ethics in tissue establishments

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Ethics In Tissue Establishments

Author : Morales Pedraza Jorge
ISBN : 9789814616775
Genre : Medical
File Size : 61. 33 MB
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At present, the international community cannot be assured that the quality and, in particular the safety of tissues for transplants, is properly guaranteed in all countries and regions. Shortcomings of international and regional ethical rules and standards in the field of tissue banking, the lack of national ethical rules and standards in force in several countries, the lack of proper regulatory oversight and overall lack of harmonisation of existing ethical rules and standards, contribute to the problem.This book addresses the issues by promoting the adoption of an ethical policy and the use of a model code of ethics and a model code of practice as a reference for the tissue banking community, government agencies and policy-makers worldwide. This will facilitate the use of tissue processed in one country in any other country that needs it with the additional assurance of quality and safety that is lacking presently.

Ethical Policy And Principles In Tissue Banking

Author : Jorge Morales Pedraza
ISBN : 9783319316734
Genre : Law
File Size : 87. 39 MB
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This book highlights the importance of adopting ethical policies and a code of ethics concerning tissue banking. It also shares the experience of a select group of countries in the adoption, implementation, and use of ethics in the creation and maintenance of tissue establishments. Describing the difficulties faced and the measures adopted to overcome them, the book provides several essential recommendations for governments, professional associations and international organizations involved in tissue banking, with the goal of strengthening tissue banking activities in interested countries and improving the quality of all tissue establishments.

Legal Basis Of Global Tissue Banking

Author : Glyn O Phillips
ISBN : 9789814663458
Genre : Medical
File Size : 85. 11 MB
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The banking of human tissues for clinical transplantation has grown exponentially in the past 10-15 years. Tissue banks have been set up throughout the world, initially on an ad hoc basis. More recently these have grown and in many countries have linked up with larger international companies. While standards for the procurement, processing and storage of the tissues have kept pace with the growth of the subject, this is not so with the legal considerations associated with the practice. There is no unified legal system which is internationally operated. Europe, USA, Asia, Latin America, China have been developing legal systems on an individual basis. This book describes the present state of the development of laws to control and make the banking and use of tissues legal and safe. It describes, for the first time, the current systems which are used throughout the world and points the way to setting up a harmonized global legal system. Contents:Introduction: From a Cottage Industry to a Global Business (Glyn O Phillips)Legal Framework for International Operation of Tissue Banks (Peter Myint)The Legal and Regulatory Framework for Tissues and Cells in the European Union (Deborah R Hutchison)Litigation Risks Facing Tissue Banks in the United States (Daniel D Harshman)The Importance of a Code of Ethics and a Code of Practice for Tissue Establishments (Jorge Morales Pedraza)Ethical, Religious, Legal, and Cultural Issues for Tissue Banking, with Special Reference to the Asia-Pacific Region (Aziz Nather and Wee Lin)Challenges for Tissue Banking in the Asia-Pacific Region and Recent Progress in Malaysia (Norimah Yusof)Legal System for Tissue Banking in Latin America (Eulogia Kairiyama)Establishing a Legal System for Tissue Banking in China (Li Bao Xing, Zhao Yaping and Glyn O Phillips)Independence for Wales from the Remainder of the United Kingdom: A Change from Informed Consent to Presumed Consent (Glyn O Phillips)Germany: Regulation of Tissues and Tissue Banking — A Special Case (Peter Hergert and Ralf R Tönjes)Legal Issues Associated with Producing and Marketing Tissues Internationally (Caroline A Hartill)A Retrospective Look at the Largest Recall of Processed Bone Tissue in History (Helena Lazares and John T Salvucci)Polymethyl Methacrylate: An Acceptable Material for Tissue Augmentation and Reconstruction (Mario Cabraja, Jack Klecan and Glyn O Phillips) Readership: Ethicists, lawyers, policymakers, clinicians, healthcare professionals, stem cell scientists, researchers and academics in bioethics, and general public. Key Features:China practices are opened up for the first time to the WestThe European highly complex systems are described clearly and succinctly which may make the system understandable even to the European CommissionWales will change its legal system of tissue procurement and its difference from the remainder of the UK is describedGermany is a special case in Europe and is authoritatively coveredThere is a description of probably the most notable tissue banking litigation in the USAThe pioneering global work of the International Atomic Agency in setting basic systems in place is describedThe influence of religious belief on tissue and legal practices is also coveredKeywords:Tissue Banking;Transplantation;Tissue Law;Procurement;Commercial Tissues;Tissue Laws in China;Asia;Latin America;Europe and USA

The Ethical And Legal Regulation Of Human Tissue And Biobank Research In Europe

Author : Katharina Beier
ISBN : 9783863950316
Genre : Biobanks
File Size : 54. 35 MB
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Human tissue and biobank research is of increasing importance for understanding the causes of widespread diseases and developing effective therapies. However, while the success of biobank research depends on the availability of a large number of samples and the consolidation of collections across country borders is very desirable from the perspective of researchers, the legal and ethical requirements for the procurement, storage and use of human tissue samples are rather heterogeneous across different countries. Moreover, the lack of comprehensive supranational regulation on human tissue and biobanking can be seen as posing a serious threat to transnational biomedical research. Against this background, it was one of the aims of the EU-funded Tiss. EU project ("Evaluation of Legislation and Related Guidelines on the Procurement, Storage and Transfer of Human Tissues and Cells in the European Union - an Evidence-Based Impact Analysis") to analyse the ethical and legal regulation of human tissue and biobank research across the 27 European Member States plus Switzerland. The results of nine international workshops and three conferences are gathered in this volume. While the country reports evaluate the implementation of ethical and legal guidelines at a national level, point out their strengths and deficits, and, where required, create an evidence base for the revision of said legislation, the conference reports address more general ethical and legal issues in this field. The volume is completed by a final presentation of project's results.

Ethics Law And Society

Author : Dr Anthony Wrigley
ISBN : 9781409471462
Genre : Law
File Size : 56. 41 MB
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This volume forms part of a series exploring key issues in ethics, law and society, published in association with the Cardiff Centre for Ethics, Law and Society. The works collectively address new technological, social and regulatory developments and the fresh ethical dilemmas these pose, and also critically compel an urgent revisiting of social and legal issues that were once the subject of controversy but which have now fallen out of the line of sight of academics, politicians and policy-makers. This fifth and final volume brings the series to a close and is dedicated to the memory of Dr Jennifer Gunning.

Ethics Law And Society

Author : Jennifer Gunning
ISBN : 9781351567817
Genre : Law
File Size : 77. 1 MB
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This key collection brings together a selection of papers commissioned and published by the Cardiff Centre for Ethics, Law & Society. It incorporates contributions from a group of international experts along with a selection of short opinion pieces written in response to specific ethical issues. The collection addresses issues arising in biomedical and medical ethics ranging from assisted reproductive technologies to the role of clinical ethics committees. It examines broader societal issues with particular emphasis on sustainability and the environment and also focuses on issues of human rights in current global contexts. The contributors collect responses to issues arising from high profile cases such as the legitimacy of war in Iraq to physician-related suicide. The volume will provide a valuable resource for practitioners and academics with an interest in ethics across a range of disciplines.

The Challenges Of The New Eu Pharmaceutical Legislation

Author : José Luis Valverde
ISBN : 1586035215
Genre : Medical
File Size : 69. 14 MB
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In the domain of public policy on pharmaceuticals, protecting public health requires a dual strategy: robust regulation on the one hand and stimulation of competitiveness and innovation on the other. Regulation must be robust to ensure that only medicines meeting exact standards of safety, quality and efficacy are authorised for human and animal use. At the same time, competitiveness and innovation must be stimulated. Without innovation in pharmaceuticals, the incurable diseases of today will remain incurable. Competitiveness drives innovation and innovation saves lives. Increased competitiveness of the pharmaceutical sector will not only better protect public health, but will also create high quality jobs and create growth. In this context the implementation of the G10 recommendations, particularly regarding the pricing and reimbursement of medicines by Member States, remains a considerable challenge. In order to make potentially life-saving pharmaceuticals available as soon as possible to patients and to enable industry to quickly recoup its investments and to reinvest into future R&D, still existing delays in some Member States between marketing authorization and the selling of the medicine have to be minimized. The proposed paediatric regulation, currently under discussion in Council and Parliament, is another example where a better protection of (childrens) health goes together with a stimulation of competitiveness and innovation in the European pharmaceutical industry. This publication focuses on the recent review of the EU pharmaceutical legislation. The revised legislation is a key part of the above-mentioned dual strategy.

Guide To The Quality And Safety Of Tissues And Cells For Human Application

Author : European Directorate for the Quality of Medicines & Healthcare
ISBN : 9287176396
Genre : Cell transplantation
File Size : 54. 7 MB
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This guide provides state-of-the-art information in order to maximise the quality and minimise the risks during donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells. As with all transplanted material of human origin, tissues and cells carry risks of disease transmission, which must be controlled by the application of scrupulous donor selection criteria (including testing) and comprehensive quality systems. The idea behind this guide is to help professionals on a practical level by providing generic guidance that will help improve the rate of successful clinical application of tissues and cells. The guide makes reference to EU mandatory requirements where appropriate and describes generally-accepted good practice. It has been divided into two parts. Part A contains general requirements applicable to all establishments involved in the donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells. Part B contains specific guidelines and requirements for the different tissue and/or cell types

The Immortal Life Of Henrietta Lacks

Author : Rebecca Skloot
ISBN : 0307589382
Genre : Science
File Size : 82. 55 MB
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Now an HBO® Film starring Oprah Winfrey and Rose Byrne #1 NEW YORK TIMES BESTSELLER Her name was Henrietta Lacks, but scientists know her as HeLa. She was a poor black tobacco farmer whose cells—taken without her knowledge in 1951—became one of the most important tools in medicine, vital for developing the polio vaccine, cloning, gene mapping, and more. Henrietta's cells have been bought and sold by the billions, yet she remains virtually unknown, and her family can't afford health insurance. This phenomenal New York Times bestseller tells a riveting story of the collision between ethics, race, and medicine; of scientific discovery and faith healing; and of a daughter consumed with questions about the mother she never knew.

Ethics Of Emerging Technologies

Author : Thomas F. Budinger
ISBN : STANFORD:36105114451961
Genre : Technology & Engineering
File Size : 76. 87 MB
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An insightful guide to understanding and navigating the ethical issues faced by anyone affected by the ethical dilemmas associated with current and emerging technologies Ethics of Emerging Technologies provides the background, insight, and tools for approaching and solving ethical dilemmas across a broad range of topics. The text discusses ethical problems, using examples and reasoning tools that will aid engineers, scientists, managers, administrators, and the public who wish to understand risks, benefits, and possible approaches to resolving conflicts associated with new technologies in the context of the global community. Solutions we choose to ethical dilemmas accompanying new technologies will profoundly affect future generations. Scientific facts and guides to decision-making for all associated with emerging technologies are presented. Some of the topics are: * Human health and environmental effects of alternative energy production methods * Communications and privacy * Plagiarism and authorship * Genetic modification of organisms * Human and animal experimentation * Synthetic biology and bioterrorism * Confidentiality in science, engineering, and business communications * Risks and consequences of enhancing human beings through new technologies * Cloning of human beings and stem cell research * Brain modifications * Space exploration

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