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.
Introduction 1. Stem Cell Research and the Regulation of a Moving Target 2. Regulate to Innovate: Principles-Based Regulation of Stem Cell Research 3. Enhancing Regulatory Legitimacy Through Reflexive Collaboration 4. Property In Tissues Provided for Stem Cell Research 5. Embryos and their Providers to Stem Cell Research 5. Ova Provision For Stem Cell Research: The Perils of Ineffective Regulation Conclusion
Scientific and clinical advances, social and political developments and the impact of healthcare on our lives raise profound ethical and legal questions. Medical law and ethics have become central to our understanding of these problems, and are important tools for the analysis and resolution of problems – real or imagined.
In this series, scholars at the forefront of biomedical law and ethics will contribute to the debates in this area, with accessible, thought-provoking, and sometimes controversial ideas. Each book in the series will develop an independent hypothesis and argue cogently for a particular position. One of the major contributions of this series is the extent to which both law and ethics are utilised in the content of the books, and the shape of the series itself.