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.

中文翻译：

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实施基于组学的女性癌症风险预测的伦理、法律和监管问题：需要考虑的问题

背景和目的：组学的进步为癌症风险预测和基于风险的筛查干预开辟了新的机会。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计划的伦理、法律和监管方面。为了支持决策，我们分析了道德、法律和监管问题，并制定了一系列要考虑的要点来支持这些问题的管理。方法：我们分析了 7 个欧洲国家适用于乳腺癌和宫颈癌筛查计划的法律和政策框架。我们确定了要考虑的最相关的问题，并根据文献、法律和政策框架以及我们在类似问题上的经验，制定了对其管理的考虑。结果：考虑集中在五个主题上：(A) 卫生服务规划，(B) 信息和邀请，(C) 同意和数据/样本收集，(D) 风险计算和结果交流，以及 (E) 数据和剩余样本的存储。结论：由于这些方法的不同特征，当前的框架可能不足以实施使用组学因素的风险预测方法。