International Research Guidance

Version Date: August 15, 2010

Guidelines and considerations for researchers submitting IRB applications that involve sites outside the United States

Study teams should allow additional time for IRB review for studies involving site or personnel outside the United States, as these projects may require additional expert opinion, obtaining documentation of the qualifications of the individuals responsible for the translation of consent documents, and obtaining of documentation of review by an IRB or ethics committee in the country in which the research will be conducted.