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The Law and Ethics of Medical Research

Author: Aurora Plomer

Publisher: Routledge

Published: 2013-03-04

Total Pages: 335

ISBN-13: 1135338329

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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.

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.

Clinical Research and the Law

Author: Patricia M. Tereskerz

Publisher: John Wiley & Sons

Published: 2012-05-07

Total Pages: 295

ISBN-13: 1405195673

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This book provides a comprehensive resource for medical professionals on the various legal aspects involved in conducting clinical research. It encompasses legal and ethical issues such as duty of care, research malpractice and negligence, standards of care, informed consent, liability issues for Institutional Review Boards (IRB), conflicts of interest, insider trading and the disclosure and withholding of clinical trial results. It will also provide legal guidance on research contracts, setting up clinical trials and common legal pitfalls encountered in medical research.

Book Synopsis Clinical Research and the Law by : Patricia M. Tereskerz

Download or read book Clinical Research and the Law written by Patricia M. Tereskerz and published by John Wiley & Sons. This book was released on 2012-05-07 with total page 295 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive resource for medical professionals on the various legal aspects involved in conducting clinical research. It encompasses legal and ethical issues such as duty of care, research malpractice and negligence, standards of care, informed consent, liability issues for Institutional Review Boards (IRB), conflicts of interest, insider trading and the disclosure and withholding of clinical trial results. It will also provide legal guidance on research contracts, setting up clinical trials and common legal pitfalls encountered in medical research.

Law and Ethics in Biomedical Research

Author: Duff William Ramus Waring

Publisher: University of Toronto Press

Published: 2006-01-01

Total Pages: 281

ISBN-13: 0802086438

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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.

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.

Ethical Issues in Clinical Research

Author: Bernard Lo

Publisher: Lippincott Williams & Wilkins

Published: 2012-03-28

Total Pages: 302

ISBN-13: 1451152779

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This book teaches researchers how to resolve the ethical dilemmas that can arise at any stage in clinical research. In addition to explaining pertinent regulations and laws, Dr. Lo helps investigators understand the gaps and uncertainties in regulations, as well as situations in which merely complying with the law may not fulfill ethical responsibilities. Most chapters include real-life examples that the author walks through, discussing the salient issues and how to approach them. This book can be used in courses on research ethics that are required or encouraged by major National Institutes of Health grants in academic health centers.

Book Synopsis Ethical Issues in Clinical Research by : Bernard Lo

Download or read book Ethical Issues in Clinical Research written by Bernard Lo and published by Lippincott Williams & Wilkins. This book was released on 2012-03-28 with total page 302 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book teaches researchers how to resolve the ethical dilemmas that can arise at any stage in clinical research. In addition to explaining pertinent regulations and laws, Dr. Lo helps investigators understand the gaps and uncertainties in regulations, as well as situations in which merely complying with the law may not fulfill ethical responsibilities. Most chapters include real-life examples that the author walks through, discussing the salient issues and how to approach them. This book can be used in courses on research ethics that are required or encouraged by major National Institutes of Health grants in academic health centers.

Legal and Ethical Regulation of Biomedical Research in Developing Countries

Author: Remigius N. Nwabueze

Publisher: Routledge

Published: 2016-04-22

Total Pages: 377

ISBN-13: 1317106415

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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.

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.

Manual for Research Ethics Committees

Author: Sue Eckstein

Publisher: Cambridge University Press

Published: 2003-02-20

Total Pages: 584

ISBN-13: 9780521810043

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The sixth edition of the Manual for Research Ethics Committees was first published in 2003, and is a unique compilation of legal and ethical guidance which will prove useful for members of research ethics committees, researchers involved in research with humans, members of the pharmaceutical industry and students of law, medicine, ethics and philosophy.

Book Synopsis Manual for Research Ethics Committees by : Sue Eckstein

Download or read book Manual for Research Ethics Committees written by Sue Eckstein and published by Cambridge University Press. This book was released on 2003-02-20 with total page 584 pages. Available in PDF, EPUB and Kindle. Book excerpt: The sixth edition of the Manual for Research Ethics Committees was first published in 2003, and is a unique compilation of legal and ethical guidance which will prove useful for members of research ethics committees, researchers involved in research with humans, members of the pharmaceutical industry and students of law, medicine, ethics and philosophy.

Healthcare Research Ethics and Law

Author: Hazel Biggs

Publisher: Routledge

Published: 2009-10-16

Total Pages: 233

ISBN-13: 1135309272

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The book explores and explains the relationship between law and ethics in the context of medically related research in order to provide a practical guide to understanding for members of research ethics committees (RECs), professionals involved with medical research and those with an academic interest in the subject. Healthcare Research Ethics and Law sets out the law as it relates to the functions of Research Ethics Committees (RECs) within the context of the process of ethical review and aims to be accessible and readily understood by REC members. Each chapter begins by locating the material within the practical context of ethical review and then provides a more theoretical and analytical discussion detailing how the theory and practice fit together. The key legal issues of confidentiality, consent and negligence are addressed in detail, alongside practical guidance as to how and when liability may be incurred in these areas. In addition, the practical and legal implications of the implementation of European Directive 2001/20/EC, the Human Tissue Act 2004 and the Mental Capacity Act 2005 are considered alongside a discussion of their socio-political background and relevance for medical research in the UK.

Book Synopsis Healthcare Research Ethics and Law by : Hazel Biggs

Download or read book Healthcare Research Ethics and Law written by Hazel Biggs and published by Routledge. This book was released on 2009-10-16 with total page 233 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book explores and explains the relationship between law and ethics in the context of medically related research in order to provide a practical guide to understanding for members of research ethics committees (RECs), professionals involved with medical research and those with an academic interest in the subject. Healthcare Research Ethics and Law sets out the law as it relates to the functions of Research Ethics Committees (RECs) within the context of the process of ethical review and aims to be accessible and readily understood by REC members. Each chapter begins by locating the material within the practical context of ethical review and then provides a more theoretical and analytical discussion detailing how the theory and practice fit together. The key legal issues of confidentiality, consent and negligence are addressed in detail, alongside practical guidance as to how and when liability may be incurred in these areas. In addition, the practical and legal implications of the implementation of European Directive 2001/20/EC, the Human Tissue Act 2004 and the Mental Capacity Act 2005 are considered alongside a discussion of their socio-political background and relevance for medical research in the UK.

First Do No Harm

Author: Sheila A. M. McLean

Publisher: Routledge

Published: 2016-04-15

Total Pages: 622

ISBN-13: 1317134982

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This collection brings together essays from leading figures in the field of medical law and ethics which address the key issues currently challenging scholars in the field. It has also been compiled as a lasting testimony to the work of one of the most eminent scholars in the area, Professor Ken Mason. The collection marks the academic crowning of a career which has laid one of the foundation stones of an entire discipline. The wide-ranging contents and the standing of the contributors mean that the volume will be an invaluable resource for anyone studying or working in medical law or medical ethics.

Book Synopsis First Do No Harm by : Sheila A. M. McLean

Download or read book First Do No Harm written by Sheila A. M. McLean and published by Routledge. This book was released on 2016-04-15 with total page 622 pages. Available in PDF, EPUB and Kindle. Book excerpt: This collection brings together essays from leading figures in the field of medical law and ethics which address the key issues currently challenging scholars in the field. It has also been compiled as a lasting testimony to the work of one of the most eminent scholars in the area, Professor Ken Mason. The collection marks the academic crowning of a career which has laid one of the foundation stones of an entire discipline. The wide-ranging contents and the standing of the contributors mean that the volume will be an invaluable resource for anyone studying or working in medical law or medical ethics.

The Law and Regulation of Clinical Research

Author: Pamela A. Andanda

Publisher:

Published: 2006

Total Pages: 404

ISBN-13:

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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:

The Limits of Consent

Author: Oonagh Corrigan

Publisher: Oxford University Press

Published: 2009-01-29

Total Pages: 247

ISBN-13: 019923146X

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Since its inception as an international principle to protect the welfare of patients and volunteers taking part in medical research, informed consent has become increasingly important within healthcare. Despite its ubiquitous status, there are a number of scholars who are beginning to question whether consent is adequate for contemporary biomedical research. The Limits of Consent considers a number of criticisms that have been levelled at the prominence given to autonomy, a central tenet underpinning the rationale for informed consent in Western bioethics. It raises questions about how quickly and easily this principle has been adopted, and how appropriate it is for those actively engaged in research. In the context of genetic research, for example, the individual's overriding right of autonomy to give consent to research could have huge implications for other members of their families. The Limits of Consent questions the assumption that informed consent protects or facilitates individual autonomy, and discusses empirical studies which suggest that gaining a truly informed consent can be difficult to achieve in practice. With the expectation of treatment and guidance from the physician, how much is the process of consent governed by social norms and expectations? The Limits of Consent focuses upon three principal areas within biomedical research: clinical trials, genetic research, and research with those who may have impaired capacity to consent. It is a truly multi-disciplinary book, incorporating perspectives from medicine, law, philosophy and sociology. The Limits of Consent is a fascinating exploration of the inadequacies of consent, and will appeal to those in the fields of bioethics, socio-legal studies, sociology, and health law. Policy makers, research ethics committee members, and those healthcare professionals with an interest in medical ethics, will also find the book of interest.

Book Synopsis The Limits of Consent by : Oonagh Corrigan

Download or read book The Limits of Consent written by Oonagh Corrigan and published by Oxford University Press. This book was released on 2009-01-29 with total page 247 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since its inception as an international principle to protect the welfare of patients and volunteers taking part in medical research, informed consent has become increasingly important within healthcare. Despite its ubiquitous status, there are a number of scholars who are beginning to question whether consent is adequate for contemporary biomedical research. The Limits of Consent considers a number of criticisms that have been levelled at the prominence given to autonomy, a central tenet underpinning the rationale for informed consent in Western bioethics. It raises questions about how quickly and easily this principle has been adopted, and how appropriate it is for those actively engaged in research. In the context of genetic research, for example, the individual's overriding right of autonomy to give consent to research could have huge implications for other members of their families. The Limits of Consent questions the assumption that informed consent protects or facilitates individual autonomy, and discusses empirical studies which suggest that gaining a truly informed consent can be difficult to achieve in practice. With the expectation of treatment and guidance from the physician, how much is the process of consent governed by social norms and expectations? The Limits of Consent focuses upon three principal areas within biomedical research: clinical trials, genetic research, and research with those who may have impaired capacity to consent. It is a truly multi-disciplinary book, incorporating perspectives from medicine, law, philosophy and sociology. The Limits of Consent is a fascinating exploration of the inadequacies of consent, and will appeal to those in the fields of bioethics, socio-legal studies, sociology, and health law. Policy makers, research ethics committee members, and those healthcare professionals with an interest in medical ethics, will also find the book of interest.