complaint in the form of a Statutory Declaration is
made, and they have no authority to deal with
nonmedical research personnel. Nurses and
midwives are responsible for their behavior to the
UK Central Council, and other healthcare workers
have their own governing bodies.
There are potential criminal sanctions against
fraudulent researchers, but these are seldom, if
ever, pursued. In most countries, there is no law
specifically relating to fraud. One needs to draw
elements from laws relating to deception, theft,
offences against the person and forgery and coun-
terfeiting. However, the police and judiciary
would find it difficult to follow the intricacies of
research fraud, and as the amount of money
involved is usually relatively small, might not be
particularly interested in following a case through.
Perhaps, more importantly, the time that it would
typically take for such a case to come before a
criminal or civil court would allow even more
fraud to be committed, and more patients to be
put at risk.
The pharmaceutical industry has been extre-
mely active in its efforts to prevent and detect
research fraud and misconduct, and most compa-
nies are now comfortable taking action when
appropriate. The Association of the British Phar-
maceutical Industry (ABPI) has encouraged its
member companies to do so and has provided
much support and encouragement. The new Eur-
opean Directive on clinical trials and the Interna-
tional Conference on Harmonization (ICH) have
both aided a growing understanding and aware-
ness of the issue, and most pharmaceutical com-
panies now have standard procedures for handling
cases of suspected fraud. The interests of the
industry lie partly in protecting patients, but also
in protecting and maintaining the quality and
integrity of clinical research.
Many of the doctors brought before the GMC for
research misconduct have been involved with more
than one pharmaceutical company, and the Medi-
cal Director of the ABPI has a process to bring
together two or more companies with suspicions
about the same doctor to enable a joint case to be
made. A similar process exists in Germany. Sadly,
there are, as yet, no sanctions if a company refuses
to cooperate or investigate.
49.10 Conclusions
Research fraud is a reality, but in the past, health-
care professionals and academia have sometimes
chosen to turn a blind eye, and pharmaceutical
companies tacitly condoned it by choosing not to
investigate fully and to bring prosecutions. The
climate now is changing, driven by all those par-
ties, but medical research is still vulnerable in the
absence of any effective mechanism to combat and
detect fraud.
To pretend that fraud does not exist is to condone
it. To take no action when fraud is suspected or
when blatant evidence is seen is not acceptable.
The most vulnerable potential victims are the
patients; whichever definition of fraud is used,
the fact that patients have been exploited remains.
This exploitation occurs when ethics committee
authorization is not sought or is forged, denying
patients the protection of review of the safety and
ethics of the study. It occurs when safety data are
not recorded or when patients are treated with
inappropriate drugs. It occurs when drugs are
licensed or withdrawn from the market using frau-
dulent data. It occurs when there are incorrect
details on their patient notes.
The eradication of research fraud will not be
easy. Research Governance will be a significant
step toward eradication, but only if everyone
accepts the possibility for the existence of fraud
and is alert to its presence. SOPs provide a frame-
work within which it is easier to follow up suspi-
cions of fraud and misconduct, but they only work
if everyone concerned has been trained in their use
and remembers to use them: their presence alone is
not a safeguard against fraud. Ethics committees
too have their place in the fight against fraud.
Again, they need to be aware of the possibility of
fraud, and need to have a mechanism whereby they
can report concerns, for example, of an inappropri-
ate number of studies running at one site.
Three elements are necessary to improve the
situation. There must be official bodies in each
country with real powers to investigate and prose-
cute clinical research fraud. There must be a wide-
spread and unequivocal acceptance that failure
to act on suspicions of fraud is itself serious
misconduct. And finally there must be an640 CH49 FRAUD AND MISCONDUCT IN CLINICAL RESEARCH