Innovative Treatment
·
Ethics committees must review
research and innovative treatments
·
The difference:
o Research is for the benefit of society and future patients
o Treatment is for the benefit of the patient
o Innovative practice sites between these
·
Defn: Innovative treatment is
those procedures which are new to a particular provider setting in NZ, or which
are being used for a new purpose (Has often been harmful, at a minimum it
introduces greater or new risk of harm)
· 3 issues:
o Proving they are safe and effective. Issues here vary – if it is an established technique overseas the issue is whether the NZ practitioners are and will remain competent. If it‟s entirely new, is it safe?
o Etc. Proving safety is difficult in surgical procedures – the surgeon is gaining skill, case comparison is complicated, random allocation may be unethical. Safety should be established early on. Effectiveness should be assessed in a way that gives good statistical evidence
o Gaining informed consent to non-standard treatment
o Defining what constitutes an innovative procedure
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