Case Studies in
Ethics and HIV Research
Case Studies in
Ethics and HIV Research
Sana Loue Earl C. Pike
Sana Loue Earl C. Pike
Case Western Reserve University, AIDS Taskforce of Greater Cleveland,
Cleveland, OH Cleveland, OH
ISBN-13: 978-0-387-71361-8 e-ISBN-13: 978-0-387-71362-5
Library of Congress Control Number: 2007925374
© 2007 Springer Science⫹ Business Media, LLC
All rights reserved. This work may not be translated or copied in whole or in part without the written permission of the publisher (Springer Science⫹ Business Media, LLC, 233 Spring Street, New York, NY 10013, USA), except for brief excerpts in connection with reviews or scholarly analysis. Use in connection with any form of information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed is forbidden.
The use in this publication of trade names, trademarks, service marks, and similar terms, even if they are not identified as such, is not to be taken as an expression of opinion as to whether or not they are subject to proprietary rights.
Printed on acid-free paper.
9 8 7 6 5 4 3 2 1 springer.com
Preface
This book represents the compilation of efforts by researchers across the country, each of whom is dedicated not only to the prevention and elimination of HIV infection, but also to the conduct of research according to the highest ethical prin- ciples. The authors of the case studies have graciously agreed to share their expe- riences in conducting research, which raised questions for them and will motivate us to further inquiry and examination.
The views that are presented in this text are diverse and readers may or may not agree with the analyses of the editor-authors or the authors of the case studies.
We do not aim for agreement among readers, but rather, the studied analysis of the ethical issues raised in the conduct of HIV research. We clearly emphasize the protection of the individuals participating in such research, as well as their communities, and view research not as an enterprise undertaken by researchers, but rather as a negotiated exchange between researchers, participants, and com- munities that also involves interplay with funding sources, ancillary partners, and governments.
We clearly do not address all ethical quandaries that may arise during the course of an HIV-related investigation, and it would be impossible to do so within one text. We have focused in the first section on issues that underlie not only HIV research, but all research involving human participants. The second portion of the text examines ethical issues related to the design and methodology of research studies. Each chapter is followed by a case study authored by a prominent HIV/AIDS researcher. These case studies explore such topics as the selection of study participants, the standard of care to be provided to individuals in the control group of a study, the personal safety of the researcher in the field and its relation to the safety of participants, the retention of study participants, and the conduct of research at multiple study sites. The authors of each case study describe the context of the issues that arise, the ethical issues that they confronted, the process that they utilized to arrive at a solution, and the ethical principles that guided their decision.
Parts III and IV of the text is similarly structured, with each chapter followed by a case study. Part III focuses on the conduct of research with specific populations,
v
including children, cognitively impaired individuals, minority-identified individu- als, communities outside of the United States, and individuals who are often identified in relation to their activities, such as sex work and injection drug use.
Part IV discusses various issues that arise in the context of training both researchers and community members, including the ownership of data and confi- dentiality, among others.
As researchers and educators, we must constantly challenge ourselves to exam- ine not only the science of what we do, but also the processes that we utilize, and their impact on our research participants, their relations, and their communities.
We owe no less.
Sana Loue Earl C. Pike vi Preface
Acknowledgments
We gratefully acknowledge the substantial and significant contributions of the researchers who have shared their experiences with us and our readers through the development of their case studies. The studies from which these case studies were derived were often made possible through funding from various institutes of NIH and/or foundation grants; these are mentioned specifically by the authors of the case studies following their contributions.
vii
Contents
PREFACE . . . v
CASE STUDIES CONTRIBUTED BY . . . xi
PART I. FOUNDATIONS 1. Human Rights, International Guidelines and HIV Research . . . 1
2. U.S. Regulations and HIV-Related Research . . . 15
3. The Informed Consent Process . . . 23
4. Working with Boards and Committees: ECs, DSMBs, CABs . . . 37
5. Researcher-Participant Relations . . . 57
6. Researcher-Community Relations . . . 69
PART II. ETHICS AND METHODOLOGY 7. Recruiting for HIV-Related Research . . . 79
Case Study One: Ethical Issues in Internet-Based HIV Primary Prevention Research . . . 95
B. R. Simon Rosser, Ph.D., M.P.H. and Keith Horvath, Ph.D. 8. Clinical Trials . . . 103
Case Study Two: Clinical Trials and International Ethics: Preventing Tuberculosis in Africa . . . 126
C.C. Whalen, M.D., M.S. 9. Observational Studies . . . 137
Case Study Three: Challenges and Strategies for Personal Safety in Fieldwork. . . 151
Nancy Me´ndez and Ingrid Vargas 10. Behavioral Intervention Studies. . . 159
Case Study Four: Protecting the Rights of Human Subjects Who Participate in HIV/AIDS Research: Balancing the Ethics of Beneficence and Justice . . . 168
Cheryl Gore-Felton, Ph.D. & Michael DiMarco, Psy.D.
ix
11. Ethical Issues in Multicenter/Multisite Studies . . . 175 Case Study Five: Managing Multi-Site Collaborative Research with
Community-Based Agencies . . . 184 David Lounbury, Ph.D., Paulette Murphy, Psy.D.,
Janice Robinson, and Bruce Rapkin, Ph.D.
PART III. POPULATIONS
12. HIV Research with Children . . . 205 Case Study Six: Informed Consent and Assent
with Juvenile Detainees . . . 216 Andrea Boyd, Geri Donenberg, Ph.D., and Kristi Jordan, Ph.D.
13. HIV-Related Research with Cognitively Impaired Persons . . . 221 Case Study Seven: Balancing Risks and Benefits in Research
with Severely Mentally Ill Participants . . . 236 Sana Loue, J.D., Ph.D., M.P.H., Martha Sajatovic, M.D.,
Nancy Me´ndez, and Ingrid Vargas
14. Studies with Minority Populations . . . 245 Case Study Eight: Ethical Issues: A Case Study Involving
a Research Study Logo and African American Families . . . 257 Kristi Y. Jordan, Ph.D., Geri R. Donenberg, Ph.D.,
and Andrea Boyd, Ph.D.
15. Research in International Settings . . . 261 Case Study Nine: Ethical Challenges in a Multi-Site
International HIV Prevention Study with Serodiscordant Couples . . . 274 Patricia Marshall, Ph.D., Janet W. McGrath, Ph.D., Moses Kamya, MbChb, Andrew Fullem, M.P.H., and David D. Celentano, Sc.D.
16. Activity-Defined Populations . . . 285 Case Study Ten: Research Relating to Injection Drug Users . . . 298
Linda S. Lloyd, Dr.P.H.
PART IV. LOOKING TOWARDS THE FUTURE
17. Training the Next Generation of Researchers . . . 303 Case Study Eleven: Ethical Issues in Training
the Next Generation of Researchers . . . 310 Oscar Grusky, Ph.D.
18. Training Community . . . 321 Case Study Twelve: San Diego HIV/AIDS Needs Assessment . . . 332
Daniel J. O’Shea
Index . . . 339 x Contents
Case Studies Contributed By
Andrea Boyd, Healthy Youths Program, Institute for Juvenile Research, University of Illinois at Chicago, Chicago, IL
David D. Celentano, Department of Epidemiology, John Hopkins School of Public Health, Baltimore, MD
Geri R. Donenberg, Healthy Youths Program, Institute for Juvenile Research, University of Illinois at Chicago, Chicago, IL
Andrew Fullem, Family Health International, Durham, NC
Cheryl Gore-Felton, Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA
Oscar Grusky, Department of Sociology, University of California, Los Angeles, CA Kristi Y. Jordan, Department of Psychiatry, University of Illinois at Chicago, Chicago, IL
Moses Kamya, Department of Medicine, Makerere University, Kampala, Uganda.
Linda S. Lloyd, Alliance Healthcare Foundation, San Diego, CA
Sana Loue, Department of Epidemiology and Biostatistics, Case Western Reserve University, School of Medicine, Cleveland, OH
David W. Lounsbury, Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, NY
Patricia Marshall, Department of Bioethics, Department of Medicine, Case Western Reserve University, School of Medicine, Cleveland, OH
Janet W. McGrath, Department of Anthropology, Case Western Reserve University, Cleveland, OH
Nancy Me´ndez, Center for Minority Public Health, Case Western Reserve University, Cleveland, OH
xi
Paulette Murphy, Department of Psychiatry & Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, NY
Daniel P. O’Shea, HIV, STD, and Hepatitis Branch, Public Health Services, County of San Diego Health and Human Services Agency, San Diego, CA Bruce Rapkin, Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, NY
Janice Robinson, Department of Pediatrics, Albert Einstein College of Medicine of Yeshiva University, Bronx, NY
B. R. Simon Rosser, Division of Epidemiology & Community Health, University of Minnesota School of Public Health, Minneapolis, MN
Martha Sajatovic, University Hospitals Case Medical Center & Department of Psychiatry, Case Western Reserve University, School of Medicine, Cleveland, OH Ingrid Vargas, Center for Minority Public Health, Case Western Reserve University, Cleveland, OH
Christopher Whalen, Department of Epidemiology and Biostatistics, Case Western Reserve University, School of Medicine, Cleveland, OH
xii Case Studies Contributed By
