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Author: Duff William Ramus Waring
Publisher: University of Toronto Press
ISBN: 0802086438
Category : Medical
Languages : en
Pages : 281
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Book Description
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.
Author: Duff William Ramus Waring
Publisher: University of Toronto Press
ISBN: 0802086438
Category : Medical
Languages : en
Pages : 281
Get Book Here
Book Description
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.
Author: James M. Humber
Publisher: Springer Science & Business Media
ISBN: 1468422235
Category : Philosophy
Languages : en
Pages : 716
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Book Description
In the past few years an increasing number of colleges and universities have added courses in biomedical ethics to their curricula. To some extent, these additions serve to satisfy student demands for "relevance. " But it is also true that such changes reflect a deepening desire on the part of the academic community to deal effectively with a host of problems which must be solved if we are to have a health-care delivery system which is efficient, humane, and just. To a large degree, these problems are the unique result of both rapidly changing moral values and dramatic advances in biomedical technology. The past decade has witnessed sudden and conspicuous controversy over the morality and legality of new practices relating to abortion, therapy for the mentally ill, experimentation using human subjects, forms of genetic interven tion, suicide, and euthanasia. Malpractice suits abound and astronomical fees for malpractice insurance threaten the very possibility of medical and health-care practice. Without the backing of a clear moral consensus, the law is frequently forced into resolving these conflicts only to see the moral issues involved still hotly debated and the validity of existing law further questioned. In the case of abortion, for example, the laws have changed radically, and the widely pub licized recent conviction of Dr. Edelin in Boston has done little to foster a moral consensus or even render the exact status of the law beyond reasonable question.
Author: Hazel Biggs
Publisher: Routledge
ISBN: 1135309272
Category : Law
Languages : en
Pages : 233
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Book Description
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.
Author: Jane Reichel
Publisher: Springer Nature
ISBN: 3030493881
Category : Biobanks
Languages : en
Pages : 432
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Book Description
Part I Setting the scene -- Introduction: Individual rights, the public interest and biobank research 4000 (8) -- Genetic data and privacy protection -- Part II GDPR and European responses -- Biobank governance and the impact of the GDPR on the regulation of biobank research -- Controller' and processor's responsibilities in biobank research under GDPR -- Individual rights in biobank research under GDPR -- Safeguards and derogations relating to processing for archiving purposes in the scientific purposes: Article 89 analysis for biobank research -- A Pan-European analysis of Article 89 implementation and national biobank research regulations -- EEA, Switzerland analysis of GDPR requirements and national biobank research regulations -- Part III National insights in biobank regulatory frameworks -- Selected 10-15 countries for reports: Germany -- Greece -- France -- Finland -- Sweden -- United Kingdom -- Part IV Conclusions -- Reflections on individual rights, the public interest and biobank research, ramifications and ways forward. .
Author: Baruch A. Brody
Publisher: Oxford University Press, USA
ISBN: 9780195090079
Category : Medical
Languages : en
Pages : 412
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Book Description
A broad critical review of national policies on biomedical research - human, epidemiologic, clinical trials, genetic, reproductive, etc.
Author: Robert P. Charrow
Publisher: University of Chicago Press
ISBN: 0226101665
Category : Science
Languages : en
Pages : 342
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Book Description
The National Institutes of Health and the National Science Foundation together fund more than $40 billon of research annually in the United States and around the globe. These large public expenditures come with strings, including a complex set of laws and guidelines that regulate how scientists may use NIH and NSF funds, how federally funded research may be conducted, and who may have access to or own the product of the research. Until now, researchers have had little instruction on the nature of these laws and how they work. But now, with Robert P. Charrow’s Law in the Laboratory, they have a readable and entertaining introduction to the major ethical and legal considerations pertaining to research under the aegis of federal science funding. For any academic whose position is grant funded, or for any faculty involved in securing grants, this book will be an essential reference manual. And for those who want to learn how federal legislation and regulations affect laboratory research, Charrow’s primer will shed light on the often obscured intersection of government and science.
Author: United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher:
ISBN:
Category : Ethics, Medical
Languages : en
Pages : 614
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Book Description
Author: Markus D. Dubber
Publisher: Oxford University Press
ISBN: 0190067411
Category : Law
Languages : en
Pages : 1000
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Book Description
This volume tackles a quickly-evolving field of inquiry, mapping the existing discourse as part of a general attempt to place current developments in historical context; at the same time, breaking new ground in taking on novel subjects and pursuing fresh approaches. The term "A.I." is used to refer to a broad range of phenomena, from machine learning and data mining to artificial general intelligence. The recent advent of more sophisticated AI systems, which function with partial or full autonomy and are capable of tasks which require learning and 'intelligence', presents difficult ethical questions, and has drawn concerns from many quarters about individual and societal welfare, democratic decision-making, moral agency, and the prevention of harm. This work ranges from explorations of normative constraints on specific applications of machine learning algorithms today-in everyday medical practice, for instance-to reflections on the (potential) status of AI as a form of consciousness with attendant rights and duties and, more generally still, on the conceptual terms and frameworks necessarily to understand tasks requiring intelligence, whether "human" or "A.I."
Author: Stevie Martin
Publisher:
ISBN: 9780367628437
Category :
Languages : en
Pages :
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Book Description
Author: Remigius N. Nwabueze
Publisher: Routledge
ISBN: 1317106423
Category : Law
Languages : en
Pages : 335
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Book Description
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.
