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Legal and Ethical Regulation of Biomedical Research in Developing Countries

Legal and Ethical Regulation of Biomedical Research in Developing Countries Author Remigius N. Nwabueze
ISBN-10 9781317106425
Release 2016-04-22
Pages 334
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There has been a rapid increase in the pace and scope of international collaborative research in developing countries in recent years. This study argues that whilst ethical regulation of biomedical research in Africa and other developing countries has attracted global attention, legal liability issues, such as the application of common law rules and the development of legally enforceable regulations, have been neglected. It examines some of the major research scandals in Africa and suggests a new ethical framework against which clinical trials could be conducted. The development of research guidelines in Uganda, Tanzania, Malawi and Nigeria are also examined as well as the role of ethics committees. Providing a detailed analysis of the law of negligence and its application to research ethics committees and their members, common law and constitutional forms of action and potential negligence claims, the book concludes by suggesting new protocols and frameworks, improved regulation and litigation. This book will be a valuable guide for students, researchers, and policy-makers with an interest in medical law and ethics, bioethics, customary law in Africa and regulation in developing countries.



Human Medical Research

Human Medical Research Author Jan Schildmann
ISBN-10 9783034803908
Release 2012-03-12
Pages 188
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Medical research involving human subjects has contributed to considerable advancements in our knowledge, and to medical benefits. At the same time the development of new technologies as well as further globalisation of medical research raises questions that require the attention of researchers from a range of disciplines. This book gathers the contributions of researchers from nine different countries, who analyse recent developments in medical research from ethical, historical, legal and socio-cultural perspectives. In addition to reflections on innovations in science such as genetic databases and the concept of “targeted therapy” the book also includes analyses regarding the ethico-legal regulation of new technologies such as human tissue banking or the handling of genetic information potentially relevant for participants in medical research. Country and culture-specific aspects that are relevant to human medical research from a global perspective also play a part. The value of multi- and interdisciplinary analysis that includes the perspectives of scholars from normative and empirical disciplines is a shared premise of each contribution.



Double Standards in Medical Research in Developing Countries

Double Standards in Medical Research in Developing Countries Author Ruth Macklin
ISBN-10 0521541700
Release 2004-05-27
Pages 280
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Recent international developments show that essential medications can be made affordable and accessible to developing countries, and that double standards need not prevail. This is the first book to examine these issues, drawing the bold conclusion that double standards in medical research are ethically unacceptable."--BOOK JACKET.



Routledge Handbook of Medical Law and Ethics

Routledge Handbook of Medical Law and Ethics Author Yann Joly
ISBN-10 9781134448654
Release 2014-09-19
Pages 480
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This book explores the scope, application and role of medical law, regulatory norms and ethics, and addresses key challenges introduced by contemporary advances in biomedical research and healthcare. While mindful of national developments, the handbook supports a global perspective in its approach to medical law. Contributors include leading scholars in both medical law and ethics, who have developed specially commissioned pieces in order to present a critical overview and analysis of the current state of medical law and ethics. Each chapter offers comprehensive coverage of longstanding and traditional topics in medical law and ethics, and provides dynamic insights into contemporary and emerging issues in this heavily debated field. Topics covered include: Bioethics, health and human rights Medical liability Law and emerging health technologies Public health law Personalized medicine The law and ethics of access to medicines in developing countries Medical research in the genome era Emerging legal and ethical issues in reproductive technologies This advanced level reference work will prove invaluable to legal practitioners, scholars, students and researchers in the disciplines of law, medicine, genetics, dentistry, theology, and medical ethics.



Comparative Health Law and Policy

Comparative Health Law and Policy Author Irehobhude O. Iyioha
ISBN-10 9781472436771
Release 2015-02-28
Pages 348
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Health law and policy in Nigeria is an evolving and complex field of law, spanning a broad legal landscape and drawn from various sources. In addressing and interacting with these sources the volume advances research on health care law and policy in Nigeria and spells the beginning of what may now be formally termed the ‘Nigerian health law and policy’ legal field. The collection provides a comparative analysis of relevant health policies and laws, such as reproductive and sexual health policy, organ donation and transplantation, abortion and assisted conception, with those in the United Kingdom, United States, Canada and South Africa. It critically examines the duties and rights of physicians, patients, health institutions and organizations, and government parastatals against the backdrop of increased awareness of rights among patient populations. The subjects, which are discussed from a legal, ethical and policy-reform perspective, critique current legislation and policies and make suggestions for reform. The volume presents a cohesive, comparative, and comprehensive analysis of the state of health law and policy in Nigeria with those in the US, Canada, South Africa, and the UK. As such, it provides a valuable comparison between Western and Non-Western countries.



Research Ethics in Africa

Research Ethics in Africa Author Mariana Kruger
ISBN-10 9781920689308
Release 2014-06-01
Pages 224
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The aim of this book is to provide research ethics committee members with a resource that focuses on research ethics issues in Africa. The authors are currently active in various aspects of research ethics in Africa and the majority have been trained in the past by either the Fogarty International Center or Europe and Developing Countries Clinical Trial Partnership (EDCTP) sponsored bioethics training programmes .



Ethical and Regulatory Aspects of Clinical Research

Ethical and Regulatory Aspects of Clinical Research Author Ezekiel J. Emanuel
ISBN-10 UOM:39015058788673
Release 2003-09-30
Pages 490
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"Many of the chapters easily deserve to be required reading... Most of the readings that have been chosen for the book can lay claim to being classics. They represent sophisticated thinking on various topics." -- Bulletin of the World Health Organization "This book provides excellent matieral on a broad variety of ethical topics in clinical research." -- Quality Assurance Journal All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical trial process.



Human Population Genetic Research in Developing Countries

Human Population Genetic Research in Developing Countries Author Yue Wang
ISBN-10 9781135047115
Release 2013-11-12
Pages 255
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Human population genetic research (HPGR) seeks to identify the diversity and variation of the human genome and how human group and individual genetic diversity has developed. This book asks whether developing countries are well prepared for the ethical and legal conduct of human population genetic research, with specific regard to vulnerable target group protection. The book highlights particular issues raised by genetic research on populations as a whole, such as the potential harm specific groups may suffer in genetic research, and the capacity for current frameworks of Western developed countries to provide adequate protections for these target populations. Using The People’s Republic of China as a key example, Yue Wang argues that since the target groups of HPGR are almost always from isolated and rural areas of developing countries, the ethical and legal frameworks for human subject protection need to be reconsidered in order to eliminate, or at least reduce, the vulnerability of those groups. While most discussion in this field focuses on the impact of genetic research on individuals, this book breaks new ground in exploring how the interests of target groups are also seriously implicated in genetic work. In evaluating current regulations concerning prevention of harm to vulnerable groups, the book also puts forward an alternative model for group protection in the context of human population genetic research in developing countries. The book will be of great interest to students and academics of medical law, ethics, and the implications of genetic research.



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.



Issues in Medical Research Ethics

Issues in Medical Research Ethics Author Jürgen Boomgaarden
ISBN-10 1571816011
Release 2003-01
Pages 136
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With the advances of medicine, questions of medical ethics have become more urgent and are now considered of great social and political significance. An innovatively designed, activity-based workbook, this text was prepared using papers and case studies collected from several countries in the European Union. It reflects the issues and concerns that confront clinical practitioners throughout Europe and elsewhere today and presents varying national responses in law and policy to these concerns, as identified by ethicists, lawyers, theologians and practitioners. The problems they examine include the relationship between medical research and medical practice, elementary regulations of medical research, the complexity of informed consent, and the role of the sponsor or scientific community.



Ethical Issues in International Biomedical Research

Ethical Issues in International Biomedical Research Author James V. Lavery
ISBN-10 9780195179224
Release 2007
Pages 371
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Ethical Issues in International Biomedical Research is the definitive book on the ethics of research involving human subjects in developing countries. Using 21 actual case studies, it covers the most controversial topics, including the ethics of placebo research in Africa, what benefits should be provided to the community after completion of a research trial, how to address conflicts between IRBs in developed and developing countries, and undue inducement of poor people in developing countries. Each case is accompanied by two expert commentaries, written by many of the worlds leading experts in bioethics as well as new voices with research experience in developing countries. No other volume has this scope. Students in bioethics, public and international health, and ethics will find this book particularly useful.



Ethical Imperialism

Ethical Imperialism Author Zachary M. Schrag
ISBN-10 0801899141
Release 2010-09-01
Pages 264
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This short, smart analysis will engage scholars across academia.



The Law and Ethics of Medical Research

The Law and Ethics of Medical Research Author Aurora Plomer
ISBN-10 9781135338329
Release 2013-03-04
Pages 158
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The growing globalization of medical research and the application of new biotechnologies in morally contested areas has forced a revision of international ethical guidelines. This book examines the controversies surrounding biomedical research in the twenty-first century from a human rights perspective, analyzing the evolution and changes in form and content of international instruments regulating the conduct of biomedical research. The approach adopted is comparative and includes an evaluation of human rights and UK and US law on embryonic stem cell research, the HIV/AIDS trials in the developing world, the Alder Hey Inquiry and the human radiation and nerve gas experiments on human subjects in the US and the UK. This is the first book to analyze some of the major issues in biomedical research today from an international, comparative human rights perspective.



The Globalization of Health Care

The Globalization of Health Care Author I. Glenn Cohen
ISBN-10 9780199917907
Release 2013-04-11
Pages 454
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The Globalization of Health Care is the first book to offer a comprehensive legal and ethical analysis of the most interesting and broadest reaching development in health care of the last twenty years: its globalization. It ties together the manifestation of this globalization in four related subject areas - medical tourism, medical migration (the physician "brain drain"), telemedicine, and pharmaceutical research and development, and integrates them in a philosophical discussion of issues of justice and equity relating to the globalization of health care. The time for such an examination is right. Medical tourism and telemedicine are growing multi-billion-dollar industries affecting large numbers of patients. The U.S. heavily depends on foreign-trained doctors to staff its health care system, and nearly forty percent of clinical trials are now run in the developing world, with indications of as much of a 10-fold increase in the past 20 years. NGOs across the world are agitating for increased access to necessary pharmaceuticals in the developing world, claiming that better access to medicine would save millions from early death at a relatively low cost. Coming on the heels of the most expansive reform to U.S. health care in fifty years, this book plots the ways in which this globalization will develop as the reform is implemented.



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.



Principles and Practice of Clinical Research

Principles and Practice of Clinical Research Author John I. Gallin
ISBN-10 9780128499047
Release 2017-11-17
Pages 824
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Principles and Practice of Clinical Research, Fourth Edition has been thoroughly revised to provide a comprehensive look at both the fundamental principles and expanding practice of clinical research. New to this edition of this highly regarded reference, authors have focused on examples that broadly reflect clinical research on a global scale while including a discussion of international regulations, studies, and implications. In addition to key topics such as bioethics, clinical outcome data, cultural diversity, protocol guidelines, and “omic platforms, this edition contains new chapters devoted to electronic health records and information resources for clinical researchers, as well as the many opportunities associated with big data. Covering a vast number of topics and practical advice for both novice and advanced clinical investigators, this book is a highly relevant and essential resource for all those involved in conducting research. Features input from experts in the field dedicated to translating scientific research from bench to bedside and back Provides expanded coverage of global clinical research Contains hands-on, practical suggestions, illustrations, and examples throughout Includes new chapters on the international regulation of drugs and biologics, the emergence of the important role of comparative effectiveness research and how to identify clinical risks and manage patient safety in a clinical research setting



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.