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Comparative Issues in the Governance of Research Biobanks
In the last few years, the boom in biobanking has prompted a lively debate on a host of interrelated legal issues, such as the Gordian knot of the ownership of biological materials, as well as privacy concerns. The latter are due to the difficulty of accepting that biological samples must be completely anonymous without making it practically impossible to exploit their information potential. The issues also include the delicate role and the changing content of the donor’s “informed consent” as the main legal tool that may serve to link the privacy and property interests of donors with the research interests and the set of principles that should be at the core of the biobanking practice...
Ethics, Law and Governance of Biobanking
Biobank research and genomic information are changing the way we look at health and medicine. Genomics challenges our values and has always been controversial and difficult to regulate. In the future lies the promise of tailored medical treatments and pharmacogenomics but the borders between medical research and clinical practice are becoming blurred. We see sequencing platforms for research that can have diagnostic value for patients. Clinical applications and research have been kept separate, but the blurring lines challenges existing regulations and ethical frameworks. Then how do we regulate it? This book contains an overview of the existing regulatory landscape for biobank research in t...
Science and American Foreign Relations since World War II
The sciences played a critical role in American foreign policy after World War II. From atomic energy and satellites to the green revolution, scientific advances were central to American diplomacy in the early Cold War, as the United States leveraged its scientific and technical pre-eminence to secure alliances and markets. The growth of applied research in the 1970s, exemplified by the biotech industry, led the United States to promote global intellectual property rights. Priorities shifted with the collapse of the Soviet Union, as attention turned to information technology and environmental sciences. Today, international relations take place within a scientific and technical framework, whether in the headlines on global warming and the war on terror or in the fine print of intellectual property rights. Science and American Foreign Relations since World War II provides the historical background necessary to understand the contemporary geopolitics of science.
Global Genes, Local Concerns
With interdisciplinary chapters written by lawyers, sociologists, doctors and biobank practitioners, Global Genes, Local Concerns identifies and discusses the most pressing issues in contemporary biobanking. Addressing pressing questions such as how do national biobanks best contribute to translational research and how could academic and industrial exploitation, ownership and IPR issues be addressed and facilitated, this book contributes to the continued development of international biobanking by highlighting and analysing the complexities in this important area of research.
Contract and Regulation
Contract and Regulation: A Handbook on New Methods of Law Making in Private Law sheds light on the darker side of contracts. It begins by exploring the ‘regulatory space’ in which projects are planned, deals are done, and goods and services are consumed, then shows how a ‘bottom-up’ approach can be adopted in order to view this transactional space through the eyes of contractors. The expert contributors explore modes of governance that do not fit nicely into traditional contract theory, paying special attention to three key examples: governance and codes of conduction, networks and relations, compliance and use.
Specimen Science
Advances in medicine often depend on the effective collection, storage, research use, and sharing of human biological specimens and associated data. But what about the sources of such specimens? When a blood specimen is drawn from a vein in your arm, is that specimen still you? Is it your property, intellectual or otherwise? Should you be allowed not only to consent to its use in research but also to specify under what circumstances it may be used? These and other questions are at the center of a vigorous debate over the use of human biospecimens in research. In this book, experts offer legal, regulatory, and ethical perspectives on balancing social benefit and human autonomy in biospecimen research. After discussing the background to current debates as well as several influential cases, including that of Henrietta Lacks, the contributors consider the rights, obligations, risks, and privacy of the specimen source; different types of informed consent under consideration (broad, blanket, and specific); implications for special patient and researcher communities; and the governance of biospecimen repositories and the responsibilities of investigators.
The Impact of Science and Technology on the Rights of the Individual
The volume is devoted to the relevant problems in the legal sphere, created and generated by recent advances in science and technology. In particular, it investigates a series of cutting-edge contemporary and controversial case-studies where scientific and technological issues intersect with individual legal rights. The book addresses challenging topics at the intersection of communication technologies and biotech innovations such as freedom of expression, right to health, knowledge production, Internet content regulation, accessibility and freedom of scientific research.
The Ethical and Legal Regulation of Human Tissue and Biobank Research in Europe
"Human tissue and biobank research is of increasing importance for understanding the causes of widespread diseases and developing effective therapies. However, while the success of biobank research depends on the availability of a large number of samples and the consolidation of collections across country borders is very desirable from the perspective of researchers, the legal and ethical requirements for the procurement, storage and use of human tissue samples are rather heterogeneous across different countries. Moreover, the lack of comprehensive supranational regulation on human tissue and biobanking can be seen as posing a serious threat to transnational biomedical research. Against this...
