Combined UA-Banner Health Informed Consent/PHI* - In collaboration with the Clinical Research Coordinators and Banner Health, a new combined UA-Banner Health informed consent/PHI template is attached and has been loaded on the HSPP website.
Linking of Sponsored Projects Services proposals and Human Subjects protocols* - Changes to the funding questions on the IRB applications have been made to assist both Sponsored Project Services (SPS) and the HSPP capture necessary UAccess account information. This will enable the institution to make links between active awards and IRB approved protocols. Please ensure that this section is completed thoroughly so projects are accounted for in institutional level reports.
IRB audit of deferred studies * - The HSPP will be conducting an internal audit of all deferred studies (where another IRB is reviewing the project). Investigators will be contacted for status updates, missing information, or copies of documents. This audit will focus on informed consents and HIPAA language, renewal status, and reportable items. Should you have questions or concerns please contact me at the numbers below. The time needed for the audit should be very minimal for research personnel.
Change in procedure
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Humanitarian Use Device and Emergency Use*
Humanitarian Use Devices (HUDs) and Emergency use of an unapproved drug or device inherently are NOT research, however, they require IRB oversight per the FDA regulations.
As part of our ongoing efforts to streamline process with Banner Health, all NEW requests for approval of a HUD or Emergency Use will be reviewed by the Banner Health IRB.
For additional information, please review the following:
Any previously approved Emergency Use or HUDs by the UA IRB will REMAIN with the UA IRB. This procedural change is effective only for NEW submissions effective immediately. • Any research on a HUD will be reviewed by the UA IRB. • Exception from Informed Consent (EFIC) studies are research and the UA IRB will review these if conducted at Banner Health.