compensating victims and paying for their health care, particularly if a major new
disease is unleashed on the broader population.
12.6 Conclusions
As will be apparent from the above review, the law regulating nursing research is
currently too vague and loaded in favour of the researcher. In particular there is an
absence of clear guidance on consent and disclosure of risks; and too little has
been done to ensure that research programmes are adequately monitored. Given
this, it is especially problematic that no adequate arrangements exist to ensure
compensation for research subjects if they are injured in the course of a clinical
trial. Governments have consistently seemed disinclined to impose greater reg-
ulatory control in this area. However, there is now considerable impetus to ensure
that good clinical practice is observed in the conduct of research. At the national
level, the shortcomings revealed by the North Staffordshire Inquiry have resulted
in proposals and subsequent guidance which should contribute towards the
introduction of a more robust governance framework encompassing better mon-
itoring and accounting procedures. The Griffiths Report highlighted the disparity
between current best practice and the formal guidance available, which left con-
siderable scope for individual latitude in how individual projects were managed.
As a consequence it called for the development of formal guidance on research
governance within the NHS, which should be issued to the NHS and to partners
whose research it hosts [111]. This guidance has now been issued and aims to
establish mechanisms to ensure the quality of clinical research [112].
The new guidance stresses the duties and accountability assumed by all NHS
organisations before they agree to host any research, whether undertaken by its
own employees or others. It emphasises the necessity for a favourable opinion by
an appropriate ethical review committee para. 2.22) and highlights the
significance of informed consent, particularly in the case of research involving
organs or tissue, which, as we have seen, has recently been especially contentious
paras 2.2.3±4). A particularly clear responsibility is placed on the named prin-
cipal investigator in any project, who must apply for approval by a research ethics
committee and retains responsibility for the scientific and ethical conduct of the
research para. 3.6.1). The need for systematic expert review of scientific evidence
is also stressed para. 2.3.1). This guidance also requires that organisations which
employ researchers must be in a position to compensate anyone harmed, although
only if such harm results from negligence *para. 2.6.2).
The North Staffordshire Inquiry also recommended that the Department of
Health, professional and regulatory bodies should consult with a view to produ-
cing agreed guidance clarifying issues of consent for participation in clinical trials
[113]. As we saw above, in the case of trials involving medicinal products, such
changes are being imposed at European Community level, in recognition of
variations in practice across member states. This is likely to presage future
reforms. In the meantime, the onus is on researchers to be as truthful and clear as
possible in their communications with patients about the risks and benefits of
proposed research programmes.
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