11/2/09, 4/26/10, 9/9/10
Procedure for the Informed Consent Process and Documentation of Informed Consent
In this procedure, the term research includes clinical investigation. The terms subject and participant are used interchangeably.
In this procedure, the term legally authorized representative (LAR) includes parents and guardians as well as legally authorized representatives and is used to represent both singular and plural usage as appropriate to the context.
Additional Responsibilities for Documentation of Informed Consent Process with Oral Presentation Using Short Form
(Note: The IRB will not approve the use of the short form consent for FDA-regulated research.)
Additional Responsibilities for Informed Consent Involving Non-English Speaking Participants
Additional Responsibilities for Informed Consent Involving Participants or Their LAR Who are Unable to Read
The Senior Staff:
The Administrative Staff:
The Primary Review Team reviews and presents the following information to the convened IRB:
The Convened IRB or Experienced IRB Reviewer for the Expedited Procedure:
Approved on October 29, 2010, by:
Ferdinand Urthaler, MD
Sheila Deters Moore, CIP