International Research

Human research conducted outside of the United States must conform to the same ethical standards, university policies, and regulatory standards to which research conducted within the United States is held, as appropriate. International research must be conducted in accordance with applicable Kennesaw State University (KSU) policies for the conduct and review of human research, regardless of the location of the research. 

Investigators are responsible for complying with laws or requirements relevant to their human research activities. Visit the Office for Human Research Protection (OHRP) website for compiled information on international requirements. Investigators should be aware that research determined exempt from the U.S. regulations by the KSU IRB may still be subject to requirements in the foreign country. 

In addition to obtaining KSU IRB approval, if there is a local ethics board (e.g., local IRB, Independent Ethics Committee, or equivalent) in the country or at the international institution where the research will be conducted, review of the human research protocol by the local ethics board may be required by the country or international institution.

The IRB may also require that the investigator and/or research staff demonstrate their knowledge of cultural norms and local laws relevant to their research or identify and consult with a local expert or community leader that can identify local cultural norms and laws prior to IRB review of the application. The local expert or community leader may be asked to provide information on the cultural experience of the locale where there is no equivalent ethics board or group, as appropriate. This local expert should be a native of the locale or have lived in the foreign country. The local expert should help the investigator design the research so that it is sensitive to the cultural norms of that locale and that it meets local requirements. The investigator would be responsible for identifying and recruiting such an individual. For research reviewed at the expedited or full board review level, the IRB may require, when appropriate, documentation of such review by the local ethics board, or description of how local approval or support of the research will be obtained. 

In international research the consent process may present additional challenges. Consideration must be given to the consent process, including considering the literacy level of the subjects and the cultural norms. Consent must be obtained in a language that is comprehensible to the subjects. The consent form or verbal consent script and instruments provided to the IRB must include the English translation and should also include the native language versions when practicable. If research will be conducted in a country where there may be several different languages and cultures, the researcher should consider how to address this in advance and obtain consent documentation in all the languages that might be encountered when appropriate. 

Additional expertise may be obtained as part of any of the IRB review processes (e.g., initial, continuing, modifications) when needed.