Section XVII:

Special Requirements and Guidance for Investigators

WPP #: XVII-11

Title 11:

Involving Foreign Institutions/Sites in VCU Human Subjects Research

Effective Date:

08-06-14

Revision History:

06-21-06

Policy Statement

All research conducted outside of the United States must comply with standard requirements established throughout the VCU IRB Written Policies and Procedures including policies for determining investigator qualifications to conduct the proposed research, initial review and approval, modifications to research, continuing review, reporting of unanticipated problems or non-compliance, and handling of complaints, among others. In addition, all international studies must 1) involve a cultural consultant who will be available to advise the investigator as well as the IRB prior to initiation of the research; 2) utilize translated research documents including informed consent forms and research instruments; and 3) when applicable, provide access to ongoing cultural expertise to advise the investigator as study conduct progresses. When a foreign institution is engaged in expedited or full review research, local IRB or Ethics Committee review is required.

Procedures and Guidance

Research conducted by VCU researchers in foreign countries falls under VCU IRB policies and procedures.

The key to determining what additional details must be in the application to the VCU IRB is FIRST determining if the foreign institution is also ENGAGED in the human subjects research activity. A simple definition (and link to additional information) is provided below:

An institution becomes "engaged" in human subjects research when its employees or agents1 (i) intervene or interact with living individuals for research purposes; or (ii) obtain individually identifiable private information for research purposes [45 CFR 46.102(d),(f)]. Please refer to the OHRP guidance, Engagement of Institutions in Research, for helpful examples.

Once the determination (of engagement) has been made, you should review the section that correlates to your needs, below. Next, you will see that the requirements for ensuring proper oversight of the activities at the foreign site are divided by level of research risk (type of VCU IRB review required).

  1. Foreign Institution/Site is ENGAGED IN THE RESEARCH:

    The principal investigator must ensure that the VCU IRB submission fully describes how he/she will meet the following additional requirements (based upon type of IRB review):

    1. EXEMPT Research*

      If the research qualifies for review as exempt, the following 3 additional requirements apply:

      1. VCU IRB review and approval is required, including:
        1. Consultant references (C.V. with clear description of cultural expertise) must be proposed to the VCU IRB with the submission for review. This person would serve as a consultant to the IRB for the purpose of review and should not be otherwise affiliated with the research. Proposed consultant(s) must demonstrate knowledge of the local research context and perceived level of risk (using the cultural standard of that country). NOTE: Consultant costs are the responsibility of the submitting principal investigator and should be factored into the cost of conducting the research.
        2. Translated documents - The principal investigator must be prepared to translate all IRB-approved documents (intended for distribution to research subjects) using a certified (or duly qualified) translator. Also, special requirements may need to be made for an interpreter to facilitate communication with research participants on an ongoing basis, as necessary. Please see also WPP XI-5 Enrolling Research Subjects with Limited English Proficiency (LEP)
        3. Ongoing Cultural Expertise – depending upon the interaction with the research subjects, it may be necessary for a person to collaborate with the research staff on an ongoing basis to ensure that the research activities are in the best interest of the community and its members.
      2. A letter of permission must be provided by the foreign institution (that is engaged in the research) and retained with the compliance records for the study. This letter may be requested by the VCU IRB.
      3. Other applicable laws of the foreign country and/or additional requirements of the institution must be followed, as appropriate (e.g., local IRB review may be required by the foreign institution, but dual review is not a requirement of the VCU IRB in this case).
    2. EXPEDITED Research*

      If the research qualifies for expedited review, the following 3 additional requirements apply:

      1. VCU IRB review and approval is required, including:
        1. Consultant references (C.V. with clear description of cultural expertise) must be proposed to the VCU IRB with the submission for review. Proposed consultant(s) must demonstrate knowledge of the local research context and perceived level of risk (using the cultural standard of that country). NOTE: Consultant costs are the responsibility of the submitting principal investigator and should be factored into the cost of conducting the research.
        2. Translated documents - The principal investigator must be prepared to translate all IRB-approved documents (intended for distribution to research subjects) using a certified (or duly qualified) translator. Also, special requirements may need to be made for an interpreter to facilitate communication with research participants on an ongoing basis, as necessary. Please see also WPP XI-5 Enrolling Research Subjects with Limited English Proficiency (LEP)
        3. Ongoing Cultural Expertise – depending upon the interaction with the research subjects, it may be necessary for a person to collaborate with the research staff on an ongoing basis to ensure that the research activities are in the best interest of the community and its members.
      2. Local review is required. The foreign institution may use an Ethics Board, its own IRB or another IRB able to review on their behalf (in addition to the VCU IRB review). [NOTE: If the research project involves a DIRECT FEDERAL award to VCU (or application for such), OHRP requires the foreign institution to have a Federalwide Assurance (FWA) or obtain one. Please see OHRP guidance for assisting the foreign institution in obtaining a Federalwide Assurance and IRB Registration].
      3. Other applicable laws of the foreign country and/or additional requirements of the foreign institution must be followed.
    3. FULL BOARD Research*

      If the research requires a full board review (greater than minimal risk), the following additional requirements apply:

      1. VCU IRB review and approval is required, including:
        1. Consultant references (C.V. with clear description of cultural expertise) must be proposed to the VCU IRB with the submission for review. Proposed consultant(s) must demonstrate knowledge of the local research context and perceived level of risk (using the cultural standard of that country). NOTE: Consultant costs are the responsibility of the submitting principal investigator and should be factored into the cost of conducting the research.
        2. Translated documents - The principal investigator must be prepared to translate all IRB-approved documents (intended for distribution to research subjects) using a certified (or duly qualified) translator. Also, special requirements may need to be made for an interpreter to facilitate communication with research participants on an ongoing basis, as necessary.; Please see also WPP XI-5 Enrolling Research Subjects with Limited English Proficiency (LEP)
        3. Ongoing Cultural Expertise – depending upon the interaction with the research subjects, it may be necessary for a person to collaborate with the research staff on an ongoing basis to ensure that the research activities are in the best interest of the community and its members.
      2. Local review is required. The foreign institution may use an Ethics Board, its own IRB or another IRB able to review on their behalf (in addition to the VCU IRB review). [NOTE: If the research project involves a DIRECT FEDERAL award to VCU (or application for such), OHRP requires the foreign institution to have a Federalwide Assurance (FWA) or obtain one. Please see OHRP guidance for assisting the foreign institution in obtaining a Federalwide Assurance and IRB Registration].
      3. Other applicable laws of the foreign country and/or additional requirements of the foreign institution must be followed.
  2. Foreign Institution/Site is NOT ENGAGED IN THE RESEARCH:

    The principal investigator must ensure that the VCU IRB submission fully describes how he/she will meet the following additional requirements (based upon type of IRB review):

    1. VCU IRB review and approval is required, including:
      1. Consultant references (C.V. with clear description of cultural expertise) must be proposed to the VCU IRB with the submission for review. This person would serve as a consultant to the IRB for the purpose of review and should not be otherwise affiliated with the research. Proposed consultant(s) must demonstrate knowledge of the local research context and perceived level of risk (using the cultural standard of that country). NOTE: Consultant costs are the responsibility of the submitting principal investigator and should be factored into the cost of conducting the research.
      2. Translated documents - The principal investigator must be prepared to translate all IRB-approved documents (intended for distribution to research subjects) using a certified (or duly qualified) translator. Also, special requirements may need to be made for an interpreter to facilitate communication with research participants on an ongoing basis, as necessary. Please see also WPP XI-5 Enrolling Research Subjects with Limited English Proficiency (LEP)
      3. Ongoing Cultural Expertise – depending upon the interaction with the research subjects, it may be necessary for a person to collaborate with the research staff on an ongoing basis to ensure that the research activities are in the best interest of the community and its members.
    2. A letter of permission must be provided by the foreign institution (even though they are not technically engaged in the human subjects research activity). This letter may be requested by the VCU IRB.
    3. Other applicable laws of the foreign country and/or additional requirements of the institution must be followed, as appropriate (e.g., local IRB review may be required by the foreign institution, but dual review is not a requirement of the VCU IRB in this case).
  3. Foreign LOCATION (not affiliated with an institution or other facility):

    This research might involve conducting ‘man on the street interviews’ or surveys of persons by random phone contact, etc. The principal investigator must ensure that the VCU IRB submission fully describes how he/she will meet the following additional requirements (based upon type of IRB review):

    1. VCU IRB review and approval is required, including:
      1. Consultant references (C.V. with clear description of cultural expertise) must be proposed to the VCU IRB with the submission for review. This person would serve as a consultant to the IRB for the purpose of review and should not be otherwise affiliated with the research. Proposed consultant(s) must demonstrate knowledge of the local research context and perceived level of risk (using the cultural standard of that country). NOTE: Consultant costs are the responsibility of the submitting principal investigator and should be factored into the cost of conducting the research
      2. Translated documents - The principal investigator must be prepared to translate all IRB-approved documents (intended for distribution to research subjects) using a certified (or duly qualified) translator. Also, special requirements may need to be made for an interpreter to facilitate communication with research participants on an ongoing basis, as necessary. Please see also WPP XI-5 Enrolling Research Subjects with Limited English Proficiency (LEP)
      3. Ongoing Cultural Expertise – depending upon the interaction with the research subjects, it may be necessary for a person to collaborate with the research staff on an ongoing basis to ensure that the research activities are in the best interest of the community and its members.
    2. Other applicable laws of the foreign country.

    *NOTE: As a reminder, though the investigator may request an Exempt or Expedited review, the IRB may upgrade the review based upon level of risk and/or other factors.

References

45 CFR 46.102(d),(f)
OHRP Guidance: Engagement of Institutions in Research
OHRP Guidance: Knowledge of Local Research Context
VCU IRB WPP IV-2:  Membership Issues (Including Use of Consultants)
WPP XI-5 Enrolling Research Subjects with Limited English Proficiency (LEP)