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IRB Updates!

Webinar: Ethics & Regulation in the Digital Age*

Live stream

Date: 21 July 2016

[HSPP Event Description]


The HSPP will live stream this one-day conference on July 21, 2016 at our office. 
  • RSVP to attend - Space is limited.  
Digital and emerging technologies are revolutionizing the conduct of clinical trials. How can regulators and IRBs keep up with these changes?

This summer, join leaders from across the country and regulators from the FDA and OHRP for a day of education and networking.

The presentations will challenge our thinking regarding the ethical and regulatory issues generated by the use of technology in research.  
RSVP
HSPP Webinar Link
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Update Overview

Important Update - IRB Forms!

Due to many changes, HSPP forms and guidance have been updated. The new forms, dated July 2016, will be required effective September 1, 2016.*
For the latest information on forms and policies...Visit the HSPP website
  • Humanitarian Use Device and Emergency UseChange in procedure*  - 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.
  • 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.  
  • Native American ‘enhanced’ consent language and change in procedure* - Consistent with the Arizona Board of Regent’s policy on consultation with tribes (http://nptao.arizona.edu/spotlight/abor-tribal-consultation-policy), the HSPP has made changes to process and documents to obtain more information about research with Native Peoples.
  • 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
Click images to learn more!

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:

EXCEPTIONS*

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.

Questions?

In Tucson, please contact...

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