67. DoD Requirements for Multi-site or Transnational Research
For multi-site DoD-sponsored research, the participating organizations must have a formal agreement that specifies the roles and responsibilities of each party.
University and affiliate investigators proposing to conduct transnational DoD-research must complete and submit an application for international research. This form requests information about the foreign government's standards of review, identification of the host site and local mentor, and the name of the local IRB or ethics board with contact person.
- The investigator must have permission to conduct research in that country by certification of local ethics review and provide the IRB with documentation of that approval.
- Documentation of local ethics review must address specific local requirements for human subject research and identify any legal issues that bear consideration.
- If local review is not required, the PI must verify to the IRB that local review is not required.
- If local review is not possible, the PI must submit a letter to the IRB explaining why local review is not possible.
- The investigator must agree to abide by all applicable local laws regulations, customs, and practices, and all requirements of the local IRB or ethics board reviewing the research.
Periodically, but no less than annually, the RIO QA/QI Officer, qualified designee, or local entity must conduct a systematic and independent examination to assess whether the research activities were implemented; and the data were recorded, analyzed and accurately reported according to the IRB protocol.
- The examination may involve a review of materials and documents provided by the investigator.
- The assessment may include interviews with the local mentor, monitoring body (if present) or research participants; or a site visit.