International Research

Overview: International research is defined as any study that is intentionally designed to target individuals outside the United States in its stated procedures for participant recruitment, data collection, data analysis, or results dissemination. 

Researcher Responsibilities: 

The researcher must consult the International Compilation of Human Research Standards provided by the HHS Office of Human Research Protections.  This list includes laws, regulations, and guidelines on human subjects protections in 133 countries and many international organizations.  Researchers are expected to be aware of all relevant laws and regulations and to remain compliant with them when conducting international research.  If ethics review is required in that country, it is the responsibility of the researcher to seek and obtain approval. 

The researcher must follow European General Data Protection Regulation (GDPR) regarding privacy and security of personal data of natural persons located (living or traveling) in the European Economic Area (EAA).  The UW Oshkosh IRB SOP #11: Guidance on General Data Protection Regulation (GPPR) and the Compilation of Guidance on the EU General Data Collection provided by the HHS Office of Human Research Protections should be referenced as applicable.