USC faculty or students who intend to conduct human subjects research abroad must obtain USC IRB approval prior to commencing research activities. Research conducted outside the U.S. must respect applicable national laws.
If a study involves more than minimal risk, investigators will be required to obtain approval from a Research Ethics Board, an IRB equivalent, or a ministry of health. Local collaborators and local IRBs can provide insight on local laws, such as privacy or other laws that may restrict the export from other countries of personally identifiable data. As determined by the IRB, an expert in the culture of the other country may be used in lieu of the IRB equivalent.
USC IRB has no oversight responsibility when research with human subjects is performed at another site by USC faculty members who are on an unpaid leave of absence, or are otherwise not conducting research in connection with their USC responsibilities. If the faculty member brings back identifiable private or intends to continue the research at USC, a new USC IRB application must be submitted.
Many international universities have Ethics Committees that can review and approve research. HHS provides a resource to identify federally assured sites that is updated annually.
If a study involves minimal risk, the IRB equivalent to an approval letter or permission letter from the research site may be acceptable. The USC IRB will review these on a case-by-case basis. Investigators are encouraged to contact the Chair of the appropriate USC IRB to discuss issues related to International Research.
All international research studies must adhere to recognized Ethics Codes such as Title 45 CFR 46, the Declaration of Helsinki, the Nuremberg Code, or the Belmont Report. Consent and recruitment documents must be in the language that is readable and understandable by the subjects or the short form and translator method may be used.
International research must also conform to USC’s policy on International Collaborations and Export Contro.
Resources for International Research
Ethics of International Research (USC)
Resources for International Research(OHRP)
Compilation of International Human Research Standards (PDF)
Good Clinical Practice (International Conference on Harmonisation)
International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS)
The Eubios Ethics Institute(Japan)
Canadian Institutes of Health Research
National Council on Ethics in Human Research (Canada)