Law And The Regulation Of Scientific Research

Author : Mark Davies
Publisher : Taylor & Francis
Page : 304 pages
File Size : 45,8 Mb
Release : 2022-08-12
Category : Law
ISBN : 9780429959950

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Law and the Regulation of Scientific Research by Mark Davies Pdf

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,Trudo Lemmens
Publisher : University of Toronto Press
Page : 281 pages
File Size : 51,6 Mb
Release : 2006-01-01
Category : Medical
ISBN : 9780802086433

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Law and Ethics in Biomedical Research by Duff William Ramus Waring,Trudo Lemmens Pdf

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 : Wendy E. Wagner,Rena I. Steinzor
Publisher : Unknown
Page : 0 pages
File Size : 42,8 Mb
Release : 2014
Category : Electronic
ISBN : OCLC:1375311922

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Rescuing Science from Politics by Wendy E. Wagner,Rena I. Steinzor Pdf

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,Policy and Global Affairs,Science, Technology, and Law Panel
Publisher : National Academies Press
Page : 81 pages
File Size : 46,9 Mb
Release : 2002-03-13
Category : Law
ISBN : 9780309083102

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The Age of Expert Testimony by National Research Council,Policy and Global Affairs,Science, Technology, and Law Panel Pdf

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 : National Academies of Sciences, Engineering, and Medicine,Policy and Global Affairs,Board on Higher Education and Workforce,Committee on Science, Technology, and Law,Committee on Federal Research Regulations and Reporting Requirements: A New Framework for Research Universities in the 21st Century
Publisher : National Academies Press
Page : 283 pages
File Size : 50,7 Mb
Release : 2016-06-29
Category : Science
ISBN : 9780309379519

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Optimizing the Nation's Investment in Academic Research by National Academies of Sciences, Engineering, and Medicine,Policy and Global Affairs,Board on Higher Education and Workforce,Committee on Science, Technology, and Law,Committee on Federal Research Regulations and Reporting Requirements: A New Framework for Research Universities in the 21st Century Pdf

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 : Cosimo Marco Mazzoni
Publisher : Martinus Nijhoff Publishers
Page : 276 pages
File Size : 45,7 Mb
Release : 2002-04-11
Category : Science
ISBN : 9041117423

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Ethics and Law in Biological Research by Cosimo Marco Mazzoni Pdf

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 : Jacqueline Peel
Publisher : Cambridge University Press
Page : 417 pages
File Size : 54,8 Mb
Release : 2010-11-04
Category : Law
ISBN : 9781139493239

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Science and Risk Regulation in International Law by Jacqueline Peel Pdf

The regulation of risk is a preoccupation of contemporary global society and an increasingly important part of international law in areas ranging from environmental protection to international trade. This book examines a key aspect of international risk regulation - the way in which science and technical expertise are used in reaching decisions about how to assess and manage global risks. An interdisciplinary analysis is employed to illuminate how science has been used in international legal processes and global institutions such as the World Trade Organization. Case studies of risk regulation in international law are drawn from diverse fields including environmental treaty law, international trade law, food safety regulation and standard-setting, biosafety and chemicals regulation. The book also addresses the important question of the most appropriate balance between science and non-scientific inputs in different areas of international risk regulation.

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 118 pages
File Size : 43,9 Mb
Release : 2012-04-04
Category : Medical
ISBN : 9780309222174

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Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf

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.

Author : National Research Council,Division on Earth and Life Studies,Institute for Laboratory Animal Research
Publisher : National Academies Press
Page : 23 pages
File Size : 52,6 Mb
Release : 2006-02-19
Category : Science
ISBN : 9780309101172

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Science, Medicine, and Animals by National Research Council,Division on Earth and Life Studies,Institute for Laboratory Animal Research Pdf

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 : Nicola Lucchi
Publisher : Springer
Page : 187 pages
File Size : 44,7 Mb
Release : 2016-06-14
Category : Law
ISBN : 9783319304397

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The Impact of Science and Technology on the Rights of the Individual by Nicola Lucchi Pdf

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.

Author : Wendy Elizabeth Wagner,Rena Steinzor
Publisher : Cambridge University Press
Page : 259 pages
File Size : 55,7 Mb
Release : 2006-07-24
Category : Law
ISBN : 9780521855204

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Rescuing Science from Politics by Wendy Elizabeth Wagner,Rena Steinzor Pdf

This book examines how dominant interest groups manipulate the available science to support their positions.

Author : National Research Council,Institute of Medicine,Division on Earth and Life Studies,Institute for Laboratory Animal Research,Policy and Global Affairs,Committee on Science, Technology, and Law,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Publisher : National Academies Press
Page : 102 pages
File Size : 41,5 Mb
Release : 2012-06-26
Category : Science
ISBN : 9780309252119

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International Animal Research Regulations by National Research Council,Institute of Medicine,Division on Earth and Life Studies,Institute for Laboratory Animal Research,Policy and Global Affairs,Committee on Science, Technology, and Law,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders Pdf

Animals are widely used in neuroscience research to explore biological mechanisms of nervous system function, to identify the genetic basis of disease states, and to provide models of human disorders and diseases for the development of new treatments. To ensure the humane care and use of animals, numerous laws, policies, and regulations are in place governing the use of animals in research, and certain animal regulations have implications specific to neuroscience research. To consider animal research regulations from a global perspective, the IOM Forum on Neuroscience and Nervous System Disorders, in collaboration with the National Research Council and the Institute for Laboratory Animal Research, held a workshop in Buckinghamshire, UK, July 26-27, 2011. The workshop brought together neuroscientists, legal scholars, administrators, and other key stakeholders to discuss current and emerging trends in animal regulations as they apply to the neurosciences. This document summarizes the workshop.

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
Publisher : National Academies Press
Page : 445 pages
File Size : 51,9 Mb
Release : 2004-07-09
Category : Medical
ISBN : 9780309133388

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Ethical Conduct of Clinical Research Involving Children by Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children Pdf

In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Author : Florian Wegelein
Publisher : BRILL
Page : 409 pages
File Size : 43,6 Mb
Release : 2005-06-01
Category : Law
ISBN : 9789047408024

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Marine Scientific Research by Florian Wegelein Pdf

The present analysis examines the legal framework for marine scientific research with a focus on research platforms

Author : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher : Unknown
Page : 614 pages
File Size : 47,6 Mb
Release : 1978
Category : Human experimentation in medicine
ISBN : UCSD:31822000897728

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The Belmont Report by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Pdf