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, such as General Data Protection Regulation (GDPR), 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 HS IRB has developed an International Research Guidance and an International Research Checklist. These materials are also available in the eIRB library:

• Guidance: International Research with Human Subjects
• Checklist: International Research with Human Subjects
• Certificate of Translation

These documents are tools to be used by researchers when developing their protocols and IRB applications. The IRB expects researchers to address each applicable point in the checklist 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:

• Review and approval of research in the host country or community
• Evaluating and describing the local context of the host country or community, and how the local context may interact with the research
• The informed consent process, including alterations of the informed consent process (for vulnerable populations or to respond to the local context), the use of translators, and the  translation of study documents
• The Principal Investigator’s post-approval responsibilities

Practical Tips for Planning a Successful International Research Project

1.   Start planning early.

• It takes time to understand the local context and cultivate local relationships. In addition, international research projects must obtain review and approval from the local IRB, ethics board, or community leaders, in addition to review and approval by the Tufts HS IRB.

2.   Expect delays.

• Coordinating the review and approval of the study from two (or more) sites and translating study documents for review requires additional time. The Tufts HS IRB may also need to consult with expert content reviewers, which can extend typical turn-around times.

3.   Don’t ever assume final approval is granted.

• Research activities cannot be performed without formal, written documentation of final approval from all applicable IRBs. The IRB cautions research teams from making purchases and date-specific arrangements until final approval has been obtained (e.g. airline tickets, scheduling recruitment meetings or study interventions).

4.   Communication is key.

• International research often involves collaborators and research team members at the local site. Principal Investigators (PIs) are responsible for ensuring that all members of the study team are up-to-date with regard to the protocol’s status. This makes communication about IRB review and your research protocol essential. If you are the PI, it is your responsibility to make sure that there is a well understood line of communication at the local site. You are also responsible for ensuring compliance with IRB regulations, ensuring that the protocol is followed, promptly reporting adverse events, and staying abreast of changes to the study.

5.   Stay organized.

• Managing a study at multiple sites, in multiple languages, making sure all the necessary approvals are in place, and making sure that all sites are working from the correct and current protocols and consent forms means that organization is very important. The IRB advises PIs to set up clear written communication and responsibility plans, particularly if the PI will not be on-site during the conduct of the research.