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.
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.
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.
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.
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.
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.
Download or read book Science and Risk Regulation in International Law written by Jacqueline Peel and published by Cambridge University Press. This book was released on 2010-11-04 with total page 417 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book International Animal Research Regulations written by National Research Council and published by National Academies Press. This book was released on 2012-06-26 with total page 102 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Responsible Science written by Committee on Science, Engineering, and Public Policy (U.S.). Panel on Scientific Responsibility and the Conduct of Research and published by National Academies. This book was released on 1992 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt: Responsible Science is a comprehensive review of factors that influence the integrity of the research process. Volume I examines reports on the incidence of misconduct in science and reviews institutional and governmental efforts to handle cases of misconduct. The result of a two-year study by a panel of experts convened by the National Academy of Sciences, this book critically analyzes the impact of today's research environment on the traditional checks and balances that foster integrity in science. Responsible Science is a provocative examination of the role of educational efforts; research guidelines; and the contributions of individual scientists, mentors, and institutional officials in encouraging responsible research practices.
Download or read book Public Health Service Policy on Humane Care and Use of Laboratory Animals written by National Institutes of Health (U.S.). Office for Protection from Research Risks and published by . This book was released on 1986 with total page 40 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Use of Laboratory Animals in Biomedical and Behavioral Research written by National Research Council and published by National Academies Press. This book was released on 1988-02-01 with total page 113 pages. Available in PDF, EPUB and Kindle. Book excerpt: Scientific experiments using animals have contributed significantly to the improvement of human health. Animal experiments were crucial to the conquest of polio, for example, and they will undoubtedly be one of the keystones in AIDS research. However, some persons believe that the cost to the animals is often high. Authored by a committee of experts from various fields, this book discusses the benefits that have resulted from animal research, the scope of animal research today, the concerns of advocates of animal welfare, and the prospects for finding alternatives to animal use. The authors conclude with specific recommendations for more consistent government action.
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.
Download or read book Ethics and Law in Biological Research written by Cosimo Marco Mazzoni and published by Martinus Nijhoff Publishers. This book was released on 2002-04-11 with total page 276 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.
Download or read book Biotechnology Research in an Age of Terrorism written by National Research Council and published by National Academies Press. This book was released on 2004-03-02 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years much has happened to justify an examination of biological research in light of national security concerns. The destructive application of biotechnology research includes activities such as spreading common pathogens or transforming them into even more lethal forms. Policymakers and the scientific community at large must put forth a vigorous and immediate response to this challenge. This new book by the National Research Council recommends that the government expand existing regulations and rely on self-governance by scientists rather than adopt intrusive new policies. One key recommendation of the report is that the government should not attempt to regulate scientific publishing but should trust scientists and journals to screen their papers for security risks, a task some journals have already taken up. With biological information and tools widely distributed, regulating only U.S. researchers would have little effect. A new International Forum on Biosecurity should encourage the adoption of similar measures around the world. Seven types of risky studies would require approval by the Institutional Biosafety Committees that already oversee recombinant DNA research at some 400 U.S. institutions. These "experiments of concern" include making an infectious agent more lethal and rendering vaccines powerless.
Download or read book The Belmont Report written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1978 with total page 614 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Improved Standards for Laboratory Animals Act and Enforcement of the Animal Welfare Act by the Animal and Plant Health Inspection Service written by United States. Congress. House. Committee on Agriculture. Subcommittee on Department Operations, Research, and Foreign Agriculture and published by . This book was released on 1985 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt:
