What are "foreign research sites," and how do they affect IRB jurisdiction?

"Foreign research sites" refer to locations outside of the United States where research activities are conducted. When research is performed at these sites, it introduces complexities regarding Institutional Review Board (IRB) jurisdiction because different countries may have varying cultural norms, ethical standards, and regulatory requirements related to research involving human subjects.

The involvement of foreign sites necessitates careful consideration of these differing standards to ensure that the research remains ethical, respects local customs, and complies with both U.S. regulations and those in the host country. This understanding is crucial for the IRB to ensure that all research conducted at foreign locations is protective of participants' rights and welfare, and maintains scientific integrity.

In essence, recognizing the unique challenges posed by foreign research sites enables IRBs to better fulfill their mission of safeguarding the rights and welfare of research participants while balancing adherence to legal and ethical principles across diverse cultural contexts.