Page 2: Editorial fix to Question 2.2 clarifying who can be designated as faculty advisor/PI. Updated guidance in plugin.
Page 2a: Outside collaborators can be added to Section 2a, an iStar account is not required. Section 2a is accessible by answering “Yes” to Question 2.3. Human Subjects certificates still required.
Page 4: Urgent Review Function for Ceded Applications (Add Industry Funding)
Page 4: (USC) Urgent review parameters expanded to include special cases of non-funding or funding from other sources.
Page 5: Section 5.2 - make required for all applications, edit question for clarity
Page 9: (USC) Added warning that exemption is only applicable in cases where a subject is informed that the research involves deception.
Pages 9 and 35: HIPAA & GCP Certificate Linked to Sub-Sections, require them to be current
A table will populate on the respective pages listing all the individuals that are pending updated certificates.
Page 11 and 12: Removed page 11/12 and textboxes referring to the grant/protocol on page 10. New studies will be required to add a protocol based on the templates provided to Section 5.2.
Page 24: Waivers of Consent needs new options for new rule; (CHLA) Removed CDW as a selection for subject recruitment tools
Page 26: Section 26.4 - Alter wording
Page 26: Add new sub questions to 26.5
Page 26: Add new option to 26.5 for CHLA
Page 26: 26.7 remove options after "electronically" is selected for CHLA
Page 35: Change PHI to "PHI/ePHI" wherever it shows up in application
Page 36: Remove Preparatory to research option from HIPAA
Page 39: Add a way for study teams to indicate that there is an updated COI management plan
Page 42: (USC) Make Section 42 available for Ceded and Exempt applications.
Page 50: CHLA - Change to Section 50 IS questions
Page 50: Make ACCM ROC a required division on ACCM protocols
Page 50: CHLA Changes to IS questions in Section 50
Page 50: Alter CHLA HIROC Routing
Page 50: Alter CHLA PLM Review - Question - 50c.2.4.1
Page 50 Validations should remain after return to pre-submission
Page D1: Add iStar Section D1.2 to All Ceded Applications
Make all the Approval Letters PDFs
Change references of HSIRB to BioIRB and references of UPIRB to SBIRB
IRB Admin Update Meeting Names in iStar
New text-box and editorial changes are needed for COI Review activity on Amendment
Allow i2b2 to be chosen in the Ceded Review Application
Amendment Templates: Notes to PI and Attachments Not Appearing for Amendments Without Agenda Items
USC Ceded Applications - Notifications to Maria Brown
Enhance the COI Annual Disclosure Status webservice
Update List of Exempt/Expedited Reviewers for CHLA
New Report of Personnel on Recently Approved Studies (CHLA)
Alter Monthly CHLA Activity Report Activity
Give HIROC the ability to run reports in iStar (CHLA)
Make editorial changes to PI Assurance for CHLA IS
Section D1.2. added to all ceded applications
(CHLA) When requesting reactivation, archived applications will transition to “Reactivation Requested” state during which an IRBA can either approve/deny your request for continuing review.
(CHLA) Prevent submission of applications for protocols and amendments if any of the study personnel’s disclosures are not current.
Bug Fixes
Scientific Reviews no longer transition to “Awaiting IRBA Assignment” upon submission of completed review if the application has already been approved.
CHLA Director inboxes now includes protocols in the “Assigned to Committee Meeting” state.
CHLA Pharmacy Reviewer access levels fixed.
Study will transition to “Awaiting IRBA Assignment” - if study team submits response and there is no IRBA listed as owner - instead of “IRB Staff Review”.
COI review activity in history log no longer shows incorrect status.
Fix HIPAA Authorization Waiver regulatory reference.
Misc Functionality
(CHLA) Altered text that shows when new users register for an iStar account.
(CHLA) Approval letter template changes.
(CHLA) Report for missing/expired disclosures set. Scheduled job can be used to add all IRB projects to person entity allowing custom searches involving protocols on person.
Meeting minutes now display IRB Internal notes where IRBAs can list controverted issues.
Column added to IRBA inbox (“My Complete Inbox” and “Studies Inbox”) for review type. Allows prioritization of full board amendments.
Various miscellaneous bug fixes and enhancements.
IACUC Changes
Form Changes
New Species Added: Dipodomys deserti, Dipodomys merriami, Blue-banded Goby, Blacksmith, Rainbow Scorpionfish, Bay Blenny, Wrasse, Opaleye, Kelp Bass, California Morray Eel, Rhesus macaque (Macaca mulatta)
Updated Anesthetic and Analgesic dosages for species
Species 1.4. reworded to "Provide the maximum number of animals for this species/strain for this project. If there are multiple strains and/or genetically modified lines, enter each strain and/or line separately. If there is only one strain or genetically modified line, only complete a single entry for this species." "Max # of Animals"
Species Antibody Production 5.3.1. - 5.3.5. will only appear if 5.3. is answered "Yes"
"Communication" tab added for IACUC Protocols, Amendments, Renewals, Monitoring Reports, NC Reports to show all the communication between PI and IACUC staff.
Changes for Staff
New role added for Controlled Substances Reviewer and these reviewers have the ability to review protocols for controlled substances similar to IBC/RSC.
Pre-Review Email Review Assignment Confidentiality - Committee Members will no longer see who is assigned to review a particular protocol in the Pre-Review email that is sent. Specialists can still see who is assigned in the activity.
