Regulatory Stewardship of Health Research

Regulatory Stewardship of Health Research
Author: Edward S. Dove
Publisher: Edward Elgar Publishing
Total Pages: 266
Release: 2020-02-28
Genre: Law
ISBN: 1788975359

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’.

Fundamentals of Clinical Data Science

Fundamentals of Clinical Data Science
Author: Pieter Kubben
Publisher: Springer
Total Pages: 219
Release: 2018-12-21
Genre: Medical
ISBN: 3319997130

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.

The Cambridge Handbook of Health Research Regulation

The Cambridge Handbook of Health Research Regulation
Author: Graeme Laurie
Publisher:
Total Pages: 444
Release: 2021-06-09
Genre: Law
ISBN: 1108576095

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

Trust in the system

Trust in the system
Author: Adam Hedgecoe
Publisher: Manchester University Press
Total Pages: 245
Release: 2020-12-15
Genre: Social Science
ISBN: 1526152908

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.

The Cambridge Handbook of Health Research Regulation

The Cambridge Handbook of Health Research Regulation
Author: Graeme Laurie
Publisher: Cambridge University Press
Total Pages: 443
Release: 2021-06-24
Genre: Law
ISBN: 1108653383

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.

Law and Legacy in Medical Jurisprudence

Law and Legacy in Medical Jurisprudence
Author: Edward S. Dove
Publisher: Cambridge University Press
Total Pages: 449
Release: 2022-03-10
Genre: Law
ISBN: 1108905161

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.

Stronger Food and Drug Regulatory Systems Abroad

Stronger Food and Drug Regulatory Systems Abroad
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 243
Release: 2020-04-09
Genre: Medical
ISBN: 0309670438

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.

Advancing the Discipline of Regulatory Science for Medical Product Development

Advancing the Discipline of Regulatory Science for Medical Product Development
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 105
Release: 2016-08-11
Genre: Medical
ISBN: 0309438845

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.