Legal liability of physicians in medical research

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.