Practicing research ethics: Private-sector physicians & pharmaceutical clinical trials

Practicing research ethics: Private-sector physicians & pharmaceutical clinical trials
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DOI:
10.1016/j.socscimed.2008.02.001
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发表时间:
2008-06-01
影响因子:
5.4
通讯作者:
Fisher, Jill A.
Fisher, Jill A.
中科院分区:
医学2区
文献类型:
--
作者:
Fisher, Jill A.

文献摘要

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本文主要探讨美国初级保健医生在从事制药行业合同研究时的研究伦理建设。本文首先借鉴了医生作为调查者的历史研究,然后在美国西南部进行了为期12个月的定性实地调查,分析了塑造医生与患者/受试者和制药公司关系的不断变化的情境化伦理。就像在20世纪80年代编纂可接受的研究行为之前,医生遵循职业道德守则一样,今天的医生继续发展隐性的研究道德体系。本文认为,私营部门的医生主要是概念化他们的道德行为与制药公司雇用他们,而不是人类受试者,他们参加了临床试验。这并不是说这些医生不遵循美国的正式法规来保护人类受试者,而是说他们与制药行业的财务关系对他们作为研究人员的身份以及他们对道德责任的构建有更大的影响。(C)2008爱思唯尔有限公司保留所有权利。
This paper focuses on constructions of research ethics by primary care physicians in the USA as they engage in contract research for the pharmaceutical industry. Drawing first on historical studies of physicians as investigators and then on 12 months of qualitative fieldwork in the Southwestern US, this paper analyzes the shifting, contextualized ethics that shape physicians' relationships with patients/subjects and pharmaceutical companies. Just as physicians followed professional codes of ethics prior to the codification of acceptable research conduct in the 1980s, physicians today continue to develop tacit systems of research ethics. This paper argues that private-sector physicians primarily conceptualize their ethical conduct in relation to the pharmaceutical companies hiring them, not to human subjects they enroll in clinical trials. This is not to say that these physicians do not follow the formal U.S. regulation to protect human subjects, but rather that their financial relationships with the pharmaceutical industry have a greater influence on their identities as researchers and on their constructions of their ethical responsibilities. (C) 2008 Elsevier Ltd. All rights reserved.