Title of Human and Biological Form

Institutional Review Board Human Research Protections Appendix H – International Research Version 04-18-2017

Research conducted by UC Irvine researchers falls under the University's purview and guidelines even when conducted elsewhere. Note: For protocols that require full committee review, the research study must be approved by the local equivalent of an IRB at the international location before UCI IRB approval will be granted. When there is no equivalent board or group, investigators may rely on local experts or community leaders to provide approval. Documentation of "local approval" must be provided to the UCI IRB.

HS#: (to be completed by the IRB)

Lead Researcher/Investigator Name:      

1. 
   Describe the researcher(s) qualifications (e.g., relevant coursework, past experience/research, or training) to conduct human subjects research in an international setting?     
   

2. 
   Explain how the cultural norms differ compared with U.S. culture in respect to research autonomy, consent, recruitment, confidentiality etc. Include an explanation of the cultural sensitivities that will be required to conduct this study: Consider current events (Include additional documentation if necessary):      
   

3. 
   Does the researcher(s) speak/read/write the language of the potential subjects?
   

 Yes

 No - explain how recruitment, the informed consent discussion and data collection will take place:      

4. 
   Will the consent form or information study sheet be translated into other language(s)?
   

 Yes

 No - Explain:      

5. 
   Does the researcher have knowledge of local community attitudes to mitigate the cultural norms and remain in compliance with U.S. regulations for research?
   

 Yes – Explain:      

 No – Explain:      

6. 
   Has the researcher(s) been invited into the community?
   

 Yes – Explain:      

 No.

7. 
   For full Committee protocols - Has the host country approved the study?
   

 Yes

• 
  Final IRB approval is contingent upon approval by the host country.
  
• 
  Submit host country’s review board approval.
  

 No

 N/A

8. 
   Is this research therapeutic?
   

 Yes - What provisions have been made to provide continued access to the therapeutic intervention after completion of the study?:      
 No - Address how the subject population will benefit from the study:      

9. 
   What arrangements will be in place for the study data to be available to the subject population at the conclusion of the study?:      
   

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