Deception: the deliberate concealment
of a conflict of interest or inclusion
of deliberately misleading statements
in research funding proposals
or other documents
Kimon Angelides ran a university laboratory in the
United States when he was found to have intention-
ally falsified data in five grant applications sub-
mitted to the National Institutes of Health, seeking
a total of $4 million in research funds. Initial con-
cerns were raised by his departmental head who
noticed inconsistencies in grant applications.
On being investigated, Angelides conceded that
elements of his grant applications were false, but
attempted to deflect responsibility by accusing two
members of his laboratory (a graduate student and a
postdoctoral fellow) of deceiving him by providing
the falsified data. Other false information, particu-
larly those appearing in the published papers, he
claimed to be matters of data interpretation or sim-
ple errors.
Recruiting and consenting patients
without ethics approval
Independent ethical review of clinical research is
central to the protection of the rights of patients. It
can sometimes be a time-consuming process. Using
modern scanners and copying equipment, it is
relatively easy to produce a document that appears
to be ethics committee or Institutional Review
Board approval to start a study. Studies may not
start without ethical approval, and funding will not
be forthcoming until it is given, so time is probably
the driving force behind this type of fraud.
Failure to document consent
appropriately
Forged consent forms are one of the most common
types of research fraud. A monitor from a Contract
Research Organization (CRO) took the trouble to
lay out all the patient consent forms at one site side
by side. She noticed that the patients’ signatures
looked similar to each other and some of the letters
resembled the handwriting of one of the study
team. It transpired that none of the patients
involved in the study had any knowledge of being
in a trial. The study involved the women taking
hormone replacement therapy (HRT) over several
months, with a biopsy of their uterine lining being
done before and after treatment. All had been
supplied with the drug from the desk drawer of
their GP, but none had given consent.Misquotation or misrepresentation
of the results of other researchersThis was how William McBride achieved the mate-
rial for his infamous publication. Phil Vardy was a
scientist working for McBride who discovered that
the results of his experiments had been falsified.
When he confronted McBride, he was sacked, and
had to move away from the area to get another
job, losing his marriage in the process. It was five
years before Vardy was persuaded to publicize the
fraud.Noncompliance: the wilful failure
to comply with statutory and sponsor
and professional body obligationsInvestigation of one case can show several differ-
ent fraudulent practices. John Anderton, an exemp-
lary and highly respected physician in Edinburgh,
came under suspicion when the trial monitor
noticed that the signatures of some patients on
the consent forms did not seem to match other
signatures in their hospital notes. It was found
that electrocardiograms (ECGs) and nuclear med-
icine investigations were apparently reported on
forms that had gone out of use some time before the
start of the study. Records had been created doc-
umenting the effects of treatment before the
patients were actually treated, and there were
major discrepancies between the case record
forms and the letters to patients’ GPs. Hospital
registers did not record patients’ attendance for
many of their stated visits, some patients were
listed as attending hospital on public holidays
when the outpatient department was closed, and634 CH49 FRAUD AND MISCONDUCT IN CLINICAL RESEARCH