IRB review and approval of international research involves a number of challenges, including local laws and customs, translation of consent and research materials, and the security of subjects and data.
The IRB must be convinced that the researcher has the depth of understanding of the ethical challenges, risks and benefits, as well as the ability to deal with unexpected or adverse events in research. These procedures apply to both minimal risk and greater than minimal risk research.
Research conducted in collaboration with a foreign institution may require a formal agreement delineating the authorities of the local IRB and the ISU IRB to assure the appropriate level of review is taking place. For research projects being conducted under an organization such as the Peace Corps, appropriate approval from the organization must be submitted along with the protocol.
Letters of agreement from the appropriate officials (e.g., government officials, school officials, community officials, Chief Executive Officers, etc.) indicating that the research protocol and any and all instruments to be used (including any biomedical equipment) have been reviewed and are acceptable to those officials are to be submitted.
There are a number of responsibilities that the PI should be aware of when conducting international research.
The IRB must ensure that the proposed research is culturally appropriate in the local setting where it is to be conducted.
Learn about Local Research and Ethics Reviews
If it is expected that participants who do not speak English will be enrolled in a study, translated documents should be made available.
Learn about Translation Documents
Principal investigators should be prepared to describe any local exceptions to the required consent process and how these will be addressed, as well as provide local contact information for participants who have questions.
Review Considerations for Informed Consent
As with all protocols, issues regarding data collection and security must be addressed both in the protocol and the informed consent process.
Learn about Data Collection and Security
If compensation is being offered, it should be appropriate for the setting. What may be considered minimal compensation in the U.S. may be a windfall in another country.
Under the Belmont Report principles, subjects should not bear the burden of the research without reaping some benefit therefrom.