This document provides comprehensive guidance on the IRB review requirements for international research and outlines the responsibilities of the researchers.
International Research Guidance
These guidance materials were created by the Washington University International Research with Human Subjects Committee and provide detailed instructions on the human subjects requirements for conducting international research.
International Human Subjects Research Guidance
International Prep Work Checklists
The researcher is responsible for completing all requirements that apply to their international research project. The International Research Prep Work Checklist provides valuable information on the requirements that must be completed prior to submitting the study to the WU IRB. Completing these tasks prior to WU IRB submission will avoid delays with IRB review and approval.
Flow chart – Do I need a Local Context Advisor or approval from a Foreign IRB/Ethics Committee?
This flow chart outlines when a local context advisor review or foreign IRB/Ethics Committee review is required. This decision point hinges on the requirements of the country in which the research will be conducted, the type of research and funding source, if any.
Oversight of International Collaborators
There may be times when certain language must be included in the consent form even if a foreign IRB is responsible for the review of the consent form.
Consent Template Language – COC and GDPR (log in required)
- Certificate of Confidentiality (COC)
Include COC template language when a study is covered under a COC. For more information about COC requirements and applicability, refer to the resources available on the Office of the Vice Chancellor for Research website.
- General Data Protection Regulation (GDPR)
Language about GDPR protections should be in the consent when there is a transfer of personal data collected from citizens of the EEA (most countries in Europe including the United Kingdom) and transferred outside of Europe. See the International Human Subjects Research guidance document for more information.
- Key Information
A key information section in the consent form is required when a study receives federal funds and the study is NOT exempt.
The research guide includes instructions on how to write a key information section.
|Cindy Brantmeier, PhD
Professor – Faculty Fellow, International Research
Director – Applied Linguistics
Expedited Review Specialist
Assistant Director of Social Behavioral Research &