协调“伦理”临床试验：研究协调员在合同研究行业中的作用。
Co-ordinating 'ethical' clinical trials: the role of research coordinators in the contract research industry.
作者信息
Fisher Jill A
机构信息
Women and Gender Studies Program, Arizona State University, AZ 85287, USA.
出版信息
Sociol Health Illn. 2006 Sep;28(6):678-94. doi: 10.1111/j.1467-9566.2006.00536.x.
Abstract
Change in the way new drugs are developed, including the privatisation of clinical trials, has altered the arrangement and roles of healthcare professions. In this paper I examine one aspect of this change: the role of research coordinators in the conduct of contract research in the United States. My focus on coordinators highlights the ethical conflicts embedded in clinical trials. I describe the ways in which coordinators experience and contend with the conflict between research and care and show how their construction of ethics is distinct from institutional conceptions formally associated with human subjects research. My analysis demonstrates how the coordinators' focus on ethics is a response to their role conflict and an attempt to reinsert individualised care into the context of research.
摘要
新药研发方式的改变，包括临床试验的私有化，已经改变了医疗行业的布局和角色。在本文中，我将探讨这一变化的一个方面：研究协调员在美国合同研究开展过程中的作用。我对协调员的关注凸显了临床试验中所蕴含的伦理冲突。我描述了协调员体验并应对研究与护理之间冲突的方式，并展示了他们构建的伦理观念如何有别于与人体研究正式相关的机构观念。我的分析表明，协调员对伦理的关注是对其角色冲突的一种回应，也是将个性化护理重新融入研究背景的一种尝试。
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