Glass K C, Freedman B
McGill Centre for Medicine, Ethics and Law, Montreal, Quebec.
Clin Invest Med. 1991 Apr;14(2):176-80.
In Weiss vs Solomon, the heirs of a subject who died while a volunteer in a nontherapeutic study successfully sued the investigator and his university-affiliated hospital. Without referring to any 'standard of practice', including the MRC Guidelines, the judge found the principal investigator and the hospital (for its research ethics committee) equivalently responsible for not disclosing a rare but fatal complication caused by fluorescein dye and not adequately screening the subject, who suffered from undisclosed hypertropic cardiomyopathy. From the point of view of research institutions, members of research committees, and the investigators themselves, the judgement has left serious uncertainty and ambiguity concerning their responsibilities for subject selection and safety, and disclosure for the purposes of informed consent.
在魏斯诉所罗门案中，一名受试者在参与一项非治疗性研究时作为志愿者死亡，其继承人成功起诉了研究人员及其大学附属医院。法官在未参考任何“实践标准”（包括医学研究委员会指南）的情况下，认定主要研究人员和医院（因其研究伦理委员会）负有同等责任，原因是未披露荧光素染料引起的一种罕见但致命的并发症，且未对患有未披露的肥厚型心肌病的受试者进行充分筛查。从研究机构、研究委员会成员以及研究人员自身的角度来看，该判决在受试者选择与安全以及为获得知情同意而进行信息披露方面，给他们的责任带来了严重的不确定性和模糊性。
