1.26 PI Qualifications and Responsibilities

Last Revised: 6/27/2022

1.0 Purpose

The purpose of this policy and procedure is to describe the qualifications and responsibilities of the PI during the conduct of research within the Organization and at external sites under the PI’s protocol.


2.0 Policy

It is the policy of the Organization that the PI and all other personnel involved in the conduct of research must possess the required experience, skill, and appropriate medical licensure to safely conduct the research in full compliance with all applicable regulatory and Organizational requirements specified in HRPP policy 1.1 (Human Research Protection Program).


3.0 Definitions


4.0 Qualification Requirements for the PI


5.0 Responsibilities of the PI During the Conduct of Research


6.0 Responsibilities of the PI for the Conduct of PI-Initiated Multicenter Research


7.0 Additional Responsibilities of the PI during the Conduct of Research under the Oversight of an External IRB


8.0 Additional Responsibilities of the PI During Conduct of FDA Regulated Research

Note: FDA guidance regarding investigator responsibilities can be found in “Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects” (October 2009)


9.0 Additional Responsibilities of a Sponsor-Investigator under an Investigator-Initiated IND


10.0 Additional Responsibilities of a Sponsor-Investigator under an Investigator-Initiated IDE


DOCUMENT HISTORY:

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

 Revised: 9/27/2017 - revision not documented

 Revised: 3/3/2018 - revision not documented

 Revised: 9/5/2018 - revision not documented

 Revised: 10/11/2019 - revision not documented

 Revised: 12/10/2019 - revision not documented

 Revised: 6/27/2022 - "Clarification of definition of "volunteer faculty; inclusion of emeritus faculty; inclusion of individuals operating under a special memorandum of understanding; clarification of requirement that volunteer conducting research with direct subject contact be present physically on campus, or have UNMC co-investigator physically on campus; faculty".


Revision #17
Created 21 October 2019 21:52:39 by Autumn M Eberly
Updated 17 April 2025 15:36:08 by Robert A Lewis