monitoring clinical research. First, there is no requirement for trials undertaken
outside the NHS to receive ethics committee approval, although some private
organisations have established their own ethics committees. Therefore, a
researcher contravenes no law in carrying out research without ethics committee
approval. However, failure to obtain such approval will lead to difficulties in
publishing research.
Moreover, there is considerable dispute over variations in the practices of eth-
ics committees, especially since trials are scrutinised on a local rather than
national basis. In 1996 the Department of Health recommended that regional
bodies ± multi-centre research ethics committees MRECs) ± should be estab-
lished to scrutinise multi-centre research protocols where it is proposed to
undertake a number of trials at different locations throughout the country. While
this certainly reduces variation in local rates of approval, since LRECs are
required to state reasons if they reject a protocol approved by an MREC, a cynical
view is that they are a convenient way of enabling researchers and drug compa-
nies to gain approval for projects notwithstanding objections at a local level. It is
also worth noting that with the growth of new areas of biotechnology, such as
reproductive technologies, gene therapy and xenotransplantation, a proliferating
number of committees have been established to oversee research, with con-
sequent problems concerning the overlapping roles and functions of these var-
ious bodies [63]. However, the research governance framework see end of this
section) promulgated in 2001 aims to eliminate such variations in practice.
The limitations of research ethics committees became strikingly apparent
during the investigation into research on children at North Staffordshire Hospital.
The Griffiths Inquiry found that, although the North Staffordshire LREC generally
operated in accordance with Department of Health Guidelines, the level of detail in
their minutes compared unsatisfactorily with minutes provided by a selection of
other LRECs to the review. Additionally, the computer-held register of research
projects failed to include all the details required by the guidelines. The inquiry also
noted a lack of clarity in respect of how and when variations to a research project
were to be reported [64]. Moreover the LREC was criticised for doing little to
ascertain whether its opinion was well informed or bore any relation to what other
ethical review committees did or might have done in similar circumstances ±
something which is increasingly regarded as good practice para. 9.2.2). These
criticisms indicate the increasingly onerous duties which are entailed by
membership of such committees.
Afurther concern about the role of research ethics committees is that they have
inadequate resources to monitor research, once the initial approval is granted [65].
McNeil contends that research ethics committees are typical of self-regulating
groups in their failure to deal adequately with non-compliance [66], especially if
the researcher is not seeking overseas grants or publication in international
journals [67]. Although the Declaration of Helsinki stresses the obligation on
researchers to provide monitoring information to the ethical review committee and
in particular to report adverse events para. 13), there is generally no sanction for
failure to do so. In an effort to tackle this, the Medical Research Council requires
that applicants for funding include with their research protocol their plans to
ensure independent supervision of the clinical trial. They recommend that this
262 Nursing Law and Ethics