The Institutional Review Board Approval Process

  • Chad R. Gordon
  • Maria Z. Siemionow


Since 2005, ten face transplants have been performed in four countries: France, the USA, China, and Spain. These encouraging short-term outcomes, with the longest survivor approaching 5 years, have led to an increased interest in establishing face transplant programs worldwide. Therefore, the purpose of this chapter is to facilitate the dissemination of relevant details as per our experience in an effort to assist those medical centers interested in obtaining an Institutional Review Board (IRB)-approved protocol. In this chapter, we address the logistical challenges involved with face transplantation including: essential program requirements, pertinent protocol details, face transplant team assembly, project funding, the organ procurement organization (OPO), and the coroner. It must be emphasized that face transplantation is still experimental and its therapeutic value remains to be validated. All surgical teams pursuing this endeavor must dedicate an attention to detail and should accept a responsibility to publish their outcomes in a transparent manner in order to contribute to the international field. However, due to its inherent complexity, facial transplantation should only be performed by university-affiliated medical institutions capable of orchestrating a specialized multidisciplinary team with a long-term commitment to its success.


Team Leader Transplant Surgeon Organ Procurement Organization Face Transplant Institutional Review Board Protocol 
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Copyright information

© Springer London 2011

Authors and Affiliations

  1. 1.Department of Plastic SurgeryCleveland ClinicClevelandUSA

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