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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.

Routledge Handbook of Medical Law and Ethics

Routledge Handbook of Medical Law and Ethics Author Yann Joly
ISBN-10 9781134448722
Release 2014-09-19
Pages 492
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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 Dr Irehobhude O Iyioha
ISBN-10 9781472436757
Release 2015-02-28
Pages 332
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The collection provides a comparative analysis of relevant health policies and laws in Nigeria, 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.

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.

Ethical and Legal Issues in Neurology

Ethical and Legal Issues in Neurology Author Timothy Lahey
ISBN-10 9780128080870
Release 2014-01-09
Pages 472
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The increasing conduct of clinical research in low- and middle-income countries (LMIC) is motivated by the desire to promote host country access to biomedical research, to enhance LMIC access to modern clinical care, and opportunities to conduct research with simpler regulatory requirements and at lower cost. Yet clinical research in LMIC is associated with ethical risks beyond those of clinical research conducted in high-income countries (HIC). Ethical challenges particular to clinical research in LMIC include the conduct of placebo-controlled clinical trials in LMIC despite HIC availability of effective comparator interventions, obtaining informed consent despite power inequities, and the obligation of HIC researchers to redress health disparities in LMIC. This chapter covers these and additional ethical challenges of clinical research in LMIC, and proposes ways to navigate these challenges through awareness, regulatory oversight, consultation, and collaboration with LMIC investigators and community representatives. With its ethical challenges properly managed, clinical research in LMIC provides historic opportunities to bring biomedical research and better healthcare infrastructure to countries previously left behind in the modern rush to biomedical innovation.

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.

United States Participation in Clinical Research in Developing Countries

United States Participation in Clinical Research in Developing Countries Author Institute of Medicine (U.S.)
ISBN-10 NAP:13817
Release 1980
Pages 34
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United States Participation in Clinical Research in Developing Countries has been writing in one form or another for most of life. You can find so many inspiration from United States Participation in Clinical Research in Developing Countries also informative, and entertaining. Click DOWNLOAD or Read Online button to get full United States Participation in Clinical Research in Developing Countries book for free.

A Gateway to Biomedical Research in Africa

A Gateway to Biomedical Research in Africa Author Takafira Mduluza
ISBN-10 1600214444
Release 2007
Pages 184
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This book reveals the necessary steps required by researchers from both developing and industrialised areas to conduct biomedical research in resource poor communities. This book goes beyond the ethical consideration and concentrates on issues considered minor by many researchers during planning of their research conduct. The communities considered are diverse both culturally and geographically. The communities are exposed by the authors with several years' experience working in the area on hierarchy, beliefs and fears, the economical and social aspects. Probably the education levels and how this is developing, impacting on research have been discussed. The boundaries and religions that make each community as an important aspect demarcating Africa into the social structures. Planning and preparing to undertake biomedical research in resource poor communities of Africa goes even deeper than the normal ethical considerations.

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.

The Limits of Consent

The Limits of Consent Author Oonagh Corrigan
ISBN-10 9780199231461
Release 2009-01-29
Pages 234
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Informed consent in medical research : a procedure stretched beyond breaking point? / Søren Holm and Søren Madsen -- Trust and exploitation in clinical research / Paul B. Miller and Charles Weijer -- Consent and private liability in clinical research / Paul B. Miller and Josephine Johnston -- The decision to decline to enroll in a clinical trial : a blind spot in the literature on decision-making for research participation / Clare Snowdon, Diana Elbourne, and Jo Garcia -- Beyond a rebarbative commitment to consent / Kathy Liddell -- The normative status of the requirement to gain an informed consent in clinical trials : comprehension, obligations, and empirical evidence / Angus Dawson.

Medical Law A Very Short Introduction

Medical Law  A Very Short Introduction Author Charles Foster
ISBN-10 9780191636011
Release 2013-02-28
Pages 144
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Medical law is concerned with our bodies, and what happens to them during and after our lives. When things go wrong with our bodies, we want to know what our rights are, and what governs the conduct of the clinicians into whose hands we put our lives and limbs. Dealing with matters of life and death, it can therefore have a fundamental impact on medical practice. Headlines in the media often involve the core issues of medical law - organ transplantation, abortion, withdrawal of treatment, euthanasia, confidentiality, research on humans - these are topics that affect us all. Headlines can misrepresent, however. In order to fully understand the issues and their relevance, we have to delve into the cases and into the principles behind them. In this highly readable Very Short Introduction, Charles Foster explores different examples to illustrate the key problems and principles of medical law. ABOUT THE SERIES: The Very Short Introductions series from Oxford University Press contains hundreds of titles in almost every subject area. These pocket-sized books are the perfect way to get ahead in a new subject quickly. Our expert authors combine facts, analysis, perspective, new ideas, and enthusiasm to make interesting and challenging topics highly readable.

Health Research Governance in Africa

Health Research Governance in Africa Author Cheluchi Onyemelukwe-Onuobia
ISBN-10 1138036773
Release 2018-08-15
Pages 288
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The globalisation of research has resulted in the increased location of research involving humans in developing countries. Countries in Africa, along with China and India have seen research grow significantly. With emerging infectious diseases, such as Ebola and Zika emphasising the risk of public health crises throughout the world, a further increase in health research, including clinical research in developing countries, often the sites of these diseases, becomes inevitable. This growth raises questions about domestic regulation and governance of health research. This book presents a comprehensive and systemic view of the regulation of research involving humans in African countries. It employs case studies from four countries in which research activities continue to rise and which have taken steps to regulate health research activity: South Africa, Nigeria, Kenya and Egypt. The book examines the historical and political contexts of these governance efforts. It describes the research context, some of the research taking place, and the current challenges. It also looks at the mechanisms ranging from new ethical guidelines, legal frameworks, the strengthening of existing regulatory agencies and the professional regulatory bodies. The book analyses the adequacy of current governance arrangements and puts forward recommendations to improve the emerging governance systems for health research in African and other developing countries. The book will be a valuable resource for academics, researchers, practitioners and policy-makers working in the area of health research, biomedical ethics, health law and regulation in developing countries.

Silent Partners

Silent Partners Author Rebecca Dresser
ISBN-10 9780190459277
Release 2016-11-01
Pages 320
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When is a human study ethical? For years, science and society have struggled with this question. Experts have put great effort into developing ethical principles and rules that adequately protect and respect volunteers in studies aimed at improving human health. But experts have missed something important. They have created a research ethics system without the help of people who know what it is like to be a research subject. This is a serious omission. Experienced research subjects can make valuable contributions to research ethics. People who have been in studies have information about the experience that other people can overlook. Their experience as subjects gives them special insights into ethics, too. Experienced subjects also know about problems that can lead people to refuse to join studies, or drop out before studies are complete. Scientists and ethicists often speak of subjects as partners in research, but the reality is quite different. Experienced subjects are rarely appointed to the advisory groups that create guidelines for ethical research, or to the committees that review individual studies to determine whether they meet ethical and regulatory standards. A large body of work describes the perceptions and viewpoints of people who have participated in research. But experts rarely use this material to guide improvements in human subject protection. Although subjects have the power to decide whether to participate in a study, they have little control over anything else that goes on in research. Silent Partners moves research subjects to the forefront. It examines what research participation is like for healthy volunteers and patients. It explains why subjects' voices should influence research ethics. Silent Partners shows how experienced research subjects can become real-not just symbolic-partners in research.

Legislating an Epidemic

Legislating an Epidemic Author
Release 2003
Pages 349
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Legislating an Epidemic has been writing in one form or another for most of life. You can find so many inspiration from Legislating an Epidemic also informative, and entertaining. Click DOWNLOAD or Read Online button to get full Legislating an Epidemic book for free.

The Use of Human Beings in Research

The Use of Human Beings in Research Author S.F. Spicker
ISBN-10 9789400927056
Release 2012-12-06
Pages 294
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This volume, which has developed from the Fourteenth Trans Disciplinary Symposium on Philosophy and Medicine, September 5-8, 1982, at Tel Aviv University, Israel, contains the contributions of a group of distinguished scholars who together examine the ethical issues raised by the advance of biomedical science and technology. We are, of course, still at the beginning of a revolution in our understanding of human biology; scientific medicine and clinical research are scarcely one hundred years old. Both the sciences and the technology of medicine until ten or fifteen years ago had the feeling of the 19th century about them; we sense that they belonged to an older time; that era is ending. The next twenty-five to fifty years of investigative work belong to neurobiology, genetics, and reproductive biology. The technologies of information processing and imaging will make diagnosis and treatment almost incomprehensible by my generation of physicians. Our science and technology will become so powerful that we shall require all of the art and wisdom we can muster to be sure that they remain dedicated, as Francis Bacon hoped four centuries ago, "to the uses of life." It is well that, as philosophers and physicians, we grapple with the issues now when they are relatively simple, and while the pace of change is relatively slow. We require a strategy for the future; that strategy must be worked out by scientists, philosophers, physicians, lawyers, theologians, and, I should like to add, artists and poets.

The Globalization of Health Care

The Globalization of Health Care Author I. Glenn Cohen
ISBN-10 9780199324125
Release 2013-03-19
Pages 480
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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.