1st Edition

European Neonatal Research
Consent, Ethics Committees and Law




ISBN 9781138703445
Published December 31, 2018 by Routledge
286 Pages

USD $41.95

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Book Description

This title was first published in 2001. An important book presenting the results of the European Union funded EURICON project in biomedical ethics. Involving experts in eleven countries, this project was motivated by European neonatal clinicians’ concerns about the problem of obtaining informed consent in neonatal research. It addressed the difficulties of obtaining consent from subjects involved in such research, and investigated the relevance and appropriateness of obtaining consent from parents. The project also examined the work of Research Ethics Committees in Europe. It explored their responses to EURICON’s analysis of the views of clinicians and parents, and their attitudes towards the relevant laws and legal requirements. The wide geographical scope of the project enabled international comparisons of the opinions of clinicians and parents, the legal frameworks governing neonatal research, and the effectiveness of Research Ethics Committees. This is the first such investigation on a European scale, and it offers a unique interdisciplinary approach to these issues. Incorporating clinical, ethical, legal and sociological perspectives, the results and recommendations presented in this book will be of widespread significance to practitioners, researchers and policy makers throughout Europe and beyond.

Table of Contents

Contents: Background Information on the Euricon Study: Ethical issues and practical problems in obtaining informed consent for neonatal research, P.J. Allmark, S.A. Mason and C. Megone; The practical problems in obtaining informed consent for a neonatal randomized controlled trial, A.B. Gill. Research Ethics Committees in Europe: Their Role in Ethical Review: The structure, composition and operation of European RECs, C. Megone, S.A. Mason, P.J. Allmark, S. Reiter-Theil, D. Bratlid, P. Dalla-Vorgia, P. Morrogh, A.B. Gill and A. Langlois; The attitudes of RECs in 11 European countries to informed consent in neonatal research, C. Megone, S.A. Mason, P.J. Allmark, S. Reiter-Theil, D. Bratlid, P. Dalla-Vorgia, P. Morrogh, A.B. Gill S. Holm and A. Langlois; The views of RECS in 8 European countries on the process of obtaining informed consent in neonatal research and on the structure and organization of RECs, C. Megone, S.A. Mason, P.J. Allmark, S. Reiter-Theil, D. Bratlid, P. Dalla-Vorgia, P. Morrogh, A.B. Gill, S. Holm and A. Langlois; The role of RECs in Europe in the ethical review of paediatric research: a critical discussion, J.H. Solbakk; The role of research ethics committees and of the law in the ethical review of medical research: a critical discussion, S. Holm. Comparative Analysis of the Law on Informed Consent in Neonatal Research Within Europe: Overview of European legislation on informed consent in neonatal research, P. Dalla-Vorgia, S.A. Mason, C. Megone, P.J. Allmark, D. Bratlid, A.B. Gill, P. Morrogh, A. Plomer, S. Reiter-Theil; The regulation of neonatal research in Finland, S. Lötjönen; The regulation of neonatal research in Greece, P. Dalla-Vorgia; The regulation of neonatal research in Ireland, C. Craven; The regulation of neonatal research in Norway, M. Halvorsen; The regulation of neonatal research in Spain, C.M. Romeo-Casabona; The regulation of neonatal research in Sweden, E. Rynning; The regulation of neonatal research in the UK, A. Plomer; Pr

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Reviews

’Essential reading not only for anyone involved in neonatal research but also for medical ethicists and members of research ethics committees. This book offers both a stimulating and critical discussion of the informed consent issues and a comparative analysis of regulation in Europe’ Professor Ruth Chadwick, Lancaster University ’European Neonatal Research is the first comprehensive project to examine the related subjects of informed consent for neonatal research and the function of research ethics committees in Europe... Anyone interested in research with human subjects or neonatal research will find this work valuable. The editors are to be commended for effectively balancing the presentation of research results with chapters that critically reflect on the significance of the research findings.’ George J. Agich, F.J. O’Neill Chair in Clinical Bioethics, Cleveland Clinic Foundation, US 'Incorporating clinical, ethical, legal and sociological perspectives, the results and recommendations presented in this book will be of widespread significance to practitioners, researcher and policy makers throughout Europe and beyond.' Human Reproduction and Genetic Ethics ’...worth reading for doctors who design clinical research projects in neonatology as well as for members of RECs, irrespective of their professional discipline.’ Medicine, Health Care and Philosophy 'There is much useful information and advice in this volume, which should be available to any REC or IRB that reviews protocols froma neonatal intensive care unit.' Bulletin of Medical Ethics