Ethical issues in evidence-based surgery.

Evidence-based medicine, although ostensibly concerned with the research evidence underlying claims of efficacy for surgical procedures,has a direct connection with the ethics of surgical decision making. Questions of whether new procedures should ever be performed on patients outside of a formal research protocol, what the patient should be told about the uncertainties inherent in the use of nonvalidated innovative procedures, when formal evaluation is necessary, what form that evaluation should take, and how the burdens and results of such research can be distributed fairly all involve balancing competing ethical principles. Good ethics requires good facts, and evidence from well-controlled experiments provides best information upon which to base decisions in these areas and to build ethical surgical practice.