518. Updated Documentation for Use of External IRB

Updated August 23, 2021

For new projects approved by administrative review, only projects that are using an external IRB are to submit updated documentation of Reviewing (external) IRB approval.

Principal Investigators (PIs) conducting research projects approved by an external IRB are to keep the University IRB apprised of the status of the research by updating documentation of continued approval from the Reviewing IRB. The IRB will review these updates administratively.

Updates are to be submitted as new packages to the existing project in IRBNet, according to the approval period determined by the Reviewing IRB.

To facilitate monitoring of research subject to review and oversight by an external IRB, PIs are asked to update approved versions of the following materials in a continuing review package in IRBNet as relevant:

• Part I, Cover sheet: update only as needed to reflect changes in sponsorship or University study personnel
• Update documentation of approval from the Reviewing IRB
• Update approved version of consent documents (only if changed during the approval period)

Required Signatures

• University or affiliate PI signature (electronic, through IRBNet)

NOTE: The approved version of the Request to Use External IRB researcher form remains in effect for the duration of the research unless there are substantive amendments to the University PI's role in the research. In the latter case, the PI should contact the Research Integrity office (775.327.2367) promptly after the amendments are approved by the External IRB.