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Consent Guidance Update

November 5th, 2018

In anticipation of the revisions to the Common Rule that go into effect on January 21, 2019, the IRB is excited to announce changes to the informed consent guidance we offer the research community. 

What is changing?

The University of Utah IRB is moving away from offering consent document templates towards a more flexible paradigm where we offer guidance for conducting a consent process and drafting a consent document.  The consent templates will continue to be available until January 2019. 

We encourage you to view our Consent Guidance Introduction video to learn more.

Why is this change being made?

There are many reasons, but primarily:

  1. The UU IRB is working with more institutions and groups outside of the University than ever before.  The need for more generalizable and adaptable guidance has never been greater.
  2. The changes to the Common Rule include many provisions that are not applicable to everyone, and are not as easily categorized by Health Sciences vs. Main Campus.  In order to capture as many scenarios as possible while still offering useful examples, less rigid models for obtaining consent are needed.

Where can I learn more?

Please visit the new Informed Consent page, and review the Consent Guidance FAQ for more information about these changes. 

As always, if you have any questions, please contact the IRB at 801-581-3655 or irb@hsc.utah.edu.  We are happy to assist you. 

  • GCP Training Requirements

    Effective January 1, 2017, the University of Utah IRB requires clinical investigators and staff listed on an IRB application funded by the NIH to have both human subjects training and GCP training before an IRB application will be approved.

  • IRB Staff Telephone Availability Interruption

    The IRB office is currently undergoing construction. Several of our staff members have moved to temporary accommodations away from their desks and usual telephones while the remodel is under way.

  • IRB Staff Changes

    Please join us in welcoming our new Panel 4 Coordinator.

  • Delayed Pre-Review Timelines

    Due to new staff onboarding and training currently happening at the IRB, as well as a greater than usual amount of applications submitted in recent weeks, we are running several days behind schedule on pre-reviews for all applications.

  • IRB Staff Changes

    We are excited to welcome a new Administrator to the IRB.

  • IRB Staff Changes

    We are happy to welcome a new IRB Coordinator. We are also pleased to announce that Jessica Loayza has joined the Administrator team.

  • Delayed Pre-Review Timelines

    Due to new staff onboarding and training currently happening at the IRB, as well as a greater than usual amount of applications submitted in recent weeks, we are running several days behind schedule on pre-reviews for all applications.

  • IRB Staff Changes

    We have added two new positions to the IRB.

  • IRB Staff Changes

    We are pleased to welcome a new Coordinator to the IRB.

  • IRB Staff Changes

    We are happy to welcome a new IRB Administrator to the New Study pre-review team.

  • IRB Updates

    Due to F&A increase to 36.5%, the IRB fee schedule is changing for industry-sponsored new studies, continuing reviews, and amendments. The new IRB fee schedule will be effective on July 1, 2016.

  • IRB Staff Changes

    Please join us in welcoming our new IRB Clerk.

  • RDRC-HUS Workflow for Amendments

    Effective 5/1/2016, the RDRC-HUS will now review all amendments related to radiation use within the ERICA system.

  • IRB Staff Changes

    Please join us in welcoming our newest IRB Administrator.

  • IRB Updates

    All studies conducted at Shriners Hospitals for Children in Salt Lake City are now required to obtain approval from Shriners Hospital leadership before the IRB will issue final approval of the study.

  • Institutional Conflict of Interest Policy

    Beginning January 15, 2016, the conflict of interest review process for all New Study applications will include a review for Institutional Conflicts of Interest (ICoI).

Last Updated: 11/5/18