When a foreign institution, site and/or investigator is to be ‘engaged” in UM human subject research, the following policies apply:
1) The research requires review and approval by the UM IRB
2) The UM IRB may approve the study if the foreign entity's procedures afford protections of the rights and welfare of the participants that are at least equivalent to those provided in 45 CFR 46, 21 CFR 50, 21 CFR 56 and the written policies of the UM IRB and if the resources and facilities are appropriate for the research.
3) The foreign institution or site must hold an FWA ("Federal Wide Assurance") approved by the U.S. Department of Health and Human Services (DHHS), Office for Human Research Protections (OHRP) affirming that it is in compliance with DHHS regulations contained within 45 CFR 46, 21 CFR 50, and 21 CFR 56.
4) As part of its review/approval process, the UM IRB must receive and review the foreign institution or site’s IRB or Independent Ethics Committee (IEC (or equivalent) review and approval of the study [NOTE – An IEC is a specially constituted review body responsible to ensure the protection of the rights, welfare and safety of research participants. An IEC shares the same composition and operations as an Institutional Review Board at a foreign site]
5) As part of its review/approval process, the UM IRB must review all subcontracts or other agreements between UM and the foreign entity and/or investigator
6) UM IRB approval is contingent upon documentation of foreign governmental approvals as applicable.
7) The study may not commence at the foreign entity or by the foreign investigator prior to UM IRB approval