1.7 IRB Member, Consultant, Staff and Guest Conflict of Interest Identification and Management

Last Revised: 9/25/2024

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for the identification and management of IRB member, consultant, staff and guest potential conflicts of interest. For the purpose of this policy, staff refers to IRB Analysts (whether voting members or not) and other employees of the ORA.


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 Procedures for identification and management of conflict of interest by members and consultants


5.0 Procedures for identification and management of conflict of interest by IRB staff


6.0. Procedures for identification and management of conflict of interest by guests at the IRB meeting


DOCUMENT HISTORY:

 Written: 12/29/2015 (Approved: 12/29/2015) - original author not recorded

 Revised: 2/1/2018 - revision not documented

 Revised: 10/10/2022 - Added identification and management of COI for a guest at IRB meeting; clarified that any financial interest by IRB members, consultants, staff and guests at the meeting is considered a significant financial interest within the context of this policy; clarified definitions of financial and non-financial COI; added definition of guest; clarified timing of disclosure of COI by IRB members; added IRB member whose only conflict is that he/she is participating personnel on a protocol may serve as protocol reviewer, and may participate in the discussion regarding the protocol, may remain in the meeting room during the vote, but will abstain from voting; added that IRB staff with COI must leave room during the discussion and voting phases of the review of the protocol in which they have a conflict; deleted option for member with COI to request exception from recusal; stylistic changes for clarity.

 Revised: 9/25/2024 – stylistic changes


Revision #14
Created 21 October 2019 21:44:31 by Autumn M Eberly
Updated 17 April 2025 15:20:24 by Robert A Lewis