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IRB INTERNATIONAL RESEARCH REQUIREMENTS

Posted 6/5/2008 Printable Fact Sheet

International Research Requirements

IRB review and approval of international research involves a number of challenges. These procedures apply to both minimal and greater than minimal risk research. The IRB must ensure that the proposed research is acceptable in the local setting where it is to be conducted. Local community/ethical concerns, subject population, institutional policies and values must be taken into account along with the country's and any local laws regarding human use research.

Because the AFRL Wright Site IRB may not be able to be fully aware of the local research context, human use research that is to be conducted in a country other than the United States must be reviewed and approved by an IRB or similar body in the country where the research will take place. The institution engaged in research must designate this IRB and document such a designation per the Research Review Agreement, which can be found in the "Forms & Templates" section. The agreement delineates the authorities of the local IRB and the WRS IRB and assures the appropriate level of review is taking place. Documentation of the overseas IRB's approval must be provided in writing to the WRS IRB.

Also, because overseas research frequently involves a contract (normally through EOARD or AOARD) to do the research, the PI or local Program Manager must ensure that the appropriate Assurance of Compliance is filed for the protocol, please refer to the "Assurance of Compliance" section. The assurance ensures that any overseas research investigators along with the contracted company, university, etc., understand and will abide by human use ethical guidelines, as well as DoD and Air Force Regulations concerning human use research.

Finally, a Directorate Cover Letter must be submitted along with the protocol, certifying that the organization sponsoring the research and the AOARD or EOARD Program Manager, if applicable, approve of the project. The PI Cover Letter should come from the Principal Investigator listed on the protocol, who is directly engaged in research with the subjects.

All overseas, non-exempt research will be reviewed by the Full WRS IRB.

International Exempt Requests

Because of the concerns of local research context as discussed above, any Request for Exemption for research that is going to be carried out overseas must also be reviewed, and found to be exempt by an IRB or similar body in the country in which that research will take place. Written certification of the exemption should be provided to the WRS IRB with the Exemption Request. 

All overseas exempt research will be forwarded to HQ USAF/SGRC.

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