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New Consent Guidance and Revised Common Rule

November 6th, 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 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 online through January 2019. Instead of templates, the IRB now offers consent checklists to assist you in designing your consent process and drafting your consent document.

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.

Last Updated: 11/30/22