513. New Projects - Submission Requirements for Administrative Review

Updated August 23, 2021

Three types of New Projects may be submitted in IRBNet for Administrative Review: requests for human research determinations, reports of emergency use of a test article, and requests to use an external IRB. (For more information, see Administrative Review in IRB Policy Manual Review Types.)

Administrative Review of New Project for Determination of Not Human Research

When University and affiliate faculty, students, or staff believe a project/activity does not constitute research or does not involve human participants, or to receive documentation that a project does not require exempt or IRB review, the new project may be submitted following instructions for a human research determination.

Administrative Review of New Project to Report Emergency Use of a Test Article

Mandatory Submission Requirements for Administrative Review of New Project to Report Emergency Use of a Test Article

• Add Part I, Cover sheet
• Add Emergency Use of FDA-Regulated Drug or Device – Single Patient researcher form signed by the requesting and independent physicians
• Add materials used to inform and obtain consent from patient or legally authorized representative (if prior consent was obtained)

Administrative Review of New Project to Request Use of an External IRB

University or affiliate investigators may use an external IRB as the Reviewing IRB under specific conditions and following IRB acknowledgement, (more information may be found in IRB Policy Manual for using an external IRB).

Mandatory Submission Requirements for Administrative Review of New Project: Request to Use an External IRB

• Add Part I, Cover Sheet
• Add Request to Use External IRB researcher form
• Add proposed consent form (if applicable)
• Obtain University or affiliate Principal Investigator (PI) signature electronically through IRBNet
• Obtain University or affiliate Responsible Official signature (electronic, through IRBNet), if applicable

Study-Specific Submission Requirements for Administrative Review of New Project: Request to Use an External IRB

• IRB Authorization Agreement: Required only if an existing agreement is not in place. Contact Research Integrity for information (775.327.2368).

Additional Mandatory Submission Requirements Administrative Review, Following Approval by the Reviewing IRB

NOTE: Following review and approval by the Reviewing (External) IRB, the University or affiliate PI must add the following materials as a new package in the existing project in IRBNet:

• Documentation of approval from the Reviewing IRB
• Copy of the consent form approved by the External IRB (if applicable)