Emmanuelle Lévesque1, Emily Kirby2, Ineke Bolt3, Bartha Maria Knoppers4, Inez de Beaufort5, Nora Pashayan6, Martin Widschwendter7. 1. Center of Genomics and Policy, Department of Human Genetics, Faculty of Medicine, McGill University, Montréal, Québec, Canadaemmanuelle.levesque@mcgill.ca. 2. Public Population Project in Genomics and Society (P³G), Montréal, Québec, Canada. 3. Department of Medical Ethics and Philosophy of Medicine, Erasmus Medical Center, Rotterdam, The Netherlands. 4. Center of Genomics and Policy, Department of Human Genetics, Faculty of Medicine, McGill University, Montréal, Québec, Canada. 5. Erasmus Medical Center, Rotterdam, The Netherlands. 6. Department of Applied Health Research, University College London, London, United Kingdom. 7. University College London Hospital, London, United Kingdom.
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. The Author(s). Published by S. Karger AG, Basel.
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. The Author(s). Published by S. Karger AG, Basel.
Authors: Christopher G Bell; Robert Lowe; Peter D Adams; Andrea A Baccarelli; Stephan Beck; Jordana T Bell; Brock C Christensen; Vadim N Gladyshev; Bastiaan T Heijmans; Steve Horvath; Trey Ideker; Jean-Pierre J Issa; Karl T Kelsey; Riccardo E Marioni; Wolf Reik; Caroline L Relton; Leonard C Schalkwyk; Andrew E Teschendorff; Wolfgang Wagner; Kang Zhang; Vardhman K Rakyan Journal: Genome Biol Date: 2019-11-25 Impact factor: 13.583
Authors: Celmira Laza-Vásquez; María José Hernández-Leal; Misericòrdia Carles-Lavila; Maria José Pérez-Lacasta; Inés Cruz-Esteve; Montserrat Rué Journal: Int J Environ Res Public Health Date: 2022-01-27 Impact factor: 3.390
Authors: Celmira Laza-Vásquez; Núria Codern-Bové; Àngels Cardona-Cardona; Maria José Hernández-Leal; Maria José Pérez-Lacasta; Misericòrdia Carles-Lavila; Montserrat Rué Journal: PLoS One Date: 2022-02-04 Impact factor: 3.240
Authors: Alexandra Roux; Rachel Cholerton; Jonathan Sicsic; Nora Moumjid; David P French; Paolo Giorgi Rossi; Corinne Balleyguier; Michal Guindy; Fiona J Gilbert; Jean-Benoit Burrion; Xavier Castells; David Ritchie; Debbie Keatley; Camille Baron; Suzette Delaloge; Sandrine de Montgolfier Journal: BMC Cancer Date: 2022-05-06 Impact factor: 4.638
Authors: Nora Pashayan; Antonis C Antoniou; Urska Ivanus; Laura J Esserman; Douglas F Easton; David French; Gaby Sroczynski; Per Hall; Jack Cuzick; D Gareth Evans; Jacques Simard; Montserrat Garcia-Closas; Rita Schmutzler; Odette Wegwarth; Paul Pharoah; Sowmiya Moorthie; Sandrine De Montgolfier; Camille Baron; Zdenko Herceg; Clare Turnbull; Corinne Balleyguier; Paolo Giorgi Rossi; Jelle Wesseling; David Ritchie; Marc Tischkowitz; Mireille Broeders; Dan Reisel; Andres Metspalu; Thomas Callender; Harry de Koning; Peter Devilee; Suzette Delaloge; Marjanka K Schmidt; Martin Widschwendter Journal: Nat Rev Clin Oncol Date: 2020-06-18 Impact factor: 65.011