Guidance and Processes
International Research
Consenting Subjects Who Do Not Read, Speak or Understand English
Process for International Research Involving Undergraduate Students
Forms (also available in IRBNet)
Sample Short Form Consent Template
International Research Appendix
Translation Documentation Form
Flow Charts
Preferred Method for Obtaining and Documenting Informed Consent from Non-English Speaking Subjects
Short-form Method for Obtaining and Documenting Informed Consent from Non-English Speaking Subjects
IRB Review Process for Translated Materials
External References
U.S. Department of Health & Human Services, Office of Human Research Protections - International Compilation of Human Research Standards
NIH ClinRegs - Compilation of international clinical research regulations
- Sierra Leone: https://clinregs.niaid.nih.gov/country/sierra-leone
- China: https://clinregs.niaid.nih.gov/country/china
- India: https://clinregs.niaid.nih.gov/country/india
- Mexico: https://clinregs.niaid.nih.gov/country/mexico
Researchers are encouraged to conduct international human subjects research according to the principles of the Brocher Declaration.