International Research (6.2.7)
Researchers often carry out studies in countries outside of the United States. In these studies, both researchers and the IRB have the responsibility to ensure that the research performed in other countries meets comparable levels of protection to those that would be required in the United States. In addition, researchers and the IRB have the responsibility to ensure that research adheres to local laws and regulations (and any relevant international standards), including those that require review by an ethics committee or IRB equivalent in the country in which the research is performed, and that the local cultural context is taken into account in the design of data collection and the informed consent process and when making assessments of risks to research participants.
When preparing a proposal for an international study, the researcher should review in-country laws and regulations (and any relevant international standards) and present the IRB with information about these laws and regulations and with a plan for adhering to them as part of the research proposal. Additionally, the researcher should explain whether the local cultural context presents risks to participants or other concerns that would differ from those in the United States. In cases where participants are not fluent in English, the researcher should provide the IRB with a version of informed consent materials translated into participants’ language(s) and should explain how participants’ privacy and the confidentiality of the data will be maintained if translators and/or interpreters are to be used during data collection.
If it is deemed necessary, the IRB may seek the services of a consultant with local cultural and legal knowledge as part of the review process. The IRB may also require a researcher to provide evidence of review and approval of the proposed project by an in-country ethics committee or IRB equivalent, as well as memoranda of understanding with any in-country organizations or institutions that are involved in the research.