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  1. Becoming partners, retaining autonomy: ethical considerations on the development of precision medicine.Alessandro Blasimme & Effy Vayena - 2016 - BMC Medical Ethics 17 (1):67.
    Precision medicine promises to develop diagnoses and treatments that take individual variability into account. According to most specialists, turning this promise into reality will require adapting the established framework of clinical research ethics, and paying more attention to participants’ attitudes towards sharing genotypic, phenotypic, lifestyle data and health records, and ultimately to their desire to be engaged as active partners in medical research.Notions such as participation, engagement and partnership have been introduced in bioethics debates concerning genetics and large-scale biobanking to (...)
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  • (2 other versions)Incidental findings of uncertain significance: To know or not to know - that is not the question.Bjørn Hofmann - 2016 - BMC Medical Ethics 17 (1):1-9.
    BackgroundAlthough the “right not to know” is well established in international regulations, it has been heavily debated. Ubiquitous results from extended exome and genome analysis have challenged the right not to know. American College of Medical Genetics and Genomics Recommendations urge to inform about incidental findings that pretend to be accurate and actionable. However, ample clinical cases raise the question whether these criteria are met. Many incidental findings are of uncertain significance. The eager to feedback information appears to enter the (...)
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  • Ethical Issues Raised by the Clinical Implementation of New Diagnostic Tools for Genetic Diseases in Children: Array Comparative Genomic Hybridization (aCGH) as a Case Study.Julia S. & Soulier A. - 2015 - Journal of Clinical Research and Bioethics 6 (6).
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  • The Fiduciary Relationship Model for Managing Clinical Genomic “Incidental” Findings.Gabriel Lázaro-Muñoz - 2014 - Journal of Law, Medicine and Ethics 42 (4):576-589.
    This paper examines how the application of legal fiduciary principles , can serve as a framework to promote management of clinical genomic “incidental” or secondary target findings that is patient-centered and consistent with recognized patient autonomy rights. The application of fiduciary principles to the clinical genomic testing context gives rise to at least four physician fiduciary duties in conflict with recent recommendations by the American College of Medical Genetics and Genomics . These recommendations have generated much debate among lawyers, clinicians, (...)
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  • Response to Open Peer Commentaries on “Do Researchers Have an Obligation to Actively Look for Genetic Incidental Findings?”.Catherine Gliwa & Benjamin E. Berkman - 2013 - American Journal of Bioethics 13 (5):W10-W11.
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  • Revealing the results of whole-genome sequencing and whole-exome sequencing in research and clinical investigations: some ethical issues: Table 1.Nina Hallowell, Alison Hall, Corinna Alberg & Ron Zimmern - 2015 - Journal of Medical Ethics 41 (4):317-321.
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  • Health Research with Big Data: Time for Systemic Oversight.Effy Vayena & Alessandro Blasimme - 2018 - Journal of Law, Medicine and Ethics 46 (1):119-129.
    To address the ethical challenges in big data health research we propose the concept of systemic oversight. This approach is based on six defining features and aims at creating a common ground across the oversight pipeline of biomedical big data research. Current trends towards enhancing granularity of informed consent and specifying legal provisions to address informational privacy and discrimination concerns in data-driven health research are laudable. However, these solutions alone cannot have the desired impact unless oversight activities by different stakeholders (...)
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