title: Surgical innovation: the ethical agenda: A systematic review.
abstract: The aim of the present article was to systematically review the ethics of surgical innovation and introduce the components of the learning health care system to guide future research and debate on surgical innovation.Although the call for evidence-based practice in surgery is increasingly high on the agenda, most surgeons feel that the format of the randomized controlled trial is not suitable for surgery. Innovation in surgery has aspects of, but should be distinguished from both research and clinical care and raises its own ethical challenges.To answer the question "What are the main ethical aspects of surgical innovation?", we systematically searched PubMed and Embase. Papers expressing an opinion, point of view, or position were included, that is, normative ethical papers.We included 59 studies discussing ethical aspects of surgical innovation. These studies discussed 4 major themes: oversight, informed consent, learning curve, and vulnerable patient groups. Although all papers addressed the ethical challenges raised by surgical innovation, surgeons hold no uniform view of surgical innovation, and there is no agreement on the distinction between innovation and research. Even though most agree to some sort of oversight, they offer different alternatives ranging from the formation of new surgical innovation committees to establishing national registries. Most agree that informed consent is necessary for innovative procedures and that surgeons should be adequately trained to assure their competence to tackle the learning curve problem. All papers agree that in case of vulnerable patients, alternatives must be found for the informed consent procedure.We suggest that the concept of the learning health care system might provide guidance for thinking about surgical innovation. The underlying rationale of the learning health care system is to improve the quality of health care by embedding research within clinical care. Two aspects of a learning health care system might particularly enrich the necessary future discussion on surgical innovation: integration of research and practice and a moral emphasis on "learning activities." Future research should evaluate whether the learning health care system and its adjacent moral framework provides ethical guidance for evidence-based surgery.
authors.affiliation: Department of Neurosurgery, Brain Center Rudolf Magnus Institute of Neurosciences Department of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Marike L
authors.initials: ML
authors.lastname: Broekman
authors.forename: Michelle E
authors.initials: ME
authors.lastname: Carrière
authors.forename: Annelien L
authors.initials: AL
authors.lastname: Bredenoord
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D004059:Diffusion of Innovation; D004992:Ethics, Medical; D013502:General Surgery / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D010820:Physicians / Q000941:ethics*; D012941:Social Responsibility; D013514:Surgical Procedures, Operative / Q000941:ethics*