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Liver biopsies for research performed during surgery without consent (00HDC07593)
Download Liver biopsies for research performed during surgery without consent (00HDC07593) (PDF 12Kb)
(00HDC07593, 30 August 2002)
Surgeon ~ Gastrointestinal
surgery ~ Biopsy ~ Informed consent ~ Pain management ~ Research ~
Record-keeping ~ Rights 4(1), 6(1)(d), 7(1), 7(6)(a)
A 44-year-old woman complained that during the performance of
other procedures a surgeon conducted two liver biopsies, for which
he did not obtain specific consent, as he saw it as a relatively
trivial extension to a major operation.
Independent surgical advice stated that the first biopsy taken
during the gastric bypass operation may have been justified on
clinical grounds, although most surgeons would not have taken one
as it would not alter management. The second biopsy taken during
the laparoscopic cholecystectomy would not be considered routine
clinical practice in the absence of a specific abnormality.
The liver biopsies did not add significantly to the risk of the
procedures, but a reasonable patient would want to be told that the
surgeon proposed to perform such a non-standard procedure. The
surgeon breached Rights 6(1) and 7(1) because he failed to inform
the patient, prior to both biopsies, that they were non-standard
procedures, and did not obtain specific consent.
Another aspect of the complaint was that during consultations with
the patient, the surgeon collected data and completed
questionnaires for his own information, without the patient's
knowledge and consent. A detailed database had been compiled from
information from each patient's personal record, and the surgeon
had published the information internationally and used it to make
improvements to his procedures.
The Commissioner reasoned that where a clinician performs tests or
procedures that are not regarded as a routine or necessary part of
clinical management by a responsible body of the relevant
speciality, and the clinician collects such data for research and
publication purposes, the test or procedure is properly classified
as a research intervention.
Accordingly, notwithstanding the view that the biopsy could be
accepted as part of clinical care, the surgeon should have informed
the patient that he was undertaking research and obtained her
written consent, as required by Right 6(1)(d) and 7(6)(a).
The woman also complained that following surgery, when she
telephoned the surgeon complaining of severe pain and bruising and
having developed a haematoma, he failed to advise her to come in
for an examination and instead prescribed stronger pain relief.
However, the surgeon did not breach Right 4(1) because a gall
bladder bed haematoma is a recognised complication of
cholecystectomy and, on the balance of probabilities, cannot be
attributed to the biopsy. The surgeon responded appropriately by
ensuring that the patient received stronger pain relief.
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