什么使得临床研究伦理?
E J Emanuel1, D Wendler, C Grady
1Warren G. Magnuson Clinical Center, Bldg 10, Room 1C118, National Institutes of Health, Bethesda, MD 20892-1156, USA.
JAMA
|May 20, 2000
概括
仅仅是知情同意并不能确保伦理临床研究. 包括科学有效性和公平的主题选择在内的七个要求的全面框架对于伦理研究实践是必要的,也是足够的.
科学领域:
- 生物伦理学生物伦理学
- 临床研究伦理学
- 人类对象保护 人类对象保护
背景情况:
- 临床研究的伦理行为对于推进医学知识和改善患者护理至关重要.
- 知情同意被广泛认为是伦理研究的基石,但它的充分性受到争议.
- 现有的道德准则和声明为人类受试者研究提供了基本原则.
研究的目的:
- 批判性地评估知情同意在伦理临床研究中的作用.
- 为确保伦理临床研究提出一个包括七项基本要求的综合框架.
- 建立评估涉及人类受试者的研究研究的伦理完整性的标准.
主要方法:
- 分析基本的哲学基础的主要代码,声明和与人类主体研究相关的文件.
- 制定一个系统的框架,包括七个不同的要求进行伦理研究评估.
- 综合原则,以确保价值,有效性,公平选择,有利的风险效益平衡,独立审查,知情同意和对受试者的尊重.
主要成果:
- 对伦理临床研究而言,知情同意本身既不必要也不够.
- 提出了七个要求的框架:价值,科学有效性,公平的主题选择,有利的风险/收益比,独立审查,知情同意和对主题的尊重.
- 满足所有七个要求被认为是伦理临床研究的必要和充分条件.
结论:
- 伦理临床研究需要一种超越知情同意的整体方法,包括七个核心原则.
- 这七个要求为评估和确保伦理研究实践提供了通用框架.
- 这些原则适应特定的健康,经济,文化和技术背景对于全球研究伦理至关重要.
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