Sample Policy on International Research

I. To What Does This Policy Apply:

This policy defines the standards and parameters for the conduct of biomedical, behavioral and social science done outside the United States.

II. Policy Statement:

• This organization is committed to upholding the standards for ethical research and informed consent expectations articulated in the Belmont Report for all research conducted outside the United States. Research conducted outside the United States will conform to the same ethical and regulatory standards to which domestic research is held and will be conducted in accordance with US Federal regulations for the protection of human research subjects (45 CFR 46, et seq.) regardless of the funding source.
• Research conducted outside the United States will comply with the relevant laws of the host country. Researchers will collaborate whenever possible with a research or educational institution familiar with the local culture and research-related issues. It will be incumbent upon all researchers to ensure that the cultural caveats of the host country are respected and that the participants will not be subjected to retaliation from local authorities or the local community. No research involving humans shall be initiated prior to obtaining appropriate IRB approval.
• An IRB must review and approve all international research involving human subjects. An international institution or site considered engaged in research must obtain IRB approval from an institution that holds a Federalwide Assurance in the country where the research is taking place (if the research is supported by federal funding). Review by a local IRB or Ethics Board will be sought whenever possible even for research not supported by federal funding. The IRB or Ethics Board must be knowledgeable about and sensitive to, local community composition, mores and standards of conduct. In the event that no such local IRB or Ethics Board exists in the immediate local where the research is to take place, steps will be taken either to identify such a review board within the general region or to identify a local institution that could serve in a comparable capacity (i.e., a tribal council, school board, town committee, hospital board, etc.). Copies of the local IRB approval will be maintained by the Human Protections Administrator with other pertinent research documentation.
• The informed consent discussion, as well as all consent documents, will be in the subjects' native language. A translator/interpreter may be employed to help with the consent process. Family members will not be asked to provide such translation because they may not be able to fully explain the study's risks and benefits to the potential subjects. If subjects are likely to be unable to provide written consent, the researchers will provide justification in the protocol submitted to the IRB for a waiver of written consent as well as an acceptable alternative method of obtaining oral consent that is appropriate to both the subjects and their culture.

DEPARTMENT: Yale University
POLICY NUMBER:
SECTION: IRB Policies for Research Affiliate Institutions
REVIEW RESPONSIBILITY: IRB Leadership and Research Collaborators
ORIGINAL CREATION DATE: April 14, 2005
REVISION DATES: August 13, 2005

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