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Ethical, Legal, and Regulatory Issues for the Implementation of Omics-Based Risk Prediction of Women's Cancer: Points to Consider

Lévesque, E; Kirby, E; Bolt, I; Knoppers, BM; de Beaufort, I; Pashayan, N; Widschwendter, M; (2019) Ethical, Legal, and Regulatory Issues for the Implementation of Omics-Based Risk Prediction of Women's Cancer: Points to Consider. Public Health Genomics , 21 (1-2) pp. 37-44. 10.1159/000492663. Green open access

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Abstract

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.

Type: Article
Title: Ethical, Legal, and Regulatory Issues for the Implementation of Omics-Based Risk Prediction of Women's Cancer: Points to Consider
Open access status: An open access version is available from UCL Discovery
DOI: 10.1159/000492663
Publisher version: https://doi.org/10.1159/000492663
Language: English
Additional information: © 2018 The Author(s). Published by S. Karger AG, Basel. This article is licensed under the Creative Commons AttributionNonCommercial-NoDerivatives 4.0 International License (CC BYNC-ND) (http://www.karger.com/Services/ OpenAccessLicense). Usage and distribution for commercial purposes as well as any distribution of modified material requires written permission.
Keywords: Cancer, Ethical issues, Genetics, Legal issues, Risk prediction
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Epidemiology and Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Epidemiology and Health > Applied Health Research
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL EGA Institute for Womens Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > UCL EGA Institute for Womens Health > Womens Cancer
URI: https://discovery.ucl.ac.uk/id/eprint/10058764
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