Research involving human participants conducted by USD investigators in foreign countries remains under the purview of USD IRB policies and procedures. Adjustments may be made as appropriate to respect cultural differences, but the standards for ethical conduct regarding research with human participants are not lessened. The Principal Investigator should contact the IRB, irb@sandiego.edu, as soon as possible when considering conducting research in a foreign country.
In making a determination about any research project involving human participants that takes place in a foreign country, the IRB will rely on guidance from the U.S. Department of Health and Human Services, Office for Human Research Protections (OHRP), International Compilation of Human Research Standards. The International Compilation of Human Subjects Protections lists over 1,000 laws, regulations, and guidelines on human participants protections in over 100 countries and from several international organizations.
The IRB may require that research projects be approved by the foreign 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. This documentation must be current, dated and signed by the appropriate authority. 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, the study may not be approved.
The IRB may also contact OHRP to determine whether procedures described by a foreign institution provide protections to human research that are at least equivalent to U.S. regulations and may be substituted for the U.S. regulations (45 CFR 46.101(h)). 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.