Procedures for the protection of human research subjects internationally may be different from U.S. federal regulations and institutional policies. Federally funded projects involving research activities conducted in a foreign country may be approved by the USC IRB if ethical protections provided by a Research Ethics Review Board (IRB equivalent) in the foreign country are equivalent to those in the U.S.
If a study involves more than minimal risk, investigators will be required to obtain approval from the Research Ethics Review Board. Many international universities have Ethics Committees that can review and approve research. 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.
Resources for International Research
- Ethics of International Research (USC)
- Resources for International Research (OHRP)
- Compilation of International Human Research Standards
- Good Clinical Practice (International Conference on Harmonisation)
- Research in Developing Countries (Nuffield Council on Bioethics)
- Bioethics Resources (NIH Fogartey Center)
- International Clinical Trials (NIH National Cancer Institute)
- International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS)
- Comparison of International Guidelines for Research Involving Humans 2005 (Hogan & Hartson L.L.P.)
- The Eubios Ethics Institute (Japan)
- Canadian Institutes of Health Research
- National Council on Ethics in Human Research (Canada)