Innovative treatments: ethical requirements for evaluation

An innovative surgical treatment may arise as a deliberate strategy to solve a clinical problem or as a serendipitous discovery in the course of clinical care. In either case there is a need to evaluate the procedure and there are ethical requirements on such evaluation concerning the reasons for its introduction, patient consent, patient safety and clinical efficacy. Some of these ethical considerations may tell against a randomized controlled trial but the need for monitoring and evaluation along with genuine informed consent remain as absolute requirements. Two cases are introduced and discussed, one of which concerns potentially dangerous surgery and the other a new technology. In each case the ethical requirements are examined and discussed and the possible substitutes for prospective randomized controlled studies in clinical surgery are explored. It is concluded that there are defensible and scientific ways to introduce surgical innovation even where the 'gold standard' of a prospective randomized controlled trial cannot be met.