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- BookDeborah Mascalzoni, editor.Summary: 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.
Contents:
Introduction / Deborah Mascalzoni
Biobanks: a definition / Barbara Parodi
A participatory space beyond the "autonomy versus property" dichotomy / Mariachiara Tallacchini
Intellectual Property and Biobanks / Naomi Hawkins
Consent, Privacy and Property in the Italian Biobanks Regulation: A Hybrid Model within EU / Matteo Macilotti, Simone Penasa, Marta Tomasi
Data Protection Principles and Research in the Biobanks Age / Roberto Lattanzi
The New General Data Protection Regulation: where are we are and where might we be heading? / Jane Reichel and Anna-Sara Lind
The Tension between Data Sharing and the Protection of Privacy in Genomics Research / Jane Kaye
Incidental findings: the time is not yet ripe for a policy for biobanks / Jennifer Viberg, Mats G. Hansson, Sophie Langenskiöld, Pär Segerdahl
Biobanking across borders: the challenges of harmonization / Ruth Chadwick, Heather Strange
Governing Biobanks Through A European Infrastructure / Emmanuelle Rial-Sebbag, Anne Cambon-Thomsen
EU governance for research and ethics in biobanks / Jane Reichel
A Bold Experiment: Iceland's Genomic Venture / David Winickoff
The Estonian Genome Center, University of Tartu / Aime Keis
The management of the ethical aspects of a local mental diseases biobank for research purposes. An Italian experience / Corinna Porteri
Biobank governance in Spain: From the autonomy of research ethics committees to the autonomy of lay people / Antonio Casado da Rocha
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 / Claudio Corradetti, Gillian Bartlett
Making researchers moral / Linus Johnsson, Stefan Eriksson, Gert Helgesson, Mats G. Hansson. - ArticleCunnane SC, Manku MS, Horrobin DF.Med Hypotheses. 1979 Apr;5(4):403-14.Pinealectomy leads to increased formation of fibrous tissue in the abdominal cavity, increased skin pigmentation and elevated cholesterol and alkaline phosphatase levels. It also leads to reduced formation and/or action of prostaglandin (PG) E1 and thromboxane (TX) A2. PGE1 plays an important role in enhancing function of T suppressor lymphocytes which control overactive antibody-producing B lymphocytes. In primary biliary cirrhosis there are increased skin pigmentation, hepatic fibrosis, elevated cholesterol and alkaline phosphatase levels, defective T lymphocytes and hyperactive B lymphocytes. Primary biliary cirrhosis may be a pineal deficiency disease. Serotonin is important in the pineal and the serotonin antagonist methysergide may cause retroperitoneal fibrosis by interfering with pineal function. There is a good deal of other evidence which suggests that melatonin PGE1 and TXA2 are important in the regulation of fibrosis in other situations such as "collagen" diseases, lithium-induced fibrosis and cardiomyopathies. This suggests that enhancement of formation of PGE1 and TXA2 may be of value in diseases associated with excess fibrosis and defective T suppressor cell function. PGE1 levels may be raised by zinc, penicillin, penicillamine and essential fatty acids. TXA2 levels may be raised by low dose colchicine. These new approaches to treatment may prove safer and more effective than existing ones. They may be of value in disorders such as cardiomyopathy, Hodgkin's disease and other lymphomas, multiple sclerosis, Crohn's disease, atopy and other diseases in which defective T cell function is suspected.