Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development


Book Description

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.




Law and Ethics in Biomedical Research


Book Description

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.




Law and the Regulation of Scientific Research


Book Description

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.




Science and Risk Regulation in International Law


Book Description

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.




Rescuing Science from Politics


Book Description

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




Food Regulation


Book Description

Featuring case studies and discussion questions, this textbook – with revisions addressing significant changes to US food law – offers accessible coverage appropriate to a wide audience of students and professionals. Overviews the federal statutes, regulations, and regulatory agencies concerned with food regulation and introduces students to the case law and statutory scheme of food regulation Focuses updated content on the 2011 FDA Food Safety Modernization Act (FSMA), the biggest change to US food law since the 1930s Contains over 20% new material, particularly a rewritten import law chapter and revisions related to food safety regulation, health claims, and food defense Features case studies and discussion questions about application of law, policy questions, and emerging issues




Responsible Science


Book Description

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.




Law, Technology and Society


Book Description

This book considers the implications of the regulatory burden being borne increasingly by technological management rather than by rules of law. If crime is controlled, if human health and safety are secured, if the environment is protected, not by rules but by measures of technological management—designed into products, processes, places and so on—what should we make of this transformation? In an era of smart regulatory technologies, how should we understand the ‘regulatory environment’, and the ‘complexion’ of its regulatory signals? How does technological management sit with the Rule of Law and with the traditional ideals of legality, legal coherence, and respect for liberty, human rights and human dignity? What is the future for the rules of criminal law, torts and contract law—are they likely to be rendered redundant? How are human informational interests to be specified and protected? Can traditional rules of law survive not only the emergent use of technological management but also a risk management mentality that pervades the collective engagement with new technologies? Even if technological management is effective, is it acceptable? Are we ready for rule by technology? Undertaking a radical examination of the disruptive effects of technology on the law and the legal mind-set, Roger Brownsword calls for a triple act of re-imagination: first, re-imagining legal rules as one element of a larger regulatory environment of which technological management is also a part; secondly, re-imagining the Rule of Law as a constraint on the arbitrary exercise of power (whether exercised through rules or through technological measures); and, thirdly, re-imagining the future of traditional rules of criminal law, tort law, and contract law.




International Animal Research Regulations


Book Description

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.




Science, Medicine, and Animals


Book Description

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.