Human subjects research conducted outside the United States creates additional areas of concern for both the Principal Investigator and the IRB.
- Cultural, economic, or political conditions of the research site(s) may increase the risk for participants.
- Other countries and institutions may have their own IRB or Ethics Committees that require review of the research before it can be conducted in that site.
- When reviewing protocols which will be conducted outside the US, the IRB may not be familiar with the current political and social climate at your site. The IRB relies on the information provided in the application to address any additional risks, and to accurately describe the conditions at the site. If any study team members have experience with the region/culture/etc. please provide this background in the application. The IRB may also consult with other faculty who are experts in the region/site as it is a requirement to obtain appropriate expertise in IRB review.
Please be aware that some studies conducted outside of the US require review by the Full IRB, therefore, it is generally best to allow 2-3 months for final approval.