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Acceptable Risk in Biomedical Research

Acceptable Risk in Biomedical Research Author Sigmund Simonsen
ISBN-10 9789400726789
Release 2012-01-04
Pages 296
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This book is the first major work that addresses a core question in biomedical research: the question of acceptable risk. The acceptable level of risks is regulated by the requirement of proportionality in biomedical research law, which state that the risk and burden to the participant must be in proportion to potential benefits to the participant, society or science. This investigation addresses research on healthy volunteers, children, vulnerable subjects, and includes placebo controlled clinical trials. It represents a major contribution towards clarifying the most central, but also the most controversial and complex issue in biomedical research law and bioethics. The EU Clinical Trial Directive, the Council of Europe’s Oviedo Convention (and its Additional Protocol), and national regulation in member states are covered. It is a relevant work for lawyers and ethicists, and the practical approach makes a valuable tool for researchers and members of research ethics committees supervising biomedical research.



Reviewing Clinical Trials

Reviewing Clinical Trials Author Chinese University of Hong Kong
ISBN-10 9881904110
Release 2010
Pages 153
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The idea for this manual came from Pfizer in the US, which provided the Clinical Trials Centre at The University of Hong Kong, Hong Kong SAR, PR China with a nonbinding grant for its development. The general project layout protocol was accepted by Pfizer in July 2009. Pfizer has not in any way interfered with the project, except for providing nonbinding comments to the final product. The entire text of this manual was written by Johan PE Karlberg. Marjorie A Speers provided considerable and essential comments on the contents and the first and subsequent drafts. A group of international human research protection experts mostly working in non-profit institutions or organisations - see Contributors for details - reviewed and provided important comments on the contents and final draft. It was solely created with the intention to promote human research protection of participants in clinical trials. This manual will be translated into numerous languages and is provided free of charge as an electronic file over the Internet (http://www.ClinicalTrialMagnifier.com) and offered in print for a fee. The objective beyond this project is to establish educational activities, developed around the manual, and jointly organised with leading academic institutions worldwide.



Advance Directives

Advance Directives Author Peter Lack
ISBN-10 9789400773776
Release 2013-10-21
Pages 213
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This volume gives an overview on the currently debated ethical issues regarding advance directives from an international perspective. It focuses on a wider understanding of the known and widely accepted concept of patient self-determination for future situations. Although advance directives have been widely discussed since the 1980s, the ethical bases of advance directives still remain a matter of heated debates. The book aims to contribute to these controversial debates by integrating fundamental ethical issues on advance directives with practical matters of their implementation. Cultural, national and professional differences in how advance directives are understood by health care professions and by patients, as well as in laws and regulations, are pinpointed.



The Impact of Off Label Compassionate and Unlicensed Use on Health Care Laws in Preselected Countries

The Impact of Off Label  Compassionate and Unlicensed Use on Health Care Laws in Preselected Countries Author Vanessa Plate
ISBN-10 9783838201351
Release 2010-07-01
Pages 174
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In times of situational therapeutic impasse, health care professionals (HCPs) are under pressure to conduct off-label, unlicensed and compassionate drug use—generally summarized under the term non-licensed drug use (NDU). Liability, contractual and penal risks pose a problem when treating a patient in a non-licensed way. There is a knowledge gap about institutional and governmental methods to resolve these problems. Different countries have developed strategies to manage NDU. Vanessa Platé gives a comprehensive overview of practices Canada, the U.S., the U.K., Japan, France, Germany, Switzerland, Austria, and the transnational E.U. A must-read for everyone interested in the discussion on how to administer the best treatment, especially regarding early access to yet unapproved treatments.



Encyclopedia of Forensic and Legal Medicine

Encyclopedia of Forensic and Legal Medicine Author
ISBN-10 9780128000557
Release 2015-09-29
Pages 3120
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Encyclopedia of Forensic and Legal Medicine, Volumes 1-4, Second Edition is a pioneering four volume encyclopedia compiled by an international team of forensic specialists who explore the relationship between law, medicine, and science in the study of forensics. This important work includes over three hundred state-of-the-art chapters, with articles covering crime-solving techniques such as autopsies, ballistics, fingerprinting, hair and fiber analysis, and the sophisticated procedures associated with terrorism investigations, forensic chemistry, DNA, and immunoassays. Available online, and in four printed volumes, the encyclopedia is an essential reference for any practitioner in a forensic, medical, healthcare, legal, judicial, or investigative field looking for easily accessible and authoritative overviews on a wide range of topics. Chapters have been arranged in alphabetical order, and are written in a clear-and-concise manner, with definitions provided in the case of obscure terms and information supplemented with pictures, tables, and diagrams. Each topic includes cross-referencing to related articles and case studies where further explanation is required, along with references to external sources for further reading. Brings together all appropriate aspects of forensic medicine and legal medicine Contains color figures, sample forms, and other materials that the reader can adapt for their own practice Also available in an on-line version which provides numerous additional reference and research tools, additional multimedia, and powerful search functions Each topic includes cross-referencing to related articles and case studies where further explanation is required, along with references to external sources for further reading



The National Bioethics Advisory Commission

The National Bioethics Advisory Commission Author Elisa Eiseman
ISBN-10 0833033646
Release 2003
Pages 172
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The National Bioethics Advisory Commission (NBAC) was established in 1995 to advise various government entities on issues arising from research on human biology and behavior. During its five-year tenure, NBAC submitted six reports to the White House containing 120 recommendations on several complex bioethical issues including the cloning of human beings and embryonic stem cell research. This study assesses NBAC's contribution to policymaking by tracking the response to NBAC's recommendations from the president, Congress, government, societies and foundations, other countries, and international groups.



Ethics of Animal Use

Ethics of Animal Use Author Peter Sandøe
ISBN-10 9781118691199
Release 2013-05-30
Pages 192
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An interesting and accessible introduction to ethical issues raised by various forms of human use of animals. This textbook avoids moral lecturing and presents a range of ethical viewpoints without defending or applying any specific stance. Readers are encouraged and provoked to reflect for themselves, and to sharpen their own points of view regarding the ethical limits on our use of animals. They will also gain further understanding of the views held by other people. Early chapters of this interdisciplinary book cover changes over time in our view of animals, the principles of animal ethics, and different views of what counts as a good animal life. Later chapters apply the conceptual tools to specific issues including: food animal production, advanced veterinary treatment of pets, control of infectious diseases, wildlife management, as well as the use of animals in research. Specifically designed for students of veterinary medicine, animal science, welfare and behaviour, and veterinary nursing. Also of interest to those wanting to combine an up-to-date, science-based account of animal issues with clear-headed moral reflection. "The book covers an impressive range of topics with accuracy and fairness. Despite its ambitious scope, the authors have achieved remarkable unity in the book, and have produced a book that is easy and pleasant to read. Their work will surely provide a major tool for rationalizing the debate about the ethics of animal use, and I commend them for their invaluable contribution." From the Foreword by Professor Bernard Rollin, Colorado State University.



The Ethical and Legal Regulation of Human Tissue and Biobank Research in Europe

The Ethical and Legal Regulation of Human Tissue and Biobank Research in Europe Author Katharina Beier
ISBN-10 9783863950316
Release 2011
Pages 170
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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.



Registries for Evaluating Patient Outcomes

Registries for Evaluating Patient Outcomes Author Agency for Healthcare Research and Quality/AHRQ
ISBN-10 9781587634338
Release 2014-04-01
Pages 356
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This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.



Ethical Issues in Prison Psychiatry

Ethical Issues in Prison Psychiatry Author Norbert Konrad
ISBN-10 9789400700864
Release 2013-08-23
Pages 434
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Recent surveys demonstrate a high and possibly increasing prevalence of mental disorders in prisoners. They have an increased risk of suffering from a mental disorder that transcends countries and diagnoses. Ethical dilemmas in prison psychiatry arise from resource allocation and include issues of patient choice and autonomy in an inherently coercive environment. Ethical conflicts may arise from the dual role of forensic psychiatrists giving raise to tensions between patient care/protection of the public.This book describes models and ethical issues of psychiatric healthcare in prison in several countries. Relevant issues are: the professional medical role of a psychiatrist and/or psychotherapist working in prison, the involvement of psychiatrists in disciplinary or coercive measures; consent to treatment, the use of coercion in forcing a prisoner to undergo treatment, hunger strike, confidentiality. The book ends with consensus guidelines concerning good practice in Prison Psychiatry.



The Use of Non human Primates in Research

The Use of Non human Primates in Research Author
ISBN-10 OCLC:259709168
Release 2006
Pages 147
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The Use of Non human Primates in Research has been writing in one form or another for most of life. You can find so many inspiration from The Use of Non human Primates in Research also informative, and entertaining. Click DOWNLOAD or Read Online button to get full The Use of Non human Primates in Research book for free.



Toward Precision Medicine

Toward Precision Medicine Author Committee on a Framework for Development a New Taxonomy of Disease
ISBN-10 9780309222228
Release 2011-12-16
Pages 142
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Motivated by the explosion of molecular data on humans-particularly data associated with individual patients-and the sense that there are large, as-yet-untapped opportunities to use this data to improve health outcomes, Toward Precision Medicine explores the feasibility and need for "a new taxonomy of human disease based on molecular biology" and develops a potential framework for creating one. The book says that a new data network that integrates emerging research on the molecular makeup of diseases with clinical data on individual patients could drive the development of a more accurate classification of diseases and ultimately enhance diagnosis and treatment. The "new taxonomy" that emerges would define diseases by their underlying molecular causes and other factors in addition to their traditional physical signs and symptoms. The book adds that the new data network could also improve biomedical research by enabling scientists to access patients' information during treatment while still protecting their rights. This would allow the marriage of molecular research and clinical data at the point of care, as opposed to research information continuing to reside primarily in academia. Toward Precision Medicine notes that moving toward individualized medicine requires that researchers and health care providers have access to very large sets of health- and disease-related data linked to individual patients. These data are also critical for developing the information commons, the knowledge network of disease, and ultimately the new taxonomy.



And the Band Played On

And the Band Played On Author Randy Shilts
ISBN-10 142993039X
Release 2007-11-27
Pages 656
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Upon it's first publication twenty years ago, And The Band Played on was quickly recognized as a masterpiece of investigative reporting. An international bestseller, a nominee for the National Book Critics Circle Award, and made into a critically acclaimed movie, Shilts' expose revealed why AIDS was allowed to spread unchecked during the early 80's while the most trusted institutions ignored or denied the threat. One of the few true modern classics, it changed and framed how AIDS was discussed in the following years. Now republished in a special 20th Anniversary edition, And the Band Played On remains one of the essential books of our time.



European Law and New Health Technologies

European Law and New Health Technologies Author Mark L Flear
ISBN-10 9780199659210
Release 2013-03-14
Pages 442
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New health technologies promise great things but they also pose significant challenges for governments, particularly around safety concerns, effectiveness, and value for money. This collection analyses the defining features of the relationship between EU law and new technologies, and the roles of risk, rights, ethics, and markets.



Engineering Ethics Concepts and Cases

Engineering Ethics  Concepts and Cases Author Charles E. Harris, Jr.
ISBN-10 9781337670746
Release 2018-01-01
Pages 50
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Packed with examples pulled straight from recent headlines, ENGINEERING ETHICS, Sixth Edition, helps engineers understand the importance of their conduct as professionals as well as reflect on how their actions can affect the health, safety and welfare of the public and the environment. Numerous case studies give readers plenty of hands-on experience grappling with modern-day ethical dilemmas, while the book's proven and structured method for analysis walks readers step by step through ethical problem-solving techniques. It also offers practical application of the Engineering Code of Ethics and thorough coverage of critical moral reasoning, effective organizational communication, sustainability and economic development, risk management, ethical responsibilities, globalized standards for engineering and emerging challenges relating to evolving technology. Important Notice: Media content referenced within the product description or the product text may not be available in the ebook version.



Public Health Ethics Cases Spanning the Globe

Public Health Ethics  Cases Spanning the Globe Author Drue H. Barrett
ISBN-10 9783319238470
Release 2016-04-12
Pages 329
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This Open Access book highlights the ethical issues and dilemmas that arise in the practice of public health. It is also a tool to support instruction, debate, and dialogue regarding public health ethics. Although the practice of public health has always included consideration of ethical issues, the field of public health ethics as a discipline is a relatively new and emerging area. There are few practical training resources for public health practitioners, especially resources which include discussion of realistic cases which are likely to arise in the practice of public health. This work discusses these issues on a case to case basis and helps create awareness and understanding of the ethics of public health care. The main audience for the casebook is public health practitioners, including front-line workers, field epidemiology trainers and trainees, managers, planners, and decision makers who have an interest in learning about how to integrate ethical analysis into their day to day public health practice. The casebook is also useful to schools of public health and public health students as well as to academic ethicists who can use the book to teach public health ethics and distinguish it from clinical and research ethics.



Communicating Risks and Benefits

Communicating Risks and Benefits Author Baruch Fischhoff
ISBN-10 0160901790
Release 2012-03-08
Pages 240
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Effective risk communication is essential to the well-being of any organization and those people who depend on it. Ineffective communication can cost lives, money and reputations. Communicating Risks and Benefits: An Evidence-Based User’s Guide provides the scientific foundations for effective communications. The book authoritatively summarizes the relevant research, draws out its implications for communication design, and provides practical ways to evaluate and improve communications for any decision involving risks and benefits. Topics include the communication of quantitative information and warnings, the roles of emotion and the news media, the effects of age and literacy, and tests of how well communications meet the organization’s goals. The guide will help users in any organization, with any budget, to make the science of their communications as sound as the science that they are communicating.