International Research

When conducting international research, additional review and documentation is required from both the international site and the Marist College IRB. It is imperative that you start the process early and request a consultation with the IRB staff during the initial planning stages.  If the PI is a student, we highly recommend that both the faculty mentor and student PI meet with the IRB staff consultant.

Email Erik.Moody@Marist.edu to request an IRB consultation.

When is IRB review required?

All human subject research conducted by Marist College faculty, staff, or students, regardless of funding source or the location at which the research will be conducted, requires submission to the Marist IRB.

What additional regulatory reviews are needed?

When research is conducted outside the United States, investigators must comply both with the U.S. regulations and with the local policies and regulations governing the international research sites. It is important to do your homework early and, if possible, enlist a local collaborator to help you address that site’s requirements and assist in identifying who to contact and what is required to obtain ethics reviews and permissions to conduct research at that international site.

Two documents are required for studies where international regulations do not require local ethics review

1. Memo of Cultural Appropriateness authored by an individual completely independent of your study who is highly familiar with the culture of the region where the research will be conducted
   • Required elements:

     • Reference the title of the study displayed in the IRB application

     • Describe the expertise of the individual preparing the letter to address the local cultural and social norms

     • Confirm they understand the intent of the research and activities to be performed

     • Confirm the planned study does not conflict with local and cultural norms

     • Document is signed and dated

     • Documentation that the local regulations do not require a local ethics review

     • Providing direct references to the local regulations that state ethics review is not required
        

2. Acknowledgment of Unregulated Research Activities letter confirming that local ethics review is not required
   • Required elements:

     • Provided on the official letterhead of the signatory

     • Document is signed and dated

     • Clearly state the planned research does not require local regulatory oversight

     • Confirm the Regulatory Official understands the intent of the research and activities to be performed

     • Reference the title of the study displayed in the IRB application

Required document for studies where international regulations do require local ethics review

Letter of Approval from an Ethics Committee

• Required Elements:
  • Reference the title of the study displayed in the IRB application
  • Clearly state the research study was designated Minimal Risk by the committee
  • Clearly state the planned research was reviewed and approved
  • Document is signed and dated
  • Provided on the official letterhead of the signatory

Why is it important to have a local collaborator and knowledge of the local culture?

Investigators are strongly encouraged to collaborate with an individual or organization with expertise in the region. This collaboration will greatly assist in identifying appropriate research sites, navigating the local regulations and policies, understanding culture, local infrastructure, overcoming language barriers & increasing community partnership.

Based upon study location and risk level, the IRB may require a local site collaborator.

What are the additional requirements for enrolling non-English speaking participants?

When enrolling non-English speaking research subjects, investigators must have a plan to manage communications with participants during all phases of study participation. Given that participants may have questions or concerns at any time, Investigators must be prepared to manage communication beyond the consent process and data collection.

The initial IRB submission should only include the English version of documents that will be used with research subjects, (recruitment materials, consent documents, data collection materials, etc.). Once the materials are approved both by the Marist College IRB and foreign Ethics Committee, the approved documents should be submitted to a translator. Once translated, a Modification must be submitted to and approved by the Marist IRB to provide the final English language documents, final translated documents, back translations (if required) and a signed translator certification form. The documents may not be used until this Modification is approved.

Why is it important to start the process early?

Now that you have a good understanding of the required review and documentation process, you can see that research in some areas of the world can require a significant timeline to accomplish.  Investigators’ most common mistake when implementing international research is not allowing a realistic amount of time for protocol development and regulatory reviews.

When developing project timelines, Investigators should consider issues such as the stability of local government and infrastructure, time differences between countries, availability of communication technology in the foreign location, the responsiveness of foreign offices, cultural differences within professional organizations and how frequently regulatory bodies convene.

Specific travel plans and the purchasing of plane tickets should not occur until all of the required reviews and approvals have been obtained.