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

Lévesque, Emmanuelle; Kirby, Emily; Bolt, Ineke; Knoppers, Bartha Maria; Beaufort, Inez de; Pashayan, Nora; Widschwendter, Martin

doi:10.1159/000492663

Cited by 15 publications

(17 citation statements)

References 24 publications

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“…To stimulate the necessary discussions, the first pioneering epigenetic reports including age estimates have been issued to study participants of the Personal Genome Project UK [215]. A comprehensive framework on the Ethical, Legal, and Social Implications (ELSI) is still required to be developed and formulated [216, 217]. Further illustrating the future of epigenomic analysis, distinct personal and multi-timepoint longitudinal DNA methylome changes were recently reported in an individual in relation to their chronic disease state [218].…”

Section: Challengementioning

confidence: 99%

DNA methylation aging clocks: challenges and recommendations

et al. 2019

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Epigenetic clocks comprise a set of CpG sites whose DNA methylation levels measure subject age. These clocks are acknowledged as a highly accurate molecular correlate of chronological age in humans and other vertebrates. Also, extensive research is aimed at their potential to quantify biological aging rates and test longevity or rejuvenating interventions. Here, we discuss key challenges to understand clock mechanisms and biomarker utility. This requires dissecting the drivers and regulators of age-related changes in single-cell, tissue- and disease-specific models, as well as exploring other epigenomic marks, longitudinal and diverse population studies, and non-human models. We also highlight important ethical issues in forensic age determination and predicting the trajectory of biological aging in an individual.

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Section: Challengementioning

confidence: 99%

DNA methylation aging clocks: challenges and recommendations

et al. 2019

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“…Despite the interest raised by this personalized approach, its implementation raises organizational issues ( Chowdhury et al 2013 ; Hall et al 2013 ; Lévesque et al 2018a ; Rainey et al 2018 ). Our previous work with stakeholders revealed that the implementation of the personalized approach in the province of Quebec would raise organizational challenges with regard to many steps of the screening trajectory in the healthcare system ( Figure 1 ; Dalpé et al 2017 ; Hagan et al 2016 ; Lévesque et al 2018b ).…”

Section: Introductionmentioning

confidence: 99%

Envisioning Implementation of a Personalized Approach in Breast Cancer Screening Programs: Stakeholder Perspectives

Esquivel-Sada¹,

Lévesque²,

Hagan³

et al. 2019

hcpol

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Background: Advances in genomics and epidemiology can foster the implementation of a riskbased approach to current age-based breast cancer screening programs. This personalized approach would challenge the trajectory for women in the healthcare system by adding both a risk-assessment step (including a genomic test) and screening options. Objective: The aim of this study is to explore, from an organizational perspective, the acceptability of different proposals for each step of the trajectory for women in the healthcare system should a personalized approach be implemented in the province of Quebec. Methods: We interviewed 20 professional stakeholders who are either involved in the current breast cancer screening program in Quebec or who are likely to play a role in the future implementation of a personalized risk-based approach. Results and discussion: Preferences are split between proposals supporting self-management by the women themselves (e.g., solicitation through media campaign, self-collection of information and sample and results provided by letter) and proposals prioritizing more interaction between women and healthcare providers (e.g., solicitation by health professionals, collection of information and samples by a nurse and results provided by health professionals). Résumé Contexte : Les avancées de la science en génomique et en épidémiologie pourraient favoriser l'implantation d' une approche basée sur le risque dans les programmes de dépistage du cancer du sein qui sont actuellement basés sur l'âge. Cette approche personnalisée poserait des défis à la trajectoire des femmes dans le système de santé en ajoutant à la fois une étape d'évaluation du risque (incluant un test génomique) et des options de dépistage. Objectif : L' objectif de cette étude est d' explorer, dans une perspective organisationnelle, l' acceptabilité de différentes propositions pour chaque étape de la trajectoire des femmes dans le système de santé si une telle approche était implantée dans la province de Québec. Méthode : Nous avons mené des interviews auprès de 20 acteurs du milieu de la santé qui sont impliqués dans le programme actuel de dépistage du cancer du sein au Québec ou qui seraient appelés à jouer un rôle advenant l'implantation d' une approche personnalisée basée sur le risque. Résultats et discussion : Les préférences des interviewés sont partagées entre les propositions qui favorisent l' autogestion par les femmes elles-mêmes (p. ex. sollicitation par des campagnes médiatiques, collecte autonome d'information et d'échantillon, résultat transmis par lettre) et les propositions qui favorisent plus d'interactions entre les femmes et les fournisseurs de soins (p. ex. sollicitation par des professionnels de la santé, collecte d'information et d'échantillon par une infirmière et résultat transmis par un professionnel de la santé).

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“…Screening programmes have the potential to increase health inequalities, owing to differences in the level of uptake between socioeconomic groups, including those covered under universal health systems 204 – 206 . Risk-based screening programmes might exacerbate these differences 201 , given their additional complexity and inherent selectivity relative to universal screening. Efforts are needed to mitigate this possibility, for example, through ‘proportionate universalism’ 207 , whereby social inequalities are considered and programme resources are targeted commensurately 208 .…”

Section: Methodsmentioning

confidence: 99%

“…Ethical, legal and social issues need to be considered at every step of implementation of risk-based interventions, from health-service planning, invitation of participants and consent and sample collection, to risk calculation, communication of results and storage of data 201,202 . Some of the issues associated with risk-stratified screening will be dependent on the methods by which a programme is implemented 202 .…”

Section: Ethical Legal and Social Implicationsmentioning

confidence: 99%

“…Communication relating to screening and risk assessment has to be accessible and congruent to the literacy and numeracy level of the recipients while also accurately presenting both the potential benefits and risks 209 . Meeting these requirements will not only avoid misinterpretation of the information provided and subsequent inequitable use of screening services, but also enable each individual to make an informed decision 201 . In addition, robust legislation is necessary to prevent discrimination and stigmatization, in particular, by insurers and employers.…”

Section: Ethical Legal and Social Implicationsmentioning

confidence: 99%

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Personalized early detection and prevention of breast cancer: ENVISION consensus statement

et al. 2020

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The European Collaborative on Personalized Early Detection and Prevention of Breast Cancer (ENVISION) brings together several international research consortia working on different aspects of the personalized early detection and prevention of breast cancer. In a consensus conference held in 2019, the members of this network identified research areas requiring development to enable evidence-based personalized interventions that might improve the benefits and reduce the harms of existing breast cancer screening and prevention programmes. The priority areas identified were: 1) breast cancer subtype-specific risk assessment tools applicable to women of all ancestries; 2) intermediate surrogate markers of response to preventive measures; 3) novel non-surgical preventive measures to reduce the incidence of breast cancer of poor prognosis; and 4) hybrid effectiveness–implementation research combined with modelling studies to evaluate the long-term population outcomes of risk-based early detection strategies. The implementation of such programmes would require health-care systems to be open to learning and adapting, the engagement of a diverse range of stakeholders and tailoring to societal norms and values, while also addressing the ethical and legal issues. In this Consensus Statement, we discuss the current state of breast cancer risk prediction, risk-stratified prevention and early detection strategies, and their implementation. Throughout, we highlight priorities for advancing each of these areas.

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

Cited by 15 publications

References 24 publications

DNA methylation aging clocks: challenges and recommendations

DNA methylation aging clocks: challenges and recommendations

Envisioning Implementation of a Personalized Approach in Breast Cancer Screening Programs: Stakeholder Perspectives

Personalized early detection and prevention of breast cancer: ENVISION consensus statement

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