participation in a research project the only cause of action lies in negligence, but
such an action would probably fail if a properly conducted research programme
had been approved by an ethics committee and carried out in accordance with a
responsible body of professional opinion [102].
Given the difficulties in pursuing a legal remedy for injury suffered as a result of
participation in clinical trials, attention has focused on mechanisms for compen-
sating those who suffer harm. There is no formal legal requirement that volunteers
for research should be indemnified, although the Association of British Pharma-
ceutical Industry guidelines provide that where commercial companies sponsor
research they should give contractually binding guarantees to healthy volunteers if
they should be injured. However these guidelines are not mandatory [103]. In
recognition of the inadequate protection given to participants in clinical research,
the Pearson Commission recommended years ago that `any volunteer for medical
research who suffers severe damage as a result should have a cause of action, on
the basis of strict liability, against the authority to whom he has consented to make
himself available' [104]. However no government has taken action to implement
this proposal [105]. The possibility of a major claim for compensation is parti-
cularly likely in the case of certain new technologies, where potentially very
hazardous risks are difficult to estimate with any degree of certainty, as discussed
in the following case study on xenotransplantation. The new European Union
Directive on medicinal products, noted above, will require that ethics committees
take into account the provision for indemnity or compensation in the event of
injury or death when deciding whether to approve a clinical trial Article 6 h)).
Afurther source of controversy concerns the care provided in the aftermath of
clinical trials. As noted above, one incentive to enrol in a clinical trial is the way it
offers an avenue to high quality medical care, but this raises ethical issues about
the care of patients once their participation in research is complete.
12.5 Case study ± xenotransplantation
As new biotechnologies are developed, new ethical and legal dilemmas are raised
for researchers. One area which potentially gives rise to huge concerns is that of
xenotransplantation.
Xenotransplantation may be defined as the transplant of tissue between species.
Most attention to date has centred on the transplant of whole animal organs *such
as hearts, kidneys and livers) into humans. Biotechnology companies are currently
breeding genetically engineered pigs, which are viewed as a likely source of these
organs. The ethics and safety of xenotransplantation was considered in two major
reports in the mid-1990s [106]. Both broadly concluded that xenotransplantation,
using pigs, was an ethically acceptable solution to the chronic organ shortage,
although it was not at that point safe to proceed to human trials given the incal-
culable risks posed.
The major risk identified is that diseases will spread from the pig source to the
recipient and possibly the broader population. Notwithstanding such concerns, it
is now clear that animal trials have progressed to the stage where there is an
increased impetus towards permitting human trials. The decision to proceed to
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