title: How to control the risk of novel surgical procedures.
abstract: Novel surgical procedures impose particular problems in addition to the general issues of clinical research [1, 7]. Surgical procedures are usually highly technical and therefore difficult to judge by the institutional ethics committee. The ethics committee has therefore to rely on external experts and a relatively large responsibility remains with the surgeon in charge. There are no generally valid regulations regarding new surgical procedures. At our institution, informed consent by the patient, a detailed risk analysis, testing and training in the anatomy/animal lab are required, and in addition a formation/training visit if know-how is available elsewhere. In emergency situations, if during a procedure circumstances call for a new surgical procedure, all the above preconditions cannot be met. A suggested minimum requirement in such a situation is that the decision for a new procedure is achieved by agreement of two board certified specialists. A problem that has to be solved in the future is how to make the negative experiences with new surgical procedures generally available in order to prevent that the same mistakes are repeated in other institutions.
authors.affiliation: Department of Neurosurgery, Ludwig Maximilians University, Klinikum Grosshadern, Munich, Germany.
authors.forename: H J
authors.initials: HJ
authors.lastname: Steiger
mesh_terms: D000818:Animals; D004059:Diffusion of Innovation; D004992:Ethics, Medical; D005858:Germany; D006805:Human Experimentation; D006801:Humans; D019635:Neurosurgical Procedures; D011785:Quality Assurance, Health Care / Q000379:methods*; D012106:Research; D012308:Risk Management / Q000379:methods*