The importance of individual, first-party consent and informed decision-making is almost universally accepted in the health context, and is viewed as a vital component of responsible health practice and research. Health care in most Western societies is based on this form of consent and, for research, international and national declarations and guidelines emphasise the importance of obtaining consent, as do the UK's Clinical Trials Regulations 2004. Clinical trials in Europe should accord with the ethical principles set out in the Declaration of Helsinki and the consent of the individual participant is at the centre of this. Xenotransplantation requires a reconsideration of this focus on the individual's consent because of the nature and magnitude of the risks, and ‘[r]esponsibility for one's choices demands consideration of how these choices will affect others’. There are no reported cases on consenting to clinical research in the UK, but the UK's DH has stated that the requirements on consenting to medical treatment apply. Consenting to experimental procedures is not specifically addressed in UK legal or ethical guidance but it is similarly assumed that the requirements for consent to treatment and research also apply. This is problematic. Medical treatment, clinical research and experimental procedures are very different in nature and different standards of information disclosure for research, especially non-therapeutic, than for treatment may be appropriate.

Individual consent is undoubtedly important, can help to enhance patient autonomy, and ‘frees the researcher from the suspicion that the patient's vulnerability has been exploited for the researcher's profit’. However, in some societies where an individual's ‘rights’ and ideas of ‘choice’ are emphasised, there is a sense that provided a competent informed adult agrees anything is possible. Three key issues raised by the legal and ethical norm of relying on first-party consent in the xenotransplantation context are explored. First, whether competent informed individuals should be able to consent to a genetically engineered solid organ xenotransplant because the risks go beyond the intended beneficiary. It should not be assumed that it is legally possible to consent to this, and consideration must be given to an assessment of private benefit and public risk, the ‘obligation to protect society from the spread of infection’, and the situation of those who need a transplant but cannot obtain one. Secondly, if it is possible to legally consent, is traditional ‘first-party’ consent appropriate for xenotransplants? To provide ‘real’ consent to a treatment, a clinical trial and, presumably, an experimental procedure in the UK, the participant/recipient must be: (i) competent; (ii) acting voluntarily; and (iii) informed ‘in broad terms of the nature of the [experimental procedure or clinical trial]’. Will the first xeno-recipients be able to meet these requirements? There is a developing consensus that the first xeno-recipients should be competent adults, with those with no other hope likely candidates, and I consider whether they can be competent because of their health status. Concerns have long been raised about the voluntariness of patients' consent to involvement in research, especially when their doctor requests their participation, and the health status of proposed xeno-recipients may further affect their ability to consent voluntarily. Furthermore, does the limited information available make it (im)possible for a patient to make an informed choice to be involved?