Consenting to bio-risk : xenotransplantation and the law

Research into alternative sources of organs for transplantation, including the use of organs from non-human genetically engineered animals, has occurred since the introduction of allotransplantation in the 1960s. Xenotransplantation is different from other developing genetic technologies because whilst the potential benefit is to the individual, the possible risks are to society as a whole. The risks include the transmission of unknown and currently indeterminable infectious diseases. This article explores whether the current regulator framework is able to address this issue and, in particular, whether ‘first-party’ consent to involvement in a clinical trial is a sufficient to protect third parties from harm. The competence of a xeno-recipient to consent is also considered, and it is suggested that, at the very least, public debate and participation in deciding whether clinical trials should be permitted must occur, because by allowing xenotransplant trials to help an individual, the risks will be borne by all.