`When obtaining informed consent for the research project the physician
should be particularly cautious if the subject is in a dependent relationship
with the physician or may consent under duress. In that case the informed
consent should be obtained by a well-informed physician who is not engaged
in the investigation and who is completely independent of this relationship'
*para. 23).In common with many legal documents, the Helsinki declaration focuses on the
role of doctors. However, the tension between scientific dispassion and concern
for the patient is likely to be particularly disconcerting for nurses. Not only is it
arguable that nursing is more firmly grounded in notions of care and nurturance
than other health professions [40], but in practice nurses tend to have closer
relationships with their patients than do doctors. It may follow that nurses are
viewed as better placed to explain the consequences of enrolment in a trial to a
patient and to obtain their consent. Certainly, if a nurse finds herself in the
position of seeking consent, guidelines promulgated by bodies such as the Medical
Research Council MRC) and General Medical Council GMC) stress the need for
explanations to be given in clear and easily comprehensible language. Any special
communication or language needs of the participants should be taken into
account.
As pointed out by the Griffiths Review into the conduct of research trials
involving children at North Staffordshire Hospital during the 1990s [41], it is
important to appreciate the difficulty of understanding and giving a valid consent
at a time of severe physical, psychological or emotional stress *para. 14.3.6).
Potential subjects should also be given written information and time to reflect on it.
Draft guidance, on which the GMC is currently consulting, stresses that patients or
volunteers are entitled to an explanation as to why they have been asked to par-
ticipate, which should include an accurate description of the patient's clinical
condition [42]. The MRC suggests that it is useful, as well as good practice, to seek
advice from consumers or lay persons in drafting information for potential
subjects [43]. As noted above, participants should also be clearly informed of their
right to withdraw from participation at any time without reprisal [44]. Addition-
ally, they must be given an explanation of how personal information will be stored,
transmitted and published.
12.2.5 Consent to randomised controlled trials
Particular problems arise in the context of consent to randomised controlled trials
RCTs). In recent years RCTs, which aim to compare treatments or approaches in
two or more groups of subjects who are allocated randomly to those groups [45],
have been promoted as the most scientifically valid method of evaluating proce-
dures [46]. Those who endorse randomisation which aims to rule out a purely
psychological reaction to new drugs) argue that if drugs are not investigated using
randomisation and blinding of both researchers and patients to the process, then
there is a strong possibility that bias will enter the study and affect the results.
However, others have argued that RCTs may adversely affect the health profes-
sional±patient relationship by harming the bond of trust and mutual respect which
258 Nursing Law and Ethics