Chandler Jennifer A, Cabrera Laura Y, Doshi Paresh, Fecteau Shirley, Fins Joseph J, Guinjoan Salvador, Hamani Clement, Herrera-Ferrá Karen, Honey C Michael, Illes Judy, Kopell Brian H, Lipsman Nir, McDonald Patrick J, Mayberg Helen S, Nadler Roland, Nuttin Bart, Oliveira-Maia Albino J, Rangel Cristian, Ribeiro Raphael, Salles Arleen, Wu Hemmings
Faculty of Law, University of Ottawa, Ottawa, ON, Canada.
Center for Ethics & Humanities in the Life Sciences and Dept. Translational Neuroscience, Michigan State University, East Lansing, MI, United States.
Front Hum Neurosci. 2021 Jan 13;14:588458. doi: 10.3389/fnhum.2020.588458. eCollection 2020.
Neurosurgery for psychiatric disorders (NPD), also sometimes referred to as psychosurgery, is rapidly evolving, with new techniques and indications being investigated actively. Many within the field have suggested that some form of guidelines or regulations are needed to help ensure that a promising field develops safely. Multiple countries have enacted specific laws regulating NPD. This article reviews NPD-specific laws drawn from North and South America, Asia and Europe, in order to identify the typical form and contents of these laws and to set the groundwork for the design of an optimal regulation for the field. Key challenges for this design that are revealed by the review are how to define the scope of the law (what should be regulated), what types of regulations are required (eligibility criteria, approval procedures, data collection, and oversight mechanisms), and how to approach international harmonization given the potential migration of researchers and patients.
用于精神疾病的神经外科手术（NPD），有时也被称为精神外科手术，正在迅速发展，新的技术和适应症正在积极研究中。该领域的许多人认为，需要某种形式的指导方针或法规来帮助确保这个有前景的领域安全发展。多个国家已经颁布了规范NPD的具体法律。本文回顾了从北美、南美、亚洲和欧洲提取的针对NPD的法律，以确定这些法律的典型形式和内容，并为该领域的最佳监管设计奠定基础。通过此次回顾揭示的该设计的关键挑战包括如何界定法律范围（应监管什么）、需要何种类型的法规（资格标准、审批程序、数据收集和监督机制），以及鉴于研究人员和患者可能的流动，如何实现国际协调。
