involve the establishment of a trial steering committee which should include at
least one of the principal investigators conducting the research, and at least three
independent members, one of whom would chair the committee. It would meet to
approve the final protocol before the start of the trial and thereafter at least
annually to monitor the progress of the trial and to maximise the chances of
completing it within the agreed time scale [68]. In similar vein, the consultation
paper on draft governance arrangements for RECs encourages RECs to follow up
their initial grant of approval by seeking progress reports. Nevertheless, until the
implementation of the Clinical Trials Directive see p. 257), the absence of any
legal provision for monitoring remains a concern, since in practice most com-
mittees approve over 90% of research proposals after asking the researchers to
consider minor modifications [69].
In the USA similar criticisms led to the establishment of a National Bioethics
Advisory Commission to provide advice and recommendations on the appro-
priateness of certain government policies and practices in bioethics, including
principles for the ethical conduct of research [70]. Some commentators have
called for a similar commission to be set up in the UK [71]. Such developments
are now being superseded at European level by the adoption of the EU Directive
on trials of medicinal products, which, as noted above, aims to ensure conformity
among EU member states. The Directive stresses the importance of monitoring
clinical trials. Before commencing any clinical trial of medical products, the
sponsor will be required to submit a valid request for authorisation to the com-
petent authority of the relevant member state. If a member state has objective
grounds for considering that the conditions in the request for authorisation are
no longer met, or has doubts about the safety or scientific validity of the clinical
trial, it will have powers to suspend or prohibit the clinical trial, or inform those
responsible for conducting the trial how to remedy the situation Article 12).
Member states will be required to appoint investigators to inspect the sites on
which clinical trials are conducted Article 15) and they must report all serious
adverse events Article 16).
In addition to general doubts about the operation of research ethics commit-
tees, their composition is a matter of some concern. In its advice to nurse
researchers, the UKCC recommends that they have regard to the make-up of the
LREC, and whether there are registered practitioners on it [72]. However, a more
pertinent problem is the under-representation of lay people and the fact that one
British study found that women and ethnic minority groups are poorly repre-
sented [73]. A further issue relates to the lack of training for members. Thus, the
North Staffordshire Inquiry found that many members of the ethics committee
had never been offered training. This is a central plank of the new clinical gov-
ernance framework and the proposed new Department of Health guidance on
research ethics committees. The North Staffordshire Inquiry also stresses that
appointment of members should be an open process, compatible with Nolan
standards and requiring public advertisement in the media as well as profes-
sional networks and the submission of CVs. It proposes that out of the recom-
mended 12±18 members there should be a balanced age and gender distribution,
while efforts should be made to recruit ethnic minorities and those with dis-
abilities.
Clinical Research and Patients 263