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分散临床试验和知情同意的伦理:考虑到技术的软影响
Tessa I van Rijssel1, Ghislaine J M W van Thiel2, Johannes J M van Delden2
1Department of Bioethics and Health Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands. t.i.vanrijssel@umcutrecht.nl.
分散临床试验 (DCT) 带来了伦理挑战,特别是关于知情同意的问题. 更广泛的伦理观点对于解决数字化对参与者理解,信任和DCT隐私的微妙影响至关重要.
科学领域:
- 临床研究伦理学
- 数字卫生技术数字卫生技术
- 在知情同意的情况下同意.
背景情况:
- 分散临床试验 (DCT) 提供了进步,但也带来了伦理困境,特别是关于知情同意.
- 当前的伦理讨论往往集中在数据保护和安全等直接风险上,忽视了更广泛的影响.
研究的目的:
- 检查DCT对知情同意程序的伦理影响.
- 分析数字化对参与者参与和理解DCT的"软影响".
- 倡导为DCT制定一个全面的道德框架.
主要方法:
- 在DCT背景下分析知情同意的四个关键要素:参与者信息和理解,参与者自主权和负担,研究员-参与者信任和隐私.
- 考虑数字技术对更广泛的社会和行为影响.
主要成果:
- 通过影响参与者的理解,自主,信任和隐私,DCT显著影响知情同意.
- 数字化对行为,经验和价值观的微妙影响需要仔细的伦理考虑.
- 现有的监管框架可能无法充分解决DCT带来的新伦理挑战.
结论:
- 广泛的伦理观点对于DCT的有效和负责任行为至关重要.
- 了解DCT对知情同意的多方面的伦理影响对于未来的研究至关重要.
- 认识到这些深远的影响对于指导DCT实践和维护临床研究价值观至关重要.
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