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Examines the ethical and policy dimensions of testing novel medical interventions in human beings for the first time.
Human gene transfer is widely regarded as one of the most promising technologies for the treatment of a variety of disorders, but it presents practitioners with a variety of difficult ethical questions. Gene Transfer and the Ethics of First-in-Human Research examines the ethical and policy dimensions of testing interventions in human beings for the first time. The book discusses the difficult ethical challenges that arise from attempting to translate laboratory discoveries into clinical applications. These range from which available techniques to use, when to initiate human testing, questions of consent, expectation in public arenas, how to define acceptable risk, and the inclusion of vulnerable or disadvantaged subjects in early phase trials. This book is relevant to ethicists, legal practitioners, policy makers, geneticists and clinicians involved in clinical trials of new medical interventions.
The development of new pharmaceutical products and behavioral interventions aimed at improving people's health, as well as research that assesses the efficacy and cost-effectiveness of public policies, such as policies designed to improve children's education or reduce poverty, depends on research conducted with human participants. It is imperative that research with human subjects is conducted in accordance with sound ethical principles and regulatory requirements. Featuring 45 original essays by leading research ethicists, The Oxford Handbook of Research Ethics offers a critical overview of the ethics of human subjects research within multiple disciplines and fields, including biomedicine, public health, psychiatry, sociology, political science, and public policy.
In this book, scholars with different disciplinary and national backgrounds argue for possible answers and analyse case studies on current issues of governance in biomedical research. These issues comprise among others the research-care distinction, risk evaluation in early human trials, handling of incidental findings, nocebo effects, cluster randomized trials, publication bias, or consent in biobank research. This book demonstrates how new technologies and research possibilities multiply or intensify already known governance challenges, leaving room for ethical analysis and complex moral choices. Clinical researchers, research ethics committee members and research ethicists have all to deal with such challenges on a daily basis. While general reflection on core concepts of research ethics is seldom pointless, those confronted with hard moral choices do need more practical and contextualized reflection on the said issues. This book particularly provides such contextualized reflections and aims to inform all those who study, conduct, regulate, fund, or participate in biomedical research.
This Open Access book provides illustrative case studies that explore various research and innovation topics that raise challenges requiring ethical reflection and careful policymaking responses. The cases highlight diverse ethical challenges and provide lessons for the various options available for policymaking. Cases are drawn from many fields, including artificial intelligence, space science, energy, data protection, professional research practice and pandemic planning. Case studies are particularly helpful with ethical issues to provide crucial context. This book reflects the ambiguity of ethical dilemmas in contemporary policymaking. Analyses reflect current debates where consensus has not yet been achieved. These cases illustrate key points made throughout the PRO-RES EU-funded project from which they arise: that ethical judgement is a fluid enterprise, where values, principles and standards must constantly adjust to new situations, new events and new research developments. This book is an indispensable aid to policymaking that addresses, and/or uses evidence from, novel research developments.
For many years, the ethical discussion surrounding human embryonic stem cell research has focused on the moral status of the embryo. This text takes a wider moral berth and focuses on numerous ethical, legal and social aspects involved in translating the results of stem cell research into diagnostic and therapeutic applications. Translational Stem Cell Research is broken into ten sections. It opens with an overview of the latest in stem cell research, focusing on specific diseases and the treatment of burn victims. Part II discusses the issues involved in the many steps from bench to bedside, ranging from first research in vitro to clinical trials. Part III covers scientific, regulatory and ...
This book explores relevant questions within this multi-faceted and rapidly growing field, and will help to define and foster scholarship within the intersection of neuroethics and clinical neuroscience.
This Open Access book builds on the experiences of one of the largest European projects in the domain of responsible Research and Innovation: NewHoRRIzon. It highlights the potential of and opportunity in responsible R&I to conduct innovation in a socially responsible way. Employing the methodology of Social Labs, the book analyses responsible R&I from an experience-based viewpoint and further explores the application of responsible R&I beyond scholarly and industrial interests. The contributors analyze the current European R&I landscape, provide reflection and reconceptualization of its core concepts, and project future challenges in relation to responsible R&I. The book complements the readers' line of work by providing insights on how responsible R&I can be applied by the audience, for example, in their decision-making processes.
Explains how artificial intelligence is pushing the limits of the law and how we must respond.