Research
As part of their duty to protect life and
health to an acceptable professional standard, surgeons have a subsidiary
responsibility to strive to improve operative techniques through research — to
assure themselves and their patients that the care proposed is the best that is
currently possible. Yet, there is moral tension between the duty to act in the
best interests of individual patients and the duty to improve surgical standards
through exposing patients to the unknown. risks which any form of research
inevitably entails.
The
willingness to expose patients to such risks may be further increased by the
professional and academic pressures on many surgeons to maintain a high research
profile in their work. For this reason, surgeons, and physicians who face the
same dilemmas, now accept that their research must be externally regulated to
ensure that patients give their informed consent, that any known risks to
patients are far outweighed by the potential benefits and that other forms of
protection for the patient are in place (e.g. proper indemnity) in case they are
unexpectedly harmed. The administration of such regulation is through research
ethics committees, and surgeons should not participate in research which has
not been approved by such bodies.
In
practice, it is not always clear what is to count as surgical research which
should be subjected to regulation and what constitutes a minor innovation
dictated by the contingencies of a particular clinical situation. Surgeons must
always ask themselves in such circumstances whether or not the innovation in
question falls within the boundaries of standard procedures in which they are
trained. If so, what may be a new technique for them will count not as research
but as an incremental improvement on personal practice.
Yet,
if the improvement is to be thought of in this way, no conclusions can be drawn
from it to alterations in standard practice or to an evaluation of their
efficacy. Equally, there will be no consequences for surgical training, as the
innovation in question should only have been attempted against the background
of the already existing training and experience of the surgeon in question.
Where a proposed innovation exceeds these conditions then it does count as
research and should be approved by a research ethics committee. Such surgical
research should also be subject to a clinical trial designed to ensure that
findings about outcomes are systematically compared with the best available
treatment and that favourable results are not because of arbitrary factors (e.g.
unusual surgical skill among researchers) which cannot be replicated.