1.10 Scientific and Other Committee Review of Research

Last Revised: 4/8/2025

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for scientific and scholarly merit review, and for review by other component committees of the HRPP, of all non-exempt human subject research conducted under the jurisdiction of the UNMC IRB.


2.0 Policy

It is the policy of the Organization that


3.0 Department, Division, School, College, or Institute (collectively, “Unit”) Review of Scientific Merit


4.0 Reviews by Other Components of the HRPP

Depending upon the nature of the research, proposals may be subject to additional review and approval by one or more components of the HRPP. None of these components has the authority to approve human subject research that has not yet been approved by the IRB, or has been disapproved by the IRB, as per HRPP policy 1.2 (Authority Granted to the IRB by the Organization).


DOCUMENT HISTORY:

 Written: 5/6/2016 (Approved: 5/6/2016) - original author not recorded

 Revised: 2/12/2018 - revision not documented

 Revised: 5/17/2021 - Clarified responsibility for, and process of, scientific review; clarified responsibilities of the P&T Committee, and process of review; simplified description of function and activities of IDRC; clarified responsibilities of the IBC regarding human subject research; updated description of activities of CCTR; added reference to “other committees as directed by institution and/or IO”; clarified responsibilities of ORA vs IRB

 Revised: 8/1/2023 - Corrected typographic errors; changed “administrator” to “analyst” {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised: 3/11/2025 - Specified responsibility for ancillary review of CIRB and SIRB protocols; clarified that scientific review will be undertaken by the investigator’s unit, if such a process exists within the unit; clarified scope and timing of SRC, P&T, IDRC and IBC reviews; added Export Control as ancillary committee of the HRPP, and defined scope and timing; clarified that IRB members have access to reviews by ancillary committees; stylistic changes.

 Revised: 4/8/2025 – clarified scope of IDRC review (section 4.3.1).


Revision #13
Created 21 October 2019 21:45:49 by Autumn M Eberly
Updated 17 April 2025 15:22:10 by Robert A Lewis