Page 4: A linked Kuali application in 4.6 links directly to the award/application in KC.
Page 5: Short descriptions of the review types show up beside 5.1
Page 5a and 5b: Eliminated. The study team is no longer asked to indicate the category of expedited or exempt review
Page 6a: Studies that involve LAC will now ask for a study member to be designated as the LAC contact and a LAC employee or contractor number will be required
Page 6d will now show up for exempt studies (GDPR compliance update)
Page 6d: Q 6d.1. will have an abbreviated form for exempt studies
Page 13: Supplemental Q for Retrospective studies have been moved here from 5a or 5b
Page 16: Exempt studies involving deception will be reminded that they must obtain prospective agreement to the deception prior to initiating study activities.
Page 18: Questions on using devices in the Keck or Norris hospitals are now referred to Ellen Whalen
Page 22: Changed the word "vulnerable" to "special"
Page 24: (New Rule) New waiver of written consent criterion for indigenous/native populations for whom signing a document is not common or acceptable.
Page 24: New option at 24.10 to indicate that the consent process will begin with summary to help people decide whether they will participate
Page 26: New way of dealing with data security at 26.3: Question has changed and new options provided
Page 26: New rule automatically issues a Certificate of Confidentiality - information displayed to indicate that
Page 35: Ceded question asking whether the reviewing IRB will be serving as the HIPAA board has been eliminated.
Exempt applications for USC will no longer require pages 24 and 40.
New Activity for IRB to indicate New Rule status of a protocol. When the new rule goes into effect, the IRB will be able to designate which studies will be under the new rule and which will not.
The Expedited Reviewer activity has been altered to reflect the new rule changes - new categories for exempt (if new rule) and if new rule, the reviewer must justify any expiration date on expedited studies. CHLA will have the new Exempt categories 7 and 8 but USC will not.
Review of Continuing Review: Federal Review Criteria required for approvable studies
Individual Investigator sign offs - IRBA now gets notified, since policy will be altered to remove IRB Director sign off
Expiration dates on Expedited studies are no longer required (under the new rule it is required to justify giving one)
Copying of exempt-flex studies no longer keeps the review type as exempt-flex
Exempt-Flex Categories no longer have numbers (i.e. 7 and 8), but are just labeled as "flex"
IRBAs will no longer receive "inStateTooLong" notices for items in their inboxes for over 2 days
USC IRBAs will have access to all studies at USC (eliminating the distinction between UPC and HSC IRBAs)
New Activity for Emergency Use submissions to allow reviewers to upload consents. Documents can now get uploaded to applications that have already been acknowledged by the IRB.
LAC+USC Administrators now have the ability to view all study submissions regardless of campus if it will involve an LAC site.
The Expedited Reviewer activity was altered so that questions related to DHS and LAC will be visible on all submissions if research will be conducted at an LAC site.
Various miscellaneous bug fixes and enhancements
IACUC Changes
Form Changes
“Chinchilla”, “Wild Mice”, and “Spiny Mice” are new species that can be added to protocols
Staff
“Submit Staff Review” activity is now available for Non Compliance Reports
“Reassign Designated Member Reviewers” is now renamed as “Adjust Designated Member Reviewers”
“IACUC PI & Staff” Dashboard now contains a button for “Manage Contacts” (permission based)
“IACUC Chair” Dashboard now contains a “In Veterinarian Review” section (permission based)
History Log entries for “Submit Review” and “Submit Pre Review” is enhanced to show items for IBC Review (if any)
Motion is now required for “Record Meeting Minutes” activity
All email messages now contain consistent protocol information
Various miscellaneous bug fixes and enhancements
IBC Changes
Form Changes
Question 1.4. and 1.4.1. was updated to include “Recombinant Organisms”
Question 1.6. text was updated to “More information to determine Risk Groups may be found online.”
Web link in Question 1.7. was updated
Question 14.4. (Risk Assessment) was renumbered as 14.5. and a new CHLA only question about whether or not project was done internally/externally was added as 14.4.
Staff
“Other Attendees/Guests” was added to the “Confirm Attendees” activity
New Email templates were added for CHLA for amendment and renewal approvals; existing email template for IBC approval was also updated to reflect the paper version
IBC staff now have the ability to administratively withdraw any protocol prior to approval
Various miscellaneous bug fixes and enhancements
RSC Changes
Form Changes
Principal Investigator and Permit Holder are now called IRB Principal Investigator and RAM Permit Holder throughout the application
Both IRB Principal Investigator and RAM Permit Holder can now be added to an RUA. If both are added, the IRB Principal Investigator will be the primary.
When selecting the radioisotope for Human Use of Radionuclide in Question 1., the compound is now also asked in 1.1.
Staff
“Other Attendees/Guests” was added to the “Confirm Attendees” activity
