Four Faces of Fair Subject Selection
Four Faces of Fair Subject Selection
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DOI：
10.1080/15265161.2019.1701731
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发表时间：
2020-02-01
影响因子：
13.4
通讯作者：
Saylor, Katherine Witte
中科院分区：
文献类型：
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作者：
MacKay, Douglas;Saylor, Katherine Witte
尽管公平受试者选择的原则是临床研究伦理的广泛认可的要求，但它经常产生相互冲突的要求，从而引发有关参与者选择的重大伦理困境。在本文中，我们诊断了这个问题的根源，认为公平主题选择的原则最好被理解为四个不同的子原则的集合，每个子原则都具有规范性力量，并且每个子原则都产生不同的命令：（1）公平包容； (2) 公平分担负担； (3) 公平的机会； (4)第三方风险的公平分配。我们首先制定这些不同的子原则，然后确定它们在纳入和排除标准的设计以及参与者的招募方面产生相互冲突的要求的方式。然后，我们为决策者应如何应对这些相互冲突的要求提供指导，以确保公平地选择参与者。
Although the principle of fair subject selection is a widely recognized requirement of ethical clinical research, it often yields conflicting imperatives, thus raising major ethical dilemmas regarding participant selection. In this paper, we diagnose the source of this problem, arguing that the principle of fair subject selection is best understood as a bundle of four distinct sub-principles, each with normative force and each yielding distinct imperatives: (1) fair inclusion; (2) fair burden sharing; (3) fair opportunity; and (4) fair distribution of third-party risks. We first map out these distinct sub-principles, and then identify the ways in which they yield conflicting imperatives for the design of inclusion and exclusion criteria, and the recruitment of participants. We then offer guidance for how decision makers should navigate these conflicting imperatives to ensure that participants are selected fairly.