Faculty of Law, University of Malaya, 50603, Kuala Lumpur, Malaysia.
Dev World Bioeth. 2014 Apr;14(1):20-8. doi: 10.1111/dewb.12004. Epub 2012 Nov 22.
This article examines issues relating to ethics decision-making in clinical trials. The overriding concern is to ensure that the well being and the interests of human subjects are adequately safeguarded. In this respect, this article will embark on a critical analysis of the ICH-GCP Guideline. The purpose of such an undertaking is to highlight areas of concern and the shortcomings of the existing ICH-GCP Guideline. Particular emphasis is made on how ethics committees perform their duties and responsibilities in line with the principles outlined in the ICH-GCP Guideline. This article will draw attention to the need for a new approach to addressing the weaknesses of the ICH-GCP Guideline in its present form.
本文探讨了临床试验中伦理决策的相关问题。首要关注的是确保人类受试者的福祉和利益得到充分保障。在这方面，本文将对 ICH-GCP 指南进行批判性分析。这样做的目的是突出关注的领域和现有 ICH-GCP 指南的不足之处。特别强调伦理委员会如何根据 ICH-GCP 指南中概述的原则履行其职责和义务。本文将提请注意需要采取新方法来解决 ICH-GCP 指南目前形式中的弱点。
