IRB & International Research

Summary

Research with human participants in countries outside the United States must comply ethical standards. Additional considerations may be required depending on the country of research. Furthermore, attention must be given to the cultural context and local regulations.

Full Description

Data Laws

Before submitting to the IRB, international data laws should be reviewed so that the PI is aware of any restrictions in place when exporting/importing identifiable data in/out of countries. Data export laws also affect research in countries with US embargoes or trade restrictions, such as Iran. Additionally, the EU/UK regulate what types of information/data can be collected from EU/UK citizens (see GDPR). 

Contact Export Controls, University Counsel, and IT Security before collecting or accessing data countries outside the United States. This conversation should be started before a protocol to the IRB is submitted. 

Data Protection Laws of the World

Expectations for Researchers

• Host Country researcher should be trained on the U.S. policies regarding human research. Conversely, the W&M PI should have an understanding of the in-country's policies/laws regarding human research and data collection. 
• Review the international resources and laws relevant to human research
  • Investigators will be required to obtain IRB approval for research done internationally from the W&M IRB and also from the local IRB/Ethics Committee within the country in which they will be doing their research.
    • The IRB strongly recommends you clearly understand the host country's requirements for reviewing and approving human subject research. Some countries have clear ethical guidelines that must be met for conducting domestic and/or international research.
    • Other countries will not have a formal process but might rely on other neighboring countries to assist with the review.
    • Where there is no equivalent board or group, researchers must rely on local experts or community leaders to provide approval. If the researcher has difficulty determining the existence of an IRB/Ethics Committee in the foreign country, they should contact the IRB.
  • International Complications of Human Research Standards lists over 1,000 laws, regulations, and guidelines on human s in over 100 countries and international organizations.
  • Visit Yale's International Toolkit for helpful resources and information.
• IRB Approval must be granted PRIOR to study beginning. Your protocol must be submitted to the W&M IRB at least 4 weeks prior to your anticipated study start date. If reviews from host country's IRB is required, please make sure to plan accordingly so that approvals are secured prior to your planned departure (if leaving the country).
• Obtain approval from the host country. All PIs conducting research outside the US must also obtain approval from the country where the research will be conducted to ensure all local regulations and policies are met. The review process might take months and approval is not a guarantee, so please plan your research timeline accordingly. The PI is responsible for:
  • understanding the research regulations of the country;
  • establishing contact with the appropriate office, institution, and/or authority;
  • following their given instructions and guidance
  • contacting them directly with any questions
• Conflicts between ethical standards. When two sets of standards from host country and the US conflict, the PIs must meet the higher standard. We will not relax our standards for ethical conduct of research.
• Demonstrate cultural understanding and make accommodations accordingly. Your protocol should describe how you account for cultural differences when conducting your research and your plan to accommodate them. The PI should learn about local customs along with culture and region norms.
  
  • Language Differences: If your research population's primary language is not English, make sure to submit BOTH the English version and translated versions of all participant-facing documents (e.g. recruitment materials, surveys, consent forms, etc.) to the W&M IRB and host country's review board. There also needs to be someone who is able to communicate with their participants in their native language.
• Communicate with IRB while abroad. If problems arise or amendments are needed, please notify the IRB office and Research Compliance Office immediately. Please do not proceed with changes until approval from the IRB has been confirmed. Contact information of a local research compliance official should provided to the W&M IRB in case questions arise.

External (Non-W&M) Collaborators

All external collaborators (whether foreign or domestic) must have proof of ethics training submitted as part of the protocol submission. W&M requires as part of the IRB protocol submission proof of ethics training and allows “equivalent”  training other than CITI. The IRB will review the training (if not CITI) to determine if it is acceptable. If you would like to sign up a foreign collaborator for CITI training, please follow the instructions on our CITI Information Page.

External collaborators not affiliated with an FWA-covered institution should complete an Individual investigator agreement (IIA). If external collaborators are affiliated with an FWA-covered institution, there should be an IRB Authorization Agreement in place if the study is to be reviewed by one institution or each institution must conduct their own review of the proposed study. 

Approval from Local Ethics Committees (LECs)

Approval from the local ethics committee (LEC) where the research will take place should be documented in the protocol submission.

When submitting to the W&M IRB, please note in your application whether permission has been obtained and if so, please attach relevant approval documents. If approval from a foreign country is contingent on our IRB approving the research, please state so that in your submission and detail how you will be obtaining permission from the local ethics committee. A modification may be required to be submitted once approval from the local ethics committee has been granted.

If no LEC exists for the country or region where the research will be conducted, please note that a "Cultural Context Letter" may be requested from the IRB. 

Protocol Submission and Review

International research studies can qualify for an exemption if it is no more than minimal risk and all of the research procedures fit within one or more of the exemption categories in the federal regulations.

All protocols are submitted via SPARCS. When submitting your protocol to the IRB, PIs should include:

• the informed consent process
• recruitment strategies
• local contact information for participants in case of questions
• cities, regions, and countries of research
• Justification for conducting research internationally
• Description of data security measures, including while traveling and while in the host country
• Current/socio-political events that may affect research conduct or alter the risks/benefits
• Impact of societal and cultural beliefs on research conduct or risks/benefits
• Role of women and children in society, including their ability and legal capacity to make decisions
• Literacy rate of potential population
• Languages and dialects of population
• Involvement of local organizations/individuals assisting with the research or population
• Personnel qualifications/expertise of the country of research
• Relevance of research to the area
• Distribution of risks and current and future benefits
• Detail any proposed remuneration (payment, gifts, incentives, etc.)