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  1.  31
    23andMe: A New Two-Sided Data-Banking Market Model.Henri-Corto Stoeklé, Marie-France Mamzer-Bruneel, Guillaume Vogt & Christian Hervé - 2016 - BMC Medical Ethics 17 (1):1-11.
    BackgroundSince 2006, the genetic testing company 23andMe has collected biological samples, self-reported information, and consent documents for biobanking and research from more than 1,000,000 individuals, through a direct-to-consumer online genetic-testing service providing a genetic ancestry report and a genetic health report. However, on November 22, 2013, the Food and Drug Administration halted the sale of genetic health testing, on the grounds that 23andMe was not acting in accordance with federal law, by selling tests of undemonstrated reliability as predictive tests for (...)
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  2.  4
    Systemic Modelling in Bioethics.Henri-Corto Stoeklé, Philippe Charlier, Marie-France Mamzer-Bruneel, Christian Hervé & Guillaume Vogt - 2020 - The New Bioethics 26 (3):197-209.
    We present here a new method for bioethics: systemic modelling. In this method, the complex phenomenon being studied (e.g. personalized medicine, genetic testing, gene therapy, genetically modified...
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  3.  15
    Molecular Tumor Boards: Ethical Issues in the New Era of Data Medicine.Christian Hervé, Guillaume Vogt, Pierre Laurent-Puig, Christophe Tourneau, Charles-Henry Frouart, Marie-France Mamzer-Bruneel & Henri-Corto Stoeklé - 2018 - Science and Engineering Ethics 24 (1):307-322.
    The practice and development of modern medicine requires large amounts of data, particularly in the domain of cancer. The future of personalized medicine lies neither with “genomic medicine” nor with “precision medicine”, but with “data medicine”. The establishment of this DM has required far-reaching changes, to establish four essential elements connecting patients and doctors: biobanks, databases, bioinformatic platforms and genomic platforms. The “transformation” of scientific research areas, such as genetics, bioinformatics and biostatistics, into clinical specialties has generated a new vision (...)
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  4.  16
    Molecular Tumor Boards: Ethical Issues in the New Era of Data Medicine.Henri-Corto Stoeklé, Marie-France Mamzer-Bruneel, Charles-Henry Frouart, Christophe Le Tourneau, Pierre Laurent-Puig, Guillaume Vogt & Christian Hervé - 2018 - Science and Engineering Ethics 24 (1):307-322.
    The practice and development of modern medicine requires large amounts of data, particularly in the domain of cancer. The future of personalized medicine lies neither with “genomic medicine” nor with “precision medicine”, but with “data medicine”. The establishment of this DM has required far-reaching changes, to establish four essential elements connecting patients and doctors: biobanks, databases, bioinformatic platforms and genomic platforms. The “transformation” of scientific research areas, such as genetics, bioinformatics and biostatistics, into clinical specialties has generated a new vision (...)
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  5.  22
    Improving the Quality of Host Country Ethical Oversight of International Research: The Use of a Collaborative ‘Pre‐Review’ Mechanism for a Study of Fexinidazole for Human A Frican Trypanosomiasis.Carl H. Coleman, Chantal Ardiot, Séverine Blesson, Yves Bonnin, Francois Bompart, Pierre Colonna, Ames Dhai, Julius Ecuru, Andrew Edielu, Christian Hervé, François Hirsch, Bocar Kouyaté, Marie-France Mamzer-Bruneel, Dionko Maoundé, Eric Martinent, Honoré Ntsiba, Gérard Pelé, Gilles Quéva, Marie-Christine Reinmund, Samba Cor Sarr, Abdoulaye Sepou, Antoine Tarral, Djetodjide Tetimian, Olaf Valverde, Simon Van Nieuwenhove & Nathalie Strub-Wourgaft - 2015 - Developing World Bioethics 15 (3):241-247.
    Developing countries face numerous barriers to conducting effective and efficient ethics reviews of international collaborative research. In addition to potentially overlooking important scientific and ethical considerations, inadequate or insufficiently trained ethics committees may insist on unwarranted changes to protocols that can impair a study's scientific or ethical validity. Moreover, poorly functioning review systems can impose substantial delays on the commencement of research, which needlessly undermine the development of new interventions for urgent medical needs. In response to these concerns, the Drugs (...)
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  6.  13
    Les Limites de L’Approche Fondée Sur le Risque de la Loi du 5 Mars 2012 Relative aux Recherches Impliquant la Personne Humaine, Dite « Loi Jardé ». [REVIEW]Manon de Fallois, Adeline Jouannin & Marie-France Mamzer-Bruneel - 2019 - Médecine et Droit 2019 (158):118-129.
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