2.4 IRB Review of Changes in Previously Approved Research

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for IRB review of changes in previously approved research, including single subject protocol deviations.


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 Investigator Responsibilities


5.0 IRB and/or ORA Responsibilities


Appendix to HRPP Policy 2.4 (Changes in Previously Approved Research)

Examples of Major and Minor Changes in Protocol or Single Subject Protocol Deviations (per Sections 3.1 and 3.2) Examples of Major Changes:

Note: Multiple minor changes in the protocol, instruments, and/or consent may, together, be considered a major change subject to convened IRB review.


Examples of Minor Changes:


DOCUMENT HISTORY:

 Written: 1/5/2016 (Approved: 1/5/2016) - original author not recorded

 Revised: 1/24/2018 - revision not documented

 Revised: 10/4/2018 - revision not documented

 Revised 1/18/2025 – clarified level of review associated with changes in PI and/or research personnel; clarified that changes to CIRB protocols are considered administrative changes; removed references to pre-2018 HHS regulations; stylistic changes {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}


Revision #10
Created 24 October 2019 21:26:39 by Autumn M Eberly
Updated 5 February 2025 19:22:12 by Robert A Lewis