International research poses unique and complex ethical challenges. As a result, the IRB expects you to acknowledge and understand the following:
- You must obtain IRB approval before your study can begin. Whether you are a UVa faculty member, staff or student, your research study must be approved by the IRB before it can begin. To reduce confusion, make sure you have the IRB's approval before you leave the country. We suggest you apply to the IRB at least six to nine months before you leave to ensure adequate time for reviews. Bring your written IRB approval with you on your trip.
- Demonstrate cultural understanding and sensitivity. Is the typical process of signing an informed consent document culturally acceptable for your study? Are there other cultural barriers you might encounter once you arrive? Your IRB protocol should describe any anticipated cultural sensitivities of conducting your research and how you intent to overcome those barriers. The IRB will help you develop alternative methods for consent (or other issues) to ensure your research practices are ethically sound and respectful of the culture you are studying.
- Understand the research ethics guidelines of the host country. Investigators will be required to obtain IRB approval for research done internationally from the UVa IRB and also from the local IRB/Ethics Committee within the country in which they will be doing their research. This approval must be on file with the IRB prior to IRB approval being granted. The IRB strongly recommends you clearly understand the host country's requirements for reviewing and approving human subject research. Some countries have clear ethical guidelines that must be met for conducting domestic and/or international research. Other countries will not have a formal process but might rely on other neighboring countries to assist with the review. If the researcher has difficulty determining the existence of an IRB/Ethics Committee in the foreign country, they should contact the IRB.
- Please contact the IRB while abroad if you encounter any problems or need to change your IRB-approved protocol. If you find that upon arrival in the host country, some aspects of your research study must be modified for whatever reason, please notify the IRB office immediately . The IRB will do its best to quickly respond to your notification with further instructions and guidance. Please wait to hear back from the IRB before making any changes to your protocol!
Consent Form Template for International Research
Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries
NIH: Global Clinical Regulations
International Compilation of Human Subject Protections
Harvard Global Research Ethics Map
Learning Shot: IRB-HSR protocol submission requirements for international research
Learning Shot: Center for Global Health and the IRB
Website- Center for Global Health-University Scholar Award & Pfizer Initiative in International Health Research Award Instructions and Guidelines