clinical governance and the increased involvement of the European Union,
discussed below.
12.1 Definition of clinical research
Clinical research is traditionally classified in a number of ways. It is first
distinguished from conventional treatment, which uses approved methods and
techniques for therapeutic purposes. It is then sub-divided into two broad classes
of research. The first consists of those which do not involve any direct interference
with the subject, for example, those involving psychological observation [5], and
the use of personal medical records or tissue samples [6]. Once again it can be
difficult to draw distinctions between this and the second category ± invasive
research ± which gives rise to much greater concern, as it involves direct physical
or psychological interference with the subject. My focus in this chapter will pri-
marily be on the issue of invasive research on human beings, but in the light of
recent concerns, the issue of research using personal information and tissue
samples is discussed below. Invasive research on subjects is conventionally further
divided into two types:
1) therapeutic research is performed on a patient, and the use of new methods
and techniques carries prospects of direct benefit to the patient;
2) non-therapeutic research involves the use of new procedures or drugs for
purely or mainly scientific purposes which are unlikely to benefit the
individual participant. While it may herald some collective benefit, the aim of
the trial is the acquisition of scientific knowledge [7].
It is worth noting that this therapeutic/non-therapeutic dichotomy, which has
generated much bioethical scholarship, has recently been subject to attack.
Commentators have suggested that it is a problematic distinction for the following
reasons. First, it is often difficult to distinguish between research and innovative
therapy. For instance, it is unclear whether a new surgical technique, such as
keyhole surgery, should be subject to special regulation, as the introduction of a
new drug procedure would be [8]. Secondly, in response to the lobbying of well
organised health pressure groups, such as AIDs patients, high quality clinical care
and responsible research have come to be recognised as a continuum rather than a
dichotomy [9].
Notwithstanding the validity of these points however, there may be good reason
to retain the distinction between therapeutic and non-therapeutic research, given
that advances attributed to non-therapeutic research have been obtained at the
cost of many blighted lives. In this regard, it is significant that these costs have
been disproportionately borne by members of oppressed groups in society [10]. A
major advantage of the distinction is that it enables commentators to argue that
there should be a greater obligation to disclose risks in the context of non-ther-
apeutic research. Consequently, considerable controversy has been generated by
the recent revision of the Declaration of Helsinki ± the most prominent
international agreement governing research ± which in 2001 abandoned the
distinction between therapeutic and non-therapeutic research.
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