a Emory University School of Medicine.
b Harvard University T H Chan School of Public Health.
Am J Bioeth. 2017 Dec;17(12):3-11. doi: 10.1080/15265161.2017.1388448.
Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals.
虽然知情同意在临床研究中很重要，但对于何时需要知情同意、需要什么内容以及如何获得知情同意，仍存在一些疑问。研究伦理的标准观点认为，知情同意的作用是尊重个人自主权。然而，同意过程是多维度的，也具有其他伦理功能。当存在同意障碍时，这些功能值得特别关注。我们认为，同意有七个具有重要伦理意义且概念上不同的功能。前四个功能主要涉及个体参与者：（1）提供透明度；（2）允许控制和授权；（3）促进与参与者价值观的一致性；（4）保护和促进福利利益。另外三个功能是系统性或政策重点：（5）促进信任；（6）满足监管要求；（7）促进研究的完整性。围绕这些功能重新构建同意，可以指导针对具体情况的同意方法，使可实现的目标最大化。
