Research Ethics Consultation: A Casebook PDF
Preview Research Ethics Consultation: A Casebook
■ Research Ethics Consultation This page intentionally left blank Research Ethics Consultation A Casebook Marion Danis, MD Emily Largent, BSN, RN Christine Grady, RN, PhD David Wendler, PhD Sara Chandros Hull, PhD Seema Shah, JD Joseph Millum, PhD Benjamin Berkman, JD, MPH Department of Bioethics Clinical Center, National Institutes of Health 1 1 Oxford University Press, Inc., publishes works that further Oxford University’s objective of excellence in research, scholarship, and education. Oxford New York Auckland Cape Town Dar es Salaam Hong Kong Karachi Kuala Lumpur Madrid Melbourne Mexico City Nairobi New Delhi Shanghai Taipei Toronto With offi ces in Argentina Austria Brazil Chile Czech Republic France Greece Guatemala Hungary Italy Japan Poland Portugal Singapore South Korea Switzerland Th ailand Turkey Ukraine Vietnam Copyright © 2012 Oxford University Press Published by Oxford University Press, Inc. 198 Madison Avenue, New York, New York 10016 www.oup.com Oxford is a registered trademark of Oxford University Press All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitt ed, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior permission of Oxford University Press. _________________________________________________________________ Library of Congress Cataloging-in-Publication Data Clinical research consultation : a casebook / Marion Danis . . . [et al.]. p.; cm. Includes bibliographical references. ISBN 978-0-19-979803-2 (alk. paper) 1. Medical ethics consultation–Case studies. I. Danis, Marion. [DNLM: 1. Ethics Consultation–Case Reports. 2. Ethics, Research–Case Reports. W 20.55.E7] R724.C527 2012 174.2–dc23 2011027685 _________________________________________________________________ 1 3 5 7 9 8 6 4 2 Th e opinions expressed are those of the authors and do not refl ect the position or policy of the National Institutes of Health, the Public Health Service, or the Department of Health and Human Services. Printed in the United States of America on acid-free paper ■ A C K N O W L E D G M E N T S We greatly appreciate the support for and trust in our consultation service extended by the National Institutes of Health research community. We espe- cially thank all of the requestors who kindly agreed to inclusion of their consulta- tion requests in this book. Some requestors provided us with further insights about the consultations in which they were involved and about what happened aft er the consultation, for which we are grateful. We also wish to thank John Gallin, the director of the NIH Clinical Center; Zeke Emanuel who encouraged the creation of the electronic database that made this book possible; Catherine Yao, who carefully and cheerfully assisted us in reviewing the consultation data- base and selecting the cases presented herein; all members—past and present— of the Bioethics Consultation Service; and our friends and colleagues in the Department of Bioethics, particularly Alan Wertheimer who provided invalu- able feedback on an earlier draft , Ben Chan who shared his expertise on evalua- tion of ethics consultation, and Catie Gliwa who off ered meticulous revisions as we fi nalized the book. v This page intentionally left blank ■ C O N T E N T S Foreword xi Introduction 1 1 Starting Research 21 Consult 1.1: Assessing Social Value 24 Consult 1.2: Assessing Social Value for Local Populations 28 Consult 1.3: Assessing Scientifi c Validity 32 Consult 1.4: Placebo-Controlled Trials 35 Consult 1.5: Addressing Ethical Issues in International Research 37 Consult 1.6: Designing an Ethical Screening Process 41 Consult 1.7: Reconciling Diff erent Judgments Reached by Multiple Institutional Review Boards 44 2 Enrolling Research Participants 49 Consult 2.1: Use of Nonmedical Criteria in Determinations of Study Inclusion or Exclusion 53 Consult 2.2: Exclusion of an Individual Based on a New Comorbidity 57 Consult 2.3: Enrolling Staff Members in Clinical Studies 59 Consult 2.4: Identifi cation of Potential Study Participants Th rough Publicly Available Records 62 Consult 2.5: Enrollment of Research Participants in Multiple Protocols 66 Consult 2.6: Obtaining Informed Consent from Individuals Who Are Blind, Illiterate, or Do Not Understand the Language in Which Consent Documents are Writt en 69 Consult 2.7: Assessing whether Study Procedures are Coercive or Unduly Infl uential 72 3 Protecting Research Participants 78 Consult 3.1: Justifi cation of Research Risks 81 Consult 3.2: Evaluation of Evolving Risks 83 Consult 3.3: Respecting Participant Preferences While Minimizing Risk 87 vii viii ■ Contents Consult 3.4: Addressing Medical Error 90 Consult 3.5: Reconciling Confi dentiality and the Duty to Warn 92 Consult 3.6: Risks to Th ird Parties 97 4 Conducting Research with Vulnerable Populations 100 Consult 4.1: Exposing Children to Risk When Th ere is no Prospect of Direct Benefi t 105 Consult 4.2: Informing a Minor of His Diagnosis 107 Consult 4.3: Assignment of a Surrogate Decision Maker by a Cognitively Impaired Research Participant 110 Consult 4.4: Consent for Research in an Emergency 113 Consult 4.5: Research with the Terminally Ill 116 Consult 4.6: Caring for the Economically Disadvantaged 118 5 Balancing Clinical Research and Clinical Care 122 Consult 5.1: Fulfi lling Ancillary Care Obligations 125 Consult 5.2: Disclosure of Incidental Findings 129 Consult 5.3: Obligations to Individuals Tangentially Related to Research 134 Consult 5.4: Withholding Care for Reasons of Scientifi c Validity 138 Consult 5.5: Meeting Clinical Needs without Compromising Scientifi c Validity 141 Consult 5.6: Access to Experimental Drugs Outside a Study Protocol 145 Consult 5.7: Noncompliance 147 6 Navigating Interpersonal Diffi culties 157 Consult 6.1: Obligations to Prevent Harm and Protect Confi dentiality 160 Consult 6.2: Excluding a Noncompliant Participant from a Study with the Prospect of Direct Benefi t 164 Consult 6.3: Excluding a Noncompliant Participant from a Study with No Prospect of Benefi t 166 Consult 6.4: Discharging an At-Risk Participant 168 Consult 6.5: Futile Care 171 Consult 6.6: Confl ict Between the Research Team and Family Members 174 Consult 6.7: Confl ict Between the Research Team and Surrogate Decision Maker 176 Consult 6.8: Respecting Medical Beliefs 182 Contents ■ ix 7 Ending Research 185 Consult 7.1: Study Discharge aft er Violation of Rules 189 Consult 7.2: Discharge to Less Optimal Care 192 Consult 7.3: Managing Participant’s Post-trial Expectations 196 Consult 7.4: Fulfi lling Post-trial Obligations to Uninsured Participants 199 Consult 7.5: Planning for Post-trial Consequences of Trial Intervention 202 Consult 7.6: Addressing a Request for Withdrawal of Tissue Samples 205 Consult 7.7: Questions about Discontinuation of a Trial by the Data Safety Monitoring Board 208 Consult 7.8: Assigning Authorship 212 Appendices 219 A ppendix 1 Consultations Organized by Subject Matt er 219 Appendix 2 Evaluation of the Clincal Center Bioethics Consultation Service 220 Appendix 3 Clinical Center Policy M77-2: Informed Consent 225 Appendix 4 Clinical Center Policy M92-7: Advance Directives 237 Appendix 5 NIH Advance Directive for Health Care and Medical Research Participation 242 Appendix 6 Clinical Center Policy M87-4: Research Involving Adults Who Are or May Be unable to Consent 245 Appendix 7 Selected Publications Inspired or Informed by the Work of the Bioethics Consultation Service 249 Index 251
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