Xenotransplantation - Nuffield Council on Bioethics
Xenotransplantation - Nuffield Council on Bioethics
Xenotransplantation - Nuffield Council on Bioethics
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Summary of recommendati<strong>on</strong>s<br />
6 A code of practice should be drawn up specifying which organisms should be<br />
excluded from specified-pathogen free animals. <str<strong>on</strong>g>Xenotransplantati<strong>on</strong></str<strong>on</strong>g> teams should be<br />
required to exclude from source animals all the pathogens listed in the code of<br />
practice (paragraph 10.27). A regulatory framework should be devised to c<strong>on</strong>trol the<br />
safety and quality of animal organs and tissue for xenotransplantati<strong>on</strong><br />
(paragraph 10.27).<br />
7 Standards and mechanisms for m<strong>on</strong>itoring xenograft recipients and for the acti<strong>on</strong> to<br />
be taken in case of disease transmissi<strong>on</strong> should be in place before human trials begin.<br />
It should be a requirement of clinical trials that the need for m<strong>on</strong>itoring is explained<br />
to the patient and that it is made clear that c<strong>on</strong>sent to the operati<strong>on</strong> also implies<br />
c<strong>on</strong>sent to subsequent m<strong>on</strong>itoring (paragraph 10.28). <str<strong>on</strong>g>Xenotransplantati<strong>on</strong></str<strong>on</strong>g> teams<br />
should be required to record all informati<strong>on</strong> c<strong>on</strong>cerning individual xenograft<br />
recipients in a xenotransplantati<strong>on</strong> register maintained by an independent body<br />
(paragraph 10.29).<br />
8 The Working Party recommends that the Department of Health should establish an<br />
Advisory Committee <strong>on</strong> <str<strong>on</strong>g>Xenotransplantati<strong>on</strong></str<strong>on</strong>g> (paragraph 10.31).<br />
Early patients<br />
9 No xenotransplantati<strong>on</strong> trials involving human recipients should proceed until the<br />
proposed Advisory Committee <strong>on</strong> <str<strong>on</strong>g>Xenotransplantati<strong>on</strong></str<strong>on</strong>g> is in place and has approved<br />
the trials (paragraph 10.32). C<strong>on</strong>sent of patients to participati<strong>on</strong> in<br />
xenotransplantati<strong>on</strong> trials should be sought by appropriately trained professi<strong>on</strong>als<br />
who are independent of the xenotransplantati<strong>on</strong> team. The informati<strong>on</strong> given to<br />
prospective recipients should include an estimati<strong>on</strong> of likely success, attendant risks<br />
and subsequent quality of life (paragraph 10.34). No protocol to c<strong>on</strong>duct a trial<br />
should be accepted unless it c<strong>on</strong>tains a commitment to a robust descripti<strong>on</strong> and<br />
assessment of the patient’s pre-operative and post-operative quality of life (paragraph<br />
10.35).<br />
10 The first xenotransplantati<strong>on</strong> trials should involve adults rather than children<br />
(paragraph 10.36). The first xenotransplantati<strong>on</strong> trials should not involve adults<br />
incapable of c<strong>on</strong>senting to participati<strong>on</strong> <strong>on</strong> their own behalf (paragraph 10.38).<br />
11 At any stage in the development of xenotransplantati<strong>on</strong>, patients who, for whatever<br />
reas<strong>on</strong>s, refuse xenografts should remain entitled to c<strong>on</strong>siderati<strong>on</strong> for human organs<br />
<strong>on</strong> the same basis as before their refusal (paragraph 10.40). Xenograft recipients<br />
should remain entitled to c<strong>on</strong>siderati<strong>on</strong> for human organ transplantati<strong>on</strong> <strong>on</strong> the same<br />
basis of clinical need as before xenotransplantati<strong>on</strong> (paragraph 10.41).<br />
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