International Research

In reviewing international research, the IRB must be able to assess the risk of the research in the local context. All recruitment materials, research procedures, and consent documents must be presented in the language understood by the subjects, either through a written document or a qualified translator. We suggest first submitting all documents in English, and then once the English versions of the documents are approved, submitting those documents as translated into the local language. This will prevent translated documents needing to be changed if in the event the IRB requests changes

Local IRB or Ethics Committee Review

We recommend starting your application early and enlisting a local collaborator to help you address local requirements. Approval from an in-country IRB, Ethics Committee (EC), or country equivalent is necessary for studies that pose a greater than minimal risk. Many international universities have IRBs or ECs that review research. The U.S. Department of Health and Human Services provides a resource to help locate these types of review boards.

In certain cases, a local governing body (ministry of health/ education) must review the research and approve whether it can be conducted within the country. These international requirements can be found on the Department of Health and Human Services website. These requirements may not be up to date and it is the responsibility of the Principal Investigator to determine the appropriate standards for review and acquire documentation. A PI may provide written documentation from in-country officials that the research does not require review.

For studies in which international regulations or local government does not require review, the PI must submit documentation of such. This letter should:

• Be on official letterhead of the signatory
• Include the title of the study as displayed in the IRB application
• Include contact information for the signatory
• Clearly state the planned research does not require local regulatory oversight
• Confirm the regulatory official understands the intent of the research activities to be performed
• Be signed, dated, and provide contact information

For studies where international regulations do require local ethics review, a letter of approval must be submitted. This letter should:

• Be on official letterhead of the signatory
• Include the title of the study as displayed in the IRB application
• State the level of risk that was designated by the committee
• State that the planned research was reviewed and approved
• Be signed, dated, and provide contact information

Memo of Cultural Appropriateness

If local IRB or Ethics Committee review is not required, researchers are required to submit a memo of cultural appropriateness from an expert who is familiar with the culture of the community where the research will take place. The expert must be completely independent from the research team. The documentation must contain the following:

• Reference the title of the study as displayed in the iMedRIS application
• Describe the expertise of the individual preparing the letter to address the cultural and social norms
• Confirm the individual writing the letter understands the intent of the research activities to be performed
• Confirm the planned study does not conflict with local and cultural norms
• Signature, date, and contact information for the signee

Note: This document may be combined with the local context documentation that states an ethics review is not required.

We understand that conducting research internationally is important, and that it can also be complicated. Do not hesitate to reach out to us with any issues or questions that arise as you are planning your international research study.