Regulatory Stewardship of Health Research

Regulatory Stewardship of Health Research PDF Author: Edward S. Dove
Publisher: Edward Elgar Publishing
ISBN: 1788975359
Category : Law
Languages : en
Pages : 266

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Book Description
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’.

Regulatory Stewardship of Health Research

Regulatory Stewardship of Health Research PDF Author: Edward S. Dove
Publisher: Edward Elgar Publishing
ISBN: 1788975359
Category : Law
Languages : en
Pages : 266

Get Book

Book Description
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’.

The Cambridge Handbook of Health Research Regulation

The Cambridge Handbook of Health Research Regulation PDF Author: Graeme Laurie
Publisher:
ISBN: 1108576095
Category : Law
Languages : en
Pages : 444

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Book Description
The definitive reference guide to designing scientifically sound and ethically robust medical research, considering legal, ethical and practical issues.

A New Pathway for the Regulation and Governance of Health Research

A New Pathway for the Regulation and Governance of Health Research PDF Author: Academy of Medical Sciences (Great Britain)
Publisher:
ISBN: 9781903401316
Category :
Languages : en
Pages : 123

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Book Description


Beyond the HIPAA Privacy Rule

Beyond the HIPAA Privacy Rule PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309124999
Category : Computers
Languages : en
Pages : 334

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Book Description
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.

Law and Legacy in Medical Jurisprudence

Law and Legacy in Medical Jurisprudence PDF Author: Edward S. Dove
Publisher: Cambridge University Press
ISBN: 1108842437
Category : Law
Languages : en
Pages : 449

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Book Description
Introduction and investigation of the concept - and utility - of legacy in the field of medical jurisprudence.

Optimizing the Nation's Investment in Academic Research

Optimizing the Nation's Investment in Academic Research PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309379512
Category : Science
Languages : en
Pages : 283

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Book Description
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.

Digital Infrastructure for the Learning Health System

Digital Infrastructure for the Learning Health System PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309154162
Category : Medical
Languages : en
Pages : 336

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Book Description
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.

Stronger Food and Drug Regulatory Systems Abroad

Stronger Food and Drug Regulatory Systems Abroad PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309670438
Category : Medical
Languages : en
Pages : 243

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Book Description
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.

Mason and Mccall Smith's Law and Medical Ethics

Mason and Mccall Smith's Law and Medical Ethics PDF Author:
Publisher: Oxford University Press
ISBN: 0192866222
Category :
Languages : en
Pages : 699

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Book Description
Trusted for over 40 years for its authoritative account of medical law, this text provides the right balance between in-depth legal coverage and analysis of ethical issues.This classic textbook focuses on medical law and its relationship with medical practice and modern ethics. It provides thorough coverage of all topics found on medical law courses, and in-depth analysis of recent court decisions and legislation, encouraging students to thinkcritically about this area of study. - Covers the whole field of modern ethical medical practice, making the book suitable for use on all undergraduate and postgraduate medicallaw courses- Clearly sets a diversity of views in ethical debates, and offers the authors' own perspectives, encouraging students to explore and form their own opinions- Takes account of the influence of international policy and legal developments in shaping medical law in the UKNew to this edition:· Two brand new chapters introduce students to concepts, theories, and tools that frame interpretation and analysis ofhealth and medical law· A new chapter provides an overview of UK health systems and examines these in the context of devolution, the Covid-19 pandemic, and Brexit· The table of contents has beenreorganised and streamlined to enhance clarity and focus on current issues in the discipline· Includes coverage of developments such as the Health and Social Care Act 2022, Mental Health Bill 2022, Medicines and Medical Devices Act 2021, Coronavirus Act 2020, new regimes for organ donation, Bell v Tavistock, ABC v St George's Healthcare NHS Trust, Khan v Meadows, and moreDigital formatsThis twelfth edition is availablefor students and institutions to purchase in a variety of formats.The e-book offers a mobile experience and convenient access along with functionality tools, navigation features, and links that offer extra learningsupport: www.oxfordtextbooks.co.uk/ebooks

Sharing Linked Data for Health Research

Sharing Linked Data for Health Research PDF Author: Carolyn Adams
Publisher: Cambridge University Press
ISBN: 1108619916
Category : Law
Languages : en
Pages : 279

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Book Description
Health research around the world relies on access to data, and much of the most valuable, reliable, and comprehensive data collections are held by governments. These collections, which contain data on whole populations, are a powerful tool in the hands of researchers, especially when they are linked and analyzed, and can help to address “wicked problems” in health and emerging global threats such as COVID-19. At the same time, these data collections contain sensitive information that must only be used in ways that respect the values, interests, and rights of individuals and their communities. Sharing Linked Data for Health Research provides a template for allowing research access to government data collections in a regulatory environment designed to build social license while supporting the research enterprise.