research or deliberate, dangerous or negligent devia-
tions from accepted practices in carrying out
research. It includes failure to follow established
protocols if this failure results in unreasonable harm
or risk to humans, other vertebrates or the environ-
ment and facilitating misconduct in research by col-
lusion in, or concealment of, such actions by others. It
also includes intentional, unauthorized use, disclo-
sure or removal of or damage to research-related
property of another including apparatus, materials,
writings, data, hardware or software or any other
substances or devices used in or produced by the
conduct of research.
It does not include honest error or honest differences
in the design, execution, interpretation or judgement
in evaluating research methods or results, or miscon-
duct unrelated to the research process. Similarly, it
does not include poor research unless this encom-
passes the intention to deceive’.Another method of differentiation relates to
those affected. Others are always harmed by
fraud, whereas in some cases of misconduct there
may be no obvious victims. Foremost among those
harmed by fraud are patients or research subjects
who may have received unnecessary treatment, not
had full safety assessments while taking an experi-
mental drug or been entered into a study about
which they knew nothing. Patient records may
have been altered to show untrue diagnoses to
make them appear eligible for the study: this
often remains uncorrected.
Sponsoring pharmaceutical companies are
harmed if they have paid for fraudulent data that
they cannot subsequently use or if a drug is delayed
in gaining a licence, and the families of fraudulent
doctors who lose their licence to practice when
prosecuted and found guilty also suffer financially.
Journal editors who unknowingly publish the frau-
dulent results can be harmed, as happened to Prof
Geoffrey Chamberlain in the Pearce case discussed
later in this chapter.
All fraud is also misconduct by definition, but
misconductper seis not so clear-cut. It could be
accidental, for example missing the due date for
patient assessments, or carelessly completing
case record forms, but the point where careless-
ness becomes misconduct and misconduct
becomes fraud is indistinct. A safety assessment
might be omitted because the research team forgot
about it or the research subject did not present
himself or herself to the laboratory to have the
blood drawn. Equally, it might be because a
researcher decided not to do it because of too
much work or because he decided it was not
important. Serious but non-fraudulent miscon-
duct might be the inappropriate delegation of
study tasks to an inexperienced member of the
study team without input or supervision from the
Principal Investigator.
Distinction must be drawn between clinical
research that is of poor quality and that which is
fraudulent. Errors are common, represent lack of
attention to detail, pressure of work and time,
inadequate or overcomplicated case record forms
or plain carelessness. By contrast, immaculately
completed record forms may prove to be too good
to be true.49.4 What constitutes research
fraud?There are many types of research fraud, and this list
is not exhaustive, but it is useful to consider the
various categories.Fabrication: the deliberate invention of
research data/results, or the deliberate
fabrication of laboratory analysisAn eminent UK gynecologist, Malcolm Pearce,
published two papers in the British Journal of
Obstetrics and Gynaecology in 1994, one claiming
to have successfully reimplanted an ectopic fetus,
the second being an extensive series of case studies
in a syndrome so uncommon that a major referral
center was seeing only one or two new cases a
month. Over three years, Pearce reported on 191
women he claimed to have seen and on whom he
had run a battery of complex tests, including kar-
yotyping both thewomenand their partners. Pearce
was an editor of the journal and the Editor in Chief,
Professor Geoffrey Chamberlain, was his head of
department and named as co-author of one of
the papers. Chamberlain’s role in the work is not
known, but he was quoted by a newspaper as632 CH49 FRAUD AND MISCONDUCT IN CLINICAL RESEARCH