Navigating international IRB partnerships: What you need to know

The role of the institutional review board (IRB), known internationally as “Ethics Committees,” is to provide ethical and regulatory oversight of research that involves human subjects in order to protect the rights, welfare, and well-being of research participants; comply with laws and regulations; assess risk; and adhere to the Belmont Report. However, laws and the standard of human rights differ greatly between countries. When working with international IRBs researchers might have to educate the local IRB on US federal requirements such as annual review, ethics or data safety monitoring, standard format and language. A primary step in conducting international epidemiologic or field research using US federal funds is to identify an in-country IRB that is registered with the Office of Human Research Protection (OHRP) and is associated with an institution with Federal Wide Assurance (FWA). In addition, multi-site studies often have several IRBs with different consent and regulatory requirements. Ensuring that the associated institutions and IRBs comply with the OHRP guidelines, adhere to each other's specifications, and consider the nuances of the local language and cultural can be challenging. The authors have conducted studies in China, Mexico, Norway, Nigeria and South Africa. Case studies will be used to illustrate strategies for effectively navigating international IRBs. Challenges such as identifying qualified translators to translate study documents into rarely-spoken languages, classifying the IRB of record, maintaining multiple IRBs' schedules, and determining the order of submission will be discussed.