ABSTRACT

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.

part I|19 pages

Background Information on the Euricon Study

part II|84 pages

Research Ethics Committees in Europe: Their Role in Ethical Review

chapter 3|20 pages

The Structure, Composition, and Operation of European Research Ethics Committees

ByC. Megone, S.A. Mason, P.J. Allmark, S. Reiter-Theil, D. Bratlid, P. Dalla-Vorgia, P. Morrogh, A.B. Gill, A. Langlois

chapter 4|20 pages

The Attitudes of RECs in 11 European Countries to Informed Consent in Neonatal Research

ByC. Megone, S.A. Mason, P. J. Allmark, S. Reiter-Theil, D. Bratlid, P. Dalla-Vorgia, P. Morrogh, A.B. Gill, S. Holm, A. Langlois

chapter 5|20 pages

The Views of RECs in Eight European Countries on the Process of Obtaining Informed Consent in Neonatal Research, and on the Structure and Organisation of RECs

ByC. Megone, S.A. Mason, P.J. Allmark, S. Reiter-Theil, D. Bratlid, P. Dalla-Vorgia, P. Morrogh, A.B. Gill, S. Holm, A. Langlois

part III|102 pages

Comparative Analysis of the Law on Informed Consent in Neonatal Research Within Europe

chapter 8|13 pages

Overview of European Legislation on Informed Consent in Neonatal Research 1

ByP. Dalla-Vorgia, Dr S.A. Mason, C. Megone, P.J. Allmark, D. Bratlid, A.B. Gill, P. Morrogh, A. Plomer, S. Reiter-theil

chapter 9|15 pages

The Regulation of Neonatal Research in Finland

ByS. Lötjönen

chapter 10|5 pages

The Regulation of Neonatal Research in Greece

ByP. Dalla-Vorgia

chapter 11|6 pages

The Regulation of Neonatal Research in Ireland

ByC. Craven

chapter 12|5 pages

The Regulation of Neonatal Research in Norway

ByJuris M. Halvorsen

chapter 13|11 pages

The Regulation of Neonatal Research in Spain

ByC.M. Romeo-Casabona

chapter 14|17 pages

The Regulation of Neonatal Research in Sweden 1

ByE. Rynning

chapter 15|5 pages

The Regulation of Neonatal Research in the UK

ByA. Plomer

part IV|51 pages

Informed Consent in Neonatal Research

chapter 17|27 pages

Is Obtaining Informed Consent to Neonatal Randomised Controlled Trials an Elaborate Ritual? Interviews with Parents and Clinicians 1

ByS.A. Mason, P.J. Allmark, C. Megone, D. Bratlid, P. Dalla-Vorgia, A.B. Gill, P. Morrogh, S. Reiter-Theil, V. Fellman, G. Greisen, L. Hellstrom-westas, G. Latini, N. Leroux, N. Modi, M. Moya, N. Nelson, S. Petmezaki, A. Phillips, G. Russell, C.A. Ryan, E. Saliba, A.M. Weindling

chapter 19|9 pages

Doing Without Informed Consent for Some Neonatal Studies?

ByD. Bratlid

part V|14 pages

Consensus Statement

chapter 20|12 pages

Consensus Statement of the Euricon Project