VA international research is defined as any VA-approved research conducted at international sites (i.e., not within the United States (U.S.), its territories, or Commonwealths), any VA-approved research using either identifiable or de-identified human biological specimens or identifiable or de-identified human data originating from international sites, or any VA-approved research that entails sending such specimens or data out of the U.S. This definition applies regardless of the funding source (funded or unfunded) and to research conducted through any mechanism of support including MOUs, CRADAs, grants, contracts, or other agreements. NOTE: Research conducted at U.S. military bases, ships, or embassies is not considered international research.

• Sending specimens or data to individuals with VA appointments at international sites (e.g., a WOC appointment, a VA investigator on sabbatical at an international site) is considered international research. Remote use of data that is maintained on VA computers within the U.S. or Puerto Rico and accessed via a secure connection is not considered international research.
• International research includes multi-site trials involving non-U.S. sites where VA is the study sponsor, a VA investigator is the overall study-wide PI, VA holds the Investigational New Drug (IND), or the VA manages the data collection and the data analyses.
• International research does not include studies in which VA is only one of multiple participating sites where the overall study-wide PI is not a VA investigator (i.e., the PI for the study as a whole is not a VA investigator).

Before approving international research involving human subjects research, the IRB must ensure that human subjects outside of the U.S. who participate in research projects in which VA is a collaborator receive equivalent protections as research participants inside the U.S. (see OHRP guidance at http://www.hhs.gov/ohrp/international/index.html). NOTE: The VA medical facility Director must approve participation in the proposed international research.

All international research must also be approved explicitly in a document signed by the VA medical facility Director, except for Cooperative Studies Program activities which must be approved by the CRADO.