human trials would have to be approved by the Xenotransplantation Interim
Regulatory Authority established on the recommendation of the Department of
Health review of this technology *the Kennedy Report). However, it is envisaged
that this body, and any subsequent statutory body which may be set up by legis-
lation, would operate alongside existing LREC and MRECs, so that any decision in
principle to authorise clinical trials will still require LREC/MREC approval.
Even if such approval is granted, questions remain concerning the role of health
professionals involved in such trials. As with enrolment in most clinical trials, the
crucial issue will be obtaining valid consent. However, xenotransplantation raises
particular problems over and above the general difficulties of obtaining informed
consent. In the first place, potential recipients of pig tissue are in an especially
difficult situation, where it is questionable whether the decision to enter clinical
trials actually represents an informed choice. If a particular class of patients rea-
lises that the only alternatives to enrolling in a potentially hazardous clinical trial
are the slim chance of obtaining a suitable organ, or death, the likelihood is that
they will be willing to take that risk regardless of the hazards it potentially creates
for them or others.
Secondly, as an entirely new procedure, arguably it is not possible to assess the
inherent risks with any degree of accuracy. In general, little is known about pig
diseases, but the history of animal±human viruses lends plausibility to the view
that xenotransplantation offers a unique opportunity for prion-type diseases to
jump the species barrier. This is particularly so if source animals are genetically
engineered with human genes. Two problems arise. The first is the practical
difficulty posed by the Kennedy Report's suggestion that huge amounts of infor-
mation would have to be given to research subjects. It is recommended that for an
informed decision to be taken, potential recipients should be given information
regarding the psychological and social effects of xenotransplantation as well as
information about the source of tissue, breeding and genetic information, and
animal suffering [107]. It is questionable how many patients are equipped to fully
assimilate and evaluate such quantities of information.
Astill more fundamental problem is whether individual recipients should be
able to consent to a procedure which has the potential to unleash unsuspected
hazards on the broader population. How should this sort of risk be explained to a
potential participant in a clinical trial? A further issue is that, given these risks,
those who enrol in the first trials, if they are authorised, must submit to surveil-
lance and monitoring of their movements [108]. This gives rise to problems about
how to present potentially very intrusive interferences with civil liberties
*including the right to reproduce) to potential research subjects.
The case of xenotransplantation highlights the need for fuller consideration to
be given to the adequacy of counselling and information provision when subjects
are enrolled in clinical trials, especially where the research concerns new
biotechnologies and there is no existing way of treating the disease [109]. This case
study also raises concerns over how an effective system of scrutiny and account-
ability may be implemented, especially when a number of committees with
potentially overlapping remits exist to regulate this procedure [110]. A final issue
raised by xenotransplanatation is that, should the worst fears of its opponents be
realised, a crucial factor yet to be addressed is who should bear the costs of
270 Nursing Law and Ethics