UT-Houston investigators conducting international research must adhere to the same high standards of research ethics required for human subjects research conducted in the U.S. while at the same time being sensitive to local cultures and practices CPHS considerations/requirements for this research are dependent upon the role of the foreign institution/site in the research.

Research Where Foreign Site Is Actively Involved in Research
If the foreign site/institution is actively involved in the proposed research, additional requirements beyond those for domestic research include the following.

1. The foreign site must file an assurance of compliance with OHRP.
   
2. The foreign site must have procedures that provide protections at least equivalent to those in 45 CFR 46.
   
3. The CPHS must have a copy of the foreign site’s Research Ethics Board (REB)/Independent Ethics Committee’s review/approval of the study.

Research Where Foreign Site Is Not Actively Involved in Research
If the foreign site/institution is not actively involved in the proposed research, additional requirements beyond those for domestic research include the following.

1. The CPHS must have a copy of the foreign site’s REB’s (1) review/approval of the study or (2) documentation that approval is not required. If the site does not have an REB, the PI must submit a letter of cooperation that documents appropriate institutional officials have approved the proposed research.
   
2. The PI and foreign site must notify the CPHS if the role of the foreign site changes.

UTHealth’s Compliance Hotline (1-888-472-9868)
For other questions, please call us at 713-500-7943.