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.