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Author: Academy of Medical Sciences (Great Britain)
Publisher:
ISBN: 9781903401316
Category :
Languages : en
Pages : 123
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Book Description
Author: Academy of Medical Sciences (Great Britain)
Publisher:
ISBN: 9781903401316
Category :
Languages : en
Pages : 123
Get Book
Book Description
Author: William W. Lowrance
Publisher: Cambridge University Press
ISBN: 1139510827
Category : Law
Languages : en
Pages :
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Book Description
The potential of the e-health revolution, increased data sharing, database linking, biobanks and new techniques such as geolocation and genomics to advance human health is immense. For the full potential to be realized, though, privacy and confidentiality will have to be dealt with carefully. Problematically, many conventional approaches to such pivotal matters as consent, identifiability, and safeguarding and security are inadequate. In many places, research is impeded by an overgrown thicket of laws, regulations, guidance and governance. The challenges are being heightened by the increasing use of biospecimens, and by the globalization of research in a world that has not globalized privacy protection. Drawing on examples from many developed countries and legal jurisdictions, the book critiques the issues, summarizes various ethics, policy, and legal positions (and revisions underway), describes innovative solutions, provides extensive references and suggests ways forward.
Author: Graeme Laurie
Publisher: Cambridge University Press
ISBN: 1108653383
Category : Law
Languages : en
Pages : 443
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Book Description
The first ever interdisciplinary handbook in the field, this vital resource offers wide-ranging analysis of health research regulation. The chapters confront gaps between documented law and research in practice, and draw on legal, ethical and social theories about what counts as robust research regulation to make recommendations for future directions. The Handbook provides an account and analysis of current regulatory tools - such as consent to participation in research and the anonymization of data to protection participants' privacy - as well as commentary on the roles of the actors and stakeholders who are involved in human health research and its regulation. Drawing on a range of international examples of research using patient data, tissue and other human materials, the collective contribution of the volume is to explore current challenges in delivering good medical research for the public good and to provide insights on how to design better regulatory approaches. This title is also available as Open Access on Cambridge Core.
Author: Edward S. Dove
Publisher: Edward Elgar Publishing
ISBN: 1788975359
Category : Law
Languages : en
Pages : 266
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Book Description
This timely book examines the interaction of health research and regulation with law through empirical analysis and the application of key anthropological concepts to reveal the inner workings of human health research. Through ground-breaking empirical inquiry, Regulatory Stewardship of Health Research explores how research ethics committees (RECs) work in practice to both protect research participants and promote ethical research. This thought-provoking book provides a new perspective on the regulation of health research by demonstrating how RECs and other regulatory actors seek to fulfil these two functions by performing a role of ‘regulatory stewardship’.
Author: Great Britain: Parliament: House of Commons: Science and Technology Committee
Publisher: The Stationery Office
ISBN: 9780215062321
Category : Medical
Languages : en
Pages : 210
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Book Description
Many of the trials taking place today are unregistered and unpublished, meaning that the information that they generate remains invisible to both the scientific community and the public. This undermines public trust, slowing the pace of medical advancement and potentially putting patients at risk. All trials conducted on NHS treatments-and all other trials receiving public funding-should be prospectively registered and their results published in a scientific journal. While the focus should be on implementing this change for future trials, the Government must also do what it can to ensure that historic trials are registered and published, particularly where they have been publically funded. The Government should also take steps to facilitate greater sharing of the raw data generated during a trial in a responsible and controlled way, with the knowledge and consent of patients. The report also draws attention to the recent fall in the number of trials taking place in the UK. It finds that the need for multiple governance approvals from participating NHS organisations remained the biggest barrier to setting up a UK trial, but that lack of public awareness was also a key issue. Recruiting participants can also be a challenge. The report calls on the Government to take its recommendations into account in ongoing discussions regarding the revision of European clinical trials legislation and in its response to the European Medicines Agency's consultation on the release of clinical trial data, which closes at the end of this month
Author: Margaret Brazier
Publisher: Manchester University Press
ISBN: 1526100517
Category : Law
Languages : en
Pages : 678
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Book Description
Embryo research, cloning, assisted conception, neonatal care, saviour siblings, organ transplants, drug trials - modern developments have transformed the field of medicine almost beyond recognition in recent decades and the law struggles to keep up. In this highly acclaimed and very accessible book, now in its sixth edition, Margaret Brazier and Emma Cave provide an incisive survey of the legal situation in areas as diverse as fertility treatment, patient consent, assisted dying, malpractice and medical privacy. The book has been fully revised and updated to cover the latest cases, from assisted dying to informed consent; legislative reform of the NHS, professional regulation and redress; European regulations on data protection and clinical trials; and legislation and policy reforms on organ donation, assisted conception and mental capacity. Essential reading for healthcare professionals, lecturers, medical and law students, this book is of relevance to all whose perusal of the daily news causes wonder, hope and consternation at the advances and limitations of medicine, patients and the law.
Author: J. Gillott
Publisher: Springer
ISBN: 1137374993
Category : Social Science
Languages : en
Pages : 203
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Book Description
Through case studies, theoretical research and interviews with leading players in science and governance, this book introduces a new understanding of change in governance of bioscience research. In particular it examines change as it is shaped by approaches developed by Science and Technology Studies and Sociology of Scientific Knowledge theorists.
Author: British Medical Association
Publisher: John Wiley & Sons
ISBN: 1444355643
Category : Medical
Languages : en
Pages : 919
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Book Description
This is your source for authoritative and comprehensive guidance from the British Medical Association (BMA) Medical Ethics Department covering both routine and highly contentious medico-legal issues faced by health care professionals. The new edition updates the information from both the legal and ethical perspectives and reflects developments surrounding The Mental Capacity Act, Human Tissue Act, and revision of the Human Fertilisation and Embryology Act.
Author: Jane Kaye
Publisher: Bloomsbury Publishing
ISBN: 1847318835
Category : Law
Languages : en
Pages : 380
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Book Description
Biobanks are proliferating rapidly worldwide because they are powerful tools and organisational structures for undertaking medical research. By linking samples to data on the health of individuals, it is anticipated that biobanks will be used to explore the relationship between genes, environment and lifestyle for many diseases, as well as the potential of individually-tailored drug treatments based on genetic predisposition. However, they also raise considerable challenges for existing legal frameworks and research governance structures. This book critically examines the current governance structures in place for biobanks in England and Wales. It shows that the technologies, techniques and practices involved in biobanking do not always conform neatly to existing legal principles and frameworks that apply to other areas of medical research. Using a socio-legal approach, including interview data gathered from the scientific community, this book provides unique insights and makes recommendations about appropriate governance mechanisms for biobanking in the future. It also explores the issues around the secondary use of information, such as consent and how to protect privacy, when biobanks are accessed by a number of different third parties. These issues have relevance both within England and Wales and to a wide international audience, as well as for other areas where large datasets are used.
Author: Graeme T. Laurie
Publisher: Oxford University Press
ISBN: 0198747519
Category : Bioethics
Languages : en
Pages : 795
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Book Description
This is an analysis of medical ethical concepts based on legal principles and court decisions, describing what actually happens in practice rather than what should happen and, where there are no precedents available, what is most likely to happen.
