International research poses special considerations for interactions with human subjects. 51³Ô¹ÏºÚÁÏ maintains a Federalwide Assurance (FWA) and therefore must comply with 45 CFR 46 for all research, including international research. Additionally, many countries have human subjects regulations with which investigators must comply (see: the Department of Health and Human Services website on .
Special attention must be given to local context and cultural norms. Investigators must understand and demonstrate cultural sensitivity and an understanding of research ethics guidelines in the country where the work will occur. Investigators should pay special attention to appropriate consent practices in the local context. A waiver of written consent may be justified if oral consent is the only viable option. Consent may also need to be sought from individuals outside of the normal U.S. consent procedures (e.g., village leaders).
Many countries have a local equivalent of the IRB that will need to approve the research prior to the 51³Ô¹ÏºÚÁÏ IRB review process. 51³Ô¹ÏºÚÁÏ IRB review may require additional time since experts may need to be located to address the required local context evaluation.