European Neonatal Research Consent, Ethics Committees and Law

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

Biography

Su Mason, Chris Megone

’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