Sidley Austin.
J Law Med Ethics. 2013 Summer;41(2):424-39. doi: 10.1111/jlme.12053.
This article reviews the history of the debate over use of biospecimens in research, the legal and ethical arguments that have been presented both in support of and in opposition to such use, court cases and judicial opinions involving disputes between specimen contributors, researchers, and institutions, and public attitudes regarding the use of biospecimens in research. The paper argues that proposed changes to the Common Rule are inadequate to resolve the legal and ethical concerns that have been raised with respect to the use of biospecimens. It argues that there is a need to distinguish between the dual roles - subject and donor - played by contributors of biospecimens.
本文回顾了关于在研究中使用生物样本的争论历史，以及支持和反对这种使用的法律和伦理论点，包括涉及样本提供者、研究人员和机构之间争议的案例和司法意见，以及公众对研究中使用生物样本的态度。本文认为，对《普遍规则》的拟议修改不足以解决围绕生物样本使用提出的法律和伦理问题。本文认为，有必要区分生物样本提供者所扮演的双重角色——主体和供体。
