Ethics And Clinical Neuroinnovation

New ways of understanding the brain – its nature, its capacities, its function, and its dysfunction – hold great promise for human wellbeing. Novel therapeutics spurred by this understanding have important roles addressing many clinical conditions, including Alzheimer Disease, depression, addiction, and obsessive-compulsive disorder. This unique title explores a wide range of groundbreaking sciences and clinical practices for brain-based conditions, including deep brain stimulation, optogenetics, technology-delivered therapies, predictive testing, and new clinical uses of ketamine, cannabis, and other psychoactive substances. An introduction to the imperative to develop new treatments for devastating brain disorders and the state of current therapeutics in psychiatry, addiction, and behavioral disorders is presented, and chapters from leading physician-scientists and neuroethicists outline the clinical and the ethical issues arising in innovation and in the creation of new therapeutics for brain diseases. Written by renowned thought leaders in their fields, the book presents tightly written contributions on novel qualitative and quantitative data from stakeholders in the field, including neuroscientist-clinicians, people living with mental illness and/or addictions, and oversight/policy stakeholders. Concise, anticipatory, and centered on the principles governing human biomedical research and innovation in developing novel therapeutics for brain disorders, Ethics and Clinical Neuroinnovation will be of great value to clinicians, researchers, and students from a vast array of backgrounds, including neuroethics, neuroscience, psychology, psychiatry, philosophy, entrepreneurship, and the law.

The brain represents the final frontier in medical sciences. Clinical neurosciences include the subspecialties of neurology, neurosurgery, neuro-imaging, cerebrovascular interventional specialties, neurocritical care, and the allied specialties in pharmacy and nursing. The first lens through which we see our patients is the clinical perspective; however, the complexity of neurosciences and the rapidity of the advances in these subspecialties require that clinicians not lose sight of the personhood of the patients, the professionalism required in the care of these complex patients, or the regulatory environment in which we practice. Science and technology are advancing more rapidly than regulations or the law can interpret and integrate them into a supportive or regulatory framework. Thus, morality, ethics, and the law comprise the final lens through which we approach complex patient management issues, frame our communications with patients and families, and evaluate the risks and potential benefits of new technology. Ethics and Law for Neurosciences Clinicians is written for all clinicians in the neurosciences specialties to examine and re-examine the ethical and legal implications of advances in clinical neurosciences.

In this chapter, we use the special features of neuroimaging to illustrate research ethics issues for the clinical neurologic sciences, and focus on one particularly compelling case: studies involving first-episode schizophrenic treatment-naïve individuals (FESTNIs) (). FESTNIs are scanned prior to the administration of medication in order to control for the confounding effects of treatment. By concentrating on this program of research, we capture the distinctive ethical challenges associated with neuroimaging research overall, and foreground the issues particular to neuroimaging research involving FESTNIs that have yet to receive sufficient attention in the literature. We highlight assessment of risks and burdens, including risks associated with treatment delays and incidental findings; assessment of benefit, including direct benefit, social value, and scientific quality; subject selection; justice questions related to responsiveness and poststudy access; and, finally, issues related to consent and capacity.

Advances in our understanding of the brain and rapid advances in the medical practice of neurology are creating questions and concerns from an ethical and legal perspective. Ethical and Legal Issues in Neurology provides a detailed review of various general aspects of neuroethics, and contains chapters dealing with a vast array of specific issues such as the role of religion, the ethics of invasive neuroscience research, and the impact of potential misconduct in neurologic practice. The book focuses particular attention on problems related to palliative care, euthanasia, dementia, and neurogenetic disorders, and concludes with examinations of consciousness, personal identity, and the definition of death. This volume focuses on practices not only in North America but also in Europe and the developing world. It is a useful resource for all neuroscience and neurology professionals, researchers, students, scholars, practicing clinical neurologists, mental health professionals, and psychiatrists. A comprehensive introduction and reference on neuroethics Includes coverage of how best to understand the ethics and legal aspects of dementia, palliative care, euthanasia and neurogenetic disorders Brings clarity to issues regarding ethics and legal responsibilities in the age of rapidly evolving brain science and related clinical practice

Almost every neurologist encounters ethical issues daily. This exemplary ethics text meets the needs of students, residents, fellows, and practicing neurologists who want an accessible case-based text for learning, and it meets the needs of directors of medical student clerkships and residency programs in neurology who want an accessible case-based text for teaching. The book’s case-based approach places key ethical principles into a practical, real-world context to aid in decision-making. Each chapter includes an outstanding array of learning features includes Learning Objectives, Clinical Vignettes, Questions to guide self-study and group discussions, Key Points, Key Words, Suggestions for Further Reading, and more. Clinical Pragmatism model helps readers analyze ethical issues in a clinical context. Practical Ethics in Clinical Neurology is a companion to the most highly respected ethics text in neurology and neurosurgery, Bernat's Ethical Issues in Neurology, 3rd edition.

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.

This thought-provoking study examines the ethical, legal, and social problems that arise with cutting-edge medical technology. Using as examples four powerful and largely unregulated technologies—off-label use of drugs, innovative surgery, assisted reproduction, and neuroimaging—Margaret L. Eaton and Donald Kennedy illustrate the difficult challenges faced by clinicians, researchers, and policy makers who seek to advance the frontiers of medicine safely and responsibly. Supported by medical history and case studies and drawing on reports from dozens of experts, the authors address important practical, ethical, and policy issues. They consider topics such as the responsible introduction of new medical products and services, the importance of patient consent, the extent of the duty to mitigate harm, and the responsibility to facilitate access to new medical therapies. This work's insights into the nature and consequences of medical innovation contribute to the national debate on how best to protect patients while fostering innovation and securing benefits.

The use of human subjects in medical and scientific research has given rise to troubling ethical questions. How should human subjects be selected for experiments? What should they be told about the research in which they are involved? How can their privacy be protected? When is it permissible to deceive them? How do we deal with subjects such as children, fetuses, and the mentally infirm, for whom informed consent is impossible? In this book, Dr. Robert J. Levine reviews federal regulations, ethical analysis, and case studies in an attempt to answer these questions. His book is an essential reference for everyone--members of institutional review boards, scientists, philosophers, lawyers--addressing the ethical issues involved. "[Levine's] experience as a clinician, IRB chairman, writer and editor of a journal devoted exclusively to issues faced by IRBS makes him uniquely qualified to bring together the legal, ethical, and practical dimensions. . . [The book] is sophisticated but readable. . . [and] should be on every IRB administrator's desk and in every medical ethics library."--Norman Fost, M.D., The New England Journal of Medicine "Levine. . . is one of the foremost historians of contemporary clinical science. . . . His book is at once a guide to primary sources for the history of clinical research in the late twentieth century and a pioneering secondary source about that history."--Daniel M. Fox, Bulletin of the History of Medicine "You will be charmed by the [book's] elegance and lucidity and. . . persuaded of its relevance to doctors in any country."--Alex Paton, British Medical Journal "Should be of wide interest to those keen to see advances in medical research brought into general medical practice."--Gilbert Omenn, Issues in Science and Technology