For protocols with research activity taking place in-person or online with participants who reside in countries outside of the United States, additional consideration is required.
To streamline the IRB approval process for international research, be certain your protocol application includes the following aspects prior to submitting your protocol to MSOE IRB:
- In what country, region, province, city, or other geographical location, as applicable, do your potential participants reside? Be as specific as possible. Explain why the location was chosen.
- Clearly explain if/when you plan to travel to conduct the research. And, if not, how the research will be successfully completed.
- Explain your qualifications for doing research in this location and the experience you have with the location.
- Name local residents/contacts who have been involved with the planning of your research and explain their connection to you. Identify any conflict of interest they (or you) may have with the study.
- Explain what language(s) potential participants speak and in what language the research will be conducted. Explain your proficiency with the language(s). Who will provide translation, and what are their qualifications in doing so? Have your translator provide a letter of qualification describing their training and proven experience with the language in which the research will be conducted to personally certify their credentials.
- Explain what governing agency/institution oversees research in this location and the process for gaining approval from the entity.
- Explain cultural, economic, political, and literacy considerations that you believe should be understood by your protocol reviewers to inform their understanding of typical potential participants in your study.
- Explain if/how results of the study will be communicated with participants and why you have decided this approach is appropriate.
