6.4 Emergency Use of a Test Article

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


8.0 Informed Consent


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. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board notified: 1/16/2023

 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. {Approved Russell McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}


Revision #8
Created 24 October 2019 21:41:52 by Autumn M Eberly
Updated 25 January 2024 15:58:22 by Robert A Lewis