The Cambridge handbook of health research regulation / / edited by Graeme Laurie [and others].

• Superior document: Social Sciences
• TeilnehmendeR: Laurie, G. T.
• Place / Publishing House: Cambridge : : Cambridge University Press,, 2021.
• Year of Publication: 2021
• Language: English
• Series: Social Sciences
• Physical Description: 1 online resource (xix, 421 pages) :; digital, PDF file(s).
• Notes: Title from publisher's bibliographic system (viewed on 11 Jun 2021).

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.

Table of Contents

Introduction / Graeme Laurie -- Vulnerability / Wendy Rogers -- Proportionality / Owen Schaefer -- Social Value / Hans van Delden and Rieke van der Graaf -- Solidarity / Katharina Kieslich and Barbara Prainsack -- Public Interest / Annie Sorbieh -- Privacy / David Townend -- Trust and institutions : global health research collaborations / Angeliki Kerasidou -- Vulnerabilities and power : the political side of health research / Iain Brassington -- Consent / Jane Kaye and Megan Prictor -- Forms of engagement / Mhairi Aitken and Sarah Cunningham-Burley -- Participatory governance in health research : patients and publics as stewards of health research systems / Kim Chuong and Kieran O'Doherty -- Risk-benefit analysis / Carl Coleman -- The regulatory role of patents in innovative health research and its translation from the laboratory to the clinic / Dianne Nicole and Jane Nielsen -- Benefit sharing - from compensation to collaboration / Kadri Simm -- Taking failure seriously : health research regulation for medical devices, technological risk and preventing future harm / Mark Flear -- Rules, principles and the added value of best practice in health research regulation / Nayha Sethi -- Research ethics review / Edward Dove -- Data access governance / Mahsa Shabani, Adrian Thorogood, and Madeline Murtagh -- Is the red queen sitting on the throne? Current trends and future developments in human health research regulation / Stuart Nicholls -- Regulatory authorities and decision-making in health research : the institutional dimension / Aisling McMahon -- The once and future role of policy advice for health regulation by experts and advisory committees / Eric Meslin -- Changing identities in disclosure of research findings / Emily Postan -- Health research and privacy through the lens of public interest : a monocle for the myopic? / Mark Taylor and Tess Whitton -- Mobilising public expertise in health research regulation / Michael Burges -- Towards adaptive governance in big data health research : implementing regulatory principles / Effy Vayena and Alessandro Blasimme -- Regulating automated healthcare and research technologies : first do no harm (to the commons) / Roger Brownsword -- When learning is continuous : bridging the research-therapy divide in the regulatory governance of artificial intelligence as medical devices / Calvin Ho -- The oversight of clinical innovation in a medical marketplace / Wendy Lipworth, Miriam Wiersma, Narcyz Ghinea, Tereza Hendly, Ian Kerridge, Tamra Lysaght, Megan Munsie, Chris Rudge, Cameron Stewart, and Catherine Waldby -- The challenge of 'evidence' : research and regulation of traditional and non-conventional medicines / Nayeli Urquiza Haas and Emilie Cloatre -- Experiences of ethics, governance, and scientific practice in neuroscience research / Martyn Pickersgil -- Humanitarian research : ethical considerations in conducting research during global health emergencies / Agomoni Ganguli-Mitra and Matthew Hunt -- Governance framework for advanced therapies in Argentina / Fabiana Arzuaga -- Human gene editing : traversing normative systems / Rosario IsasiRosario Isasi -- Modification and the future of health research regulation / Sarah Chan -- Human organs and animal bodies : regulating interspecies research / Amy Hinterberger and Sara Bea -- When is human? Rethinking the 14-day rule / Catriona McMillan -- A perfect storm : non-evidence-based medicine in the fertility clinic / Emily Jackson -- Margins or mainstream? Enhancement and the need for a new regulatory perspective / Shawn Harmon -- Afterword : what could a learning health research regulation system look like? / Graeme Laurie.