1.28 External Investigator Assurance

Last Revised: 12/3/202210/7/2025

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for initiating ana collaborating individual or institutional investigator agreement (previously External Investigator AssuranceAgreement; (XIA) (also referred to as a “Collaborating Institutional Investigator Agreement”).

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2.0 Policy

It is the policy of the Organization that:

• 1.2.1. AnA XIACollaborating Agreement is required when the UNMC IRB is the IRB of record for non-exempt research conducted at any site by an external investigator (XI) whoas isdefined not faculty, employee or student of the Organization, and who is not under the jurisdiction of another IRB which has an IRB Reliance Agreement with UNMC.below.

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3.0 Definitions

• 3.1. An External Investigator (XI) means an investigator who is not faculty, employee or student of the Organization who is engaged in research for which the UNMC IRB is the IRB of record.record, and who is not under the jurisdiction of another IRB which has an reliance agreement with UNMC.
  • 3.1.1. The Organization considers the criteria for “engagement” of an individual in the same manner as for an institution, as described in “OHRP Guidance: Engagement of Institutions in Human Subjects Research (2008).” In general, an External Investigator is “engaged in research” when he/shethey obtainsobtain (1) data about thea subjectssubject of the research through intervention or interaction with them; (2) identifiable private information about thea subjectssubject of the research; or (3) the informed consent of a human subjectssubject for the research.
  • 3.1.2. An investigator who is employed by or otherwise representing another institution and who is under the jurisdiction of another IRB which has an IRB Reliance Agreement with UNMC and for which the UNMC is acting as the IRB of record, is NOT considered an XI for the purpose of this policy. The reliance agreement which exists between UNMC and the relying institution obligates that institution to hold investigators at that institution to the same standards as the XIA.Collaborating Agreement.
• 3.2. An External Site means a facilitylocation not underoverseen the jurisdiction ofby the Organization where research for which the UNMC IRB is the IRB of recordresearch is performed, and which is not subject to the jurisdiction of another IRB which has an IRB Reliance Agreement with UNMC.
  • 3.2.1. In general, the Organization considers a facilitylocation “performing research” as equivalent to the criteria for “engagement” of a facilitylocation as described in “OHRP Guidance: Engagement of Institutions in Human Subjects Research (2008).”

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4.0 Requirements for, and Content of, ana External InvestigatorCollaborating Agreement (XIA)

• 4.1. AnCollaborating XIAInvestigator Agreement
  • 4.1.1. A Collaborating Investigator Agreement between the Organization and the XI is required when an XI is engaged in research under a UNMC IRB approved research protocol and is not subject to the jurisdiction of an external IRB with which the UNMC IRB has an IRB Reliance Agreement in place.
  • 4.1.2. AnA XIACollaborating Investigator Agreement must be in effect for each XI at that site and a copy maintained on file with the UNMC PI
    • 4.1.2.1. Generally, if there is more than one individual investigator at a site, use of a Collaborating Institutional Agreement (see below), rather than multiple Investigator Agreements, is appropriate.
  • 4.1.3. A Collaborating Investigator Agreement is study specific. Each XI needs to sign a separate Agreement for each protocol that the XI conducts under the oversight of the UNMC IRB.
• 4.2. Collaborating Institutional Agreement
  • 4.2.1. A Collaborating Institutional Agreement between the Organization and the external site is required when an external site is engaged in research under a UNMC IRB approved research protocol for which there is not an IRB reliance agreement in place between UNMC and the site.
  • 4.3.2.2. The XIACollaborating Institutional Agreement must be in effect before any research activities may be performed at that site.
  • 4.4.2.3. AnA XIACollaborating mustInstitutional beAgreement inis effectstudy specific. Each external site needs to sign a separate Agreement for each XIprotocol that is conducted at thatthe external site, unless a master agreement exists between the external site and aUNMC.
  copy
  maintained on file with the UNMC PI
• 4.5.3. The XIACollaborating Agreement describes responsibilities of the XI or the External Site including, but not limited to, assuring compliance with 45 CFR 46 including subparts as applicable, 21 CFR 50, 56, 312, 812, and HIPAA Privacy Rule, state laws, HRPP policies, and the protocol.
• 4.6. An XIA is effective for all studies that the XI conducts under the oversight of the UNMC IRB; therefore only one XIA is required.
• 4.7. The Organization, ORA, the UNMC IRB or the UNMC investigator may revoke the XIACollaborating Agreement at any time, itif there is reason to believe that the XI or the External Site is not satisfying responsibilities as described in the XIA.Collaborating Agreement.

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DOCUMENT HISTORY:

 Written: 1/12/2018 (Approved: 1/12/2018) - original author not recorded (previous policy #3.14)

 Revised: 2/6/2018 - revision not documented

 Revised: 12/3/2022 - Clarified that XIA is synonymous with “Collaborating Institutional Investigator Agreement”; revised definition of XI to include an investigator who is “not faculty, employee or student of the Organization, and who is not under the jurisdiction of another IRB which has an IRB Reliance Agreement with UNMC”; clarified that an XIA is required for an XI conducting research at any site (including sites operated by the Organization), not just an external site; revised definitions for clarity; provided definition of “external site”; clarified that XIA is required between the Organization and the external site when an external site is engaged in research under a UNMC IRB approved research protocol for which there is not an IRB reliance agreement in place between UNMC and the site.

 Revised 10/7/2025 - Revised titles of agreements throughout; clarified that Collaborating Investigator Agreement is study specific (section 4.1.3), and that if there is more than one individual investigator at a site, use of a Collaborating Institutional Agreement (see below), rather than multiple Investigator Agreements, is appropriate (section 4.1.2.1); clarified characteristics of Collaborating Institutional Agreement (section 4.2.); stylistic changes