This information is intended for researchers who wish to conduct human subjects research studies outside of the United States. The information on this page has been gathered to provide researchers with general information and considerations for international research studies. The information provided on this page may not be applicable to all countries or regions. Depending on the country and/or region you to plan to conduct research in, additional requirements may be necessary to obtain the proper research ethics approval.
If you have any questions regarding international research guidelines, especially those specific to your own research study, you are strongly encouraged to contact Sarah Muenster-Blakley, Director of the Institutional Review Board at firstname.lastname@example.org or call (651)-962-6035.
Prior to Travel:
All international researchers must register their travels with the UST Study Abroad Office before departure. Information and directions on registering your travels with the Study Abroad Office can be found here. Please submit a copy of the completed registration form with your IRB application.
Considerations for International Research Studies:
Below is a list of considerations for researchers who are planning on conducting international research. Researchers should keep the following circumstances in mind as they plan their research:
- The economic condition of the area in relation to the prospective study population;
- Political stability of the area;
- The influence of the local official or leaders on the population;
- Whether the country or area allows foreign visitors;
- The nature of the procedures conducted (some countries, societies, or areas may not allow invasive procedures);
- The literacy rate of the area;
- The legal rights of the population under local law (confer with local IRB as necessary to determine, for example, age of legal consent, disclosure and required reporting of illegal activities, and applicable privacy laws);
- How complaints will be reported and to whom;
- The relevance of the research to the region’s health or socio-economic needs; and
- The possibility or requirement of including officials from the area in the monitoring of the research;
- Cultural understanding of the consent process.
This list does not include every consideration that should be made by researchers. There may be additional considerations depending on the country and/or region the study is intended for.
Receiving Approval for an International Research Study:
Study approval may need to be obtained from an ethics committee that is appropriate for the country/region that research is to be conducted in as well as the University of St. Thomas. Researchers are encouraged to contact local authorities or ethics committees for accurate and complete information regarding proper study approval. In order to receive approval from the University of St. Thomas IRB, all consent and recruitment documents related to the research study must first be written in English and then translated to a language that is understood by the research subject(s). Additionally, all international research studies must adhere to recognized Ethics Codes such as Title 45 CFR 46, the Declaration of Helsinki, the Nuremberg Code, or the Belmont Report in order to be approved by the University of St. Thomas IRB.
Required Materials for IRB Approval:
- Application for Initial Review (found on IRBNet) and all associated documents (surveys, questionnaires, study information, etc.) written in English. Before study approval, associated documents (e.g. surveys and questionnaires) must be translated to a language that is understood by the population they are intended for. Additionally, be sure to list any foreign collaborators that are working with the study on the Application for Initial Review.
- All informed consent and recruitment documents, written in English. Before approval will be granted by the IRB, consent and recruitment documents must be translated into a language that is understood by the population they are intended for
- A letter or other evidence of approval from proper authorities of the country/region where research is to be conducted. If approval is not possible in a given country/region, the principal investigator must submit a letter to the UST IRB that states approval is not possible and explain why.