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.
Obtains signatures and the dates of signature on informed consent documents (including assent forms) for the following individuals unless the IRB has waived documentation of informed consent process: (Note: The IRB cannot approve a waiver of documentation of informed consent for FDA-regulated research.)
Additional Responsibilities for Documentation of Informed Consent Process with Oral Presentation Using Short Form
Additional Responsibilities for Informed Consent Involving Non-English Speaking Participants
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 September 25, 2015, by:
Ferdinand Urthaler, MDIRB Chair
Jonathan Miller, MPPA, CIPOIRB Director