1.

Record Nr.

UNINA9910404149203321

Autore

Dove E. S (Edward S.)

Titolo

Regulatory stewardship of health research : navigating participant protection and research promotion / / Edward S. Dove

Pubbl/distr/stampa

Northampton : , : Edward Elgar Publishing, , 2020

ISBN

1-78897-535-9

Descrizione fisica

1 online resource (232 pages)

Collana

Elgar studies in law and regulation

Disciplina

613

Soggetti

Health - Research

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Includes index.

Nota di bibliografia

Includes bibliographical references.

Nota di contenuto

Contents: 1. Introduction -- 2. Conceptual framework - setting the scene for 'protection' and 'promotion' -- 3. The making of recs as health research regulators -- 4. Anthropology of regulation -- 5. Operationalising 'next-generation' health research regulation - what is happening in practice? -- 6. Charting a framework for regulatory stewardship -- 7. Conclusion -- Index.

Sommario/riassunto

"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 new perspectives 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'. This involves guiding researchers through stages of research approval, as well as seeking to maximise benefits for participants and society while minimising risks. Arguing that participant protection and research promotion should rightly be treated as twin objectives for health research regulators, this book asserts that there is a need for more overt recognition of the importance and function of the deliberative space in which RECs can negotiate the risks relevant to a research application. This book is a key resource for academics and



students interested in health research and regulation, and the dynamic interaction of ethics and the law. Regulators and policy-makers will also find it to be an insightful and illuminating text for the practical insights that it reveals about research governance in action"--