1.6 IRB Composition, Leadership, Qualifications, and Responsibilities

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for IRB composition, leadership, member qualifications, and responsibilities.


2.0 Policy

It the policy of the Organization that the membership of its IRBs will satisfy requirements of 45 CFR 46.107 and 21 CFR 56.107, and will include an appropriately diverse mixture of backgrounds, gender, and race/ethnicity.


3.0 Composition of the IRBs


4.0 IRB Leadership

ADMINISTRATIVE APPROVAL: Bruce Gordon, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS Russell McCulloh, MD


DOCUMENT HISTORY:

 Written: 4/11/2016 (Approved: 4/11/2016) - original author not documented

 Revised: 3/27/2018 - revision not documented

 Revised: 7/29/2021 - Removed redundant material; removed references to pre-2019 Common Rule; clarified items included in roster of IRB members; clarified responsibilities of IRB chairs and Vice-Chairs.

 Revised: 4/15/2022 - Clarified that an IRB administrator serving as a voting or alternate member of the IRB may not serve as primary reviewer for a protocol for which he/she primary administrator (section 4.5.9.2). {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised: 7/14/2022 - Revised to clarify that consultants are not officially appointed by EC; removed reference to Compliance Officer as a consultant; clarified that IRB Administrators appointed as IRB members or alternate members by the IO, in consultation with the IRB Executive Chair; simplified designation of IRB administrators as scientists or non-scientists; specified that IRB administrators must have at least 2 years-experience with the ORA or another IRB, and must be approved by the IRB Executive Chairperson, before they can act as an expedited reviewer. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised: 10/11/2022 - Clarified that a consultant or a knowledgeable board member may provide information to the IRB regarding Community Based Participatory Research (section 3.9). {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/15/2022

 Revised 4/3/2024 – clarified that assigned analyst may not be the primary reviewer for initial review, but may be for other actions (for example, CR, AE, incident reports) (section 5.4.9.3); deleted reference to “expedited review” in section 4.6.4. {Approved Russell McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}


Revision #13
Created 21 October 2019 21:43:55 by Autumn M Eberly
Updated 2 July 2024 16:20:28 by Robert A Lewis