Public Health Ethics: Cases Spanning the Globe

Publication date: 2016

Series Editor: Michael J. Selgelid Public Health Ethics Analysis 3 Drue H. Barrett · Leonard W. Ortmann Angus Dawson · Carla Saenz Andreas Reis · Gail Bolan Editors Public Health Ethics: Cases Spanning the Globe Public Health Ethics Analysis Volume 3 Edited by Michael J. Selgelid Monash University , Melbourne , Australia During the 21st Century, public health ethics has become one of the fastest growing subdisciplines of bioethics. This is the fi rst book series dedicated to the topic of public health ethics. It aims to fi ll a gap in the existing literature by providing thoroughgoing, book-length treatment of the most important topics in public health ethics—which have otherwise, for the most part, only been partially and/or sporadically addressed in journal articles, book chapters, or sections of volumes concerned with public health ethics. Books in the series will include coverage of central topics in public health ethics from a plurality of disciplinary perspectives including: philosophy (e.g., both ethics and philosophy of science), political science, history, economics, sociology, anthropology, demographics, law, human rights, epidemiology, and other public health sciences. Blending analytically rigorous and empirically informed analyses, the series will address ethical issues associated with the concepts, goals, and methods of public health; individual (e.g., ordinary citizens’ and public health workers’) decision making and behaviour; and public policy. Inter alia, volumes in the series will be dedicated to topics including: health promotion; disease prevention; paternalism and coercive measures; infectious disease; chronic disease; obesity; smoking and tobacco control; genetics; the environment; public communication/trust; social determinants of health; human rights; and justice. A primary priority is to produce volumes on hitherto neglected topics such as ethical issues associated with public health research and surveillance; vaccination; tuberculosis; malaria; diarrheal disease; lower respiratory infections; drug resistance; chronic disease in developing countries; emergencies/disasters (including bioterrorism); and public health implications of climate change. More information about this series at http://www.springer.com/series/10067 http://www.springer.com/series/10067 Drue H. Barrett • Leonard W. Ortmann Angus Dawson • Carla Saenz • Andreas Reis Gail Bolan Editors Public Health Ethics: Cases Spanning the Globe ISSN 2211-6680 ISSN 2211-6699 (electronic) Public Health Ethics Analysis ISBN 978-3-319-23846-3 ISBN 978-3-319-23847-0 (eBook) DOI 10.1007/978-3-319-23847-0 Library of Congress Control Number: 2015960197 © The Editor(s) (if applicable) and The Author(s) 2016 . This book is published open access. Open Access This book is distributed under the terms of the Creative Commons Attribution- Noncommercial 2.5 License ( http://creativecommons.org/licenses/by-nc/2.5/ ) which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited. The images or other third party material in this chapter are included in the work’s Creative Commons license, unless indicated otherwise in the credit line; if such material is not included in the work’s Creative Commons license and the respective action is not permitted by statutory regulation, users will need to obtain permission from the license holder to duplicate, adapt or reproduce the material. This work is subject to copyright. All commercial rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifi cally the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfi lms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specifi c statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. Printed on acid-free paper This Springer imprint is published by Springer Nature The registered company is Springer International Publishing AG Switzerland Editors Drue H. Barrett Offi ce of Scientifi c Integrity, Offi ce of the Associate Director for Science, Offi ce of the Director Centers for Disease Control and Prevention Atlanta , GA , USA Angus Dawson Center for Values, Ethics and the Law in Medicine, Sydney School of Public Health The University of Sydney Sydney , Australia Andreas Reis Global Health Ethics Department of Information, Evidence and Research World Health Organization Geneva , Switzerland Leonard W. Ortmann Offi ce of Scientifi c Integrity, Offi ce of the Associate Director for Science, Offi ce of the Director Centers for Disease Control and Prevention Atlanta , GA , USA Carla Saenz Regional Program on Bioethics Offi ce of Knowledge Management, Bioethics, and Research Pan American Health Organization Washington , DC , USA Gail Bolan Division of STD Prevention National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention Centers for Disease Control and Prevention Atlanta , GA , USA http://creativecommons.org/licenses/by-nc/2.5/ v Disclaimer The contents of this casebook represent the opinions, fi ndings, and conclusions of the authors and do not necessarily refl ect the offi cial position, views, or policies of the editors, the editors’ host institutions, or the authors’ host institutions. vii Pref ace Public health ethics can be seen both as the application of principles and norms to guide the practice of public health and as a process for identifying, analyzing, and resolving ethical issues inherent in the practice of public health. Public health ethics helps us decide what we should do and why. Although the practice of public health has always considered ethical issues, the emergence of public health ethics as a discipline is relatively new. Although rooted in bioethics and clinical and research ethics, public health ethics has many characteristics that set it apart. The defi ning characteristics are its focus on achieving social goods for populations while respect- ing individual rights and recognizing the interdependence of people. Currently there are few practical training resources for public health practitio- ners that consider ethical issues and dilemmas likely to arise in the practice of pub- lic health. In public health ethics training, we have found it advantageous to use cases to illustrate how ethical principles can be applied in practical ways to decision making. The use of cases encourages refl ection and discussion of ethics, reinforces basic ethical concepts through application to concrete examples, highlights practi- cal decision making, allows learners to consider different perspectives, and sensi- tizes learners to the complex, multidimensional context of issues in public health practice. The case-based approach (known as casuistry) contrasts with the theoreti- cal approach to considering moral principles, rules, and theories. By describing scenarios, cases allow the learner to use ethical principles in the context of a realis- tic situation that sheds light on ethical challenges and illustrates how ethical prin- ciples can help in making practical decisions. This casebook comprises a broad range of cases from around the globe to high- light the ethical challenges of public health. For those new to public health ethics, Section I introduces public health ethics. Chapter 1 , “Public Health Ethics: Global Cases, Practice, and Context” by Ortmann and colleagues, summarizes basic concepts and describes how public health ethics differ from bioethics, clinical ethics, and research ethics. The chapter also includes an approach for conducting an ethical analysis in public health. In Chap. 2 , “Essential Cases in the Development of Public Health Ethics,” Lee, Spector-Bagdady, and Sakhuja highlight important http://dx.doi.org/10.1007/978-3-319-23847-0_1 http://dx.doi.org/10.1007/978-3-319-23847-0_2 viii events that shaped the practice of public health and explain how practitioners address and prevent ethical challenges. Section II is organized into chapters that discuss the following public health topics: • Resource allocation and priority setting • Disease prevention and control • Chronic disease prevention and health promotion • Environmental and occupational public health • Vulnerability and marginalized populations • International collaboration for global public health • Public health research We have invited some of the leading writers and thinkers in public health ethics to provide an overview of the major ethical considerations associated with each topic. The topic overviews offer the authors’ perspectives about applicable ethical theories, frameworks, and tools and draw attention to the cases that follow. The cases are meant to highlight the ethical issues in practice. Each represents the work of authors from around the globe who responded to a solicitation from the U.S. Centers for Disease Control and Prevention. We worked with the authors to ensure that each case included a concise articulation of a public health situation that raises ethical tensions, challenges, or concerns that require decisions or recommendations from public health offi cials or practitioners. The cases are presented in a standard format that includes a background, case description, discussion questions, and ref- erences. However, we also allowed for variation in the amount of detail provided in each section and the approach used to set up the case. Our goal was to include just enough contextual information to orient the reader who is not an expert in the case topic. We include the case setting, population, or intervention in question, legal or regulatory landscape, and questions to stimulate discussion on core ethical issues. Each case—although fi ctionalized—is as realistic as possible to refl ect the ethical challenges that public health practitioners face daily. Sometimes the cases were based on actual or composite events. In these instances, the case details were modi- fi ed to exclude identifying information that could be considered private, sensitive, or disputable by others involved in the case. We deliberately did not attempt to provide a resolution or solution for the cases. Often in public health practice, there is no single correct answer. Instead, ethical analysis in public health is a process to identify the ethical dimensions of the options available and to arrive at a decision that is ethically justifi able, through deliberation and consideration of relevant facts, values, and contexts. The cases and other writings in this book represent the opinions, fi ndings, and conclusions of the authors and do not necessarily refl ect the offi cial position, views, or policies of the editors, the editors’ host institutions, or the authors’ host institu- tions. We decided which topic category to place the case in to best distribute the cases across chapters. However, you may note that some cases cross topic areas and could just as easily have been included in another chapter. Preface ix This casebook is written for public health practitioners, including frontline work- ers, fi eld epidemiology trainers and trainees, and managers, planners, and decision makers with an interest in learning about how to integrate ethical analysis in their day-to-day public health practice. However, the casebook will also be useful to instructors in schools of public health and public health students as well as to aca- demic ethicists who can use the book to teach public health ethics and distinguish it from clinical and research ethics. Our hope is that the casebook will increase awareness and understanding of pub- lic health ethics and the value of ethical analysis in public health practice in all of its forms. This includes applied public health research; public health policy develop- ment, implementation, and evaluation; and public health decision making in national and international fi eld settings and training programs. By emphasizing prospective practical decision making, rather than just presenting a theoretical academic discus- sion of ethical principles, we hope this casebook will serve as a useful tool to sup- port instruction, debate, and dialogue about the nature of ethical challenges encountered in public health practice and how to resolve these challenges. We rec- ommend discussing the cases in small groups and using the discussion questions, the ethical framework described in Chap. 1 , and the information provided in the topic area overview sections as a starting place for exploring the ethical issues refl ected in the cases. The ultimate goal of case-based learning is to develop skills in ethical analysis and decision making in daily public health practice. The ethical framework provides a convenient tool for putting our ideas into practice. Atlanta , GA , USA Drue H. Barrett, PhD Atlanta, GA, USA Leonard W. Ortmann, PhD Sydney , Australia Angus Dawson, PhD Washington , DC , USA Carla Saenz, PhD Geneva , Switzerland Andreas Reis, MD Atlanta , GA , USA Gail Bolan, MD Preface http://dx.doi.org/10.1007/978-3-319-23847-0_1 xi Contents Section I Introduction to Public Health Ethics 1 Public Health Ethics: Global Cases, Practice, and Context . 3 Leonard W. Ortmann , Drue H. Barrett , Carla Saenz , Ruth Gaare Bernheim , Angus Dawson , Jo A. Valentine , and Andreas Reis 1.1 Introduction . 3 1.2 Public Health . 5 1.3 Ethics . 9 1.4 Public Health Ethics . 19 1.5 Ethical Frameworks . 27 1.6 A Three-Step Approach to Public Health Decision Making . 28 References . 33 2 Essential Cases in the Development of Public Health Ethics . 37 Lisa M. Lee , Kayte Spector-Bagdady , and Maneesha Sakhuja 2.1 Introduction . 37 2.2 Case Study: Jacobson v. Massachusetts . 39 2.3 Case Study: U.S. Public Health Service Research on Sexually Transmitted Disease: Alabama and Guatemala . 44 2.4 Case Study: The New York City A1C Registry . 50 2.5 Conclusions and Implications . 54 References . 55 Section II Topics in Public Health Ethics 3 Resource Allocation and Priority Setting . 61 Norman Daniels 3.1 Resource Allocation in Public Health . 61 3.2 Collective Lessons from the Cases . 62 3.3 Specifi c Ethical Issues in Resource Allocation . 65 xii 3.4 Decision-Making Process . 69 References . 70 3.5 Case 1: Priority Setting and Crisis of Public Hospitals in Colombia . 71 References . 74 3.6 Case 2: Intersection of Public Health and Mental Health: Meeting Family Needs . 74 References . 79 3.7 Case 3: Public-Private Partnerships: Role of Corporate Sponsorship in Public Health . 80 References . 83 3.8 Case 4: Black-White Infant Mortality: Disparities, Priorities, and Social Justice . 84 References . 86 3.9 Case 5: Priority Setting in Health Care: Ethical Issues . 87 References . 89 3.10 Case 6: Critical Care Triage in Pandemics . 90 References . 93 4 Disease Prevention and Control . 95 Michael J. Selgelid 4.1 Introduction . 95 4.2 Mandatory Treatment and Vaccination . 95 4.3 Disease Screening and Surveillance . 97 4.4 Stigma . 98 4.5 Access to Care . 99 4.6 Health Promotion Incentives . 100 4.7 Emergency Response . 101 4.8 Conclusion . 102 References . 103 4.9 Case 1: Mandatory Vaccination in Measles Outbreaks . 103 References . 107 4.10 Case 2: Public Health Approaches to Preventing Mother-to-Child HIV Transmission . 108 References . 111 4.11 Case 3: Newborn Bloodspot Screening: Personal Choice or Public Health Necessity? Storage and Ownership of Newborn Bloodspots. 111 References . 114 4.12 Case 4: Decoding Public Health Ethics and Inequity in India: A Conditional Cash Incentive Scheme—Janani Suraksha Yojana . 116 References . 119 4.13 Case 5: HIV Criminalization and STD Prevention and Control . 120 References . 124 Contents xiii 4.14 Case 6: Ethics of Administering Anthrax Vaccine to Children . 125 References . 128 4.15 Case 7: Non-adherence to Treatment in Patients with Tuberculosis: A Challenge for Minimalist Ethics . 129 References . 132 4.16 Case 8: Mass Evacuation . 132 References . 135 5 Chronic Disease Prevention and Health Promotion . 137 Harald Schmidt 5.1 Introduction . 137 5.2 Individuals . 140 5.3 Formal and Informal Health Workers . 141 5.4 Governments (At Different Levels) . 144 5.5 Corporate Entities . 147 5.6 Case Studies . 149 References . 151 5.7 Case 1: Municipal Action on Food and Beverage Marketing to Youth . 153 References . 157 5.8 Case 2: Obesity Prevention in Children: Media Campaigns, Stigma, and Ethics. 158 References . 161 5.9 Case 3: Obesity Stigma in Vulnerable and Marginalized Groups . 162 References . 166 5.10 Case 4: Water Fluoridation: The Example of Greece . 167 References . 170 5.11 Case 5: The Prohibition of Smoking in Public Places in Bulgaria. 172 References . 175 6 Environmental and Occupational Public Health . 177 Bruce Jennings 6.1 Environment and Workplace: Key Venues for Public Health . 177 6.2 Population Benefi ts, Individual Rights, and Ethically Acceptable Risk . 180 6.3 Systems and Power: The Ethical Importance of Ecological and Social Context . 183 References . 185 6.4 Case 1: Assessing Mining’s Impact on Health Equity in Mongolia . 186 References . 190 6.5 Case 2: Exceptions to National MRSA Prevention Policy for a Medical Resident with Untreatable MRSA Colonization . 191 References . 194 Contents xiv 6.6 Case 3: Safe Water Standards and Monitoring of a Well Construction Program . 195 References . 198 6.7 Case 4: Implementation of Global Public Health Programs and Threats to Personal Safety . 199 References . 201 7 Vulnerability and Marginalized Populations . 203 Anthony Wrigley and Angus Dawson 7.1 Introduction . 203 7.2 Different Approaches to the Concept of Vulnerability . 204 7.3 Concerns Surrounding Approach (V2): Universal Condition . 205 7.4 Concerns Surrounding Approach (V3): Specifi c Attributes, Contexts, or Groups . 206 7.5 Concerns Surrounding Approach (V4): Overarching Concepts . 207 7.6 Simplifying the Concept of Vulnerability (V5): The Moral-Marker Approach . 208 References . 210 7.7 Case 1: Reducing Sudden Infant Death Syndrome in a Culturally Diverse Society: The New Zealand Cot Death Study and National Cot Death Prevention Programme . 211 References . 215 7.8 Case 2: Medical Tourism and Surrogate Pregnancy: A Case of Ethical Incoherence . 216 References . 220 7.9 Case 3: Compulsory Treatment for Injection Drug Use after Incarceration . 220 References . 224 7.10 Case 4: Unanticipated Vulnerability: Marginalizing the Least Visible in Pandemic Planning . 226 References . 229 7.11 Case 5: Can Asylum Seeking Be Managed Ethically? . 230 References . 233 7.12 Case 6: Tuberculosis Screening, Testing, and Treatment among Asylum Seekers . 235 References . 239 8 International Collaboration for Global Public Health . 241 Eric M. Meslin and Ibrahim Garba 8.1 Introduction . 241 8.2 The Rise of Globalization and Global Health . 242 8.3 Ethics Frameworks for Global Health . 246 8.4 Summary . 253 References . 253 8.5 Case 1: The Ethics of HIV Testing Policies . 256 References . 259 Contents xv 8.6 Case 2: Just Allocation of Pre-exposure Prophylaxis Drugs in Sub-Saharan Africa . 260 References . 262 8.7 Case 3: Drug Trials in Developing Countries . 263 References . 265 8.8 Case 4: Ethical Issues in Responding to International Medication Stock-Outs . 266 References . 269 8.9 Case 5: Transmitting Cholera to Haiti. 270 References . 274 8.10 Case 6: Perilous Path to Middle East Peace: The Sanctions Dilemma . 274 References . 278 8.11 Case 7: Advancing Informed Consent and Ethical Standards in Multinational Health Research . 279 References . 283 9 Public Health Research . 285 Drue H. Barrett , Leonard W. Ortmann , Natalie Brown , Barbara R. DeCausey , Carla Saenz , and Angus Dawson 9.1 Introduction . 285 9.2 What Is Different About Public Health Research? . 287 9.3 Ethical Considerations for Protecting the Public during Health Research . 289 9.4 How Ethical Challenges Can Arise in Public Health Research: Lessons Learned from Cases . 296 9.5 Conclusions . 297 References . 298 9.6 Case 1: To Reveal or Not to Reveal Potentially Harmful Findings: A Dilemma for Public Health Research . 300 References . 303 9.7 Case 2: Ethical Challenges in Impoverished Communities: Seeking Informed Consent in a Palestinian Refugee Camp in Lebanon . 305 References . 309 9.8 Case 3: Improving Review Quality and Effi ciency of Research Ethics Committees to Enhance Public Health Practice in Africa . 310 References . 313 9.9 Case 4: Internet-Based HIV/AIDS Education and Prevention Programs in Vulnerable Populations: Black Men Who Have Sex with Men . 314 References . 317 Index . 319 Contents xvii Contributors Rima Afi fi , PhD, MPH Department of Health Promotion and Community Health, Faculty of Health Sciences , American University of Beirut , Beirut , Lebanon Waleed Al-Faisal , PhD Department of Family and Community Medicine, Faculty of Medicine , Damascus University , Damascus , Syrian Arab Republic Primary Health Care, Dubai Health Authority , Dubai , United Arab Emirates Silviya Aleksandrova-Yankulovska , MD, PhD, DSc Faculty of Public Health, Department of Public Health Sciences , Medical University of Pleven , Pleven , Bulgaria Aikaterini A. Aspradaki , PhD, MA, DDS Joint Graduate Programme in Bioethics, University of Crete , Crete , Greece Drue H. Barrett , PhD Offi ce of Scientifi c Integrity, Offi ce of the Associate Director for Science, Offi ce of the Director, Centers for Disease Control and Prevention , Atlanta , GA , USA Michael T. Bartenfeld , MA Children’s Preparedness Unit, Disability and Health Branch, Division of Human Development and Disability, National Center on Birth Defects and Developmental Disabilities , Centers for Disease Control and Prevention , Atlanta , GA , USA Carrie Bernard , MD MPH CCFP FCFP Department of Family and Community Medicine , University of Toronto , Toronto , ON , Canada Department of Family Medicine McMaster University , Hamilton , ON , Canada Ruth Gaare Bernheim , JD, MPH Department of Public Health Sciences , University of Virginia , Charlottesville , VA , USA Divya Kanwar Bhati , BSc, MSc, MBA World Health Organization Collaborating Centre for District Health System Based on Primary Health Care , Indian Institute of Health Management Research University , Jaipur , Rajasthan , India xviii Dhrubajyoti Bhattacharya , JD, MPH, LLM Department of Population Health Sciences, School of Nursing and Health Professions , University of San Francisco , San Francisco , CA , USA Erika Blacksher , PhD Department of Bioethics and Humanities , University of Washington , Seattle , WA , USA Karin Johansson Blight , RGN, MSc, PhD The Policy Institute , Kings College London , London , UK Gail Bolan , MD Division of STD Prevention , National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention , Atlanta , GA , USA Renaud F. Boulanger , BA Biomedical Ethics Unit , McGill University , Montréal , QC , Canada Andrew Boyd , MD Department of Medicine, Section of Hospital Medicine , Columbia University , New York, NY , USA Natalie Brown , MPH Human Research Protections Offi ce, Offi ce of Scientifi c Integrity, Offi ce of the Associate Director for Science, Offi ce of the Director, Centers for Disease Control and Prevention , Atlanta , GA , USA Cynthia H. Cassell , PhD Birth Defects Branch, Division of Birth Defects and Developmental Disabilities, National Center on Birth Defects and Developmental Disabilities , Centers for Disease Control and Prevention , Atlanta , GA , USA Paul Christopher , MD Department of Psychiatry and Human Behavior, Warren Alpert Medical School , Brown University , Providence , RI , USA Brian Cook , PhD Toronto Food Strategy, Toronto Public Health , Toronto , ON , Canada Maite Cruz-Piqueras , BA Andalusian School of Public Health , Granada , Spain Norman Daniels , PhD Department of Global Health and Population , Harvard T.H. Chan School of Public Health , Boston , MA , USA Colleen Davison , MPH, PhD Clinical Research Centre and Department of Emergency Medicine , Kingston General Hospital , Kingston , ON , Canada Department of Public Health Sciences , Queen’s University , Kingston , ON , Canada Angus Dawson , PhD Center for Values, Ethics and the Law in Medicine, Sydney School of Public Health , The University of Sydney , Sydney , Australia Barbara R. DeCausey , MPH, MBA Clinical Research Branch, Division of Tuberculosis Elimination, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention , Centers for Disease Control and Prevention , Atlanta , GA , USA M. Gabriela Doberti , MD Hospital Padre Hurtado, Facultad de Medicina , Clínica Alemana–Universidad del Desarrollo , Santiago , Chile Contributors xix Dora M. Dumont , PhD, MPH Division of Community, Family Health and Equity , Rhode Island Department of Health , Providence , RI , USA Ewout Fanoy , MD Department of Infectious Disease Control , Municipal Health Service Utrecht , Zeist , The Netherlands National Institute for Public Health and the Environment, Centre for Infectious Disease Control , Bilthoven , The Netherlands Sherry Fontaine , PhD Department of Management , University of Wisconsin-La Crosse , La Crosse , WI , USA Joseph B. R. Gaie , PhD Department of Theology and Religious Studies , University of Botswana , Gaborone , Botswana Ibrahim Garba , MA, JD, LLM Indiana University Center for Bioethics , Indianapolis , IN , USA Public Health Law Program , Offi ce of State, Tribal, Local, and Territorial Support, Centers for Disease Control and Prevention , Atlanta , GA , USA Rachel M. Glassford , BS School of Public Health and Health Services , George Washington University , Falls Church , VA , USA Daniel S. Goldberg , JD, PhD Department of Bioethics and Interdisciplinary Studies, Brody School of Medicine , East Carolina University , Greenville , NC , USA M. Inés Gómez , MD, Masters of Bioethics Centro de Bioética Facultad de Medicina , Clínica Alemana–Universidad del Desarrollo , Santiago , Chile Susan D. Goold , MD, MHSA, MA Department of Internal Medicine and Department of Health Management and Policy , Center for Bioethics and Social Sciences in Medicine, University of Michigan , Ann Arbor , MI , USA María del Pilar Guzmán Urrea , PhD Department of Community Medicine , El Bosque University , Bogotá , Colombia Riripeti Haretuku , MEd Maori SIDS and Research , MauriOra Associates , Auckland , New Zealand Alison Hayward , MD, MPH Department of Emergency Medicine , Yale School of Medicine, Yale University , New Haven , CT , USA Uganda Village Project , Iganga , Uganda Margaret Henning , MA, PhD International Health Systems Program , Harvard T. H. Chan School of Public Health , Boston , MA , USA Health Science , Keene State College , Keene , NH , USA Ildefonso Hernández-Aguado , MD, PhD Department of Public Health, History of Science and Gynecology , Universidad Miguel Hernández and CIBER de Epidemiología y Salud Pública , San Juan, Alicante , Spain Contributors xx Sylvia Hoang , MPH Social and Epidemiological Research Department , Centre for Addiction and Mental Health , Toronto , ON , Canada Matthew R. Hunt , PT, PhD School of Physical and Occupational Therapy , McGill University , Montréal , QC , Canada Centre for Interdisciplinary Research on Rehabilitation , Montréal , QC , Canada Hamid Hussain , MD, PhD Faculty of Medicine , University of Baghdad , Baghdad , Iraq Dubai Residency Training Program and Public Health Consultant , Dubai Health Authority , Dubai , United Arab Emirates Carel IJsselmuiden , MD, MPH Council on Health Research for Development , Geneva , Switzerland School of Applied Human Sciences, South African Research Ethics Training Initiative, University of KwaZulu-Natal , Pietermaritzburg , South Africa Craig Janes , PhD School of Public Health and Health Systems , University of Waterloo , Waterloo , ON , Canada Bruce Jennings , MA Center for Biomedical Ethics and Society , Vanderbilt University , Nashville , TN , USA Kipton E. Jensen , PhD Department of Philosophy and Religion , Morehouse College , Atlanta , GA , USA Monique Jonas , PhD School of Population Health, Faculty of Medical and Health Sciences , The University of Auckland , Auckland , New Zealand Amar Kanekar , PhD, MPH, MB, MCHES, CPH Department of Health, Human Performance and Sport Management , University of Arkansas at Little Rock , Little Rock , AR , USA Mary Kasule , PhD Offi ce of Research and Development , University of Botswana , Gaborone , Botswana Carla Kessler , MA Ethics Institute , Utrecht University , Utrecht , The Netherlands Sarah A. Kleinfeld , MD Department of Psychiatry , Medstar Georgetown University Hospital , Washington , DC , USA Sarah Ann Kotchian , JD Education and Early Childhood Policy , Holland Children’s Movement and the Holland Children’s Institute , Omaha , NE , USA Maria Kousis , PhD, MSc Center for Research and Studies in Humanities, Social Sciences and Pedagogics , University of Crete , Crete , Greece André Krom , PhD Technology Assessment , Rathenau Institute , The Hague , The Netherlands Contributors xxi Juan Laguna-Sorinas , MD, MPH Department of Epidemiological Surveillance, Provincial Offi ce of Health and Social Welfare of Granada Department of Health and Social Welfare–Regional Government of Andalusia , Granada , Spain Lory Laing , PhD School of Public Health , University of Alberta , Edmonton , AB , Canada Drew E. Lee , MD, MA Department of Family Medicine , Advocate Lutheran General Hospital , Park Ridge , IL , USA Lisa M. Lee , PhD, MA, MS Presidential Commission for the Study of Bioethical Issues , Washington , DC , USA Justin List , MD, MAR, MSc Robert Wood Johnson/VA Clinical Scholars Program , University of Michigan , Ann Arbor , MI , USA Oyunaa Lkhagvasuren , MD, MPH, MEd Leading Researchers , Ulaanbaatar , Mongolia Lorna Luco , MD, Master of Bioethics Centro de Bioética, Facultad de Medicina , Clínica Alemana–Universidad del Desarrollo , Santiago , Chile Blanca Lumbreras , PhD Department of Public Health, History of Science and Gynecology , Universidad Miguel Hernández and CIBER de Epidemiología y Salud Pública , San Juan, Alicante , Spain Catherine L. Mah , MD, FRCPC, PhD Faculty of Medicine , Memorial University , St. John’s , NL , Canada Jihad Makhoul , DrPH, MPH Department of Health Promotion and Community Health, Faculty of Health Sciences , American University of Beirut , Beirut , Lebanon Isabel Marin-Rodríguez , MD, MPH Provincial Offi ce of Health and Social Welfare of Granada , Department of Health and Social Welfare–Regional Government of Andalusia , Granada , Spain Christopher W. McDougall , MA Institute of Health Policy, Management and Evaluation, and Joint Centre for Bioethics , University of Toronto , Toronto , ON , Canada Eric M. Meslin , PhD Indiana University Center for Bioethics , Indianapolis , IN , USA Jennifer Milburn , MHA Newborn Screening Ontario , Children’s Hospital of Eastern Ontario , Ottawa , ON , Canada Joseph Millum , PhD Clinical Center Department of Bioethics and Fogarty International Center , National Institutes of Health , Bethesda , MD , USA Contributors xxii Raquel de Mock , MD Adult Health Program, Ministry of Health, University of Panama , Panama City , Panama Boitumelo Mokgatla , BMedSc, MSc (Bioethics) Africa Offi ce for Council on Health Research for Development , Gaborone , Botswana Mapping African Research Ethics Review and Medicines Regulatory Capacity , Gaborone , Botswana Indira Nair , MSc, PhD Department of Engineering and Public Policy , Carnegie Mellon University , Pittsburgh , PA , USA Rima Nakkash , DrPH, MPH Department of Health Promotion and Community Health, Faculty of Health Sciences , American University of Beirut , Beirut , Lebanon Stuart G. Nicholls , MSc, MRes, PhD School of Epidemiology, Public Health and Preventive Medicine , University of Ottawa , Ottawa , ON , Canada Lloyd Novick , MD, MPH Brody School of Medicine , East Carolina University , Greenville , NC , USA Leonard W. Ortmann , PhD Offi ce of Scientifi c Integrity, Offi ce of the Associate Director for Science, Offi ce of the Director, Centers for Disease Control and Prevention , Atlanta , GA , USA Georgina Peacock , MD, MPH, FAAP Division of Human Development and Disability , National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention , Atlanta , GA , USA Anastas Philalithis , AKC, MBBS, PhD, MRCP, MS Department of Social Medicine, Faculty of Medicine , University of Crete , Crete , Greece Daryl Pullman , MA, PhD Division of Community Health and Humanities, Faculty of Medicine , Memorial University , St. John’s , NL , Canada Andreas Reis , MD, MSc Global Health Ethics, Department of Information, Evidence and Research , World Health Organization , Geneva , Switzerland Christy A. Rentmeester , PhD AMA Journal of Ethics , American Medical Association , Chicago , IL , USA Josiah D. Rich , MD, MPH Department of Medicine, Warren Alpert Medical School , Brown University , Providence , RI , USA Jorge Rodríguez , MD Sexual and Reproductive Health , Ministry of Health , Panama City , Panama Panamanian Family Medicine Association , Panama City , Panama Miguel Angel Royo-Bordonada , MD, MPH, PhD National School of Public Health , Madrid , Spain Contributors xxiii Babette Rump , MD Department of Infectious Disease Control , Municipal Health Service Utrecht , Zeist , The Netherlands Carla Saenz , PhD Regional Program on Bioethics , Offi ce of Knowledge Management, Bioethics, and Research, Pan American Health Organization , Washington , DC , USA Maneesha Sakhuja , MHS Presidential Commission for the Study of Bioethical Issues , Washington , DC , USA Harald Schmidt , MA, PhD Department of Medical Ethics & Health Policy, Center for Health Incentives and Behavioral Economics , University of Pennsylvania , Philadelphia , PA , USA Michael J. Selgelid , MA, PhD Centre for Human Bioethics , Monash University , Melbourne , Australia Kasturi Sen , BA, Dip Soc Pol, PhD Global Public Health, Wolfson College (Common Room) , University of Oxford , Oxford , UK Pablo Simón-Lorda , MD, PhD Primary Health Care Centre Chauchina, UGC Santa Fe , Granada, Spain Department of Health and Social Welfare–Regional Government of Andalusia , Granada , Spain Maxwell J. Smith , MS Dalla Lana School of Public Health and the Joint Centre for Bioethics , University of Toronto , Toronto , ON , Canada Jeremy Snyder , PhD Faculty of Health Sciences , Simon Fraser University , Burnaby , BC , Canada Daniel M. Sosin , MD, MPH, FACP Offi ce of Public Health Preparedness and Response , Centers for Disease Control and Prevention , Atlanta , GA , USA Kayte Spector-Bagdady , JD, M Bioethics Presidential Commission for the Study of Bioethical Issues , Washington , DC , USA Maribel Tamayo-Velázquez , PhD Andalusian School of Public Health , Granada , Spain Emily Taylor , MA Dalla Lana School of Public Health , University of Toronto , Toronto , ON , Canada Olinda Timms , DA, PGDMLE, PGDB Department of Health and Humanities , St. Johns Research Institute , Bangalore , Karnataka , India Ioannis Tzoutzas , DDS, Dr. Odont., FIADR, FASM School of Dentistry , National and Kapodistrian University of Athens , Athens , Greece Contributors xxiv Jo A. Valentine , MSW Division of STD Prevention, National Center for HIV/ AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention , Atlanta , GA , USA Jim van Steenbergen , MD, PhD National Institute for Public Health and the Environment , Centre of Infectious Disease Control , Bilthoven , The Netherlands Leiden University Medical Centre, Centre for Infectious Diseases , Leiden , The Netherlands Claude Vergès , MD, EdD, MA (Bioethics, Law) Children’s Hospital , University of Panama , Panama City , Panama Marcel Verweij , PhD Department of Social Sciences , Communication, Philosophy and Technology: Centre for Integrated Development, Wageningen University , Wageningen , The Netherlands A. M. Viens , PhD Centre for Health, Ethics and Law, Southampton Law School , University of Southampton , Southhampton , UK Meghan Wagler , MPH Faculty of Health Sciences, Simon Fraser University , Burnaby , BC , Canada Frank Wagner , MA, MHSc Department of Family and Community Medicine , Faculty of Medicine, University of Toronto , Toronto , ON , Canada Toronto Central Community Care Access Centre and the University of Toronto Joint Centre for Bioethics Toronto, ON, Canada Douglas Wassenaar , PhD South African Research Ethics Training Initiative, School of Applied Human Sciences , University of KwaZulu-Natal , Pietermaritzburg , South Africa Marjan Wassenberg , MD, PhD Department of Medical Microbiology , Utrecht University Medical Centre , Utrecht , The Netherlands Anthony Wrigley , PhD Centre for Professional Ethics , Keele University , Staffordshire , UK Susan Zinner , MSJ, MHA, JD School of Public and Environmental Affairs , Indiana University Northwest , Gary , IN , USA Contributors Section I Introduction to Public Health Ethics 3© The Author(s) 2016 D.H. Barrett et al. (eds.), Public Health Ethics: Cases Spanning the Globe, Public Health Ethics Analysis 3, DOI 10.1007/978-3-319-23847-0_1 Chapter 1 Public Health Ethics: Global Cases, Practice, and Context Leonard W. Ortmann , Drue H. Barrett , Carla Saenz , Ruth Gaare Bernheim , Angus Dawson , Jo A. Valentine , and Andreas Reis 1.1 Introduction Introducing public health ethics poses two special challenges. First, it is a relatively new fi eld that combines public health and practical ethics . Its unfamiliarity requires considerable explanation, yet its scope and emergent qualities make delineation dif- fi cult. Moreover, while the early development of public health ethics occurred in a Western context, its reach, like public health itself, has become global. A second challenge, then, is to articulate an approach specifi c enough to provide clear The opinions, fi ndings, and conclusions of the authors do not necessarily refl ect the offi cial posi- tion, views, or policies of the editors, the editors’ host institutions, or the authors’ host institutions. L. W. Ortmann , PhD (*) • D. H. Barrett , PhD Offi ce of Scientifi c Integrity, Offi ce of the Associate Director for Science, Offi ce of the Director , Centers for Disease Control and Prevention , Atlanta , GA , USA e-mail: lortmann@cdc.gov C. Saenz , PhD Regional Program on Bioethics, Offi ce of Knowledge Management, Bioethics, and Research , Pan American Health Organization , Washington , DC , USA R. G. Bernheim , JD, MPH Department of Public Health Sciences , University of Virginia , Charlottesville , VA , USA A. Dawson , PhD Center for Values, Ethics and the Law in Medicine, Sydney School of Public Health , The University of Sydney , Sydney , Australia J. A. Valentine , MSW Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention , Centers for Disease Control and Prevention , Atlanta , GA , USA A. Reis , MD, MSc Global Health Ethics, Department of Information, Evidence and Research , World Health Organization , Geneva , Switzerland mailto:lortmann@cdc.gov 4 guidance yet suffi ciently fl exible and encompassing to adapt to global contexts. Broadly speaking, public health ethics helps guide practical decisions affecting population or community health based on scientifi c evidence and in accordance with accepted values and standards of right and wrong. In these ways, public health ethics builds on its parent disciplines of public health and ethics. This dual inheri- tance plays out in the defi nition the U.S. Centers for Disease Control and Prevention (CDC) offers of public health ethics: “A systematic process to clarify, prioritize , and justify possible courses of public health action based on ethical principles , values and beliefs of stakeholders , and scientifi c and other information ” (CDC 2011 ). Public health ethics shares with other fi elds of practical and professional ethics both the general theories of ethics and a common store of ethical principles, values , and beliefs. It differs from these other fi elds largely in the nature of challenges that pub- lic health offi cials typically encounter and in the ethical frameworks it employs to address these challenges. Frameworks provide methodical approaches or proce- dures that tailor general ethical theories, principles , values, and beliefs to the spe- cifi c ethical challenges that arise in a particular fi eld. Although no framework is defi nitive, many are useful, and some are especially effective in particular contexts. This chapter will conclude by setting forth a straightforward, stepwise ethics frame- work that provides a tool for analyzing the cases in this volume and, more impor- tantly, one that public health practitioners have found useful in a range of contexts. For a public health practitioner, knowing how to employ an ethics framework to address a range of ethical challenges in public health—a know-how that depends on practice—is the ultimate take-home message. We learn new things more readily when we can relate them to familiar things, and we understand complex things by breaking them into their components. Accordingly, throughout this introductory chapter, we will relate public health eth- ics to more familiar concepts and better-known related fi elds, while the immediately following section will explore the components of public health ethics that derive from its parent disciplines of public health and ethics. After describing public health’s core activities, goals, and values , we will explain why ethical concepts like the right to health , social justice , and health equity directly follow as central con- cerns of public health. After defi ning ethics broadly in everyday terms, we will examine the complementary roles facts and values play in public health. This exam- ination is important because the respective bases of the two parent disciplines differ considerably; public health science rests on the logic of scientifi c discovery, whereas ethics rests on the logic of right action and good decision making. We will then contrast the more familiar, everyday understanding of morality with the formal dis- cipline of ethics as a prelude to considering three well-known ethical theories rele- vant to public health. Because both laws and ethical rules establish parameters for public health practice, their similarity and difference need to be clarifi ed. This extended account, fi rst of parent disciplines, then of kindred concepts, and fi nally of family resemblances between the related fi elds of clinical ethics , bioethics , and research ethics , will culminate in an effort to characterize what is distinctive about public health ethics. L.W. Ortmann et al. 5 1.2 Public Health There are many defi nitions of public health. They often begin as descriptions of cur- rent practice but once established become prescriptions for subsequent practice. It is important, then, to consider defi nitions, because they shape not only public health practice, but also how we conceive of public health ethics (Dawson and Verweij 2007 ). The same logic applies to how we think about the individual concepts of health and the public. Defi ning health as the absence of disease or symptoms, for example, more readily fi ts allopathic medicine, which focuses on negating symp- toms to treat disease. But it hardly fi ts public health’s emphasis on preventive mea- sures that address root causes rather than symptoms. Nor does it cover public health’s promotion of health and well-being across a range of interventions. In this regard, the World Health Organization (WHO) offers a defi nition of health more suitable to public health: “A state of complete physical, mental, and social well- being and not merely the absence of disease or infi rmity” (WHO 2006 ). But even this more holistic defi nition does not suffi ciently clarify the meaning of “public” in public health. Dawson and Verweij ( 2007 ) identify two primary meanings of “pub- lic” in public health, each of which they break down into three senses. Public can mean population-wide and refer to (1) the epidemiologically measured health of a population or group, (2) the distribution of health in a population, or (3) the underly- ing social and environmental conditions impacting everyone’s health. Public also can mean collectively accomplished and requiring (1) the concerted actions of many people and institutions whether governmental or nongovernmental; (2) the coopera- tion or involvement of the public, or (3) the public’s joint participation to realize the health improvement. In a practical fi eld like public health, defi nition often takes the form of enumerat- ing key activities, such as surveillance , sanitation , maintaining food and workplace safety , disease prevention and control , and promoting healthy behavior. The identi- fi cation of the ten essential services of public health illustrates this enumerative approach (Fig. 1.1 ) (Public Health Functions Steering Committee 1994 ). These ser- vices fall under three overarching functions of assessment, policy development, and assurance that constitute an integrated cyclic process. The delivery of these services in local, regional, or national public health agencies accordingly defi nes public health practice. In this schema, research is a distinct practical service but also integral to all public health activities, providing insights and innovative solutions at every point. Public health ethics addresses the entire spectrum of ethical issues that arise in any area of public health practice but especially in those areas where no specifi c guidelines govern practice. Such lists have the advantage of concretely specifying current activities but lack criteria that defi nitions normally provide for including or excluding additional activ- ities as a fi eld develops. In 1920, Charles Edward A. Winslow, an infl uential public health theorist and leader, pioneered a defi nition of public health that still informs many European and international public health institutions, including WHO (Marks et al. 2011 ). 1 Public Health Ethics: Global Cases, Practice, and Context 6 Public health is the science and the art of preventing disease, prolonging life, and promoting physical health and effi ciency through organized community efforts … and the development of the social machinery which will ensure to every individual in the community a standard of living adequate for the maintenance of health (Winslow 1920 ). Even more succinctly, the U.S. Institute of Medicine (IOM) defi nes public health as “what we, as a society, do collectively to assure the conditions for people to be healthy” (IOM 1988 ). These two defi nitions highlight the importance of collective action to address the health needs of populations . Public health’s population focus distinguishes it from clinical medicine’s focus on individual patients, though examples like vaccination indicate that the two fi elds can overlap. Epidemiologists statistically aggregate the health data of individuals to provide a picture of population health , but populations ultimately originate from communities of individuals who constitute social wholes. Fig. 1.1 Essential Public Health Services . (1) Monitor health status to identify community health problems. (2) Diagnose and investigate health problems and health hazards in the community. (3) Inform, educate, and empower people about health issues. (4) Mobilize community partnerships and action to identify and solve health problems. (5) Develop policies and plans that support indi- vidual and community health efforts. (6) Enforce laws and regulations that protect health and ensure safety . (7) Link people to needed personal health services and assure the provision of health care when otherwise unavailable. (8) Assure competent public and personal health care workforce. (9) Evaluate effectiveness , accessibility, and quality of personal and population-based health ser- vices. (10) Research for new insights and innovative solutions to health problems (From Public Health Functions Steering Committee 1994 . Essential Public Health Services . Available at http:// www.cdc.gov/nphpsp/essentialServices.html ) L.W. Ortmann et al. http://www.cdc.gov/nphpsp/essentialServices.html http://www.cdc.gov/nphpsp/essentialServices.html 7 Individuals in society stand in complex relations of interdependence , competition, and solidarity that can impact health in ways that transcend the individual. Thus, in addition to aggregating individual medical data, epidemiologists need to measure the impact of various social factors on health. To tackle the complex, often compet- ing health needs of social groups, public health practitioners need to dialogue and partner with their communities. At a higher administrative level, public health offi - cials need to manage intersectoral collaborations , navigate political processes, and formulate public health law. Four distinguishing features of public health practice— the pursuit of the collective good, a focus on prevention , the use of government or collective action, and an emphasis on an outcome-based (utilitarian) approach— generate most of the ethical challenges public health practitioners typically face (Faden and Shebaya 2010 ). 1.2.1 Core Values People value many things such as friends and family, material goods and resources, knowledge, and art. Some things people value are ethical virtues like courage or honesty, whereas others are ethical principles like justice and equality. People gen- erally value what they consider important, what matters to them, and what gives their lives meaning. Public health’s primary goals and commitments refl ect its core values, which are rooted in health, science, and the community (Public Health Leadership Society 2002 ). Everyone recognizes the value of health, but public health approaches health in relation to science and the community in its endeavor to prevent disease and injury, protect the public from harm, and promote health and well-being. But seeing how science and community represent values requires a word of explanation. The commitment to science as a value stance often becomes apparent only in relation to people who distrust science or prioritize other value commitments such as economic interests or religion. Public health values science by endeavoring to base interventions and policies on the best available data and evidence-based prac- tices. That endeavor entails a commitment to conduct surveillance and research , because only by understanding the social burden of disease and its underlying or structural causes can public health impact the health of the entire population . The qualifi er “best available” is a reminder of the need to continuously improve practice and not rely on tradition or current practices. It also reminds us that during emergen- cies, time and resource constraints limit the ability to gather evidence. Public health values community in two obvious senses. First, it recognizes that the success of most health interventions depends on a community’s acceptance, cooperation, or participation . Second, it recognizes that to be successful, public health must respect the community’s values and gain the trust of its members. Yet there is a third, deeper sense in which community represents a value. A community is, to emphasize again, neither a statistical abstraction nor a mere aggregate of indi- viduals but rather a network of relationships and emotional bonds between people 1 Public Health Ethics: Global Cases, Practice, and Context 8 sharing a life in common organized through a political and moral order (Jennings 2007 ). The value that best refl ects this fundamental, relational character of social life is solidarity . Solidarity can remain unspoken yet operative because it forms the basis of social life and collective action. Just as communities are not mere aggre- gates of individuals, neither are the agencies or organizations that make the collec- tive decisions that affect the community. Personal interests, to be sure, can motivate individuals, but the felt recognition of a common plight, that we are all in it together, underlies the collective decisions society and public health must make to solve col- lective problems. To say that public health values community means that it values solidarity, even when solidarity remains unacknowledged as is often the case (Dawson and Jennings 2012 ). 1.2.2 Health Equity , Social Justice, and Social Determinants of Health As the foregoing goals, defi nitions, core values , and commitments of public health clearly suggest, the right to health and health equity are central, not peripheral, to public health’s mission. Chapter 8 on international collaboration will examine some practical challenges in addressing the right to health and social determinants of health, so the emphasis here will be on the rationale for achieving health equity as a matter of social justice. Despite greater individual access to health care and advances in public health, high burdens of disease remain across much of the globe. Some differences in dis- ease burden result from genetics and some from variable risks of exposure to infec- tious agents and other threats, but most of the differential burden arises from social, economic, and political conditions . These conditions include poverty, lack of educa- tion, and discrimination against particular social groups and often refl ect historical injustices or long-standing systemic, structural defi ciencies. Collectively, these con- ditions have come to be known as social determinants of health (Blane 1999 ). Greater access to individual health care can mitigate their effect, but an adequate response to them requires concerted public action to address their underlying causes. Whether comparing countries or groups within countries, social stratifi cation by social determinants correlates with differences in health status (Marmot 2007 ). These health differences have aroused widespread concern, but how one defi nes them signifi cantly affects public health practice (Braveman 2006 ). In particular, dis- tinguishing health disparity from health in equity is critical. As a comparative indi- cator of health status, health disparity is a neutral, epidemiologic term that need not imply an ethical obligation to remedy. Health disparities , however, can and fre- quently do refl ect underlying inequities. WHO defi nes health inequities as health differences that are “socially produced; systematic in their distribution across the population ; and unfair” (WHO 2007 ). Terms like “inequity” and “unfair” are ethical terms that imply an obligation to redress an in justice. Justice has a range of mean- L.W. Ortmann et al. http://dx.doi.org/10.1007/978-981-287-561-7_8 9 ings that include giving people what they deserve or are owed and distributing goods and services fairly. Justice in a medical context often involves the individual’s access to health services. In public health, discussions of health equity usually involve questions of how to distribute health benefi ts fairly or how to achieve better health outcomes among communities or groups that suffer health inequities . Attaining greater equity might involve the politically controversial strategy of dis- proportionally distributing resources within a population , by, for example, distribut- ing more to those most in need. A less-controversial strategy is to improve health outcomes for all, even while devoting special efforts to those most in need. WHO defi nes health equity as “the absence of unfair and avoidable or remediable differ- ences in health among population groups defi ned socially, economically, demo- graphically, or geographically” (WHO 2007 ). Achieving health equity is most urgent for groups who have experienced histo- ries of marginalization and discrimination and who continue to experience higher rates of illness and premature deaths than members of the mainstream population . Especially for these groups, “social injustice is killing people on a grand scale” (WHO 2008 ). Realizing the goal of social justice with respect to health means achieving health equity. Doing so requires not only a fair distribution of health out- comes , it also means that “ideally everyone should have a fair opportunity to attain their full health potential” and that “no one should be disadvantaged from achieving this potential, if it can be avoided” (Whitehead 1992 ). For many, these goals imply that social justice obligates public health to improve any social condition that pre- vents people from maintaining a standard of life adequate to maintain health (Powers and Faden 2006 ). Although some believe that improving social conditions that affect health overextends public health’s mandate, such a broad mandate is arguably consistent with both Winslow’s and IOM’s defi nitions of public health. Moreover, such a broad mandate has both nineteenth century precursors in the social medicine movement and more recent precedents in the “Health for All” strategy that empha- sizes health promotion and the “Health in All Policies” strategy (Kickbusch 2003 ; Freiler et al. 2013 ). But a major milestone was reached with the 2008 report of the WHO Commission on Social Determinants of Health that sought to “marshal the evidence on what can be done to promote health equity , and to foster a global move- ment to achieve it” (WHO 2008 ). Although governments can guarantee human rights and essential services, establish policies that provide an equitable basis for health improvement, and gather and monitor data on health equity , achieving equity ultimately will depend on the cooperation of government and civil society (Blas et al. 2008 ). 1.3 Ethics People strive to be “good,” to do the “right” thing and to lead a “good life,” but where do such basic, familiar moral values as good and right originate? Throughout his- tory, religious people have explained these ideas as revelations of divine command. 1 Public Health Ethics: Global Cases, Practice, and Context 10 Anthropologists, however, view morals as customs that govern social interactions, and because all cultures display such customs, interpret moral practices in terms of a survival function rooted in human nature. By contrast, many social and political thinkers emphasize that moral concepts result from social conventions or agree- ments that are subject to deliberation and change. Governments today often consult social scientists and health experts who empirically investigate what fosters or improves human life, health, and happiness. Where science informs law and policy , it helps defi ne in a conventional sense what we mean by good and right. In particu- lar, public health science helps establish what is considered good for the health of populations and communities. Further below we will examine three ethical theories prominent in public health ethics that offer contrasting perspectives on the nature and basis of morality . In the meantime, we will address three general questions that a public health practitioner fi rst approaching the study of ethics might well ask: how does science relate to ethics, what is the difference between ethics and mora lity, and what sort of things count as principles or basic concepts in ethics? 1.3.1 Scientifi c Facts and Ethical Values Public health practice increasingly requires appreciation of the complementary roles facts and values play in making and justifying decisions. Observation reveals facts, while scientifi c research controls and manipulates the experimental context to discover causation or correlation. Data on disease burden , research on intervention effectiveness , and estimates of the resultant health benefi ts for the population gener- ally inform public health interventions . Health messaging can often inform the pub- lic about the scientifi c rationale underlying public health interventions. Nevertheless, in the mind of the public, scientifi c evidence does not always invalidate or outweigh other sources of evidence or appeals to emotions, interests, and values. While public health practitioners give more weight to community health and scientifi c evidence, they also need to consider how the public will respond to an intervention. Successfully implementing public health actions, then, will often entail weighing the public’s attitudes, interests, and values in relation to public health’s core values. Two mundane features of public health practice often serve to conceal value assumptions: shared core values and standard practice. First, sharing values can render them invisible as assumptions, until they unexpectedly become contested. Unwelcome surprises occur when interventions that presuppose core values affect stakeholders who do not share those values, as when parents refuse to have children vaccinated based on media hearsay or individuals reject a highly effective program as governmental intrusion. Avoiding such surprises begins with becoming aware of one’s own value presuppositions in relation to those of other stakeholders and com- munity members. Second, routine use of evidence-based standards can conceal underlying value assumptions. If developed and tested to address a known health problem, as is common, an intervention’s purpose and effectiveness is taken for L.W. Ortmann et al. 11 granted. Standard interventions, then, generally require no more justifi cation than noting their standard status or seeing that “the facts dictated” their use. “Dictating” facts are indicators that trigger use of a standard intervention (e.g., meeting the cri- teria of a case defi nition or documenting exposure to a dangerous level of a contami- nant). Such “dictating facts,” more properly speaking, only indicate the appropriate intervention but cannot literally dictate that anything be done. What in the end dic- tate actions are the values, goals, and obligations that the standard intervention pre- supposes and that practitioners tacitly ratify each time they apply the standard. In other words, values, goals, and obligations , even when tacit, form a necessary bridge between knowledge and action. Though standard practices tacitly incorporate ethical principles , they seldom raise ethical challenges. Challenges more typically arise in unusual or extreme situ- ations where standards are not yet in place, are changing, or are competing. These situations include emergency operations, foreign cultural settings, emergent fi elds with innovative interventions, or periods of severe budget constraints that force pri- oritization of programs. In such challenging situations where no value consensus exists or where evidence does not point to a single course of action, public health ethics provides a process to determine and justify a course of action. That justifi ca- tion can incorporate a number of factors: evidence base for the intervention, cost effectiveness , analysis of relevant ethical rules and stakeholder values , a cre- ative design of options or alternatives that embody these values, and a fair and trans- parent decision-making process that incorporates stakeholder contributions. Recognizing one’s own value assumptions in relation to those of the public will be critical for implementing new interventions wherever success depends on public acceptance. The public will not embrace interventions that embody or presuppose values that clash with community values or whose relative importance is low com- pared to other community values. Members of the public generally are more com- mitted to their political views, ethical and religious values, and an intervention’s impact on them personally than to scientifi c evidence or community impact. Public health practitioners need to recognize that no matter how compelling to them, com- munity impact and scientifi c rationale seldom resonate as deeply with the public. Consequently, in communicating, public health practitioners need to supplement scientifi c messaging with dialogue, an appeal to common values, or enlistment of spokespersons who share the value orientation of the relevant stakeholder s or com- munity. Regarding some controversial matters, ultimate success in implementing an intervention may require building a social consensus (Ortmann and Iskander 2013 ). In certain situations, untangling factual claims based on science from value judg- ments is critical for success. For example, suppose independent investigators have scientifi cally verifi ed the level of worker exposure to a toxic chemical used in indus- try. Determining what level of exposure would be safe, however, remains a value judgment that depends on the degree of concern that people have about safety . Placing a higher value on safety might result in stricter controls that decrease risk for workers, but the fi nancial costs of decreasing risks could cut industry profi ts or jobs, even as health costs fall. Stakeholders representing industry, workers, or public health practitioners might have different positions regarding a safe level of exposure. 1 Public Health Ethics: Global Cases, Practice, and Context 12 To make a good decision about a safe exposure level, the value of safety might have to be discussed and weighed in relation to business, employment, and health consid- erations. However, these varying positions regarding safety need not imply disre- gard for safety or disagreement on the underlying facts. Rather, they illustrate that confl icting value judgments can coexist despite a consensus on both the underlying facts and the importance of a particular value such as safety . Directly addressing the value confl icts in such situations through ethical delib- eration makes more sense than calling into question the underlying facts and can lead to better, fairer, and more transparent decisions. It is also important to recog- nize that doubting the science often represents an underlying value dispute mas- querading as a scientifi c dispute (Brunk et al. 1991 ). Sowing doubt on scientifi c assessments merely as a tactic to oppose an evidence-based policy or recommenda- tion undermines science. This doubt can exert pressure to test and retest results, raising the bar for scientifi c validity ever higher (Michaels 2008 ). The solution is not to litigate, as it were, the science, but to recognize that communicating risk is a social process that goes beyond science messaging and must take cultural attitudes, perceptions, and symbolic meanings into account (Krimsky and Plough 1988 ). Where profound value disagreements prevail, public health legitimately prioritizes its core values but cannot speak for everyone. Stakeholder views require a fair hear- ing, whether through media research , stakeholder analysis, or direct solicitation of input from individuals, focus groups, or public meetings. By design, a fair, transpar- ent ethical decision-making procedure can help determine what value tradeoffs are feasible and what values may be nonnegotiable. Such a deliberative procedure can help to gain public acceptance and become part of the justifi cation for a course of action. To those accustomed to rigorous research methods and evidence-based standards of practice, navigating the world of ethical values and rules can be perplexing. Values, as the term itself implies, manifest valences, that is, variable degrees of commitment or estimations of importance along a continuum. Individuals rank val- ues differently, change their rankings, and will alter their relative ranking of values in different contexts. The range of options for ethical rules are far more limited, namely, to obey or not obey. Nevertheless, the ethical rules governing particular situations also vary from country to country or even from jurisdiction to jurisdiction within a country. Despite this variability in values and ethical rules, reducing ethical judgment to mere opinion or to a consensus of opinion relative only to personal or cultural preferences would be a mistake. Ethical values and rules enjoy the approval of history, custom, law , and religious tradition, but they also fi nd anchor biologi- cally, psychologically, and socially in human life. Value judgments and ethical determinations, then, are not relative as much as correlative; that is, they correlate and resonate with these deeper roots of human life that we share. If humans indeed share a set of fundamental values, then ethical confl icts primarily refl ect differences in prioritizing values in a particular context, rather than a fundamental disagreement about values. This point of view provides grounds for optimism about the possibil- ity of fi nding a deeper basis for understanding and mutual respect , if not agreement, when ethical tensions surface. L.W. Ortmann et al. 13 1.3.2 Ethics and Morality Although many use the terms ethics and morality interchangeably, we will distin- guish the formal discipline of ethics from the common morality that guides every- day actions and behavior. Morality refers to a society’s shared, stable beliefs about what is good and bad, right and wrong. Through upbringing and socialization, each generation passes this common morality to the next. Common morality envelopes the individual like an ecosphere of shared customs, rules, and values . For most cir- cumstances, people habitually rely on this common morality to guide their conduct, and it serves them well, just as standard practice generally serves professional prac- titioners well. Still, common morality can fall short where its rules confl ict , where it inadequately illuminates novel moral problems, or where intense disagreement prevails among rival stakeholder s. In such instances, the formal discipline of ethics offers a deliberate, systematic way of addressing troubling moral issues, confl icts , and dilemmas . Ethics can assist in: • Recognizing ethical issues and distinguishing them from factual issues; • Providing a vocabulary to systematically discuss ethics; • Identifying appropriate ethical principles to guide action in a particular context; • Using these principles to analyze actions in regard to their ethical acceptability; • Understanding the competing moral claims and values of stakeholders ; • Designing alternative courses of action that incorporate these claims and values; • Evaluating which alternative best fi ts a given context, all things considered • Establishing a procedurally just, transparent process for decision making; and • Justifying decisions regarding recommendations, policies, or intervention s. 1.3.3 Ethical Principles Principles are general categories, rules, or guidelines that form the basis of a disci- pline. In ethics, there are various kinds of principles and many examples of each kind. The kinds include basic ethical categories (e.g., virtues, values , or rights), ethi- cal commands or rules of conduct (e.g., not stealing, not harming, or treating others with respect ), and guidelines for weighing outcomes (e.g., achieving the greatest good for the greatest number, distributing burdens and benefi ts fairly, or properly proportioning benefi t to harm). Ethical principles like justice or respect for auton- omy are simultaneously values, ideals, and the basis for deriving rules of conduct. Such rules serve as ethical standards to evaluate past and pending actions, programs, and policy recommendations . When addressing complex or controversial issues or issues involving numerous stakeholders , many different principles can come into play. But because ethical decision making depends on context (e.g., on local circum- stances, community stakeholders, and decision makers), no formula can determine the most relevant ethical principles. Nevertheless, most ethicists and practitioners 1 Public Health Ethics: Global Cases, Practice, and Context 14 working in a fi eld would agree that certain principles, theories, or frameworks pro- vide more helpful guidance for that fi eld. Given the need for fl exibility, some prefer to speak not of ethical principles but of “general moral considerations” that can provide guidance in public health practice (Childress et al. 2002 ). At any rate, a complex ethical challenge involving stakeholders with competing moral claims fre- quently demands consideration of a variety of ethical principles and theories to address the situation and justify a proposed intervention. For these reasons, it will be useful both to examine below several ethical theories used in public health ethics and to provide at the end of the chapter a framework that is generally applicable to ethical issues that arise in public health. 1.3.4 Ethical Theories As used here, an ethical framework refers to a tool or approach for practically addressing ethical challenges that often includes a stepwise procedure. An ethical framework may rely heavily on just one ethical theory, but frameworks generally take a pragmatic approach that procedurally allows for using a variety of theories or principles as the issue or context demands. Whereas an ethical framework has a practical orientation, an ethical theory also addresses more fundamental questions, so-called “metaethical” questions. Does morality originate in divine command, human nature, or human convention? Is it essentially a habit, intuition, form of rea- soning, or a quality or purpose of an action? An ethical theory will offer a distinct, coherent understanding of the source and nature of morality that will shape how one reasons about moral issues and determine which principles are most important. Two persons employing the same theory, however, will not necessarily reach the same conclusion about an ethical issue; much will depend on which aspects of the issue they deem most important and on how they weigh different factors. Nevertheless, because a particular ethical theory tends to favor certain principles or types of prin- ciples, using the same theoretical approach will lead to similar lines of reasoning and selection of principles . The diversity of ethical theories does not imply their mutual opposition so much as points to the extensive range of the moral landscape and the need to illuminate its various contours. A helpful way of illuminating this landscape is to distinguish theories depending on whether they focus on the actor, the action, or the results of action. To illustrate this particular way of carving up the moral landscape, Table 1.1 describes some well-known ethical theories. Aristotle’s virtue ethics is an ethical theory that focuses on the moral character of the actor or agent (Bartlett and Collins 2011 ). Classic virtues are dispositions or stable patterns of behavior that lie between extremes of vice; courage, for example, lies between the extremes of cowardice and foolhardiness in taking risks. Habit and practice are necessary to develop virtues whose possession we equate with good character and that equip a person to be effective in society or an organization. Because good character translates into virtuous action that others aspire to emulate, L.W. Ortmann et al. 15 we tacitly invoke virtue ethics whenever we ask how an outstanding public fi gure or health leader would handle a situation. In a modern professional context, virtues also include the skills the profession has identifi ed that lead to success in that pro- fession and which professional education and training instill in practitioners. Once established, virtues readily become the standards of obligation and accountability to evaluate professional performance and function similarly to the rules and principles of duty discussed below. Holding public health institutions accountable for the pro- fessional competence of their employees illustrates virtue ethics (Public Health leadership Society 2002 ). More recently, th e capabilities approach has exploited the potential of virtue ethics to guide decisions about policy or interventions in a way that goes beyond matters of professional training and responsibilities. This approach takes a broader developmental view of human agency and capacity building. It con- ceives health as a fundamental capability necessary for individuals to succeed in society, one on which many further capabilities depend (Sen 2009 ; Ruger 2010 ). An ethical theory that focuses on action or, more properly, the rules governing action, is deontology. The word deontology comes from the ancient Greek word, deontos , which means duty. Because duties oblige us to obey rules that govern actions or conduct, they bind or constrain the will ahead of action. In judging whether an action is right or wrong, deontology ignores consideration of harmful or benefi cial consequences and relies on these rules of duty to serve as the standard of judgment. People usually have rules of duty or obligation in mind when they speak of ethical standards or worry that standards are breaking down. Examples of these rules include religious commandments to honor parents , not lie, or not steal and Table 1.1 Ethical theories Theory Agent-centered Deontology Utilitarianism Focus Agent Action Result of action Key fi gure Aristotle Immanuel Kant John Stuart Mill Main concept Virtues : Acquired habits, skills, or dispositions that make people effective in social or professional settings Duties : Ethical rules or commands that constrain one’s action or defi ne obligations owed to others Results : Good or bad outcomes of actions and policies or their benefi cial or harmful effects on individuals and society Examples Honesty, courage, modesty, trustworthiness, transparency, reliability, and perseverance Ethical and religious commandments, obligations to seek justice or respect persons and their rights Burdens, risks, harms, or costs versus the benefi ts, advantages, or savings resulting from interventions or policies Ethical action Doing what a virtuous person would do in a given situation Fulfi lling an obligation or duty owed to oneself or society Maximizing the net balance of benefi ts over harms Uses Assessing skills and capacities needed for success in a community, organization, or profession Establishing compliance rules and regulations, and setting standards for evaluating actions and behavior Conducting population- level cost-benefi t, risk-benefi t, or cost-effectiveness analyses 1 Public Health Ethics: Global Cases, Practice, and Context 16 rules of social interaction such as treating people fairly, doing them no harm, or respecting their rights. Rights often are said to stand in reciprocal relation to duties. Thus, the right to free speech presupposes a duty to respect the right of others to speak or the public health obligation to ensure conditions for maintaining health presupposes a right to health . Deontology as a theory owes most to Im manuel Kant’s view of the “good will” and his closely linked account of autonomy . A person of morally good will does the right thing for its own sake, which means acting purely for the sake of duty. Duties are moral rules or laws that bind the will and limit the scope of action. For Kant, basing decision for one’s action solely on duty without regard to the potential good or bad consequences of the action is the only legitimate basis for moral action. Kant even goes so far as to say that “a free will and a will under moral laws are one and the same” (Gregor et al. 2012 ). Kant conceives duty as the quintessential expression of autonomy , which may come as a surprise to those who equate autonomy with rational free choice or even just following one’s preferences without interference. However, the meaning of autonomy for Kant derives from its literal meaning in Greek, autos (self) and nomos ( law) ; namely, self-legislating. Autonomy enacts from within the moral rules and principles that bind the will and guide action. However, not every self-originating impulse should be obeyed; only actions conceivable as universal laws morally bind the will. Morally laying down the law for oneself entails legislating for everyone, but universally legislating does not mean asserting one’s will over others. Nor does it mean that the ethical content of a moral law or duty is valid eternally and every- where. Rather, it refers to the “categorical imperative” an unconditional require- ment for an action to be moral. To qualify as a duty, a rule that commands action must apply to every rational person. Stealing, for example, could never qualify as a duty , because a situation where everyone steals from everyone else would undercut the one-sided advantage of stealing that the thief hopes to exploit. Although self- directed, autonomous action is necessarily other-regarding. Kant maintains that the categorical imperative can be expressed in two other ways equivalent to universality, namely, “respect for humanity” and a “kingdom of ends” (Gregor et al. 2012 ). In each, this other-regarding dimension of autonomy is evident. Respecting humanity means never treating persons as mere means or objects but always treating them as ends, that is, regarding them as fellow autono- mous agents. Autonomously agreeing on actions, interventions, or policies requires that decision makers mutually consider and understand their reasons for action and be willing to abide by the rules derived from these reasons as laws they collectively impose upon themselves (O’Neill 2002 ). The idea of a fellowship of mutual consideration comes out most clearly in Kant’s concept of a kingdom of ends. This concept is really the ideal of a systematic union or commonwealth of autonomous individuals making law s that apply to everyone. This ideal presupposes that ethical deliberation places respect for others as ends, as autonomous agents, above self-interest. The core idea is that we only consider actions that could gain acceptance by a community in which all see them- selves as sovereigns who lay down universal laws binding on themselves and others. L.W. Ortmann et al. 17 The hope is that the body of law governing society progressively embodies this ideal. Such mutual regard in laying down the moral laws that will bind one’s actions differs signifi cantly from insistence on noninterference with individual free choice, let alone with personal preferences. Conversely, the aspiration behind Kant’s view of autonomy harmonizes well with the public health obligation to address collective problems through collective action. For utilitarianism , judging the rightness of an action depends on an estimation of its subsequent practical outcome or result rather than on its conformity to principles of duty . Utilitarianism considers ethically best that course of action that will result in the greatest net benefi ts over harms. A utilitarian approach underlies cost-benefi t analyses that weigh an intervention’s costs ( risks , harms, burdens, or disadvantages) against its benefi ts (advantages, utility, improvements, cost savings). In addition to its focus on consequences, utilitarianism is egalitarian, communitarian, and scien- tifi c in outlook. It is egalitarian in considering everyone’s benefi t and equally weighting each person’s good, as opposed to privileging certain people. It is com- munitarian in attempting to increase benefi ts to society rather than individuals, seeking the “greatest good for the greatest number.” It endeavors to be scientifi c by quantifying harms and benefi ts, accounting for probability, and calculating net ben- efi t. Calculating net benefi ts over harms is less problematic when relevant factors employ a common scale of measurement, for example, weighing the fi nancial costs of treating a disease with the cost savings from preventing that disease. Comparing different outcomes (e.g., fi nancial costs versus quality-adjusted life years ) some- times involves diffi cult judgments about the relative value of each outcome. Because the utilitarian approach seeks to determine and promote the collective good based on aggregate measures, it readily lends itself to justifying public health interventions . 1.3.5 Law Versus Ethics Laws share certain deontological features with ethical principles of action (and with religious commandments). They all defi ne one’s obligations or duties and typically take the form of rules or commands regarding what one should or should not do. They can lay down positive requirements to fulfi ll but more commonly establish parameters that prohibit certain actions or constrain liberty in some way. Laws do not differ from ethical rules primarily based on content, because an ethical rule can become a law without changing the rule’s content. For Kant, at least, the crucial difference between ethics and law concerns one’s reason for obeying; namely, whether one acts purely voluntarily out of a sense of duty or merely in external conformity with duty, either to appear to be moral or out of fear of penalty or pun- ishment. Laws are rules enforced by penalty or punishment, which many people might otherwise break. Society can tolerate the fl outing of some rules, but disobedi- ence of more important rules can disrupt society or create danger. For these reasons, society establishes and enforces laws regarding socially important matters, not 1 Public Health Ethics: Global Cases, Practice, and Context 18 leaving their compliance up to individual prerogative. An ethical rule’s enactment as law, therefore, implies agreement by society or the law’s enactors on the importance of strictly regulating the behavior the law governs. Law can be a blunt instrument that effectively compels compliance, which suffi ces to satisfy the reasons for its enactment, even if it cannot coax voluntary obedience from an inward sense of duty. In theory, deontologically evaluating a past or proposed action is a straightfor- ward binary determination of compliance or noncompliance with a legal or ethical rule. In practice, however, defi ning a rule’s scope or determining exactly which actions fall under it can prove diffi cult. Moreover, when different rules apply, deter- mining which should take precedence often becomes problematic, especially when they confl ict . Lying to protect a relative, for example, can put the duty to speak truthfully into confl ict with familial obligations . Determining which rule takes pre- cedence can involve reasoning clearly from ethical principles , weighing the under- lying values embodied in the law , or considering the practical impact of the intervention in context. Because laws demand compliance , they are more rigid. Additional legal stipulations can prioritize or specify how to apply laws in certain situations, but doing so increases their complexity. Ethical guidelines operate more fl exibly than rigid, compulsory laws and more readily accommodate compromise. With ethical guidelines, decision makers can consider and rank the underlying val- ues the ethical rules serve to promote. Doing so allows for trade-offs between com- peting ethical considerations and for deciding which values it makes sense to prioritize in the given context. Conversely, law’s comparative rigidity can be a virtue where only stricter oversight and enforcement will ensure compliance and establish order. Across cultures, legal, ethical, and religious rules prohibiting basic offenses such as lying, theft and murder show considerable overlap. However, cultures vary in exactly which rules are matters of individual choice and which are matters of legal enforcement and punishment. This variability also applies to the status of rules and standards governing research on human subjects. Even within a country, signifi cant variability can prevail in whether human subjects’ research rules and standards are legal regulations or ethical guidelines (U.S. Department of Health and Human Services 2015 ). Some se e the lack of legal regulation as a breach in protections, but others prefer guidelines, arguing that regulations tie reviewer hands, making it more diffi cult to make trade-offs or nuanced judgments based on moral discernment of the particulars of each case (Verweij and Dawson 2009 ). Because each approach offers advantages and disadvantages, political culture and local context must ulti- mately decide whether human subjects’ research rules exist as enforceable regula- tions or ethical guidelines . Regardless of whether it takes the form of guidelines or law , research ethics will govern only a fraction of the ethical issues that the fi eld of public health must address. In many areas of public health practice, there are no specifi c ethical guide- lines or regulations . To address ethical challenges in these areas or to address emer- gent challenges, the ethical practice of public health therefore requires the ability to use general ethical frameworks. Such frameworks can employ checklists of ques- tions and stepwise procedures. However, because novel challenges continually L.W. Ortmann et al. 19 emerge and changing contexts introduce nuances no set of rules can anticipate, pub- lic health professionals ultimately need to practice ethical decision making over time in order to cultivate moral judgment and discernment. By laying down and enforcing what may, must, or cannot be done, legal rules function as boundaries of acceptable behavior. Ethics, science, budgets or politics, each in its own way, also can restrict the scope of action. Public health practitioners and offi cials therefore fi rst need to conduct a feasibility analysis to determine the relevant limits on possible interventions or policies. Determining these limits sel- dom will restrict the scope of action to a single possible course. Given multiple possibilities, most people will aspire to the best course of action beyond the legal fl oor of minimally acceptable behavior yet within the other relevant limits. As a result, the ethical challenges public health practitioners face seldom involve stark choices between right or wrong, good or evil. A good feasibility analysis will have ruled out any unethical or illegal options or alternative courses of action in advance. Rather, the tough choices more frequently involve selecting the best alternative from among competing goods, each of which to a greater or lesser degree realizes the public health goal and embodies relevant stakeholder values. Whereas determining and complying with the various limits on action is largely an analytic process, designing alternatives is a synthetic, creative process. Alternatives should all realize the public health goal and incorporate the perspectives and values of subject matter experts and relevant stakeholders. Deciding upon the best alterna- tive must take into account how it will realize the public health goal in a particular context and with respect to the stakeholders. For example, advocating contraceptives to reduce unwanted teen pregnancy might seem to promise success based on effi - cacy studies, but ethical controversy could render such a program less than optimal in some contexts. Political culture or social norms can confer partisan advantage or disadvantage to some alternatives, while other alternatives may enjoy an advantage because of the experience and expertise of a health department. Whatever alterna- tive practitioners fi nally choose, their choice will presuppose a prioritizing of val- ues. The foregoing account highlights why public health practitioners need to see ethics as something more than a compliance matter. It transcends compliance because public health ethics also involves practical decision making, which should include stakeholder analysis, the incorporation of stakeholder values in the design of alternatives, and a fair, transparent deliberative process to evaluate alternatives. 1.4 Public Health Ethics Compared with more established fi elds of practical ethics such as clinical ethics , research ethics , and bioethics , the fi eld of public health ethics is relatively new. Consequently, many public health practitioners may be better acquainted with these more established fi elds than with public health ethics. In particular, practitioners may already be acquainted with the four principles these fi elds rely on for ethical evaluation: benefi cence , nonmalefi cence , respect for persons ( autonomy ), and 1 Public Health Ethics: Global Cases, Practice, and Context 20 justice (U.S. Department of Health, Education, and Welfare 1979 ; Beauchamp and Childress 2012 ). Being applicable to health and research , these four principles also are relevant to public health, but having arisen to address issues in other fi elds, they need to be adapted to a public health context. Even then, they still fall short in addressing the ethical challenges that arise in public health. Examining these related ethics fi elds and showing how the four principles fi t into a public health context can serve by way of contrast to indicate what is distinctive about public health ethics. 1.4.1 Research Ethics , Clinical Ethics, and Bioethics : Principlism and the Four Principles Research ethics entails the wider notion of scientifi c integrity but is best known and most developed in relation to medical research involving human subjects. The development of human subjects’ research ethics guidelines can neither be divorced from breaches of ethical conduct in human subjects’ research nor wholly reduced to a reaction to these events. But beginning with the Nuremberg Code ( 1947 ), balanc- ing risks and benefi ts to research subjects and getting their informed consent have been cornerstones of international research ethics guidelines. Far more infl uential than the Nuremberg Code , the Declaration of Helsinki from the World Medical Association (WMA) is a fundamental document in international human subjects’ research ethics guidelines . Its initial 1964 version included provisions for proxy consent for those with diminished autonomy . Its 1975 revision called for review of research by an independent committee, now known as an ethics review committee (WMA 1964 , 1975, 2013). The use of such committees began spreading under the aegis of WHO and then in response to the HIV/AIDS pandemic, as the number of large-scale vaccine and drug trials grew in developing countries. In the United States , research regulations set forth in the Common Rule govern ethics review committees as well as all human subjects’ research that receives U.S. government funding (U.S. Department of Health and Human Services 2009 ). In the United States, a standing ethics review committee generally functions within a specifi c governmental or university institution and therefore is referred to as an institutional review board (IRB). Beginning in 1982, the Council for International Organizations of Medical Sciences (CIOMS) , in collaboration with WHO, proposed i nternational ethical guidelines for biomedical research involving human subjects (CIOMS 2002 ). Our discussion of these documents has only highlighted key provisions of what is required to ensure the safety of human subjects. CIOMS’s most recent research guidelines ( 2002 ), for example, contain more than 60 pages of text, explanation, and commentary. But ensuring ethical conduct and scientifi c integrity in research requires more than the oversight function of ethical review committees. It also requires extensive training not only in research ethics but also in a number of related L.W. Ortmann et al. 21 areas. Training and guidelines should cover, among other things, mentoring of junior researchers, authorship and publications policy , confl icts of interest that arise in partnerships and collaborative science, and data acquisition, management, shar- ing and ownership. Ethics training can help develop moral judgment. The hope is that training and application will enable practitioners to reason about new, diffi cult, or ambiguous cases in morally discerning ways. Clinical ethics address the ethical issues that arise in clinical practice. Until the advent of bioethics , medical professionalism emphasized the health care provider’s obligation to prioritize the patient’s welfare, the health care provider’s professional judgment about what would most benefi t the patient, and the importance of estab- lishing patient trust . The traditional model of clinical ethics was frankly paternalis- tic . Under the infl uence of bioethics, many health care providers began embracing a more patient-centered model of care that emphasized patient autonomy and informed consent . This patient-centered model conceives care as a contract between patient and provider. The emphasis on contracts strikes some as an inappropriate consumerist model that undervalues professional judgment and undermines patient trust in the medical profession. Tensions between these two models have led to a compromise that reasserts the importance of medical professionalism and clinical judgment, while acknowledging the importance of respecting patient autonomy (ABIM Foundation et al. 2002 ). Bioethics has a range of meanings, the fi rst of which applies to ethical issues brought about by advances in biomedicine and biotechnology . Ethical issues that arise from using life-sustaining technologies in end-of-life and beginning-of-life care epitomize this sense of bioethics. But bioethics also arose in response to medi- cal paternalism and to the abuse of human subjects in medical research . Bioethics has championed informed consent , patient autonomy in doctor-patient relationships and the safety of human subjects in research. However, many bioethicists think the focus on clinical ethics and on personal autonomy unduly restricts bioethics’ pur- view. They advocate a more holistic, social justice approach in bioethics, which has been referred to as “population-based bioethics” or “integrative bioethics” (Sodeke 2012 ). It can be argued that this expansion of bioethics beyond clinical ethics into population issues moves bioethics into the arena of public health ethics (Callahan and Jennings 2002 ). Principlism came into being in a 1979 document called the Belmont Report (U.S. Department of Health, Education, and Welfare 1979 ). The report was the work of the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research , which convened in 1974 partly in response to the exposé of the U.S. Public Health Service Tuskegee Syphilis Study. The Belmont Report became the basis for revising 45 CFR 46, the so-called Common Rule , part of the legally binding U.S. Code of Federal Regulations, governing the protection of human subjects (U.S. Department of Health and Human Services 2009 ). The Belmont Report clearly explained the underlying ethical principles that informed existing regulations and provided an ethical framework for thinking about subse- quent regulations. Principlism has remained the predominant ethical framework in biomedical ethics (Beauchamp and Childress 2012 ). Its explanatory groundwork 1 Public Health Ethics: Global Cases, Practice, and Context 22 accounts for much of its success, but its relevance to medicine and research , the prestige that attaches to these fi elds, and its compatibility with liberal individualism also have played a role. Benefi cence (doing good) and nonmalefi cence (doing no harm) date back to the Hippocratic Oath as medical principles. Collapsing them both into benefi cence, as the Belmont Report does, underscores the practical consideration that biomedical decisions generally aim to optimize net benefi t over harm, rather than to maximize only benefi ts or minimize only harms or risks . However, these principles are dis- tinct, not mere opposites. Not doing harm has a certain priority (fi rst, do no harm), because not benefi tting someone seems a less serious offense than doing that person harm. That priority partly refl ects the human tendency more readily to forgive over- looked benefi ts (errors of omission) than deliberate actions resulting in harm (errors of commission). Justice has several meanings that include due process and fair deliberative proce- dure, properly assessing what people are owed or due, and equitable distribution of burdens and benefi ts. According to philosophic tradition, justice has always func- tioned dually, applying to individuals but more importantly serving as an overarch- ing principle for adjudicating competing claims in relation to the group or to other members of society. The phrase, “ social justice ,” then, is redundant but in political contexts marked by individualism serves as a reminder of justice’s social dimen- sion. In fact, this phrase came into vogue in public health circles to counter the ideology of “market justice,” which views the equal access of individuals to the free market as a valid, reliable, and preferred means for sorting out issues of economic and social justice (Beauchamp 1976 ). The notion of health equity , which compares different groups, primarily refers to this social dimension of justice , although denial of access to health care, a contributing factor to health inequity , violates what the individual is owed. Respect for persons emphasizes that individuals, as agents in charge of their own lives and bodies, have the right to make decisions and choices free from undue interference. Respect for persons forms the basis of informed consent , namely, the right of patients and human research subjects to be informed of, and to assent to, medical or research procedures they might undergo, especially procedures that pose potential harm or risk . Conducting research on human subjects or performing medi- cal procedures on patients without their prior knowledge or consent in most cases violates their personal autonomy . However, health professionals have a special (i.e., paternal) obligation to look out for the welfare of people with diminished decisional capacity—such as those in a coma or the very young—and to protect them from harm. These four principles were originally conceived as prima facie principles, that is, each expressed a self-evident though not absolutely binding obligation and none had an inherent priority over another. However, in many Western countries and in the United States in particular, respect for persons has dominated discussion in bio- ethics , clinical ethics, and research ethics where it often takes precedence as a moral consideration over the other principles. This ascendancy most likely refl ects the high value that these countries place on liberty and freedom . At any rate, in public L.W. Ortmann et al. 23 discourse generally and in public debate about public health interventions , respect for persons often amounts to an insistence on noninterference with individual free choice or with personal preferences. Although Kant’s other-regarding idea of moral autonomy , harmonizes well with collective decision making, the insistence on non- interference with personal choice often creates impediments to the implementation of public health interventions . In part for this reason, the social justice movement has had to challenge the emphasis on respect for persons in order to promote the public good and health equity . 1.4.2 Contrast between Clinical Ethics and Public Health Ethics Table 1.2 contrasts the individual focus of clinical ethics with the community/ population focus of public health ethics. Because public health and clinical practice can overlap, the items in the respective columns represent tendencies along a con- tinuum rather than stark opposites. Where separate agencies carry out public health services and medical care, these contrasts may be more pronounced. The overlap between public health and clinical practice makes it even more important to high- light their differences to bring out distinctive features of public health ethics. The table makes clear that the Belmont principles of benefi cence (seeking ben- efi ts), nonmalefi cence (avoiding harm), respect for persons , and justice remain important in public health, but must be extended to accommodate the broader scope Table 1.2 Comparison of areas of focus/tendency in clinical ethics and public health ethics Clinical ethics focus/tendency Public health ethics focus/tendency Treatment of disease and injury Prevention of disease and injury Medical interventions by clinical professionals Range of interventions by various professionals Individual benefi t seeking and harm avoidance based on health care provider’s fi duciary relation to a patient Social, community, or population benefi t seeking and harm avoidance based on collective action Respect for individual patients Relational autonomy of interdependent citizens Professional duty to place the interests of the patient over that of provider Duty to the community to address health concerns that individuals cannot solve and that require collective action Authority based on the prestige and trustworthiness of the physician and the medical profession as a whole Authority based on law , which is a principal tool of public health policy for creating health regulations Informed consent sought from an individual patient for specifi c medical interventions Community consent and building a social consensus through ongoing dialogue and collaboration with the public Justice concerns largely limited to treating patients equally and ensuring universal access to health care Central concern with social justice regarding health and achieving health equity 1 Public Health Ethics: Global Cases, Practice, and Context 24 of public health interventions . This broader scope entails many types of profession- als , interventions and policies that display a political and social dimension, and a wider range of activities such as community engagement, intersectoral collabora- tion , collective decision making, and governmental administration. As a result, pre- vailing political philosophies and culture will necessarily shape the way public health functions. The crucial point is that differences of scale that produce a higher order of complexity also produce qualitative differences that introduce different pat- terns of causation. Among other things, this means that social factors do not merely represent aggregated individual factors and so cannot always be addressed in the same way as individual factors. 1.4.3 Individual Versus Relational Autonomy For understanding what is qualitatively distinct about public health, the contrast between respect for individual persons and the relational autonomy of community members is key. Respect for persons upholds an individual’s right to make indepen- dent decisions free from undue pressure, but relational autonomy emphasizes that individual actions occur in the context of other people whom these actions will affect. The potential harmful impact of individual action on the welfare of others sets a limit to individual action. Relational autonomy draws attention, then, to the interdependence of people living in communities and to the solidarity that arises from the emotional bonds that shared lives create. Anthropology teaches that people always fi nd themselves in a network of social relations, while evolutionary biology has shown how profoundly people are built from the physiological ground up as sociopolitical beings. Because it presupposes the social context of language and reasoning ability, individual autonomy also depends developmentally on relational autonomy. That is, people only become autonomous through relations and interac- tions with others. As African humanism (ubuntu philosophy) epitomizes it, umuntu ngumuntu ngabantu , “a person is a person through other persons” (Louw 2008 ). Familial and communal deliberate processes are foundational for the development of individual autonomy and provide an even deeper basis for collective decisions than the type of solidarity that comes to the fore in crises or in the face of common predicaments. Kant would reject any suggestion that developmental context, emo- tional bonds or feelings of solidarity underpin moral autonomy. Nevertheless, moral autonomy and relational autonomy both display an inner-directed, but other- oriented feature that readily aligns with collective decision making. These points about the foundational character of social relatedness, solidarity , interdependence , and communal decision making do not readily align with certain features of social contract theory , on whose principles liberal democracy is based. Whereas virtually every other political tradition conceives the sociopolitical realm as a natural feature of human life, social contract theory posits humankind’s original state, the state of nature, as one of solitary individualism . In this view, society or at L.W. Ortmann et al. 25 least civil society come into existence voluntarily through a contract that creates government through the consent of the governed (Riley 1982 ). Although never seri- ously advanced as a scientifi c account of society’s origins, social contract theory nevertheless has exerted a powerful infl uence as a political founding myth. As such, it has made personal liberty , free choice, and consent of the governed presumptive values of societies whose governing political philosophy rests on social contract theory. By “presumptive,” we mean that the value, norm , or claim is assumed to be valid or have priority, so that the onus is on the person who objects to the presump- tion to justify a different value, norm, or claim. 1.4.4 Personal Autonomy as a Presumptive Value of Liberal Democracy Personal autonomy in a clinical and research context generally means respect for the patient’s right to receive an explanation of a medical procedure or research inter- vention, to be informed of any potential benefi ts or harms, and to freely choose whether to accept the procedure or participate in the research. More generally and in other contexts, personal autonomy has come to mean an insistence on liberty , free choice, and noninterference with personal preferences. Personal autonomy in this more general sense owes more to John Stuart Mill’s nineteenth-century views on liberty than to Kant’s eighteenth-century idea of autonomy (O’Neil 2002 ; Dawson 2011 ). An important aspect of Mill’s view of liberty is the “ harm principle ,” which holds that “the only purpose for which power can be rightfully exercised over any member of a civilized community, against his will, is to prevent harm to others” (Mill 1989 ) . What people choose to do regarding themselves is no business of gov- ernment . Interfering with this private sphere of self-determination constitutes gov- ernmental paternalism . This interference diminishes the sphere of liberty that affords individuals the chance to direct their own lives and develop their talents and character to the highest degree. A chief advantage of democratic society, one that benefi ts the entire society, is the creative social dynamism that emerges from the synergism between individuals who are developing their talents and abilities. Arguably, the primary aim of the harm principle is to promote the kind of indi- vidual self-development that benefi ts society rather than to champion every exercise of free choice. At any rate, some have sought to distinguish this edifying version of personal autonomy from an all-encompassing version that demands undue defer- ence to any and all personal choices and preferences merely because they are per- sonal (O’Neill 2002 ; Dawson 2011 ; Powers et al. 2012 ). Presuming, or insisting on, the validity of personal autonomy makes more sense in the delimited context of medicine and biomedical research on human subjects where an individual’s body is the focus of activity. It makes less sense in the far wider sphere of public health activity where social interactions and the interdependence of people come into play. Absolutizing personal autonomy in the sphere of public health would give effective 1 Public Health Ethics: Global Cases, Practice, and Context 26 veto power over every collective decision aimed at the public good to any individual who felt constrained by that decision. A more moderate version might distinguish levels of importance of personal choices and exercises of liberty . A collective deci- sion concerning the public good could override some personal choices and limit liberty, even when they did not involve direct harm to others. Such decisions, when made in the context of a fair, transparent process of ethical deliberation involving stakeholders , are more likely to get buy-in from a community and less likely to be labeled paternalistic . Because public health considers the relation between individuals and the collec- tive good, it necessarily has a political dimension. How a country’s political culture balances this relation will drive and constrain public health practice and so shape the nature of the ethical frameworks that are appropriate to a country’s politics (Hyder et al. 2008 ). In the brief history of public health ethics, the most important ethics frameworks have emerged in the political context of liberal democracy. Many of these frameworks refl ect the tensions between public health’s obligation to act col- lectively for the common good and the presumptive value of personal autonomy . The principle of least infringement and Kass’s code of restraint illustrate the effort to mediate such tensions (Kass 2001 ). The code of restraint strives to balance auton- omy claims against the obligation to safeguard community health by determining what intervention most effectively protects health while minimally infringing on liberty . In a liberal political context that recognizes Mill’s harm principle , this strat- egy justifi es the trumping of personal autonomy as long as imminent harm threatens the populace, for example, in a deadly outbreak of contagious disease. But where the threat of harm to others is indirect or not immediate, as with the obesity epi- demic, the harm principle less readily justifi es a liberty-limiting intervention such as banning or taxing certain foods. Utilitarian approaches that weigh the health advan- tages of intervention and the disadvantages of obesity clearly support obesity inter- vention, but limiting interventions to those that do not restrict personal choices also have limited effectiveness . In Chap. 6 , Jennings considers the relative merits of these approaches in his overview of the ethical issues in environmental and occupa- tional public health. His discussion raises the question of the extent to which an ethical framework should adapt itself to the presumptive values of the political con- text or should refl ect the nature of the practical fi eld under investigation. To some extent, it must do both. The three-step framework offered in the next section is designed to guide deci- sion makers, through questions, to assess the ethical dimensions of a case, including which moral considerations (e.g., population utility or liberty ) may have more weight than others, given the issue or context. This contextual approach provides the fl exibility and starting point for deliberation to accommodate the issues globally and to uncover the varying perspectives of stakeholders with potentially different presumptive moral norms (e.g., solidarity versus individual rights ). L.W. Ortmann et al. http://dx.doi.org/10.1007/978-981-287-561-7_6 27 1.5 Ethical Frameworks What at fi rst glance demarcates public health ethics from related fi elds of health ethics are the ethical problems that public health professionals typically encounter in their practice and the ethical frameworks used in practice to address these prob- lems. Regarding these ethical problems, this casebook offers a representative, but not exhaustive, sample. Regarding ethical frameworks, this chapter has suggested two competing criteria for choosing. On the one hand, ethical frameworks should be grounded in their topics. Dawson ( 2011 ) expresses the point succinctly by arguing that public health should be the foundation of public health ethics. Accordingly, we have presented a view of public health ethics that builds on the defi nitions of public, health, and public health, and on the goals of public health practice. But we have also defi ned ethics and indicated how public health ethics draws on numerous ethical theories and can provide a moral guide grounded in the norms of benefi ting others, preventing harms, and providing utility. We have pointed out its distinguishing principles based on the facts of community and interdependence . Lastly, we have situated public health ethics within the process of ethical decision making about which options are the most justifi able means to achieve public health goals in a particular context. In the end, grounding public health ethics in public health may require public health leaders to have the courage to advocate public health values and goals, even when that position is unpopular. Such a stance may be justifi ed, for example, where the feasibility of a much-needed public health intervention requires a long- range strategy to change social norms or build social consensus . On the other hand, precisely because public health itself is practical, pragmatic, and community oriented, an ethical framework designed for it must accommodate itself to a country’s presumptive values and political culture. This consideration illustrates that the feasibility of public health interventions usually depends on their alignment with the political culture, while their success usually implies public acceptance. Many established frameworks, like that of Kass, seem designed with a liberal political context in mind that gives presumptive weight to individual liberty , which may limit the range of interventions that can be justifi ed. Newer approaches to ethical analysis in public health place more emphasis on social values like equity and solidarity , although these newer approaches often are diffi cult to put into practice (Lee 2012 ). In addition, while newer approaches may offer clear reasons to justify a broader range of interventions, the reasons may be less persuasive if they do not consider the presumptive values in context. For example, in Chap. 3 , Daniels dis- cusses the ethical confl icts that arise during pandemics between the standard goal of improving population health and emergency contexts that demand allocating scarce resources in a way that treats people fairly. He asks, if in the pandemic context we believe that saving the most lives trumps giving priority to those who are sickest, can we justify revising the usual priority given to the sickest in health care? Arguably, what would be most useful is not a set of frameworks designed for specifi c presumptive values , but, rather, a framework that can accommodate any presumptive values and consider them in relation to values rooted in public health 1 Public Health Ethics: Global Cases, Practice, and Context http://dx.doi.org/10.1007/978-981-287-561-7_3 28 or in context. The three-step framework that follows is a straightforward tool to help practitioners analyze the ethical tensions in a particular context. It addresses Daniels’ tough question directly by considering health care’s presumptive prioriti- zation of the sickest in relation to the public health value of saving the most lives in a pandemic . 1.6 A Three-Step Approach to Public Health Decision Making We offer the following framework, drawn from public health practice and described by Bernheim et al. ( 2007 ), as an example of an analytic tool that can guide decision makers through reasoning and deliberation. It is not meant to introduce a rigid application of ethical principles, nor does it presume that any one moral norm has greater weight that trumps other norms. Instead, the questions are designed to help decision makers clarify whether a particular moral norm (e.g., solidarity or liberty or equity ) is weightier than others in context, and if so, then strong reasons must be offered to override the presumptive moral norm . For example, during an epidemic, equity may carry presumptive weight and trump other moral norms in some con- texts. Ethicists at the Joint Centre for Bioethics offered the following insight from the SARS experience: In the case of an epidemic, it is important to control the spread of the disease, but as much attention should be paid to the rights of the noninfected patients who need urgent medical care. There may be as many people who died from other illnesses and could not get into hospital as there were who died from SARS. Equity is required in the amount of attention given to a wide array of people, including patients with and without SARS. Accountability for making reasonable decisions, transparency and fairness are expected …. (Singer et al. 2003 ) The questions clarify the relevant factors, such as stakeholder claims, alternative actions, and possible justifi cations for deciding on one course of action. 1.6.1 An Approach to Ethical Analysis and Justifi cation in Context Step I: Analyze the Ethical Dimensions of the Public Health Issue and Context • What are the risks , harms, or concerns? • What are the appropriate public health goals in this context? • What is the scope and legitimacy of legal authority, and which laws and regu- lations apply? • What are the moral norms and claims of stakeholders , and how strong are they? L.W. Ortmann et al. 29 • Are precedent legal or ethical cases relevant for identifying the presumptive moral norms ? • Which features of the social-cultural-historical context apply? • Do professional codes of ethics provide guidance? Step II: Formulate Alternative Courses of Action and Evaluate their Ethical Dimensions • What are the short- and long-term options, given the assessment of the public health issue and context in Step I? • What are the ethical dimensions and tensions of each option? – Utility: Does the public health action produce the best balance of benefi ts over harms and other costs ? – Equity and Justice : Is health equity advanced? Are the benefi ts and bur- dens distributed fairly ( distributive justice )? Is there appropriate public participation , including the participation of affected parties ( procedural justice )? – Respect for Individual and Community Interests: Does the public health action respect self-determination and human rights , as well as civic roles and community values (e.g., trustworthiness, solidarity ) (Dawson and Jennings 2012 )? • Other Moral Considerations in Public Health: Are there other moral consider- ations in public health that are important to consider? (For example, reciproc- ity, solidarity, protecting privacy and confi dentiality; keeping promises and commitments; or disclosing information and speaking honestly, sometimes grouped as transparency.) Step III: Provide Justifi cation for a Particular Public Health Decision • Effectiveness : Is the public health action likely to be effective? • Proportionality : Will the probable benefi ts of the action outweigh the infringed moral considerations? • Necessity: Is the action necessary (i.e., will overriding a confl icting ethical norm achieve an important public health goal)? • Least Infringement : Is the public health action the least restrictive means available? • Public Justifi cation: Can decision makers offer public justifi cation in the political and cultural context that stakeholders , the public, and those most affected fi nd acceptable? Consider the following scenario described by Melnick ( 2015a ). A family adopted several children from a developing country with a high tuberculosis (TB) preva- lence, including multidrug-resistant TB (MDR-TB) . Screening on arrival revealed that the children were infected with TB but did not have active disease and were not contagious. The family has strong religious beliefs about medical care and refused treatment , immunizations, and other preventive care. The children were home- 1 Public Health Ethics: Global Cases, Practice, and Context 30 schooled, but they did attend community activities. Soon after arrival one of the teenage children developed TB symptoms, and after several months the family con- sulted a pediatrician who diagnosed active pulmonary TB. Cultures revealed that the child had MDR-TB. Directly observed treatment (DOT) is part of the standard of care for active TB in the United States , and the local health department nurse visited the family to provide DOT. The parents objected to the home visit, stating that DOT was an invasion of their privacy and parental rights. The health depart- ment has the statutory authority to require in-person DOT and even impose isolation of the case and removal from the family to protect the public’s health. What should health offi cials do? Drawing on questions in Step I, health offi cials might fi rst clar- ify the harms and risks and the goals of public health action. The public health goals are to prevent TB transmission and ensure the child receives appropriate care. Requiring DOT creates risks for the child such as side effects from treatment and social and behavioral harms associated with isolation and loss of privacy during visits, and potential community harm, by driving cases underground. Who are the stakeholders , and what are their moral claims? There are several stakeholders: the child, the child’s family (including parents but also sev- eral siblings), and the public, which expects the health department to protect the community from TB. Regarding moral claims, the child has some expectations of freedom of move- ment, and privacy ; the family has similar expectations regarding privacy, respect for paren- tal rights, and the freedom to administer medications to their child at a convenient time and place. However, these claims are not absolute, and competing moral claims can outweigh them. The child has a moral claim that could compete with her parent’s claim, specifi cally, that receiving DOT will reduce the risk of inappropriate treatment and relapse compared to having her parents administer the medications. In addition, the public has a moral claim based on two expectations: ( 1 ) that the health department will protect the community from TB, and ( 2 ) that people contagious for TB and other infectious diseases will protect others by behaving in an appropriate manner, including staying home when contagious and coop- erating with treatment recommendations. This is especially concerning in this case because the immigration health offi cials had discussed the risks with the parents, warning them to seek treatment as soon as the child developed symptoms, yet the parents waited several months before taking the child to a pediatrician (Melnick 2015a , 175). Consider another short scenario that illustrates the value of exploring options under Step II. A new policy is being considered that would require parental consent for newborn screening . Parental consent currently is not required, although newborn testing is not conducted if there are parental objections. The health department has been asked to take a position on the pending policy. What position should the health department take? What are the options? Options include mandatory screening without consent , routine screening with advance notifi cation (Opt In), routine screening without advance notifi cation (Opt Out) (i.e., screening and testing done unless the parents object), voluntary screening (i.e., screening requires full consent and might also include a pre- and post- counseling session with each new mother). Some arguments that might be offered against requiring parental consent focus on the fact that (1) the benefi ts of screening are obvious and substantial, relative to potential harms; (2) parents have few good rea- sons to justify parental refusal and place their child at risk for harm; (3) obtaining L.W. Ortmann et al. 31 consent from each parent is diffi cult, costly, and an unwarranted expenditure of time and money; and (4) the history of newborn screening has become acceptable and routine. Some arguments that may be raised for requiring parental consent include (1) parental consent is necessary because refusal of newborn screening is reasonable given the increasing list of diseases included in the battery of newborn tests and the low probability of many of these diseases; (2) newborn screening can have adverse consequences such as psychological harms associated with false positive tests; (3) long-term parental caretaking is enhanced when parents are included in all clinical decisions about their children ; and (4) the process of obtaining consent need not be time-consuming or burdensome but rather can help enhance the health professional- patient relationship (CDC 2012 ) . Which arguments are stronger, and which of the options are the most ethically justifi able? The answer may depend on the social and political context in which the issue is considered, and which ethical values carry weight in that context. Whether there were presumptive values in place would be explored through the questions in Step I, which examines previous cases, the appli- cable laws and policies, and stakeholder claims in context. So, for example, in a society that has a strong moral norm or presumption for solidarity , there could be a presumption for continuing population newborn screening without parental con- sent . On the other hand, for a society that has a liberal political context that has a presumption for individual liberty , there may be a presumption for an option that seeks more explicit consent from parents . In either context, the presumptive moral norms are not determinative but are rebuttable, so the arguments or reasons to over- ride those norms must be stronger. Consider a third case from public health practice in which a person (the index case) infected with primary syphilis and HIV refuses to provide contact information for his wife, insisting that he and his wife had not had sexual relations for several years. Contact tracing and partner notifi cation have been important tools historically for public health offi cials, although these interventions can involve thorny ethical tensions, requiring health offi cials to justify their decisions. In this type of situation, health offi cers will consider several options, starting with those that infringe least on the index case’s choices. For example, they might fi rst provide to the index case additional information and assurance about confi dentiality while allowing him to notify his wife voluntarily, either alone or with the help of public health workers. If this proves unsuccessful, other interventions might be considered, such as incen- tives, the threat of restrictions such as isolation, or attempts to notify the wife with- out his knowledge or consent . Each of these options would be determined in context, using the questions in Step III. Questions considered may include (1) Would the options likely accomplish the goal of warning and testing the wife without risking greater harm or possible adverse outcomes for the wife (e.g., domestic violence, loss of income, or loss of housing)? (2) Is there signifi cant concern about a risk of harm to others, such as family members or children , so that the burdens and benefi ts of the action would not be distributed fairly? (3) Is the action the least restrictive of the important moral claims of the stakeholders ? (4) Is it necessary now to override confl icting claims to achieve the public health goal? Answering the questions in Step III helps decision makers consider whether actions are justifi able. As one 1 Public Health Ethics: Global Cases, Practice, and Context 32 health offi cer explains, “Public health offi cials should justify their decisions with deliberations that build not only community support and trust , but also build support and trust from the individuals and families directly affected” (Melnick 2015b ). As the scenarios illustrate, public health is a social and political undertaking. Thus, making diffi cult choices in public health implicates important social, cultural, and political norms embedded in a particular context and community of stakehold- ers (Childress and Bernheim 2008 ). Regardless of whether decision makers work in a government public health agency, community nonprofi t, nongovernmental organi- zation (NGO) from another country, or a global organization, decision makers must rigorously assess the public health issue in context , to minimally be able to act “in ways that preserve the moral foundations of social collaboration” at the core of col- lective health activity (Calabresi and Bobbitt 1978 ). The context specifi cally includes attention to stakeholders and relationships among public health stakeholders and community members, including the common understanding of their roles, obligations , and collaborations . Especially in global public health , it is important to note that even the decision makers are stakeholders, in some sense, and often, when they are health professionals , they have their own social-cultural norms and their own professional codes that can provide guidance. Appeals to the codes of particular professions, however, do not provide a suffi cient justifi cation for a public health decision, since justifi cations should be grounded in a society’s widely shared ethical values and norms . Engaging stakeholders and addressing claims, especially those of the people most affected by a public health issue, in ethical analysis, is especially important and can sometimes support and strengthen the collaboration and cohesion needed for public acceptance of a decision. The ways to engage and reason with stakehold- ers in an ethical analysis will vary in different settings and communities, depending on community values , cohesion, and expectations, and can range from establishing an ethics board for deliberation, to gathering information from focus groups or social media, to including stakeholder representatives on the decision-making team. Stakeholder norms and claims are a critical feature for an ethical analysis in order to achieve a primary goal in public health—the development and maintenance of relationships of trust , defi ned in a report from IOM as “the belief that those with whom one interacts will take one’s interests into account, even in situations in which one is not in a position to recognize, evaluate, or thwart a potentially negative course of action by those trusted” (IOM 1996 ). Ethical analysis is a dynamic process and, particularly for the practice of public health, is best accomplished through group deliberations that involve understanding others’ perspectives and thinking independently and imaginatively. Public health professionals often have to decide how best to realize numerous important societal norms and values when pursuing public health goals. Ethical tensions do occur in public health and at times require overriding an important principle , value, or moral consideration to undertake a justifi able public health action. However, a structured ethical analysis can often lead to imaginative alternatives that transcend or mini- mize ethical tensions and to decisions that most or many stakeholders fi nd acceptable. L.W. Ortmann et al. 33 References ABIM Foundation, ACP–ASIM Foundation, and European Federation of Internal Medicine. 2002. Medical professionalism in the new millennium: A physician charter. Annals of Internal Medicine 136: 243–246. Bartlett, R., and S. Collins. 2011. Aristotle’s Nicomachean ethics . Chicago/London: University of Chicago Press. Beauchamp, D.E. 1976. Public health as social justice. Inquiry 13(1): 3–14. Beauchamp, T.L., and J.F. Childress. 2012. Principles of biomedical ethics , 7th ed. New York: Oxford University Press. Bernheim, R.G., P. Nieburg, and R.J. Bonnie. 2007. Ethics and the practice of public health. In Law in public health practice , 2nd ed, ed. R.A. Goodman, 110–135. New York: Oxford University Press. Blane, D. 1999. The life course, the social gradient, and health. Social Determinants of Health 2: 54–77. Blas, E., L. Gilson, M.P. Kelly, et al. 2008. Addressing social determinants of health inequities: What can the state and civil society do? Lancet 372(9650): 1684–1689. Braveman, P. 2006. Health disparities and health equity: Concepts and measurement. Annual Review of Public Health 27: 167–194. Brunk, C.E., L. Haworth, and B. Lee. 1991. Value assumption in risk assessment: A case study of the alachlor controversy . Waterloo: Wilfrid Laurier University Press. Calabresi, G., and P. Bobbitt. 1978. Tragic choices . New York: Norton. Callahan, D., and B. Jennings. 2002. Ethics and public health: Forging a strong relationship. American Journal of Public Health 92(2): 169–176. Centers for Disease Control and Prevention (CDC). 2011. Advancing excellence & integrity of CDC science. Public health ethics . http://www.cdc.gov/od/science/integrity/phethics/ . Accessed 14 Feb 2014. Centers for Disease Control and Prevention. 2012. Unit 2: Ethics and the law. In Public Health Law 101: A foundational case for public health practices. Public Health Law Program, Centers for Disease Control and Prevention. http://www.cdc.gov/phlp/publications/phl_101.html . Accessed 24 June 2015. Childress, J.F., and R.G. Bernheim. 2008. Public health ethics: Public justifi cation and public trust. Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz 51(2): 158–163. doi: 10.1007/s00103-008-0444-6 . Childress, J.R., R.R. Faden, R.D. Gaare, et al. 2002. Public health ethics: Mapping the terrain. Journal of Law, Medicine & Ethics 30(2): 170–178. Council for International Organizations of Medical Sciences (CIOMS). 2002. International ethical guidelines for biomedical research involving human subjects . Geneva: Council for International Organizations of Medical Sciences. http://www.cioms.ch/publications/layout_guide2002.pdf . Accessed 14 Feb 2014. Open Access This chapter is distributed under the terms of the Creative Commons Attribution- Noncommercial 2.5 License ( http://creativecommons.org/licenses/by-nc/2.5/ ) which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and source are credited. The images or other third party material in this chapter are included in the work’s Creative Commons license, unless indicated otherwise in the credit line; if such material is not included in the work’s Creative Commons license and the respective action is not permitted by statutory regulation, users will need to obtain permission from the license holder to duplicate, adapt or reproduce the material. 1 Public Health Ethics: Global Cases, Practice, and Context http://www.cdc.gov/od/science/integrity/phethics/ http://www.cdc.gov/phlp/publications/phl_101.html http://dx.doi.org/10.1007/s00103-008-0444-6 http://www.cioms.ch/publications/layout_guide2002.pdf http://creativecommons.org/licenses/by-nc/2.5/ 34 Dawson, A. 2011. Resetting the parameters: Public health as the foundation for public health eth- ics. In Public health ethics: Key concepts and issues in policy and practice , ed. A. Dawson, 1–19. Cambridge: Cambridge University Press. Dawson, A., and B. Jennings. 2012. The place of solidarity in public health ethics. Public Health Reviews 34: 65–79. Dawson, A., and M. Verweij. 2007. The meaning of “public” in public health. In Ethics, preven- tion, and public health , ed. A. Dawson and M. Verweij, 13–29. Oxford: Clarendon Press. Faden, R., and S., Shebaya. 2010. Public health ethics. In Stanford encyclopedia of philosophy , ed. E. N. Zalta. http://plato.stanford.edu/archives/sum2010/entries/publichealth-ethics/ . Accessed 14 Feb 2014. Freiler, A., C. Muntaner, K. Shankardass, et al. 2013. Glossary for the implementation of Health in All Policies (HiAP). Journal of Epidemiology and Community Health 67: 1068–1072. doi: 10.1136/jech-2013-202731 . Gregor, M., J. Timmermann, and C.M. Korsgaard (eds.). 2012. Kant: Groundwork of the meta- physics of morals . New York: Cambridge University Press. Hyder, A., M. Merritt, J. Ali, N. Tran, K. Subramaniam, and T. Akhtar. 2008. Integrating ethics, health policy and health systems in low- and middle-income countries: Case studies from Malaysia and Pakistan. Bulletin of the World Health Organization 86(8): 606–610. Institute of Medicine (IOM). 1988. The future of public health . Washington, DC: National Academy Press. Institute of Medicine. 1996. Healthy communities: New partnerships for the future of public health . Washington, DC: National Academy Press. Jennings, B. 2007. Public health and civic republicanism. In Ethics, prevention, and public health , ed. A. Dawson and M. Verweij, 30–58. Oxford: Oxford University Press. Kass, N. 2001. An ethics framework for public health. American Journal of Public Health 91(11): 1776–1782. Kickbusch, I. 2003. The contribution of the World Health Organization to a new public health and health promotion. American Journal of Public Health 93(3): 383–388. Krimsky, S., and A. Plough. 1988. Environmental hazards: Communicating risks as a social pro- cess . Dover: Auburn House. Lee, L.M. 2012. Public health ethics theory: Review and path to convergence. Journal of Law Medicine & Ethics 40(1): 85–98. Louw, D.J. 2008. The African concept of ubuntu and restorative justice. In Handbook of restor- ative justice: A global perspective , ed. D. Sullivan and L. Tifft, 161–171. New York: Routledge. Marks, L., D.J. Hunter, and R. Alderslade. 2011. Strengthening public health capacity and services in Europe: A concept paper . Geneva: World Health Organization. http://www.euro.who.int/__ data/assets/pdf_fi le/0007/152683/e95877.pdf . Accessed 10 Dec 2013. Marmot, M. 2007. Achieving health equity: From root causes to fair outcomes. Lancet 370: 1153–1163. Melnick, A.L. 2015a. Chapter 8, Containing Communicable Diseases: Personal Control Measures. In Essentials of public health ethics, ed. R.G. Bernheim, J.F. Childress, R.J. Bonnie, and A.L. Melnick, Burlington: Jones & Bartlett Learning. Melnick, A.L. 2015b. Chapter 6, Case fi nding: Screening, testing, and contact tracing. In Essentials of public health ethics, ed. R.G. Bernheim, J.F. Childress, R.J. Bonnie, and A.L. Melnick, Burlington: Jones & Bartlett Learning. Michaels, D. 2008. Doubt is their product: How industry’s assault on science threatens your health . New York: Oxford University Press. Mill, J.S. 1989. In On liberty and other writings , ed. S. Collini. Cambridge: Cambridge University Press. Nuremberg Code . 1947. Trials of war criminals before the Nuremberg Military Tribunals under Control Council Law No. 10 , vol. 2, 181–182. Washington, DC: U.S. Government Printing Offi ce, 1949. http://www.hhs.gov/ohrp/archive/nurcode.html . Accessed 3 June 2014. O’Neill, O. 2002. Autonomy and trust in bioethics (Gifford lecture) . Cambridge: Cambridge University Press. L.W. Ortmann et al. http://plato.stanford.edu/archives/sum2010/entries/publichealth-ethics/ http://dx.doi.org/10.1136/jech-2013-202731 http://www.euro.who.int/__data/assets/pdf_file/0007/152683/e95877.pdf http://www.euro.who.int/__data/assets/pdf_file/0007/152683/e95877.pdf http://www.hhs.gov/ohrp/archive/nurcode.html 35 Ortmann, L., and J. Iskander. 2013. The role of public health ethics in vaccine decision making: Insights from the Centers for Disease Control and Prevention. In Vaccinophobia and vaccine controversies of the 21st century , ed. A. Chatterjee, 291–305. New York: Springer. Powers, M., and R. Faden. 2006. Social justice: The moral foundations of public health and health policy . New York: Oxford University Press. Powers, M., R. Faden, and Y. Saghai. 2012. Liberty, mill and the framework of public health ethics. Public Health Ethics 5(1): 6–15. Public Health Functions Steering Committee. 1994. Essential public health services . http://www. health.gov/phfunctions/public.htm . Accessed 2 Jan 2014. Public Health Leadership Society. 2002. Principles of the ethical practice of public health . http:// phls.org/CMSuploads/Principles-of-the-Ethical-Practice-of-PH-Version-2.2-68496.pdf . Accessed 1 Feb 2013. Riley, P. 1982. Will and political legitimacy: A critical exposition of social contract theory in Hobbes, Lock, Rousseau, Kant, and Hegel . Cambridge, MA: Harvard University Press. Ruger, J. 2010. Health and social justice . New York: Oxford University Press. Sen, A. 2009. The idea of justice . London: Allen Lane. Singer, P.A., S.R. Benatar, M. Bernstein, et al. 2003. Ethics and SARS: Lessons from Toronto. British Medical Journal 327(7427): 1342–1344. Sodeke, S. 2012. Tuskegee University experience challenges conventional wisdom: Is integrative bioethics practice the new ethics for the public’s health? Journal of Health Care for the Poor and Underserved 23(4): 15–33. doi: 10.1353/hpu.2012.0169 . U.S. Department of Health and Human Services. 2009. Code of Federal Regulations, Title 45, Part 46, Protection of Human Subjects. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46. html . Accessed 3 June 2014. U.S. Department of Health and Human Services. 2015. International Compilation of Human Research Standards. Offi ce for Human Research Protections. http://www.hhs.gov/ohrp/inter- national/intlcompilation/2015internationalcompilation.doc.doc . Accessed 23 June 2015. U.S. Department of Health, Education, and Welfare. 1979. The Belmont report: Ethical principles and guidelines for the protection of human subjects of research , Publication No. (OS) 78-0012. Washington, DC: U.S. Government Printing Offi ce. Verweij, M., and A. Dawson. 2009. Public health ethics: A research agenda. Public Health Ethics 2(1): 1–6. Whitehead, M. 1992. The concepts and principles of equity and health. International Journal of Health Services 22(3): 429–445. Winslow, C.-E.A. 1920. The untilled fi elds of public health. Science 51(1306): 23–33. World Health Organization (WHO). 2006. Constitution of the World Health Organization–Basic documents , 45th ed., suppl. www.who.int/governance/eb/who_constitution_en.pdf . Accessed 29 Apr 2014. World Health Organization (WHO). 2007. A conceptual framework for action on the social deter- minants of health (Discussion paper draft) . Geneva: Commission on Social Determinants of Health, World Health Organization. http://www.who.int/social_determinants/resources/csdh_ framework_action_05_07.pdf . Accessed 4 Mar 2014. World Health Organization (WHO). 2008. Closing the gap in a generation: Health equity through action on the social determinants of health , Final Report of the Commission on Social Determinants of Health. Geneva: Commission on Social Determinants of Health, World Health Organization. http://whqlibdoc.who.int/publications/2008/9789241563703_eng.pdf . Accessed 4 Mar 2014. World Medical Association (WMA). 1964, 1975, 2013. WMA Declaration of Helsinki—Ethical principles for medical research involving human subjects . http://www.wma.net/ en/30publications/10policies/b3/ . Accessed 4 Mar 2014. 1 Public Health Ethics: Global Cases, Practice, and Context http://www.health.gov/phfunctions/public.htm http://www.health.gov/phfunctions/public.htm http://phls.org/CMSuploads/Principles-of-the-Ethical-Practice-of-PH-Version-2.2-68496.pdf http://phls.org/CMSuploads/Principles-of-the-Ethical-Practice-of-PH-Version-2.2-68496.pdf http://dx.doi.org/10.1353/hpu.2012.0169 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html http://www.hhs.gov/ohrp/international/intlcompilation/2015internationalcompilation.doc.doc http://www.hhs.gov/ohrp/international/intlcompilation/2015internationalcompilation.doc.doc http://www.who.int/governance/eb/who_constitution_en.pdf http://www.who.int/social_determinants/resources/csdh_framework_action_05_07.pdf http://www.who.int/social_determinants/resources/csdh_framework_action_05_07.pdf http://whqlibdoc.who.int/publications/2008/9789241563703_eng.pdf http://www.wma.net/en/30publications/10policies/b3/ http://www.wma.net/en/30publications/10policies/b3/ 37© The Author(s) 2016 D.H. Barrett et al. (eds.), Public Health Ethics: Cases Spanning the Globe, Public Health Ethics Analysis 3, DOI 10.1007/978-3-319-23847-0_2 Chapter 2 Essential Cases in the Development of Public Health Ethics Lisa M. Lee , Kayte Spector-Bagdady , and Maneesha Sakhuja 2.1 Introduction While “public health” has been defi ned as what society does to “assure the condi- tions for people to be healthy” (Institute of Medicine 2003 , xi), public health ethics is a “systematic process to clarify, prioritize , and justify possible courses of public health action based on ethical principles , values and beliefs of stakeholders , and scientifi c and other information ” ( Schools of Public Health Application Service 2013 ). Despite several important characteristics that distinguish public health from clinical medicine, at its start public health ethics borrowed heavily from clinical ethics and research ethics (see Chap. 1 ). In the 1980s, with the onset of the AIDS epidemic and unprecedented advances in biomedicine, the inability of clinical eth- ics to accommodate the ethical challenges in public health from existing frame- works led pioneering ethicists to reframe and adapt clinical ethics from an individual and autonomy focused approach to one that better refl ected the tension between individual rights and the health of a group or population (Bayer et al. 1986 ; Beauchamp 1988 ; Kass 2001 ; Childress et al. 2002 ; Upshur 2002 ). Others called for public health ethics to emphasize relational ethics and political philosophy (Jennings 2007 ). More recently, some authors have suggested outlining foundational values from which operating principles for public health ethics can be articulated only after careful consideration of the goals and purpose of public health. This approach would require us to establish a clear defi nition of the moral endeavor of public The opinions, fi ndings, and conclusions of the authors do not necessarily refl ect the offi cial posi- tion, views, or policies of the editors, the editors’ host institutions, or the authors’ host institutions. L. M. Lee , PhD, MA, MS (*) • K. Spector-Bagdady , JD, M Bioethics M. Sakhuja , MHS Presidential Commission for the Study of Bioethical Issues , Washington , DC , USA e-mail: lisa.lee@bioethics.gov http://dx.doi.org/10.1007/978-981-287-561-7_1 mailto:lisa.lee@bioethics.gov 38 health as a fi eld (Lee 2012 ) and construct an ethical framework stemming from the nature of it (Dawson 2011 ). A versatile framework for public health ethics must accommodate public health in practice and research . In public health practice, an ethics framework must guide decisions about activities like infectious disease control, primary prevention , and environmental health , as well as newer expectations of public health such as chronic disease control and preparedness. In public health research , biomedical and behav- ioral research ethics provide a great deal of guidance—but research that focuses on population-based outcomes and community concerns reveals additional ethical considerations. A fundamental tension in public health is one between individual- and population- based interests. Various political traditions place different value on each, and these values can fl uctuate within the same political structure over time. When authorities intervene to affect population health , they must fi nd an equilibrium between indi- vidual and population interests in all political contexts, whether authoritarian, socialist, or liberal individualist. To consider individual interests as well as popula- tion interests, regardless of the philosophical tradition within which these interests are valued, is a challenge for a public health ethics framework . The cases we present in this chapter illustrate how this equilibrium between individual and population interests has been established in the context of dynamic political and historical infl uences. One way of approaching public health ethics deliberation is through the method of casuistry , defi ned as “the interpretation of moral issues, using procedures of reasoning based on paradigms and analogies, leading to the formulation of expert opinion about the existence and stringency of particular moral obligations , framed in terms of rules or maxims that are general but not universal or invariable, since they hold good with certainty only in the typical conditions of the agent and the circumstances of action” (Jonsen and Toulmin 1988 , 297). Consideration of case studies and the use of casuistic methods of resolution of morally similar cases through interpretation of ethical principles have played important roles in the devel- opment of public health ethics—particularly before public health ethics was viewed as distinct from clinical ethics . Individual case studies enable discussions about which ethical norms we should adopt for the practice of public health and how pub- lic health professionals should deliberate to resolve ethical problems in practice (Centers for Disease Control and Prevention [CDC] 2012 ) . In this chapter, we review several seminal cases that shaped the ethics of public health research and practice over the past century to provide the foundation of current public health eth- ics and lay the groundwork for a casebook to enable casuist analysis. Our fi rst case example is Jacobson v Massachusetts , set in the beginning of the twentieth century. Jacobson is a foundational U.S. public health legal case that sup- ports states’ rights to create and enforce laws and regulations that limit individual autonomy to protect the public’s health and stop the spread of communicable dis- ease. Our second case study, from the mid-1900s, looks at two ethically troubling U.S. Public Health Service ( PHS ) protocols for studying sexually transmitted dis- eases (STDs) in the U.S. state of Alabama and Guatemala . These experiments, like L.M. Lee et al. 39 most research protocols, were not intended to benefi t the subjects; rather their intent was the broader benefi t of the public’s health. They show however, that researchers, despite the apparent motivation to advance public health, can breach public health research ethics and harm research subjects. The fi nal case, a contemporary example of the New York City A1C Registry to monitor and address the diabetes epidemic in the city, demonstrates how addressing the ethical dimensions of public health inter- ventions can facilitate their implementation. This case moves our focus from public health interventions targeting communicable diseases to those supporting second- ary prevention of noncommunicable diseases . It focuses on the ethical dimensions that can arise when technological advances in communication might affect indi- vidual privacy . Unlike the consistent movement forward with which casuistry has moved clinical ethics , (Jonsen 1991 ), the outcomes in the cases we describe here shaped, and sometimes jolted, the nascent fi eld of public health ethics. These three case studies, occurring within the same political structure over the span of a century, illustrate the tension between individual autonomy and protection of public health in very different ways. The fi rst case depicts a situation where the balance tipped in favor of protection of the public’s health in the context of infec- tious diseases . The second case demonstrates unconscionable exploitation of vul- nerable research subjects for the benefi t of other communities. Finally, the third case presents a situation in which solutions to public health problems based on techno- logical advances and access to data can strike a balance with individual health pri- vacy concerns. Each case illustrates the quest for equilibrium between individual and population interests . 2.2 Case Study: Jacobson v. Massachusetts The earliest activities associated with modern public health are sanitation and infec- tious disease control. From the fi rst public health surveillance system in colonial America that required tavern keepers in Rhode Island to report contagious disease, to John Snow removing the Broad Street pump handle in London to end the 1854 cholera epidemic, control of communicable diseases has been fi rmly in the jurisdic- tion of public health (Thacker 2010 ). Discovery of the physiological mechanisms of vaccines in the eighteenth century gave us new tools to control infectious diseases but also raised critical questions about how to carry out—effectively and ethically— policies and plans that support individual and community health . 2.2.1 Background By the turn of the twentieth century, public health campaigns—including improved hygiene, sanitation, and access to safer food and water—had already extended the average life expectancy in the United States (CDC 1999 ). But infectious diseases 2 Essential Cases in the Development of Public Health Ethics 40 were still the leading cause of mortality, with tuberculosis , pneumonia, and diar- rheal disease accounting for 30 % of U.S. citizen deaths (Cohen 2000 ). Evolving support for the government’s involvement in protecting public health led to the establishment of hygienic laboratories in 1887 (Kass 1986 ). These laboratories con- tinue today to provide essential services such as diagnostics, public health surveil- lance , research , and vaccine development. Edward Jenner , who discovered that a vaccine for smallpox could be created using cowpox lesions, sent his vaccine from England to Benjamin Waterhouse at Harvard University in 1800 (Riedel 2005 ). After successfully vaccinating the mem- bers of his household, Waterhouse began selling the vaccine in Boston, Massachusetts (Kass 1986 ). Not all physicians vaccinated as meticulously as Waterhouse however, and in one unfortunate incident, adulterated smallpox vaccine caused an epidemic in the Boston area (Kass 1986 ). As interest in and concern about the vaccine grew, the Board of Health of Boston decided to perform one of the fi rst controlled clinical trials in U.S. history, which eventually demonstrated effectiveness of the vaccine (Kass 1986 ). A century later, Massachusetts had established vaccination campaigns, but smallpox persisted: One hundred cases were reported in Massachusetts in 1900 with 2314 cases by 1902 (Parmet et al. 2005 ). The Board of Health had originally promoted a voluntary vac- cination scheme until January 1902 when two children , one in Boston, died of post- vaccination complications within a month of each other (Willrich 2011 ). After voluntary efforts stalled, the Board ordered mandatory vaccination in February, but did not enforce the order. After an outbreak sent another 50 adults and children to the hospital and caused seven deaths, the Board voted that the regulations needed to be enforced (Willrich 2011 ). Local public health offi cials employed creative ways to follow enforcement orders, “many of which were scientifi cally sound but not all of which were apt to inspire public trust ” (Parmet et al. 2005 , 653). The Boston Herald, for example, reported in March 1902 that public health doctors and guards forcibly vaccinated “Italians, negroes and other employees” (Parmet et al. 2005 , 653). Despite the suc- cess of the smallpox vaccine in curtailing disease, anti-vaccinationists described compulsory vaccination as “the greatest crime of the age” and as “more important than the slavery question, because it is debilitating the whole human race” (Washington Post 1905 ; Gostin 2008 , 122). Pro-vaccinationists were as polarizing, describing the debate as “a confl ict between intelligence and ignorance, civilization and barbarism” (New York Times 1885 ; Gostin 2008 , 122). 2.2.2 Case Description It was in this context that the U.S. Supreme Court heard Jacobson v. Massachusetts , which despite, and perhaps because of, the vastly different ways it has been inter- preted and applied since then, is arguably the most important legal public health case ever decided in the United States (Gostin 2005 ). Under the doctrine of “police L.M. Lee et al. 41 power,” it had already been established in the late 1800s that states had the authority to enforce “sanitary laws , laws for the protection of life, liberty , health or property within its limits [and] laws to prevent persons and animals suffering under conta- gious or infectious diseases …” within their own boundaries (R. R. Co. v. Husen 1877 , 465, 472). In 1885, the Supreme Court confi rmed that this included ensuring conditions essential to the “ safety , health, peace, good order and morals of the com- munity” as “even liberty itself… is only freedom from restraint under conditions essential to the equal enjoyment of the same right by others” (Crowley v. Christensen 1890 , 86, 89). In 1902, in response to the increase in smallpox cases discussed above, the Cambridge, Massachusetts Board of Health issued an order, which became law , requiring citizens be vaccinated against smallpox or pay a $5 fi ne (the equivalent of about $135 in 2015) (Massachusetts Revised Laws 1902 ; Commonwealth v. Henning Jacobson 1903 ; Mariner et al. 2005 ). Henning Jacobson , a Cambridge minister, refused both the vaccination and to pay the fi ne. He argued he had previ- ously received the smallpox vaccination in Sweden as a child and had experienced “great and extreme suffering, for a long period” as a result and that one of his sons had experienced adverse events from vaccination as well (Commonwealth v. Henning Jacobson 1903 , 246). Jacobson argued that the law was thus “hostile to the inherent right of every freeman to care for his own body and health in such way as to him seems best .” (Jacobson v. Massachusetts 1905 , 26) . The case went to trial. At trial, Jacobson argued that his history of adverse reaction to the smallpox vac- cine should grant him an exception from the law . However, the law did not actually provide for such exceptions for adults (as it did for children ). Jacobson was found guilty of “the crime of refusing vaccination ” (Willrich 2011 , 285). He appealed to the superior court, where the judge again ruled that Jacobson’s medical history was “immaterial” to his legal violation. The judge also refused Jacobson’s plea to tell the jury that the law was a violation of the constitutions of Massachusetts and the United States because it offered no such exception. The court again found Jacobson guilty (Willrich 2011 ) . Jacobson fared no better in the Massachusetts Supreme Court. It too rejected Jacobson’s evidence of his prior adverse experience with the vaccination as well as his son’s as “matters depending upon his personal opinion, which could not be taken as correct, or given effect, merely because he made it a ground of refusal to comply with the requirement” (Commonwealth v. Henning Jacobson 1903 , 246). Moreover, it pointed out that even if Jacobson could prove that he would suffer adverse effects from the vaccine , the statute did not offer an exception for such a case. In response to Jacobson’s argument that this defi ciency rendered the statute unconstitutional, the court responded that the “theoretical possibility of an injury in an individual case as a result of its enforcement does not show that as a whole it is unreasonable. The application of a good law to an exceptional case may work hardship” (Commonwealth v. Henning Jacobson 1903 , 247). However, the Massachusetts court held that if citi- zens refused to be vaccinated it was not within the power of public health authorities to vaccinate them by force (as the Boston Herald had reported occurring) (Commonwealth v. Henning Jacobson 1903 ; Parmet et al. 2005 ) . 2 Essential Cases in the Development of Public Health Ethics 42 When the Jacobson case fi nally made its way to the U.S. Supreme Court, the Court found that the vaccination statute was generally a reasonable protection of the public health while maintaining individual liberty . The Supreme Court did conclude that to subject someone to vaccination who was unfi t because of a health condition “would be cruel and inhuman in the last degree;” it stipulated that “we are not inclined to hold that the statute establishes the absolute rule that an adult must be vaccinated if it be apparent or can be shown with reasonable certainty that he is not at the time a fi t subject of vaccination or that vaccination, by reason of his then condition, would seriously impair his health or probably cause his death” (Jacobson v. Massachusetts 1905 , 38–39) . However, the Court found that Jacobson was “in perfect health and a fi t subject of vaccination” and that he simply “refused to obey the statute and the regulation adopted in execution of its provisions for the protec- tion of the public health and the public safety , confessedly endangered by the pres- ence of a dangerous disease” (Jacobson v. Massachusetts 1905 , 39) . The Court ordered Jacobson to submit to vaccination or pay the fi ne (Jacobson v. Massachusetts 1905 ). Three years after his legal fi ght began, Jacobson paid the $5 penalty (Willrich 2011 ). 2.2.3 Discussion Legal cases since 1890 had allowed states to require citizens be vaccinated, but around the turn of the century, limits to that right began appearing that included a “present danger” standard requiring a real and immediate threat and adherence to the harm avoidance principle protecting citizens from undue burden as much as pos- sible (Willrich 2011 ). Jacobson has endured as a fundamental philosophical foun- dation of the reconciliation of individual interests with those of the public’s health in a political system emphasizing liberal individualism . Despite the limitations of the facts in Jacobson , it has been interpreted in many ways to support numerous public health activities over the past century. Notably, the Supreme Court did not require that otherwise healthy citizens submit to vaccination , only that it was constitutional to require citizens to be vaccinated or pay a fi ne. Also, while the Court found that a lack of a health exception to the vaccination mandate would be unconstitutional, it did not grant Jacobson this exception for himself. However, as with so many examples in the lexicon of medical ethics, one of the most important practical effects of historical cases is how they have been interpreted and applied to future circumstances. Part of Jacobson ’ s legacy has been the Court’s “community oriented philosophy” based in social-contract (or compact) theory (Gostin 2005 , 578): “a fundamental principle of the social compact [is] that the whole people covenants with each citizen, and each citizen with the whole people, that all shall be governed by certain laws for ‘the common good ….’” (Jacobson v. Massachusetts 1905 , 26) . While the Court recognized individual liberty interests protected by the Constitution, it found that these interests did not impart an absolute right of freedom from restraint because “on any other basis organized society could L.M. Lee et al. 43 not exist with safety to its members” (Jacobson v. Massachusetts 1905 , 26) . It noted that no citizen could enjoy full liberty in a society that recognized “the right of each individual person to use his own [liberty] … regardless of the injury that may be done to others” (Jacobson v. Massachusetts 1905 , 26). The Court also found that reasonable regulations to protect the public health and safety were among these constitutional limits on liberty (Jacobson v. Massachusetts 1905 ). Despite the fact that Jacobson found mandatory vaccination distressing and objectionable, it was the responsibility of the city board of health to “not permit the interests of the many to be subordinated to the wishes or convenience of the few” (Jacobson v. Massachusetts 1905 , 29) . As discussed above, the Court found that exceptions were needed for citizens with established concerns for their health—but did not apply this exception in Jacobson’s case. The social contract implied in this case also needed to be reconciled with limits on government and constitutional protections of individual liberty . While the Court had already established a standard of fair application of public health interventions (e.g., not targeting a specifi c race-based group) (Jew Ho v. Williamson 1900 ; Gostin 2008 ), Jacobson built on several cases to further explain standards of constitutional protections (i.e., there must be a public health threat to the community, and the state or board of health must design the public health intervention to combat that threat). The Court found that the intervention must be proportionately tailored to that threat creating a “reasonable balance … between the public good and the degree of per- sonal invasion ” and should not harm citizens in and of itself (Gostin 2008 , 126–127). While it is hard to reconcile some of the facts of Jacobson with its lofty consti- tutional deliberation, it is the Court’s desire to reconcile individual interests with those of the public health in a society that values liberal individualism that has become its enduring legacy. Many court decisions following Jacobson reaffi rmed states’ use of police power for the public health (Gostin 2005 ), and in 1922 the Supreme Court agreed that states could require vaccinations for children who attend school (Zucht v. King 1922 ). Jacobson was an important step in the lengthy public health battle against smallpox, culminating in its eradication in 1977 (Cohen 2000 ). The legal and ethical boundaries between the individual and public health remain mobile in public health law and policy despite the Jacobson decision. Notwithstanding its rejection of forced vaccination, coercion—as opposed to the modern emphasis on education—continued as a public health tactic, employed fre- quently and often directed toward vulnerable citizens (e.g., quarantined sex work- ers during World War I) (Colgrove and Bayer 2005 ). And despite the liberty protections it carved out, the Court itself struggled with upholding both individual rights and constitutional liberties. In 1927, citing Jacobson , the Court upheld a forced-sterilization law in Virginia of “mental defectives.” The Buck v. Bell deci- sion reasoned that “[i]t is better for all the world, if instead of waiting to execute degenerate offspring for crime, or to let them starve for their imbecility, society can prevent those who are manifestly unfi t from continuing their kind. The principle that sustains compulsory vaccination is broad enough to cover cutting the fallopian tubes” (Buck v. Bell 1927 , 207). 2 Essential Cases in the Development of Public Health Ethics 44 In more communitarian-leaning societies, Jacobson ’ s value serves less as a map for navigating public good in an individualist context, and more as an illustration of how individual and community interests can be balanced within the political and social structure. Even within the United States , however, Jacobson has been inter- preted over the decades to be a foundation for diverse legal opinions supporting remarkable expansions of federal power —including warrantless entry into homes in time-sensitive circumstances of compelling need and a defense of the federal govern- ment’s right to detain U.S. citizens without due process as “enemy combatants” (in a dissenting opinion) (Willrich 2011 ). Many of these cases, and certainly Buck v. Bell serve as a stark reminder that federal powers ostensibly in the public interest cannot be used solely to maximize perceived public benefi t—they must be tempered by jus- tice and fairness to both communities and individuals (Lombardo 2008 ). But as the legal community continued to struggle with what the implications and contours of what Jacobson should be in the United States , offi cials continued to press on in what was then an unregulated fi eld—that of public health research . 2.3 Case Study: U.S. Public Health Service Research on Sexually Transmitted Disease: Alabama and Guatemala Since the 1940s, contemporary research ethics has developed rapidly through a desire to protect human participants in research. Internationally, the Nuremberg Trials for Nazi war criminals, including the trial of Nazi physicians who conducted torturous medical experiments on subjects, resulted in the Nuremberg Code ( 1947 ), a compilation of guidelines for conducting research with human participants. In 1964, the World Medical Association’s (WMA) Declaration of Helsinki further refi ned ethical guidance for research with humans, and in particular the participa- tion of vulnerable populations (WMA 1964 ). The next case study focuses on two separate mid-century U.S. PHS experiments on sexually transmitted diseases in the U.S. state of Alabama and Guatemala . While one of the ten essential public health services is to “conduct research to attain new insights and innovative solutions to health problems” (CDC 2013b ; Harrell et al. 1994 , 29), these experiments demonstrate how an imbalance of population and indi- vidual interests—coupled with disregard for respect for persons—can lead to tragic results. 2.3.1 Background In the early 1900s, STDs—and syphilis in particular—were major concerns for public health. Conservative estimates suggested that syphilis affected 10–15 % of the U.S. population (Jabbour 2000 ) with symptoms ranging from sores to paralysis, L.M. Lee et al. 45 blindness, and death (CDC 2013a ). One leading expert at the time described syphi- lis as a plague “which, in these times of public enlightenment, is still shrouded in obscurity, entrenched behind a barrier of silence, and armed, by our own ignorance and false shame, with a thousand times its actual power to destroy…” (Stokes 1920 , 7). In 1905, German scientists isolated the microbe that caused syphilis, and in 1910 other scientists proposed salvarsan (a preparation of arsenic) as the cure (Jones 1993 ). Salvarsan treatment involved a painful set of injections over a long period and ultimately turned out to be highly toxic (Jones 1993 ). In 1912, the U.S. government established PHS to join other federal public health efforts to improve administration and distribution of public health aid to the states, to oversee interstate infectious diseases and sanitation , and to conduct public health research (Jones 1993 ). In 1918, PHS established a Division of Venereal Disease to organize and support state prophylactic and treatment work (Jones 1993 ). World War I had highlighted the harmful effect of STDs on the U.S. armed forces, but after interest in the disease from a wartime perspective abated, public health workers focused on syphilis as a poverty-linked disease—and a disease that reportedly affected African Americans in particular. Some physicians even argued that syphilis was a “quintessential black disease” and African Americans a “notoriously syphilis- soaked race” (Jones 1993 , 24, 27). Funding for and interest in preventing and treating STDs waned during peace- time, though they remained a public health problem. With World War II on the horizon, the director of the PHS Venereal Disease Research Laboratory argued that “[t]he prevention of the primary invasion of the male by the syphilis spirochete, as a means of minimizing the loss of effectiveness which is incident to established disease, still constitutes one of the most pressing problems of military medicine” (Mahoney 1936 , 78–79). When the United States became involved in World War II, public health offi cials once again became concerned about STD rates in American troops and predicted “approximately 350,000 fresh infections with gonorrhea [in the armed forces], [which] will account for 7,000,000 lost man days per year, the equivalent of putting out of action for a full year the entire strength of two full armored divisions or of ten aircraft carriers” (Presidential Commission for the Study of Bioethical Issues [PCSBI] 2011 , 12). The cost of treating the anticipated infections was $34 million (about $465 million in 2015, adjusted for infl ation) (PCSBI 2011 , 12) . 2.3.2 Case Description In search of a more effective treatment for syphilis, U.S. PHS researchers in the 1930s had turned to African-American communities for public health research in part because of the perception of high rates of infection, as discussed above. PHS surveyed six southern counties and found the highest syphilis rates among black men in Macon County, Alabama, where the city of Tuskegee serves as the county seat. Created in part by a confl uence of economic, social, and clinical 2 Essential Cases in the Development of Public Health Ethics 46 factors—including the Great Depression, lack of public and private funds for con- tinuation of development projects, pervasive racism in American medicine, and failed attempts in the pre-penicillin era to treat syphilis with heavy metals—public health researchers decided to conduct a study to observe the “natural progression” of untreated syphilis (Brandt 1978 ; U.S. Department of Health, Education, and Welfare [HEW] 1973 ). The Tuskegee syphilis study or, more accurately, the U.S. Public Health Service Study of Untreated Syphilis in the Male Negro , Macon County , Alabama , was an observational study of 399 men with syphilis, and 201 men without, conducted from 1932 through 1972. After 40 years, it fi nally ended when a PHS STD investigator, Peter Buxton, went to the press with allegations of gross ethical violations, includ- ing a lack of informed consent for participation , deception, withholding treatment , as well as racism and lack of scientifi c soundness (Jones 1993 ; Brandt 1978 ). During this study, public health researchers posed as physicians and told the men, who were already infected with syphilis , that they were going to treat them for “bad blood” (which, in common vernacular referred to a range of chronic conditions of unknown origin that could have included anything from syphilis to anemia). In reality, the researchers were not treating the subjects for any of these diseases. While during the salvarsan-era, nontreatment would not necessarily have made a large difference clinically , once the Venereal Disease Research Laboratory estab- lished that penicillin was a safe, effective, and inexpensive cure for syphilis in 1943, the profound clinical detriment of being a study participant became clear. After 1943, the researchers actively kept subjects from receiving penicillin for other ail- ments so as not to interfere with their ability to analyze the primary outcome of interest, which was the natural progression of untreated syphilis (CDC 2013c ). Throughout the study, the public health researchers practiced active deceit result- ing in 399 infected men being kept from penicillin treatment until their death or 1972 when the study was stopped. The Assistant Secretary for Health and Scientifi c Affairs, under the then U.S. Department of Health, Education, and Welfare, char- tered an advisory panel to investigate the circumstances surrounding the study. The panel later issued the Final Report of the Tuskegee Study Ad Hoc Advisory Panel in April 1973 (HEW 1973 ). Meanwhile, the experience of soldiers during World War II had confi rmed the need for improved diagnosis and treatment of STDs. After the war, these efforts were revitalized by animal studies that demonstrated the effectiveness of a new post-exposure prophylaxis called “orvus-mapharsen.” PHS was interested in whether this solution would be effective in humans, and it was believed that establishing effi cacy in humans required controlled intentional exposure in humans—preferably via the “natural method” of sexual intercourse. Because, in part, commercial sex work was legal in the prison in Guatemala City, Guatemala, the researchers planned to conduct prophylaxis experiments there. The plan was to intentionally expose prisoners to STDs through sexual intercourse with commercial sex workers carrying infection (PCSBI 2011 ). As a result, from 1946 through 1948, the U.S. government funded, via a federal grant from the National Institutes of Health and approved by the highest echelons of L.M. Lee et al. 47 PHS (including Surgeon General Thomas Parran) , STD, serological, and inocula- tion experiments in Guatemala (Spector-Bagdady and Lombardo 2013 ). The researchers, led on the ground by a senior surgeon in the PHS, John C. Cutler , soon discovered that they could not reliably infect prison subjects with STDs through sexual intercourse with commercial sex workers ; the researchers were thus unable to compare the effectiveness of the prophylaxis regimen they were testing. In an effort to increase infection rates, researchers expanded to other vulnerable popula- tions , such as soldiers and psychiatric patients, and engaged in more invasive meth- ods of intentional exposure, such as abrasion of genitals and manually applying syphilitic emulsion—despite objections of their PHS supervisors that the latter methods of inoculation were scientifi cally unsound (PCSBI 2011 ). By the end of these experiments, considered by some at the time to be “ethically impossible” in design (Kaempffert 1947 ), public health researchers intentionally exposed approximately 1300 Guatemalan prisoners , soldiers, commercial sex work- ers , and psychiatric patients to syphilis , gonorrhea, and/or chancroid without informed consent . The researchers documented some form of treatment for only half of the subjects they exposed to infection (PCSBI 2011 ). The Guatemala STD experiments ended in 1948 when the researchers decided not to apply for a continuation of funding due to concerns about reporting project activities to the approving study section and the new surgeon general in the United States (PCSBI 2011 ) . The Guatemala STD experiments remained undiscovered for nearly 65 years until Cutler’s papers , uncovered in 2003, were brought to the atten- tion of the U.S. government and presented at a professional meeting in 2010 (PCSBI 2011 ; Reverby 2011 ). Upon learning of the experiments, President Barack Obama requested that his Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) conduct a historical review and ethical analysis of the stud- ies in Guatemala. The Bioethics Commission concluded its analyses and reported its results to President Obama in September 2011 (PCSBI 2011 ). 2.3.3 Discussion The U.S. PHS Study of Untreated Syphilis in the Negro Male unmasked a range of important ethical issues that fi t into three fi elds of bioethics we now call profes- sional ethics, public health ethics, and research ethics . Through the lens of profes- sional ethics, the untreated syphilis study calls into question what it means to be an ethical scientist, an ethical physician, and an ethical government steward of public trust . Through the public health ethics lens, it raises issues of imposing the risk of harm to individuals to benefi t the community, appropriate engagement with the affected community, and justice and fairness . Far and away, however, the untreated syphilis study in Tuskegee had the most substantial impact on research ethics . It was not the fi rst study to egregiously disrespect personal autonomy and grossly exploit vulnerable populations . Indeed, by 1966, Henry Beecher had outlined 22 such studies in clinical research, some 2 Essential Cases in the Development of Public Health Ethics 48 involving children , mentally and physically compromised patients, and incarcerated individuals (Beecher 1966 ). Nor was it the fi rst instance of African Americans being mistreated by the medical establishment (Gamble 1997 ), but it was the fi rst unethi- cal study of this magnitude scandalously exposed by the mainstream media involv- ing and funded by the U.S. federal government. While the original intent of the untreated syphilis study in Tuskegee was to contribute to the greater and seemingly more urgent social good, it has been remembered for withholding treatment from a socially and politically vulnerable group by actively deceiving them. Comprehensive scholarship has examined the legacy of the untreated syphilis study. Its impact is as deep as it is broad in the bioethics community and the social culture of the United States . This case study examines only the policy outcomes that resulted from the ethical review and analysis of the untreated syphilis study, which is but a small slice of its legacy, yet one that has profoundly shaped the way clinical and public health research is conducted in the United States. The Tuskegee Study Ad Hoc Advisory Panel (Advisory Panel) submitted its fi nal report to then Assistant Secretary for Health, Charles C. Edwards, in April 1973 (HEW 1973 ). The Advisory Panel found that the study was ethically unjustifi ed in 1932 due to the lack of evidence that any consent was obtained from participants, breaking “… one fundamental ethical rule…that a person should not be subjected to avoidable risk of death or physical harm unless he freely and intelligently consents” (HEW 1973 , 7). Also, the lack of a study protocol or plan left the study’s scientifi c soundness highly suspect, especially in light of the “disproportionately meager” scientifi c data it produced (HEW 1973 , 8). Besides the lack of informed consent , other important ethical violations noted by the Advisory Panel included researchers lying and withholding penicillin even after it was established to be effective as a treatment for syphilis. The insults to basic dignity and respect for persons forced on the men in the study convinced the Advisory Panel to recommend a permanent body to regulate all federally supported research involving human participants. This permanent body was to formulate poli- cies for establishing institutional review boards (IRBs) , compensating research par- ticipants who suffer research-related injury, and reviewing protocols at local institutions before beginning research studies . It also called for creating local sub- ject advisory groups to monitor consent procedures (HEW 1973 ). While the U.S. Department of Health, Education, and Welfare (now the U.S. Department of Health and Human Services ) had guidelines for research grants and contracts, the Advisory Panel recommended “… that serious consideration should be given to developing, through Congressional action, rules and procedures which apply to the entire human research enterprise without reference to the source of funding” (HEW 1973 , 37). The Advisory Panel report paved the way for creation of the fi rst congressionally formed national bioethics committee : the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission) . As a direct consequence of the ethical investigation into the untreated syphilis study, and acknowledgment that this was not an isolated incident, the National Commission began work in 1974 developing national guidelines for research involving human participants. L.M. Lee et al. 49 The National Commission’s most cited work, the Belmont Report , outlined three ethical principles for research still in use today: respect for persons , benefi cence , and justice (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1979 ) . It also provided guidance on informed consent , special rules for vulnerable populations , and requirements for review of protocols by IRBs . These recommendations, later codifi ed into federal regulations that govern federally funded research with human participants, continue to infl u- ence human research today—helping ensure the respectful and ethical treatment of participants in biomedical and public health research (U.S. Department of Health and Human Services 2009 ). A more subtle, but enduring impact of the National Commission’s efforts spe- cifi c to public health research was its focus on engaging the community in which research is to be conducted. Although only anecdotally reported, a lack of trust in government , health care, and research is widely believed to be a lasting consequence of the untreated syphilis study (Gamble 1993 ; Swanson and Ward 1995 ). Empirical data suggest, however, that the untreated syphilis study itself did not deter participa- tion (Katz et al. 2008 ), but rather a lack of trust stemming from a larger social legacy of racism and fears of exploitation originating in the era of slavery in the United States (Gamble 1993 ). In recent times, these fears resurfaced at the onset of the AIDS epidemic in the 1980s in the form of suspicion of intentional infection and genocide (Jones 1993 ). This mistrust resulted in the distribution of misinformation and diffi culties in delivering education and care for those at high risk for HIV (Thomas and Quinn 1991 ). Since then, methods and best practices for community engagement have been developed and published both in the United States (Barnett 2012 ; U.S. Department of Health and Human Services 2011 ) and internationally (World Health Organization [WHO] 2012 ; UNAIDS 2011 ). When analyzing the effect of the Guatemala STD experiments on public health ethics, it is important to note that while the experiments took place in the 1940s, they were critically investigated only recently—65 years after their occurrence. Despite the stark contrast of today’s regulated research context with research con- ducted in the 1940s, scholars continue to examine the original research documents, and our ability to learn from past errors continues. That the U.S. government, at least, had learned lessons from the Tuskegee study is evident by the swiftness of its response to the discovery of the Guatemala STD experiments. While it took 25 years for a U.S. president to apologize to the Tuskegee syphilis study participants, fami- lies, and community (The White House 1997 ), President Barack Obama called President Alvaro Colom of Guatemala to apologize for the STD research immedi- ately following the announcement of its discovery to the public in 2010. The PHS research studies in Tuskegee and Guatemala demonstrate the serious consequences that can result when the relative interests of the individual and the population are inappropriately reconciled. Indeed, these abuses of individual research subjects have created an enduring legacy of cautionary tales that, together with an orientation toward liberal individualism , have provided a lasting and powerful check on public health authority in the United States . Major policy changes were put into practice after the discovery of the syphilis studies in Alabama . 2 Essential Cases in the Development of Public Health Ethics 50 These policies were intended to protect research participants from being treated as mere means to an end, to bring back into equilibrium the individual and population interests that public health must reconcile. Still, public health interventions continue to face resistance to actions perceived to limit individual choice—making substan- tive engagement of the relevant community even more critical for turn-of-the-cen- tury public health campaigns. The case that follows describing the New York City A1C Registry highlights how, even after all of the regulatory and ethical work accomplished over the past four decades, innovative approaches to public health advances interpreted to curtail some individual liberty can still inspire debate about the optimal role of government in promoting public health. 2.4 Case Study: The New York City A1C Registry Public health increasingly has focused on secondary prevention , or the prevention of disability from disease. As the burden of disease in the United States has shifted from communicable diseases like smallpox and STDs to noncommunicable diseases , public health professionals face new ethical challenges related to monitoring chronic conditions and inspiring individuals to improve their health. The following case illustrates how new technologies affect public health interventions and can limit the precedent set by Jacobson when health risks are neither communicable nor imminent. Such cases call for a recalibration of population and individual interests when considering dramatically different health and social settings. 2.4.1 Background Although infectious diseases accounted for more than 80 % of deaths in the United States in the 1900s (Steinbrook 2006 ), in 2011, WHO estimated that noncommuni- cable diseases were responsible for 66 % of deaths worldwide (WHO 2013 ). These changes in the causes of morbidity and mortality are typical of an “epidemiologic transition,” a population health phenomenon that occurs when populations carry out public health measures such as sanitation and immunization, which decrease death rates from infectious diseases , increase life expectancy, and simultaneously begin to increase risk for noncommunicable conditions (McKeown 2009 ). Of noncommunicable disease deaths worldwide in 2008, deaths from diabetes alone accounted for 1.3 million (WHO 2011 ). In the United States , 8.3 % of the population (about 25.8 million people) had diabetes in 2011 (CDC 2011 ) . Because of the signifi cant impact that noncommunicable diseases , such as diabetes, have on health systems, WHO has promoted lifestyle modifi cations and other public health interventions (WHO 2011 ). Several interventions, such as providing advice about physical activity and a healthy diet to people with impaired glucose tolerance, have lowered rates of diabe- L.M. Lee et al. 51 tes (Dornhorst and Merrin 1994 ; Ramachandran et al. 2006 ). Research also has shown that controlling blood sugar levels (measured by A1C levels), blood pres- sure, and LDL cholesterol can reduce the risk of long-term complications and death among people with diabetes (Chamany et al. 2009 ). Some evidence suggests improvements from educating patients in diabetes management, but more evidence is needed (Chamany et al. 2009 ). Although there are effective ways of controlling risk factors for complications once diabetes is diagnosed, management of these risk factors across the United States has been deemed inadequate (Chamany et al. 2009 ). In New York City the percentage of adults who reported having diabetes more than doubled from 3.7 % in 1994 to 9.2 % in 2004 (Chamany et al. 2009 ). A 2005 report of the New York City Department of Health and Mental Hygiene (NCY DOHMH) showed that diabetes prevalence was higher among non-white residents (NCY DOHMH 2007 ; NCY DOHMH 2006a ). In 2004, NCY DOHMH found that diabetes was the fourth lead- ing cause of death in the city’s population (NCY DOHMH 2004 ), and a survey of New York City adults in 2004 showed that fewer than 10 % of those with diabetes were able to manage blood sugar, blood pressure, and cholesterol satisfactorily according to city public health standards (Chamany et al. 2009 ). In New York City, 37 % of diabetes patients on state and federally funded Medicaid had an A1C level (refl ecting average blood sugar) greater than 9 %—which suggests poor glycemic control (Barnes et al. 2007 ). WHO has found that policies that promote manage- ment of these risk factors have potential to reduce spending for individuals and the public (WHO 2011 ). 2.4.2 Case Description In December 2005, the NCY DOHMH submitted a proposal to the New York City Board of Health that would require laboratories with electronic reporting capabili- ties to submit A1C test results for New York City residents to the NCY DOHMH (NCY DOHMH 2005a ). After a period for public comment, the New York City Board of Health approved this proposal, creating the fi rst U.S. program requiring public health reporting of A1C results. Supported by evidence from the success of other disease control programs (such as programs targeting lead poisoning and tuberculosis ), this program established a public health surveillance system to track diabetes in the population and to support those who could benefi t from diabetes control (Chamany et al. 2009 ). The mandate required applicable laboratories to submit A1C test results to the NCY DOHMH within 24 h of completion. Data to be reported included date of the test; name of the testing facility; name and address of the ordering facility or provider; and name, address, and date of birth of the individual tested (Chamany et al. 2009 ). The NCY DOHMH proposed to use the reported A1C results to gener- ate a registry to monitor glycemic control in the New York City population and to provide mechanisms to support patients and physicians in controlling diabetes 2 Essential Cases in the Development of Public Health Ethics 52 (NCY DOHMH 2005a ). The data in the registry were analyzed by various factors including age, location, and type of health care facility to determine distinctions in testing patterns, health care usage, and glycemic control. However, race and ethnic- ity data were not reported and therefore not included in the longitudinal analysis (Chamany et al. 2009 ). After the A1C test results reached the NCY DOHMH, if the average blood sugar level exceeded a predetermined threshold, the patient and provider were notifi ed. Providers were mailed a roster of their patients ordered from highest to lowest A1C level, listing the patients’ two most recent test results calling special attention to A1C levels greater than 9 % (NCY DOHMH 2006b ). Patients at least 18 years of age with an A1C level greater than 9 % or who were overdue for testing also received a letter informing them of their test results, advising them on how to control their A1C level, and specifi cally recommending a follow-up appointment with their pro- vider. The letter was printed in English and Spanish (NCY DOHMH 2005a ). The goals of the provider and patient notifi cation program were to increase pro- viders’ knowledge about glycemic control in their patient population , facilitate pro- viders in assisting and guiding patients at high risk for complications, and inform and aid patients at high risk for devastating sequelae (NCY DOHMH 2012 ). While patients had the

View the publication