基于组学的女性癌症风险预测实施中的伦理、法律和监管问题：需考虑的要点。
Ethical, Legal, and Regulatory Issues for the Implementation of Omics-Based Risk Prediction of Women's Cancer: Points to Consider.
作者信息
Lévesque Emmanuelle, Kirby Emily, Bolt Ineke, Knoppers Bartha Maria, de Beaufort Inez, Pashayan Nora, Widschwendter Martin
机构信息
Center of Genomics and Policy, Department of Human Genetics, Faculty of Medicine, McGill University, Montréal, Québec,
Public Population Project in Genomics and Society (P³G), Montréal, Québec, Canada.
出版信息
Public Health Genomics. 2018;21(1-2):37-44. doi: 10.1159/000492663. Epub 2018 Sep 17.
BACKGROUND AND OBJECTIVE
Advances in omics open new opportunities for cancer risk prediction and risk-based screening interventions. However, implementation of risk prediction in clinical practice may impact the ethical, legal, and regulatory aspects of current cancer screening programs. In order to support decision-making, we analyzed the ethical, legal, and regulatory issues and developed a set of Points to Consider to support management of these issues.
METHODS
We analyzed the legal and policy frameworks applicable to breast and cervical cancer screening programs in 7 European countries. We identified the most relevant issues to be considered, and we developed considerations for their management, based on the literature, the legal and policy frameworks, and our experience with similar issues.
RESULTS
The considerations focus on five topics: (A) health services planning, (B) information and invitation, (C) consent and data/sample collection, (D) risk calculation and communication of results, and (E) storage of data and residual samples.
CONCLUSION
Current frameworks might not be adequate to implement a risk prediction approach using omics factors due to the different characteristics of such approaches.
背景与目的
组学技术的进步为癌症风险预测和基于风险的筛查干预带来了新机遇。然而，在临床实践中实施风险预测可能会影响当前癌症筛查项目的伦理、法律和监管层面。为支持决策制定，我们分析了伦理、法律和监管问题，并制定了一套“考虑要点”以支持对这些问题的管理。
方法
我们分析了适用于7个欧洲国家乳腺癌和宫颈癌筛查项目的法律和政策框架。我们确定了最相关的需考虑问题，并基于文献、法律和政策框架以及我们处理类似问题的经验，制定了对这些问题的管理考量。
结果
这些考量聚焦于五个主题：（A）卫生服务规划，（B）信息与邀请，（C）同意与数据/样本收集，（D）风险计算与结果沟通，以及（E）数据与剩余样本的存储。
结论
由于基于组学因素的风险预测方法具有不同特点，当前框架可能不足以实施此类方法。
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