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Guidelines for International Research

Research involving human subjects conducted outside the United States creates additional areas of concern for both the Principal Investigator and the Institutional Review Board (IRB). Cultural, economic, or political conditions of the host country may alter the risk for participants compared to the same research conducted within the U.S. Other countries and institutions within foreign countries may have Institutional Review Boards or Ethics Committees which require review of the research before it can be conducted in that country.

The IRB, when reviewing protocols which will be conducted outside the U.S., may not be familiar with the current political and social climate in every other part of the world even though committee members have broad expertise.

In order to facilitate the review of protocols that involve human subjects in international settings, the following questions should be addressed in the protocol when it is submitted for IRB review:

1. Are there any aspects of the cultural, political or economic climate, in the country where the research will be conducted, which would increase the risks for participants compared to the risk for participants in the U.S.? If yes, what steps will the PI take to mitigate that risk?

2. Is there an IRB or Ethics Committee in the country, or at the institution, where the research will be conducted? A list of registered international IRB’s may be found on the OHRP web site at: http://ohrp.osophs.dhhs.gov. Many of these IRB’s may review biomedical research but not social science research. If a review committee exists and review by that IRB is required, please submit a copy of the approval or evidence that the protocol has been submitted to the IRB for review when your protocol is sent to the UW-IRB.

3. The federal regulations require that the participant be given the opportunity to ask questions. The IRB requires that the name and 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 telephones or 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 who will be easily available to subjects.

Consideration should be given to the most appropriate method of obtaining informed consent, taking into account the literacy level of the subjects and confidentiality concerns. In some cases, oral consent may be more appropriate than written consent because signing a consent form would put the participants at greater risk. Consent should always be obtained in the native language of the participants. The consent form or oral consent script must be provided to the IRB in the participant’s native language and an English translation must be provided.

All key personnel, including key personnel from outside the U.S. are required to have completed training in human subject research before the protocol is submitted for review by the IRB.

Please be aware that in many cases, it will not be possible to expedite protocols which are conducted outside the U.S. Allow enough time for the full review process. Additional information may be required by the IRB depending on the nature of the research and the level of risk to subjects.

Revised 1/6/2005

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Last updated on June 6, 2008
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