Nursing Law and Ethics

12.2.2 The criminal law

Notwithstanding the considerable discretion thus entrusted to the scientific
researcher, it should be noted that all activities by health professionals, as is the
case with all citizens, are circumscribed by the criminal law. English criminal law
provides that undue harm may not be inflicted on an individual even if they are
prepared to consent to the infliction of such harm Rv.Brown1993)). In a
consultation paper,Consent in the Criminal Law,the Law Commission *the body
which deals with law reform issues in England and Wales) addressed the subject of
what harm a person may legitimately consent to. It provisionally suggested that:

`a person should not be guilty of an offence if she causes injury to another, of

whatever degree of seriousness, if such injury is caused during the course of

properly approved medical research *i.e. approved by a Local Research Ethics

Committee) and with the consent of the other person'. [18]

This is consistent with the Law Commission's general stance regarding medical
treatment, which is that legitimate clinical procedures may be undertaken
regardless of the degree of harm which may result. However, the Commission did
not consider the issue of how acceptable risk may be defined. This leaves open the
question whether a high risk trial may be undertaken if the patient is prepared to
accept that risk ± a matter considered below in the context of xenotransplantation.
Certainly, failure to obtain the consent of an individual before they are included in
aclinical trial may give rise to a criminal prosecution for battery. There is a remote
possibility that a prosecution could be brought for manslaughter if a research
subject died while participating in a high risk trial.

12.2.3 The civil law

As well as potentially constituting a criminal offence, battery/trespass to the
person is also a civil wrong entitling the patient to sue for compensation. Thus,
where any research involves examining, operating on or injecting the patient,
consent must be obtained in advance for it to be carried out lawfully; unauthorised
contact entitles the patient to damages. Consequently, obtaining adequate consent
to participation is the key legal requirement in relation to nursing research since,
in the absence of statutory regulation, authority to carry out research on an adult
human subject derives from that person's consent [19]. Effectively, English law
imposes responsibility on the individual research subject to protect themself from
abuse by giving or withholding consent [20]. The upshot, as Berg has argued, is
that virtually all documented cases of abuses of medical experimentation have
been those which failed to employ satisfactory informed consent procedures [21].
Given this, it is not surprising that the key principle enshrined in the Helsinki
declaration is that:

`each potential subject must be adequately informed of the aims, methods,

sources of funding, any possible conflicts of interest, institutional affiliations of

the researcher, the anticipated benefits and potential risks of the study and the

discomfort it may entail. The subject should be informed of the right to abstain

Clinical Research and Patients 255