1.30 Use of the Rapid Response IRB

1.0 Purpose

The purpose of this policy is to describe the constitution of, the criteria for use of, and the procedures for review by, the Rapid Response IRB (RR-IRB; IRB-03).


2.0 Policy

It is the policy of the Organization that


3.0 Constitution


4.0 Criteria for Use


5.0 Process of IRB review and ORA release


DOCUMENT HISTORY:

 Written: 2/5/2018 (Approved: 2/5/2018) - original author not recorded

 Revised 10/17/2024 – clarified the size and composition of the RR-IRB (sections 3.2 and 3.4); deleted requirement that RR-IRB include representatives from UNMC, NM and CN (section 3.4); clarified the role of the non-voting observer when the RR-IRB reviews protocols tabled by another board (section 4.1.1); when RR-IRB review occurs concurrently with review by other committees specified who is responsible for assuring that those reviews do not raise conflicts with the IRB review (section 5.4.3.1); added that Executive Chair and/or RR-IRB Chair may waive the requirements that some or all of the ancillary committee reviews be completed prior to ORA release (section 5.4.6); stylistic changes. {Approved Russell McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}


Revision #8
Created 21 October 2019 21:54:12 by Autumn M Eberly
Updated 12 December 2024 16:27:45 by Robert A Lewis