Ethics, Law and Governance of Biobanking: National, European and International Approaches (The International Library of Ethics, Law and Technology Book 14)

"Biobank research and genomic information are changing the way we look at health and medicine. Genomics challenges our values and has always been controversial and difficult to regulate. In the future lies the promise of tailored medical treatments and pharmacogenomics but the borders between medical research and clinical practice are becoming blurred. We see sequencing platforms for research that can have diagnostic value for patients. Clinical applications and research have been kept separate, but the blurring lines challenges existing regulations and ethical frameworks. Then how do we regulate it? This book contains an overview of the existing regulatory landscape for biobank research in the Western world and some critical chapters to show how regulations and ethical frameworks are developed and work. How should international sharing work? How design an ethical informed consent? An underlying critique: the regulatory systems are becoming increasingly complex and opaque. The international community is building systems that should respond to that. According to the authors in fact, it is time to turn the ship around. Biobank researchers have a moral responsibility to look at and assess their work in relation to the bigger picture: the shared norms and values of current society. Research ethics shouldn't only be a matter of bioethicists writing guidelines that professionals have to follow. Ethics should be practiced through discourse and regulatory frameworks need to be part of that public discourse. Ethics review should be then not merely application of bureaucracy and a burden for researchers but an arena where researchers discuss their projects, receive advice and practice their ethics skills"--Back cover "Biobank research and genomic information are changing the way we look at health and medicine Genomics challenges our values and has always been controversial and difficult to regulate In the future lies the promise of tailored medical treatments and pharmacogenomics but the borders between medical research and clinical practice are becoming blurred We see sequencing platforms for research that can have diagnostic value for patients Clinical applications and research have been kept separate, but the blurring lines challenges existing regulations and ethical frameworksThen how do we regulate it? This book contains an overview of the existing regulatory landscape for biobank research in the Western world and some critical chapters to show how regulations and ethical frameworks are developed and work How should international sharing work? How design an ethical informed consent? An underlying critique: the regulatory systems are becoming increasingly complex and opaque The international community is building systems that should respond to that According to the authors in fact, it is time to turn the ship around Biobank researchers have a moral responsibility to look at and assess their work in relation to the bigger picture: the shared norms and values of current society Research ethics shouldn't only be a matter of bioethicists writing guidelines that professionals have to follow Ethics should be practiced through discourse and regulatory frameworks need to be part of that public discourse Ethics review should be then not merely application of bureaucracy and a burden for researchers but an arena where researchers discuss their projects, receive advice and practice their ethics skills - Font no determinada This book contains an overview of the existing regulatory landscape for biobank research in the Western world and some critical chapters to show how regulations and ethical frameworks are developed and work. How should international sharing work? How do we design an ethically informed consent? Biobank research and genomic information are changing the way we look at health and medicine. Genomics challenge our values and have always been controversial and difficult to regulate. In the future lies the promise of tailored medical treatments and pharmacogenomics but the borders between medical research and clinical practice are becoming blurred. We see sequencing platforms for research that can have diagnostic value for patients. Clinical applications and research have been kept separate, but the blurring lines challenge existing regulations and ethical frameworks. Then how do we regulate it? An underlying critique: the regulatory systems are becoming increasingly complex and opaque. The international community is building systems that should respond to that. The authors argue that it is time to turn the ship around. Biobank researchers have a moral responsibility to look at and assess their work in relation to the bigger picture: the shared norms and values of current society. Research ethics shouldn’t only be a matter of bioethicists writing guidelines that professionals have to follow. Ethics should be practiced through discourse and regulatory frameworks need to be part of that public discourse. Ethics review should therefore not merely be an application of bureaucracy and a burden for researchers but an arena where researchers discuss their projects, receive advice and practice their ethics skills. Front Matter....Pages i-viii Ethics Law and Governance of Biobanking: A Very Complex Normative Puzzle....Pages 1-14 Biobanks: A Definition....Pages 15-19 A Participatory Space Beyond the “Autonomy Versus Property” Dichotomy....Pages 21-38 Intellectual Property and Biobanks....Pages 39-51 Consent, Privacy and Property in the Italian Biobanks Regulation: A Hybrid Model Within EU?....Pages 53-77 Data Protection Principles and Research in the Biobanks Age....Pages 79-93 The New General Data Protection Regulation—Where Are We Are and Where Might We Be Heading?....Pages 95-100 The Tension Between Data Sharing and the Protection of Privacy in Genomics Research....Pages 101-120 Incidental Findings: The Time Is not yet Ripe for a Policy for Biobanks....Pages 121-131 Biobanking Across Borders: The Challenges of Harmonisation....Pages 133-138 Governing Biobanks Through a European Infrastructure....Pages 139-151 EU Governance for Research and Ethics in Biobanks....Pages 153-185 A Bold Experiment: Iceland’s Genomic Venture....Pages 187-209 The Estonian Genome Center, University of Tartu....Pages 211-218 Management of the Ethical Aspects of a Local Mental Diseases Biobank for Research Purposes: The Italian Experience....Pages 219-225 Biobank Governance in Spain: From the Autonomy of Research Ethics Committees to the Autonomy of Lay People....Pages 227-239 Public Deliberation and the Role of Stakeholders as a New Frontier in the Governance of Science: The British Columbia Biobank Deliberation and the DePGx Project....Pages 241-260 Making Researchers Moral....Pages 261-277