513. New Projects - Submission Requirements for Administrative w88

Updated June 7, 2024

Three types of New Projects may be submitted in IRBNet for Administrative Review: requests for human w88 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 w88

When University and affiliate faculty, students, or staff believe a project/activity does not constitute w88 or does not involve human participants, or to receive documentation that a project doesnotrequire exempt or IRB review, the new project may be submitted following instructions for a human w88 determination.

Administrative w88 ofNew Project toReportEmergency Use of a Test Article

Mandatory Submission Requirements for Administrative w88 of New Project to Report Emergency Use of a Test Article

• AddPart I, Cover sheet
• AddEmergency Use of FDA-Regulated Drug or Device – Single Patientresearcher form signed by the requesting and independent physicians
• Addmaterials used to inform and obtain consent from patient or legally authorized representative (if prior consent was obtained)

Administrative w88 ofNew Project toRequest 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 w88 of New Project: Request to Use an External IRB

• AddPart I, Cover Sheet
• AddRequest to Use External IRBresearcher form
• Addproposed consent form (if applicable)
• ObtainUniversity or affiliate Principal Investigator (PI) signature electronically through IRBNet
• ObtainUniversity or affiliate Responsible Official signature (electronic, through IRBNet), if applicable

Study-Specific Submission Requirements for Administrative w88 of New Project: Request to Use an External IRB

• IRB Authorization Agreement: Requiredonlyif an existing agreement is not in place. Contact w88 Integrity & Security for information (775.327.2368).

Additional Mandatory Submission Requirements Administrative w88, Following Approval by the Reviewing IRB

NOTE: Following w88 and approval by the Reviewing (External) IRB, the University or affiliate PI mustaddthe following materials as a newpackagein the existing project in IRBNet:

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