Guidance for International Research
Research conducted by Boise State investigators in foreign countries remains under Boise State purview and guidelines. While adjustments may be made to some requirements to respect cultural differences, our standards for ethical conduct are not relaxed.
The IRB may require that research projects be approved by the local equivalent of an IRB before the IRB will grant final approval. Where there is no equivalent board or group, investigators must rely on local experts or community leaders to provide approval. The PI must provide the IRB with documentation of this “local approval” and documentation of the authority and expertise of the individual or group who granted approval. There must also be detailed plans in place for local monitoring of studies that pose more than minimal risk to participants. Researchers must describe what, if any, knowledge or experience they possess regarding the language and culture of the country in question. If the IRB is not satisfied with the review of local experts and/or the plans for continued monitoring there is the possibility that the study will not be approved.
The IRB may seek guidance first from OHRP’s International Compilation of Human Subject Research Protections or it may contact OHRP to determine whether procedures described by a foreign institution afford protections that are at least equivalent to U.S. regulations 45 CFR 46.101(h) and may be substituted for the U.S. regulations. Under this provision, OHRP investigates the foreign country’s guidelines for human participants’ research, and if the foreign guidelines are found to be equivalent to U.S. regulations, the investigator is permitted to substitute those foreign procedures.
OHRP offers information on research in foreign countries. The International Compilation of Human Subjects Protections is a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in over 100 countries and from several international organizations. Many of the listings embed hyperlinks to the source document.