Acceptable Risk in Biomedical Research European Perspectives
This book is the first major work that addresses a core question in biomedical research: the question of acceptable risk. The acceptable level of risks is regulated by the requirement of proportionality in biomedical research law, which state that th
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INTERNATIONAL LIBRARY OF ETHICS, LAW, AND THE NEW MEDICINE Founding Editors DAVID C. THOMASMA† DAVID N. WEISSTUB, Université de Montréal, Canada THOMASINE KIMBROUGH KUSHNER, University of California, Berkeley, U.S.A.
Editor DAVID N. WEISSTUB, Université de Montréal, Canada
Editorial Board TERRY CARNEY, University of Sydney, Australia MARCUS DÜWELL, Utrecht University, Utrecht, the Netherlands SØREN HOLM, University of Manchester, United Kingdom GERRIT K. KIMSMA, Vrije Universiteit, Amsterdam, the Netherlands DAVID NOVAK, University of Toronto, Canada EDMUND D. PELLEGRINO, Georgetown University, Washington D.C., U.S.A. DOM RENZO PEGORARO, Fondazione Lanza and University of Padua, Italy DANIEL P. SULMASY, The University of Chicago, U.S.A.
VOLUME 50 For other titles published in this series, go to http://www.springer.com/series/6224
Sigmund Simonsen
Acceptable Risk in Biomedical Research European Perspectives
123
Dr. Sigmund Simonsen Norwegian University of Science and Technology (NTNU), Royal Norwegian Air Force Academy Pb. 4133, 7450 Trondheim Norway [email protected]
ISSN 1567-8008 ISBN 978-94-007-2677-2 e-ISBN 978-94-007-2678-9 DOI 10.1007/978-94-007-2678-9 Springer Dordrecht Heidelberg London New York Library of Congress Control Number: 2011943499 © Springer Science+Business Media B.V. 2012 No part of this work may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, microfilming, recording or otherwise, without written permission from the Publisher, with the exception of any material supplied specifically for the purpose of being entered and executed on a computer system, for exclusive use by the purchaser of the work. Printed on acid-free paper Springer is part of Springer Science+Business Media (www.springer.com)
Preface
The topic of this book is the legal requirement of proportionality between risks, burdens, and potential benefits in interventional biomedical research on human beings. The book is based on my more extensive doctoral thesis, which was delivered June 2009 and defended February 2010. The topic was chosen after an investigation of biomedical research law, which revealed that surprisingly little appeared to be known about this old and obviously central professional, ethical, and legal requirement. Although more information about the requirement was found later on, the requirement of proportionality in European biomedical research law appeared largely unexplored in legal theory, in European Convention (ECHR) law and Community (EU) law. The purpose of this book is to contribute to enhanced knowledge about the requirement’s normative content in the first two jurisdictions, and, consequently, also in national law of European countries. Hopefully, this clarification of the law may improve assessments of proportionality in practice, and consequently improve the respect for and protection of research participants’ individual interests, welfare (including health), and human dignity. I am enormously grateful and
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