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对涉及遗传学的基于人口的研究进行知情同意.
L M Beskow1, W Burke, J F Merz
1Office of Genetics and Disease Prevention, Centers for Disease Control and Prevention, 4770 Buford Hwy NE, MS K-28, Atlanta, GA 30341-3724, USA. laura_beskow@unc.edu
JAMA
|November 17, 2001
概括
制定基因研究指南至关重要. 这种方法确保参与者了解人口研究中遗传变异带来的风险和好处.
科学领域:
- 遗传学 是一个遗传学.
- 生物伦理学生物伦理学
- 公共卫生 公共卫生
背景情况:
- 基于人口的遗传研究需要特定的伦理准则,与基于家庭的研究不同.
- 了解基因变异和基因环境相互作用是预测疾病风险的关键.
- 低透基因变异在遗传研究中具有独特的考虑.
研究的目的:
- 为基于人口的遗传研究制定知情同意方法.
- 解决对将遗传变异数据纳入研究的指导方针的需求.
- 为了促进基因研究参与者的知情决策.
主要方法:
- 在疾病控制和预防中心召开了一个多学科小组.
- 利用了专家意见,联邦法规以及现有的道德报告和文献.
- 为知情同意文件和补充小册子开发了建议的语言.
主要成果:
- 创建了一个知情同意框架,强调结果解释和健康结果之间的联系.
- 建议同意过程应评估产生可行的,基于证据的干预措施的可能性.
- 为同意表格和小册子生成语言,以帮助参与者理解.
结论:
- 建议的知情同意方法旨在提高参与者对遗传研究的理解.
- 鼓励讨论关于在人口遗传学中获得知情同意的最佳实践.
- 为研究赞助商,IRB和研究人员提供关于遗传研究伦理学的考虑.
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