International Centers – Institutional Review Board (IRB) Approval
International transplant centers must follow their country’s laws and regulations governing human subjects and privacy protection. The transplant center is responsible for obtaining the necessary institutional review and approval for the Observational Database.
If the recipient does not consent to participate in the Observational Database according to the laws and regulations of their country, the CIBMTR requests the completion of CRID Assignment Form 2804, the Indication for CRID Assignment Form 2814, the Pre-Transplant Essential Data Form 2400, and the Pre-TED Disease Classification Form 2402, each indicating consent to research as ‘no’. This reporting will help ensure that the epidemiological integrity of the database is maintained, and the recipient’s information will not be used in research. This applies to recipients of allogeneic (related and unrelated) and autologous HCT.