Sava H, Matlow P T, Sole M J
Lang Michener, Barristers & Solicitors, Toronto, Ontario.
Clin Invest Med. 1994 Apr;17(2):148-84.
The intent of this paper is to provide an overview, in layperson's language, of the concepts in law which may be applicable to a physician who undertakes research. The paper is divided into 2 parts. Part I deals with liability issues and standards of care. It is meant to enable the physician/researcher to recognize a potential liability situation. Part II examines insurance and related issues such as the role of the Canadian Medical Protective Association (CMPA). The paper begins with a review of 2 potential categories of liability: criminal and civil tort. Next, legal issues surrounding the consent process, which form the majority of negligence claims, are dealt with. The research process is then discussed with emphasis on the Medical Research Council of Canada Guidelines on Human Experimentation. Part II covers how research projects are funded and identifies the parties from whom insurance coverage may be sought. Information is provided from the various sources offering insurance and quasi-insurance protection with special attention on the CMPA. Each source details the circumstances necessary for its particular coverage to be triggered. Other issues addressed include those arising when research is conducted outside Canada and multiple coverage.
本文旨在以通俗易懂的语言概述可能适用于从事研究工作的医生的法律概念。本文分为两部分。第一部分涉及责任问题和护理标准。其目的是使医生/研究人员能够识别潜在的责任情况。第二部分探讨保险及相关问题，如加拿大医学保护协会（CMPA）的作用。本文首先回顾了两类潜在的责任：刑事和民事侵权。接下来，处理了构成大多数过失索赔的围绕同意过程的法律问题。然后讨论了研究过程，重点是加拿大医学研究理事会关于人体实验的指南。第二部分涵盖研究项目的资金来源，并确定可能寻求保险的各方。提供了来自提供保险和准保险保护的各种来源的信息，特别关注CMPA。每个来源都详细说明了触发其特定保险范围所需的情况。其他涉及的问题包括在加拿大境外进行研究以及多重保险时出现的问题。
