University of North Carolina at Chapel Hill.
Am J Bioeth. 2020 Feb;20(2):5-19. doi: 10.1080/15265161.2019.1701731.
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.
虽然公平的受试者选择原则是伦理临床研究的一个广泛认可的要求，但它往往会产生相互冲突的命令，从而对参与者的选择产生重大的伦理困境。在本文中，我们诊断了这个问题的根源，认为公平的受试者选择原则最好被理解为一组四个不同的子原则，每个子原则都有规范的力量，每个子原则都产生不同的命令：（1）公平包容；（2）公平负担分担；（3）公平机会；（4）第三方风险的公平分配。我们首先阐述了这些不同的子原则，然后确定了它们在制定纳入和排除标准以及招募参与者方面产生相互冲突的命令的方式。然后，我们为决策者提供了如何驾驭这些相互冲突的命令的指导，以确保公平地选择参与者。
