Su Mason - European Neonatal Research: Consent, Ethics Committees and Law

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European Neonatal Research

First published 2001 by Ashgate Publishing

Reissued 2018 by Routledge

2 Park Square, Milton Park, Abingdon, Oxon OX14 4RN

711 Third Avenue, New York, NY 10017, USA

Routledge is an imprint of the Taylor & Francis Group, an iriforma business

Copyright Su Mason and Chris Megone 2001

All rights reserved. No part of this book may be reprinted or reproduced or utilised in any form or by any electronic, mechanical, or other means, now known or hereafter invented, including photocopying and recording, or in any information storage or retrieval system, without permission in writing from the publishers.

Notice:

Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation without intent to infringe.

Publishers Note

The publisher has gone to great lengths to ensure the quality of this reprint but points out that some imperfections in the original copies may be apparent.

Disclaimer

The publisher has made every effort to trace copyright holders and welcomes correspondence from those they have been unable to contact.

A Library of Congress record exists under LC control number: 00054305

ISBN 13: 978-1-138-70342-1 (hbk)

ISBN 13: 978-1-315-20315-7 (ebk)

Contents

Mr P.J. Allmark, Dr S.A. Mason, Dr C. Megone

Dr A.B. Gill

Dr C. Megone, Dr S.A. Mason, Mr P.J. Allmark, PD Dr S. Reiter-Theil, Professor D. Bratlid, Professor P. Dalla-Vorgia, Mrs P. Morrogh, Dr A.B. Gill, Professor A. Langlois

Dr C. Megone, Dr S.A. Mason, Mr P.J. Allmark, PD Dr S. Reiter-Theil, Professor D. Bratlid, Professor P. Dalla-Vorgia, Mrs P. Morrogh, Dr A.B. Gill, Dr S. Holm, Professor A. Langlois

Dr C. Megone, Dr S.A. Mason, Mr P.J. Allmark, PD Dr S. Reiter-Theil, Professor D. Bratlid, Professor P. Dalla-Vorgia, Mrs P. Morrogh, Dr A.B. Gill, Dr S. Holm, Professor A. Langlois

Professor J.H. Solbakk

Dr S. Holm

Professor P. Dalla-Vorgia, Dr S.A. Mason, Dr C. Megone, Mr P.J. Allmark, Professor D. Bratlid, Dr A.B. Gill, Mrs P. Morrogh, Dr A. Plomer, PD Dr S. Reiter-Theil, on behalf of the Euricon Study Group

Ms S. Ltjnen

Professor P. Dalla-Vorgia

Dr C. Craven

Dr juris M. Halvorsen

Professor C.M. Romeo-Casabona

Associate Professor E. Rynning

Dr A. Plomer

Dr A. Plomer

Dr S.A. Mason, Mr P.J. Allmark, Dr C. Megone, Professor D. Bratlid, Professor P. Dalla-Vorgia, Dr A.B. Gill, Mrs P. Morrogh, PD Dr S. Reiter-Theil, Dr V. Fellman, Dr G. Greisen, Dr L. Hellstrom-Westas, Dr G. Latini, Mrs N. LeRoux, Dr N. Modi, Professor M. Moya, Dr N. Nelson, Dr S. Petmezaki, Mrs A. Phillips, Dr G. Russell, Dr C.A. Ryan, Dr E. Saliba, Dr A.M. Weindling, on behalf of the Euricon Study Group

Dr N. Modi

Professor D. Bratlid

Euricon Partnership

Guide

Euricon Study Group

Management Team
Dr Susan A. Mason	Northern & Yorkshire Clinical Trials & Research Unit at the University of Leeds, UK
Dr Christopher Megone	Department of Philosophy, University of Leeds, UK
Mr Peter J. Allmark	Faculty of Medicine, University of Sheffield, UK
Professor Dag Bratlid	University Hospital, Trondheim, Norway
Professor Panagiota Dalla-Vorgia	University of Athens Medical School,Greece
Dr A. Bryan Gill	Leeds General Infirmary, UK
Mrs Patricia Morrogh	University College, Cork, Eire
Mrs Angela Phillips	Northern & Yorkshire Clinical Trials & Research Unit at the University of Leeds, UK
PD Dr Stella Reiter-Theil	Centre for Ethics & Law in Medicine, University of Freiburg, Germany
The late Craig Sykes	Northern & Yorkshire Clinical Trials & Research Unit at the University of Leeds, UK
Partnership
Dr Vineta Fellman	Hospital for Children and Adolescents, University of Helsinki, Finland
Dr Gorm Greisen	National University Hospital Copenhagen, Denmark
Dr Lena Hellstrom-Westas	University Hospital, Lund, Sweden
Dr Sren Holm	University of Copenhagen, Denmark, and University of Manchester, UK
Professor Anne Langlois	Department of Medical Ethics, Crteil, France
Dr Giuseppe Latini	The A. Di Summa Private Hospital, Brindisi, Italy
Dr Neena Modi	Hammersmith Hospital, London, UK
Professor Manuel Moya	University Hospital of San Juan, Spain
Dr Sophia Petmezaki	Mitera Hospital, Athens, Greece
Dr Aurora Plomer	Faculty of Law, University of Leeds, UK
Dr Glyn Russell	St Michaels Hospital, Bristol, UK
Dr C. Anthony Ryan	Cork Regional Hospital, Eire
Dr Elie Saliba	University Hospital, Tours, France
Professor Jan Helge Solbakk	National Committee for Medical Research Ethics, Oslo, Norway
Dr A. Michael Weindling	Liverpool Womens Hospital, Liverpool, UK
The late Professor Nils Svenningsen	University Hospital, Lund, Sweden
Partner Representatives
Mrs Nadge LeRoux	Research Centre for Medical Ethics and Public Health, Paris, France
Dr Nina Nelson	Department of Pediatrics, University Hospital, Linkping, Sweden
Legal Representatives
Judge Christian Byk	62 Bd de Port-Royal, Paris, France
Professor Carlos M. Romeo-Casabona	Chair of Human Rights and Genome Research, Bilbao, Spain
Dr Ciaran Craven	Law School, Trinity College, Dublin, Ireland
Professor Panagiota Dalla-Vorgia	University of Athens Medical School, Greece
Dr juris Marit Halvorsen*	Institute for Public Law, Oslo, Norway
Dr Hans-Georg Koch*	University of Freiburg, Germany
Ms Salla Ltjnen	University of Helsinki, Finland
Professor Linda Nielsen*	University of Copenhagen, Denmark
Dr Aurora Plomer	University of Leeds, UK
Associate Professor Elisabeth Rynning	Uppsala University, Sweden
Ms Elisabeth Gording Stang	Institute for Public Law, Oslo, Norway

Note

* Provided legal information but not in attendance at Euricon legal colloquium.

The Euricon Project, Is obtaining informed consent for neonatal research an elaborate ritual? - A European Study , was a three year European Union BioMed-funded study which commenced in 1996.

The conception of the study was at a meeting in Leeds, UK, of the European Neonatal Brain Club (an informal pan-European organisation) where, following a short presentation by Su Mason, a long plenary discussion was stimulated on the problems of obtaining informed consent for neonatal research. Here, it was agreed that this was a relevant question, which required study. At the same time Chris Megone was preparing a study of the work of European Research Ethics Committees (in some countries known as Institutional Review Boards or Scientific Ethics Committees), which are charged with the ethical review of medical research protocols such as randomised controlled trials on neonates. It was felt that this work dovetailed nicely with the examination of the issue of consent. Hence the Euricon project, with its twin strands of investigation, was bom.

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