Law And The Regulation Of Scientific Research

Author : Mark Davies
Publisher : Taylor & Francis
ISBN 13 : 0429959958
Total Pages : 304 pages
Book Rating : 4.50/5 ( download)

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Download or read book Law and the Regulation of Scientific Research written by Mark Davies and published by Taylor & Francis. This book was released on 2022-08-12 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Scientific research is fundamental to addressing issues of great importance to the development of human knowledge. Scientific research fuels advances in medicine, technology and other areas important to society and has to be credible, trustworthy and able to command confidence in the face of inevitable uncertainties. Scientific researchers must be trusted and respected when they engage with knowledge acquisition and dissemination and as ethical guardians in their education and training roles of future generations of researchers. The core values of scientific research transcend disciplinary and national boundaries and approaches to the organisation and oversight of research systems can impact significantly upon the ethics and conduct of researchers. This book draws upon legal expertise to critically analyse issues of regulation, conduct and ethics at the important interface between scientific research and regulatory and legal environments. In so doing it aims to contribute important additional perspectives to the existing literature. Case studies are engaged with to assist with the critical analysis of the current position and the consideration of future possibilities. The book will be of interest to academics in the fields of science, law and policy; science and law students; and scientific researchers at more advanced stages of their careers. Research professionals in government and the private sector and legal practitioners with interests in the regulation of research should also find the work of interest.

Author : Duff William Ramus Waring
Publisher : University of Toronto Press
ISBN 13 : 0802086438
Total Pages : 281 pages
Book Rating : 4.33/5 ( download)

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Download or read book Law and Ethics in Biomedical Research written by Duff William Ramus Waring and published by University of Toronto Press. This book was released on 2006-01-01 with total page 281 pages. Available in PDF, EPUB and Kindle. Book excerpt: When a young man named Jesse Gelsinger died in 1999 as a result of his participation in a gene transfer research study, regulatory agencies in the United States began to take a closer look at what was happening in medical research. The resulting temporary shutdown of some of the most prestigious academic research centres confirmed what various recent reports in the United States as well as Canada had claimed; that the current system of regulatory oversight was in need of improvement. Law and Ethics in Biomedical Research uses the Gelinger case as a touchstone, illustrating how three major aspects of that case - the flaws in the regulatory system, conflicts of interest, and legal liability - embody the major challenges in the current medical research environment. Editors Trudo Lemmens and Duff R. Waring, along with a host of top scholars in the field, demonstrate why existing models of research review and human subject protection are in need of improvement, and how more stringent regulatory and legal means can be used to strengthen the protection of research subjects and the integrity of research. The contributors also address conflicts of interest, paying particular attention to the growing commercialization of medical research, as well as the legal liability of scientific investigators, research institutions, and governmental agencies. Legal liability is a growing concern in medical research and this fascinating study is, in the international context, one of the first to explore the liability of various parties involved in the research enterprise.

Author : Pamela A. Andanda
Publisher :
ISBN 13 :
Total Pages : 404 pages
Book Rating : 4.67/5 ( download)

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Download or read book The Law and Regulation of Clinical Research written by Pamela A. Andanda and published by . This book was released on 2006 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309083109
Total Pages : 81 pages
Book Rating : 4.02/5 ( download)

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Download or read book The Age of Expert Testimony written by National Research Council and published by National Academies Press. This book was released on 2002-03-13 with total page 81 pages. Available in PDF, EPUB and Kindle. Book excerpt: The federal courts are seeking ways to increase the ability of judges to deal with difficult issues of scientific expert testimony. The workshop explored the new environment judges, plaintiffs, defendants, and experts face in light of "Daubert" and "Kumho," when presenting and evaluating scientific, engineering, and medical evidence.

Author : Wendy E. Wagner
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.22/5 ( download)

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Download or read book Rescuing Science from Politics written by Wendy E. Wagner and published by . This book was released on 2014 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rescuing Science from Politics debuts fourteen chapters by the nation's leading academics in law, science, and philosophy who explore the ways that special interests can abuse the law to intrude on the way that scientists conduct research. The high stakes and adversarial features of regulation create the worst possible climate for the production and use of honest science, especially by those who will ultimately bear the cost of the resulting regulatory standards. Yet the academic or popular literature has paid scant attention to efforts by dominant interest groups to distort the available science in support of their positions. The book begins by establishing what should be noncontroversial principles of good scientific practice. These principles serve as the benchmark against which each chapter's author explains how science is misused in specific regulatory settings and isolates problems in the integration of science by the regulatory process. Dr. Donald Kenney, editor of Science, writes the prologue for the book.

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309101174
Total Pages : 23 pages
Book Rating : 4.72/5 ( download)

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Download or read book Science, Medicine, and Animals written by National Research Council and published by National Academies Press. This book was released on 2006-02-19 with total page 23 pages. Available in PDF, EPUB and Kindle. Book excerpt: Science, Medicine, and Animals explains the role that animals play in biomedical research and the ways in which scientists, governments, and citizens have tried to balance the experimental use of animals with a concern for all living creatures. An accompanying Teacher's Guide is available to help teachers of middle and high school students use Science, Medicine, and Animals in the classroom. As students examine the issues in Science, Medicine, and Animals, they will gain a greater understanding of the goals of biomedical research and the real-world practice of the scientific method in general. Science, Medicine, and Animals and the Teacher's Guide were written by the Institute for Laboratory Animal Research and published by the National Research Council of the National Academies. The report was reviewed by a committee made up of experts and scholars with diverse perspectives, including members of the U.S. Department of Agriculture, National Institutes of Health, the Humane Society of the United States, and the American Society for the Prevention of Cruelty to Animals. The Teacher's Guide was reviewed by members of the National Academies' Teacher Associates Network. Science, Medicine, and Animals is recommended by the National Science Teacher's Association NSTA Recommends.

Author : Cosimo Marco Mazzoni
Publisher : BRILL
ISBN 13 : 9047403061
Total Pages : 272 pages
Book Rating : 4.67/5 ( download)

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Download or read book Ethics and Law in Biological Research written by Cosimo Marco Mazzoni and published by BRILL. This book was released on 2002-04-01 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: Scientific research on biotechnologies has become the protagonist of discoveries that exert a formidable impact on public opinion. Every day popular opinion is challenged by the media, so that it becomes not only a witness of these developments, but is also, to a certain extent, forced to become a judge of those cases where human and animal genetics have been investigated over the last decades. The man-in-the-street is thus confronted by moral positions ranging from cautious approval, to wait-and-see attitudes, to unconditional condemnation. On the other hand, scientists are involved in the ethical evaluation of the results of their own research. However, the results of scientific pursuits are capable of producing immediate effects on the daily life of every human being. Consequently, alongside the scientists, people feel strongly about their need and their right to contribute to an accurate assessment of the effects of science on society. This is a collection of essays reflecting a considerable range of different cultural experiences and different ethical underpinnings. The main subject is cloning. Cloning is the most accessible and most readily perceived point of convergence from which ethical judgments on the current developments of scientific investigations can be proposed. Cloning is also the `paradox' on which the confrontation between scientific research and popular imagination is focused.

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309379512
Total Pages : 283 pages
Book Rating : 4.19/5 ( download)

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Download or read book Optimizing the Nation's Investment in Academic Research written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-06-29 with total page 283 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research universities are critical contributors to our national research enterprise. They are the principal source of a world-class labor force and fundamental discoveries that enhance our lives and the lives of others around the world. These institutions help to create an educated citizenry capable of making informed and crucial choices as participants in a democratic society. However many are concerned that the unintended cumulative effect of federal regulations undercuts the productivity of the research enterprise and diminishes the return on the federal investment in research. Optimizing the Nation's Investment in Academic Research reviews the regulatory framework as it currently exists, considers specific regulations that have placed undue and often unanticipated burdens on the research enterprise, and reassesses the process by which these regulations are created, reviewed, and retired. This review is critical to strengthen the partnership between the federal government and research institutions, to maximize the creation of new knowledge and products, to provide for the effective training and education of the next generation of scholars and workers, and to optimize the return on the federal investment in research for the benefit of the American people.

Author : Wendy Elizabeth Wagner
Publisher : Cambridge University Press
ISBN 13 : 0521855209
Total Pages : 259 pages
Book Rating : 4.04/5 ( download)

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Download or read book Rescuing Science from Politics written by Wendy Elizabeth Wagner and published by Cambridge University Press. This book was released on 2006-07-24 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines how dominant interest groups manipulate the available science to support their positions.

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309222176
Total Pages : 118 pages
Book Rating : 4.74/5 ( download)

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Download or read book Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development written by Institute of Medicine and published by National Academies Press. This book was released on 2012-04-04 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.