1.3 UNMC IRB Serving as the Single IRB for Multisite Research

Last Revised: 4/21/2025

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for the UNMC IRB to serve as the Single IRB (SIRB) for multisite research.


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0. UNMC IRB, Relying Institution, and Lead PI Responsibilities


DOCUMENT HISTORY:

 Undocumented activity: 4/4/2016

 Undocumented activity: 3/27/2018

 Revised: 10/21/2021 - Major revisions in format; content revised to be consistent responsibilities described in HRPP 1.4, Notification: not documented

 Revised: 8/25/2023 - Added additional responsibility for UNMC HRPP regarding review of relying institution COI management plan (section 4.1.1.1).

 Revised: 11/13/2024 – clarified which UNMC HRPP policies must be complied with by participating sites (section 5.7); corrected typographic errors; stylistic changes.

 Revised 4/21/2025 - Clarified that the Assistant Vice-Chancellor for Regulatory Affairs and/or Director or Assistant Director of the Office of Regulatory Affairs (ORA) have authority to determine whether or not to allow the UNMC IRB to serve as the Single IRB for multisite research (section 2.2); added definition of ORA (section 3.8); clarified that UNMC IRB is responsible for making determinations required by HIPAA Privacy Rule when the relying IRB does not accept the responsibility to make those determinations (section 4.1.4); clarified that, should termination of a reliance agreement occur, UNMC IRB will ensure that it is clear who will have the responsibility of continued oversight of study activities until closure or transfer of the study (section 4.1.5); clarified that the Relying Institution will be responsible to ensure that all investigators participating in the research are qualified by education, training, experience and licensure (as applicable) to conduct the research in accordance with all applicable regulations and relying institution HRPP policies (section 4.2.3); clarified that the Relying Institution is responsible to ensure investigators at the participating site comply with relevant UNMC HRPP policies except when adherence to local institutional policy is required by law, regulation, or specific agreement between UNMC IRB and the participating site (section 4.2.9); deleted description of processes more suited for SOPs; stylistic changes.


Revision #22
Created 18 October 2019 15:43:05 by Autumn M Eberly
Updated 14 May 2025 19:31:54 by Robert A Lewis