Under the Medicines Act 1968 and the Medicines for Human Use Authorisation
Etc.) Regulations 1994, before drugs are used in clinical trials, a clinical trial
certificate CTC) must generally be obtained from the licensing authority, unless a
clinical trial exemption has been granted [31]. CTCs will only be granted where
prior research indicates that harm to humans will be unlikely. A complex reporting
system has been established under this legislation to monitor the impact of the
drug in question, whereby unexpected outcomes during treatment with the drug
must be reported to the Committee on Safety of Medicines. However, in 2001
queries were raised about the effectiveness of these procedures [32]. Earlier that
year a European Directive was issued on the approximation of the laws regulating
clinical trials of medicinal products, which aims to ensure that good clinical
practice is observed in the design, conduct, recording and reporting of clinical
trials on human subjects [33].
12.2.4 The relationship between the investigator and research subject
Further concerns stem from the problematic nature of the relationship of the
research subject with the health care professional engaged in research. As McNeil
argues, the history of human experimentation is one of imbalance in favour of the
interests of the researcher [34]. It has been extensively documented how in the
research context the role of the health care professional has changed from that of a
physician or more recently a nurse) to a scientific investigator, to become, in Jay
Katz's term, a `physician-investigator' or `nurse-investigator'). Not only does this
entail a potential conflict of loyalties to patients, employers and research aims,
owing to the multiple priorities as teacher, researcher, health professional and
administrator [35], it also means that the researcher is likely to be seen in a more
ambivalent light by the subject. Kennedy has suggested that a health professional's
primary duty to care for their patient is inevitably compromised by their duty to
carry out clinical trials with due scientific rigour [36]. The researcher's commit-
ment to such rigour leaves the patient in an even more disempowered position
than is normally the case in engagement with health professionals, since
requirements of scientific ideology generally require the researcher to view the
subject with dispassion and detachment [37]. As Katz points out [38], it follows
that:
`... the commitment to objectivity invites the investigator's thought processes to
become objectified and, in turn, to transform the human beings who are the
subjects of research into data points to be plotted on a chart that will prove or
disprove a research hypothesis'.Such power imbalances are especially likely to arise where the research subject is
differentiated from the investigator by factors such as gender, class, race and
ethnicity, which may make communicating more difficult. Given these power
imbalances, researchers need to bear in mind Morehouse's claim that `[t]here are
many ways of introducing a research project to a patient which fall short of
pressurising the patients, but certainly do not conform to total objectivity' [39].
This may be particularly true in the case of vulnerable groups of patients,
discussed below. The Declaration of Helsinki provides that:
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