575. IRB Review of International Research

Updated July 13, 2021

To ensure protections for research conducted by University and Affiliate faculty, students, and staff in other countries are equivalent to those for research conducted in the US, the University IRB applies the ethical principles of the Belmont Report, the Department of Health and Human Services (DHHS) regulations (at 45 CFR 46), other applicable federal requirements, and relevant University policy to non-exempt research conducted outside of the United States. The IRB reviews international research according to IRB policy for new projects by Full Committee or for new projects by Expedited Review), and for post-approval monitoring. Post-approval monitoring includes:

• continuing review and approval for non-exempt research by Full Committee or continuing review and approval for non-exempt research by Expedited Review according to the approval period specified by the IRB;
• review and approval of amendments for non-exempt research by Full Committee or review and approval of amendments for non-exempt research by Expedited Review);
• administrative assessment and management of problem reports;
• review of potential noncompliance and Unanticipated Problems and adverse events;
• data safety monitoring (e.g., per 45 CFR 46.111, item (6); 21 CFR 56.111, item (a)(6); 21 CFR 312.32, and 38 CFR 16.111, item (a)(6) or other federal regulations as applicable); and
• research monitoring in accordance with Research Integrity's quality improvement program (QIP).

The University IRB complies with the research standards in the International Conference on Harmonization - Good Clinical Practice E6 only so far as these reflect the regulatory requirements of DHHS, FDA, and other federal agencies as applicable.

NOTE: See the Research Integrity webpage for International Research and the IRB policy for investigators conducting international research for additional information.

IRB Assessment of Researcher Qualifications

The IRB may request any or all the following to assess University/Affiliate researcher qualifications to conduct the research in the targeted locales:

• curriculum vitae including other studies conducted,
• letters of reference,
• evidence of completion of Export Control Training
• evidence of completion of ethical conduct of research international site
• information from the sponsor of the research, and
• information from licensing boards and professional societies.

Additional IRB Considerations for International Research

Knowledge about local laws is obtained from the International Compilation of Human Research Standards available from the International page of the DHHS website; IRB member, consultant, and researcher expertise; or other reputable sources. Laws affecting the conduct of human research include those governing human research protection; requirements for local IRB or ethics board or committee approval; medical practitioner certification or licensing; and age of majority. The University IRB ensures mechanisms exist for communication and coordination with local IRBs when appropriate.

The University IRB assesses information about local research context (e.g., cultural norms, superstitions, perceptions about scientific research or the concept or disease under study, languages, and environmental influences) to ensure the rights and welfare of participants are sufficiently protected. Information for this assessment may be obtained from the application or other reputable sources; and through discussions with the Principal Investigator, knowledgeable IRB members, or expert consultants.

Additional Considerations

The IRB follows the same policies and procedures when reviewing research conducted in the United States and research conducted internationally. However, there may be additional considerations to appropriately address the unique situations and populations relevant to specific international projects. The following items should be considered when designing and conducting international research projects.

Informed consent:

• Does the consent document need to be translated into a language other than English?
• Do the consent discussion and participant interactions require the use of an interpreter?
• Are participants able to read and write?
• Is it culturally appropriate for participants to provide consent without consultation with family or other members of the community?
• Is it culturally appropriate to obtain a signature from the participants?
• What is the age of majority for giving legal consent versus needing parental permission?

Conducting study procedures:

• Are interventions, questionnaires, surveys, and data collection tools culturally appropriate and valid for the population?
• What is the culturally appropriate method of providing compensation to participants?

Post-approval monitoring:

• What is the most effective method for communicating with local collaborators and authorities over long distance?
• How will participant complaints, non-compliance, and other unanticipated problems be handled within the cultural context?
• Are local collaborators appropriately trained to identify and report participant complaints, non-compliance, and other unanticipated problems to the investigator?
• How will data be monitored over long distance for compliance, completeness, and validity?
• How will confidentiality of data be maintained over long distance?