1.10 Scientific and Other Committee Review of Research

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for scientific and scholarly merit review, and review by other component committees of the HRPP, of all human subject research protocols (see HRPP policy 1.9 Review of Resources Necessary to Protect Subjects) conducted under the jurisdiction of the UNMC IRB.


2.0 Policy


3.0 Department, Division, School, College, or Institute 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 of the following groups. None of these committees has the authority to approve human subject research to begin that has not yet been approved, 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)}


Revision #9
Created 21 October 2019 21:45:49 by Autumn M Eberly
Updated 22 December 2023 01:21:15 by Max V. Kuenstling