(NPRI) received funding in a joint venture headed
by UK Universities and the Department of Health/
NHS. It is hoped that it will become operational in
2005, with potentially huge benefits to patients, the
pharmaceutical industry and the medical profes-
sion, although its scope is not yet defined. It is not
clear whether the actual body will have a direct
investigative function, which could be a real deter-
rent to those who might be considering fraud, or
willmerelybeasetterofstandards.Anymechanism
that unified response to and actions taken against
clinical research fraud would be a major step
forward, and the progress toward this will be
watched closely and with much interest. It is widely
hoped that such a national body will restore the
United Kingdom’s position as a leading country in
biomedical research.
In the United Kingdom, some groups involved in
biomedical research are already subject to disci-
plinary action by their professional bodies. Doctors
answer to the GMC, the Statutory Body registering
doctors to practice, charged with the responsibility
of monitoring standards and protecting patients.
Nurses, health visitors and midwives are responsi-
ble to the UK Central Council. Over 20 doctors in
the United Kingdom have been reported to the
GMC in the last 10 years. All but one were found
guilty of serious professional misconduct, and
most were suspended or erased from the Medical
Register, thus losing their licence to practice med-
icine. The GMC has made it clear that it regards
research fraud as extremely serious and will punish
it hard. Although other countries have official
channels for its investigation, more cases have
been reported in the United Kingdom, but there is
no reason to suppose that the incidence of fraud
here differs from other countries.
There have been many criticisms of the slowness
of the process of bringing doctors to the GMC to
account for their activities, and accusations that the
process is not sufficiently transparent.
49.6 Why commit research fraud?
This is a difficult question to answer, and there is
certainly more than one answer. The creation of
fraudulent data probably takes as long – if not
longer – than its legitimate counterpart. Money
seems to be one motivator, others being vanity or
arrogance and the need to achieve publications to
further career aims. Peter Jay, co-founder with
Frank Wells of MedicoLegal Investigations, lists
greed, need and breed as the main tempters. The
first is self-explanatory, the second category
includes addiction to drugs, alcohol and gambling
and the third acknowledges the adrenaline buzz
achieved by lying, cheating and deceiving. (The
GMC recognizes that ‘need’ is better dealt with
under its health procedures.)49.7 What will be the impact
of European legislation?The EuropeanUnion (EU)Clinical Trials Directive
came into force in May 2004, enacted in the Mem-
ber States of the EU and so enshrining good clinical
practice (GCP) in law, and giving for the first time
specific legal standing to research in human sub-
jects. Under the new laws, compliance with GCP
becomes a legal obligation, and providing false
information to an EC or the national authority
issuing authority to carry out human research,
therefore, by definition becomes an offence.
Although the legislation does not specifically men-
tion the investigation and prosecution of research
fraud and misconduct, it does allow the ‘Compe-
tent Authorities’ – the bodies established by each
Member State to authorize clinical research – to
undertake inspections of sponsors and investiga-
tional sites, thus bringing Europe more into line
with the United States and the FDA. It is too early at
the time of writing this chapter to see the extent of
any impact that this will bring, but it is widely
hoped that the presence of a statutory framework
for research will reduce the incidence of fraud.
Some, though, point to the higher incidence of
research fraud and misconduct in the United States,
who have had their Federal Regulations, very simi-
lar to Europe’s new laws, for many years. One
wonders if that is because there is more fraudper
se, or because there are official bodies involved
with proactive powers and roles to identify and
investigate it.638 CH49 FRAUD AND MISCONDUCT IN CLINICAL RESEARCH