Research Oversight:

International research must meet the ethical and regulatory requirements for conducting research at VU/VUMC, but also respect the cultural norms and research regulations in the host country. Researchers must obtain review of the research in the host country prior to initiating the research, in addition to fulfilling Vanderbilt’s IRB review requirements. The VUMC IRB will not assume IRB of Record responsibilities for international sites.

  1. Applications for international research should include the name of local IRB, Ethics Committee, or government entity that will perform review in the host country.    
    • If not yet approved, indicate the status of the local ethics review.
    • Once approved, provide a copy of the approval letter with translation into English.
  2. For international sites engaged in research that do not have a local ethics committee, the VUMC IRB can assist with getting an FWA set up and identifying a local resource to review the research for the international site.
  3. For international sites not engaged in the research, if the site has an IRB or Ethics Committee, approval (or documentation that approval is not required) must be obtained.  For those that do not have an established IRB or Ethics Committee, provide a letter of support from an individual in the host country who has the relevant expertise or institutional authority to review the research.
  4. If the research is sponsored by a US federal agency:
    • All domestic and international sites engaged in the conduct of research must hold a Federalwide Assurance (FWA) with the Department of Health and Human Services (DHHS).
    • The international site must rely upon the approval of an IRB that is registered with DHHS. This requirement applies whether VU/VUMC is the primary awardee or a sub-contract of federal funding.
    • Any international research funded by the FDA must also comply with FDA regulations.
  5. Investigators involved in international research are strongly advised to consult the Office for Human Research Protection (OHRP) International Compilation of Human Subject Research Protections.
  6. If available, consider providing the name and contact information of a person who has expertise on the local context of the country or community where the research will be conducted.

Local Context:

The Principal Investigator (PI) must consider the local context of the host country/community to ensure that adequate provisions for protecting human subjects are in place. The VUMC IRB will review the plans in general which may include:

  1. Cities, regions countries where research will be conducted
  2. Scientific/ethical justification for conducting the research in an international setting and the relevance of the research to the area’s health, economic, educational, or other needs
  3. Description of the research team’s knowledge of or experience in the host country
  4. Current events, societal and cultural beliefs, economic status, or the socio-political environment that may impact the research or alter the risks or benefits to subjects
  5. The role of women and children in society, including autonomy and legal capacity to make decisions
  6. Languages, dialects, and literacy rates of the potential subject population
  7. Involvement of organizations, community leaders, or experts in engaging the subject population or conducting the research
  8. Distribution of risks and current and future benefits
  9. Compensation offered (payment, gifts, etc.) including the value in US and local currency, household income information (e.g. average household monthly earnings), payment schedule and to whom

Consent Process:

Consent procedures in the host country may differ from US federal regulations the considerations should be made to provide equivalent protections to subjects.  The following are approved by the local oversight body.  Researchers should address the following informed consent topics that apply to the research:

  1. If a waiver of written consent for research is appropriate, provide justification for the request and describe how consent will be documented. Examples include low literacy levels, the cultural significance of providing signatures, etc.
  2. Provide the legal age of majority and if minors will be enrolled, describe the assent process for the local context.
  3. Consider the role of family and community within the consent process or issues related to autonomy (e.g. consent from community leaders or supplemental consent from male family members). Describe how the research team will address additional consent processes.
  4. Consider whether the research intersects with any cultural sensitivities or societal norms. If so, describe how this will be addressed in study documents (e.g. research on illegal drug use; vaccine trials on a disease that is stigmatized in the host country).
  5. Informed Consent Documents (ICDs) and other study documents must be presented in language understandable to the participants, taking into account the literacy and education levels of the study population. ICDs must be translated in the participant’s language by a qualified translator
  6. The research team should provide subjects with locally-based and US-based contact information. Researchers should provide contact information to ensure subjects have access to individuals who can answer research-related questions, even after the research team has left the host country.

Post-Approval Responsibilities:

The PI must consider how to fulfill the following responsibilities once the study is approved:

  1. Modifications to the approved protocol must be submitted as an amendment and approved before initiating any changes in the research unless the change is necessary to eliminate immediate hazards to a subject(s). The PI must contact the IRB within 5 days of the event.
  2. Whether the VU/VUMC PI operates in the US or internationally, they must maintain oversight and ensure protocol compliance with US and international regulations. If the VU/VUMC investigator is the primary awardee of a grant, the PI is responsible for overseeing all international collaborators.
  3. Implement a data and record retention plan consistent with VUMC IRB policies. Study records must be accessible to the IRB/federal agencies even if the records are maintained in the host country.
  4. Provide the VUMC IRB with reports of serious adverse events, unanticipated problems, non-compliance, protocol deviations, data and safety monitoring reports, subject complaints, and correspondence with the local oversight body.
  5. Ensure all study sites are notified of protocol and study document updates.
  6. For student projects, describe the plan to ensure communication and oversight between the advisor and student during the conduct of the research.