6.4 Emergency Use of a Test Article

Last Revised: 1/22/2024

1.0 Purpose

The purpose of this policy is to describe the requirements for utilization of a test article under emergency circumstances where there is not sufficient time to obtain IRB approval at a convened meeting.


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 General Considerations


5.0 IRB Requirements


6.0 FDA Notification


7.0 Procedures for Emergency Use of a Test Article



DOCUMENT HISTORY:

 Written: 1/12/2016 (Approved: 1/12/2016) - original author not recorded

 Revised: 2/12/2018 - revision not documented

 Revised: 12/7/2022 - Deleted description of expanded access and referred instead to HRPP Policy 6.5; revised procedures to reflect modified “Emergency Use of a Test Article Report” in RSS (including sequential completion of sections I and II of the report); clarified that IRB notification will be made at a convened meeting.

 Revised: 1/22/2024 – revised section 4.1 to specify “test article (unapproved drug, device or biologic)” rather than just drug or biologic; minor stylistic changes.


Revision #12
Created 24 October 2019 21:41:52 by Autumn M Eberly
Updated 17 April 2025 16:08:16 by Robert A Lewis