Case studies of twelve existing human biospecimen repositories performed to evaluate their utility for genomics- and proteomics-based cancer research and to identify "best practices" in collection, processing, annotation, storage, privacy, ethical concerns, informed consent, business plans, operations, intellectual property rights, public relations, marketing, and education that would be useful in designing a national biospecimen network.
This extensively revised new edition comprehensively reviews the rise of clinical research informatics (CRI). It enables the reader to develop a thorough understanding of how CRI has developed and the evolving challenges facing the biomedical informatics professional in the modern clinical research environment. Emphasis is placed on the changing role of the consumer and the need to merge clinical care delivery and research as part of a changing paradigm in global healthcare delivery. Clinical Research Informatics presents a detailed review of using informatics in the continually evolving clinical research environment. It represents a valuable textbook reference for all students and practising healthcare informatics professional looking to learn and expand their understanding of this fast-moving and increasingly important discipline.
Following the boom in population databases in recent years there has been sustained and intense international debate about political processes and legal and ethical issues surrounding the protection and use of genetic data. As a result, several national and international organizations and committees have published widely differing guidelines and statements concerning genetic databases and biobanks. Ethical Issues of Human Genetic Databases compares the new area of biobanking with the tradition of ethically accepted classical research and highlights the distinctive features of existing databases and guidelines. The volume identifies areas of consensus and controversy while investigating the challenges posed to classical health research ethics by the existence of genetic databases, analyzing the reasons for such varying guidelines. The book will be essential to academics, biobankers, policy-makers and researchers in the field of medical ethics.
The field of genetics is rapidly evolving and new medical breakthroughs are occuring as a result of advances in knowledge of genetics. This series continually publishes important reviews of the broadest interest to geneticists and their colleagues in affiliated disciplines. Five sections on the latest advances in complex traits Methods for testing with ethical, legal, and social implications Hot topics include discussions on systems biology approach to drug discovery; using comparative genomics for detecting human disease genes; computationally intensive challenges, and more
In this book, nine thought-leaders engage with some of the hottest moral issues in science and ethics. Based on talks originally given at the annual "Purdue Lectures in Ethics, Policy, and Science," the chapters explore interconnections between the three areas in an engaging and accessible way. Addressing a mixed public audience, the authors go beyond dry theory to explore some of the difficult moral questions that face scientists and policy-makers every day. The introduction presents a theoretical framework for the book, defining the term "bioethics" as extending well beyond human well-being to wider relations between humans, nonhuman animals, the environment, and biotechnologies. Three sections then explore the complex relationship between moral value, scientific knowledge, and policy making. The first section starts with thoughts on nonhuman animal pain and moves to a discussion of animal understanding. The second section explores climate change and the impact of "green" nanotechnology on environmental concerns. The final section begins with dialog about ethical issues in nanotechnology, moves to an exploration of bio-banks (a technology with broad potential medical and environmental impact), and ends with a survey of the impact of biotechnologies on (synthetic) life itself. Contents: Part 1: Animals: Moral agency, moral considerability, and consciousness (Daniel Kelly) and From minds to minding (Mark Bernstein); Animal Pain: What is it and why does it matter? (Bernard Rollin). Part 2: Environment: The future of environmental ethics (Holmes Rolston III); Climate change, human rights, and the trillionth ton of carbon (Henry Shue); Ethics, environment, and nanotechnology (Barbara Karn). Part 3: Biotechnologies: Nanotechnologies: Science and society (James Leary); Ethical issues in constructing and using bio-banks (Eric Meslin); Synthetic life: A new industrial revolution (Gregory Kaebnick).
Founded during the Civil War as the Army Medical Museum, the Armed Forces Institute of Pathology (AFIP) amassed the world's largest collection of human pathologic specimens and was considered a premier consultation, education, and research facility by the end of the 20th century. Samples from the AFIP were instrumental in helping to solve public health mysteries, such as the sequence of the genome of the 1918 influenza virus that killed more than 40 million people worldwide. In 2005, the federal Base Realignment and Closure Commission recommended that the AFIP be closed, and its biorepository was transferred to the newly created Joint Pathology Center. During the transition, the Department of Defense asked the IOM to provide advice on operating the biorepository, managing its collection, and determining appropriate future use of specimens for consultation, education, and research. Future Uses of the Department of Defense Joint Pathology Center Biorepository, the IOM proposes a series of protocols, standards, safeguards, and guidelines that could help to ensure that this national treasure continues to be available to researchers in the years to come, while protecting the privacy of the people who provided the materials and maintaining the security of their personal information.
Legal, regulatory, and ethical perspectives on balancing social benefit and human autonomy in research using human biospecimens. 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. Contributors Rebecca A. Anderson, Heide Aungs, Avery Avrakotos, Mark Barnes, Jill Barnholtz-Sloan, Benjamin Berkman, Barbara E. Bierer, Mark A. Borreliz, Jeffrey R. Botkin, Dan Brock, Ellen Wright Clayton, I. Glenn Cohen, Lisa Eckstein, Barbara J. Evans, Emily Chi Fogler, Nanibaa' A. Garrison, Pamela Gavin, Aaron J. Goldenberg, Christine Grady, Kate Gallin Heffernan, Marylana Saadeh Helou, Sara Chandros Hull, Elisa A. Hurley, Steven Joffe, Erin P. Johnson, Julie Kaneshiro, Aaron S. Kesselheim, Isaac Kohane, David Korn, Russell Korobkin, Bernard Lo, Geoffrey Lomax, Kimberly Hensle Lowrance, Holly Fernandez Lynch, Bradley A. Malin, Karen J. Maschke, Eric M. Meslin, P. Pearl O'Rourke, Quinn T. Ostrom, David Peloquin, Rebecca Pentz, Jane Perlmutter, Ivor Pritchard, Suzanne M. Rivera, Erin Rothwell, Andrew P. Rusczek, Rachel E. Sachs, Carol Weil, David Wendler, Benjamin Wilfond, Susan M. Wolf
This two-volume set — winner of a 2013 Highly Commended BMA Medical Book Award for Medicine — provides an in-depth look at one of the most promising avenues for advances in the diagnosis, prevention and treatment of human disease. The inclusion of the latest information on diagnostic testing, population screening, predicting disease susceptibility, pharmacogenomics and more presents this book as an essential tool for both students and specialists across many biological and medical disciplines, including human genetics and genomics, oncology, neuroscience, cardiology, infectious disease, molecular medicine, and biomedical science, as well as health policy disciplines focusing on ethical, legal, regulatory and economic aspects of genomics and medicine.Volume One Includes:Principles, Methodology and Translational Approaches, takes readers on the journey from principles of human genomics to technology, informatic and computational platforms for genomic medicine, as well as strategies for translating genomic discoveries into advances in personalized clinical care.Volume Two Includes:Genome Discoveries and Clinical Applications presents the latest developments in disease-based genomic and personalized medicine. With chapters dedicated to cardiovascular disease, oncology, inflammatory disease, metabolic disease, neuropsychiatric disease, and infectious disease, this work provides the most comprehensive guide to the principles and practice of genomic and personalized medicine. - Highly Commended 2013 BMA Medical Book Award for Medicine - Contributions from leaders in the field provide unparalleled insight into current technologies and applications in clinical medicine. - Full colour throughout enhances the utility of this work as the only available comprehensive reference for genomic and personalized medicine. - Discusses scientific foundations and practical applications of new discoveries, as well as ethical, legal/regulatory, and social issues related to the practice of genomic medicine.
Introduction and overview; State of the art of DNA storage: results of a world wide survey; DNA storage as a complementary conservation strategy; Platforms for DNA banking; The role of bioinformatics in coordinating conservations efforts; DNA banks: a primary resource for conservation research; Tissue collections as a means of storing DNA: a contribution to the conservation of Colombian biodiversity; Opportunities. limitations and needs for DNA banks; A model for DNA banking to enhance the management, distribution and use of ex situ stored PGR.
