UIS supports international research that promotes cultural exchange and global awareness, a highlight of our General Education learning goals. Human subjects research conducted outside the United States requires investigators to consider extra factors beyond the typical research protocol.
Research with international subjects requires sensitivity, as different cultural contexts may indicate certain classes of people are more vulnerable to being coerced or influenced to participate in human subjects research. There may also be increased risks to breaches of confidentiality or the consequences of such a breach. Therefore it is recommended that the investigator seek the expertise of someone familiar with the culture of the country where the research will take place.
Additional considerations when conducting international research include ensuring that all consent documentation are translated into the native language of the target population. If a translator is needed, care should be taken to vet the translator for potential conflicts of interest and require them to complete a Confidentiality Agreement.* The monitoring plan needs to include someone in-country for subjects to contact with their questions and concerns.
Finally, the investigator needs to be aware of local laws and customs which may limit contact with subjects or indicate different privacy regulations than what are expected in the United States. For example, people residing in the European Union Economic Area (EEA) have rights in the General Data Protection Regulations (GDPR) which determine what is considered private information and how a researcher can collect, transport, analyze, and share personal data (see the UI system GDPR information page). Thus the investigator needs to obtain approval from the local equivalent of an IRB, when possible. When there is not an equivalent board or group, researchers are asked to rely on local experts or community leaders to provide approval. An example of an acceptable authority would be a government official (e.g. contact the embassy) or a university administrator. Documentation of such approval needs to be submitted to the UIS IRB.
The NIH Office for Human Research Protections (OHRP) annually compiles a list of international research regulations.
Export controls may also apply to the research, depending upon the nature of the samples collected.
*Note: contracts with foreign nationals take 12 weeks for OBFS to process and have tax implications.
For investigators conducting research outside the United States, there is an additional required training module on the CITI course: International Research – SBR
Completion of this module is required before the research may commence. Investigators should email their course completion document to firstname.lastname@example.org. Instructions for accessing the research course are on the Required Training area of this webpage.
A checklist for international research protocols can be found in the Forms, Templates, and Checklists area of this webpage. There is also a template for when consent documents need to be translated from English.