49.8 What can be done to prevent
fraud?Research Governance
In 2000 in the United Kingdom, the Research
Governance Framework for Health and Social
Care laid down standards, delivery mechanisms
and monitoring requirements for all NHS research
in England and Wales. The stress is on the rights
and well being of study participants, but it also
actively promotes good quality research, which
by definition excludes fraud. It puts stress on the
needfor thereview of research at all stages, and this
is seen as being a significant potential tool in the
prevention of fraud.
Publications
The editors of scientific journals, vehemently
expressing their abhorrence of research and pub-
lication fraud, established the Committee on Pub-
lication Ethics (COPE) in the United Kingdom in
- They recommend peer review and require all
named authors to sign the letter of submission,
coupled with clear declarations from all parties as
to conflict of interest. Such procedures would have
prevented Pearce’s fraud as the paper on the reim-
plantation of the ectopic fetus had not undergone
peer review, and the co-authors were not required
to detail their involvement.
Standard operating procedures (SOPs)
Adherence to SOPs has a major protective effect in
suspected research fraud and misconduct. First, it
enables an organization to make clear the conse-
quences of research fraud to the researcher at the
start of the research with the intent of preventing
such dishonesty. Second, it gives a framework for
the reporting and subsequent investigation of
potential misconduct, and consequent legal protec-
tion for those following such guidelines, especially
if the finding of the investigation is that there was
no misconduct.
SOPs should begin with an unequivocal state-
ment that all cases of suspected misconduct and
fraud will be vigorously investigated and, if indi-
cated, prosecuted, and that failure to investigate
is not acceptable. There should be a clearly
described process for the reporting of suspicions
within the hierarchy of the organization or spon-
soring company, and detailed guidance for the
investigation of such suspicions, including the
recruitment of external agencies when so indi-
cated. But the best thought out, best written SOP
is without value if all parties concerned do not
receive training in its use, so this must be a priority
for all new staff joining an organization concerned
with research, whether as researcher or sponsor. It
should make clear that an employee of any orga-
nization who sees potential fraud and does not
report it would himself or herself be guilty of
misconduct.49.9 What can be done if fraud
is suspected?In general, the role of national bodies involved in
the investigation of research fraud and misconduct
is merely to advise and support the relevant institu-
tions, but it is for those institutions themselves to
decide whether to take action against those found
to have acted dishonestly. The situation in the
United States is somewhat different; the FDA can
order the closure of institutions and circulates the
names of wrongdoers on their ‘Black List’. The
ORI can recommend the withdrawal of Federal
funding, and the French authorities, too, can take
direct action.
The system for dealing with doctors suspected of
research crime in the United Kingdom revolves
around the GMC, which stated in 1992 that their
disciplinary committee would take a very serious
view of proven clinical research fraud. Since 1990,
26 doctors accused of research fraud have been
reported to the GMC, all but 1 being found guilty.
The penalties imposed ranged from erasure from the
Medical Register, to admonishment and limitation
of future research. The GMC can only investigate
suspected fraud or misconduct after a formal49.9 WHAT CAN BE DONE IF FRAUD IS SUSPECTED? 639