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Regulatory Stewardship Of Health Research
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Book Synopsis Regulatory Stewardship of Health Research by : Edward S. Dove
Download or read book Regulatory Stewardship of Health Research written by Edward S. Dove and published by Edward Elgar Publishing. This book was released on 2020-02-28 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: This timely book examines the interaction of health research and regulation with law through empirical analysis and the application of key anthropological concepts to reveal the inner workings of human health research. Through ground-breaking empirical inquiry, Regulatory Stewardship of Health Research explores how research ethics committees (RECs) work in practice to both protect research participants and promote ethical research. This thought-provoking book provides a new perspective on the regulation of health research by demonstrating how RECs and other regulatory actors seek to fulfil these two functions by performing a role of ‘regulatory stewardship’.
Book Synopsis Fundamentals of Clinical Data Science by : Pieter Kubben
Download or read book Fundamentals of Clinical Data Science written by Pieter Kubben and published by Springer. This book was released on 2018-12-21 with total page 219 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book comprehensively covers the fundamentals of clinical data science, focusing on data collection, modelling and clinical applications. Topics covered in the first section on data collection include: data sources, data at scale (big data), data stewardship (FAIR data) and related privacy concerns. Aspects of predictive modelling using techniques such as classification, regression or clustering, and prediction model validation will be covered in the second section. The third section covers aspects of (mobile) clinical decision support systems, operational excellence and value-based healthcare. Fundamentals of Clinical Data Science is an essential resource for healthcare professionals and IT consultants intending to develop and refine their skills in personalized medicine, using solutions based on large datasets from electronic health records or telemonitoring programmes. The book’s promise is “no math, no code”and will explain the topics in a style that is optimized for a healthcare audience.
Book Synopsis The Law and Regulation of Clinical Research by : Pamela A. Andanda
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:
Book Synopsis The Cambridge Handbook of Health Research Regulation by : Graeme Laurie
Download or read book The Cambridge Handbook of Health Research Regulation written by Graeme Laurie and published by . This book was released on 2021-06-09 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: The definitive reference guide to designing scientifically sound and ethically robust medical research, considering legal, ethical and practical issues.
Book Synopsis The Cambridge Handbook of Health Research Regulation by : Graeme Laurie
Download or read book The Cambridge Handbook of Health Research Regulation written by Graeme Laurie and published by Cambridge University Press. This book was released on 2021-06-24 with total page 443 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first ever interdisciplinary handbook in the field, this vital resource offers wide-ranging analysis of health research regulation. The chapters confront gaps between documented law and research in practice, and draw on legal, ethical and social theories about what counts as robust research regulation to make recommendations for future directions. The Handbook provides an account and analysis of current regulatory tools - such as consent to participation in research and the anonymization of data to protection participants' privacy - as well as commentary on the roles of the actors and stakeholders who are involved in human health research and its regulation. Drawing on a range of international examples of research using patient data, tissue and other human materials, the collective contribution of the volume is to explore current challenges in delivering good medical research for the public good and to provide insights on how to design better regulatory approaches. This title is also available as Open Access on Cambridge Core.
Book Synopsis A New Pathway for the Regulation and Governance of Health Research by : Academy of Medical Sciences (Great Britain)
Download or read book A New Pathway for the Regulation and Governance of Health Research written by Academy of Medical Sciences (Great Britain) and published by . This book was released on 2011 with total page 123 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis EBOOK: Regulating Healthcare by : Kieran Walshe
Download or read book EBOOK: Regulating Healthcare written by Kieran Walshe and published by McGraw-Hill Education (UK). This book was released on 2003-06-16 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare organizations in the UK and the USA face a growing tide of regulation, accreditation, inspection and external review, all aimed at improving their performance. In the US, over three decades of regulation by state and federal government, and by non-governmental agencies, has created a complex, costly and overlapping network of oversight arrangements for healthcare organizations. In the UK, regulation of the government-run National Health Service is central to current health policy, with the creation of a host of new national agencies and inspectorates tasked with overseeing the performance of NHS hospitals and other organizations. But does regulation work? This book: . explores the development and use of healthcare regulation in both countries, comparing and contrasting their experience and drawing on regulatory research in other industries and settings . offers a structured approach to analysing what regulators do and how they work . develops principles for effective regulation, aimed at maximising the benefits of regulatory interventions and minimising their costs Regulating Healthcare is aimed at all with an interest or involvement in health policy and management, be they policy makers, healthcare managers or health professionals. It is particularly suitable for use on postgraduate health and health-related programmes.
Book Synopsis Beyond the HIPAA Privacy Rule by : Institute of Medicine
Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.
Book Synopsis Digital Infrastructure for the Learning Health System by : Institute of Medicine
Download or read book Digital Infrastructure for the Learning Health System written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-21 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: Like many other industries, health care is increasingly turning to digital information and the use of electronic resources. The Institute of Medicine's Roundtable on Value & Science-Driven Health Care hosted three workshops to explore current efforts and opportunities to accelerate progress in improving health and health care with information technology systems.
Book Synopsis Law and Legacy in Medical Jurisprudence by : Edward S. Dove
Download or read book Law and Legacy in Medical Jurisprudence written by Edward S. Dove and published by Cambridge University Press. This book was released on 2022-03-10 with total page 449 pages. Available in PDF, EPUB and Kindle. Book excerpt: Graeme Laurie stepped down from the Chair in Medical Jurisprudence at the University of Edinburgh in 2019. This edited collection pays tribute to his extraordinary contributions to the field. Graeme often spoke about the importance of 'legacy' in academic work and forged a remarkable intellectual legacy of his own, notably through his work on genetic privacy, human tissue and information governance, and the regulatory salience of the concept of liminality. The essays in this volume animate the concept of legacy to analyse the study and practice of medical jurisprudence. In this light, legacy reveals characteristics of both benefit and burden, as both an encumbrance to and facilitator of the development of law, policy and regulation. The contributions reconcile the ideas of legacy and responsiveness and show that both dimensions are critical to achieve and sustain the health of medical jurisprudence itself as a dynamic, interdisciplinary and policy-engaged field of thinking.
Book Synopsis The Behavioral Code by : Benjamin van Rooij
Download or read book The Behavioral Code written by Benjamin van Rooij and published by Beacon Press. This book was released on 2021-10-26 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: A 2022 PROSE Award finalist in Legal Studies and Criminology A 2022 American Bar Association Silver Gavel Award Finalist A Behavioral Scientist’s Notable Book of 2021 Freakonomics for the law—how applying behavioral science to the law can fundamentally change and explain misbehavior Why do most Americans wear seatbelts but continue to speed even though speeding fines are higher? Why could park rangers reduce theft by removing “no stealing” signs? Why was a man who stole 3 golf clubs sentenced to 25 years in prison? Some laws radically change behavior whereas others are consistently ignored and routinely broken. And yet we keep relying on harsh punishment against crime despite its continued failure. Professors Benjamin van Rooij and Adam Fine draw on decades of research to uncover the behavioral code: the root causes and hidden forces that drive human behavior and our responses to society’s laws. In doing so, they present the first accessible analysis of behavioral jurisprudence, which will fundamentally alter how we understand the connection between law and human behavior. The Behavioral Code offers a necessary and different approach to battling crime and injustice that is based in understanding the science of human misconduct—rather than relying on our instinctual drive to punish as a way to shape behavior. The book reveals the behavioral code’s hidden role through illustrative examples like: • The illusion of the US’s beloved tax refund • German walls that “pee back” at public urinators • The $1,000 monthly “good behavior” reward that reduced gun violence • Uber’s backdoor “Greyball” app that helped the company evade Seattle’s taxi regulators • A $2.3 billion legal settlement against Pfizer that revealed how whistleblower protections fail to reduce corporate malfeasance • A toxic organizational culture playing a core role in Volkswagen’s emissions cheating scandal • How Peter Thiel helped Hulk Hogan sue Gawker into oblivion Revelatory and counterintuitive, The Behavioral Code catalyzes the conversation about how the law can effectively improve human conduct and respond to some of our most pressing issues today, from police misconduct to corporate malfeasance.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309379512 Total Pages :283 pages Book Rating :4.3/5 (93 download)
Book Synopsis Optimizing the Nation's Investment in Academic Research by : National Academies of Sciences, Engineering, and Medicine
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.
Book Synopsis Regulatory Stewardship Strategy by : New Zealand. Ministry for Primary Industries
Download or read book Regulatory Stewardship Strategy written by New Zealand. Ministry for Primary Industries and published by . This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309670438 Total Pages :243 pages Book Rating :4.3/5 (96 download)
Book Synopsis Stronger Food and Drug Regulatory Systems Abroad by : National Academies of Sciences, Engineering, and Medicine
Download or read book Stronger Food and Drug Regulatory Systems Abroad written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-09 with total page 243 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ensuring the safety of food and the quality and safety of medicines in a country is an important role of government, made more complicated by global manufacturing and international trade. By recent estimates, unsafe food kills over 400,000 people a year, a third of them children under 5, mostly in low- and middle-income countries; every year poor quality medicines cause about 70,000 excess deaths from childhood pneumonia and roughly 8,500 to 20,000 malaria deaths in sub-Saharan Africa alone. The Federal Drug Administration (FDA) Office of Global Policy and Strategy is charged with improving capacity of the agency's foreign counterpart offices and increasing understanding of the importance of regulatory systems for public health, development, and trade. At the request of the FDA, this study sets out a strategy to support good quality, wholesome food and safe, effective medical products around the world. Its goal is to build on the momentum for strengthening regulatory systems and to set a course for sustainability and continued progress. The 2012 report Ensuring Safe Food and Medical Products Through Stronger Regulatory Systems Abroad outlined strategies to secure international supply chains, emphasized capacity building and support for surveillance in low- and middle-income countries, and explored ways to facilitate work sharing among food and medical product regulatory agencies. This new study assess progress made and the current regulatory landscape.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309438845 Total Pages :105 pages Book Rating :4.3/5 (94 download)
Book Synopsis Advancing the Discipline of Regulatory Science for Medical Product Development by : National Academies of Sciences, Engineering, and Medicine
Download or read book Advancing the Discipline of Regulatory Science for Medical Product Development written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2016-08-11 with total page 105 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of endeavors known as "regulatory science" has grown out of the need to link and integrate knowledge within and among basic science research, clinical research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could inform biomedical product development and regulatory decision making. Substantial efforts have been devoted to defining regulatory science and communicating its value and role across the scientific and regulatory ecosystems. Investments are also being made in technology infrastructure, regulatory systems, and workforce development to support and advance this burgeoning discipline. In October 2015, the National Academies of Sciences, Engineering, and Medicine held a public workshop to facilitate dialogue among stakeholders about the current state and scope of regulatory science, opportunities to address barriers to the discipline's success, and avenues for fostering collaboration across sectors. Participants explored key needs for strengthening the discipline of regulatory science, including considering what are the core components of regulatory science infrastructure to foster innovation in medical product development. This report summarizes the presentations and discussions from the workshop.
Book Synopsis Trust in the system by : Adam Hedgecoe
Download or read book Trust in the system written by Adam Hedgecoe and published by Manchester University Press. This book was released on 2020-12-15 with total page 245 pages. Available in PDF, EPUB and Kindle. Book excerpt: Based on extensive observations, interviews, and archival research, this book provides an in-depth insight into one of the most crucial forms of regulation around medical research: Research Ethics Committees. Every month, groups of people from all over the United Kingdom decide what kind of research should be carried out on patients within the National Health Service. These groups – Research Ethics Committees (RECs) – made up of doctors, nurses, researchers, and members of the general public – help shape the future of medicine, and play a crucial role in the regulation of a wide range of research from social science to epidemiology, vaccine and drugs trials, and surgery. In providing one of the first empirical examinations of this kind of regulation, this book highlights how, despite the trappings of a modern regulatory system, REC decision making revolves around outdated aspects of social life. Hedgecoe argues that an accurate understanding of this kind of regulation requires an acceptance of the inherently social nature of the processes involved. In placing trust at the centre of ethics decision making, this book challenges the impersonal, de-socialised, and mechanical models of REC decision making that dominate mainstream accounts, and documents the subtle, messy, and complex way in which these bodies decide what kind of research should take place.
Book Synopsis Public Ends, Private Means by : Alexander S. Preker
Download or read book Public Ends, Private Means written by Alexander S. Preker and published by World Bank Publications. This book was released on 2007-01-01 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt: Great progress has been made in recent years in securing better access and financial protection against the cost of illness through collective financing of health care. Managing scarce resources effectively and efficiently is an important part of this story. Experience has shown that, without strategic policies and focused spending, the poor are likely to get left out. The use of purchasing to enhance public sector performance is well-documented in other sectors. Extension to the health sector of lessons from this experience is now successfully implemented in many developing countries. Public.
