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1.5 Requirements for Research Conducted with International Sites

Last Revised: 6/10/2026

For an abbreviated version intended for investigators, coordinators, and study teams - please visit here: International Research

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for research conducted with international sites.

Note: 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:

  • 2.1. The PI assumes responsibility for the safe and proper conduct of the research in full compliance with all applicable US regulations, country specific laws and regulations, local IRB requirements and UNMC HRPP policies.

    Note: For the purpose of this policy, a “local IRB” may refer to an Independent Ethics Committee (IEC), Research Ethics Board (REB), Ethical Review Board (ERB) or Research Ethics Committee (REC), or equivalent body.

  • 2.2. Non-exempt research conducted with an international site by (or under the direction of) the Organization’s faculty, staff, students, or other representative of the Organization, must be reviewed and approved by both the UNMC IRB, and by any local IRB at the international site which has review and oversight jurisdiction over the research. If there is no local IRB, an exception may be granted by the IRB Executive Chair/designee.

  • 2.3. Exempt research conducted with an international site by (or under the direction of) the Organization’s faculty, staff, students, or other representative of the Organization, must be reviewed and approval by both the ORA, and by any local IRB or official which has review and oversight jurisdiction. If there is no local IRB or official which has review and oversight jurisdiction, an exception may be granted by the IRB Executive Chair/designee.

  • 2.4. When reviewing research conducted entirely or in part in other countries, the IRB must have appropriate knowledge concerning the laws, regulations, guidance, and customs in that country. Knowledge can be obtained through any or all of the following: (1) direct expertise by an IRB member; or (2) use of consultants; or (3) use of the “OHRP International Compilation of Human Research Standards”; or (4) information provided by the investigator in Addendum T of the IRB application.

  • 2.5. When conducting or participating in research conducted entirely or in part in other countries, the investigator must have appropriate knowledge concerning the laws, regulations, guidance, and customs in that country either through direct expertise or by use of consultants.

  • 2.6. Protection for human subjects at the international site must be at least equivalent to HHS regulations at 45 CFR 46.

  • 2.7. International research involving prisoners is not permitted.

3.0 Investigator Responsibilities

  • 3.1. Non-Exempt International Research

    • 3.1.1. The PI must submit to the IRB for review:
      • 3.1.1.1. The appropriate IRB application, which includes Addendum T (International Research).
      • 3.1.1.2. A copy of the local IRB approval letter (if there is a local IRB with jurisdiction).
      • 3.1.1.3. A copy of the ICF translated into English (which has been approved by the local IRB if there is a local IRB with jurisdiction).
      • 3.1.1.4. A copy of the ICF in the native language (which has been approved by the local IRB if there is a local IRB with jurisdiction).
    • 3.1.2. The PI must confirm that the international site understands and will abide by its responsibilities to protect human subjects. These responsibilities include, but are not limited to:
      • 3.1.2.1. Research will undergo continuing review no less often than required by 45 CFR 46.109(f) and/or 21 CFR 56.109(f).
      • 3.1.2.2. Post approval monitoring as appropriate will be conducted at the site.
      • 3.1.2.3. Reports of complaints, serious or continuing noncompliance, protocol deviations, and unanticipated problems involving risk to the subject or others will be reported to the UNMC IRB.
      • 3.1.2.4. Reports of other serious problems in the conduct of the research will be reported to the UNMC IRB.

  • 3.2. Exempt International Research

    • 3.2.1. The PI must submit to the ORA for review::
      • 3.2.1.1. The appropriate IRB application, which includes Addendum T (International Research )
      • 3.2.1.2. A copy of the approval letter from the local IRB or authorized official
      • 3.2.1.3. A copy of the ICF translated into English approved by the local IRB or authorized official (if a consent form is required).
      • 3.2.1.4. A copy of the ICF in the native language approved by the local IRB or authorized official (if a consent form is required).

  • 3.3. When any international research involves the shipment of human biological materials, hazardous materials, or dangerous goods, the PI must comply with applicable Export Control and shipping policies.

    Note: For more information contact the UNMC Biosafety Officer or the UNMC/Nebraska Medicine Department of Environmental Health & Safety, or the UNO Office of Research and Creative Activity (ORCA).

  • 3.4. When any international research involves transfer of individually identifiable data, the PI must comply with UNMC or UNO Export Control policy, other policies as dictated by the Organization components, or the Global Data Protection Regulation (GDPR) as applicable.

    Note: For more information contact the UNMC Export Control Office, the UNMC Chief Compliance Officer, or the UNO Office of Research and Creative Activity (ORCA).

  • 3.5. The PI is responsible for ensuring all appropriate host country permissions to conduct research and/or to transfer data or human biological materials (as appropriate) are in place (including as appropriate, institutional, governmental or ministerial, IRB or EC, local or tribal approvals).

4.0 IRB/ORA Responsibilities

  • 4.1. Non-Exempt International Research
    • 4.1.1. In addition to the criteria for approval under 45 CFR 46.111 and/or 21 CFR 56.111, when conducting its review, the IRB will consider whether:
      • 4.1.1.1. The PI and research personnel are qualified to conduct research in the specified country, including knowledge of relevant laws, regulations, guidance, and customs.
      • 4.1.1.2. The consent process and consent documents are appropriate for the languages and culture of the subjects, and appropriate arrangements have been made to allow communication with the subjects throughout the research.
      • 4.1.1.3. The PI has in place an adequate process for handling:
        • 4.1.1.3.1. Modifications to the research.
        • 4.1.1.3.2. Complaints, noncompliance, protocol deviations, and unanticipated problems involving risk to subject or others.
        • 4.1.1.3.3. Post-approval monitoring of the research.
      • 4.1.1.4. There is an adequate mechanism for communication between the IRB, the PI, and the research personnel at the international site.
    • 4.1.2. The UNMC IRB will review the protocol in accordance with HRPP policies 2.2 (Full IRB Review) and HRPP 2.3 (Expedited Review).
    • 4.1.3. For research not subject to FDA regulations, written documentation of informed consent may be waived by the IRB/ORA if the conditions of 45 CFR 46.117(c)(1) are met, and such waiver is consistent with local laws and regulations.
    • 4.1.4. For research subject to FDA regulations, written documentation of informed consent may be waived by the IRB/ORA if the conditions of 56.109(c)(1) are met, and such waiver is consistent with local laws and regulations.
    • 4.1.5. If a conflict arises between country specific laws/regulations and applicable US regulations, the IRB will consult with legal counsel, OHRP, and FDA as necessary.
  • 4.2. Exempt International Research
    • 4.2.1. The ORA will review the protocol in accordance with HRPP policy 2.6 (Exempt Research).
    • 4.2.2. As appropriate, the ORA will consider whether:
      • 4.2.2.1. The PI and research personnel are qualified to conduct research in the specified country, including knowledge of relevant laws, regulations, guidance, and customs.
      • 4.2.2.2. If informed consent is required, the consent process and consent documents are appropriate for the languages and culture of the subjects, and appropriate arrangements have been made to allow communication with the subjects throughout the research.
      • 4.2.2.3. The PI has in place an adequate process for handling complaints, noncompliance, protocol deviations, and unanticipated problems involving risk to subject or others.
      • 4.2.2.4. There is an adequate mechanism for communication between the ORA, the PI, and the research personnel at the international site.
  • 4.3. If a conflict arises between country specific laws/regulations and applicable US regulations, the ORA will consult with legal counsel, OHRP, and FDA as necessary.

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.

 Revised 6/10/2026 - Defined local IRB as referring to an Independent Ethics Committee (IEC), Research Ethics Board (REB), Ethical Review Board (ERB) or Research Ethics Committee (REC), or equivalent body; clarified authority of IRB Executive Chair/designee to grant exception for requirement of local IRB approval in the absence of a local IRB with jurisdiction; listed possible sources for the IRB of appropriate knowledge concerning the laws, regulations, guidance, and customs in that country; clarified required materials for submission by the PI to the IRB; clarified additional committee review and approval requirements; clarified regulatory requirements for waiver of documentation under the Common Rule and FDA regulations; stylistic changes.

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