6. to section 2.3.
Section 7C was updated to replace "RAC" with "NExTRAC"
