Sites Outside of the U.S.
The federal regulations require that in all human research studies the participant be given the opportunity to ask questions. The IRB requires in all research studies that the name, phone number, and email address of the faculty PI (and graduate student if the protocol supports student research) be provided on the consent form in case the subject has questions after the research has ended. In addition, the campus requires that the IRB contact information be provided on the consent form for subjects who have questions about their rights as a research subject.
When research is conducted outside the U.S., the PI should consider the best method for providing a contact point for participants. In some cases the participants may have access to computers, and an email address may be an acceptable method for them to communicate with the PI or the IRB in Madison. If the subjects do not have access to email, if they do not have the financial resources to make an international call, or if they do not speak English, it may not be helpful to provide the name and phone number for contacts in Madison. In those cases, providing the name and contact information for a person or organization in the location where the research will be conducted may be the best thing for subjects. This local contact must be willing to relay questions or complaints from subjects to the PI or the IRB and should be a stable person or organization that will be easily available to subjects. This local contact information must be provided in the consent form.
International IRB or Ethics Committee
Some countries and sites have their own IRB or Ethics Committee which may require review of your research project. If this is the case, please provide approval or evidence of submission to the IRB or Ethics Committee at the research site(s). Most IRBs and Ethics Committees around the world do not review social and behavioral or education research; please review this site for more information: http://ohrp.cit.nih.gov/search/
Letter of Support
Even if your protocol does not require the oversight of a local IRB or Ethics Committee, the IRB may still request a letter of support from someone at the site, indicating they are aware of your research, and approve of the research to be conducted at their site. This may be required if a local institution, school, or other organization is involved in or supporting the research project.