Section 4 now includes the list of Amendments submitted since the last approved continuing review.
The aforementioned list of Amendments are now visible in a new section 4.7.
Section 4 was renamed from "04. Adverse Events" to "04. Adverse Events and Amendments".
Section 4.1. now contains new Reportable Event submission categories for CHLA in an “Other” category (audits/breach of confidentiality/written report/premature suspension).
Study:
Section 2a. Language and form for non-CHLA collaborators revised. Section to be removed for USC – Section 2.3 hidden for USC.
Section 2.1. language revised to “direct in-person interaction with participants”. Prevent Non-USC affiliated personnel from being listed as PI or faculty advisor.
Section 2.2 added for USC ceded applications. Faculty advisor sign off required.
Section 4.1. options all result in the urgent review question as urgent review guidelines have expanded to include non-funded studies.
Section 5.2 links updated to relevant protocol per campus of submission. Section 5.2 is required for USC and CHLA.
Section 5A and D2 added to ceded applications since study teams from HS will be submitting SB applications.
Section 6.2: Engagement questions are always shown when using the Single IRB Model (USC Only)
Section 9.2.1. Dornsife Neuroimaging Center attestation language revised.
Section 9.3. removed validation for Section 2.1. requiring users who obtained consent/interact with patients/access identifiable data to have updated GCP certificates (CHLA only).
Section 13 to show only if either secondary analysis is indicated. Title of section revised, 13.2 language revised. Added tooltip describing what qualifies as secondary analysis.
Section 24A: New question added 24A.3.4.
Section 24P: New question added 24P.3.4.
Section 36 will be skipped if Section 35.1 is answered “Yes”, the study is exempt, and 24.3 is indicated as “consent will not be obtained”.
Section 39 instruction language updated.
Scientific Review routing fixed for HSC studies.
Section 50.c.2.8.2 wording was updated to include Heart Institute Resources such as echocardiography, electrocardiogram, cardiac MRI and exercise stress testing.
Bug Fixes
Studies will no longer archive automatically if a reportable event is pending; instead, a notification will be sent to the IRBA assigned to the protocol.
Section 13 and 18 will now properly store saved responses.
HIPAA waivers showing up on Record Staff Review where none was requested in the proposal was fixed.
Approval letter templates for CHLA fixed to remove obscure characters.
NHSR ability to submit via the IRB determination button removed.
Any amendments that fall under the new rule that are non-flexed will no longer require expiration dates.
Continuing Reviews now require expiration dates for full board and non-new rule studies.
Section 1.3 for continuing reviews shows for approved studies with null expiration dates.
IRBA no longer encounters error when attempting to suspend a protocol through reportable event.
“Submit Response to IRB Staff” activity no longer errors when there is a null set of individual investigators.
Faculty Reviewer Dashboard correctly lists studies that are in “Faculty Review”.
Section 4.1 now includes reportable event submission types “external event/internal event that requires prompt reporting” for CHLA.
Question 24.5.1.A will now appear when appropriate checkbox is selected
Enhancements
Reportable Events:
Added new functionality for Compliance Notes which can now be logged via Reportable Event reviews.
Findings of serious non-compliance, continuing non-compliance or suspensions indicated on Reportable Event Reviews will cause a compliance note to get recorded on the main study.
Findings of serious non-compliance, continuing non-compliance or suspensions indicated via Record Meeting Minutes will cause a compliance note to get recorded on the main study at the point of Acknowledgement.
IRB Analysts now have the ability to designate staff for Federal Reporting preparation via the Record Meeting Minutes activity. This is applicable to findings of serious non-compliance, continuing non-compliance or suspensions.
If a designee for Federal Reporting is selected, an email communication will go to this staff person at the time of Acknowledgement.
The Compliance Notes tab and status bubble was modified so that they can only viewed by IRB Administrative Staff and Chairs.
All communications related to Compliance Notes are limited to IRB Administrative Staff and Chairs.
IIA attestation now links to Belmont Report, CFR, and other relevant material.
Restructured pharmacy departments – created “School of Pharmacy Students” and “KCM Department of Pharmacy Services” departments. Rerouted various departments to “Clinical Services” from “Pharmacology and Pharmaceutical Sciences”.
"Re-send agenda" activity notification for meetings updated to include relevant information.
Added all review boards to “Reassign to Other Committee” and “Assign to Committee” activities.
“Assign IRBA Administrator” activity to list all IRBAs across boards.
Legacy studies will be required to submit conversions via amendments unless enrollment status marked as data collection or data analysis. If legacy team tries to open a continuing review that meets conversion criteria, they will be prompted to first submit an amendment. Amendments will automatically be converted from legacy if they meet the conversion criteria.
Right To Try submission type added to the main application. Ability to send to “Chair Review” for review prior to assignment to full board committee. Activities created to track compliance: “Submit Biannual Report” and “Log Adverse Event”.
Misc
COVID PI approval plan and attestation requirement abrogated from all “Submit” activities, page 9, and all associated activities/user dashboards. Attestation flag no longer displays on studies. Section 2.1. column tracking compliance removed. Validation removed from “Edit Study Personnel” activity.
HIPAA now expires every 3 years (USC Only)
Training Icons (HS, GCP, HIPAA) have been updated.
IACUC
Changes for PI / Study Team
Create New Renewal activity & Renewal Information page updates
New Questions asked when Third Year Renewal is selected:
Protocol R1.3. was added asking for a brief summary of study progress over the last 3 years
Protocol R1.4. was added asking about Animals Used in the last 3 years
Protocol R1.4.1.was added about animal number requirements changed if R1.4. was answered yes
Protocol R1.4.2. was added asking for an explanation for why no work was done if R1.4. was answered no
Protocol R1.4.1.1. was added asking brief summary of changes to animal numbers if R1.4.1. was answered yes
Protocol R1.4.1.2. was added asking for justification for more animals if R1.4.1. was answered no
Protocol R1.5. was added asking if personnel need to be removed/added if "Continuation Without Changes" is selected
Previous Protocol R6 was changed to Protocol R2: brief description of plans to continue
Previous Protocol R2 was changes to Protocol R3: unanticipated problems/adverse effects
Previous Protocol R3 removed: pilot study
Reminder to update protocol application wording was updated and only shows when "Continuation With Changes" and "Third Year Renewal" is selected.
Protocol 2.2. was added to ask for a brief scientific abstract
Previous Protocol 2.2. was changed Protocol 2.3. and wording was updated to reflect the 3Rs: Replace, Reduce, Refine.
Species 1.3.2. was added to for multiple strains use justification if mice, rat, zebrafish and rabbits are used.
Reminder to confirm anesthetic/analgesic usage was added when Species 3.1. was answered yes
Species 6.2. was added to ask about behavioral equipment sanitization
Species 7.5. was added for biological/chemical hazards identification
Species 10 section was renamed to "Administration of all experimental substances (e.g. Drugs, Chemicals, Cells, Imaging agents (including PET ligands), Nucleotides and Biologicals)"
Species 14.5 was added regarding radioactive materials procedures
Species 14.6 was added regarding radioactive material administration precautions
Species 16.7. was updated to include individuals responsible for anesthesia; individuals monitoring of animals undergoing procedures; and individuals responsible for recovering from anesthesia
Reminder to update section 4 was added when Species 17.1. was filled out
Wording was updated for the following questions:
Protocol 1.6. checkbox list selections
Species 1.2., 1.3., 1.5., 1.6., 1.7.
Species 2.1.
Species 4.2.1., 4.2.2., 4.2.3., 4.2.4.
Species 5.3.2.
Species 8.1.
Species 9.3. and 9.5.
Species 10.1. and 10.2.1.
Species 14.2.
Species 16.1., 16.3., 16.5., 16.8. 16.9.
Species 17.1., 17.2., 17.3.
Species 20.1.
Removing someone from the Personnel section (Protocol 1.4) now automatically also removes them from the respective sections in Surgical Personnel (Species 16)
DAR Staff was added an option to Surgical Personnel (Species 16)
Changes for IACUC Committee / Staff
More than two contingency reviewers can now be assigned for Contingency Review
Various miscellaneous bug fixes and enhancements
IBC
Changes for PI / Study Team
Chemical List found in 1.14 and Section 12 is now replaced with a link to the Prop 65 List of Common Hazardous Chemicals website
PIs no longer need to "Agree to Participate" in a separate activity. Instead, PIs can "Agree to Participate" when they "Submit Application"
Changes for IBC Committee / Staff
CHLA: New BUAs, Amendments and Renewals that do not include the use of rDNA can now be reviewed and approved by DMR
USC: _Master message templates are now available for both expedited and administrative review types
