from participation in the study or to withdraw consent to participate at any time
without reprisal. After ensuring that the subject has understood the information,
the physician should then obtain the subject's freely-given consent, preferably in
writing. If the consent cannot be obtained in writing, the non-written consent
must be formally documented and witnessed' *para. 22).Similarly, in a nursing context, the UKCC's Guidelines for Professional Practice
provide, inter alia, that arrangements for obtaining consent must be clearly
understood by all those involved; patients must not be exposed to unacceptable
risks; and they should be included in the development of proposed projects where
appropriate [22].
The major issue in relation to consent to nursing research is how to ensure that
the consent is freely-given' andinformed'. As we saw in Chapter 7, in relation to
medical treatment, the courts have stated that so long as a patient gives a very
general consent to an operation being undertaken, the health professional will not
be liable in the tort of battery Chattertonv.Gerson1981)). InSidawayv.Bethlem
*1985) the House of Lords rejected the view that the doctrine of informed consent
forms part of English law in the context of medical treatment [23]. Nevertheless,
although there have been no decided English cases on the duty of disclosure
pertaining to medical research, it is generally accepted by legal commentators that
the law as set out inSidawayand subsequent cases does not apply in the context of
research [24]. Thus, someone who volunteers for research is entitled to a fuller
explanation of the nature of the trial and risks it carries than would be the case in
relation to medical treatment. It is highly probable that English law would follow
Canadian law [25], in adopting an objective test requiring a researcher to disclose
all relevant facts which a reasonable subject would wish to know, and to provide
the opportunity for questions, to which full and honest answers would be given
[26]. This means that if inadequate information is given to a research subject the
researcher could be liable in negligence proceedings.
However, given that researchers themselves may lack adequate information
about the risks of a proposed new drug or course of treatment, some commenta-
tors question whether informed consent is truly possible in the context of clinical
research [27]. Certainly it is questionable whether the intended experimental
subject can validly consent to procedures the results of which are uncertain, of
dubious benefit or clearly harmful ± issues which are canvassed below in relation
to xenotransplantation [28]. It is thus not surprising that in those few court cases in
which judges have explored the issue of consent, they have tended to limit their
role to ensuring that fully informed, voluntary consent has been given. Yet, as
Tobias has pointed out, notwithstanding the legal emphasis on informed consent
`neither lawyers, ethicists, nor medical scientists have so far agreed precisely what
this term actually means' [29]. Furthermore, McNeil has contended that the
emphasis which courts have traditionally placed on consent is inadequate to
regulate experimentation on human subjects. In his view, the focus on consent
fails to fully address issues such as the weighting of the risks and benefits of
experimentation for subject and society, and enables courts to avoid issues like
whether they should endorse guidelines for researchers [30].
Legislative guidelines do exist in relation to trials of new pharmaceuticals.
256 Nursing Law and Ethics