在医学研究的出版物中报告伦理问题
Franklin G Miller1, Donald L Rosenstein
1Department of Clinical Bioethics, Clinical Center, National Institutes of Health, Bethesda, MD 20892-1156, USA. fmiller@nih.gov
Lancet (London, England)
|November 5, 2002
概括
临床研究人员经常无法在研究设计或患者保护中解释伦理考虑. 我们倡导全面报告伦理问题,以提高公众对临床研究的信任和问责制.
科学领域:
- 生物伦理学生物伦理学
- 临床研究伦理学
- 研究方法研究方法研究方法学
背景情况:
- 临床研究中的伦理考虑对于患者安全和公众信任至关重要.
- 调查人员经常忽略有关伦理复杂的研究设计和患者保护措施的细节.
- 对道德上具有挑战性的研究组件的知情同意过程通常被描述得不够好.
研究的目的:
- 突出在临床研究中报告伦理理学理由和保护方面的差距.
- 推一项政策,广泛报告临床研究中的伦理问题.
- 加强公众对临床研究的问责制和信任.
主要方法:
- 对临床研究中关于伦理问题的报告实践的分析.
- 为全面的道德报告制定建议.
- 解决对加强报告政策的潜在异议.
主要成果:
- 一贯缺乏关于有争议的研究设计的伦理理由的详细报告.
- 在敏感研究中,针对患者保护的具体程序的文件不足.
- 对道德上复杂的元素获得知情同意的不一致描述.
结论:
- 对伦理问题的广泛报告是必要的,以促进临床研究的公共问责制.
- 实施详细的伦理报告政策将加强研究诚信.
- 透明地解决道德复杂性对于保持公众对研究参与者福利的信心至关重要.
关键词:
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