1.23 HRPP Training Requirements

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements and opportunities for training for all personnel involved in conducting human subject research.


2.0 Policy

It is the policy of the Organization that all personnel involved in the conduct of human subject research under the oversight of the UNMC IRB will be qualified through initial and continuing education in order to fulfill their responsibility to protect the rights and welfare of human subjects.


3.0 Definitions


4.0 Required Training


5.0 Additional (Optional) Training


6.0 Procedures for Assessing Training Requirements


7.0 Procedures for Maintaining Training Records

The ORA maintains all training records for CITI Training and didactic activities described above, and maintains copies of materials sent by mail or email or posted on the website.


DOCUMENT HISTORY:

 Written: 12/28/2015 (Approved: 12/28/2015) - original author not recorded

 Revised: 6/28/2018 - revision not documented

 Revised: 8/31/2021 - Described basic vs additional modules for CITI courses; described requirement to complete additional modules based on type or research and subject population; clarified location of UNMC HRPP Policies manual; correction of references to sections within this and other policies; delineated required vs optional training; deleted training no longer offered; minor stylistic changes and clarification

 Revised: 6/30/2022 - clarification or requirements for CITI biomedical course (section 4.1.4.1) {Approved: 7/2/2022 - Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised: 8/17/2022 - clarification regarding expiration of CITI training for personnel on an active protocol (section 4.1.10) {Approved - Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board Notified: 11/16/2022


Revision #16
Created 21 October 2019 21:51:42 by Autumn M Eberly
Updated 31 August 2023 18:36:27 by Robert A Lewis