• Ethics of International Research (PDF) (Ppt)
• OHRP International Issues
• OHRP 2008 International Compilation of Human Research Protections
• Comparison of International Guidelines for Research Involving Humans (by Hogan & Hartson L.L.P.)
• Online Course On Ethical Issues in International Health Research (by the Harvard School of Public Health)
• The Eubios Ethics Institute (Japan)
• International Conference on Harmonisation: Good Clinical Practice
• Declaration of Helsinki
• Council for International Organizations of Medical Sciences (CIOMS)
• Nuremberg Code
• Canadian Institutes of Health Research
• National Council on Ethics in Human Research-Canada

Procedures normally followed outside the United States for research involving human subjects may differ from those set forth in federal and University policies. These may result from differences in language, cultural and social history, and social mores. In addition, national policies such as the availability of national health insurance, philosophically different legal systems, and social policies may make U.S. forms and procedures inappropriate. In federally funded research, research activities in a foreign country may be approved if the ethical protections adhere by a foreign institution are equivalent to those in the U.S.

If protections are deemed equivalent, requests to review or waive some standard elements of U.S. approvals may be considered. However, protections afforded subjects must approximate those provided to subjects in the United States. The investigator is encouraged to contact the Chair of the appropriate IRB to discuss these issues. Investigators will be required to obtain a Research Ethics Review Board (IRB equivalent) approval for research done internationally for studies that are more than minimal risk. Many universities outside of the United States have Ethics Committees who can review and approve the research. For studies that are minimal risk, the IRB equivalent to an approval letter or permission letter from the research site may be acceptable; however, it will be reviewed on a case-by-case basis.

International research studies must adhere to a recognized Ethics Codes such as: 45 CFR 46, Declaration of Helsinki, Nuremberg Codes, 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. Additionally, the following issues should be addressed in the IRB application or be addressed in the IRB discussion.

• Benefits to Subjects
• Community Leader
• Culturally-sensitive to Local Area
• Paternalism
• Potential Coercion
• Genetics/Homogeneity/Validity to Other Populations
• Language Sensitivity
• "Helicopter" Research (data/sample collection & leaving site with no follow-up)
• Infrastructure
• Justify Use of This Population
• Ethics Body Equivalent (Research Ethics Review Board/IRB) Approval

Ten Questions Insituional Review Boards Should Ask when Reviewing International Clinical Research Protocols

• Is there a viable ethics committee in the host country that will review the protocol and how can they be contacted?
• What is the prinicipal investigator's relationship with the community from which research volunteers will be recruited?
• Does the research protocol address the ethical challenges for conducting research in a developing country?
• Is the purpose of the research responding to the health needs of the host country?
• When negotiating informed conseny, how will the investigators assure that the research volunteers understand the consent?
• What exactly is the local standard of medical care?
• Are the risks to volunteers acceptable in the social context of the host country?
• Does anyone else in the host country know about the research?
• What public helath action will result from the findings of the research study?
• Is capacity builiding an essential element of the research protocol?