Informed Consent in European Neonatal Research

Informed Consent in European Neonatal Research

by S. A. Mason, C. Megone
     
 

ISBN-10: 0754613011

ISBN-13: 9780754613015

Pub. Date: 06/01/2001

Publisher: Ashgate Publishing, Limited

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 question of "informed consent" in neonatal research. It addressed the difficulties of obtaining consent from subjects involved in such research…  See more details below

Overview

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 question of "informed consent" in neonatal research. It addressed the difficulties of obtaining consent from subjects involved in such research, and investigated the relevance and appropriateness or 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. Contents: Background Information on the Euricon Study: Ethical issues and practical problems in obtaining informed consent for neonatal research; The practical problems in obtaining informed consent for a neonatal randomized controlled trial. Research Ethics Committees in Europe: Their Role in ethical Review: The structure, composure and operation of European RECs; The attitudes of RECs in 11 European countries to informedconsent in neonatal research; 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; The role of RECs in Europe in the ethical review of paediatric research: a critical discussion; The role of research ethics committees and of the law in the ethical review of medical research: a critical discussion. Comparative Analysis of the Law on Informed Consent in Neonatal Research Within Europe: Overview of European legislation on informed consent for neonatal research; The regulation of neonatal research in Finland; The regulation of neonatal research in Greece; The regulation of neonatal research in Ireland; The regulation of neonatal research in Norway; The regulation of neonatal research in Spain; The regulation of neonatal research in Sweden; The regulation of neonatal research in UK; principles underlying the regulation with children in Europe: international or moral bankruptcy?. Informed Consent in Neonatal Research: is obtaining informed consent to neonatal randomized controlled trials an elaborate ritual? interviews with parents and clinicians; is parental "informed consent" always necessary for research involving newborn infants?; Doing without informed consent for some neonatal studies?. Consensus Statement: Consensus statement of the Euricon project.

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Product Details

ISBN-13:
9780754613015
Publisher:
Ashgate Publishing, Limited
Publication date:
06/01/2001
Pages:
286
Product dimensions:
6.14(w) x 8.90(h) x 0.79(d)

Table of Contents

List of Contributorsviii
Prefacexi
Acknowledgementsxiii
Part IBackground Information on the Euricon Study
1Ethical Issues and Practical Problems in Obtaining Informed Consent for Neonatal Research3
2The Practical Problems in Obtaining Informed Consent for a Neonatal Randomised Controlled Trial13
Part IIResearch Ethics Committees in Europe: Their Role in Ethical Review
3The Structure, Composition, and Operation of European RECs23
4The Attitudes of RECs in 11 European Countries to Informed Consent in Neonatal Research43
5The Views of RECs in Eight European Countries on the Process of Obtaining Informed Consent in Neonatal Research, and on the Structure and Organisation of RECs63
6The Role of RECs in Europe in the Ethical Review of Paediatric Research: a Critical Discussion83
7The Role of Research Ethics Committees and of the Law in the Ethical Review of Medical Research: a Critical Discussion91
Part IIIComparative Analysis of the Law on Informed Consent in Neonatal Research Within Europe
8Overview of European Legislation on Informed Consent in Neonatal Research107
9The Regulation of Neonatal Research in Finland121
10The Regulation of Neonatal Research in Greece137
11The Regulation of Neonatal Research in Ireland143
12The Regulation of Neonatal Research in Norway149
13The Regulation of Neonatal Research in Spain155
14The Regulation of Neonatal Research in Sweden167
15The Regulation of Neonatal Research in the UK185
16Principles Underlying the Regulation of Research with Children in Europe: International Bioethics or Moral Bankruptcy?191
Part IVInformed Consent in Neonatal Research
17Is Obtaining Informed Consent to Neonatal Randomised Controlled Trials an Elaborate Ritual? Interviews with Parents and Clinicians
18Is Parental 'Informed Consent' Always Necessary for Research Involving Newborn Infants?237
19Doing Without Informed Consent for Some Neonatal Studies?249
Part VConsensus Statement
20Consensus Statement of the Euricon Project261

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