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Version 4.4 Information | January 4, 2019

 

  • IRB Changes
    • Form Changes
      • 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
    • Various miscellaneous bug fixes and enhancements

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