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Does the proposed surgical unit have sufficient technical skill and experience to optimise the chances of a successful transplant?
Does there exist at the hospital integrated clinical care between the transplant team and other surgical and medical units required to optimise short and long-term treatment?
Does a comprehensive and coherent protocol exist for the selection of suitable patients for transplantation?
Does the Research Ethics Committee (REC) protocol provide potential patients with adequate information on the basis of which valid informed consent can be given?
Does the REC protocol provide adequate information for potential patients about how little is known about some of the risks associated with facial transplantation?
Does the surgical unit have integrated links with a team with appropriate psychological expertise (including psychiatrists and psychologists) to provide support adequate to ensure that prospective patients can give valid informed consent to facial transplantation?
In addition to the surgical team obtaining consent to the procedure, are there others involved in the process of acquiring informed consent and checking understanding who are sufficiently independent from the transplant team itself to ensure that they are not explicitly or implicitly influenced by any factors other than respect for and protection of the potential transplant patient?
Whether or not there is a valid advance directive, are those who will seek the consent/agreement of appropriate donor relatives for the donation of facial tissue sufficiently trained to do so?
How will the psychological team provide long term therapeutic support to the patient in the aftermath of both successful transplantation or potential and/or actual failure? Is there sufficient evidence of expertise across the team for this to be done effectively?
Is the protocol clear about the mechanisms that will be in place to ensure satisfactory delivery of the duty of care toward the recipient's family?
Is the protocol clear about the mechanisms that will be in place to ensure satisfactory delivery of the duty of care toward the donor's family that extends beyond obtaining their consent or agreement for donation?
Can the transplant team, the psychological team and the host hospital guarantee the long term funding required to ensure that all patients will continue to receive the care and support specifically outlined in the protocol approved by the REC whether the transplants have been successful or unsuccessful?
Can the extra surgical, medical, psychological and social care resources required for affirmative answers to the preceding questions be provided for facial transplantation by the relevant institutional payer without reducing the quality of care of other patients with facial disfigurements (among others in great need) at the host hospital?
In light of the already existing shortage of transplant co-ordinators, can such scarcity be equitably managed in the care and support offered to the families of potential donors of facial tissue, both when they are approached to obtain consent or agreement and afterwards in the event of subsequent distress?
Aside from good regulatory practice in the composition of RECs to ensure appropriate and representative expertise, the membership of any such body that considers an application for facial transplantation should include experts in reconstructive surgery, immunosuppression, psychological problems posed by severe facial disfigurement and a representative of one of the organisations who provide support for those with such disfigurement.
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