Ethical Considerations in Face Transplantation: Ethical Issues Related to Inclusion Criteria for Face Transplant Candidates

On November 15, 2004, Cleveland Clinic Foundation’s Institutional Review Board (IRB) granted me the world’s first approval to perform face transplantation in humans. This approval was granted based on over 20 years of work in the field of composite tissue allotransplantation, both in the experimental laboratory as well as in the anatomy laboratory, on cadaver models. The process of approval took over 1 year and a number of meetings in front of the IRB committee, which consisted of about 20 members of different specialties including medicine, transplantation, infectious disease, and surgery; however, also experts in different fields—lawyers, social workers, as well as lay representatives, all having the right to ask questions about the validity of such a new procedure. When it comes to surgical breakthroughs, there is always a lot of controversy around the topic. It is quite understandable that the announcement of Cleveland Clinic having received approval for facial transplantation in humans, in 2004, raised considerable interest from media all over the world, and from this perspective, I must say that the international and national media interest was almost larger than when we actually performed the first US face transplantation in December 2008. Interestingly, there was a lot of support from the media perspective, since it was obvious that our IRB approval was based on years of work in the field of composite tissue allograft transplantation. Also, the medical society supported the idea that, for patients who had lost their faces and were severely disfigured, introduction of new reconstructive options which went beyond what was currently available, was something to be accepted with interest and excitement. The major opponents, however, of the idea of facial transplantation, were experts in ethics. One of them, Dr. Art Caplan, questioned the value of face transplantation and had numerous public interviews where he criticized the idea, as well as having warned society that now patients would be unwilling to donate organs and would be tearing up their drivers’ licenses since, in the United States, organ donation is voluntary and a statement indicating agreement to be an organ donor is displayed on drivers’ licenses. Interestingly, from the surgeons’ perspective, this type of approach could be ethically questionable, specifically when it comes to statements made ex cathedra, without really dealing with disfigured patients and seeing their disability, daily suffering, and inability to maintain physiological functions, as well as normal social lives. This introduces the ethical questions which we had raised during the work on our IRB approval protocol, as well as on the consent form for face transplant candidates. As for any medical procedure, when it comes to a decision about elective and novel surgery, there is always the M. Siemionow (&) Department of Plastic Surgery, Cleveland Clinic, 9500 Euclid Avenue/Desk A-60, Cleveland, OH 44195, USA e-mail: siemiom@ccf.org Arch. Immunol. Ther. Exp. (2011) 59:157–159 DOI 10.1007/s00005-011-0121-6