The Institutional Review Board Approval Process



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 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


  1. 1.
    Okie S. Facial transplantation: brave new face. N Engl J Med. 2006;354:889-894.PubMedCrossRefGoogle Scholar
  2. 2.
    Dubernard JM, Lengele B, Morelon E, et al. Outcomes 18 months after the first human partial face transplantation. N Engl J Med. 2007;357:2451.PubMedCrossRefGoogle Scholar
  3. 3.
    Gordon CR, Siemionow M, Papay F, et al. The world’s experience with facial transplantation: what have we learned thus far? Ann Plast Surg. 2009;63:121-127.CrossRefGoogle Scholar
  4. 4.
    Guo S, Han Y, Zhang X, Lu B, et al. Human facial allotransplantation: a 2-year follow-up study. Lancet. 2008;372:631-638.PubMedCrossRefGoogle Scholar
  5. 5.
    Lantieri L, Meningaud JP, Grimbert P, et al. Repair of the lower and middle parts of the face by composite tissue allotransplantation in a patient with massive plexiform neurofibroma: a 1-year follow-up study. Lancet. 2008;372:639-645.PubMedCrossRefGoogle Scholar
  6. 6.
    Associated Press. First total face transplant in Spain. MSNBC website. Accessed May 14, 2010.
  7. 7.
    Siemionow M, Zor F, Gordon CR. Face, upper extremity, and concomitant transplantation: future challenges and potential concerns. Plast Reconstr Surg. 2010;126(1):308-315.PubMedCrossRefGoogle Scholar
  8. 8.
    American Society of Reconstructive Transplantation. Website home page. Accessed November 29, 2009.
  9. 9.
    Siemionow M, Papay F, Alam D, et al. First U.S. near-total human face transplantation – a paradigm shift for massive facial injuries. Lancet. 2009;374:203-209.PubMedCrossRefGoogle Scholar
  10. 10.
    Siemionow M, Papay F, Djohan R, et al. First U.S. near-total human face transplantation – a paradigm shift for massive facial injuries. Plast Reconstr Surg. 2010;125(1):111-122.PubMedCrossRefGoogle Scholar
  11. 11.
    Gordon CR, Nazzal J, Lozano-Calderan SA, et al. From experimental rat hindlimb to clinical face composite tissue allotransplantation: historical background and current status. Microsurgery. 2006;26:566-572.PubMedCrossRefGoogle Scholar
  12. 12.
    Siemionow M, Demir Y, Mukherjee A, Klimczak A. Development and maintenance of donor-specific chimerism in semi-allogenic and fully major histocompatibility complex mismatched facial allograft transplants. Transplantation. 2005;79:558-567.PubMedCrossRefGoogle Scholar
  13. 13.
    Demir Y, Ozmen S, Klimczak A, Mukherjee AL, Siemionow M. Tolerance induction in composite facial allograft transplantation in the rat model. Plast Reconstr Surg. 2004;114:1790-1801.PubMedCrossRefGoogle Scholar
  14. 14.
    Siemionow M, Gozel-Ulusal B, Engin Ulusal A, Ozmen S, Izycki D, Zins JE. Functional tolerance following face transplantation in the rat. Transplantation. 2003;75:1607-1609.PubMedCrossRefGoogle Scholar
  15. 15.
    Siemionow M, Ortak T, Izycki D, et al. Induction of tolerance in composite tissue allografts. Transplantation. 2002;74:1211-1217.PubMedCrossRefGoogle Scholar
  16. 16.
    Gozel-Ulusal B, Ulusal AE, Ozmen S, Zins JE, Siemionow MZ. A new composite facial and scalp transplantation model in rats. Plast Reconstr Surg. 2003;112:1302-1311.CrossRefGoogle Scholar
  17. 17.
    Gordon CR, Siemionow M, Coffman K, et al. The Cleveland clinic FACES score: a preliminary assessment tool for identifying the optimal face transplant candidate. J Craniofac Surg. 2009;20(6):1969-1974.PubMedCrossRefGoogle Scholar
  18. 18.
    Morris P, Bradley A, Doyal L, et al. Face transplantation: a review of the technical, immunological, psychological and clinical issues with recommendations for good practice. Transplantation. 2007;83:109-128.PubMedCrossRefGoogle Scholar
  19. 19.
    Gordon CR, Siemionow M. Requirements for establishing a hand transplant program. Ann Plast Surg. 2009;63:262-273.PubMedCrossRefGoogle Scholar
  20. 20.
    ASRM/ASPS. Facial Transplantation – ASMS/ASPS guiding principles. Available at: Accessed on June 13, 2010.
  21. 21.
    Gordon CR, Siemionow M, Zins J. Composite tissue allotransplantation: a proposed classification system based on relative complexity. Transplant Proc. 2009;41:481-484.PubMedCrossRefGoogle Scholar
  22. 22.
    Siemionow M, Sonmez E. Face as an organ. Ann Plast Surg. 2008;61:345-352.PubMedCrossRefGoogle Scholar
  23. 23.
    Siemionow M, Unal S, Agaoglu G, Sari A. A cadaver study in preparation for facial allograft transplantation in humans: part I. What are alternative sources for total facial defect coverage? Plast Reconstr Surg. 2006;117:864-872.PubMedCrossRefGoogle Scholar
  24. 24.
    Siemionow M, Agaoglu G, Unal S. A cadaver study in preparation for facial allograft transplantation in humans: part II. Mock facial transplantation. Plast Reconstr Surg. 2006;117:876-885.PubMedCrossRefGoogle Scholar
  25. 25.
    Siemionow M, Papay F, Kulahci Y, et al. Coronal-posterior approach for face/scalp flap harvesting in preparation for face transplantation. J Reconstr Microsurg. 2006;22:399-405.PubMedCrossRefGoogle Scholar
  26. 26.
    Siemionow M, Agaoglu G. The issue of “facial appearance and identity transfer” after mock transplantation: a cadaver study in preparation for facial allograft transplantation in humans. J Reconstr Microsurg. 2006;22:329-334.PubMedCrossRefGoogle Scholar
  27. 27.
    Agich GJ, Siemionow M. Until they have faces: the ethics of facial allograft transplantation. J Med Ethics. 2005;12:707-709.CrossRefGoogle Scholar
  28. 28.
    Brill SE, Clarke A, Veale DM, Butler PE. Psychological management and body image issues in facial transplantation. Body Image. 2006;3:1-15.PubMedCrossRefGoogle Scholar
  29. 29.
    Glazier AK. Regulatory face-off: what agency should oversee face transplants? Am J Transplant. 2008;8:1393-1395.PubMedCrossRefGoogle Scholar
  30. 30.
    Clarke A, Malloy J, White P, et al. A model for structuring the donor discussion in emergent transplant procedures. Prog Transplant. 2008;18:157-161.PubMedGoogle Scholar
  31. 31.
    Lengele BG. Current concepts and future challenges in facial transplantation. Clin Plast Surg. 2009;36:507-521.PubMedCrossRefGoogle Scholar

Copyright information

© Springer London 2011

Authors and Affiliations

  1. 1.Department of Plastic SurgeryCleveland ClinicClevelandUSA

Personalised recommendations