IRB & International Research
Expectations for PIs
- Host Country researcher should be trained on the U.S. policies regarding human research. The PI of the host country must complete W&M's CITI training in order to be on the protocol. Please email Research Compliance Office with the PI's full name, institutional email, and backup email so that they can be registered. For all PIs and personnel on the protocol, please ensure the appropriate "Export Compliance" CITI modules have been completed.
- Review the international resources and laws relevant to human research
- International Complications of Human Research Standards lists over 1,000 laws, regulations, and guidelines on human s in over 100 countries and international organizations.
- 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 regulates what types of information can be taken out of Europe and imported to the US.
- Visit Yale's International Toolkit for helpful resources and information.
- IRB Approval must be granted PRIOR to study beginning. Your protocol must be submitted 3-6 months in advance of your planned departure (if leaving the country). This is to allow adequate time for review and edits to be made to the protocol.
- 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.
Protocol Requirements
Approval from the local ethics committee must be submitted to W&M IRB and documented in the protocol submission.
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 to s
- Impact of societal and cultural beliefs on research conduct or risks/benefits to s
- 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.)
