Legal and Ethical Regulation of Biomedical Research in Developing Countries

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Publisher : Routledge
ISBN 13 : 1317106415
Total Pages : 377 pages
Book Rating : 4.3/5 (171 download)

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Book Synopsis Legal and Ethical Regulation of Biomedical Research in Developing Countries by : Remigius N. Nwabueze

Download or read book Legal and Ethical Regulation of Biomedical Research in Developing Countries written by Remigius N. Nwabueze and published by Routledge. This book was released on 2016-04-22 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Double Standards in Medical Research in Developing Countries

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Publisher : Cambridge University Press
ISBN 13 : 9780521541701
Total Pages : 292 pages
Book Rating : 4.5/5 (417 download)

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Book Synopsis Double Standards in Medical Research in Developing Countries by : Ruth Macklin

Download or read book Double Standards in Medical Research in Developing Countries written by Ruth Macklin and published by Cambridge University Press. This book was released on 2004-05-27 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 Policy Issues in International Research

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Publisher :
ISBN 13 :
Total Pages : 166 pages
Book Rating : 4.3/5 ( download)

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Book Synopsis Ethical and Policy Issues in International Research by : United States. National Bioethics Advisory Commission

Download or read book Ethical and Policy Issues in International Research written by United States. National Bioethics Advisory Commission and published by . This book was released on 2001 with total page 166 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Human Medical Research

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Author :
Publisher : Springer Science & Business Media
ISBN 13 : 3034803893
Total Pages : 192 pages
Book Rating : 4.0/5 (348 download)

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Book Synopsis Human Medical Research by : Jan Schildmann

Download or read book Human Medical Research written by Jan Schildmann and published by Springer Science & Business Media. This book was released on 2012-03-14 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Health Research Governance in Africa

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Publisher : Routledge
ISBN 13 : 1351713051
Total Pages : 268 pages
Book Rating : 4.3/5 (517 download)

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Book Synopsis Health Research Governance in Africa by : Cheluchi Onyemelukwe-Onuobia

Download or read book Health Research Governance in Africa written by Cheluchi Onyemelukwe-Onuobia and published by Routledge. This book was released on 2018-09-06 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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, which are often the sites of these diseases, becomes inevitable. This growth raises questions about domestic regulation and the 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 governance mechanisms, ranging from domestic ethical guidelines to legal frameworks, the strengthening of existing regulatory agencies to the role of professional regulatory bodies. The book analyses the adequacy of current governance arrangements within African countries, and puts forward recommendations to improve the emerging governance systems for health research in African and other developing countries. It book will be a valuable resource for academics, researchers, practitioners and policy-makers working in the areas of health research, biomedical ethics, health law and regulation in developing countries.

The Law and Ethics of Medical Research

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Publisher : Routledge
ISBN 13 : 1135338329
Total Pages : 335 pages
Book Rating : 4.1/5 (353 download)

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Book Synopsis The Law and Ethics of Medical Research by : Aurora Plomer

Download or read book The Law and Ethics of Medical Research written by Aurora Plomer and published by Routledge. This book was released on 2013-03-04 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Ethical and Policy Issues in International Research: Report and recommendations of the National Bioethics Advisory Commission

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Publisher :
ISBN 13 :
Total Pages : 170 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Ethical and Policy Issues in International Research: Report and recommendations of the National Bioethics Advisory Commission by : United States. National Bioethics Advisory Commission

Download or read book Ethical and Policy Issues in International Research: Report and recommendations of the National Bioethics Advisory Commission written by United States. National Bioethics Advisory Commission and published by . This book was released on 2001 with total page 170 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Ethical and Legal Issues in Neurology

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Author :
Publisher : Elsevier Inc. Chapters
ISBN 13 : 0128080876
Total Pages : 472 pages
Book Rating : 4.1/5 (28 download)

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Book Synopsis Ethical and Legal Issues in Neurology by : Timothy Lahey

Download or read book Ethical and Legal Issues in Neurology written by Timothy Lahey and published by Elsevier Inc. Chapters. This book was released on 2014-01-09 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

The Belmont Report

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Publisher :
ISBN 13 :
Total Pages : 614 pages
Book Rating : 4.:/5 (318 download)

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Book Synopsis The Belmont Report by : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Download or read book The Belmont Report written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1978 with total page 614 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Law and Regulation of Clinical Research

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Publisher :
ISBN 13 :
Total Pages : 404 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis The Law and Regulation of Clinical Research by : Pamela A. Andanda

Download or read book The Law and Regulation of Clinical Research written by Pamela A. Andanda and published by . This book was released on 2006 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Globalization and Health

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Publisher : Springer Science & Business Media
ISBN 13 : 1402041969
Total Pages : 225 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Globalization and Health by : Belinda Bennett

Download or read book Globalization and Health written by Belinda Bennett and published by Springer Science & Business Media. This book was released on 2006-06-21 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Within contemporary society, globalization has emerged as a key concern at the centre of ethical, legal and policy debates relating to health care. Conflicts between public interests and individual rights, the challenge of regulating health professionals and access to health services, and the effects of a global market all feature prominently in these discussions. As a result of globalization, these issues can no longer be understood solely within the political boundaries that define traditional notions of individuals and communities. Rather, solutions demand a global conception of rights and obligations, which in turn requires new approaches to health policy formulation and a reevaluation of existing ethical and legal frameworks. In essence, the impact of globalization on human health is testing the robustness of modern regulatory systems, legal doctrines and ethical paradigms. PUBLIC HEALTH: DEVELOPING GLOBAL CONCERNS The interconnectedness of the global economy presents new challenges in public health. While globalization has facilitated improvements in health care, it has also created new hazards and avenues for the exploitation of vulnerable persons. It is becoming increasingly apparent that both national and international responses are required. Indeed, as the chapters in this section convey, public health is rightly a global concern. Globalization has led to a sharing of both risks and responsibilities in public health. Belinda Bennett reminds us of the ease with which infectious diseases can spread within the global community, given the speed of modern travel and trade.

Routledge Handbook of Medical Law and Ethics

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Publisher : Routledge
ISBN 13 : 1134448724
Total Pages : 607 pages
Book Rating : 4.1/5 (344 download)

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Book Synopsis Routledge Handbook of Medical Law and Ethics by : Yann Joly

Download or read book Routledge Handbook of Medical Law and Ethics written by Yann Joly and published by Routledge. This book was released on 2014-09-19 with total page 607 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Ethical and Policy Issues in International Research

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Publisher :
ISBN 13 :
Total Pages : 28 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Ethical and Policy Issues in International Research by : United States. National Bioethics Advisory Commission

Download or read book Ethical and Policy Issues in International Research written by United States. National Bioethics Advisory Commission and published by . This book was released on 2001 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Law and Ethics in Biomedical Research

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Publisher : University of Toronto Press
ISBN 13 : 0802086438
Total Pages : 281 pages
Book Rating : 4.8/5 (2 download)

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Book Synopsis Law and Ethics in Biomedical Research by : Duff William Ramus Waring

Download or read book Law and Ethics in Biomedical Research written by Duff William Ramus Waring and published by University of Toronto Press. This book was released on 2006-01-01 with total page 281 pages. Available in PDF, EPUB and Kindle. Book excerpt: When a young man named Jesse Gelsinger died in 1999 as a result of his participation in a gene transfer research study, regulatory agencies in the United States began to take a closer look at what was happening in medical research. The resulting temporary shutdown of some of the most prestigious academic research centres confirmed what various recent reports in the United States as well as Canada had claimed; that the current system of regulatory oversight was in need of improvement. Law and Ethics in Biomedical Research uses the Gelinger case as a touchstone, illustrating how three major aspects of that case - the flaws in the regulatory system, conflicts of interest, and legal liability - embody the major challenges in the current medical research environment. Editors Trudo Lemmens and Duff R. Waring, along with a host of top scholars in the field, demonstrate why existing models of research review and human subject protection are in need of improvement, and how more stringent regulatory and legal means can be used to strengthen the protection of research subjects and the integrity of research. The contributors also address conflicts of interest, paying particular attention to the growing commercialization of medical research, as well as the legal liability of scientific investigators, research institutions, and governmental agencies. Legal liability is a growing concern in medical research and this fascinating study is, in the international context, one of the first to explore the liability of various parties involved in the research enterprise.

The Ethical Aspects of Biomedical Research in Developing Countries

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Publisher :
ISBN 13 :
Total Pages : 108 pages
Book Rating : 4.:/5 (327 download)

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Book Synopsis The Ethical Aspects of Biomedical Research in Developing Countries by : Katerina Sukovski

Download or read book The Ethical Aspects of Biomedical Research in Developing Countries written by Katerina Sukovski and published by . This book was released on 2003 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Ethical Issues in International Biomedical Research

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Publisher :
ISBN 13 : 0195179226
Total Pages : 401 pages
Book Rating : 4.1/5 (951 download)

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Book Synopsis Ethical Issues in International Biomedical Research by : James V. Lavery

Download or read book Ethical Issues in International Biomedical Research written by James V. Lavery and published by . This book was released on 2007 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

International Ethical Guidelines for Health-Related Research Involving Humans

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Publisher : World Health Organization
ISBN 13 : 9789290360889
Total Pages : 0 pages
Book Rating : 4.3/5 (68 download)

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Book Synopsis International Ethical Guidelines for Health-Related Research Involving Humans by : Council for International Organizations of Medical Sciences (CIOMS)

Download or read book International Ethical Guidelines for Health-Related Research Involving Humans written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2017-01-31 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.