Stopped hearts, amputated toes and NASA: contemporary legends among healthy volunteers in US phase I clinical trials
Stopped hearts, amputated toes and NASA: contemporary legends among healthy volunteers in US phase I clinical trials
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DOI：
10.1111/1467-9566.12185
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发表时间：
2015-01-01
影响因子：
2.9
通讯作者：
Fisher, Jill A.
中科院分区：
文献类型：
--
作者：
Fisher, Jill A.
在人体中测试新药的第一阶段被称为I期临床试验。这些研究的目的是测试药物的安全性，并确定以后可以给予患者的适当剂量。大多数这些研究是在受控的住院条件下进行的，使用健康的志愿者，他们的参与是有偿的。为了探索健康志愿者在临床试验中的经验，在美国的六个住院患者I期诊所进行了人种学研究。除了观察临床活动（从知情同意程序到给药到抽血）外，还进行了268次半结构化访谈，其中33次与临床工作人员进行访谈，235次与健康志愿者进行访谈。利用这个数据集，本文探讨了健康志愿者对I期临床试验的当代传说的交流。除了可能会吓到听众并传达医学界的不信任之外，这些令人难以置信的故事还帮助参与者科普感知到的耻辱感，并建立参与试验的风险梯度，为他们参与医学研究创造了潜在的界限。文章认为，当代传说在社会中发挥着积极的作用，塑造人们如何看待自己和他人，并影响他们对危险活动的决定。
The first stage of testing new pharmaceuticals in humans is referred to as a phase I clinical trial. The purpose of these studies is to test the safety of the drugs and to establish appropriate doses that can later be given to patients. Most of these studies are conducted under controlled, in-patient conditions using healthy volunteers who are paid for their participation. To explore healthy volunteers' experiences in clinical trials, an ethnographic study was conducted at six in-patient phase I clinics in the USA. In addition to the observation of clinic activities (from informed consent procedures to dosing to blood draws), 268 semi-structured interviews were conducted, 33 with clinic staff and 235 with healthy volunteers. Drawing on this dataset, this article explores healthy volunteers' exchange of contemporary legends about phase I clinical trials. In addition to potentially scaring the listener and communicating distrust in the medical community, these incredible stories help participants cope with perceived stigma and establish a gradient of risk of trial participation, creating potential boundaries to their participation in medical research. The article argues that contemporary legends play a productive role in society, shaping how people view themselves and others and influencing their decisions about risky activities.