Human Subjects Research in an International Setting

When conducting human subjects research in an international setting, investigators must consider not only the ethical and regulatory standards applied to domestic research, but also the ethical and regulatory standards of the setting in which the research will be conducted. Investigators are responsible for paying special attention to local laws, culture, tradition, and language, as well as to the current political and social climate. They must comply with the relevant laws protecting human subjects in the host country as well as any requirements for local IRB approval. Investigators should consider partnering with local researchers in order to ensure understanding of local context and regulations.

When submitting an international research study to CPHS, investigators will need to describe the expertise they have, or have access to, which prepares them to conduct research in this location and/or with this subject population, including specific qualifications (e.g., relevant coursework, background, experience, and training). Investigators will also need to explain their knowledge of local community attitudes, local laws and regulations, and local cultural norms and sensitivities necessary to carry out the research. Investigators are encouraged to refer to the resources below to help ensure adequate protection of international research subjects as well as compliance with applicable local laws and regulations.

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Resources

UC-Issued Guidance and Information

• CPHS Guidelines on International Research
• CPHS International Research Checklist
• UCB Global Engagement Office
• UCOP Research Compliance
• UC Global Operations

Country-Specific Information

• International Compilation of Human Research Standards
• Listing of Social-Behavioral Research Standards

General Information

• OHRP Resources for International Research
• Declaration of Helsinki
• International Conference on Harmonization - Good Clinical Practice
• NIH Fogarty Bioethics Resources
• Council for International Organizations of Medical Sciences (CIOMS): International Ethical Guidelines for Biomedical Research Involving Human Subjects
• Comparison of International Guidelines for Research Involving Humans
• General Data Protection Regulation (GDPR)

Travel Preparation and Training

• Travel.State.Gov
• UCOP International Travel Information
• International Ethics and Informed Consent Training Programs
• International Research Training Modules from the Collaborative Institutional Training Initiative (CITI) Human Research Online Course:
  • Avoiding Group Harms – International Research Perspectives
  • International Studies
  • International Research – SBE-`12