Local Research and Ethics Reviews

The IRB must ensure that the proposed research is culturally appropriate in the local setting where it is to be conducted. Local community/ethical concerns and laws, subject population, institutional policies and values must be taken into account along with the country's laws regarding human subjects research.

Because the ISU IRB may not be able to be fully aware of the local research context, PIs are responsible for determining if local research and/or ethics reviews are also required. Any required approval should be obtained prior to submission of the ISU IRB protocol and attached thereto. PIs should consult the federal Office for Human Research Protections (OHRP) detailed International Compilation of Human Research Standards database for information regarding many countries.

PIs should also be aware of any travel warnings or alerts pertaining to their research activities. The U.S. Department of State travel warnings, as well as general information about the country and U.S. embassies therein, may be found through the U.S Department of State.

PIs will be expected to describe the international site(s) and provide information on local contacts or investigators. They must also describe any cultural, political, religious, or other local influences that may affect conduct of the proposed research and how these will be addressed (e.g., issues posing potential threats, requiring changes in recruitment methods, etc.). Of particular concern is the privacy and safety of the participants.

The PI must be very careful on promises of privacy or safety made to participants. In some countries, just interacting with the researchers may make the participants vulnerable. PIs should be aware that changing political climates affecting the risks and benefits of their research may require changes to or even suspension of their protocols. PIs should also be aware that local concerns may affect the level of risk, and therefore the level of IRB review required.

Researchers should also be prepared to describe their experience with conducting research (or studying or residing) in the research setting, including any relationship(s) with the community from which participants will be recruited. The IRB may require contact information for individuals who are not affiliated with the research (or researchers) who are knowledgeable about the location and population who could serve as a consultant(s) regarding the proposed research. PIs should also describe communication and oversight plans between the researchers(s) who will be on-site and those at ISU.

When appearing before the IRB to answer questions about the research, it is helpful if an individual who is familiar with the culture (unless the researcher is recognized as an "expert") can accompany the researcher.