Part 5 – International Research

International research

Research across borders has its own factors of which to consider. While all studies conducted by United States agencies must conform to the United States research ethics principles and be cleared by their respective organizations, they must also be approved and overseen by the regulatory bodies of the host country as well. Every nation’s regulations are different and may require anything from simple university approval to approval from a national department. The Office of Human Research Protection (OHRP) has a list of regulations each nation must abide by for reference. Federally funded research crossing borders will require stringent regulations that each agency has different standards for. For the most part, however, this is  waived for exempt research, though securing approval and permission in the host country may not.

A partnership between research organizations, or a “reliance agreement,” for research projects is not necessary if the host site in the other country is only providing space for researchers, or only providing information or helping establish contact between potential subjects and researchers (not enrolling or performing informed consent).

Special concern must be given to the culture of the host country. Language concerns are very important to consider: while a “state language” may be the official language of a country, the subjects may speak or read another language or dialect. Materials should be provided in a language most understandable by subjects. It is also important to note that some cultures will not allow adults to participate in research without the permission of other individuals, such as their spouses or chiefs. While there must be some form of approval process for these individuals, the subject themselves must still perform informed consent. It should also be important to be culturally sensitive to the host country. In some cultures, parent-child dynamics may make the consent-assent process need modifications, and some questions that may be acceptable in American culture may be offensive or improper in other cultures. The age of majority (age of consent) may be different in each nation than America as well. It is also wise to add an additional local contact affiliated with the study for concerns in addition the US institutional contact information on the Informed Consent form.

Finally, special care must be given when using translators. A translator must not be a minor, nor may they be someone who is of close enough relation to the participant to sway their decisions in participating in research. Also, if the translator will be handling sensitive information in the study, they are expected to be held to the same confidentiality standards as the rest of the research staff.