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1.28 External Investigator Assurance

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for initiating an External Investigator Assurance (XIA).

2.0 Policy

It is the policy of the Organization that an XIA is required when the UNMC IRB is the IRB of record for non-exempt research conducted at an external site involving an external investigator (XI) who are not employed by or otherwise representing the Organization.

3.0 Definitions

  • 3.1. An External Investigator (XI) is an investigator who is not employed by or otherwise representing the Organization who is engaged in research for which the UNMC IRB is the IRB of record.

    • 3.1.1. A researcher employed by or otherwise representing another institution who is under the jurisdiction of another IRB which has an IRB Reliance Agreement with UNMC and for which the UNMC is acting as a central or single IRB 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.

    • 3.1.2. An Individual Engaged in Research means a person who obtains (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research.

    • 3.1.3. In general, 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).”

      Examples of individuals “not engaged” include (but are not limited to) a clinician who provides standard of care treatment according to the protocol, or who performs routine clinical follow-up tests which would be performed outside of the research context, or who administers the study interventions being evaluated under the protocol on a one-time or short-term basis.

4.0 Procedures for External Investigator Agreement (XIA)

  • 4.1. An XIA is required when an XI is engaged in research under a UNMC IRB approved research protocol at an external site for which there is not an IRB Reliance Agreement in place between UNMC and the site.
  • 4.2. The XIA must be in effect before any research activities may be performed at that site.
  • 4.3. An XIA must be in effect for each XI at that site and a copy maintained on file with the UNMC PI
  • 4.4. The XIA describes responsibilities of the XI 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.
  • 4.5. An XIA is effective for all studies that the XI conducts under the oversight of the UNMC IRB; therefore only one XIA is required.
  • 4.6. The Organization, ORA, the UNMC IRB or the UNMC investigator may revoke the XIA at any time, it there is reason to believe that the XI is not satisfying responsibilities as described in the XIA.

DOCUMENT

ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:HISTORY:

REVISEDWritten: FEBRUARY1/12/2018 6,(Approved: 20181/12/2018) - original author not recorded (previous policy #3.14)

INITIALRevised: JANUARY 12, 2/6/2018 (PREVIOUS- POLICYrevision #3.14)not documented

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