title: An Advisory Committee for the Regulation of Innovation in Gynaecologic Practice: Development and Implementation.
abstract: The fundamental precepts that underpin the delivery of all medical care are safety and efficacy. Although these precepts, in theory, are accepted without challenge, in many settings where clinical care is delivered, there is a lack of formal oversight necessary to ensure their implementation in practice. Even though most medical specialties have national bodies that provide guidelines for good medical practice, and hospital accreditation makes reference to dissemination of such guidelines, there is usually not a mechanism to monitor medical uptake and adherence to good practice in the day-to-day delivery of care. Most hospitals require approval by an institutional review board before research protocols can be undertaken, but regional health authorities and hospitals do not usually have formal processes in place to regulate the adoption of new technologies into clinical practice. Recognizing the lack of a formal process at the hospital level to guide and regulate the introduction of new technologies or procedures, we set out to establish an oversight process to fill this gap. A committee was established to oversee innovation in the Gynaecology Division of our hospital. We describe here the establishment of this committee, the tools the committee used, and the processes used for the committee to do its work. We conclude that formal, local oversight of medical innovation is indispensible for ensuring the high standards of medical practice necessary to optimize patient safety.
authors.affiliation: Department of Obstetrics and Gynaecology, Dalhousie University, Halifax NS.
authors.forename: Scott A
authors.initials: SA
authors.lastname: Farrell
authors.affiliation: Department of Obstetrics and Gynaecology, Dalhousie University, Halifax NS.
authors.forename: Nancy
authors.initials: N
authors.lastname: Van Eyk
mesh_terms: D026683:Advisory Committees; D006176:Gynecology / Q000458:organization & administration / Q000592:standards; D006291:Health Policy; D006801:Humans; D035703:Therapies, Investigational
keywords: Innovation; ethics; gynaecology; practice regulation