研究伦理委员会和临床试验结果的公开传播
1University Hospital, 50 North Medical Drive, Salt Lake City, UT 84132, USA. Howard.Mann@hsc.utah.edu
Lancet (London, England)
|September 21, 2002
概括
目前,研究伦理委员会 (REC) 缺乏关于传播临床试验结果的明确指导. 本文认为,REC应在确保公众获得研究成果方面发挥关键作用,并提出如何实现这一目标.
科学领域:
- 生物伦理学生物伦理学
- 临床研究伦理学
- 研究诚信研究诚信
背景情况:
- 使用人类对象的生物医学研究需要由研究伦理委员会 (REC) 进行道德监督.
- 目前的国际和国家法规并没有明确定义REC在研究成果公开传播方面的作用.
- 这种差距影响了临床试验结果的透明度和可访问性.
研究的目的:
- 声称研究伦理委员会 (REC) 应该积极参与,确保对临床试验结果的公开传播.
- 为REC提出具体行动和责任,以促进研究成果的广泛分享.
主要方法:
- 关于管理人类研究伦理的国际准则和国家法规的文献综述.
- 对传播研究成果的公共道德要求进行论证性分析.
- 关于REC在结果传播方面的责任的提案开发.
主要成果:
- 现有的人类研究伦理框架并没有明确要求REC参与结果传播.
- 显然需要REC在促进公众分享试验结果方面发挥主动作用.
- 对于REC来说,可以定义具体的,可操作的步骤来履行这个角色.
结论:
- 研究伦理委员会 (REC) 在确保对临床试验结果的公开传播方面发挥着至关重要的,但目前尚未定义的作用.
- 实施拟议的责任将提高研究透明度和问责制.
- 加强REC在结果传播中的作用对于推动生物医学科学和公众信任至关重要.
关键词:
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