is the ideal of medical practice [47]. Oakley suggests that RCTs are ethically
problematic since chance allocation may be antithetical to good ethical practice
[48]. In particular, she expresses concern at how:
`the tension between the scientific aims of research and the humane treatment of
individuals... is expressed in the very strategy of designing an experiment so as
to restrict people's freedom to discuss with one another the commonality of the
process in which they are engaged'. *p. 188)What is certain is that the weighing up of risks and how they are presented to
potential participants is crucial with RCTs. Fletcheret al.suggest that the funda-
mental issue is the purpose for which the research is being carried out, and that
generally a trial should only proceed if the likely benefits to the individual taking part in the research and/or to society as a whole far outweigh the risks of parti- cipation' [49]. Furthermore, the Declaration of Helsinki provides that[p]hysicians
should cease any investigation if the risks are found to outweigh the potential
benefits or if there is conclusive proof of positive and beneficial results' para. 17).
Given the uncertainties until such a point is reached, RCTs pose considerable
problems for the law on informed consent, since the technique of randomisation
makes it more difficult for the researcher to fully explain the risks to an individual
patient. Certainly, the crucial issue in obtaining consent will be how the risks and
benefits of the proposed research are presented to the patient. Tobias has pointed
to the practical difficulties of gaining informed consent in such trials, especially
given the potential for misconception and anxiety if the consequences of rando-
misation are fully explained to the patient. He argues that instead we should trust
health professionals to engage in randomisation without explicit consent [50].
However, the consensus among legal commentators endorses Kennedy's view that
with RCTs it is particularly important that the materiality of risk should be defined
according to what the particular patient would want to know [51].
Numerous problems with the process for obtaining such consent were high-
lighted by the Griffiths Review into events at North Staffordshire, in which nurses
were centrally involved para 9.3.5) [52]. The review panel found that the nursing
sister assigned to a project focusing on the treatment of respiratory problems in the
premature new-born baby did not appear to have been provided with a protocol or
system of documentation which made sure that everything was complete for all
patients. It found that in general the nursing staff lacked adequate research
experience, yet were not offered any training, for the tasks that they were being
asked to do. Inadequate supervision by the researchers, coupled with a lack of
support from the Trust nursing management, contributed to problems in
documenting whether consent forms had been completed [53]. There were parti-
cular concerns about the adequacy of information given to parents who were
asked to enter their children in a trial in which a new technique ± continuous
negative extrathoracic pressure CNEP) ± was compared with the conventional
treatment of positive pressure ventilation, given that some of the children subse-
quently suffered brain damage or died. Hopefully the introduction of more
detailed guidance on clinical governance detailed below) will obviate these
problems, but nurses who are concerned by the conduct of trials should be
prepared to `blow the whistle' [54].
Clinical Research and Patients 259