Tufts Medical Center and Tufts University researchers (Tufts researchers) often conduct biomedical and social/behavioral/educational research outside of the United States. When conducting international research, Tufts and its researchers must ensure that these activities not only meet the ethical and regulatory requirements for conducting research at Tufts, but also respect the cultural norms and research regulations in the host country.
This shared responsibility can be achieved by evaluating the criteria discussed in the documents below, and by providing appropriate information to the Tufts Health Sciences Institutional Review Board (Tufts HS IRB) for the review of applications for international research.
To increase transparency about the IRB’s expectations and help researchers comply with regulatory and institutional standards for conducting international research, the Tufts Health Sciences IRB has developed an International Research Guidance and an International Research Checklist:
These documents are tools to be used by researchers when developing their protocols and IRB applications. Although research teams are not required to submit the checklist with their IRB application, the IRB expects researchers to address each applicable point and provide information in their protocols and other study documents to demonstrate a thorough consideration of the issues discussed in the guidance document. IRB office staff and IRB members will use the documents to guide their reviews of international research studies.
The guidance and checklist address the following aspects of international research:
1. Start planning early.
2. Expect delays.
3. Don’t ever assume final approval is granted.
4. Communication is key.
5. Stay organized.