Research Ethics (Routledge Annals of Bioethics)

192 Pages·2006·0.92 MB·English

by  Ana Smith Iltis

Research Ethics
Medicine in the twenty-first century is increasingly reliant on research to guarantee
the safety and efficacy of medical interventions. As a result, it is essential to
understand the ethical issues that research generates. This volume introduces the
principal areas of concern in research on human subjects, offering a framework for
understanding research ethics, and the relationship between ethics and compliance.
Research Ethicsbrings together leading scholars in bioethics and the topics covered
include the unique concerns that arise in specific areas of research such as gene
therapy and stem cell research. Individual chapters also address the ethical issues that
arise when conducting research with specific populations such as infants, children, or
adolescents, and the volume looks at important emerging issues in human subjects
research, namely financial conflicts of interest and the interpretation of scientific data.
Ana Smith Iltis teaches health-care ethics at Saint Louis University in St. Louis,
Missouri, USA and her research interests are human subjects research ethics and
organizational ethics.
Routledge Annals of Bioethics
Series editors:
Mark J. Cherry
Saint Edwards University, USA
Ana Smith Iltis
Saint Louis University, USA
Bioethics has become a truly international phenomenon. Secular Western bioethics
in particular lays claim to a universal account of proper moral deportment, including
the foundations of law and public policy as well as the moral authority for national
and international institutions to guarantee uniformity of practice, secure basic
human rights, and promote social justice.
Through foundational, philosophical, religious, and cultural perspectives, clinical
case studies, and legal analyses, the books in this series document, review, and explore
emerging bioethical viewpoints as well as the state of the art of this global endeavor.
Volumes will critically appreciate diverse legal, moral, cultural, and religious
viewpoints representing the various regions of the world, from mainland China and
Hong Kong, Taiwan, Japan, India, and East Asia more generally, to Europe, the
Middle East, Australia, and New Zealand, to South America and North America.
Moral perspectives range from Orthodox Christianity, Roman Catholicism, and
contemporary Protestant Christianity, to Orthodox, Conservative, and Reformed
Judaism, to Islam, Buddhism, Confucianism, Hinduism, and so forth, to secular
liberalism.
The Annals of Bioethics compasses monographs and edited volumes on moral
theory, normative health-care practice, case studies, and public policy as well as
volumes documenting and assessing legal, religious, and cultural responses to specific
aspects of the fast-paced developments in health care and medical technology.
1 Research Ethics
Edited by Ana Smith Iltis
Previous titles to appear in the Routledge Annals of Bioethics include:
Regional Perspectives in Bioethics
Edited by Mark J. Cherry and John F. Peppin
Religious Perspectives on Bioethics
Edited by Mark J. Cherry, Ana Iltis, and John F. Peppin
Research Ethics
Edited by
Ana Smith Iltis
First published 2006
by Routledge
270 Madison Ave, New York, NY 10016
Simultaneously published in the UK
by Routledge
2 Park Square, Milton Park, Abingdon, Oxon OX14 4RN
Routledge is an imprint of the Taylor & Francis Group
This edition published in the Taylor & Francis e-Library, 2006.
“To purchase your own copy of this or any of Taylor & Francis or Routledge’s
collection of thousands of eBooks please go to www.eBookstore.tandf.co.uk.”
© 2006 Ana Smith Iltis, selection and editorial matter;
the contributors, their own chapters
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.
Library of Congress Cataloging in Publication Data
A catalog record for this book has been requested
British Library Cataloguing in Publication Data
A catalogue record for this book is available from the British Library
ISBN 0-203-79927-5 Master e-book ISBN
ISBN 0–415–70158–9 (Print Edition)
Contents
List of tables vii
List of contributors viii
Acknowledgments ix
1 Human subjects research: ethics and compliance 1
ANA SMITH ILTIS
2 Ethics of vaccine research 22
CHRISTINE GRADY
3 Ethical issues in the conduct of genetic research 32
LISA S. PARKER AND LAUREN MATUKAITIS BROYLES
4 Embryonic stem cell research and human therapeutic cloning:
maintaining the ethical tension between respect and research 61
GERARD MAGILL
5 Conducting and terminating randomized controlled trials 86
ANA SMITH ILTIS
6 Ethics in behavioral and social science research 102
JAMES M. DUBOIS
7 When should research with infants, children,
or adolescents be permitted? 121
LORETTA M. KOPELMAN
8 Biomedical research in the developing world:
ethical issues and dilemmas 132
DAVID B. RESNIK
vi Contents
9 Financial conflicts of interest and the human passion
to innovate 147
MARK J. CHERRY
10 Interpreting scientific data ethically: a frontier for
research ethics 165
GRIFFIN TROTTER
Index 178
Tables
2.1 Framework applied to vaccine research 24
3.1 Categories of HBM 37
3.2 Characteristics constituting community or group identity 45
6.1 Common risks of BSS methodologies 107
6.2 Examples of confidentiality protection at different phases of research 111
Contributors
Lauren Matukaitis Broyles, BSN, BA, RN, Predoctoral Fellow, School of Nursing
and Center for Bioethics and Health Law, University of Pittsburgh, Pittsburgh,
Pennsylvania.
Mark J. Cherry, PhD, Associate Professor, Department of Philosophy, Saint
Edward’s University, Austin, Texas.
James M. DuBois, PhD, DSc, Associate Professor, PhD Program Director, Center
for Health Care Ethics, Saint Louis University, St. Louis, Missouri.
Christine Grady, RN, PhD, FAAN, Head, Section on Human Subjects Research,
Department of Clinical Bioethics, W.G. Magnuson Clinical Center, National
Institutes of Health, Bethesda, Maryland.
Ana Smith Iltis, PhD, Assistant Professor, Center for Health Care Ethics, Saint
Louis University, St. Louis, Missouri.
Loretta M. Kopelman, PhD, Chair, Department of Medical Humanities, Brody
School of Medicine, East Carolina University, Greenville, North Carolina.
Gerard Magill, PhD, Professor, Executive Director, Department Chair, Center for
Health Care Ethics, Saint Louis University, St. Louis, Missouri.
Lisa S. Parker, PhD, Associate Professor of Human Genetics, Director of Graduate
Education, Center for Bioethics and Health Law, University of Pittsburgh,
Pittsburgh, Pennsylvania.
David B. Resnik, JD, PhD, Department of Medical Humanities, Brody School of
Medicine, East Carolina University, Greenville, North Carolina. Current affiliation:
Bioethicist, National Institutes of Environmental Health Services/National
Institutes of Health, Research Triangle Park, North Carolina.
Griffin Trotter, MD, PhD, Associate Professor, Center for Health Care Ethics, Saint
Louis University, St. Louis, Missouri.
Acknowledgments
I would like to express my gratitude to the Center for Health Care Ethics, the
Graduate School, and my colleagues at Saint Louis University for their ongoing
support of this and other endeavors. I owe a special debt of gratitude to Barbara Anne
Hinze, who spent countless hours editing and formatting this volume.
Ana Smith Iltis
Saint Louis University