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1.5 Requirements for Research Conducted at International Sites

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for research either (1) conducted by a faculty member, staff, student, or other representative of the Organization at an international site, or (2) conducted by external investigators under the direction of a faculty member, staff, student, or other representative of the Organization.

2.0 Policy

  • 2.1. It is the policy of the Organization that the PI assumes overall responsibility for the safe and proper conduct of the research in full compliance with all applicable U.S. regulations, country specific laws and regulations, local IRB (IEC, REB, REC) requirements and UNMC HRPP policies.

  • 2.2. It is the policy of the Organization that non-exempt research conducted at an international site by 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 Institutional Official upon recommendation by the IRB Executive Chair.

  • 2.3. It is the policy of the Organization that exempt research conducted at an international site by the Organization’s faculty, staff, students, or other representative of the Organization, requires review 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 Institutional Official upon recommendation by the IRB Executive Chair.

  • 2.4. It is the policy of the Organization that, 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 either through the direct expertise by a member or by the use of consultants.

    Note: The IRB may utilize as a resource the latest edition of the “OHRP International Compilation of Human Research Standards” as well as the information provided by the investigator in Addendum T of the IRB application.

  • 2.5. It is the policy of the Organization that the investigator must have appropriate knowledge concerning the laws, regulations, guidance, and customs in that country either through the direct expertise or by the use of consultants.

  • 2.6. It is the policy of the Organization that Protections of human subjects at the international site must be at least equivalent to HHS regulations at 45 CFR 46

  • 2.7. It is the policy of the Organization that international research involving prisoners is not permitted.

3.0 Additional Requirements

  • 3.1. When any international research involves the shipment of human biological materials, hazardous materials, or dangerous goods, the PI must comply with UNMC policy #2002 (Shipment of Hazardous Materials or Dangerous Good Policy). For more information contact the UNMC Biosafety Officer or the UNMC Chemical and Radiation Safety Office.
  • 3.2. When any international research is subject to US export control regulations, the PI must comply with UNMC policy 8005 (Export Control Policy). For more information contact the UNMC Export Control Compliance Office or the UNMC Chief Compliance Officer.
  • 3.3. The PI is responsible for obtaining all appropriate host country permissions to conduct research (including as appropriate, institutional, governmental or ministerial, IRB or EC, local or tribal).

4.0 Procedures

  • 4.1. Non-Exempt International Research
    • 4.1.1. In order for the Organization’s faculty, students, staff, or other representatives to conduct non-exempt research at an international site, the following must be submitted:
      • 4.1.1.1. The appropriate IRB application
      • 4.1.1.2. Addendum T: International Research
      • 4.1.1.3. A copy of the approval letter from the local IRB as required.
      • 4.1.1.4. A copy of the ICF approved by the local IRB which has been translated into English.
      • 4.1.1.5. A copy of the ICF approved by the local IRB in the native language.
      • 4.1.1.6. An IRB Reliance Agreement which specifies the responsibilities of the local IRB which includes, but is not limited to, the following:
        • 4.1.1.6.1. Continuing review must be performed no less often than annually.
        • 4.1.1.6.2. Appropriate, ongoing post approval monitoring must be conducted at the site.
        • 4.1.1.6.3. Reports of complaints, serious or continuing noncompliance, protocol deviations, and unanticipated problems involving risk to the subject or others must be forwarded to the UNMC IRB.
        • 4.1.1.6.4. Reports of other serious problems in the conduct of the research must be forwarded to the UNMC IRB.
    • 4.1.2. In addition to the criteria for approval under 45 CFR 46.111, when conducting its review, the IRB will consider whether:
      • 4.1.2.1. The PI and research personnel are qualified to conduct research in the specified country, including knowledge of relevant laws, regulations, guidance, and customs.
      • 4.1.2.2. The consent process and consent documents are appropriate for the languages of the subjects and communication with the subject population, and whether appropriate arrangements are considered to communicate with the subjects throughout the research.
      • 4.1.2.3. The PI has in place an adequate process for handling:
        • 4.1.2.3.1. Modifications to the research. The IRB and investigators should consider as many contingencies as possible when research is reviewed and approved.
        • 4.1.2.3.2. Complaints, noncompliance, protocol deviations, and unanticipated problems involving risk to subject or others.
        • 4.1.2.3.3. Post-approval monitoring of the research.
      • 4.1.2.4. There is an adequate mechanisms for communication between the IRB and the PI and research personnel when they at the international site.
    • 4.1.3. The UNMC IRB will review the protocol in accordance with HRPP policies 2.2 (Full IRB Review) and 2.3 (Expedited Review).
    • 4.1.4. Following the effective date of the Revised Rule, written documentation of informed consent may be waived by the IRB if the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained (45 CFR 46.117(c)(1)(iii))
    • 4.1.5. If a conflict arises between country specific laws/regulations and applicable US regulations, the IRB will consult with legal counsel (per HRPP policy 1.11: HRPP Access to Legal Counsel), other legal consultants, OHRP, and FDA as necessary.
  • 4.2. Exempt International Research
    • 4.2.1. In order for the Organization’s faculty, staff, students, staff, and other representatives to conduct exempt research at an international site, the following must be submitted to the ORA:
      • 4.2.1.1. The appropriate IRB application
      • 4.2.1.2. Addendum T: International Research
      • 4.2.1.3. A copy of the approval letter from the local IRB or authorized official
      • 4.2.1.4. A copy of the ICF approved by the local IRB (if a consent form is required) which has been translated into English.
      • 4.2.1.5. A copy of the ICF approved by the local IRB (if a consent form is required) in the native language.
    • 4.2.2. The ORA will review the protocol in accordance with HRPP policy 2.6 (Exempt Research).
    • 4.2.3. If a conflict arises between country specific laws/regulations and applicable US regulations, the IRB will consult with legal counsel (per HRPP policy 1.11: HRPP Access to Legal Counsel), other legal consultants, OHRP, and FDA as necessary.

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

POLICY AMENDED:

 REVISED FEBRUARY 9, 2018

 INITIAL VERSION JANUARY 13, 2016

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