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Important Regulations

International collaboration can complicate the rules and regulations to which research must adhere. In general, research is expected to follow the regulations of all locations involved. These regulations vary with country, state and institutional guidelines. By working closely with relevant personnel at all institutions investigators can insure their research is conducted appropriately.

International Research and the IRB

When research is conducted at multiple locations it must satisfy regulations of all relevant governing bodies, approving these studies will generally take longer. As the regulations and requirements are somewhat complex, it is important to work closely with the IRB reviewers to make the process as smooth as possible. Information from the IRB office and IRB forms at the Health Sciences Institutional Review Boards site (or call them with questions at 608-263-2362).

Information for completing the IRB forms may vary, but generally you will need:

  • Consent forms in the native language of the country and translations into English
  • A letter from the translator stating that all forms have been correctly translated.
  • An official letter of approval from the foreign institution’s IRB or ethics committee

For research that is federally funded, a Federal Wide Assurance number will need to be provided and can be obtained by following the steps outlined on at the Office for Human Research Protections.

Knowing when a foreign investigator requires IRB approval can be somewhat difficult. Anyone on your list of key personnel requires IRB approval. If a collaborator from outside your institution will be involved in data collection, he/she must receive approval from his/her home institution. You must also receive approval to add him/her to your IRB list of key personnel which will require a letter of support from the IRB at your colleague’s institution. Anyone involved in the design or conduct of the study will likely need to be added to the IRB; however, if he/she will not collect data or analyze identifiable data, he/she can apply for an IRB exemption which is a much simpler form that is generally approved quickly. A collaborator who serves only as a consultant does not have interactions with subjects or see identifiable subject data may not need IRB approval.

When in doubt, it is always best to discuss your specific case with the IRB.

Import and Export Regulations

Often international collaboration involves the import or export of materials. The university works with a group called Transgroup Worldwide Logistics, Inc to navigate the customs requirements. For a summary of importing and exporting visit the Purchasing Services Website. Make sure to contact accounting prior to making any international purchases to ensure the proper procedures are followed. Laws regulating the import of materials into other countries vary based on the country, therefore it is best to refer consult with the countries consulate prior to attempting to transport materials.

International Travel

International travel requires different documents depending on the countries visited. Again, consulting with the countries consulate well before departure helps to ensure all the proper documents are collected. Several websites: UW Center for Global Health, Operation Give Back, Office of International Science and Engineering, and John E. Fogarty International Center, provide links to valuable international travel information. Copyright © 2016 The Board of Regents of the University of Wisconsin System