Procedure for Emergency Use of FDA-Regulated Test Articles
(Note: Some manufacturers will agree to allow the use of the test article, but their policy requires an acknowledgement or “IRB approval letter” before the test article will be shipped.);
The Senior Staff:
The Administrative Staff:
The IRB Chair or designee:
Each IRB member assigned to a convened IRB meeting in which emergency use exemption has been granted receives and reviews the emergency use materials supplied with the agenda in enough depth to discuss at the meeting.
The IRB confirms the emergency use acknowledged by the IRB Chair.
BASIC ELEMENTS AND DISCLOSURES INCLUDED IN INFORMED CONSENT FOR EMERGENCY USE OF TEST ARTICLES
Additional Elements, When Appropriate
When appropriate, one or more of the following elements of information will be provided to each recipient:
Approved on March 23, 2007, by:
Sheila Deters Moore, CIP