Feeding and Bleeding: The Institutional Banalization of Risk to Healthy Volunteers in Phase I Pharmaceutical Clinical Trials.
Feeding and Bleeding: The Institutional Banalization of Risk to Healthy Volunteers in Phase I Pharmaceutical Clinical Trials.
复制标题
DOI：
10.1177/0162243914554838
复制
发表时间：
2015-03-01
期刊：
影响因子：
--
通讯作者：
Fisher JA
中科院分区：
文献类型：
--
作者：
Fisher JA
第一阶段临床试验是在人体上测试新药的第一阶段。这些研究中的大多数都是在受控的住院条件下进行的，使用的是健康的志愿者，他们的参与是有报酬的。本文借鉴了对美国6个I期诊所的人种学研究，包括对研究人员和健康志愿者的268次半结构化访谈。在这篇文章中，我认为，对风险的制度化将构建参与研究的研究人员和健康志愿者的认知。对于研究人员来说，有三种机制让风险变得平淡无奇：感知到的研究同质性、Fordist工作制度和以数据为中心的论述。对于健康的志愿者，重复研究参与有助于通过对风险的脱敏过程和对诊所形成信任的过程来实现风险的制度化。我认为，风险的制度化也引发了人们对制药研究中剥削弱势群体的无形的伦理担忧。
Phase I clinical trials are the first stage of testing new pharmaceuticals in humans. The majority of these studies are conducted under controlled, inpatient conditions using healthy volunteers who are paid for their participation. This article draws on an ethnographic study of six phase I clinics in the United States, including 268 semistructured interviews with research staff and healthy volunteers. In it, I argue that an institutional banalization of risk structures the perceptions of research staff and healthy volunteers participating in the studies. For research staff, there are three mechanisms by which risk becomes banal: a perceived homogeneity of studies, Fordist work regimes, and data-centric discourse. For healthy volunteers, repeat study participation contributes to the institutional banalization of risk both through the process of desensitization to risk and the formation of trust in the clinics. I argue that the institutional banalization of risk also renders invisible ethical concerns about exploitation of underprivileged groups in pharmaceutical research.
登录
查看更多内容
影响因子：
12.7
作者：
Fisher, Jill A.;Kalbaugh, Corey A.
通讯作者：
Kalbaugh, Corey A.
影响因子：
1.8
作者：
Corrigan, DR
通讯作者：
Corrigan, DR
影响因子：
1.7
作者：
BECK, U
通讯作者：
BECK, U
影响因子：
5.4
作者：
Fisher, Jill A.
通讯作者：
Fisher, Jill A.
影响因子：
5.4
作者：
Corrigan, OP
通讯作者：
Corrigan, OP