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Stem Cell Research And The Collaborative Regulation Of Innovation

Author: Sarah Devaney
Publisher: Routledge
ISBN: 1136014403
Size: 32.10 MB
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Hopes are high that stem cell (SC) research will lead to treatments and cures for some of the most serious diseases affecting humankind today. SC science has been used in a treatment setting in the replacement of patients’ windpipes and in restoring sight to patients who were blind in one eye and in future it is hoped that when the body is injured it will be able to be stimulated to produce those types of SCs necessary to repair the particular damage caused. In the meantime, research into specific treatments for a wide range of serious conditions is being undertaken including Alzheimer’s disease, cancer, and diabetes. The book considers the regulatory governance of stem cell research, setting out a readily understandable account of the science and the challenges it poses for regulators as the research is increasingly being clinically applied. It provides a critical account of those elements of a regulatory system which will be required for any jurisdiction aiming to facilitate innovative and productive SC research while maintaining appropriate ethical and legal controls. The book addresses the specific failings in the current regulatory approach to SC research in the UK and goes on to look at the regulatory approaches in the US. The book systematically analyses the roles and responsibilities of the three key participants who collaborate in this process: regulators, scientists and tissue providers, arguing that a regulatory system which fails to recognise and facilitate the vital role which each of these three groups plays runs the risk of impairing the chances of the hopes for SC research being realised. The book places a particular emphasis on ensuring that those who contribute their bodily tissues to this endeavour are treated fairly, involving a recognition that their tissues are their property.

Ethics Dumping

Author: Doris Schroeder
Publisher: Springer
ISBN: 3319647318
Size: 74.49 MB
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This book is published under a CC BY 4.0 license. This book provides original, up-to-date case studies of “ethics dumping” that were largely facilitated by loopholes in the ethics governance of low and middle-income countries. It is instructive even to experienced researchers since it provides a voice to vulnerable populations from the fore mentioned countries. Ensuring the ethical conduct of North-South collaborations in research is a process fraught with difficulties. The background conditions under which such collaborations take place include extreme differentials in available income and power, as well as a past history of colonialism, while differences in culture can add a new layer of complications. In this context, up-to-date case studies of unethical conduct are essential for research ethics training.

Human Embryonic Stem Cells

Author: Arlene Chiu
Publisher: Springer Science & Business Media
ISBN: 1592594239
Size: 21.82 MB
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A discussion of all the key issues in the use of human pluripotent stem cells for treating degenerative diseases or for replacing tissues lost from trauma. On the practical side, the topics range from the problems of deriving human embryonic stem cells and driving their differentiation along specific lineages, regulating their development into mature cells, and bringing stem cell therapy to clinical trials. Regulatory issues are addressed in discussions of the ethical debate surrounding the derivation of human embryonic stem cells and the current policies governing their use in the United States and abroad, including the rules and conditions regulating federal funding and questions of intellectual property.

Embryonic Stem Cell Patents

Author: Aurora Plomer
Publisher: Oxford University Press, USA
ISBN: 9780199543465
Size: 17.60 MB
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A comprehensive interdisciplinary analysis of the EU patent system as applied to biotechnological inventions, this text also considers the legal and ethical controversies arising from overlapping law regimes in the morally fragmented and contested field of human embryonic stem cell related technology.

The Fetus As A Patient

Author: Dagmar Schmitz
Publisher: Routledge
ISBN: 1351692771
Size: 74.44 MB
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Due to new developments in prenatal testing and therapy the fetus is increasingly visible, examinable and treatable in prenatal care. Accordingly, physicians tend to perceive the fetus as a patient and understand themselves as having certain professional duties towards it. However, it is far from clear what it means to speak of a patient in this connection. This volume explores the usefulness and limitations of the concept of ‘fetal patient’ against the background of the recent seminal developments in prenatal or fetal medicine. It does so from an interdisciplinary and international perspective. Featuring internationally recognized experts in the field, the book discusses the normative implications of the concept of ‘fetal patient’ from a philosophical-theoretical as well as from a legal perspective. This includes its implications for the autonomy of the pregnant woman as well as its consequences for physician-patient-interactions in prenatal medicine.

Coercive Care

Author: Bernadette Mcsherry
Publisher: Routledge
ISBN: 1135016585
Size: 76.10 MB
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There has been much debate about mental health law reform and mental capacity legislation in recent years with the UN Convention on the Rights of Persons with Disabilities also having a major impact on thinking about the issue. This edited volume explores the concept of ‘coercive care’ in relation to individuals such as those with severe mental illnesses, those with intellectual and cognitive disabilities and those with substance use problems. With a focus on choice and capacity the book explores the impact of and challenges posed by the provision of care in an involuntary environment. The contributors to the book look at mental health, capacity and vulnerable adult’s care as well as the law related to those areas. The book is split into four parts which cover: human rights and coercive care; legal capacity and coercive care; the legal coordination of coercive care and coercive care and individuals with cognitive impairments. The book covers new ground by exploring issues arising from the coercion of persons with various disabilities and vulnerabilities, helping to illustrate how the capacity to provide consent to treatment and care is impaired by reason of their condition.

Cell Therapy

Author: Adrian Gee
Publisher: Springer Science & Business Media
ISBN: 9780387895840
Size: 74.29 MB
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Cell Therapy: cGMP Facilities and Manufacturing is the source for a complete discussion of facility design and operation with practical approaches to a variety of day-to-day activities, such as staff training and competency, cleaning procedures, and environmental monitoring. This in-depth book also includes detailed reviews of quality, the framework of regulations, and professional standards. It meets a previously unmet need for a thorough facility-focused resource, Cell Therapy: cGMP Facilities and Manufacturing will be an important addition to the cell therapy professional’s library. Additional topics in Cell Therapy: cGMP Facilities and Manufacturing...Standard operating procedures - Supply management - Facility equipment - Product manufacturing, review, release and administration - Facility master file.

Stem Cells

Author: Ariff Bongso
Publisher: World Scientific
ISBN: 9814289388
Size: 36.84 MB
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Stem cell biology has drawn tremendous interest in recent years as it promises cures for a variety of incurable diseases. This book deals with the basic and clinical aspects of stem cell research and involves work on the full spectrum of stem cells isolated today. It also covers the conversion of stem cell types into a variety of useful tissues which may be used in the future for transplantation therapy. It is thus aimed at undergraduates, postgraduates, scientists, embryologists, doctors, tissue engineers and anyone who wishes to gain some insight into stem cell biology. This book is important as it is comprehensive and covers all aspects of stem cell biology, from basic research to clinical applications. It will have 33 chapters written by renowned stem cell scientists worldwide. It will be up-to-date and all the chapters include self-explanatory figures, color photographs, graphics and tables. It will be easy to read and give the reader a complete understanding and state of the art of the exciting science and its applications.

Neurotechnology And Direct Brain Communication

Author: Michele Farisco
Publisher: Routledge
ISBN: 1317529588
Size: 46.69 MB
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Neurotechnology and Direct Brain Communication focuses on recent neuroscientific investigations of infant brains and of patients with disorders of consciousness (DOC), both of which are at the forefront of contemporary neuroscience. The prospective use of neurotechnology to access mental states in these subjects, including neuroimaging, brain simulation, and brain computer interfaces, offers new opportunities for clinicians and researchers, but has also received specific attention from philosophical, scientific, ethical, and legal points of view. This book offers the first systematic assessment of these issues, investigating the tools neurotechnology offers to care for verbally non-communicative subjects and suggesting a multidisciplinary approach to the ethical and legal implications of ordinary and experimental practices. The book is divided into three parts: the first and second focus on the scientific and clinical implications of neurological tools for DOC patient and infant care. With reference to these developments, the third and final part presents the case for re-evaluating classical ethical and legal concepts, such as authority, informed consent, and privacy. Neurotechnology and Direct Brain Communication will appeal to researchers and postgraduate students in the fields of cognitive science, medical ethics, medical technology, and the philosophy of the mind. With implications for patient care, it will also be a useful resource for clinicians, medical centres, and health practitioners.

The Delivery Of Regenerative Medicines And Their Impact On Healthcare

Author: Catherine Prescott
Publisher: CRC Press
ISBN: 1439836078
Size: 10.92 MB
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Now that prohibitions against stem cell research are relaxing, it is time for the field to move forward with the advances that promise to eliminate so much human suffering. However, it would be naïve to ignore the fact that regenerative medicines pose a whole new set of challenges to an industry sector that for decades has geared itself to the development and delivery of traditional pharmaceuticals. Still, significant strides are being made. Unique in its focus, The Delivery of Regenerative Medicines and Their Impact on Healthcare delves into material not included in other books. Edited by Dr. Catherine Prescott and Professor Dame Julia Polak, two of the most respected authorities in stem cell research and the business of regenerative medicine, this text presents original firsthand accounts of experts from around the globe. Professor Polak starts by summarizing the progress made and the challenges currently facing the field both as a science and an emerging industry. This is followed by topics relevant to regulators, insurers, and investors as well as pharmaceutical and biotech researchers. Offering innovative insight on topics rarely covered, this volume: Details various innovative investment models Offers a detailed overview of cell-based products and therapeutic stem cell technologies Examines concerns over safeguarding intellectual property Looks at evolving regulations in the U.S. and Europe Discusses insurance and risk management and the establishment of reimbursement parameters This book reaches out to inform a wide audience across government, industry, and academia. It goes beyond the usual discussions to help invigorate the dialogue and present solutions that must occur at the crossroads of technology and commerce for regenerative medicines to realize their promise.