IRB Application Form
In addition to the application above, researchers engaged in a project that involves subjects from outside the United States should add an addendum that answers the following supplemental questions:
- Are local research reviews required in this location? If so, attach a copy of the approved protocol.
- Describe the international site(s). Provide location, name of local contact or investigator and local contact information, as applicable.
- 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.).
- Describe any local exceptions to the required consent process and how these will be addressed (e.g., a request from outsiders to sign documents would be treated with suspicion based on customs, previous history, etc.).
- List the language(s) in which the research will be conducted. Indicate whether a member of the research team is fluent in the language of the potential participants. If not, describe the provisions in place to provide translation services throughout the duration of the study.
- What is the age of majority in this location? Will any participant be younger than this age?
- Identify any benefits to the local community that will remain with the community once the research is complete.
- Describe the researchers’ 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.
For a list of regulations, laws and guidelines pertaining to international human subjects research for selected countries, see International Compilation of Human Research Protections.
If you are conducting research with human subjects who reside in the European Union, Iceland, Liechtenstein, or Norway, please review the EU's General Data Protection Regulations (GDPR). This also applies if you are collecting and transmitting data on human subjects in the United States to the EU.
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