International Research

Ethical Considerations in International Research

Countries have different requirements for human subjects research. When requirements are not clearly defined, you must follow principles like the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report. This means you must ensure subjects participate voluntarily and with informed consent, minimize risks to subjects, and select research subjects appropriately.

Cultural Competence in International Research

Cultural competence means understanding the social habits, language, political and religious views, attitudes, values, and infrastructure of the research site.

• Include local knowledge early in the planning phase and throughout the research project to build community relationships, ensure effective communication, and support subject enrollment.
• Use methods like illustrations, videos, and demonstrations that are tailored to the site's literacy rates and cultural practices.
• Translate all written materials into the local language and obtain the necessary translation certifications.

Community Engagement

• Build and maintain community partnerships throughout the research project.
• Understand and honor community expectations, and provide feedback as needed.
• Consider sharing research results or providing training, resources, or equipment to the community.

• As an NIH investigator, you must follow federal laws, regulations, and NIH policy for both domestic and international research.
• NIH-conducted research in foreign countries must align with the HHS Federalwide Assurance (FWA) and be reviewed by a registered IRB/REC.
• You must comply with in-country laws and regulations for non-exempt research.
• If U.S. and foreign requirements differ, defer to the most restrictive approach unless it is contrary to U.S. law or policy.

• Get local IRB/REC approval before obtaining final NIH IRB initial approval.
• NIH IRB ensures compliance with U.S. federal laws, not local laws, unless there is no local IRB/EC.
• Local investigators are not under NIH IRB's oversight.
• If there's no in-country IRB/Research Ethics Committee (REC), you need a written assessment from an expert in the foreign country's culture.
• The level of NIH IRB review depends on the NIH investigators' engagement.
• When the NIH IRB reviews research conducted collaboratively with foreign investigators and/or institutions, its oversight extends only to activities covered by the NIH FWA.
• Supporting international research without direct engagement in human subjects research does not require NIH IRB review, but local IRB/REC review is still necessary.

• Follow FDA regulations, NIH requirements, and in-country approvals when shipping test articles.
• Make sure you get the necessary local approvals for test articles and biospecimens.
• Check for any restrictions on shipping biospecimens ahead of time.
• Take the Biological Materials Shipping Training Course at NIH to learn about international shipping regulations.

ClinRegs
ClinRegs serves as a central resource and time-saver for investigators involved in planning and implementing international clinical research. It is maintained by NIAID and is an online database of country-specific, clinical research regulatory information.

International Compilation of Human Research Standards
The DHHS Office for Human Research Protections publishes the International Compilation of Human Research Standards annually which can be used to aid research teams in identifying applicable international regulations and guidelines.