1.5 Requirements for Research Conducted with International Sites

Last Revised: 5/9/2023

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for research conducted with international sites. For the purposes of this policy, “Research conducted with International Sites” (international research) is defined as (1) research conducted by a faculty member, staff, student, or other representative of the Organization at an international site, or (2) research conducted by external investigators under the direction of a faculty member, staff, student, or other representative of the Organization, or (3) research where an investigator receives identifiable private information or identifiable biospecimens from an international site.


2.0 Policy

It is the policy of the Organization that:


3.0 Investigator Responsibilities


4.0 ORA Responsibilities


DOCUMENT HISTORY:

 Written: 1/13/2016 (Approved: 1/13/2016) - original author not recorded

 Revised: 2/9/2018 - revision not documented

 Revised: 12/8/2022 – revised title to stress international research includes work with international sites in addition to work at those sites; added specific definition to include research where an investigator receives or sends human biological or data from or to an international site; corrected reference to UNMC policy shipping of Hazardous Materials; corrected reference to Department of Environmental Health & Safety; added UNO policies; deleted requirement for formal reliance agreement (section 5.1.1.6); deleted references to sections effective after the revision of the Common Rule; revised section 2.3 so that exception may be granted by the Executive Chair rather than IO.

 Revised: 5/9/2023 – Revised definition of international research to remove sending human biological material or data; reformatted to separate investigator responsibilities and IRB/ORA responsibilities; clarified ORA responsibilities when considering exempt international research.


Revision #19
Created 21 October 2019 21:43:35 by Autumn M Eberly
Updated 17 April 2025 15:15:58 by Robert A Lewis