shaky ground, but ethically two principles can be invoked. The first is that, in the
case of individuals unable to consent by reason of lacking capacity to consent,
medical and nursing innovations which will benefit them are required by the
principle of beneficence. Research interventions which have a therapeutic com-
ponent can directly benefit the individual, and enrolling an individual lacking
capacity to consent would be justified by this. However, the principle of non-
maleficence requires that their special vulnerability to harm and exploitation be
noted, and special care be taken to minimise the possibility of harm to them. Here,
arguably, the principle of respect for autonomy is replaced by a principle of respect
for the dignity of the vulnerable person.
Asecond justification for research without consent is that, where the harm and
inconvenience caused to the individual is zero or negligible, all of us have, other
things being equal, a duty to benefit others 'especially if that involves no cost to us)
and participation in socially useful research is one way to do that. This might be
held to be supplemented in the UK by a sort of political claim that we are all
members of the National Health Service, and all benefit from it, and all have an
interest in its development and management. Hence, informally we mandate it to
carry out records based research and audit, without the necessity to obtain consent
provided our privacy is protected. The former version is an argument from soli-
darity; the latter is an argument from social contract theory. But what is clear is that
both arguments rest on a claim about the importance and utility of the research, a
claim that the research is minimal risk and a claim that the rational individual
would not object to their consent not being sought. All of these claims need proof
in each situation, and the burden of proof lies with the researcher; these claims
must be adjudicated by an independent research ethics committee.
Amore troubling worry about consent is the extent to which research on patients
involves people who may be emotionally vulnerable, who invest trust in health care
professionals simply because they are professionals, or perhaps because they have
come to like and rely on particular individual professionals. They may not dis-
tinguish between the individual's roles as carer and as researcher, or they may think
that they must somehow `please 'the member of staff in order to maintain good
relationships or access to care. While this is explicitly ruled out by the Declaration of
Helsinki, and patients must be told that their care will not be compromised if they
refuse, this is sometimes difficult for patients to believe or accept.
Aparticular difficulty arises where a clinical trial is being managed by a research
nurse who is requested by the principal investigator to recruit and enrol indivi-
duals in the trial. Strictly speaking, the consent must be obtained by the individual
responsible for prescribing the study treatment ± normally the physician principal
investigator. This raises more general issues about the roles and responsibilities of
the different members of the clinical team, which is beyond the scope of this
chapter.
12.12 Research and care
Ethically, the issue of most profound concern about research involving patients is
how research and care roles conflict. While the actions performed may be
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